Revisiting Antipsychotic-induced Akathisia: Current Issues and Prospective Challenges

PubMed Central

Salem, Haitham; Nagpal, Caesa; Pigott, Teresa; Teixeira, Antonio Lucio

2017-01-01

Background: Akathisia continues to be a significant challenge in current neurological and psychiatric practice. Prompt and accurate detection is often difficult and there is a lack of consensus concerning the neurobiological basis of akathisia. No definitive treatment has been established for akathisia despite numerous preclinical and clinical studies. Method: We reviewed antipsychotic-induced akathisia including its clinical presentation, proposed underlying pathophysiology, current and under investigation therapeutic strategies. Conclusion: Despite the initial promise that second generation antipsychotics would be devoid of akathisia effects, this has not been confirmed. Currently, there are limited therapeutic options for the clinical practice and the evidence supporting the most widely used treatments (beta blockers, anticholinergic drugs) is still absent or inconsistent. PMID:27928948

Bimodal Programming: A Survey of Current Clinical Practice.

PubMed

Siburt, Hannah W; Holmes, Alice E

2015-06-01

The purpose of this study was to determine the current clinical practice in approaches to bimodal programming in the United States. To be specific, if clinicians are recommending bimodal stimulation, who programs the hearing aid in the bimodal condition, and what method is used for programming the hearing aid? An 11-question online survey was created and sent via email to a comprehensive list of cochlear implant programming centers in the United States. The survey was sent to 360 recipients. Respondents in this study represented a diverse group of clinical settings (response rate: 26%). Results indicate little agreement about who programs the hearing aids, when they are programmed, and how they are programmed in the bimodal condition. Analysis of small versus large implant centers indicated small centers are less likely to add a device to the contralateral ear. Although a growing number of cochlear implant recipients choose to wear a hearing aid on the contralateral ear, there is inconsistency in the current clinical approach to bimodal programming. These survey results provide evidence of large variability in the current bimodal programming practices and indicate a need for more structured clinical recommendations and programming approaches.

Volumetric modulated arc therapy: a review of current literature and clinical use in practice

PubMed Central

Teoh, M; Clark, C H; Wood, K; Whitaker, S; Nisbet, A

2011-01-01

Volumetric modulated arc therapy (VMAT) is a novel radiation technique, which can achieve highly conformal dose distributions with improved target volume coverage and sparing of normal tissues compared with conventional radiotherapy techniques. VMAT also has the potential to offer additional advantages, such as reduced treatment delivery time compared with conventional static field intensity modulated radiotherapy (IMRT). The clinical worldwide use of VMAT is increasing significantly. Currently the majority of published data on VMAT are limited to planning and feasibility studies, although there is emerging clinical outcome data in several tumour sites. This article aims to discuss the current use of VMAT techniques in practice and review the available data from planning and clinical outcome studies in various tumour sites including prostate, pelvis (lower gastrointestinal, gynaecological), head and neck, thoracic, central nervous system, breast and other tumour sites. PMID:22011829

[Clinical Tests Testing New Therapies for Stargardt Disease].

PubMed

Kousal, B; Ďuďáková, Ľ; Hlavatá, L; Lišková, P

2016-02-01

To provide information on currently ongoing clinical trials for Stargardt disease. We have searched the clinical trial register (www.clinicaltrials.gov) for the keyword "Stargardt" and list active ongoing studies. There are currently eight registered clinical trials enrolling patients with Stargardt disease; all in phase I or II aiming at four mechanisms of action: inhibition of the production of vitamin A toxic dimers, gene therapy restoring wild type transcription of the ABCA4 gene, neuroprotection preventing retinal cells from oxidative damage, and replacement of the damaged retinal pigment epithelium using stem cell therapy. The basic prerequisite for enrolment in the vast majority of clinical trials is confirmation of the clinical diagnosis by mutational analysis. The wide variety of therapies that are registered as clinical trials for Stargardt disease significantly raises the possibility that effective treatments will be available in the near future for this currently incurable condition and that molecular genetic testing should be increasingly considered. Stargardt disease, clinical trial, ABCA4, mutation.

77 FR 31027 - Submission for OMB Review; Comment Request; Web-Based Assessment of the Clinical Studies Support...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-24

...; Comment Request; Web-Based Assessment of the Clinical Studies Support Center (CSSC) Summary: Under the... current valid OMB control number. Proposed Collection: Title: Web-Based Assessment of the Clinical Studies... Operations and Procedures (MOP); coordinating meeting space and logistics for in-person meetings, Web...

Reversible Nerve Conduction Block Using Kilohertz Frequency Alternating Current

PubMed Central

Kilgore, Kevin L.; Bhadra, Niloy

2013-01-01

Objectives The features and clinical applications of balanced-charge kilohertz frequency alternating currents (KHFAC) are reviewed. Preclinical studies of KHFAC block have demonstrated that it can produce an extremely rapid and reversible block of nerve conduction. Recent systematic analysis and experimentation utilizing KHFAC block has resulted in a significant increase in interest in KHFAC block, both scientifically and clinically. Materials and Methods We review the history and characteristics of KHFAC block, the methods used to investigate this type of block, the experimental evaluation of block, and the electrical parameters and electrode designs needed to achieve successful block. We then analyze the existing clinical applications of high frequency currents, comparing the early results with the known features of KHFAC block. Results Although many features of KHFAC block have been characterized, there is still much that is unknown regarding the response of neural structures to rapidly fluctuating electrical fields. The clinical reports to date do not provide sufficient information to properly evaluate the mechanisms that result in successful or unsuccessful treatment. Conclusions KHFAC nerve block has significant potential as a means of controlling nerve activity for the purpose of treating disease. However, early clinical studies in the use of high frequency currents for the treatment of pain have not been designed to elucidate mechanisms or allow direct comparisons to preclinical data. We strongly encourage the careful reporting of the parameters utilized in these clinical studies, as well as the development of outcome measures that could illuminate the mechanisms of this modality. PMID:23924075

Tissue Engineering of the Urethra: A Systematic Review and Meta-analysis of Preclinical and Clinical Studies.

PubMed

Versteegden, Luuk R M; de Jonge, Paul K J D; IntHout, Joanna; van Kuppevelt, Toin H; Oosterwijk, Egbert; Feitz, Wout F J; de Vries, Rob B M; Daamen, Willeke F

2017-10-01

Urethra repair by tissue engineering has been extensively studied in laboratory animals and patients, but is not routinely used in clinical practice. To systematically investigate preclinical and clinical evidence of the efficacy of tissue engineering for urethra repair in order to stimulate translation of preclinical studies to the clinic. A systematic search strategy was applied in PubMed and EMBASE. Studies were independently screened for relevance by two reviewers, resulting in 80 preclinical and 23 clinical studies of which 63 and 13 were selected for meta-analysis to assess side effects, functionality, and study completion. Analyses for preclinical and clinical studies were performed separately. Full circumferential and inlay procedures were assessed independently. Evaluated parameters included seeding of cells and type of biomaterial. Meta-analysis revealed that cell seeding significantly reduced the probability of encountering side effects in preclinical studies. Remarkably though, cells were only sparsely used in the clinic (4/23 studies) and showed no significant reduction of side effects. ln 21 out of 23 clinical studies, decellularized templates were used, while in preclinical studies other biomaterials showed promising outcomes as well. No direct comparison to current clinical practice could be made due to the limited number of randomized controlled studies. Due to a lack of controlled (pre)clinical studies, the efficacy of tissue engineering for urethra repair could not be determined. Meta-analysis outcome measures were similar to current treatment options described in literature. Surprisingly, it appeared that favorable preclinical results, that is inclusion of cells, were not translated to the clinic. Improved (pre)clinical study designs may enhance clinical translation. We reviewed all available literature on urethral tissue engineering to assess the efficacy in preclinical and clinical studies. We show that improvements to (pre)clinical study design is required to improve clinical translation of tissue engineering technologies. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Single dose treatment of malaria - current status and perspectives.

PubMed

Mischlinger, Johannes; Agnandji, Selidji T; Ramharter, Michael

2016-07-01

Despite increased international efforts for control and ultimate elimination, malaria remains a major health problem. Currently, artemisinin-based combination therapies are the treatment of choice for uncomplicated malaria exhibiting high efficacy in clinical trial settings in sub-Saharan Africa. However, their administration over a three-day period is associated with important problems of treatment adherence resulting in markedly reduced effectiveness of currently recommended antimalarials under real world settings. Antimalarial drug candidates and antimalarial drug combinations currently under advanced clinical development for the indication as single dose antimalarial therapy. Expert commentary: Several new drug candidates and combinations are currently undergoing pivotal proof-of-concept studies or clinical development programmes. The development of a single dose combination therapy would constitute a breakthrough in the control of malaria. Such an innovative treatment approach would simultaneously close the effectiveness gap of current three-day therapies and revolutionize population based interventions in the context of malaria elimination campaigns.

Molecular markers for urothelial bladder cancer prognosis: toward implementation in clinical practice.

PubMed

van Rhijn, Bas W G; Catto, James W; Goebell, Peter J; Knüchel, Ruth; Shariat, Shahrokh F; van der Poel, Henk G; Sanchez-Carbayo, Marta; Thalmann, George N; Schmitz-Dräger, Bernd J; Kiemeney, Lambertus A

2014-10-01

To summarize the current status of clinicopathological and molecular markers for the prediction of recurrence or progression or both in non-muscle-invasive and survival in muscle-invasive urothelial bladder cancer, to address the reproducibility of pathology and molecular markers, and to provide directions toward implementation of molecular markers in future clinical decision making. Immunohistochemistry, gene signatures, and FGFR3-based molecular grading were used as molecular examples focussing on prognostics and issues related to robustness of pathological and molecular assays. The role of molecular markers to predict recurrence is limited, as clinical variables are currently more important. The prediction of progression and survival using molecular markers holds considerable promise. Despite a plethora of prognostic (clinical and molecular) marker studies, reproducibility of pathology and molecular assays has been understudied, and lack of reproducibility is probably the main reason that individual prediction of disease outcome is currently not reliable. Molecular markers are promising to predict progression and survival, but not recurrence. However, none of these are used in the daily clinical routine because of reproducibility issues. Future studies should focus on reproducibility of marker assessment and consistency of study results by incorporating scoring systems to reduce heterogeneity of reporting. This may ultimately lead to incorporation of molecular markers in clinical practice. Copyright © 2014 Elsevier Inc. All rights reserved.

The effectiveness of a stratified care model for non-specific low back pain in Danish primary care compared to current practice: study protocol of a randomised controlled trial.

PubMed

Morso, Lars; Schiøttz-Christensen, Berit; Søndergaard, Jens; Andersen, Nils-Bo de Vos; Pedersen, Flemming; Olsen, Kim Rose; Jensen, Morten Sall; Hill, Jonathan; Christiansen, David Høyrup

2018-06-08

Prior studies indicate that stratified care for low back pain results in better clinical outcome and reduced costs in healthcare compared to current practice. Stratified care may be associated with clinical benefits for patients with low back pain at a lower cost, but evidence is sparse. Hence this study aims to evaluate the clinical effects and cost-effectiveness of stratified care in patients with non-specific low back pain compared to current practice. The study is a two-armed randomised controlled trial in primary care in the Regions of Southern and Central Denmark (2.5 million citizens). Patients with non-specific low back will be recruited by paticpating GPs. Patients are randomised to either (1) stratified care or (2) current practice at participating physiotherapy clinics. In the stratified care arm, the intervention is based on the patient's STarT Back Tool classification and trained accordingly, whereas physiotherapists in the current pratice arm are blinded to the STarT score. Primary outcomes in the trial will be group differences in time off work, improvement in LBP disability measured by the Roland Morris Disability Questionnaire (RMDQ) and patient-reported global change. Secondary measures will be pain intensity, patient satisfaction, data on patient healthcare resource utilisation and quality-adjusted life year based on the EQ-5D-5L. Stratified care that effectively targets treatment to relevant sub-groups of patients has potentially great impact on the treatment pathways of low back pain. Thus, if effective, this could result in better patient outcomes and at the same time reduce the costs for treatment of low back pain. ClinicalTrials.gov , NCT02612467 . Registered on 16 November 2015.

Current Trends in Nursing Informatics: Results of an International Survey.

PubMed

Peltonen, Laura-Maria; Alhuwail, Dari; Ali, Samira; Badger, Martha K; Eler, Gabrielle Jacklin; Georgsson, Mattias; Islam, Tasneem; Jeon, Eunjoo; Jung, Hyunggu; Kuo, Chiu-Hsiang; Lewis, Adrienne; Pruinelli, Lisiane; Ronquillo, Charlene; Sarmiento, Raymond Francis; Sommer, Janine; Tayaben, Jude L; Topaz, Maxim

2016-01-01

Nursing informatics (NI) can help provide effective and safe healthcare. This study aimed to describe current research trends in NI. In the summer 2015, the IMIA-NI Students Working Group created and distributed an online international survey of the current NI trends. A total of 402 responses were submitted from 44 countries. We identified a top five NI research areas: standardized terminologies, mobile health, clinical decision support, patient safety and big data research. NI research funding was considered to be difficult to acquire by the respondents. Overall, current NI research on education, clinical practice, administration and theory is still scarce, with theory being the least common. Further research is needed to explain the impact of these trends and the needs from clinical practice.

Chamomile (Matricaria recutita) may provide antidepressant activity in anxious, depressed humans: an exploratory study.

PubMed

Amsterdam, Jay D; Shults, Justine; Soeller, Irene; Mao, Jun James; Rockwell, Kenneth; Newberg, Andrew B

2012-01-01

Anxiety and depression are the most commonly reported psychiatric conditions and frequently occur as comorbid disorders. While the advent of conventional drug therapies has simplified treatment, a large segment of the population goes untreated or declines conventional therapy for financial, cultural, or personal reasons. Therefore, the identification of inexpensive and effective alternative therapies for anxiety and depression is of relevance to public health. The current study explores data from a 2009 clinical chamomile trial in humans to determine if chamomile provides clinically meaningful antidepressant activity versus a placebo. In the 2009 randomized, double-blind, placebo-controlled study, the research team examined the antianxiety and antidepressant action of oral chamomile (Matricaria recutita) extract in participants with symptoms of comorbid anxiety and depression. In the 2009 study, all of participants' evaluations took place at the Depression Research Unit at the University of Pennsylvania. The study drew participants from patients at the Department of Family Medicine and Community Health's primary care clinic at the University of Pennsylvania, Philadelphia. Of the 57 participants in the 2009 trial, 19 had anxiety with comorbid depression; 16 had anxiety with a past history of depression; and 22 had anxiety with no current or past depression. The intervention and placebo groups in the 2009 trial received identically appearing 220-mg capsules containing either pharmaceutical-grade chamomile extract standardized to a content of 1.2% apigenin or a placebo (ie, lactose monohydrate NF), respectively. In the current study, the research team used generalized estimating equations analysis to identify clinically meaningful changes over time in scores from the Hamilton Depression Rating (HAM-D) questionnaire among treatment groups. In the current study, the research team observed a significantly greater reduction over time in total HAM-D scores for chamomile vs placebo in all participants (P < .05). The team also observed a clinically meaningful but nonsignificant trend for a greater reduction in total HAM-D scores for chamomile vs placebo in participants with current comorbid depression (P = .062). When the team examined the HAM-D core mood item scores, it observed a significantly greater reduction over time for chamomile vs placebo in all participants (P < .05) and a clinically meaningful but nonsignificant trend for a greater reduction over time for chamomile vs placebo in participants without current or past depression (P = .06). Chamomile may provide clinically meaningful antidepressant activity that occurs in addition to its previously observed anxiolytic activity.

Circulating tumor cells: clinical validity and utility.

PubMed

Cabel, Luc; Proudhon, Charlotte; Gortais, Hugo; Loirat, Delphine; Coussy, Florence; Pierga, Jean-Yves; Bidard, François-Clément

2017-06-01

Circulating tumor cells (CTCs) are rare tumor cells and have been investigated as diagnostic, prognostic and predictive biomarkers in many types of cancer. Although CTCs are not currently used in clinical practice, CTC studies have accumulated a high level of clinical validity, especially in breast, lung, prostate and colorectal cancers. In this review, we present an overview of the current clinical validity of CTCs in metastatic and non-metastatic disease, and the main concepts and studies investigating the clinical utility of CTCs. In particular, this review will focus on breast, lung, colorectal and prostate cancer. Three major topics concerning the clinical utility of CTC are discussed-(1) treatment based on CTCs used as liquid biopsy, (2) treatment based on CTC count or CTC variations, and (3) treatment based on CTC biomarker expression. A summary of published or ongoing phase II and III trials is also presented.

Delivering Communication Strategy Training for People with Aphasia: What Is Current Clinical Practice?

ERIC Educational Resources Information Center

Beckley, Firle; Best, Wendy; Beeke, Suzanne

2017-01-01

Background: Communication strategy training (CST) is a recognized part of UK speech and language therapists' (SLTs) role when working with a person with aphasia. Multiple CST interventions have been published but, to date, there are no published studies exploring clinical practice in this area. Aims: To investigate UK SLTs' current CST practices.…

Transcranial direct current stimulation for depression in Alzheimer's disease: study protocol for a randomized controlled trial.

PubMed

Narita, Zui; Yokoi, Yuma

2017-06-19

Patients with Alzheimer's disease frequently elicit neuropsychiatric symptoms as well as cognitive deficits. Above all, depression is one of the most common neuropsychiatric symptoms in Alzheimer's disease but antidepressant drugs have not shown significant beneficial effects on it. Moreover, electroconvulsive therapy has not ensured its safety for potential severe adverse events although it does show beneficial clinical effect. Transcranial direct current stimulation can be the safe alternative of neuromodulation, which applies weak direct electrical current to the brain. Although transcranial direct current stimulation has plausible evidence for its effect on depression in young adult patients, no study has explored it in older subjects with depression in Alzheimer's disease. Therefore, we present a study protocol designed to evaluate the safety and clinical effect of transcranial direct current stimulation on depression in Alzheimer's disease in subjects aged over 65 years. This is a two-arm, parallel-design, randomized controlled trial, in which patients and assessors will be blinded. Subjects will be randomized to either an active or a sham transcranial direct current stimulation group. Participants in both groups will be evaluated at baseline, immediately, and 2 weeks after the intervention. This study investigates the safety and effect of transcranial direct current stimulation that may bring a significant impact on both depression and cognition in patients with Alzheimer's disease, and may be useful to enhance their quality of life. ClinicalTrials.gov, NCT02351388 . Registered on 27 January 2015. Last updated on 30 May 2016.

Rivaroxaban real-world evidence: Validating safety and effectiveness in clinical practice.

PubMed

Beyer-Westendorf, Jan; Camm, A John; Coleman, Craig I; Tamayo, Sally

2016-09-28

Randomised controlled trials (RCTs) are considered the gold standard of clinical research as they use rigorous methodologies, detailed protocols, pre-specified statistical analyses and well-defined patient cohorts. However, RCTs do not take into account the complexity of real-world clinical decision-making. To tackle this, real-world data are being increasingly used to evaluate the long-term safety and effectiveness of a given therapy in routine clinical practice and in patients who may not be represented in RCTs, addressing key clinical questions that may remain. Real-world evidence plays a substantial role in supporting the use of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) in clinical practice. By providing data on patient profiles and the use of anticoagulation therapies in routine clinical practice, real-world evidence expands the current awareness of NOACs, helping to ensure that clinicians are well-informed on their use to implement patient-tailored clinical decisions. There are various issues with current anticoagulation strategies, including under- or overtreatment and frequent monitoring with VKAs. Real-world studies have demonstrated that NOAC use is increasing (Dresden NOAC registry and Global Anticoagulant Registry in the FIELD-AF [GARFIELD-AF]), as well as reaffirming the safety and effectiveness of rivaroxaban previously observed in RCTs (XArelto on preveNtion of sTroke and non-central nervoUS system systemic embolism in patients with non-valvular atrial fibrillation [XANTUS] and IMS Disease Analyzer). This article will describe the latest updates in real-world evidence across a variety of methodologies, such as non-interventional studies (NIS), registries and database analyses studies. It is anticipated that these studies will provide valuable clinical insights into the management of thromboembolism, and enhance the current knowledge on anticoagulant use and outcomes for patients.

Precision Medicine in Gastrointestinal Pathology.

PubMed

Wang, David H; Park, Jason Y

2016-05-01

-Precision medicine is the promise of individualized therapy and management of patients based on their personal biology. There are now multiple global initiatives to perform whole-genome sequencing on millions of individuals. In the United States, an early program was the Million Veteran Program, and a more recent proposal in 2015 by the president of the United States is the Precision Medicine Initiative. To implement precision medicine in routine oncology care, genetic variants present in tumors need to be matched with effective clinical therapeutics. When we focus on the current state of precision medicine for gastrointestinal malignancies, it becomes apparent that there is a mixed history of success and failure. -To present the current state of precision medicine using gastrointestinal oncology as a model. We will present currently available targeted therapeutics, promising new findings in clinical genomic oncology, remaining quality issues in genomic testing, and emerging oncology clinical trial designs. -Review of the literature including clinical genomic studies on gastrointestinal malignancies, clinical oncology trials on therapeutics targeted to molecular alterations, and emerging clinical oncology study designs. -Translating our ability to sequence thousands of genes into meaningful improvements in patient survival will be the challenge for the next decade.

Assessing the effectiveness of a clinical instructor online training module as measured by student perception and sustained best practices.

PubMed

Engelhard, Chalee; Seo, Kay Kyeong-Ju

2015-01-01

Due to current scrutiny of physical therapy (PT) clinical education, clinical education models require revisions with close examination of current practice, including best practices in clinical instructor (CI) education. Unfortunately, depth of research currently available to support these revisions is minimal, particularly in areas of research that investigate maintaining recently taught skills in CI training and students' perceived CI effectiveness following training. This study's purpose was to explore these areas. CIs (n=21) were assigned to either a control or treatment group. Treatment group-CIs completed an online module prior to supervising a Doctor of Physical Therapy (DPT) student during a 9-week clinical rotation and then participated in data collection activities following the rotation. Data from control group-CIs established a baseline. Data from students' assessments of their CIs' performances yielded qualitative themes demonstrating differentiated learning environments and module-taught best practices for treatment group-students. Quantitative findings did not make a distinction between the two student groups. Lastly, treatment group-CIs maintained best practices after an inactive period. This study suggests CIs were able to maintain best practices using just-in-time education, distributed clinical practice, and reflection. By continuing examination of online CI education, PT clinical education can move toward new models through evidence-based CI best practices.

Stem Cell Therapies for Knee Cartilage Repair: The Current Status of Preclinical and Clinical Studies

PubMed Central

Anderson, John A.; Little, Dianne; Toth, Alison P.; Moorman, Claude T.; Tucker, Bradford S.; Ciccotti, Michael G.; Guilak, Farshid

2014-01-01

Background Articular cartilage damage of the knee is common, causing significant morbidity worldwide. Many adult tissues contain cells that are able to differentiate into multiple cell types, including chondrocytes. These stem cells have gained significant attention over the past decade and may become frontline management for cartilage defects in the very near future. Purpose The role of stem cells in the treatment of knee osteochondral defects was reviewed. Recent animal and clinical studies were reviewed to determine the benefits and potential outcomes of using stem cells for cartilage defects. Study Design Literature review. Methods A PubMed search was undertaken. The key phrase “stem cells and knee” was used. The search included reviews and original articles over an unlimited time period. From this search, articles outlining animal and clinical trials were selected. A search of current clinical trials in progress was performed on the clinicaltrials.gov website, and “stem cells and knee” was used as the search phrase. Results Stem cells have been used in many recent in vitro and animal studies. A number of cell-based approaches for cartilage repair have progressed from preclinical animal studies into clinical trials. Conclusion The use of stem cells for the treatment of cartilage defects is increasing in animal and clinical studies. Methods of delivery of stem cells to the knee’s cartilage vary from direct injection to implantation with scaffolds. While these approaches are highly promising, there is currently limited evidence of a direct clinical benefit, and further research is required to assess the overall outcome of stem cell therapies for knee cartilage repair. PMID:24220016

[Current overview of cartilage regeneration procedures].

PubMed

Schenker, H; Wild, M; Rath, B; Tingart, M; Driessen, A; Quack, V; Betsch, M

2017-11-01

Cartilage is an avascular, alymphatic and non-innervated tissue with limited intrinsic repair potential. The high prevalence of cartilage defects and their tremendous clinical importance are a challenge for all treating physicians. This article provides the reader with an overview about current cartilage treatment options and their clinical outcome. Microfracture is still considered the gold standard in the treatment of small cartilage lesions. Small osteochondral defects can be effectively treated with the autologous osteochondral transplantation system. Larger cartilage defects are successfully treated by autologous membrane-induced chondrogenesis (AMIC) or by membrane-assisted autologous chondrocyte implantation (MACI). Despite limitations of current cartilage repair strategies, such procedures can result in short- and mid-term clinical improvement of the patients. Further developments and clinical studies are necessary to improve the long-term outcome following cartilage repair.

A Phase II/III Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Ginger (Zingiber officinale) for Nausea Caused by Chemotherapy for Cancer: A Currently Accruing URCC CCOP Cancer Control Study.

PubMed

Hickok, Jane T; Roscoe, Joseph A; Morrow, Gary R; Ryan, Julie L

2007-09-01

Despite the widespread use of 5-HT3 receptor antagonist antiemetics such as ondansetron and granistron, up to 70% of patients with cancer receiving highly emetogenic chemotherapy agents experience postchemotherapy nausea and vomiting. Delayed postchemotherapy nausea (nausea that occurs >/= 24 hours after chemotherapy administration) and anticipatory nausea (nausea that develops before chemotherapy administration, in anticipation of it) are poorly controlled by currently available antiemetic agents. Scientific studies suggest that ginger (Zingiber officinale) might have beneficial effects on nausea and vomiting associated with motion sickness, surgery, and pregnancy. In 2 small studies of patients with cancer receiving chemotherapy, addition of ginger to standard antiemetic medication further reduced the severity of postchemotherapy nausea. This article describes a phase II/III randomized, dose-finding, placebo-controlled, double-blind clinical trial to assess the efficacy of ginger for nausea associated with chemotherapy for cancer. The study is currently being conducted by private practice oncology groups that are funded by the National Cancer Institute's Community Clinical Oncology Program and affiliated with the University of Rochester Cancer Center Community Clinical Oncology Program Research Base.

Management of Leigh syndrome: Current status and new insights.

PubMed

Chen, L; Cui, Y; Jiang, D; Ma, C Y; Tse, H-F; Hwu, W-L; Lian, Q

2018-06-01

Leigh syndrome (LS) is an inherited mitochondrial encephalopathy associated with gene mutations of oxidative phosphorylation pathway that result in early disability and death in affected young children. Currently, LS is incurable and unresponsive to many treatments, although some case reports indicate that supplements can improve the condition. Many novel therapies are being continuously tested in pre-clinical studies. In this review, we summarize the genetic basis of LS, current treatment, pre-clinical studies in animal models and the management of other mitochondrial diseases. Future therapeutical strategies and challenges are also discussed. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Transition of Care in Adolescents With Cerebral Palsy: A Survey of Current Practices.

PubMed

Bolger, Ashlee; Vargus-Adams, Jilda; McMahon, Mary

2017-03-01

Transition of care from pediatric to adult health care providers for youth with special needs (including cerebral palsy [CP]) is of current interest because these individuals are now living well into adulthood. Studies have attempted to identify barriers to transition, ideal timing for transition of care, and key elements for successful transition programs. These studies often encompass a wide range of diagnoses, and results cannot be fully applied to those with CP. To identify and describe current transition-of-care (TOC) practices and beliefs among physician providers of adolescents with CP in multidisciplinary CP clinics. Descriptive survey. Multidisciplinary CP clinics in the United States. Physician leaders in the aforementioned CP clinics. Respondents completed an electronic survey. Responses were deidentified and reported in aggregate by the use of descriptive statistics. Electronic survey addressing 3 domains: demographics of clinics, current opinions/practices related to TOC processes, and perceived barriers to successful TOC. Fifteen surveys were sent with 11 returned (response rate = 73%). TOC practices varied among clinics surveyed. Fifty-five percent of clinics had a structured transition program, but only one transitioned 100% of their patients to adult providers by 22 years of age. Only one clinic had an absolute upper age limit for seeing patients, and 36% of clinics accepted new patients older than 21 years. No respondent was "completely satisfied" with their transition process, and only one respondent was "moderately satisfied." The majority of respondents felt the ideal care setting for adults with CP was a comprehensive, multidisciplinary adult-focused clinic in an adult hospital/clinic with primarily adult providers. They noted the top 3 perceived barriers to successful TOC were limited adult providers willing to accept CP patients, concern about the level of care in the adult health care system, and lack of financial resources. Current TOC practices vary considerably among multidisciplinary pediatric CP clinics and are not satisfactory to individual physician providers within these clinics. Respondents desired a multidisciplinary clinic in an adult care setting with adult providers; however, the top 3 perceived barriers involved the adult health care system, making it difficult for pediatric providers to develop effective TOC programs. Not applicable. Copyright © 2017 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Assessing FDG-PET diagnostic accuracy studies to develop recommendations for clinical use in dementia.

PubMed

Boccardi, Marina; Festari, Cristina; Altomare, Daniele; Gandolfo, Federica; Orini, Stefania; Nobili, Flavio; Frisoni, Giovanni B

2018-04-30

FDG-PET is frequently used as a marker of synaptic damage to diagnose dementing neurodegenerative disorders. We aimed to adapt the items of evidence quality to FDG-PET diagnostic studies, and assess the evidence available in current literature to assist Delphi decisions for European recommendations for clinical use. Based on acknowledged methodological guidance, we defined the domains, specific to FDG-PET, required to assess the quality of evidence in 21 literature searches addressing as many Population Intervention Comparison Outcome (PICO) questions. We ranked findings for each PICO and fed experts making Delphi decisions for recommending clinical use. Among the 1435 retrieved studies, most lacked validated measures of test performance, an adequate gold standard, and head-to-head comparison of FDG-PET and clinical diagnosis, and only 58 entered detailed assessment. Only two studies assessed the accuracy of the comparator (clinical diagnosis) versus any kind of gold-/reference-standard. As to the index-test (FDG-PET-based diagnosis), an independent gold-standard was available in 24% of the examined papers; 38% used an acceptable reference-standard (clinical follow-up); and 38% compared FDG-PET-based diagnosis only to baseline clinical diagnosis. These methodological limitations did not allow for deriving recommendations from evidence. An incremental diagnostic value of FDG-PET versus clinical diagnosis or lack thereof cannot be derived from the current literature. Many of the observed limitations may easily be overcome, and we outlined them as research priorities to improve the quality of current evidence. Such improvement is necessary to outline evidence-based guidelines. The available data were anyway provided to expert clinicians who defined interim recommendations.

Application description and policy model in collaborative environment for sharing of information on epidemiological and clinical research data sets.

PubMed

de Carvalho, Elias César Araujo; Batilana, Adelia Portero; Simkins, Julie; Martins, Henrique; Shah, Jatin; Rajgor, Dimple; Shah, Anand; Rockart, Scott; Pietrobon, Ricardo

2010-02-19

Sharing of epidemiological and clinical data sets among researchers is poor at best, in detriment of science and community at large. The purpose of this paper is therefore to (1) describe a novel Web application designed to share information on study data sets focusing on epidemiological clinical research in a collaborative environment and (2) create a policy model placing this collaborative environment into the current scientific social context. The Database of Databases application was developed based on feedback from epidemiologists and clinical researchers requiring a Web-based platform that would allow for sharing of information about epidemiological and clinical study data sets in a collaborative environment. This platform should ensure that researchers can modify the information. A Model-based predictions of number of publications and funding resulting from combinations of different policy implementation strategies (for metadata and data sharing) were generated using System Dynamics modeling. The application allows researchers to easily upload information about clinical study data sets, which is searchable and modifiable by other users in a wiki environment. All modifications are filtered by the database principal investigator in order to maintain quality control. The application has been extensively tested and currently contains 130 clinical study data sets from the United States, Australia, China and Singapore. Model results indicated that any policy implementation would be better than the current strategy, that metadata sharing is better than data-sharing, and that combined policies achieve the best results in terms of publications. Based on our empirical observations and resulting model, the social network environment surrounding the application can assist epidemiologists and clinical researchers contribute and search for metadata in a collaborative environment, thus potentially facilitating collaboration efforts among research communities distributed around the globe.

Electrical Stimulation and Cutaneous Wound Healing: A Review of Clinical Evidence

PubMed Central

Ud-Din, Sara; Bayat, Ardeshir

2014-01-01

Electrical stimulation (ES) has been shown to have beneficial effects in wound healing. It is important to assess the effects of ES on cutaneous wound healing in order to ensure optimization for clinical practice. Several different applications as well as modalities of ES have been described, including direct current (DC), alternating current (AC), high-voltage pulsed current (HVPC), low-intensity direct current (LIDC) and electrobiofeedback ES. However, no one method has been advocated as the most optimal for the treatment of cutaneous wound healing. Therefore, this review aims to examine the level of evidence (LOE) for the application of different types of ES to enhance cutaneous wound healing in the skin. An extensive search was conducted to identify relevant clinical studies utilising ES for cutaneous wound healing since 1980 using PubMed, Medline and EMBASE. A total of 48 studies were evaluated and assigned LOE. All types of ES demonstrated positive effects on cutaneous wound healing in the majority of studies. However, the reported studies demonstrate contrasting differences in the parameters and types of ES application, leading to an inability to generate sufficient evidence to support any one standard therapeutic approach. Despite variations in the type of current, duration, and dosing of ES, the majority of studies showed a significant improvement in wound area reduction or accelerated wound healing compared to the standard of care or sham therapy as well as improved local perfusion. The limited number of LOE-1 trials for investigating the effects of ES in wound healing make critical evaluation and assessment somewhat difficult. Further, better-designed clinical trials are needed to improve our understanding of the optimal dosing, timing and type of ES to be used. PMID:27429287

Strengthening the reliability and credibility of observational epidemiology studies by creating an Observational Studies Register.

PubMed

Swaen, Gerard M H; Carmichael, Neil; Doe, John

2011-05-01

To evaluate the need for the creation of a system in which observational epidemiology studies are registered; an Observational Studies Register (OSR). The current scientific process for observational epidemiology studies is described. Next, a parallel is made with the clinical trials area, where the creation of clinical trial registers has greatly restored and improved their credibility and reliability. Next, the advantages and disadvantages of an OSR are compared. The advantages of an OSR outweigh its disadvantages. The creation of an OSR, similar to the existing Clinical Trials Registers, will improve the assessment of publication bias and will provide an opportunity to compare the original study protocol with the results reported in the publication. Reliability, credibility, and transparency of observational epidemiology studies are strengthened by the creation of an OSR. We propose a structured, collaborative, and coordinated approach for observational epidemiology studies that can provide solutions for existing weaknesses and will strengthen credibility and reliability, similar to the approach currently used in clinical trials, where Clinical Trials Registers have played a key role in strengthening their scientific value. Copyright © 2011 Elsevier Inc. All rights reserved.

Inclusion and exclusion criteria in randomized controlled trials of psychotherapy for PTSD.

PubMed

Ronconi, Julia M; Shiner, Brian; Watts, Bradley V

2014-01-01

Posttraumatic stress disorder (PTSD) is a prevalent and often disabling condition. Fortunately, effective psychological treatments for PTSD are available. However, research indicates that these treatments may be underutilized in clinical practice. One reason for this underutilization may be clinicians' unwarranted exclusion of patients from these treatments based on their understanding of exclusion criteria used in clinical trials of psychological treatments for PTSD. There is no comprehensive and up-to-date review of inclusion and exclusion criteria used in randomized clinical trials (RCTs) of psychological treatments for PTSD. Therefore, our objective was to better understand how patients were excluded from such RCTs in order to provide guidance to clinicians regarding clinical populations likely to benefit from these treatments. We conducted a comprehensive literature review of RCTs of psychological treatments for PTSD from January 1, 1980 through April 1, 2012. We categorized these clinical trials according to the types of psychotherapy discussed in the major guidelines for treatment of PTSD and reviewed all treatments that were studied in at least two RCTs (N=64 published studies with 75 intervention arms since some studies compared two or more interventions). We abstracted and tabulated information concerning exclusion criteria for each type of psychotherapy for PTSD. We identified multiple RCTs of cognitive behavioral therapy (n=56), eye movement desensitization and reprocessing (n=11), and group psychotherapy (n=8) for PTSD. The most common exclusions were psychosis, substance abuse and dependence, bipolar disorder, and suicidal ideation. Clinical trials varied in how stringently these criteria were applied. It is important to note that no exclusion criterion was used in all studies and there was at least one study of each type of therapy that included patients from each of the commonly excluded groups. A paucity of evidence exists concerning the treatment of patients with PTSD and four comorbidities: alcohol and substance abuse or dependence with current use, current psychosis, current mania, and suicidal ideation with current intent. Psychological treatments for PTSD have been studied in broad and representative clinical populations. It appears that more liberal use of these treatments regardless of comorbidities is warranted.

Ecological momentary assessment: what it is and why it is a method of the future in clinical psychopharmacology

PubMed Central

Moskowitz, Debbie S.; Young, Simon N.

2006-01-01

Current methods of assessment in clinical psychopharmacology have several serious disadvantages, particularly for the study of social functioning. We aimed to review the strengths and weaknesses of current methods used in clinical psychopharmacology and to compare them with a group of methods, developed by personality/social psychologists, termed ecological momentary assessment (EMA), which permit the research participant to report on symptoms, affect and behaviour close in time to experience and which sample many events or time periods. EMA has a number of advantages over more traditional methods for the assessment of patients in clinical psychopharmacological studies. It can both complement and, in part, replace existing methods. EMA methods will permit more sensitive assessments and will enable more wide-ranging and detailed measurements of mood and behaviour. These types of methods should be adopted more widely by clinical psychopharmacology researchers. PMID:16496031

Shiny FHIR: An Integrated Framework Leveraging Shiny R and HL7 FHIR to Empower Standards-Based Clinical Data Applications.

PubMed

Hong, Na; Prodduturi, Naresh; Wang, Chen; Jiang, Guoqian

2017-01-01

In this study, we describe our efforts in building a clinical statistics and analysis application platform using an emerging clinical data standard, HL7 FHIR, and an open source web application framework, Shiny. We designed two primary workflows that integrate a series of R packages to enable both patient-centered and cohort-based interactive analyses. We leveraged Shiny with R to develop interactive interfaces on FHIR-based data and used ovarian cancer study datasets as a use case to implement a prototype. Specifically, we implemented patient index, patient-centered data report and analysis, and cohort analysis. The evaluation of our study was performed by testing the adaptability of the framework on two public FHIR servers. We identify common research requirements and current outstanding issues, and discuss future enhancement work of the current studies. Overall, our study demonstrated that it is feasible to use Shiny for implementing interactive analysis on FHIR-based standardized clinical data.

Physicians' Perceptions of Clinical Teaching: A Qualitative Analysis in the Context of Change

ERIC Educational Resources Information Center

Knight, Lynn V.; Bligh, John

2006-01-01

Background: Change is ubiquitous. Current trends in both educational and clinical settings bring new challenges to clinicians and have the potential to threaten the quality of clinical teaching. Objective: To investigate hospital specialists' perceptions of clinical teaching in the context of change. Design: Qualitative study using in-depth…

A Functional Neuroimaging Study of the Clinical Reasoning of Medical Students

ERIC Educational Resources Information Center

Chang, Hyung-Joo; Kang, June; Ham, Byung-Joo; Lee, Young-Mee

2016-01-01

As clinical reasoning is a fundamental competence of physicians for good clinical practices, medical academics have endeavored to teach reasoning skills to undergraduate students. However, our current understanding of student-level clinical reasoning is limited, mainly because of the lack of evaluation tools for this internal cognitive process.…

Staff Perspectives of Service User Involvement on Two Clinical Psychology Training Courses

ERIC Educational Resources Information Center

Clarke, Simon P.; Holttum, Sue

2013-01-01

This study investigated both negative and positive staff perspectives of service user involvement on two clinical psychology training courses as part of an ongoing process of service evaluation. Ten clinical psychology staff from two training courses were interviewed over the telephone by a current trainee clinical psychologist using a…

Nurse-led clinics reduce severity of childhood atopic eczema: a review of the literature.

PubMed

Moore, E; Williams, A; Manias, E; Varigos, G

2006-12-01

The increasing prevalence and impact of atopic eczema in children in Western countries such as Australia substantiate the need to evaluate the current management of this illness. It has been well documented that the most important aspects in the management of atopic eczema are to allow adequate time for education and demonstration of treatments. However, current models of healthcare funding restrict the opportunity for patient education during medical consultation times. The contribution of nursing to patient care through nurse-led clinics has significant potential in the management of many common chronic illnesses, although atopic eczema has received minimal attention by researchers to date. To discuss the current clinical management of atopic eczema, and to identify the evidence surrounding the benefits of nurse-led clinics in managing patients with chronic illnesses. Systematic searches were undertaken using the Cochrane Library, MedLine, PUBMed and CINAHL from 1995 to 2005. Manual searches of references of retrieved articles identified two additional key studies from 1990 and 1993 which were also included in the review. In total, 22 relevant publications were identified. These included both primary research and descriptive studies that covered the medical management of eczema, patient education and improved patient outcomes. The evidence emerging from the literature indicates that the current management of eczema through doctor-led clinics could be improved, with doctors often lacking the time to offer sufficient patient education to manage chronic illnesses effectively. The literature supports the efficacy of nurse-led clinics in the management of chronic illnesses. The benefits of nurse-led clinics include increased patient satisfaction, longer consultations resulting in improved patient education and similar health outcomes when compared with care from a doctor. No studies were identified comparing nurse-led and doctor-led clinics in the management of eczema. The most effective way to manage atopic eczema is to provide adequate time for education and demonstration of treatments, which the literature suggests can be achieved through nurse-led clinics. The literature review supports an investigation researching the outcomes of a nurse-led clinic on reducing the severity of eczema in children.

Emotional intelligence, performance, and retention in clinical staff nurses.

PubMed

Codier, Estelle; Kamikawa, Cindy; Kooker, Barbara M; Shoultz, Jan

2009-01-01

Emotional intelligence has been correlated with performance, retention, and organizational commitment in professions other than nursing. A 2006 pilot study provided the first evidence of a correlation between emotional intelligence and performance in clinical staff nurses. A follow-up study was completed, the purpose of which was to explore emotional intelligence, performance level, organizational commitment, and retention. A convenience sample of 350 nurses in a large medical center in urban Hawaii participated in this study. This article reports the findings pertaining to the subset of 193 clinical staff nurses who responded. The Mayer-Salovey-Caruso Emotional Intelligence Test instrument was used to measure emotional intelligence abilities. Performance was defined as ranking on a clinical ladder. Commitment was scored on a Likert scale. The following variables measured retention: total years in nursing, years in current job, total years anticipated in current job, and total anticipated career length. Emotional intelligence scores in clinical staff nurses correlated positively with both performance level and retention variables. Clinical staff nurses with higher emotional intelligence scores demonstrated higher performance, had longer careers, and greater job retention.

Clinical correlates of enlarged cavum septum pellucidum in schizophrenia: A revisit through computed tomography.

PubMed

Srivastava, Naveen Kumar; Khanra, Sourav; Chail, Vivek; Khess, Christoday R J

2015-06-01

Like prevalence of abnormal cavum septum pellucidum in patients of schizophrenia remains controversial, its role in clinical outcome, duration of illness and effect on treatment remains less understood as well. Our study examined clinical correlates of enlarged cavum septum pellucidum in schizophrenia. A total of 139 patients diagnosed with schizophrenia during the year 2012 and 2013 were taken for the study. We compared them in respect to the presence and absence of enlarged cavum septum pellucidum. We found 16 patients with enlarged cavum septum pellucidum and were compared with those without enlarged cavum septum pellucidum for socio-demographic and clinical variables. We also correlated these clinical variables with dimension of cavum septum pellucidum. We found statistically significant increased current age and duration of illness in patients with enlarged cavum septum pellucidum. The implications of these findings are discussed with possible confounding effect of current age on neuroimaging. No meaningful correlation was found. No difference in clinical variables was found. Retrospective design and use of computed tomography were limitation of our study. Copyright © 2015 Elsevier B.V. All rights reserved.

Sub-clinical Alcohol Consumption and Gambling Disorder

PubMed Central

Harries, Michael D.; Redden, Sarah A.; Leppink, Eric W.; Chamberlain, Samuel R.; Grant, Jon E.

2017-01-01

While it is well established that gambling disorder is associated with alcohol use disorder, less is known regarding whether sub-clinical alcohol consumption increases gambling behavior. This study examined the effects of varying levels of alcohol consumption on clinical and cognitive measures. The sample consisted of 572 non-treatment seeking gamblers age 18-29 who were divided into three groups: non-current drinkers, current drinkers who did not qualify for an alcohol use disorder, and those with an alcohol use disorder (AUD). All subjects were assessed on gambling pathology, severity and impulsivity using the Structured Clinical Interview for Gambling Disorder, Yale Brown Obsessive Compulsive Scale for Pathologic Gambling and the Barratt Impulsive Scale-11 and select cognitive tests. In all of the clinical measures, controlling for age, gender and education, the AUD group was significantly more likely than the non-current and current drinkers to be a pathologic gambler and to be impulsive, compulsive and depressed. On cognitive tasks, controlling for age, gender and education, the AUD group had significantly worse strategy use on a spatial working memory task than both other groups. This study suggests that the relationship between alcohol and gambling may only exist when pathology in both alcohol consumption and gambling behavior is present. Examining this relationship with alcohol consumption as a continuous variable would provide additional insight into the potential effects alcohol consumption has on gambling behavior. PMID:27826730

Sub-clinical Alcohol Consumption and Gambling Disorder.

PubMed

Harries, Michael D; Redden, Sarah A; Leppink, Eric W; Chamberlain, Samuel R; Grant, Jon E

2017-06-01

While it is well established that gambling disorder is associated with alcohol use disorder, less is known regarding whether sub-clinical alcohol consumption increases gambling behavior. This study examined the effects of varying levels of alcohol consumption on clinical and cognitive measures. The sample consisted of 572 non-treatment seeking gamblers age 18-29 who were divided into three groups: non-current drinkers, current drinkers who did not qualify for an alcohol use disorder, and those with an alcohol use disorder (AUD). All subjects were assessed on gambling pathology, severity and impulsivity using the Structured Clinical Interview for Gambling Disorder, Yale Brown Obsessive Compulsive Scale for Pathologic Gambling and the Barratt Impulsive Scale-11 and select cognitive tests. In all of the clinical measures, controlling for age, gender and education, the AUD group was significantly more likely than the non-current and current drinkers to be a pathologic gambler and to be impulsive, compulsive and depressed. On cognitive tasks, controlling for age, gender and education, the AUD group had significantly worse strategy use on a spatial working memory task than both other groups. This study suggests that the relationship between alcohol and gambling may only exist when pathology in both alcohol consumption and gambling behavior is present. Examining this relationship with alcohol consumption as a continuous variable would provide additional insight into the potential effects alcohol consumption has on gambling behavior.

Conceptions of How a Learning or Teaching Curriculum, Workplace Culture and Agency of Individuals Shape Medical Student Learning and Supervisory Practices in the Clinical Workplace

ERIC Educational Resources Information Center

Strand, Pia; Edgren, Gudrun; Borna, Petter; Lindgren, Stefan; Wichmann-Hansen, Gitte; Stalmeijer, Renée E.

2015-01-01

The role of workplace supervisors in the clinical education of medical students is currently under debate. However, few studies have addressed how supervisors conceptualize workplace learning and how conceptions relate to current sociocultural workplace learning theory. We explored physician conceptions of: (a) medical student learning in the…

Measuring molecular biomarkers in epidemiologic studies: laboratory techniques and biospecimen considerations.

PubMed

Erickson, Heidi S

2012-09-28

The future of personalized medicine depends on the ability to efficiently and rapidly elucidate a reliable set of disease-specific molecular biomarkers. High-throughput molecular biomarker analysis methods have been developed to identify disease risk, diagnostic, prognostic, and therapeutic targets in human clinical samples. Currently, high throughput screening allows us to analyze thousands of markers from one sample or one marker from thousands of samples and will eventually allow us to analyze thousands of markers from thousands of samples. Unfortunately, the inherent nature of current high throughput methodologies, clinical specimens, and cost of analysis is often prohibitive for extensive high throughput biomarker analysis. This review summarizes the current state of high throughput biomarker screening of clinical specimens applicable to genetic epidemiology and longitudinal population-based studies with a focus on considerations related to biospecimens, laboratory techniques, and sample pooling. Copyright © 2012 John Wiley & Sons, Ltd.

Personalized medicine in psychiatry.

PubMed

Wium-Andersen, Ida Kim; Vinberg, Maj; Kessing, Lars Vedel; McIntyre, Roger S

2017-01-01

Personalized medicine is a model in which a patient's unique clinical, genetic, and environmental characteristics are the basis for treatment and prevention. Aim, method, and results: This review aims to describe the current tools, phenomenological features, clinical risk factors, and biomarkers used to provide personalized medicine. Furthermore, this study describes the target areas in which they can be applied including diagnostics, treatment selection and response, assessment of risk of side-effects, and prevention. Personalized medicine in psychiatry is challenged by the current taxonomy, where the diagnostic categories are broad and great biological heterogeneity exists within each category. There is, thus, a gap between the current advanced research prospects and clinical practice, and the current taxonomy is, thus, a poor basis for biological research. The discussion proposes possible solutions to narrow this gap and to move psychiatric research forward towards personalized medicine.

Current status of integrating information technologies into the clinical research enterprise within US academic health centers: strategic value and opportunities for investment.

PubMed

Turisco, Fran; Keogh, Diane; Stubbs, Connie; Glaser, John; Crowley, William F

2005-12-01

Little information exists about the incorporation of information technologies (ITs) into clinical research processes within US academic health centers (AHCs). Therefore, we queried a group of 37 leading AHCs regarding their current status and future plans in clinical research IT. The survey specifically inquired about the presence or absence of basic infrastructure and IT support requirements; individual applications needed to support study preparation, study conduct, and its administrative support; and integration of data from basic research, clinical trials, and the clinical information systems increasingly used in health care delivery. Of the 37 AHCs, 78% responded. All strongly agreed that a "state-of-the-art" clinical research IT program would be ideal today and will be essential tomorrow. Nonetheless, no AHC currently has an IT solution that even approached this ideal. No AHC reported having all of the essential management foundations (ie, a coherent vision, an overall strategy, a governance structure, and a dedicated budget) necessary to launch and sustain a truly successful implementation of a cohesive clinical research IT platform. Many had achieved breakthroughs in individual aspects of clinical research IT, for example, adverse event reporting systems or consent form templates. However, overall implementation of IT to support clinical research is uneven and insufficient. These data document a substantial gap in clinical research IT investments in leading US AHCs. Linking the clinical research IT enterprise with its clinical operations in a meaningful fashion remains a crucial strategic goal of AHCs. If they are to continue to serve as the "translational research engines" that our society expects, AHCs must recognize this gap and allocate substantial resource deployment to remedying this situation.

NASPGHAN Capsule Endoscopy Clinical Report.

PubMed

Friedlander, Joel A; Liu, Quin Y; Sahn, Benjamin; Kooros, Koorosh; Walsh, Catharine M; Kramer, Robert E; Lightdale, Jenifer R; Khlevner, Julie; McOmber, Mark; Kurowski, Jacob; Giefer, Matthew J; Pall, Harpreet; Troendle, David M; Utterson, Elizabeth C; Brill, Herbert; Zacur, George M; Lirio, Richard A; Lerner, Diana G; Reynolds, Carrie; Gibbons, Troy E; Wilsey, Michael; Liacouras, Chris A; Fishman, Douglas S

2017-03-01

Wireless capsule endoscopy (CE) was introduced in 2000 as a less invasive method to visualize the distal small bowel in adults. Because this technology has advanced it has been adapted for use in pediatric gastroenterology. Several studies have described its clinical use, utility, and various training methods but pediatric literature regarding CE is limited. This clinical report developed by the Endoscopic and Procedures Committee of the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition outlines the current literature, and describes the recommended current role, use, training, and future areas of research for CE in pediatrics.

Hepatitis C Virus Resistance Testing in Genotype 1: The Changing Role in Clinical Utility.

PubMed

Molino, Suzanne; Martin, Michelle T

2017-09-01

To review the role and utility of baseline resistance testing with currently available and pipeline genotype 1 hepatitis C virus (HCV) treatment. Authors reviewed liver meeting abstracts for data on currently-available and pipeline genotype 1 retreatment regimens from January 1, 2015, to March 23, 2017. Additional trials were identified from a review of clinicaltrials.gov using the pipeline medication names. Authors identified reports of current and pipeline genotype 1 retreatment regimens. Seven references were clinical study results presented at the meetings of the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver, and 2 studies were from clinicaltrials.gov . Retreatment trial data of currently available salvage regimens indicate that baseline NS5A resistance-associated substitutions (RASs) may decrease sustained virological response (SVR) rates when retreating with ledipasvir/sofosbuvir but are not affected when using elbasvir/grazoprevir + sofosbuvir + ribavirin, paritaprevir/ritonavir/ombitasvir + dasabuvir + sofosbuvir, or sofosbuvir/velpatasvir + ribavirin. Pipeline data indicate that baseline NS5A RASs do not affect SVR rates when retreating with sofosbuvir/velpatasvir/voxilaprevir or glecaprevir/pibrentasvir. Baseline resistance testing was used for decisional support for 3 clinical scenarios in patients with HCV genotype 1 infection at the time of manuscript submission. Pending the approval of 2 new direct-acting antiviral regimens in the third quarter of 2017, the rapidly evolving HCV treatment guidelines will likely reflect a decreased clinical utility for resistance testing.

Is ginger beneficial for nausea and vomiting? An update of the literature.

PubMed

Marx, Wolfgang; Kiss, Nicole; Isenring, Liz

2015-06-01

Nausea and vomiting can pose a significant burden to patients in a variety of clinical settings. Previous evidence suggests that ginger may be an effective treatment for these symptoms; however, current evidence has been mixed. This article discusses recent clinical trials that have investigated ginger as a treatment for multiple types of nausea and vomiting. In addition, the potential mechanisms of action of ginger will be discussed. This article identified nine studies and seven reviews that investigated ginger for morning sickness, postoperative nausea and vomiting, chemotherapy-induced, and antiretroviral-induced nausea and vomiting. All studies reported that ginger provided a significant reduction in nausea and vomiting; however, the clinical relevance of some studies is less certain. Common limitations within the literature include the lack of standardized extracts, poorly controlled or blinded studies, and limited sample size. In addition, recent evidence has provided further support for 5-HT3 receptor antagonism as a mechanism by which ginger may exert its potentially beneficial effect on nausea and vomiting. The results of studies in this article suggest that ginger is a promising treatment for nausea and vomiting in a variety of clinical settings and possesses a clinically relevant mechanism. However, further studies are required to address the limitations in the current clinical literature before firm recommendations for its use can be made.

Nanoparticles in the clinic

PubMed Central

Anselmo, Aaron C.

2016-01-01

Abstract Nanoparticle/microparticle‐based drug delivery systems for systemic (i.e., intravenous) applications have significant advantages over their nonformulated and free drug counterparts. For example, nanoparticle systems are capable of delivering therapeutics and treating areas of the body that other delivery systems cannot reach. As such, nanoparticle drug delivery and imaging systems are one of the most investigated systems in preclinical and clinical settings. Here, we will highlight the diversity of nanoparticle types, the key advantages these systems have over their free drug counterparts, and discuss their overall potential in influencing clinical care. In particular, we will focus on current clinical trials for nanoparticle formulations that have yet to be clinically approved. Additional emphasis will be on clinically approved nanoparticle systems, both for their currently approved indications and their use in active clinical trials. Finally, we will discuss many of the often overlooked biological, technological, and study design challenges that impact the clinical success of nanoparticle delivery systems. PMID:29313004

Support in Clinical Settings as Perceived by Nursing Students in Iran: A Qualitative Study

PubMed Central

Joolaee, Soodabeh; Ashghali Farahani, Mansoureh; Jafarian Amiri, Seyedeh Roghayeh; Varaei, Shokoh

2016-01-01

Background Although support is one of the most substantial needs of nursing students during clinical education, it is not clearly defined in the literature. Objectives The current study aimed to explore the concept of support in clinical settings as perceived by nursing students. Materials and Methods A qualitative content analysis was used to explore the meaning of student support in clinical settings. A purposive sampling with maximum variation was used to select the participants among bachelor nursing students in the nursing school of Babol University of Medical Sciences in the north of Iran. Semi-structured interviews were conducted to gather the perceptions and experiences of seventeen nursing students. Conventional content analysis was applied to analyze the data. Results In the current study, the main theme, nurturance, was emerged with seven subthemes of humanistic behavior with the student, respectful communication with students, accepting the student in the clinical setting, sustaining confidence, need based supervision, accepting the profession in the society and empowerment. Conclusions Nursing students support in the clinical education requires a nurturing care; a care that leads to the sense of worthiness and respectability in students and contributes to the improvement of their clinical abilities. PMID:27331057

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

COMPARISON OF METHODS FOR ESTIMATING CONTEMPORARY COSTS: AN APPLICATION TO LIVER TRANSPLANTATION IN THE UNITED KINGDOM.

PubMed

Singh, Jeshika; Longworth, Louise

2017-01-01

Our study addresses the important issue of estimating treatment costs from historical data. It is a problem frequently faced by health technology assessment analysts. We compared four approaches used to estimate current costs when good quality contemporary data are not available using liver transplantation as an example. First, the total cost estimates extracted for patients from a cohort study, conducted in the 1990s, were inflated using a published inflation multiplier. Second, resource use estimates from the cohort study were extracted for hepatitis C patients and updated using current unit costs. Third, expert elicitation was carried out to identify changes in clinical practice over time and quantify current resource use. Fourth, routine data on resource use were obtained from National Health Service Blood and Transplant (NHSBT). The first two methods did not account for changes in clinical practice. Also the first was not specific to hepatitis patients. The use of experts confirmed significant changes in clinical practice. However, the quantification of resource use using experts is challenging as clinical specialists may not have a complete overview of clinical pathway. The NHSBT data are the most accurate reflection of transplantation and posttransplantation phase; however, data were not available for the whole pathway of care. The best estimate of total cost, combining NHSBT data and expert elicitation, is £121,211. Observational data from routine care are potentially the most reliable reflection of current resource use. Efforts should be made to make such data readily available and accessible to researchers. Expert elicitation provided reasonable estimates.

Resveratrol and diabetes: A critical review of clinical studies.

PubMed

Öztürk, Ebru; Arslan, Ayşe Kübra Karaboğa; Yerer, Mükerrem Betül; Bishayee, Anupam

2017-11-01

Diabetes mellitus (DM) is a metabolic disease characterized by hyperglycemia. The disease results from the defects of insulin secretion and/or action. Resveratrol is a non-flavonoid polyphenol that naturally occurs as phytoalexin. The shell and stem of Vitis vinifera L. (Vitaceae) are the richest source of this compound. In addition to various in vitro and in vivo studies revealing the effectiveness of resveratrol in DM, there are many clinical trials indicating that resveratrol has the potential to benefit in DM patients. The therapeutic action of this compound in relation to diabetes is complex and involves in several beneficial roles. In view of this, clinical studies are necessary to elucidate these roles. In the near future, the use of resveratrol, alone or in combination with current anti-diabetic therapies, might be a conventional approach to effectively manage DM or its complications. This mini-review provides a critical overview of currently available clinical studies examining the effects of resveratrol in DM last decade. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Comparing Parent-Child Interactions in the Clinic and at Home: An Exploration of the Validity of Clinical Behavior Observations Using Sequential Analysis

ERIC Educational Resources Information Center

Shriver, Mark D.; Frerichs, Lynae J.; Williams, Melissa; Lancaster, Blake M.

2013-01-01

Direct observation is often considered the "gold standard" for assessing the function, frequency, and intensity of problem behavior. Currently, the literature investigating the construct validity of direct observation conducted in the clinic setting reveals conflicting results. Previous studies on the construct validity of clinic-based…

Examination of Racial Differences on the MMPI-2 Clinical and Restructured Clinical Scales in an Outpatient Sample

ERIC Educational Resources Information Center

Castro, Yessenia; Gordon, Kathryn H.; Brown, Jessica S.; Anestis, Joye C.; Joiner, Thomas E., Jr.

2008-01-01

The current study examined the possibility of differential predictive accuracy of selected Minnesota Multiphasic Personality Inventory-Second Edition (MMPI-2) clinical and Restructured Clinical (RC) scales in a group of Black and White mental health center clients. Results indicate that Black clients scored higher than White clients on one…

Cannabinoids and Epilepsy.

PubMed

Rosenberg, Evan C; Tsien, Richard W; Whalley, Benjamin J; Devinsky, Orrin

2015-10-01

Cannabis has been used for centuries to treat seizures. Recent anecdotal reports, accumulating animal model data, and mechanistic insights have raised interest in cannabis-based antiepileptic therapies. In this study, we review current understanding of the endocannabinoid system, characterize the pro- and anticonvulsive effects of cannabinoids [e.g., Δ9-tetrahydrocannabinol and cannabidiol (CBD)], and highlight scientific evidence from pre-clinical and clinical trials of cannabinoids in epilepsy. These studies suggest that CBD avoids the psychoactive effects of the endocannabinoid system to provide a well-tolerated, promising therapeutic for the treatment of seizures, while whole-plant cannabis can both contribute to and reduce seizures. Finally, we discuss results from a new multicenter, open-label study using CBD in a population with treatment-resistant epilepsy. In all, we seek to evaluate our current understanding of cannabinoids in epilepsy and guide future basic science and clinical studies.

Current directions in non-invasive low intensity electric brain stimulation for depressive disorder.

PubMed

Schutter, Dennis J L G; Sack, Alexander T

2014-01-01

Non-invasive stimulation of the human brain to improve depressive symptoms is increasingly finding its way in clinical settings as a viable form of somatic treatment. Following successful modulation of neural excitability with subsequent antidepressant effects, neural polarization by administrating weak direct currents to the scalp has gained renewed interest. A new wave of basic and clinical studies seems to underscore the potential therapeutic value of direct current stimulation in the treatment of depression. Issues concerning the lack of mechanistic insights into the workings of modifying brain function through neural polarization and how this process translates to its antidepressant properties calls for additional research. The range of its clinical applicability has yet to be established.

On-going clinical trials for elderly patients with a hematological malignancy: are we addressing the right end points?

PubMed

Hamaker, M E; Stauder, R; van Munster, B C

2014-03-01

Cancer societies and research cooperative groups worldwide have urged for the development of cancer trials that will address those outcome measures that are most relevant to older patients. We set out to determine the characteristics and study objectives of current clinical trials in hematological patients. The United States National Institutes of Health clinical trial registry was searched on 1 July 2013, for currently recruiting phase I, II or III clinical trials in hematological malignancies. Trial characteristics and study objectives were extracted from the registry website. In the 1207 clinical trials included in this overview, patient-centered outcome measures such as quality of life, health care utilization and functional capacity were only incorporated in a small number of trials (8%, 4% and 0.7% of trials, respectively). Even in trials developed exclusively for older patients, the primary focus lies on standard end points such as toxicity, efficacy and survival, while patient-centered outcome measures are included in less than one-fifth of studies. Currently on-going clinical trials in hematological malignancies are unlikely to significantly improve our knowledge of the optimal treatment of older patients as those outcome measures that are of primary importance to this patient population are still included in only a minority of studies. As a scientific community, we cannot continue to simply acknowledge this issue, but must all participate in taking the necessary steps to enable the delivery of evidence-based, tailor-made and patient-focused cancer care to our rapidly growing elderly patient population.

On-going clinical trials for elderly patients with a hematological malignancy: are we addressing the right end points?†

PubMed Central

Hamaker, M. E.; Stauder, R.; van Munster, B. C.

2014-01-01

Background Cancer societies and research cooperative groups worldwide have urged for the development of cancer trials that will address those outcome measures that are most relevant to older patients. We set out to determine the characteristics and study objectives of current clinical trials in hematological patients. Method The United States National Institutes of Health clinical trial registry was searched on 1 July 2013, for currently recruiting phase I, II or III clinical trials in hematological malignancies. Trial characteristics and study objectives were extracted from the registry website. Results In the 1207 clinical trials included in this overview, patient-centered outcome measures such as quality of life, health care utilization and functional capacity were only incorporated in a small number of trials (8%, 4% and 0.7% of trials, respectively). Even in trials developed exclusively for older patients, the primary focus lies on standard end points such as toxicity, efficacy and survival, while patient-centered outcome measures are included in less than one-fifth of studies. Conclusion Currently on-going clinical trials in hematological malignancies are unlikely to significantly improve our knowledge of the optimal treatment of older patients as those outcome measures that are of primary importance to this patient population are still included in only a minority of studies. As a scientific community, we cannot continue to simply acknowledge this issue, but must all participate in taking the necessary steps to enable the delivery of evidence-based, tailor-made and patient-focused cancer care to our rapidly growing elderly patient population. PMID:24458474

Learning about Progeria

MedlinePlus

... contemplated is the use of high-throughput screening technology to identify chemical compounds that might reverse nuclear membrane abnormalities of the type seen in the cells of children with progeria. Current NHGRI Clinical Studies Search ClinicalTrials. ...

Clinical proteomic biomarkers: relevant issues on study design & technical considerations in biomarker development

PubMed Central

2014-01-01

Biomarker research is continuously expanding in the field of clinical proteomics. A combination of different proteomic–based methodologies can be applied depending on the specific clinical context of use. Moreover, current advancements in proteomic analytical platforms are leading to an expansion of biomarker candidates that can be identified. Specifically, mass spectrometric techniques could provide highly valuable tools for biomarker research. Ideally, these advances could provide with biomarkers that are clinically applicable for disease diagnosis and/ or prognosis. Unfortunately, in general the biomarker candidates fail to be implemented in clinical decision making. To improve on this current situation, a well-defined study design has to be established driven by a clear clinical need, while several checkpoints between the different phases of discovery, verification and validation have to be passed in order to increase the probability of establishing valid biomarkers. In this review, we summarize the technical proteomic platforms that are available along the different stages in the biomarker discovery pipeline, exemplified by clinical applications in the field of bladder cancer biomarker research. PMID:24679154

Using Human Factors Methods to Design a New Interface for an Electronic Medical Record

PubMed Central

Saleem, Jason J.; Patterson, Emily S.; Militello, Laura; Asch, Steven M.; Doebbeling, Bradley N.; Render, Marta L.

2007-01-01

The Veterans Health Administration (VHA) is a leader in development and use of electronic patient records and clinical decision support. The VHA is currently reengineering a somewhat dated platform for its Computerized Patient Record System (CPRS). This process affords a unique opportunity to implement major changes to the current design and function of the system. We report on two human factors studies designed to provide input and guidance during this reengineering process. One study involved a card sort to better understand how providers tend to cognitively organize clinical data, and how that understanding can help guide interface design. The other involved a simulation to assess the impact of redesign modifications on computerized clinical reminders, a form of clinical decision support in the CPRS, on the learnability of the system for first-time users. PMID:18693914

The Lymphatic System and Pancreatic Cancer

PubMed Central

Fink, Darci M.; Steele, Maria M.; Hollingsworth, Michael A.

2016-01-01

This review summarizes current knowledge of the biology, pathology and clinical understanding of lymphatic invasion and metastasis in pancreatic cancer. We discuss the clinical and biological consequences of lymphatic invasion and metastasis, including paraneoplastic effects on immune responses and consider the possible benefit of therapies to treat tumors that are localized to lymphatics. A review of current techniques and methods to study interactions between tumors and lymphatics is presented. PMID:26742462

Whole kidney engineering for clinical translation.

PubMed

Kim, Ick-Hee; Ko, In Kap; Atala, Anthony; Yoo, James J

2015-04-01

Renal transplantation is currently the only definitive treatment for end-stage renal disease; however, this treatment is severely limited by the shortage of implantable kidneys. To address this shortcoming, development of an engineered, transplantable kidney has been proposed. Although current advances in engineering kidneys based on decellularization and recellularization techniques have offered great promises for the generation of functional kidney constructs, most studies have been conducted using rodent kidney constructs and short-term in-vivo evaluation. Toward clinical translations of this technique, several limitations need to be addressed. Human-sized renal scaffolds are desirable for clinical application, and the fabrication is currently feasible using native porcine and discarded human kidneys. Current progress in stem cell biology and cell culture methods have demonstrated feasibility of the use of embryonic stem cells, induced pluripotent stem cells, and primary renal cells as clinically relevant cell sources for the recellularization of renal scaffolds. Finally, approaches to long-term implantation of engineered kidneys are under investigation using antithrombogenic strategies such as functional reendothelialization of acellular kidney matrices. In the field of bioengineering, whole kidneys have taken a number of important initial steps toward clinical translations, but many challenges must be addressed to achieve a successful treatment for the patient with end-stage renal disease.

Suicide attempts among depressed inpatients with depressive disorder in a Malaysian sample. Psychosocial and clinical risk factors.

PubMed

Chan, L F; Maniam, T; Shamsul, A S

2011-01-01

Depressed inpatients constitute a high-risk population for suicide attempts. To describe the interactions of clinical and psychosocial risk factors influencing suicide attempts among a Malaysian sample of depressed inpatients. Seventy-five subjects were diagnosed with a depressive disorder according to the Structured Clinical Interview for DSM-IV Axis I Disorders-Clinical Version (SCID-CV). Data on suicide attempts, suicidal ideation (Scale for Suicidal Ideation, SSI), depression severity (Beck's Depression Inventory, BDI), recent life-event changes (Social Readjustment Rating Scale, SRRS), sociodemographic and other relevant clinical factors were collected. A third of the subjects presented after a current suicide attempt. Significant factors for a current suicide attempt were race, religion, recent life-event changes, suicidal ideation, and alcohol use disorder. Independent predictive risk factors for a current suicide attempt were Chinese race, recent marital separation, major mortgage or loans, and being newly diagnosed with depression. Any recent change in personal habits was shown to be a protective factor against current suicide attempt. Age and gender were nonsignificant factors. The findings are generally consistent with existing studies and highlight the role of psychosocial risk factors.

Review of the contemporary cytotoxic and biologic combinations available for the treatment of metastatic breast cancer.

PubMed

Tkaczuk, Katherine H Rak

2009-01-01

Treatment of metastatic breast cancer (MBC) with > or =2 chemotherapeutic agents concurrently has been shown to increase response rates, often at the cost of a substantial increase in toxicity, and with minimal impact on the overall survival. However, some combinations of the newer cytotoxic agents, as well as combinations of chemotherapeutic agents and targeted biologic anticancer agents, can produce synergistic efficacy with a manageable toxicity profile. The aims of this work were to provide an overview of the currently approved combination regimens available for the treatment of MBC and to consider the clinical data supporting other drug combinations that may supplement the current therapeutic choices in the near future. Literature searches were performed using MEDLINE/PubMed, with a focus on combination therapies for the treatment of MBC that are approved by the US Food and Drug Administration (FDA) or in Phase III clinical trials. The National Institutes of Health's Clinical Trial Registry was searched for relevant ongoing clinical trials in specific areas. Bibliographies were also searched for additional relevant material. Preference was given to recently published, larger, well-designed clinical trials that influence current prescribing practices. Phase I and II studies, and/or studies older than 10 years (ie, published earlier than 1999), were afforded less emphasis or were disregarded. Combinations of taxanes with capecitabine or gemcitabine, and ixabepilone plus capecitabine, are approved by the FDA as combination regimens for the treatment of MBC. The use of targeted therapies such as trastuzumab, bevacizumab, or lapatinib in combination with taxanes (for the former two) or capecitabine (for lapatinib) is also approved. Several investigational drug combinations are also currently undergoing evaluation in clinical trials, including combinations of bevacizumab and gemcitabine with capecitabine or alternative taxanes. Although results from Phase I and II studies are largely encouraging so far, the data from ongoing Phase III studies will ultimately dictate changes in clinical practice. It seems unlikely that any single agent or combination regimen will emerge as superior in all patients with MBC, given the heterogeneous nature of the disease and patient population. New combination regimens for MBC may broaden the range of treatment options currently available to delay disease progression for as long as possible. Copyright 2009 Excerpta Medica Inc. All rights reserved.

Medicare Long-Term CPAP Coverage Policy: A Cost-Utility Analysis

PubMed Central

Billings, Martha E.; Kapur, Vishesh K.

2013-01-01

Study Objectives: CPAP is an effective treatment for OSA that may reduce health care utilization and costs. Medicare currently reimburses the costs of long-term CPAP therapy only if the patient is adherent during a 90-day trial. If not, Medicare requires a repeat polysomnogram (PSG) and another trial which seems empirically not cost-effective. We modeled the cost-effectiveness of current Medicare policy compared to an alternative policy (clinic-only) without the adherence criterion and repeat PSG. Design: Cost-utility and cost-effectiveness analysis. Setting: U.S. Medicare Population. Patients or Participants: N/A. Interventions: N/A. Measurements and Results: We created a decision tree modeling (1) clinic only follow-up vs. (2) current Medicare policy. Costs were assigned based on Medicare reimbursement rates in 2012. Sensitivity analyses were conducted to test our assumptions. We estimated cumulative costs, overall adherence, and QALY gained for a 5-year time horizon from the perspective of Medicare as the payer. Current Medicare policy is more costly than the clinic-only policy but has higher net adherence and improved utility. Current Medicare policy compared to clinic-only policy costs $30,544 more per QALY. Conclusions: Current CMS policy promotes early identification of those more likely to adhere to CPAP therapy by requiring strict adherence standards. The policy effect is to deny coverage to those unlikely to use CPAP long-term and prevent wasted resources. Future studies are needed to measure long-term adherence in an elderly population with and without current adherence requirements to verify the cost-effectiveness of a policy change. Citation: Billings ME; Kapur VK. Medicare long-term CPAP coverage policy: a cost-utility analysis. J Clin Sleep Med 2013;9(10):1023-1029. PMID:24127146

The Italian cross-sectional survey of the management of bone metastasis: ZeTa study

PubMed Central

Santini, Daniele; Bertoldo, Francesco; Dell'Aquila, Emanuela; Cecchini, Isabella; Fregosi, Stefania; Bortolussi, Paolo

2012-01-01

Background Several studies have emphasized the importance of the maintenance of bone health in a comprehensive cancer care. However, no survey about approach to bone metastasis care is currently available. The ZeTa study provides a picture of the Italian oncologists' therapeutics habits in this area, in a real clinical-practice scenario. Design This study was based on online questionnaire-based interviews to Italian oncologists that included 145 questions. The aim was to collect information on the treatment of bone metastasis, the current use of bisphosphonates, the awareness of guidelines and the concerns about ONJ, the use of vitamin D supplementation. Results 445 oncologists were contacted, 283 agreed to participate. The results show that the current management of bone metastasis is still sub-optimal, as the recommendations from current clinical guidelines are not completely followed by all specialists. Conclusions This survey highlights the urgent need to improve management of bone metastasis in cancer patients. PMID:26909253

Current Clinical Interventions for Smoking Cessation: A Review of Empirical Studies.

ERIC Educational Resources Information Center

Marcellino, Robert Leonard, Jr.

This document reviews all empirical studies on clinically-based smoking cessation interventions that were reported in "Psychological Abstracts" between January 1982 and March 1990. Interventions are categorized as either physiological or psychological in orientation and are further grouped according to specific treatment type:…

Ischaemic conditioning: pitfalls on the path to clinical translation

PubMed Central

Przyklenk, Karin

2015-01-01

The development of novel adjuvant strategies capable of attenuating myocardial ischaemia-reperfusion injury and reducing infarct size remains a major, unmet clinical need. A wealth of preclinical evidence has established that ischaemic ‘conditioning’ is profoundly cardioprotective, and has positioned the phenomenon (in particular, the paradigms of postconditioning and remote conditioning) as the most promising and potent candidate for clinical translation identified to date. However, despite this preclinical consensus, current phase II trials have been plagued by heterogeneity, and the outcomes of recent meta-analyses have largely failed to confirm significant benefit. As a result, the path to clinical application has been perceived as ‘disappointing’ and ‘frustrating’. The goal of the current review is to discuss the pitfalls that may be stalling the successful clinical translation of ischaemic conditioning, with an emphasis on concerns regarding: (i) appropriate clinical study design and (ii) the choice of the ‘right’ preclinical models to facilitate clinical translation. PMID:25560903

Current status and future prospects of the development of clinical Pharmacy in China: A SWOT analysis.

PubMed

Rao, Yuefeng; Zhao, Qingwei; Zhang, Xiangyi; Yang, Hongyu; Lou, Yan; Zhang, Xingguo

2016-03-01

In many industrialized countries, clinical pharmacy has developed into a separate discipline and become a vital part of inpatient care in hospitals. However, as compared to many established branches of medicine, clinical pharmacy is still in its infancy, with much room for growth, improvement, and recognition by both the medical community and patients. In this study, a widely-recognized development strategy analysis tool, Strength, Weakness, Opportunity and Threat (SWOT), was used to systematically address several key issues to the development of clinical pharmacy in China. This analysis aims to provide feasible recommendations for the development of clinical pharmacy in China by identifying current problems and growth opportunities. Full development of clinical pharmacy as a mature clinical discipline will help promote the rational use of drugs by both clinicians and patients and lead to enhanced drug efficacy and safety.

Micrometastases in neuroblastoma: are they clinically important?

PubMed Central

Burchill, S A

2004-01-01

Despite advances in the treatment of neuroblastoma (NBL), recurrence and metastases continue to pose major problems in clinical management. The relation between micrometastases and the development of secondary disease is not fully understood. However, accurate methods to detect low numbers of tumour cells may allow the evaluation of their role in the disease process, and by implication the possible benefits of eliminating them. Although there is substantial evidence for the increased sensitivity of current molecular methods for the detection of NBL cells compared with more conventional cytology, the clinical relevance and usefulness of detecting this disease remain controversial. The primary goal of current translational research must be to evaluate the clinical relevance of micrometastatic disease detected by these methods in multicentre prospective clinical outcome studies. Only then can the clinical usefulness of these methods be defined so that they may be introduced into relevant clinical practice. PMID:14693828

Histone deacetylase inhibitors: current status and overview of recent clinical trials.

PubMed

Ma, Xujun; Ezzeldin, Hany H; Diasio, Robert B

2009-10-01

Histone deacetylase (HDAC) inhibitors are a new group of anticancer agents that have a potential role in the regulation of gene expression, induction of cell death, apoptosis and cell cycle arrest of cancer cells by altering the acetylation status of chromatin and other non-histone proteins. In clinical trials, HDAC inhibitors have demonstrated promising antitumour activity as monotherapy in cutaneous T-cell lymphoma and other haematological malignancies. In solid tumours, several HDAC inhibitors have been shown to be efficacious as single agents; however, results of most clinical trials were in favour of using HDAC inhibitors either prior to the initiation of chemotherapy or in combination with other treatments. Currently, the molecular basis of response to HDAC inhibitors in patients is not fully understood. In this review, we summarize the current status of HDAC inhibitors, as single agents or in combination with other agents in different phases of clinical trials. In most of the clinical trials, HDAC inhibitors were tolerable and exerted biological or antitumor activity. HDAC inhibitors have been studied in phase I, II and III clinical trials with variable efficacy. The combination of HDAC inhibitors with other anticancer agents including epigenetic or chemotherapeutic agents demonstrated favourable clinical outcome.

Meditation Awareness Training for the Treatment of Sex Addiction: A Case Study

PubMed Central

Van Gordon, William; Shonin, Edo; Griffiths, Mark D.

2016-01-01

Background Sex addiction is a disorder that can have serious adverse functional consequences. Treatment effectiveness research for sex addiction is currently underdeveloped, and interventions are generally based on the guidelines for treating other behavioral (as well as chemical) addictions. Consequently, there is a need to clinically evaluate tailored treatments that target the specific symptoms of sex addiction. It has been proposed that second-generation mindfulness-based interventions (SG-MBIs) may be an appropriate treatment for sex addiction because in addition to helping individuals increase perceptual distance from craving for desired objects and experiences, some SG-MBIs specifically contain meditations intended to undermine attachment to sex and/or the human body. The current study conducts the first clinical investigation into the utility of mindfulness for treating sex addiction. Case presentation An in-depth clinical case study was conducted involving an adult male suffering from sex addiction that underwent treatment utilizing an SG-MBI known as Meditation Awareness Training (MAT). Following completion of MAT, the participant demonstrated clinically significant improvements in addictive sexual behavior, as well as reductions in depression and psychological distress. The MAT intervention also led to improvements in sleep quality, job satisfaction, and non-attachment to self and experiences. Salutary outcomes were maintained at 6-month follow-up. Discussion and conclusion The current study extends the literature exploring the applications of mindfulness for treating behavioral addiction, and findings indicate that further clinical investigation into the role of mindfulness for treating sex addiction is warranted. PMID:27348560

Meditation Awareness Training for the Treatment of Sex Addiction: A Case Study.

PubMed

Van Gordon, William; Shonin, Edo; Griffiths, Mark D

2016-06-01

Background Sex addiction is a disorder that can have serious adverse functional consequences. Treatment effectiveness research for sex addiction is currently underdeveloped, and interventions are generally based on the guidelines for treating other behavioral (as well as chemical) addictions. Consequently, there is a need to clinically evaluate tailored treatments that target the specific symptoms of sex addiction. It has been proposed that second-generation mindfulness-based interventions (SG-MBIs) may be an appropriate treatment for sex addiction because in addition to helping individuals increase perceptual distance from craving for desired objects and experiences, some SG-MBIs specifically contain meditations intended to undermine attachment to sex and/or the human body. The current study conducts the first clinical investigation into the utility of mindfulness for treating sex addiction. Case presentation An in-depth clinical case study was conducted involving an adult male suffering from sex addiction that underwent treatment utilizing an SG-MBI known as Meditation Awareness Training (MAT). Following completion of MAT, the participant demonstrated clinically significant improvements in addictive sexual behavior, as well as reductions in depression and psychological distress. The MAT intervention also led to improvements in sleep quality, job satisfaction, and non-attachment to self and experiences. Salutary outcomes were maintained at 6-month follow-up. Discussion and conclusion The current study extends the literature exploring the applications of mindfulness for treating behavioral addiction, and findings indicate that further clinical investigation into the role of mindfulness for treating sex addiction is warranted.

Calculating Clinically Significant Change: Applications of the Clinical Global Impressions (CGI) Scale to Evaluate Client Outcomes in Private Practice

ERIC Educational Resources Information Center

Kelly, Peter James

2010-01-01

The Clinical Global Impressions (CGI) scale is a therapist-rated measure of client outcome that has been widely used within the research literature. The current study aimed to develop reliable and clinically significant change indices for the CGI, and to demonstrate its application in private psychological practice. Following the guidelines…

Criterion Validity of the Mood and Feelings Questionnaire for Depressive Episodes in Clinic and Non-Clinic Subjects

ERIC Educational Resources Information Center

Daviss, W. Burleson; Birmaher, Boris; Melhem, Nadine A.; Axelson, David A.; Michaels, Shana M.; Brent, David A.

2006-01-01

Background: Previous measures of pediatric depression have shown inconsistent validity in groups with differing demographics, comorbid diagnoses, and clinic or non-clinic origins. The current study re-examines the criterion validity of child- and parent-versions of the Mood and Feelings Questionnaire (MFQ-C, MFQ-P) in a heterogeneous sample of…

Glucagon-like peptide 1 in the pathophysiology and pharmacotherapy of clinical obesity

PubMed Central

Anandhakrishnan, Ananthi; Korbonits, Márta

2016-01-01

Though the pathophysiology of clinical obesity is undoubtedly multifaceted, several lines of clinical evidence implicate an important functional role for glucagon-like peptide 1 (GLP-1) signalling. Clinical studies assessing GLP-1 responses in normal weight and obese subjects suggest that weight gain may induce functional deficits in GLP-1 signalling that facilitates maintenance of the obesity phenotype. In addition, genetic studies implicate a possible role for altered GLP-1 signalling as a risk factor towards the development of obesity. As reductions in functional GLP-1 signalling seem to play a role in clinical obesity, the pharmacological replenishment seems a promising target for the medical management of obesity in clinical practice. GLP-1 analogue liraglutide at a high dose (3 mg/d) has shown promising results in achieving and maintaining greater weight loss in obese individuals compared to placebo control, and currently licensed anti-obesity medications. Generally well tolerated, provided that longer-term data in clinical practice supports the currently available evidence of superior short- and long-term weight loss efficacy, GLP-1 analogues provide promise towards achieving the successful, sustainable medical management of obesity that remains as yet, an unmet clinical need. PMID:28031776

Chronic traumatic encephalopathy and athletes

PubMed Central

Mannix, Rebekah; Zafonte, Ross; Pascual-Leone, Alvaro

2015-01-01

Recent case reports have described athletes previously exposed to repetitive head trauma while participating in contact sports who later in life developed mood disorders, headaches, cognitive difficulties, suicidal ideation, difficulties with speech, and aggressive behavior. Postmortem discoveries show that some of these athletes have pathologic findings that are collectively termed chronic traumatic encephalopathy (CTE). Current hypotheses suggest that concussions or perhaps blows to the head that do not cause the signs and symptoms necessary for making the diagnosis of concussion, so-called subconcussive blows, cause both the clinical and pathologic findings. There are, however, some athletes who participate in contact sports who do not develop the findings ascribed to CTE. Furthermore, there are people who have headaches, mood disorders, cognitive difficulties, suicidal ideation, and other clinical problems who have neither been exposed to repeated head trauma nor possessed the pathologic postmortem findings of those currently diagnosed with CTE. The current lack of prospective data and properly designed case-control studies limits the current understanding of CTE, leading to debate about the causes of the neuropathologic findings and the clinical observations. Given the potential for referral and recall bias in available studies, it remains unclear whether or not the pathologic findings made postmortem cause the presumed neurobehavioral sequela and whether the presumed risk factors, such as sports activity, cerebral concussions, and subconcussive blows, are solely causative of the clinical signs and symptoms. This article discusses the current evidence and the associated limitations. PMID:26253448

Chronic traumatic encephalopathy and athletes.

PubMed

Meehan, William; Mannix, Rebekah; Zafonte, Ross; Pascual-Leone, Alvaro

2015-10-27

Recent case reports have described athletes previously exposed to repetitive head trauma while participating in contact sports who later in life developed mood disorders, headaches, cognitive difficulties, suicidal ideation, difficulties with speech, and aggressive behavior. Postmortem discoveries show that some of these athletes have pathologic findings that are collectively termed chronic traumatic encephalopathy (CTE). Current hypotheses suggest that concussions or perhaps blows to the head that do not cause the signs and symptoms necessary for making the diagnosis of concussion, so-called subconcussive blows, cause both the clinical and pathologic findings. There are, however, some athletes who participate in contact sports who do not develop the findings ascribed to CTE. Furthermore, there are people who have headaches, mood disorders, cognitive difficulties, suicidal ideation, and other clinical problems who have neither been exposed to repeated head trauma nor possessed the pathologic postmortem findings of those currently diagnosed with CTE. The current lack of prospective data and properly designed case-control studies limits the current understanding of CTE, leading to debate about the causes of the neuropathologic findings and the clinical observations. Given the potential for referral and recall bias in available studies, it remains unclear whether or not the pathologic findings made postmortem cause the presumed neurobehavioral sequela and whether the presumed risk factors, such as sports activity, cerebral concussions, and subconcussive blows, are solely causative of the clinical signs and symptoms. This article discusses the current evidence and the associated limitations. © 2015 American Academy of Neurology.

Current progress in patient-specific modeling

PubMed Central

2010-01-01

We present a survey of recent advancements in the emerging field of patient-specific modeling (PSM). Researchers in this field are currently simulating a wide variety of tissue and organ dynamics to address challenges in various clinical domains. The majority of this research employs three-dimensional, image-based modeling techniques. Recent PSM publications mostly represent feasibility or preliminary validation studies on modeling technologies, and these systems will require further clinical validation and usability testing before they can become a standard of care. We anticipate that with further testing and research, PSM-derived technologies will eventually become valuable, versatile clinical tools. PMID:19955236

New viruses for cancer therapy: meeting clinical needs

PubMed Central

Miest, Tanner S.; Cattaneo, Roberto

2014-01-01

Early-stage clinical trials of oncolytic virotherapy have reported the safety of several virus platforms, and viruses from three families have progressed to advanced efficacy trials. In addition, preclinical studies have established proof-of-principle for many new genetic engineering strategies. Thus, the virotherapy field now has available a diverse collection of viruses that are equipped to address unmet clinical needs owing to improved systemic administration, greater tumour specificity and enhanced oncolytic efficacy. The current key challenge for the field is to develop viruses that replicate with greater efficiency within tumours while achieving therapeutic synergy with currently available treatments. PMID:24292552

Psychological and Social Predictors of Suicidal Ideation among Young Adolescents

ERIC Educational Resources Information Center

Kirkcaldy, Bruce D.; Eysenck, Michael W.; Siefen, Georg R.

2004-01-01

Although there is an enormous amount of literature demonstrating socio-psychological determinants of suicide and self-injurious behaviour among adults or clinical samples of children and adolescents, there is a scarcity of studies focussing on non-clinical adolescent samples. The current study examined associations between self-reported data on…

Aggressive behavior and anaplasia in pleomorphic xanthoastrocytoma: a plea for a revision of the current WHO classification.

PubMed

Kahramancetin, Nesibe; Tihan, Tarik

2013-11-01

Pleomorphic xanthoastrocytoma (PXA) is a rare astrocytic neoplasm that commonly affects children and young adults, and presents with seizures. PXA is typically supratentorial with a predilection to the temporal lobe, and often involves the cortex and the meninges. PXAs have a favorable prognosis with a 10-year survival probability of >70%, and are WHO grade II neoplasms. Recent observations and studies demonstrate that PXAs are clinically, histologically and genetically distinct. Some PXAs recur and exhibit aggressive clinical behavior. In such cases, certain histological and clinical factors could account for the aggressive behavior. However, the histological features that predict adverse outcome are poorly defined. In the current WHO classification of CNS tumors, there is no option for a high-grade PXA, even if the tumor had numerous recurrences and poor outcome. In this review, we focus on aggressive clinical behavior and anaplasia in PXA, and discuss how our current experience suggests modifications in the current WHO classification. We also review recent discoveries on the molecular characteristics of PXA that could help us better understand their biological behavior.

Beyond journal publications - a new format for the publication of clinical trials.

PubMed

Wieseler, Beate

2017-02-01

Journal publications are the major route to communicate methods and results of clinical trials. However, the shortcomings of this format are well known, including insufficient quality of the information provided as well as publication and outcome reporting bias. Attempts to improve the situation via peer review, reporting guidelines or study registration did not solve the problem. Currently, new ways of data presentation in electronic databases, increased access to previously confidential documents, and the potential use of anonymized individual patient data from clinical trials beyond the individual trial, have led to discussions about new publication formats for clinical trials. The current paper describes the components required for full information on a clinical trial and discusses a new format to provide this information. Copyright © 2016. Published by Elsevier GmbH.

Redesign of a computerized clinical reminder for colorectal cancer screening: a human-computer interaction evaluation

PubMed Central

2011-01-01

Background Based on barriers to the use of computerized clinical decision support (CDS) learned in an earlier field study, we prototyped design enhancements to the Veterans Health Administration's (VHA's) colorectal cancer (CRC) screening clinical reminder to compare against the VHA's current CRC reminder. Methods In a controlled simulation experiment, 12 primary care providers (PCPs) used prototypes of the current and redesigned CRC screening reminder in a within-subject comparison. Quantitative measurements were based on a usability survey, workload assessment instrument, and workflow integration survey. We also collected qualitative data on both designs. Results Design enhancements to the VHA's existing CRC screening clinical reminder positively impacted aspects of usability and workflow integration but not workload. The qualitative analysis revealed broad support across participants for the design enhancements with specific suggestions for improving the reminder further. Conclusions This study demonstrates the value of a human-computer interaction evaluation in informing the redesign of information tools to foster uptake, integration into workflow, and use in clinical practice. PMID:22126324

The facial nerve: anatomy and associated disorders for oral health professionals.

PubMed

Takezawa, Kojiro; Townsend, Grant; Ghabriel, Mounir

2018-04-01

The facial nerve, the seventh cranial nerve, is of great clinical significance to oral health professionals. Most published literature either addresses the central connections of the nerve or its peripheral distribution but few integrate both of these components and also highlight the main disorders affecting the nerve that have clinical implications in dentistry. The aim of the current study is to provide a comprehensive description of the facial nerve. Multiple aspects of the facial nerve are discussed and integrated, including its neuroanatomy, functional anatomy, gross anatomy, clinical problems that may involve the nerve, and the use of detailed anatomical knowledge in the diagnosis of the site of facial nerve lesion in clinical neurology. Examples are provided of disorders that can affect the facial nerve during its intra-cranial, intra-temporal and extra-cranial pathways, and key aspects of clinical management are discussed. The current study is complemented by original detailed dissections and sketches that highlight key anatomical features and emphasise the extent and nature of anatomical variations displayed by the facial nerve.

Is the Construct of Relapse Heuristic, and Does It Advance Alcohol Use Disorder Clinical Practice?

PubMed Central

Maisto, Stephen A.; Witkiewitz, Katie; Moskal, Dezarie; Wilson, Adam D.

2016-01-01

Objective: Alcohol use disorder (AUD) relapse is a construct that has been of major clinical and research interest but has been inconsistently defined. The purpose of this study was to review the definitions of AUD relapse that have been used in clinical research as a basis for drawing conclusions about its heuristic value. Method: A systematic review of the literature was conducted on empirical studies that (a) were published in peer-reviewed journals, (b) were published between 2010 and 2015, (c) were written in English, and (d) provided a definition of alcohol relapse (or lapse) that was used in the study. Results: The review yielded 139 individual studies that met inclusion criteria. The studies showed wide variability in how relapse was defined and interpreted in the literature, and there was little direct empirical or theoretical rationale provided for the definitions of relapse that were chosen. Furthermore, the concept of AUD relapse as a discrete state is not consistent with the empirical literature on the clinical course of alcohol consumption. Conclusions: We conclude that the heuristic value of AUD relapse as currently studied is low. An alternative approach that embeds the construct in theory and data on the clinical course of alcohol consumption and aligns with current trends in healthcare would seem to have a better chance of improving AUD clinical decision-making and knowledge about AUD in general. PMID:27797685

Is the Construct of Relapse Heuristic, and Does It Advance Alcohol Use Disorder Clinical Practice?

PubMed

Maisto, Stephen A; Witkiewitz, Katie; Moskal, Dezarie; Wilson, Adam D

2016-11-01

Alcohol use disorder (AUD) relapse is a construct that has been of major clinical and research interest but has been inconsistently defined. The purpose of this study was to review the definitions of AUD relapse that have been used in clinical research as a basis for drawing conclusions about its heuristic value. A systematic review of the literature was conducted on empirical studies that (a) were published in peer-reviewed journals, (b) were published between 2010 and 2015, (c) were written in English, and (d) provided a definition of alcohol relapse (or lapse) that was used in the study. The review yielded 139 individual studies that met inclusion criteria. The studies showed wide variability in how relapse was defined and interpreted in the literature, and there was little direct empirical or theoretical rationale provided for the definitions of relapse that were chosen. Furthermore, the concept of AUD relapse as a discrete state is not consistent with the empirical literature on the clinical course of alcohol consumption. We conclude that the heuristic value of AUD relapse as currently studied is low. An alternative approach that embeds the construct in theory and data on the clinical course of alcohol consumption and aligns with current trends in healthcare would seem to have a better chance of improving AUD clinical decision-making and knowledge about AUD in general.

Platinum, palladium, gold and ruthenium complexes as anticancer agents: Current clinical uses, cytotoxicity studies and future perspectives.

PubMed

Lazarević, Tatjana; Rilak, Ana; Bugarčić, Živadin D

2017-12-15

Metallodrugs offer potential for unique mechanism of drug action based on the choice of the metal, its oxidation state, the types and number of coordinated ligands and the coordination geometry. This review illustrates notable recent progress in the field of medicinal bioinorganic chemistry as many new approaches to the design of innovative metal-based anticancer drugs are emerging. Current research addressing the problems associated with platinum drugs has focused on other metal-based therapeutics that have different modes of action and on prodrug and targeting strategies in an effort to diminish the side-effects of cisplatin chemotherapy. Examples of metal compounds and chelating agents currently in clinical use, clinical trials or preclinical development are highlighted. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Agreement between clinical and MINI diagnoses in outpatients with mood and anxiety disorders.

PubMed

Verhoeven, F E A; Swaab, L S M A; Carlier, I V E; van Hemert, A M; Zitman, F G; Ruhé, H G; Schoevers, R A; Giltay, E J

2017-10-15

Standardized Diagnostic Interviews (SDIs) such as the Mini International Neuropsychiatric Interview (MINI) are widely used to systematically screen for psychiatric disorders in research. To support generalizability of results to clinical practice, we assessed agreement between the MINI and clinical diagnoses. Agreement was assessed in a large, real life dataset (n = 7016) using concordance statistics such as sensitivity, specificity, efficiency and area under the curve (AUC). 41.5% of clinical diagnoses were mood disorders, 26.5% were anxiety disorders. Overall, we found moderate agreement between MINI and clinical diagnoses (median efficiency: 0.92, median AUC: 0.79). For mood disorders, the AUC for all participants showed a range between 0.55 and 0.81 (median: 0.73), and for anxiety disorders the AUC ranged from 0.78 to 0.88 (median: 0.83). The AUC showed better agreement for mood disorders in the single diagnosis group than in the total group (median 0.77 vs. 0.71). For anxiety disorders, the AUC for the single diagnosis group was comparable to the AUC of the total group (median: 0.81 vs. 0.83 respectively). Numbers of false positives were high for both mood and anxiety diagnoses, but less so in the single diagnosis group. Time lag between MINI and clinical diagnosis, the availability of only the primary clinical diagnosis, and relatively high severity of the current sample are limitations of the current study. Agreement between MINI and clinical diagnoses was moderate at best, which partly reflects the difference between the different measures used in the current study. Copyright © 2017 Elsevier B.V. All rights reserved.

Sole Dependence on Urine Testing Strips and the Ability to Identify Clinically Significant Disease: Challenging the Current Paradigm for Heme Detection in General Clinical Situations.

PubMed

Rothschild, Bruce

2016-05-01

The ability of health care professionals to provide patient care is potentially compromised when predicated on untested, although longstanding, perspectives. One such example is urinalysis testing, which has been currently simplified to use only urine testing strips for detection of microscopic hematuria. To determine whether urine testing strips are sufficient for identification of clinically significant findings in urinalysis. To determine the presence of microscopic hematuria, I examined a collection of urine specimens that had tested heme negative during the 3-month study period. Of the 342 patients from whom urine specimens were examined during this interval, 50 had microscopic hematuria, despite having tested negative for heme via urine testing strip. Also, 30% were not receiving any medication known to produce microscopic hematuria, and 18% had clinically significant pathology. Diagnosis of significant clinical pathologic manifestations would have been compromised had microscopic examination not been performed on the urine specimens from the cohort individuals. Examination of the novel approach of including microscopic examination of specimens in a specific clinical situation challenges the dominant paradigm of reliance on assaying using urine testing strips only, revealing that the current method is not only unreliable for determining microscopic hematuria but also is less than optimal in general clinical practice. The findings of this study provide evidence of the importance of microscopic evaluation as a routine component of urinalysis. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Current Awareness and Use of the Strain Echocardiography in Routine Clinical Practices: Result of a Nationwide Survey in Korea.

PubMed

Lee, Ju-Hee; Park, Jae-Hyeong; Park, Seung Woo; Kim, Woo-Shik; Sohn, Il Suk; Chin, Jung Yeon; Cho, Jung Sun; Youn, Ho-Joong; Jung, Hae Ok; Lee, Sun Hwa; Kim, Seong-Hwan; Chung, Wook-Jin; Shim, Chi Young; Jeong, Jin-Won; Choi, Eui-Young; Rim, Se-Joong; Kim, Jang-Young; Kim, Kye Hun; Shin, Joon-Han; Kim, Dae-Hee; Jeon, Ung; Choi, Jung Hyun; Kim, Yong-Jin; Joo, Seung Jae; Kim, Ki-Hong; Cho, Kyoung Im; Cho, Goo-Yeong

2017-09-01

Because conventional echocardiographic parameters have several limitations, strain echocardiography has often been introduced in clinical practice. However, there are also obstacles in using it in clinical practice. Therefore, we wanted to find the current status of awareness on using strain echocardiography in Korea. We conducted a nationwide survey to evaluate current use and awareness of strain echocardiography from the members of the Korean Society of Echocardiography. We gathered total 321 questionnaires from 25 cardiology centers in Korea. All participants were able to perform or interpret echocardiographic examinations. All participating institutions performed strain echocardiography. Most of our study participants (97%) were aware of speckle tracking echocardiography and 185 (58%) performed it for clinical and research purposes. Two-dimensional strain echocardiography was the most commonly used modality and left ventricle (LV) was the most commonly used cardiac chamber (99%) for clinical purposes. Most of the participants (89%) did not think LV strain can replace LV ejection fraction (LVEF) in their clinical practice. The common reasons for not performing routine use of strain echocardiography was diversity of strain measurements and lack of normal reference value. Many participants had a favorable view of the future of strain echocardiography. Most of our study participants were aware of strain echocardiography, and all institutions performed strain echocardiography for clinical and research purposes. However, they did not think the LV strain values could replace LVEF. The diversity of strain measurements and lack of normal reference values were common reasons for not using strain echocardiography in clinical practice.

Volumetric modulated arc therapy for treatment of solid tumors: current insights

PubMed Central

Macchia, Gabriella; Deodato, Francesco; Cilla, Savino; Cammelli, Silvia; Guido, Alessandra; Ferioli, Martina; Siepe, Giambattista; Valentini, Vincenzo; Morganti, Alessio Giuseppe; Ferrandina, Gabriella

2017-01-01

Aim This article discusses the current use of volumetric modulated arc therapy (VMAT) techniques in clinical practice and reviews the available data from clinical outcome studies in different clinical settings. An overview of available literature about clinical outcomes with VMAT stereotactic/radiosurgical treatment is also reported. Materials and methods All published manuscripts reporting the use of VMAT in a clinical setting from 2009 to November 2016 were identified. The search was carried out in December 2016 using the National Library of Medicine (PubMed/Medline). The following words were searched: “volumetric arc therapy”[All Fields] OR “vmat”[All Fields] OR “rapidarc”[All Fields], AND “radiotherapy”[All Fields] AND “Clinical Trial”[All Fields]. Results Overall, 37 studies (21 prospective and 16 retrospective) fulfilling inclusion criteria and thus included in the review evaluated 2,029 patients treated with VMAT; of these patients, ~30.8% had genitourinary (GU) tumors (81% prostate, 19% endometrial), 26.2% head-and-neck cancer (H&NC), 13.9% oligometastases, 11.2% had anorectal cancer, 10.6% thoracic neoplasms (81% breast, 19% lung), and 7.0% brain metastases (BMs). Six different clinical scenarios for VMAT use were identified: 1) BMs, 2) H&NC, 3) thoracic neoplasms, 4) GU cancer, 5) anorectal tumor, and 6) stereotactic body radiation therapy (SBRT) performed by VMAT technique in the oligometastatic patient setting. Conclusion The literature addressing the clinical appropriateness of VMAT is scarce. Current literature suggests that VMAT, especially when used as simultaneous integrated boost or SBRT strategy, is an effective safe modality for all cancer types. PMID:28794640

Complement inhibition in pre-clinical models of periodontitis and prospects for clinical application.

PubMed

Hajishengallis, George; Hajishengallis, Evlambia; Kajikawa, Tetsuhiro; Wang, Baomei; Yancopoulou, Despina; Ricklin, Daniel; Lambris, John D

2016-06-01

Periodontitis is a dysbiotic inflammatory disease leading to the destruction of the tooth-supporting tissues. Current therapies are not always effective and this prevalent oral disease continues to be a significant health and economic burden. Early clinical studies have associated periodontitis with elevated complement activity. Consistently, subsequent genetic and pharmacological studies in rodents have implicated the central complement component C3 and downstream signaling pathways in periodontal host-microbe interactions that promote dysbiosis and inflammatory bone loss. This review discusses these mechanistic advances and moreover focuses on the compstatin family of C3 inhibitors as a novel approach to treat periodontitis. In this regard, local application of the current lead analog Cp40 was recently shown to block both inducible and naturally occurring periodontitis in non-human primates. These promising results from non-human primate studies and the parallel development of Cp40 for clinical use highlight the feasibility for developing an adjunctive, C3-targeted therapy for human periodontitis. Copyright © 2016 Elsevier Ltd. All rights reserved.

Base rate of performance invalidity among non-clinical undergraduate research participants.

PubMed

Silk-Eglit, Graham M; Stenclik, Jessica H; Gavett, Brandon E; Adams, Jason W; Lynch, Julie K; Mccaffrey, Robert J

2014-08-01

Neuropsychological research frequently uses non-clinical undergraduate participants to evaluate neuropsychological tests. However, a recent study by An and colleagues (2012, Archives of Clinical Neuropsychology, 27, 849-857) called into question that the extent to which the interpretation of these participants' performance on neuropsychological tests is valid. This study found that in a sample of 36 participants, 55.6% exhibited performance invalidity at an initial session and 30.8% exhibited performance invalidity at a follow-up session. The current study attempted to replicate these findings in a larger, more representative sample using a more rigorous methodology. Archival data from 133 non-clinical undergraduate research participants were analyzed. Participants were classified as performance invalid if they failed any one PVT. In the current sample, only 2.26% of participants exhibited performance invalidity. Thus, concerns regarding insufficient effort and performance invalidity when using undergraduate research participants appear to be overstated. © The Author 2014. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Estimating reliable paediatric reference intervals in clinical chemistry and haematology.

PubMed

Ridefelt, Peter; Hellberg, Dan; Aldrimer, Mattias; Gustafsson, Jan

2014-01-01

Very few high-quality studies on paediatric reference intervals for general clinical chemistry and haematology analytes have been performed. Three recent prospective community-based projects utilising blood samples from healthy children in Sweden, Denmark and Canada have substantially improved the situation. The present review summarises current reference interval studies for common clinical chemistry and haematology analyses. ©2013 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

A Comparative Study of Adolescent Risk Assessment Instruments: Predictive and Incremental Validity

ERIC Educational Resources Information Center

Welsh, Jennifer L.; Schmidt, Fred; McKinnon, Lauren; Chattha, H. K.; Meyers, Joanna R.

2008-01-01

Promising new adolescent risk assessment tools are being incorporated into clinical practice but currently possess limited evidence of predictive validity regarding their individual and/or combined use in risk assessments. The current study compares three structured adolescent risk instruments, Youth Level of Service/Case Management Inventory…

Neurocognitive Features of Attention Deficit Hyperactivity Disorder in a Non-Clinical Adult Sample

DTIC Science & Technology

2004-01-01

samples. Whether these cognitive weaknesses are associated with ADHD symptoms in non-clinical samples is unknown. The current study examined the...relationship between ADHD symptoms and cognitive performance in a non-clinical adult sample of 75 men and women (ages 20 to 49). Self-report measures of ADHD

[Support Team for Investigator-Initiated Clinical Research].

PubMed

Fujii, Hisako

2017-07-01

Investigator-initiated clinical research is that in which investigators plan and carry out their own clinical research in academia. For large-scale clinical research, a team should be organized and implemented. This team should include investigators and supporting staff, who will promote smooth research performance by fulfilling their respective roles. The supporting staff should include project managers, administrative personnel, billing personnel, data managers, and clinical research coordinators. In this article, I will present the current status of clinical research support and introduce the research organization of the Dominantly Inherited Alzheimer Network (DIAN) study, an investigator-initiated international clinical research study, with particular emphasis on the role of the project management staff and clinical research coordinators.

Exclusion of Older Patients From Ongoing Clinical Trials for Hematological Malignancies: An Evaluation of the National Institutes of Health Clinical Trial Registry

PubMed Central

Stauder, Reinhard; van Munster, Barbara C.

2014-01-01

Introduction. Cancer societies, research cooperatives, and countless publications have urged the development of clinical trials that facilitate the inclusion of older patients and those with comorbidities. We set out to determine the characteristics of currently recruiting clinical trials with hematological patients to assess their inclusion and exclusion of elderly patients. Methods. The NIH clinical trial registry was searched on July 1, 2013, for currently recruiting phase I, II or III clinical trials with hematological malignancies. Trial characteristics and study objectives were extracted from the registry website. Results. Although 5% of 1,207 included trials focused exclusively on elderly or unfit patients, 69% explicitly or implicitly excluded older patients. Exclusion based on age was seen in 27% of trials, exclusion based on performance status was seen in 16%, and exclusion based on stringent organ function restrictions was noted in 51%. One-third of the studies that excluded older patients based on age allowed inclusion of younger patients with poor performance status; 8% did not place any restrictions on organ function. Over time, there was a shift from exclusion based on age (p value for trend <.001) toward exclusion based on organ function (p = .2). Industry-sponsored studies were least likely to exclude older patients (p < .001). Conclusion. Notably, 27% of currently recruiting clinical trials for hematological malignancies use age-based exclusion criteria. Although physiological reserves diminish with age, the heterogeneity of the elderly population does not legitimize exclusion based on chronological age alone. Investigators should critically review whether sufficient justification exists for every exclusion criterion before incorporating it in trial protocols. PMID:25170014

Exclusion of older patients from ongoing clinical trials for hematological malignancies: an evaluation of the National Institutes of Health Clinical Trial Registry.

PubMed

Hamaker, Marije E; Stauder, Reinhard; van Munster, Barbara C

2014-10-01

Cancer societies, research cooperatives, and countless publications have urged the development of clinical trials that facilitate the inclusion of older patients and those with comorbidities. We set out to determine the characteristics of currently recruiting clinical trials with hematological patients to assess their inclusion and exclusion of elderly patients. The NIH clinical trial registry was searched on July 1, 2013, for currently recruiting phase I, II or III clinical trials with hematological malignancies. Trial characteristics and study objectives were extracted from the registry website. Although 5% of 1,207 included trials focused exclusively on elderly or unfit patients, 69% explicitly or implicitly excluded older patients. Exclusion based on age was seen in 27% of trials, exclusion based on performance status was seen in 16%, and exclusion based on stringent organ function restrictions was noted in 51%. One-third of the studies that excluded older patients based on age allowed inclusion of younger patients with poor performance status; 8% did not place any restrictions on organ function. Over time, there was a shift from exclusion based on age (p value for trend <.001) toward exclusion based on organ function (p = .2). Industry-sponsored studies were least likely to exclude older patients (p < .001). Notably, 27% of currently recruiting clinical trials for hematological malignancies use age-based exclusion criteria. Although physiological reserves diminish with age, the heterogeneity of the elderly population does not legitimize exclusion based on chronological age alone. Investigators should critically review whether sufficient justification exists for every exclusion criterion before incorporating it in trial protocols. ©AlphaMed Press.

Current Status and Clinical Studies of Oriental Herbs in Sexual Medicine in Korea

PubMed Central

Shin, Yu Seob; Zhao, Chen; Zhang, Li Tao

2015-01-01

Erectile dysfunction (ED) is one of the most common diseases among aging men. Although previous studies have shown that type 5 phosphodiesterase inhibitors (PDE5-Is) are very effective for the treatment of ED, many researchers are currently attempting to identify therapeutic agents from natural sources with comparable or better effects than PDE5-Is. Herbal medicine is thought to be advantageous because it is natural; moreover, it not only treats isolated symptoms, but also maintains general well-being. Furthermore, since newly created chemical compound libraries have limited structural diversity with regard to pharmaceutical agents, more attention has recently been paid to the ability of oriental herbs to enhance physical health, including sexual function. Herein, we review the current status of Korean preclinical or clinical studies of the application of oriental herbs to sexual medicine. PMID:26331122

The Abbott RealTime High Risk HPV test is a clinically validated human papillomavirus assay for triage in the referral population and use in primary cervical cancer screening in women 30 years and older: a review of validation studies.

PubMed

Poljak, Mario; Oštrbenk, Anja

2013-01-01

Human papillomavirus (HPV) testing has become an essential part of current clinical practice in the management of cervical cancer and precancerous lesions. We reviewed the most important validation studies of a next-generation real-time polymerase chain reaction-based assay, the RealTime High Risk HPV test (RealTime)(Abbott Molecular, Des Plaines, IL, USA), for triage in referral population settings and for use in primary cervical cancer screening in women 30 years and older published in peer-reviewed journals from 2009 to 2013. RealTime is designed to detect 14 high-risk HPV genotypes with concurrent distinction of HPV-16 and HPV-18 from 12 other HPV genotypes. The test was launched on the European market in January 2009 and is currently used in many laboratories worldwide for routine detection of HPV. We concisely reviewed validation studies of a next-generation real-time polymerase chain reaction (PCR)-based assay: the Abbott RealTime High Risk HPV test. Eight validation studies of RealTime in referral settings showed its consistently high absolute clinical sensitivity for both CIN2+ (range 88.3-100%) and CIN3+ (range 93.0-100%), as well as comparative clinical sensitivity relative to the currently most widely used HPV test: the Qiagen/Digene Hybrid Capture 2 HPV DNA Test (HC2). Due to the significantly different composition of the referral populations, RealTime absolute clinical specificity for CIN2+ and CIN3+ varied greatly across studies, but was comparable relative to HC2. Four validation studies of RealTime performance in cervical cancer screening settings showed its consistently high absolute clinical sensitivity for both CIN2+ and CIN3+, as well as comparative clinical sensitivity and specificity relative to HC2 and GP5+/6+ PCR. RealTime has been extensively evaluated in the last 4 years. RealTime can be considered clinically validated for triage in referral population settings and for use in primary cervical cancer screening in women 30 years and older.

An assessment of the current treatment landscape for rheumatology patients in Qatar: Recognising unmet needs and moving towards solutions.

PubMed

Emadi, Samar Al; Hammoudeh, Mohammed; Mounir, Mohamed; Mueller, Ruediger B; Wells, Alvin F; Sarakbi, Housam Aldeen

2017-04-01

Objective This study assessed the mode of application (oral, intravenous or subcutaneous (SC)) currently employed in the treatment of rheumatoid arthritis (RA) in patients from Qatar in comparison with patients' individual preferences for the mode of application of their treatment. Methods This study included 294 RA patients visiting three clinics at the main referral hospital in Qatar who were interviewed using a standard questionnaire to determine their preference of mode of application for their disease-modifying antirheumatic drug (DMARD) treatment in relation to their currently employed mode of application. Results The majority of patients were female (76%), and 93% of male patients and 61% of female patients in the study clinics were of a nationality other than Qatari. The highest patient preference recorded was for an oral therapy (69%), compared with injection (23%) and intravenous (8%) therapy. In total, 85% of patients expressed a preference to remain on oral therapy compared with 63% and 58% of intravenous and SC injection patients indicating a preference to remain on their current method of administration. Conclusions This high preference for oral therapies highlights the considerable need for incorporation of new oral targeted synthetic DMARD therapies into clinical practice within the region.

An assessment of the current treatment landscape for rheumatology patients in Qatar: Recognising unmet needs and moving towards solutions

PubMed Central

Hammoudeh, Mohammed; Mounir, Mohamed; Mueller, Ruediger B.; Wells, Alvin F.; Sarakbi, Housam Aldeen

2017-01-01

Objective This study assessed the mode of application (oral, intravenous or subcutaneous (SC)) currently employed in the treatment of rheumatoid arthritis (RA) in patients from Qatar in comparison with patients’ individual preferences for the mode of application of their treatment. Methods This study included 294 RA patients visiting three clinics at the main referral hospital in Qatar who were interviewed using a standard questionnaire to determine their preference of mode of application for their disease-modifying antirheumatic drug (DMARD) treatment in relation to their currently employed mode of application. Results The majority of patients were female (76%), and 93% of male patients and 61% of female patients in the study clinics were of a nationality other than Qatari. The highest patient preference recorded was for an oral therapy (69%), compared with injection (23%) and intravenous (8%) therapy. In total, 85% of patients expressed a preference to remain on oral therapy compared with 63% and 58% of intravenous and SC injection patients indicating a preference to remain on their current method of administration. Conclusions This high preference for oral therapies highlights the considerable need for incorporation of new oral targeted synthetic DMARD therapies into clinical practice within the region. PMID:28415924

Divergences between clinical and research methods for assessing personality disorders: implications for research and the evolution of axis II.

PubMed

Westen, D

1997-07-01

The purpose of this study was to examine the extent to which instruments for assessing axis II diverge from clinical diagnostic processes. Subjects in the first study were 52 clinicians with experience in assessment and treatment of patients with personality disorders, who were surveyed about the methods they use in clinical practice to make diagnoses and other aspects of the diagnostic process. A second study replicated the major findings with a random national sample of 1,901 experienced psychiatrists and psychologists. Whereas current instruments rely primarily on direct questions derived from DSM-IV, clinicians of every theoretical persuasion found direct questions useful for assessing axis I disorders but only marginally so for axis II. They made axis II diagnoses, instead, by listening to patients describe interpersonal interactions and observing their behavior with the interviewer. In contrast to findings with current research instruments, most patients with personality disorders in clinical practice receive only one axis II diagnosis, and if they receive more than one, one is considered primary. Clinicians reported treating a substantial number of patients for enduring personality patterns that current axis II instruments do not assess, many of which meet neither axis I nor axis II criteria, notably problems with relatedness, work, self-esteem, and chronic subclinical depressive traits. Measurements of axis II were constructed by using a model derived from axis I instruments that diverges from clinical diagnostic procedures in a way that may be problematic for the assessment of personality disorders and the development of a more clinically and empirically sound taxonomy.

Data standards for clinical research data collection forms: current status and challenges.

PubMed

Richesson, Rachel L; Nadkarni, Prakash

2011-05-01

Case report forms (CRFs) are used for structured-data collection in clinical research studies. Existing CRF-related standards encompass structural features of forms and data items, content standards, and specifications for using terminologies. This paper reviews existing standards and discusses their current limitations. Because clinical research is highly protocol-specific, forms-development processes are more easily standardized than is CRF content. Tools that support retrieval and reuse of existing items will enable standards adoption in clinical research applications. Such tools will depend upon formal relationships between items and terminological standards. Future standards adoption will depend upon standardized approaches for bridging generic structural standards and domain-specific content standards. Clinical research informatics can help define tools requirements in terms of workflow support for research activities, reconcile the perspectives of varied clinical research stakeholders, and coordinate standards efforts toward interoperability across healthcare and research data collection.

From Cannabis to Cannabidiol to Treat Epilepsy, Where Are We?

PubMed

Lippiello, Pellegrino; Balestrini, Simona; Leo, Antonio; Coppola, Antonietta; Citraro, Rita; Elia, Maurizio; Russo, Emilio; De Sarro, Giovambattista

2016-01-01

Several antiepileptic drugs (AEDs), about 25, are currently clinically available for the treatment of patients with epilepsy. Despite this armamentarium and the many recently introduced AEDs, no major advances have been achieved considering the number of drug resistant patients, while many benefits have been indeed obtained for other clinical outcomes (e.g. better tolerability, less interactions). Cannabinoids have long been studied for their potential therapeutical use and more recently phytocannabinoids have been considered a valuable tool for the treatment of several neurological disorders including epilepsy. Among this wide class, the most studied is cannabidiol (CBD) considering its lack of psychotropic effects and its anticonvulsant properties. Analyse the currently available literature on CBD also in light of other data on phytocannabinoids, reviewing data spanning from the mechanism of action, pharmacokinetic to clinical evidences. Several preclinical studies have tried to understand the mechanism of action of CBD, which still remains largely not understood. CBD has shown significant anticonvulsant effects mainly in acute animal models of seizures; beneficial effects were reported also in animal models of epileptogenesis and chronic models of epilepsy, although not substantial. In contrast, data coming from some studies raise questions on the effects of other cannabinoids and above all marijuana. There is indeed sufficient supporting data for clinical development and important antiepileptic effects and the currently ongoing clinical studies will permit the real usefulness of CBD and possibly other cannabinoids. Undoubtedly, several issues also need to be addressed in the next future (e.g. better pharmacokinetic profiling). Finally, shading light on the mechanism of action and the study of other cannabinoids might represent an advantage for future developments. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

A clinical protocol to increase chewing and assess mastication in children with feeding disorders.

PubMed

Volkert, Valerie M; Peterson, Kathryn M; Zeleny, Jason R; Piazza, Cathleen C

2014-09-01

Children with feeding disorders often cannot or do not chew when presented with table food. Children with chewing deficits also often swallow the bite before masticating it appropriately, which we will refer to as early swallowing. In the current study, we evaluated a clinical protocol to increase chews per bite, assess mastication, and eliminate early swallowing with three children with feeding disorders. The current study adds to a small body of literature on chewing and mastication of children with feeding disorders. Suggestions for future research are also discussed. © The Author(s) 2014.

Maintaining capacity for in-practice teaching and supervision of students and general practice trainees: a cross-sectional study of early career general practitioners.

PubMed

Catzikiris, Nigel; Tapley, Amanda; Morgan, Simon; Holliday, Elizabeth G; Ball, Jean; Henderson, Kim; Elliott, Taryn; Spike, Neil; Regan, Cathy; Magin, Parker

2017-08-10

Objectives Expanding learner cohorts of medical students and general practitioner (GP) vocational trainees and the impending retirement of the 'baby boomer' GP cohort threaten the teaching and supervisory capacity of the Australian GP workforce. Engaging newly qualified GPs is essential to sustaining this workforce training capacity. The aim of the present study was to establish the prevalence and associations of in-practice clinical teaching and supervision in early career GPs. Methods The present study was a cross-sectional questionnaire-based study of recent (within 5 years) alumni of three of Australia's 17 regional general practice training programs. The outcome factor was whether the alumnus taught or supervised medical students, GP registrars or other learners in their current practice. Logistic regression analysis was used to establish associations of teaching and supervision with independent variables comprising alumnus demographics, current practice characteristics and vocational training experiences. Results In all, 230 alumni returned questionnaires (response rate 37.4%). Of currently practising alumni, 52.4% (95% confidence interval (CI) 45.6-59.0%) reported current teaching or supervisory activities. Factors significantly (P<0.05) associated with alumni currently undertaking in-practice clinical teaching and supervision were: Australian medical graduation (odds ratio (OR) for international graduates 0.36; 95% CI 0.14-0.92), working in a regional or remote area (OR 2.75; 95% CI 1.24-6.11) and currently undertaking nursing home visits, home visits or after-hours work (OR 2.01; CI 1.02-3.94). Conclusions Rural-urban and country-of-graduation differences in the engagement of early career GPs in practice-based apprenticeship-like teaching or training should inform strategies to maintain workforce training capacity. What is known about the topic? Projected changes in the demand for and supply of clinical teaching and supervision within Australian general practice will require greater uptake of teaching and supervision by recently qualified GPs to ensure sustainability of this teaching model. Although interest in and undertaking of teaching roles have been documented for GP or family medicine trainees, studies investigating the engagement in these clinical roles by GPs during their early post-training period are lacking. What does this paper add? This paper is the first to document the prevalence of teaching and supervision undertaken by early career GPs as part of their regular clinical practice. We also demonstrate associations of practice rurality, country of medical graduation and undertaking non-practice-based clinical roles with GPs' engagement in teaching and supervisory roles. What are the implications for practitioners? Establishing current teaching patterns of GPs enables appropriate targeting of new strategies to sustain an effective teaching and supervisory capacity within general practice. The findings of the present study suggest that exploring focused strategies to facilitate and support international medical graduates to engage in teaching during their vocational training, aided by focused supervisor support, may be of particular value.

Chinese and Vietnamese adult male smokers' perspectives regarding facilitators of tobacco cessation behavior.

PubMed

Spigner, Clarence; Yip, Mei-Po; Huang, Bu; Tu, Shin Ping

2007-01-01

National surveys show a low prevalence of tobacco cigarette smoking within the Asian American/Pacific Islander population. However, smoking rates loom higher when data is disaggregated by ethnicity and gender. Nevertheless, few data are available on how smokers in this population quit smoking. The aim of this study was to collect first-hand perspectives from adult male Chinese and Vietnamese current and former smokers who were patients at a community clinic in Seattle, Washington, in order to understand the facilitators toward smoking cessation and the methods that they might use to quit smoking. A telephone survey was administered to age-eligible male Chinese and Vietnamese clinic patients who were current or former smokers. A total of 196 Chinese and 198 Vietnamese (N=394) adult male current and former smokers were contacted from a pool culled from the clinic database. Descriptive analysis using SPSS software revealed ethnicity-specific differences between current and former smokers regarding influences on smoking cessation behavior as well as uptake and endorsement of cessation methods. Family encouragement and physician recommendations were significant facilitators on the cessation process. Will power and self-determination were frequently mentioned by both Vietnamese and Chinese smokers as helpful methods to quit smoking. Vietnamese smokers were more resourceful than Chinese smokers in their use of smoking cessation methods. Even with access to cessation classes at a health clinic, half of current smokers indicated that they had no intention to quit. Such attitudes underscore the need for promotion of effective smoking cessation programs as well as successful strategies for reaching smokers. These conclusions are particularly important for Chinese smokers, who were comparatively less resourceful in their use of smoking cessation methods. Future studies should explore integrating the concept of will power with current mainstream state-of-the-art smoking cessation programs.

Medicare long-term CPAP coverage policy: a cost-utility analysis.

PubMed

Billings, Martha E; Kapur, Vishesh K

2013-10-15

CPAP is an effective treatment for OSA that may reduce health care utilization and costs. Medicare currently reimburses the costs of long-term CPAP therapy only if the patient is adherent during a 90-day trial. If not, Medicare requires a repeat polysomnogram (PSG) and another trial which seems empirically not cost-effective. We modeled the cost-effectiveness of current Medicare policy compared to an alternative policy (clinic-only) without the adherence criterion and repeat PSG. Cost-utility and cost-effectiveness analysis. U.S. Medicare Population. N/A. N/A. We created a decision tree modeling (1) clinic only follow-up vs. (2) current Medicare policy. Costs were assigned based on Medicare reimbursement rates in 2012. Sensitivity analyses were conducted to test our assumptions. We estimated cumulative costs, overall adherence, and QALY gained for a 5-year time horizon from the perspective of Medicare as the payer. Current Medicare policy is more costly than the clinic-only policy but has higher net adherence and improved utility. Current Medicare policy compared to clinic-only policy costs $30,544 more per QALY. Current CMS policy promotes early identification of those more likely to adhere to CPAP therapy by requiring strict adherence standards. The policy effect is to deny coverage to those unlikely to use CPAP long-term and prevent wasted resources. Future studies are needed to measure long-term adherence in an elderly population with and without current adherence requirements to verify the cost-effectiveness of a policy change.

Dexrazoxane use in the prevention of anthracycline extravasation injury.

PubMed

Hasinoff, Brian B

2006-02-01

Accidental extravasation injury from the use of the anthracycline anticancer drugs doxorubicin, daunorubicin, epirubicin and idarubicin can be a serious complication of their use. As yet, there is little consensus on the way that anthracycline extravasation injury should be clinically managed. Dexrazoxane, which is currently clinically used to reduce doxorubicin-induced cardiotoxicity, has also been shown in preclinical studies to be highly efficacious in preventing anthracycline-induced extravasation injury. Several clinical case reports of dexrazoxane for this use have also indicated positive outcomes. There are currently two multicenter Phase II/III clinical trials underway. Dexrazoxane is a prodrug analog of the metal chelator EDTA that most likely acts by removing iron from the iron-doxorubicin complex, thus preventing formation of damaging reactive oxygen species.

A Review of Clinical Trials in Spinal Cord Injury including Biomarkers.

PubMed

Badhiwala, Jetan H; Wilson, Jefferson R; Kwon, Brian K; Casha, Steve; Fehlings, Michael G

2018-06-11

Acute traumatic spinal cord injury (SCI) entered the arena of prospective randomized clinical trials almost 40 years ago, with the undertaking of the National Acute Spinal Cord Study (NASCIS) I trial. Since then, a number of clinical trials have been conducted in the field, spurred by the devastating physical, social, and economic consequences of acute SCI for patients, families, and society at large. Many of these have been controversial and attracted criticism. The current review provides a critical summary of select past and current clinical trials in SCI, focusing in particular on the findings of prospective randomized controlled trials (RCTs), the challenges and barriers encountered, and the valuable lessons learned that can be applied to future trials.

Lung cancer and chronic obstructive pulmonary disease: From a clinical perspective

PubMed Central

Dai, Jie; Yang, Ping; Cox, Angela; Jiang, Gening

2017-01-01

Chronic obstructive pulmonary disease (COPD) and lung cancer are devastating pulmonary diseases that commonly coexist and present a number of clinical challenges. COPD confers a higher risk for lung cancer development, but available chemopreventive measures remain rudimentary. Current studies have shown a marked benefit of cancer screening in the COPD population, although challenges remain, including the common underdiagnosis of COPD. COPD-associated lung cancer presents distinct clinical features. Treatment for lung cancer coexisting with COPD is challenging as COPD may increase postoperative morbidities and decrease survival. In this review, we outline current progress in the understanding of the clinical association between COPD and lung cancer, and suggest possible cancer prevention strategies in this patient population. PMID:28061470

Has molecular imaging delivered to drug development?

NASA Astrophysics Data System (ADS)

Murphy, Philip S.; Patel, Neel; McCarthy, Timothy J.

2017-10-01

Pharmaceutical research and development requires a systematic interrogation of a candidate molecule through clinical studies. To ensure resources are spent on only the most promising molecules, early clinical studies must understand fundamental attributes of the drug candidate, including exposure at the target site, target binding and pharmacological response in disease. Molecular imaging has the potential to quantitatively characterize these properties in small, efficient clinical studies. Specific benefits of molecular imaging in this setting (compared to blood and tissue sampling) include non-invasiveness and the ability to survey the whole body temporally. These methods have been adopted primarily for neuroscience drug development, catalysed by the inability to access the brain compartment by other means. If we believe molecular imaging is a technology platform able to underpin clinical drug development, why is it not adopted further to enable earlier decisions? This article considers current drug development needs, progress towards integration of molecular imaging into studies, current impediments and proposed models to broaden use and increase impact. This article is part of the themed issue 'Challenges for chemistry in molecular imaging'.

A Systematic Review on the Designs of Clinical Technology: Findings and Recommendations for Future Research

PubMed Central

PhD, Greg Alexander; Staggers, Nancy

2010-01-01

Human factors (HF) studies are increasingly important as technology infuses into clinical settings. No nursing research reviews exist in this area. The authors conducted a systematic review on designs of clinical technology, 34 articles with 50 studies met inclusion criteria. Findings were classified into three categories based on HF research goals. The majority of studies evaluated effectiveness of clinical design; efficiency was fewest. Current research ranges across many interface types examined with no apparent pattern or obvious rationale. Future research should expand types, settings, participants; integrate displays; and expand outcome variables. PMID:19707093

The Implementation and Development of an Objective Structured Clinical Examination in the Community Pharmacy Course of a Select Gulf-Region Academic Institution (Ras Al Khaimah College of Pharmaceutical Sciences): A Pilot Study

ERIC Educational Resources Information Center

Al-Azzawi, Amad Mohammed Jamil; Nagavi, B.G.; Hachim, Mahmood Y.; Mossa, Omar H.

2016-01-01

Background: Objective Structured Clinical Examinations (OSCEs) were used to assess translational pharmacotherapeutic skills of a Gulf-region representative academic institution. Aim: The aim of the current study was to assess the clinical skills of students enrolled within the third year Bachelor of Pharmacy (BPharm) programme within Ras Al…

Implementation of Point-of-Care Diagnostics in Rural Primary Healthcare Clinics in South Africa: Perspectives of Key Stakeholders.

PubMed

Mashamba-Thompson, Tivani P; Jama, Ngcwalisa A; Sartorius, Benn; Drain, Paul K; Thompson, Rowan M

2017-01-08

Key stakeholders' involvement is crucial to the sustainability of quality point-of-care (POC) diagnostics services in low-and-middle income countries. The aim of this study was to explore key stakeholder perceptions on the implementation of POC diagnostics in rural primary healthcare (PHC) clinics in South Africa. We conducted a qualitative study encompassing in-depth interviews with multiple key stakeholders of POC diagnostic services for rural and resource-limited PHC clinics. Interviews were digitally recorded and transcribed verbatim prior to thematic content analysis. Thematic content analysis was conducted using themes guided by the World Health Organisation (WHO) quality-ASSURED (Affordable, Sensitive, Specific, User friendly, Rapid and to enable treatment at first visit and Robust, Equipment free and Delivered to those who need it) criteria for POC diagnostic services in resource-limited settings. 11 key stakeholders participated in the study. All stakeholders perceived the main advantage of POC diagnostics as enabling access to healthcare for rural patients. Stakeholders perceived the current POC diagnostic services to have an ability to meet patients' needs, but recommended further improvement of the following areas: research on cost-effectiveness; improved quality management systems; development of affordable POC diagnostic and clinic-based monitoring and evaluation. Key stakeholders of POC diagnostics in rural PHC clinics in South Africa highlighted the need to assess affordability and ensure quality assurance of current services before adopting new POC diagnostics and scaling up current POC diagnostics.

Implementation of Point-of-Care Diagnostics in Rural Primary Healthcare Clinics in South Africa: Perspectives of Key Stakeholders

PubMed Central

Mashamba-Thompson, Tivani P.; Jama, Ngcwalisa A.; Sartorius, Benn; Drain, Paul K.; Thompson, Rowan M.

2017-01-01

Introduction: Key stakeholders’ involvement is crucial to the sustainability of quality point-of-care (POC) diagnostics services in low-and-middle income countries. The aim of this study was to explore key stakeholder perceptions on the implementation of POC diagnostics in rural primary healthcare (PHC) clinics in South Africa. Method: We conducted a qualitative study encompassing in-depth interviews with multiple key stakeholders of POC diagnostic services for rural and resource-limited PHC clinics. Interviews were digitally recorded and transcribed verbatim prior to thematic content analysis. Thematic content analysis was conducted using themes guided by the World Health Organisation (WHO) quality-ASSURED (Affordable, Sensitive, Specific, User friendly, Rapid and to enable treatment at first visit and Robust, Equipment free and Delivered to those who need it) criteria for POC diagnostic services in resource-limited settings. Results: 11 key stakeholders participated in the study. All stakeholders perceived the main advantage of POC diagnostics as enabling access to healthcare for rural patients. Stakeholders perceived the current POC diagnostic services to have an ability to meet patients’ needs, but recommended further improvement of the following areas: research on cost-effectiveness; improved quality management systems; development of affordable POC diagnostic and clinic-based monitoring and evaluation. Conclusions: Key stakeholders of POC diagnostics in rural PHC clinics in South Africa highlighted the need to assess affordability and ensure quality assurance of current services before adopting new POC diagnostics and scaling up current POC diagnostics. PMID:28075337

State of affairs in use of steroids in diffuse intrinsic pontine glioma: an international survey and a review of the literature.

PubMed

Veldhuijzen van Zanten, Sophie E M; Cruz, Ofelia; Kaspers, Gertjan J L; Hargrave, Darren R; van Vuurden, Dannis G

2016-07-01

Children diagnosed with diffuse intrinsic pontine glioma (DIPG) face a dismal prognosis, with severe neurologic deterioration and inevitable death at a median of 9 months from diagnosis. Steroids are widely prescribed as supportive or palliative treatment although they are known to cause severe side effects that may reduce the quality of life. This study aims to review the current knowledge on, and use of, steroids in DIPG patients. A global questionnaire-study among health care professionals was performed to ascertain information on the current (multi-)institutional and (multi-)national use of steroids, the availability of clinical guidelines, and the need for improvements in prescribing steroids to DIPG patients. In addition, an extensive literature search was performed to review studies investigating steroids in pediatric brain tumor patients. From 150 responding health care professionals, only 7 % had clinical guidelines. The use of steroids was heterogeneous and over 85 % of respondents reported serious side effects. Fourteen articles, with low level of evidence, described the use of steroids in pediatric brain tumor patients. Clinical trials investigating optimal dose or regimen were lacking. This study is a first inventory of the availability of evidence-based information and clinical guidelines, and the current attitude towards the use of steroids in DIPG patients. To date, the risk-benefit ratio of steroids in this disease is yet to be determined. We emphasize the need for clinical trials resulting in guidelines on steroids, and possibly alternative drugs, to optimize the quality of care and quality of life of DIPG patients.

Bringing antiretroviral therapy (ART) closer to the end-user through mobile clinics and home-based ART: systematic review shows more evidence on the effectiveness and cost effectiveness is needed.

PubMed

Mdege, Noreen Dadirai; Chindove, Stanley

2014-01-01

Home-based antiretroviral therapy (ART) and ART through mobile clinics can potentially increase access to ART for large numbers of people, including hard-to-reach populations. We reviewed literature on the effectiveness and cost implications of the home-based ART and mobile clinic ART models. We searched Medline, Embase, PsycInfo, CINAHL, Cochrane Library, Web of Knowledge and Current Controlled Trials Register for articles published up to March 2012. We included non-randomised and randomised controlled clinical trials that recruited HIV/AIDS positive adults with or without prior exposure to ART. Six studies were included in the review, with only four effectiveness studies (all evaluating home-based ART and none for mobile clinic ART) and four studies reporting on the cost implications. The evidence suggests home-based ART is as effective as health facility-based ART, including on clinical outcomes, viral load and CD4+ count. However, three of these studies were very small. Studies suggest health facility-based ART is the most cost-effective, followed by mobile-clinic ART, with home-based ART being the least cost-effective. Evidence on the effectiveness and cost implications of mobile clinic and home-based ART is currently limited. Although the few available studies suggest home-based ART can potentially be as effective as health facility-based ART, there is need for more research before robust conclusions can be made. Results from the few available studies also suggest that health facility-based ART is the most cost-effective. Copyright © 2013 John Wiley & Sons, Ltd.

Occlusion for implant-supported fixed dental prostheses in partially edentulous patients: a literature review and current concepts

PubMed Central

Sukotjo, Cortino

2013-01-01

Implant treatment has become the treatment of choice to replace missing teeth in partially edentulous areas. Dental implants present different biological and biomechanical characteristics than natural teeth. Occlusion is considered to be one of the most important factors contributing to implant success. Most literature on implant occlusal concepts is based on expert opinion, anecdotal experiences, in vitro and animal studies, and only limited clinical research. Furthermore, scientific literature regarding implant occlusion, particularly in implant-supported fixed dental prostheses remains controversial. In this study, the current status of implant occlusion was reviewed and discussed. Further randomized clinical research to investigate the correlation between implant occlusion, the implant success rate, and its risk factors is warranted to determine best clinical practices. PMID:23678387

Clinical effects of probiotics in cystic fibrosis patients: A systematic review.

PubMed

Van Biervliet, Stephanie; Declercq, Dimitri; Somerset, Shawn

2017-04-01

Cystic fibrosis (CF) is characterised by a build-up of thick, intransient mucus linings of the digestive and respiratory mucosa, which disrupts digestive system functioning and microbiota composition. In view of the potential for probiotics to enhance microbiota composition in other contexts, this study investigated the current evidence for probiotics as an adjunct to usual therapy for CF. Electronic clinical databases were interrogated for human randomised, controlled, intervention trials (1985-2015) testing the effects of probiotics on clinical endpoints in CF were reviewed. From 191 articles identified in initial searches, six studies met the critical inclusion criteria, and were reviewed in detail. These studies varied in size (n = 22 to 61) but were generally small and showed substantial diversity in protocol, specific probiotic species used and range of clinical outcomes measured. Probiotic administration showed beneficial effects on fecal calprotectin levels, pulmonary exacerbation risk, and quality of life indicators. In one study, such changes were associated with variations in gut microbiota composition. Despite encouraging preliminary results, the limited number of small and highly varied studies to date do not justify the addition of probiotics as an adjunct to current CF treatment protocols. Importantly, very minimal adverse effects of probiotics have been reported. Copyright © 2017 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

Stability and change in the clinical course of schizoaffective disorder.

PubMed

Durla, Anca; Lenciu, M; Bredicean, C; Papava, I; Cristanovici, M

2013-01-01

Schizoaffective disorder currently raises several questions, one of them being related to the stability of the clinical diagnosis over time. The aim of this study is to identify the clinical and evolutional particularities in the longitudinal course of schizoaffective disorder. 44 subjects with a current diagnosis of schizoaffective disorder have been assessed prospectively. Following parameters were analyzed: socio-demographic (age at onset, gender, educational, professional and marital status at onset) and clinical (total duration of evolution, diagnosis at onset, duration of the evolution until the switch to the schizoaffective disorder diagnosis). Socio-demographic parameters are similar to those in literature and the clinical assessment revealed that schizoaffective disorder is present as a diagnosis along with the longitudinal course of other types of psychosis. Schizoaffective disorder appears as a heterogeneous pathology in terms of the longitudinal course.

Machine Learning Approaches for Clinical Psychology and Psychiatry.

PubMed

Dwyer, Dominic B; Falkai, Peter; Koutsouleris, Nikolaos

2018-05-07

Machine learning approaches for clinical psychology and psychiatry explicitly focus on learning statistical functions from multidimensional data sets to make generalizable predictions about individuals. The goal of this review is to provide an accessible understanding of why this approach is important for future practice given its potential to augment decisions associated with the diagnosis, prognosis, and treatment of people suffering from mental illness using clinical and biological data. To this end, the limitations of current statistical paradigms in mental health research are critiqued, and an introduction is provided to critical machine learning methods used in clinical studies. A selective literature review is then presented aiming to reinforce the usefulness of machine learning methods and provide evidence of their potential. In the context of promising initial results, the current limitations of machine learning approaches are addressed, and considerations for future clinical translation are outlined.

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.

Novel methods to optimize the effects of transcranial direct current stimulation: a systematic review of transcranial direct current stimulation patents.

PubMed

Malavera, Alejandra; Vasquez, Alejandra; Fregni, Felipe

2015-01-01

Transcranial direct current stimulation (tDCS) is a neuromodulatory technique that has been extensively studied. While there have been initial positive results in some clinical trials, there is still variability in tDCS results. The aim of this article is to review and discuss patents assessing novel methods to optimize the use of tDCS. A systematic review was performed using Google patents database with tDCS as the main technique, with patents filling date between 2010 and 2015. Twenty-two patents met our inclusion criteria. These patents attempt to address current tDCS limitations. Only a few of them have been investigated in clinical trials (i.e., high-definition tDCS), and indeed most of them have not been tested before in human trials. Further clinical testing is required to assess which patents are more likely to optimize the effects of tDCS. We discuss the potential optimization of tDCS based on these patents and the current experience with standard tDCS.

A systematic review of neurobiological and clinical features of mindfulness meditations.

PubMed

Chiesa, A; Serretti, A

2010-08-01

Mindfulness meditation (MM) practices constitute an important group of meditative practices that have received growing attention. The aim of the present paper was to systematically review current evidence on the neurobiological changes and clinical benefits related to MM practice in psychiatric disorders, in physical illnesses and in healthy subjects. A literature search was undertaken using Medline, ISI Web of Knowledge, the Cochrane collaboration database and references of retrieved articles. Controlled and cross-sectional studies with controls published in English up to November 2008 were included. Electroencephalographic (EEG) studies have revealed a significant increase in alpha and theta activity during meditation. Neuroimaging studies showed that MM practice activates the prefrontal cortex (PFC) and the anterior cingulate cortex (ACC) and that long-term meditation practice is associated with an enhancement of cerebral areas related to attention. From a clinical viewpoint, Mindfulness-Based Stress Reduction (MBSR) has shown efficacy for many psychiatric and physical conditions and also for healthy subjects, Mindfulness-Based Cognitive Therapy (MBCT) is mainly efficacious in reducing relapses of depression in patients with three or more episodes, Zen meditation significantly reduces blood pressure and Vipassana meditation shows efficacy in reducing alcohol and substance abuse in prisoners. However, given the low-quality designs of current studies it is difficult to establish whether clinical outcomes are due to specific or non-specific effects of MM. Despite encouraging findings, several limitations affect current studies. Suggestions are given for future research based on better designed methodology and for future directions of investigation.

Ceramics in Restorative and Prosthetic DENTISTRY1

NASA Astrophysics Data System (ADS)

Kelly, J. Robert

1997-08-01

This review is intended to provide the ceramic engineer with information about the history and current use of ceramics in dentistry, contemporary research topics, and potential research agenda. Background material includes intra-oral design considerations, descriptions of ceramic dental components, and the origin, composition, and microstructure of current dental ceramics. Attention is paid to efforts involving net-shape processing, machining as a forming method, and the analysis of clinical failure. A rationale is presented for the further development of all-ceramic restorative systems. Current research topics receiving attention include microstructure/processing/property relationships, clinical failure mechanisms and in vitro testing, wear damage and wear testing, surface treatments, and microstructural modifications. The status of the field is critically reviewed with an eye toward future work. Significant improvements seem possible in the clinical use of ceramics based on engineering solutions derived from the study of clinically failed restorations, on the incorporation of higher levels of "biomimicry" in new systems, and on the synergistic developments in dental cements and adhesive dentin bonding.

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

PubMed

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

2017-12-01

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

Current Educational Reforms in Nursing in the United Kingdom and Their Impact on the Role of Nursing Lecturers in Practice: A Case Study Approach.

ERIC Educational Resources Information Center

Camiah, Sada

1998-01-01

Observations of and interviews with 41 British nurse educators found that they are expected to spend more time doing clinical teaching, developing links with clinical staff, supporting the development of the clinical learning environment, and participating in educational audits. (SK)

Current status of endoluminal grafting for exclusion of abdominal aortic aneurysms. The beauty and the beast.

PubMed Central

Diethrich, E B

1998-01-01

The exclusion of abdominal aortic aneurysms with endoluminal grafts has generated a great deal of interest since the early 1990s, and many centers are currently evaluating the procedure and comparing it to classic surgical exclusion. Although endoluminal grafting procedures show promise, development and clinical testing of devices is a time-consuming process that is influenced greatly by the regulatory climate in the country where the clinical trials take place. Nevertheless, a number of devices are currently under study, and the advantages of 2nd- and 3rd-generation technology are reflected in reduced rates of complications such as endoleaks and thrombosis. Further study will be required to perfect these devices and observe their long-term success in the exclusion of abdominal aortic aneurysms. Images PMID:9566057

Current status of endoluminal grafting for exclusion of abdominal aortic aneurysms. The beauty and the beast.

PubMed

Diethrich, E B

1998-01-01

The exclusion of abdominal aortic aneurysms with endoluminal grafts has generated a great deal of interest since the early 1990s, and many centers are currently evaluating the procedure and comparing it to classic surgical exclusion. Although endoluminal grafting procedures show promise, development and clinical testing of devices is a time-consuming process that is influenced greatly by the regulatory climate in the country where the clinical trials take place. Nevertheless, a number of devices are currently under study, and the advantages of 2nd- and 3rd-generation technology are reflected in reduced rates of complications such as endoleaks and thrombosis. Further study will be required to perfect these devices and observe their long-term success in the exclusion of abdominal aortic aneurysms.

α-Blockers, 5-α-Reductase Inhibitors, Acetylcholine, β3 Agonists, and Phosphodiesterase-5s in Medical Management of Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia: How Much Do the Different Formulations Actually Matter in the Classes?

PubMed

Chughtai, Bilal; Thomas, Dominique; Kaplan, Steven

2016-08-01

Many monotherapies are currently available to clinically treat and alleviate symptoms of lower urinary tract symptoms secondary to benign prostatic hyperplasia: α-blockers, 5ARIs, PDE5Is, β-3-andrenoceptor agonists, and anticholinergic agents. Current studies have evaluated the effective of these treatments in comparison to other groups or in combination therapies. The current review evaluates the effectiveness of class formulations. Based on the findings, α-blockers, specifically doxazosin and terazosin, were most effective in reducing IPSS scores and peak urinary flow rate, while being most cost-effective. However, further clinical investigations are required to evaluate the clinical implications of different formulations. Copyright © 2016 Elsevier Inc. All rights reserved.

Ginkgo biloba Extract in Vascular Protection: Molecular Mechanisms and Clinical Applications.

PubMed

Tian, Jinfan; Liu, Yue; Chen, Keji

2017-01-01

Leaves of Ginkgo biloba, a "living fossil," have been used as traditional herbal medicine for hundreds of years in China. Currently, its application in vascular protection is garnering much attention. In this manuscript, preclinical studies were reviewed to discuss various mechanisms underlying the vascular protection by Ginkgo biloba extract (GBE). Additionally, we reviewed clinical studies to present the application of GBE in the ischaemic disease. GBE, a commonly used dietary supplement, has been shown to act as an antioxidant and freeradical scavenger, a membrane stabilizer, an inhibitor of the platelet-activating factor, a vasodilator, and a regulator of metabolism. Currently, there exist a growing number of clinical studies about GBE in the application of cardiovascular disease, peripheral vascular disease (PVD) and diabetic vascular complications. GBE, a promising therapeutic agent for cardiovascular and ischaemic diseases, exerts vascular- protection function by a comprehensive mechanisms. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

The current evidence base for the feasibility of 48-hour continuous subcutaneous infusions (CSCIs): A systematically-structured review.

PubMed

Baker, James; Dickman, Andrew; Mason, Stephen; Ellershaw, John

2018-01-01

A continuous subcutaneous infusion (CSCI) is an effective method of multiple drug administration commonly encountered in end of life care when the oral route is compromised. At present, current practice is to limit syringe driver infusion time to a maximum of 24 hours as dictated by available chemical stability data. However, the ability to deliver prescribed medication by a CSCI over 48 hours may have numerous benefits in both patient care and health service resource utilisation. To examine and present the current evidence base for the stability of 48-hour multiple-drug CSCIs in current clinical practice. A systematically-structured review following PRISMA guidelines. Three electronic databases and the grey literature were searched with no time limits. Empirical studies reporting data on the chemical stability of continuous subcutaneous infusions or solutions stored in polypropylene syringes were included. Twenty-one empirical studies were included in this review reporting chemical compatibility and stability of 32 discrete combinations of twenty-four drugs tested at a variety of different drug concentrations. The majority of combinations reported were assessed as being chemically compatible. The greatest risk of clinically significant chemical degradation was observed with midazolam. Only one study reported the microbiological stability of the solution examined. There is currently limited evidence for the physical, chemical and microbiological stability of solutions for continuous subcutaneous infusion over a period of 48 hours. More stability data is required before the use of 48-hour CSCIs can be evaluated for use within clinical practice.

Oligonucleotide-based pharmaceuticals: Non-clinical and clinical safety signals and non-clinical testing strategies.

PubMed

Mustonen, Enni-Kaisa; Palomäki, Tiina; Pasanen, Markku

2017-11-01

Antisense oligonucleotides, short interfering RNAs (siRNAs) and aptamers are oligonucleotide-based pharmaceuticals with a promising role in targeted therapies. Currently, five oligonucleotide-based pharmaceuticals have achieved marketing authorization in Europe or USA and many more are undergoing clinical testing. However, several safety concerns have been raised in non-clinical and clinical studies. Oligonucleotides share properties with both chemical and biological pharmaceuticals and therefore they pose challenges also from the regulatory point of view. We have analyzed the safety data of oligonucleotides and evaluated the applicability of current non-clinical toxicological guidelines for assessing the safety of oligonucleotide-based pharmaceuticals. Oligonucleotide-based pharmaceuticals display a similar toxicological profile, exerting adverse effects on liver and kidney, evoking hematological alterations, as well as causing immunostimulation and prolonging the coagulation time. It is possible to extrapolate some of these effects from non-clinical studies to humans. However, evaluation strategies for genotoxicity testing of "non-natural" oligonucleotides should be revised. Additionally, the selective use of surrogates and prediction of clinical endpoints for non-clinically observed immunostimulation is complicated by its multiple potential manifestations, demanding improvements in the testing strategies. Utilizing more relevant and mechanistic-based approaches and taking better account of species differences, could possibly improve the prediction of relevant immunological/proinflammatory effects in humans. Copyright © 2017 Elsevier Inc. All rights reserved.

Preclinical to Clinical Translation of Studies of Transcranial Direct-Current Stimulation in the Treatment of Epilepsy: A Systematic Review

PubMed Central

Regner, Gabriela G.; Pereira, Patrícia; Leffa, Douglas T.; de Oliveira, Carla; Vercelino, Rafael; Fregni, Felipe; Torres, Iraci L. S.

2018-01-01

Epilepsy is a chronic brain syndrome characterized by recurrent seizures resulting from excessive neuronal discharges. Despite the development of various new antiepileptic drugs, many patients are refractory to treatment and report side effects. Non-invasive methods of brain stimulation, such as transcranial direct current stimulation (tDCS), have been tested as alternative approaches to directly modulate the excitability of epileptogenic neural circuits. Although some pilot and initial clinical studies have shown positive results, there is still uncertainty regarding the next steps of investigation in this field. Therefore, we reviewed preclinical and clinical studies using the following framework: (1) preclinical studies that have been successfully translated to clinical studies, (2) preclinical studies that have failed to be translated to clinical studies, and (3) clinical findings that were not previously tested in preclinical studies. We searched PubMed, Web of Science, Embase, and SciELO (2002–2017) using the keywords “tDCS,” “epilepsy,” “clinical trials,” and “animal models.” Our initial search resulted in 64 articles. After applying inclusion and exclusion criteria, we screened 17 full-text articles to extract findings about the efficacy of tDCS, with respect to the therapeutic framework used and the resulting reduction in seizures and epileptiform patterns. We found that few preclinical findings have been translated into clinical research (number of sessions and effects on seizure frequency) and that most findings have not been tested clinically (effects of tDCS on status epilepticus and absence epilepsy, neuroprotective effects in the hippocampus, and combined use with specific medications). Finally, considering that clinical studies on tDCS have been conducted for several epileptic syndromes, most were not previously tested in preclinical studies (Rasmussen's encephalitis, drug resistant epilepsy, and hippocampal sclerosis-induced epilepsy). Overall, most studies report positive findings. However, it is important to underscore that a successful preclinical study may not indicate success in a clinical study, considering the differences highlighted herein. Although most studies report significant findings, there are still important insights from preclinical work that must be tested clinically. Understanding these factors may improve the evidence for the potential use of this technique as a clinical tool in the treatment of epilepsy. PMID:29623027

Caffeine, Adenosine Receptors and Estrogen in Toxin Models of Parkinson’s Disease

DTIC Science & Technology

2008-10-30

these have advanced molecules to clinical studies.2,3 Thus, the NIH clinical trial registry lists over a dozen actively recruiting or completed trials ...into clinical trials ,4 and multiple other preclinical programs are apparently progressing (including publicly announced programs at Neurocrine5 and...unpublished results). Adenosine A2AR antagonists are currently in clinical trials for PD because of their symptom- improving abilities. The

A retrospective investigation of the clinical management of patients attending an out of hours dental clinic in Merseyside under the new NHS dental contract.

PubMed

Tulip, D E; Palmer, N O A

2008-12-20

To investigate the clinical management of patients attending for emergency dental treatment. A retrospective analysis of clinical record cards. Information was collected from patient record cards concerning the patient's reason for attendance and their management at an emergency dental clinic in South Sefton, Liverpool. Over a nine month period, 1,718 patients attended the clinic; 1,472 record cards were analysed. Over 80% of the patients attending the out of hours (OOH) clinic had pain associated with a localised dental infection or dental abscess. Where a diagnosis was recorded, only 67% of patients received appropriate treatment. Over 50% of patients received antibiotics alone with no other definitive treatment provided. The principal antibiotic prescribed for both adult and child patients was amoxicillin. The current study has highlighted that GDPs working within the OOH services are not adhering to current clinical and best practice guidelines with respect to patient examination, diagnosis, management, in particular the correct prescribing of antibiotics for dental infections, and clinical record keeping.

High-Resolution Methods for Diagnosing Cartilage Damage In Vivo

PubMed Central

Novakofski, Kira D.; Pownder, Sarah L.; Koff, Matthew F.; Williams, Rebecca M.; Potter, Hollis G.; Fortier, Lisa A.

2016-01-01

Advances in current clinical modalities, including magnetic resonance imaging and computed tomography, allow for earlier diagnoses of cartilage damage that could mitigate progression to osteoarthritis. However, current imaging modalities do not detect submicrometer damage. Developments in in vivo or arthroscopic techniques, including optical coherence tomography, ultrasonography, bioelectricity including streaming potential measurement, noninvasive electroarthrography, and multiphoton microscopy can detect damage at an earlier time point, but they are limited by a lack of penetration and the ability to assess an entire joint. This article reviews current advancements in clinical and developing modalities that can aid in the early diagnosis of cartilage injury and facilitate studies of interventional therapeutics. PMID:26958316

Mesenchymal stem cell therapy in cats: Current knowledge and future potential.

PubMed

Quimby, Jessica M; Borjesson, Dori L

2018-03-01

Practical relevance: Stem cell therapy is an innovative field of scientific investigation with tremendous potential for clinical application in veterinary medicine. Based on the known desirable immunomodulatory properties of mesenchymal stem cells, this therapy holds promise for the treatment of a variety of inflammatory diseases in cats. This review details our current understanding of feline stem cell biology and proposed mechanism of action. Studies performed in feline clinical trials for diseases including gingivostomatitis, chronic enteropathy, asthma and kidney disease are summarized, with the goal of providing an overview of the current status of this treatment modality and its potential for the future.

Rationale and methods of the European Study on Cardiovascular Risk Prevention and Management in Daily Practice (EURIKA).

PubMed

Rodríguez-Artalejo, Fernando; Guallar, Eliseo; Borghi, Claudio; Dallongeville, Jean; De Backer, Guy; Halcox, Julian P; Hernández-Vecino, Ramón; Jiménez, Francisco Javier; Massó-González, Elvira L; Perk, Joep; Steg, Philippe Gabriel; Banegas, José R

2010-06-30

The EURIKA study aims to assess the status of primary prevention of cardiovascular disease (CVD) across Europe. Specifically, it will determine the degree of control of cardiovascular risk factors in current clinical practice in relation to the European guidelines on cardiovascular prevention. It will also assess physicians' knowledge and attitudes about CVD prevention as well as the barriers impeding effective risk factor management in clinical practice. Cross-sectional study conducted simultaneously in 12 countries across Europe. The study has two components: firstly at the physician level, assessing eight hundred and nine primary care and specialist physicians with a daily practice in CVD prevention. A physician specific questionnaire captures information regarding physician demographics, practice settings, cardiovascular prevention beliefs and management. Secondly at the patient level, including 7641 patients aged 50 years or older, free of clinical CVD and with at least one classical risk factor, enrolled by the participating physicians. A patient-specific questionnaire captures information from clinical records and patient interview regarding sociodemographic data, CVD risk factors, and current medications. Finally, each patient provides a fasting blood sample, which is sent to a central laboratory for measuring serum lipids, apolipoproteins, hemoglobin-A1c, and inflammatory biomarkers. Primary prevention of CVD is an extremely important clinical issue, with preventable circulatory diseases remaining the leading cause of major disease burden. The EURIKA study will provide key information to assess effectiveness of and attitudes toward primary prevention of CVD in Europe. A transnational study creates opportunities for benchmarking good clinical practice across countries and improving outcomes. (ClinicalTrials.gov number, NCT00882336).

Recommendations for Clinical Pathology Data Generation, Interpretation, and Reporting in Target Animal Safety Studies for Veterinary Drug Development.

PubMed

Siska, William; Gupta, Aradhana; Tomlinson, Lindsay; Tripathi, Niraj; von Beust, Barbara

Clinical pathology testing is routinely performed in target animal safety studies in order to identify potential toxicity associated with administration of an investigational veterinary pharmaceutical product. Regulatory and other testing guidelines that address such studies provide recommendations for clinical pathology testing but occasionally contain outdated analytes and do not take into account interspecies physiologic differences that affect the practical selection of appropriate clinical pathology tests. Additionally, strong emphasis is often placed on statistical analysis and use of reference intervals for interpretation of test article-related clinical pathology changes, with limited attention given to the critical scientific review of clinically, toxicologically, or biologically relevant changes. The purpose of this communication from the Regulatory Affairs Committee of the American Society for Veterinary Clinical Pathology is to provide current recommendations for clinical pathology testing and data interpretation in target animal safety studies and thereby enhance the value of clinical pathology testing in these studies.

Study of Current Practice and Future Advancements in Blood Management and Effectiveness of a Multimodality Training Program on Improving Transfusion Knowledge, Practice and Outcomes

DTIC Science & Technology

2012-08-01

to trauma, surgery or blood diseases such as anemia, hemophilia or sickle- cell disease. But transfusions carry risks. Current practices are often...Blood Management Topic 4: Diagnosis of Red cell disorders and oxygen carrying capacity Topic 5: Diagnosis of Disorders in homeostasis Topic 6...the Clinical Transfusion Medicine Committee of the AABB. Red Blood Cell Transfusion: A Clinical Practice Guideline From the AABB. Ann Intern Med

CCR5 receptor antagonists in preclinical to phase II clinical development for treatment of HIV

PubMed Central

Kim, Michelle B.; Giesler, Kyle E.; Tahirovic, Yesim A.; Truax, Valarie M.; Liotta, Dennis C.; Wilson, Lawrence J.

2018-01-01

Introduction The chemokine receptor CCR5 has garnered significant attention in recent years as a target to treat HIV infection largely due to the approval and success of the drug Maraviroc. The side effects and inefficiencies with other first generation agents led to failed clinical trials, prompting the development of newer CCR5 antagonists. Areas covered This review aims to survey the current status of ‘next generation’ CCR5 antagonists in the preclinical pipeline with an emphasis on emerging agents for the treatment of HIV infection. These efforts have culminated in the identification of advanced second-generation agents to reach the clinic and the dual CCR5/CCR2 antagonist Cenicriviroc as the most advanced currently in phase II clinical studies. Expert opinion The clinical success of CCR5 inhibitors for treatment of HIV infection has rested largely on studies of Maraviroc and a second-generation dual CCR5/CCR2 antagonist Cenicriviroc. Although research efforts identified several promising preclinical candidates, these were dropped during early clinical studies. Despite patient access to Maraviroc, there is insufficient enthusiasm surrounding its use as front-line therapy for treatment of HIV. The non-HIV infection related development activities for Maraviroc and Cenicriviroc may help drive future interests. PMID:27791451

The effect of cone beam CT (CBCT) on therapeutic decision-making in endodontics.

PubMed

Mota de Almeida, F J; Knutsson, K; Flygare, L

2014-01-01

The aim was to assess to what extent cone beam CT (CBCT) used in accordance with current European Commission guidelines in a normal clinical setting has an impact on therapeutic decisions in a population referred for endodontic problems. The study includes data of consecutively examined patients collected from October 2011 to December 2012. From 2 different endodontic specialist clinics, 57 patients were referred for a CBCT examination using criteria in accordance with current European guidelines. The CBCT examinations were performed using similar equipment and standardized among clinics. After a thorough clinical examination, but before CBCT, the examiner made a preliminary therapy plan which was recorded. After the CBCT examination, the same examiner made a new therapy plan. Therapy plans both before and after the CBCT examination were plotted for 53 patients and 81 teeth. As four patients had incomplete protocols, they were not included in the final analysis. 4% of the patients referred to endodontic clinics during the study period were examined with CBCT. The most frequent reason for referral to CBCT examination was to differentiate pathology from normal anatomy, this was the case in 24 patients (45% of the cases). The primary outcome was therapy plan changes that could be attributed to CBCT examination. There were changes in 28 patients (53%). CBCT has a significant impact on therapeutic decision efficacy in endodontics when used in concordance with the current European Commission guidelines.

COP - Pet Owners - Open Clinical Trials | Center for Cancer Research

Cancer.gov

Current Open Clinical Trials If you are interested in learning more about the eligibility requirements for any of open studies listed below, please contact the nearest participating University or Christina Mazcko. To search studies being conducted by other groups please visit Vet Cancer Trials. This will allow you to search by location and tumor type.

Addressing Prediabetes in Childhood Obesity Treatment Programs: Support from Research and Current Practice

PubMed Central

Grow, H. Mollie; Fernandez, Cristina; Lukasiewicz, Gloria J.; Rhodes, Erinn T.; Shaffer, Laura A.; Sweeney, Brooke; Woolford, Susan J.; Estrada, Elizabeth

2014-01-01

Abstract Background: Type 2 diabetes mellitus (T2DM) and prediabetes have increased in prevalence among overweight and obese children, with significant implications for long-term health. There is little published evidence on the best approaches to care of prediabetes among overweight youth or the current practices used across pediatric weight management programs. Methods: This article reviews the literature and summarizes current practices for screening, diagnosis, and treatment of prediabetes at childhood obesity treatment centers. Findings regarding current practice were based on responses to an online survey from 28 pediatric weight management programs at 25 children's hospitals in 2012. Based on the literature reviewed, and empiric data, consensus support statements on prediabetes care and T2DM prevention were developed among representatives of these 25 children's hospitals' obesity clinics. Results: The evidence reviewed demonstrates that current T2DM and prediabetes diagnostic parameters are derived from adult-based studies with little understanding of clinical outcomes among youth. Very limited evidence exists on preventing progression of prediabetes. Some evidence suggests that a significant proportion of obese youth with prediabetes will revert to normoglycemia without pharmacological management. Evidence supports lifestyle modification for children with prediabetes, but further study of specific lifestyle changes and pharmacological treatments is needed. Conclusion: Evidence to guide management of prediabetes in children is limited. Current practice patterns of pediatric weight management programs show areas of variability in practice, reflecting the limited evidence base. More research is needed to guide clinical care for overweight youth with prediabetes. PMID:25055134

[Collaborative study on regulatory science for facilitating clinical development of gene therapy products for genetic diseases].

PubMed

Uchida, Eriko; Igarashi, Yuka; Sato, Yoji

2014-01-01

Gene therapy products are expected as innovative medicinal products for intractable diseases such as life-threatening genetic diseases and cancer. Recently, clinical developments by pharmaceutical companies are accelerated in Europe and the United States, and the first gene therapy product in advanced countries was approved for marketing authorization by the European Commission in 2012. On the other hand, more than 40 clinical studies for gene therapy have been completed or ongoing in Japan, most of them are conducted as clinical researches by academic institutes, and few clinical trials have been conducted for approval of gene therapy products. In order to promote the development of gene therapy products, revision of the current guideline and/or preparation of concept paper to address the evaluation of the quality and safety of gene therapy products are necessary and desired to clearly show what data should be submitted before First-in-Human clinical trials of novel gene therapy products. We started collaborative study with academia and regulatory agency to promote regulatory science toward clinical development of gene therapy products for genetic diseases based on lentivirus and adeno-associated virus vectors; National Center for Child Health and Development (NCCHD), Nippon Medical School and PMDA have been joined in the task force. At first, we are preparing pre-draft of the revision of the current gene therapy guidelines in this project.

Selection of Patients in Ongoing Clinical Trials on Lung Cancer.

PubMed

Schulkes, Karlijn J G; Nguyen, Cindy; van den Bos, Frederiek; van Elden, Leontine J R; Hamaker, Marije E

2016-12-01

Lung cancer is predominantly a disease of the elderly: half of all newly diagnosed patients are over 70 years old. Older patients and those with comorbidities are underrepresented in clinical trials; scientific communities have addressed this issue since the end of the 20th century. We set out to determine the characteristics of the selection of patients in lung cancer trials that are currently recruiting. We searched The United States National Institutes of Health (NIH) clinical trial registry ( www.clinicaltrials.gov ) on April 23, 2015 for currently recruiting phase I, II, or III clinical trials in lung cancer. Trial characteristics and study objectives were extracted from the registry website. Of the 419 trails selected in this overview, 88 % explicitly or implicitly excluded elderly patients. Patients were excluded based on stringent organ selection in 76 % of the trials, based on performance status (57 %) and based on age (13 %). The median number of placed restrictions per trial was seven. In the 2 % of the trials that were exclusively designed for elderly patients only fit patients were included. In this overview of current lung cancer trials registered in the NIH clinical trial registry, we found that elderly patients and those with comorbidities are often excluded from participation in clinical trials. Therefore, it is difficult for physicians and their frail patients to properly evaluate the efficacy and safety of current treatment options. More research that includes the elderly and those with comorbidities is urgently needed.

Evaluating a health care provider delivered intervention to reduce intimate partner violence and mitigate associated health risks: study protocol for a randomized controlled trial in Mexico City.

PubMed

Falb, Kathryn L; Diaz-Olavarrieta, Claudia; Campos, Paola A; Valades, Jimena; Cardenas, Roosebelinda; Carino, Giselle; Gupta, Jhumka

2014-07-30

Intimate partner violence (IPV) victimization is a prevalent issue among women residing in Mexico City. Comprehensive and integrated health care provider (HCP) delivered programs in clinic-settings are needed, yet few have been evaluated in Latin America, including Mexico. In addition, there has been minimal attention to interventions among lower income women presenting at settings outside of antenatal care clinics. The current randomized controlled trial seeks to increase midlevel HCPs' capacity, specifically nurses, who are often the first point of contact in this setting, to identify women presenting at health clinics with experiences of IPV and to assist these women with health risk mitigation. Specific outcomes include changes in past-year IPV (physical and/or sexual), reproductive coercion, safety planning, use of community resources, and quality of life. Forty-two public health clinics in Mexico City were randomized to treatment or control clinics. Nurses meeting eligibility criteria in treatment groups received an intensive training on screening for IPV, providing supportive referrals, and assessing for health and safety risks. Nurses meeting eligibility criteria at control clinics received the standard of care which included a one-day training focused on sensitizing staff to IPV as a health issue and referral cards to give to women. Women were screened for eligibility (currently experiencing abuse in a heterosexual relationship, 18-44 years of age, non-pregnant or in first trimester) by research assistants in private areas of waiting rooms in health clinics. Consenting women completed a baseline survey and received the study protocol for that clinic. In treatment clinics, women received the nurse delivered session at baseline and received a follow-up counseling session after three months. Surveys are conducted at baseline, three months, and fifteen months from baseline. This study will provide important insight into whether a nurse-delivered program can assist women currently experiencing abuse in a Latin American context. Findings can be used to inform IPV programs and policies in Mexico City's public health clinics. NCT01661504.

An Exploration of Clinical Psychology's Response to Parental Bereavement in Adults with Intellectual Disability

ERIC Educational Resources Information Center

Irwin, Lynn; O'Malley, Grace; Neelofur, Shazia; Guerin, Suzanne

2017-01-01

Background: The dearth of literature regarding how or when to intervene when an adult with intellectual disability is bereaved may impede clinical practice; this study therefore aimed to explore the current clinical psychology response, so as to enhance understanding of the role of the profession in supporting grief within this population. Method:…

A review of human factors principles for the design and implementation of medication safety alerts in clinical information systems.

PubMed

Phansalkar, Shobha; Edworthy, Judy; Hellier, Elizabeth; Seger, Diane L; Schedlbauer, Angela; Avery, Anthony J; Bates, David W

2010-01-01

The objective of this review is to describe the implementation of human factors principles for the design of alerts in clinical information systems. First, we conduct a review of alarm systems to identify human factors principles that are employed in the design and implementation of alerts. Second, we review the medical informatics literature to provide examples of the implementation of human factors principles in current clinical information systems using alerts to provide medication decision support. Last, we suggest actionable recommendations for delivering effective clinical decision support using alerts. A review of studies from the medical informatics literature suggests that many basic human factors principles are not followed, possibly contributing to the lack of acceptance of alerts in clinical information systems. We evaluate the limitations of current alerting philosophies and provide recommendations for improving acceptance of alerts by incorporating human factors principles in their design.

Clinicians’ Use of Personality Disorder Models within a Particular Treatment Setting: A Longitudinal Comparison of Temporal Consistency and Clinical Utility

PubMed Central

Samuel, Douglas B.; Widiger, Thomas A.

2012-01-01

An active line of current investigation is how the five-factor model (FFM) of personality disorder might be applied by clinicians and particularly, how clinically useful this model is in comparison to the existing nomenclature. The current study is the first to investigate the temporal consistency of clinicians’ application of the FFM and the DSM-IV-TR to their own patients. Results indicated that FFM ratings were relatively stable over six-months of treatment, supporting their use by clinicians, but also indexed potentially important clinical changes. Additionally, ratings of utility provided by the clinicians suggested that the FFM was more useful for clinical decision making than was the DSM-IV-TR model. We understand the clinical utility findings within the context of previous research indicating that the FFM is most useful among patients who are not prototypic for a personality disorder. PMID:24288580

Maintenance of Certification: How Performance in Practice Changes Improve Tobacco Cessation in Addiction Psychiatrists’ Practice

PubMed Central

Ford, James H.; Oliver, Karen A.; Giles, Miriam; Cates-Wessel, Kathryn; Krahn, Dean; Levin, Frances R.

2017-01-01

Background and Objectives In 2000, the American Board of Medical Specialties implemented the Maintenance of Certification (MOC), a structured process to help physicians identify and implement a quality improvement project to improve patient care. This study reports on findings from an MOC Performance in Practice (PIP) module designed and evaluated by addiction psychiatrists who are members of the American Academy of Addiction Psychiatry (AAAP). Method A 3-phase process was utilized to recruit AAAP members to participate in the study. The current study utilized data from 154 self-selected AAAP members who evaluated the effectiveness of the MOC Tobacco Cessation PIP. Results Of the physicians participating, 76% (n 120) completed the Tobacco PIP. A paired t-test analysis revealed that reported changes in clinical measure documentation were significant across all six measures. Targeted improvement efforts focused on a single clinical measure. Results found that simple change projects designed to improve clinical practice led to substantial changes in self-reported chart documentation for the selected measure. Conclusions The current findings suggest that addiction psychiatrists can leverage the MOC process to improve clinical care. PMID:27973746

Early Predictors of ASD in Young Children Using a Nationally Representative Data Set

ERIC Educational Resources Information Center

Jeans, Laurie M.; Santos, Rosa Milagros; Laxman, Daniel J.; McBride, Brent A.; Dyer, W. Justin

2013-01-01

Current clinical diagnosis of Autism Spectrum Disorders (ASD) occurs between 3 and 4 years of age, but increasing evidence indicates that intervention begun earlier may improve outcomes. Using secondary analysis of the Early Childhood Longitudinal Study-Birth Cohort data set, the current study identifies early predictors prior to the diagnosis of…

[Molecular typing methods for Pasteurella multocida-A review].

PubMed

Peng, Zhong; Liang, Wan; Wu, Bin

2016-10-04

Pasteurella multocida is an important gram-negative pathogenic bacterium that could infect wide ranges of animals. Humans could also be infected by P. multocida via animal bite or scratching. Current typing methods for P. multocida include serological typing methods and molecular typing methods. Of them, serological typing methods are based on immunological assays, which are too complicated for clinical bacteriological studies. However, the molecular methods including multiple PCRs and multilocus sequence typing (MLST) methods are more suitable for bacteriological studies of P. multocida in clinic, with their simple operation, high efficiency and accurate detection compared to the traditional serological typing methods, they are therefore widely used. In the current review, we briefly describe the molecular typing methods for P. multocida. Our aim is to provide a knowledge-foundation for clinical bacteriological investigation especially the molecular investigation for P. multocida.

Imaging transcranial direct current stimulation (tDCS) of the prefrontal cortex-correlation or causality in stimulation-mediated effects?

PubMed

Wörsching, Jana; Padberg, Frank; Ertl-Wagner, Birgit; Kumpf, Ulrike; Kirsch, Beatrice; Keeser, Daniel

2016-10-01

Transcranial current stimulation approaches include neurophysiologically distinct non-invasive brain stimulation techniques widely applied in basic, translational and clinical research: transcranial direct current stimulation (tDCS), oscillating transcranial direct current stimulation (otDCS), transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS). Prefrontal tDCS seems to be an especially promising tool for clinical practice. In order to effectively modulate relevant neural circuits, systematic research on prefrontal tDCS is needed that uses neuroimaging and neurophysiology measures to specifically target and adjust this method to physiological requirements. This review therefore analyses the various neuroimaging methods used in combination with prefrontal tDCS in healthy and psychiatric populations. First, we provide a systematic overview on applications, computational models and studies combining neuroimaging or neurophysiological measures with tDCS. Second, we categorise these studies in terms of their experimental designs and show that many studies do not vary the experimental conditions to the extent required to demonstrate specific relations between tDCS and its behavioural or neurophysiological effects. Finally, to support best-practice tDCS research we provide a methodological framework for orientation among experimental designs. Copyright © 2016 Elsevier Ltd. All rights reserved.

Learning about Spinal Muscular Atrophy

MedlinePlus

... causes the disorder. Top of page NHGRI Clinical Research on Spinal Muscular Atrophy Currently, NHGRI is not conducting studies on SMA. The National Institutes of Health is conducting clinical trials identified as enrolling individuals with SMA: Quantitative Analysis of SMN1 and SMN2 Gene Based on ...

Efficacy of Selected Electrical Therapies on Chronic Low Back Pain: A Comparative Clinical Pilot Study.

PubMed

Rajfur, Joanna; Pasternok, Małgorzata; Rajfur, Katarzyna; Walewicz, Karolina; Fras, Beata; Bolach, Bartosz; Dymarek, Robert; Rosinczuk, Joanna; Halski, Tomasz; Taradaj, Jakub

2017-01-07

BACKGROUND In the currently available research publications on electrical therapy of low back pain, generally no control groups or detailed randomization were used, and such studies were often conducted with relatively small groups of patients, based solely on subjective questionnaires and pain assessment scales (lacking measurement methods to objectify the therapeutic progress). The available literature also lacks a comprehensive and large-scale clinical study. The purpose of this study was to assess the effects of treating low back pain using selected electrotherapy methods. The study assesses the influence of individual electrotherapeutic treatments on reduction of pain, improvement of the range of movement in lower section of the spine, and improvement of motor functions and mobility. MATERIAL AND METHODS The 127 patients qualified for the therapy (ultimately, 123 patients completed the study) and assigned to 6 comparison groups: A - conventional TENS, B - acupuncture-like TENS, C - high-voltage electrical stimulation, D - interferential current stimulation, E - diadynamic current, and F - control group. RESULTS The research showed that using electrical stimulation with interferential current penetrating deeper into the tissues results in a significant and more efficient elimination of pain, and an improvement of functional ability of patients suffering from low back pain on the basis of an analysis of both subjective and objective parameters. The TENS currents and high voltage were helpful, but not as effective. The use of diadynamic currents appears to be useless. CONCLUSIONS Selected electrical therapies (interferential current, TENS, and high voltage) appear to be effective in treating chronic low back pain.

Efficacy of Selected Electrical Therapies on Chronic Low Back Pain: A Comparative Clinical Pilot Study

PubMed Central

Rajfur, Joanna; Pasternok, Małgorzata; Rajfur, Katarzyna; Walewicz, Karolina; Fras, Beata; Bolach, Bartosz; Dymarek, Robert; Rosinczuk, Joanna; Halski, Tomasz; Taradaj, Jakub

2017-01-01

Background In the currently available research publications on electrical therapy of low back pain, generally no control groups or detailed randomization were used, and such studies were often conducted with relatively small groups of patients, based solely on subjective questionnaires and pain assessment scales (lacking measurement methods to objectify the therapeutic progress). The available literature also lacks a comprehensive and large-scale clinical study. The purpose of this study was to assess the effects of treating low back pain using selected electrotherapy methods. The study assesses the influence of individual electrotherapeutic treatments on reduction of pain, improvement of the range of movement in lower section of the spine, and improvement of motor functions and mobility. Material/Methods The 127 patients qualified for the therapy (ultimately, 123 patients completed the study) and assigned to 6 comparison groups: A – conventional TENS, B – acupuncture-like TENS, C – high-voltage electrical stimulation, D – interferential current stimulation, E – diadynamic current, and F – control group. Results The research showed that using electrical stimulation with interferential current penetrating deeper into the tissues results in a significant and more efficient elimination of pain, and an improvement of functional ability of patients suffering from low back pain on the basis of an analysis of both subjective and objective parameters. The TENS currents and high voltage were helpful, but not as effective. The use of diadynamic currents appears to be useless. Conclusions Selected electrical therapies (interferential current, TENS, and high voltage) appear to be effective in treating chronic low back pain. PMID:28062862

Targeting the androgen receptor in triple-negative breast cancer: current perspectives.

PubMed

Mina, Alain; Yoder, Rachel; Sharma, Priyanka

2017-01-01

Triple-negative breast cancer (TNBC) is an aggressive subtype associated with frequent recurrence and metastasis. Unlike hormone receptor-positive subtypes, treatment of TNBC is currently limited by the lack of clinically available targeted therapies. Androgen signaling is necessary for normal breast development, and its dysregulation has been implicated in breast tumorigenesis. In recent years, gene expression studies have identified a subset of TNBC that is enriched for androgen receptor (AR) signaling. Interference with androgen signaling in TNBC is promising, and AR-inhibiting drugs have shown antitumorigenic activity in preclinical and proof of concept clinical studies. Recent advances in our understanding of androgenic signaling in TNBC, along with the identification of interacting pathways, are allowing development of the next generation of clinical trials with AR inhibitors. As novel AR-targeting agents are developed and evaluated in clinical trials, it is equally important to establish a robust set of biomarkers for identification of TNBC tumors that are most likely to respond to AR inhibition.

Current status of endoscopic simulation in gastroenterology fellowship training programs.

PubMed

Jirapinyo, Pichamol; Thompson, Christopher C

2015-07-01

Recent guidelines have encouraged gastroenterology and surgical training programs to integrate simulation into their core endoscopic curricula. However, the role that simulation currently has within training programs is unknown. This study aims to assess the current status of simulation among gastroenterology fellowship programs. This questionnaire study consisted of 38 fields divided into two sections. The first section queried program directors' experience on simulation and assessed the current status of simulation at their institution. The second portion surveyed their opinion on the potential role of simulation on the training curriculum. The study was conducted at the 2013 American Gastroenterological Association Training Directors' Workshop in Phoenix, Arizona. The participants were program directors from Accreditation Council for Graduate Medical Education accredited gastroenterology training programs, who attended the workshop. The questionnaire was returned by 69 of 97 program directors (response rate of 71%). 42% of programs had an endoscopic simulator. Computerized simulators (61.5%) were the most common, followed by mechanical (30.8%) and animal tissue (7.7%) simulators, respectively. Eleven programs (15%) required fellows to use simulation prior to clinical cases. Only one program has a minimum number of hours fellows have to participate in simulation training. Current simulators are deemed as easy to use (76%) and good educational tools (65%). Problems are cost (72%) and accessibility (69%). The majority of program directors believe that there is a need for endoscopic simulator training, with only 8% disagreeing. Additionally, a majority believe there is a role for simulation prior to initiation of clinical cases with 15% disagreeing. Gastroenterology fellowship program directors widely recognize the importance of simulation. Nevertheless, simulation is used by only 42% of programs and only 15% of programs require that trainees use simulation prior to clinical cases. No programs currently use simulation as part of the evaluation process.

Effect of the accountable care act of 2010 on clinical trial insurance coverage.

PubMed

Kircher, Sheetal M; Benson, Al B; Farber, Matthew; Nimeiri, Halla S

2012-02-10

The Affordable Care Act (ACA) of 2010 implemented dramatic changes in our health care system. The new law requires that insurers and health plans provide coverage for individuals participating in clinical trials. Currently, there are states that already have laws or agreements requiring clinical trial coverage, but there remain deficiencies that will need to be addressed to achieve compliance with the new law. State mandates were reviewed to determine current laws and agreements. The ACA was reviewed to outline its provisions, and these were compared with current mandates to identify deficiencies. Eighteen states meet the requirements set forth by the ACA either through a state law or agreement; 33 states do not meet the requirements. Of these 33 states, 15 do not have any existing laws or agreements in place regarding clinical trials. In states that have deficient policies in place, the most common deficiency is the lack of phase I coverage. The second most common deficiency in policy is coverage of only therapeutic studies. Most states currently do not meet the requirements of the ACA and will be required to make changes by 2014. The implications of the ACA with regard to insurance coverage of clinical trials remain unclear as implementation of the legislation unfolds. State governments can take steps to ensure insurance coverage by creating and expanding agreements with insurance companies.

Current concepts of severe asthma

PubMed Central

Raundhal, Mahesh; Oriss, Timothy B.; Ray, Prabir; Wenzel, Sally E.

2016-01-01

The term asthma encompasses a disease spectrum with mild to very severe disease phenotypes whose traditional common characteristic is reversible airflow limitation. Unlike milder disease, severe asthma is poorly controlled by the current standard of care. Ongoing studies using advanced molecular and immunological tools along with improved clinical classification show that severe asthma does not identify a specific patient phenotype, but rather includes patients with constant medical needs, whose pathobiologic and clinical characteristics vary widely. Accordingly, in recent clinical trials, therapies guided by specific patient characteristics have had better outcomes than previous therapies directed to any subject with a diagnosis of severe asthma. However, there are still significant gaps in our understanding of the full scope of this disease that hinder the development of effective treatments for all severe asthmatics. In this Review, we discuss our current state of knowledge regarding severe asthma, highlighting different molecular and immunological pathways that can be targeted for future therapeutic development. PMID:27367183

Use of near-infrared spectroscopy (NIRS) in cerebral tissue oxygenation monitoring in neonates.

PubMed

Gumulak, Rene; Lucanova, Lucia Casnocha; Zibolen, Mirko

2017-06-01

Near-infrared spectroscopy (NIRS) is a technology capable of non-invasive, continuous measuring of regional tissue oxygen saturation (StO 2 ). StO 2 represents a state of hemodynamic stability, which is influenced by many factors. Extensive research has been done in the field of measuring StO 2 of various organs. The current clinical availability of several NIRS-based devices reflects an important development in prevention, detection and correction of discrepancy in oxygen delivery to the brain and vital organs. Managing cerebral ischemia remains a significant issue in the neonatal intensive care units (NICU). Cerebral tissue oxygenation (cStO 2 ) and cerebral fractional tissue extraction (cFTOE) are reported in a large number of clinical studies. This review provides a summary of the concept of function, current variability of NIRS-based devices used in neonatology, clinical applications in continuous cStO 2 monitoring, limitations, disadvantages, and the potential of current technology.

How good is "evidence" from clinical studies of drug effects and why might such evidence fail in the prediction of the clinical utility of drugs?

PubMed

Naci, Huseyin; Ioannidis, John P A

2015-01-01

Promising evidence from clinical studies of drug effects does not always translate to improvements in patient outcomes. In this review, we discuss why early evidence is often ill suited to the task of predicting the clinical utility of drugs. The current gap between initially described drug effects and their subsequent clinical utility results from deficits in the design, conduct, analysis, reporting, and synthesis of clinical studies-often creating conditions that generate favorable, but ultimately incorrect, conclusions regarding drug effects. There are potential solutions that could improve the relevance of clinical evidence in predicting the real-world effectiveness of drugs. What is needed is a new emphasis on clinical utility, with nonconflicted entities playing a greater role in the generation, synthesis, and interpretation of clinical evidence. Clinical studies should adopt strong design features, reflect clinical practice, and evaluate outcomes and comparisons that are meaningful to patients. Transformative changes to the research agenda may generate more meaningful and accurate evidence on drug effects to guide clinical decision making.

Current concept for the use of PRP in arthroscopic surgery.

PubMed

Nourissat, G; Mainard, D; Kelberine, F

2013-12-01

PRP is commonly used in sports medicine and because it is supposed to increase healing capacities of damaged tissues, it is expected to be increase efficiency or god clinical outcomes when added to arthroscopic surgical procedure. The current review of literature explores the evidence-based medicine supporting the use of PRP in three arthroscopic related disorders. Regarding cartilage lesions of the knee, many studies are exploring several aspect of cartilage lesion treatment. It appears that PRP, in some protocols with specific concentration, should be more efficient than current therapies in the treatment of early stages of knee OA, but only in the field of rheumatology or sport medicine, not when used during surgery. PRP have been used in ACL reconstruction, no benefit has been reported in any study regarding clinical or radiological outcomes. In shoulder cuff disorder, to date, no clinical benefit nor increased healing rate have been clearly reported. Thus, in 2013, it is clear that there is no evidence base medicine data supporting the use of PRP in arthroscopic surgery. Copyright © 2013. Published by Elsevier Masson SAS.

Prevalence of xerostomia in an adolescent inpatient psychiatric clinic: a preliminary study.

PubMed

Kaur, Manvir; Himadi, Elaine; Chi, Donald L

2016-01-01

Adolescents with psychiatric conditions may be at risk for xerostomia. In this preliminary study, we estimated xerostomia prevalence in adolescents ages 9 to 17 years from an inpatient psychiatric clinic (N = 25) and examined whether: (1) gender and age were associated with xerostomia and (2) xerostomia was associated with self-reported cavities. We used a modified 11-item Xerostomia Index to identify xerostomia (no/yes) and asked if adolescents ever had or currently have cavities (no/yes). The mean age was 14 years (SD = 2.3) and 72% were male. Sixty percent reported xerostomia (SD = 50). There were no significant associations between xerostomia and gender (p = 0.99) or age (p = 0.66), or between xerostomia and past (p = 0.26) or current cavities (p = 0.11). Larger proportions of adolescents with xerostomia reported previous and current cavities. Sixty percent of adolescents from an inpatient psychiatric clinic reported having xerostomia, which may lead to increased caries risk over time. Additional research should examine the prevalence and consequences of xerostomia in high-risk adolescents. © 2015 Special Care Dentistry Association and Wiley Periodicals, Inc.

Best practices for clinical pathology testing in carcinogenicity studies.

PubMed

Young, Jamie K; Hall, Robert L; O'Brien, Peter; Strauss, Volker; Vahle, John L

2011-02-01

The Society of Toxicologic Pathology (STP) and American Society for Veterinary Clinical Pathology (ASCVP) convened a Clinical Pathology in Carcinogenicity Studies Working Group to recommend best practices for inclusion of clinical pathology testing in carcinogenicity studies. Regulatory guidance documents and literature were reviewed, and veterinary pathologists from North America, Japan, and Europe were surveyed regarding current practices, perceived value, and recommendations for clinical pathology testing in carcinogenicity studies. For two-year rodent carcinogenicity studies, the Working Group recommends that clinical pathology testing be limited to collection of blood smears at scheduled and unscheduled sacrifices to be examined only if indicated to aid in the diagnosis of possible hematopoietic neoplasia following histopathologic evaluation. Additional clinical pathology testing is most appropriately used to address specific issues from prior toxicity studies or known test article-related class effects. Inadequate data were available to make a recommendation concerning clinical pathology testing for alternative six-month carcinogenicity assays using genetically modified mice, although the Working Group suggests that it may be appropriate to use the same approach as for two-year carcinogenicity studies since the study goal is the same.

Sharing Patient-Generated Data in Clinical Practices: An Interview Study.

PubMed

Zhu, Haining; Colgan, Joanna; Reddy, Madhu; Choe, Eun Kyoung

2016-01-01

Patients are tracking and generating an increasingly large volume of personal health data outside the clinic due to an explosion of wearable sensing and mobile health (mHealth) apps. The potential usefulness of these data is enormous as they can provide good measures of everyday behavior and lifestyle. However, how we can fully leverage patient-generated data (PGD) and integrate them in clinical practice is less clear. In this interview study, we aim to understand how patients and clinicians currently share patient-generated data in clinical care practice. From the study, we identified technical, social, and organizational challenges in sharing and fully leveraging patient-generated data in clinical practices. Our findings can provide researchers potential avenues for enablers and barriers in sharing patient-generated data in clinical settings.

Finasteride Reduces the Risk of Incident Clinical Benign Prostatic Hyperplasia

PubMed Central

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

2014-01-01

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

Polycystic ovary syndrome: perceptions and attitudes of women and primary health care physicians on features of PCOS and renaming the syndrome.

PubMed

Teede, Helena; Gibson-Helm, Melanie; Norman, Robert J; Boyle, Jacqueline

2014-01-01

Polycystic ovary syndrome (PCOS) is an under-recognized, common, and complex endocrinopathy. The name PCOS is a misnomer, and there have been calls for a change to reflect the broader clinical syndrome. The aim of the study was to determine perceptions held by women and primary health care physicians around key clinical features of PCOS and attitudes toward current and alternative names for the syndrome. We conducted a cross-sectional study utilizing a devised questionnaire. Participants were recruited throughout Australia via professional associations, women's health organizations, and a PCOS support group. Fifty-seven women with PCOS and 105 primary care physicians participated in the study. Perceptions of key clinical PCOS features and attitudes toward current and alternative syndrome names were investigated. Irregular periods were identified as a key clinical feature of PCOS by 86% of the women with PCOS and 90% of the primary care physicians. In both groups, 60% also identified hormone imbalance as a key feature. Among women with PCOS, 47% incorrectly identified ovarian cysts as key, 48% felt the current name is confusing, and 51% supported a change. Most primary care physicians agreed that the name is confusing (74%) and needs changing (81%); however, opinions on specific alternative names were divided. The name "polycystic ovary syndrome" is perceived as confusing, and there is general support for a change to reflect the broader clinical syndrome. Engagement of primary health care physicians and consumers is strongly recommended to ensure that an alternative name enhances understanding and recognition of the syndrome and its complex features.

Thermal potentiation of chemotherapy by magnetic nanoparticles

PubMed Central

Torres-Lugo, Madeline; Rinaldi, Carlos

2014-01-01

Clinical studies have demonstrated the effectiveness of hyperthermia as an adjuvant for chemotherapy and radiotherapy. However, significant clinical challenges have been encountered, such as a broader spectrum of toxicity, lack of patient tolerance, temperature control and significant invasiveness. Hyperthermia induced by magnetic nanoparticles in high-frequency oscillating magnetic fields, commonly termed magnetic fluid hyperthermia, is a promising form of heat delivery in which thermal energy is supplied at the nanoscale to the tumor. This review discusses the mechanisms of heat dissipation of iron oxide-based magnetic nanoparticles, current methods and challenges to deliver heat in the clinic, and the current work related to the use of magnetic nanoparticles for the thermal-chemopotentiation of therapeutic drugs. PMID:24074390

Orthodontic treatment in periodontitis‐susceptible subjects: a systematic literature review

PubMed Central

Lindsten, Rune; Slotte, Christer; Bjerklin, Krister

2016-01-01

Abstract The aim is to evaluate the literature for clinical scientific data on possible effects of orthodontic treatment on periodontal status in periodontitis‐susceptible subjects. A systematic literature review was performed on studies in English using PubMed, MEDLINE, and Cochrane Library central databases (1965‐2014). By manually searching reference lists of selected studies, we identified additional articles; then we searched these publications: Journal of Periodontology, Periodontology 2000, Journal of Clinical Periodontology, American Journal of Orthodontics and Dentofacial Orthopedics, Angle Orthodontist, International Journal of Periodontics & Restorative Dentistry, and European Journal of Orthodontics. Search terms included randomized clinical trials, controlled clinical trials, prospective and retrospective clinical studies, case series >5 patients, periodontitis, orthodontics, alveolar bone loss, tooth migration, tooth movement, orthodontic extrusion, and orthodontic intrusion. Only studies on orthodontic treatment in periodontally compromised dentitions were included. One randomized controlled clinical trial, one controlled clinical trial, and 12 clinical studies were included. No evidence currently exists from controlled studies and randomized controlled clinical trials, which shows that orthodontic treatment improves or aggravates the status of periodontally compromised dentitions. PMID:29744163

Mitigation of eddy current heating during magnetic nanoparticle hyperthermia therapy.

PubMed

Stigliano, Robert V; Shubitidze, Fridon; Petryk, James D; Shoshiashvili, Levan; Petryk, Alicia A; Hoopes, P Jack

2016-11-01

Magnetic nanoparticle hyperthermia therapy is a promising technology for cancer treatment, involving delivering magnetic nanoparticles (MNPs) into tumours then activating them using an alternating magnetic field (AMF). The system produces not only a magnetic field, but also an electric field which penetrates normal tissue and induces eddy currents, resulting in unwanted heating of normal tissues. Magnitude of the eddy current depends, in part, on the AMF source and the size of the tissue exposed to the field. The majority of in vivo MNP hyperthermia therapy studies have been performed in small animals, which, due to the spatial distribution of the AMF relative to the size of the animals, do not reveal the potential toxicity of eddy current heating in larger tissues. This has posed a non-trivial challenge for researchers attempting to scale up to clinically relevant volumes of tissue. There is a relative dearth of studies focused on decreasing the maximum temperature resulting from eddy current heating to increase therapeutic ratio. This paper presents two simple, clinically applicable techniques for decreasing maximum temperature induced by eddy currents. Computational and experimental results are presented to understand the underlying physics of eddy currents induced in conducting, biological tissues and leverage these insights to mitigate eddy current heating during MNP hyperthermia therapy. Phantom studies show that the displacement and motion techniques reduce maximum temperature due to eddy currents by 74% and 19% in simulation, and by 77% and 33% experimentally. Further study is required to optimise these methods for particular scenarios; however, these results suggest larger volumes of tissue could be treated, and/or higher field strengths and frequencies could be used to attain increased MNP heating when these eddy current mitigation techniques are employed.

Reversing the slow death of the clinical necropsy: developing the post of the Pathology Liaison Nurse

PubMed Central

Limacher, Eileen; Carr, Urszula; Bowker, Lesley; Ball, Richard Y

2007-01-01

The adult clinical necropsy has been declining for many years and is nearing extinction in many hospitals. In Norwich, to prevent this from occurring, a Pathology Liaison Nurse (PLN) was appointed, resulting in a modest reversal of the trend. In 2005, the number of adult clinical necropsies increased to 58 (clinical necropsy rate = 2.4%) from its nadir of 34 (clinical necropsy rate = 1.4%) in 2003. Moreover, consent is now much more likely to be full and to allow histopathological and other studies. The PLN ensures that consent is properly and fully obtained, in line with current legislation. She also plays an important role in arranging for feedback to be given by clinicians to the families after the examination, and in teaching and training Trust staff about death, bereavement, and related matters. This paper describes how the role of PLN was established and evaluated, and gives details of the current state of the adult clinical necropsy in Norwich. PMID:17172474

Employment among patients with multiple sclerosis-a population study.

PubMed

Bøe Lunde, Hanne Marie; Telstad, Wenche; Grytten, Nina; Kyte, Lars; Aarseth, Jan; Myhr, Kjell-Morten; Bø, Lars

2014-01-01

To investigate demographic and clinical factors associated with employment in MS. The study included 213 (89.9%) of all MS patients in Sogn and Fjordane County, Western Norway at December 31st 2010. The patients underwent clinical evaluation, structured interviews and completed self-reported questionnaires. Demographic and clinical factors were compared between patients being employed versus patients being unemployed and according to disease course of MS. Logistic regression analysis was used to identify factors independently associated with current employment. After a mean disease duration of almost 19 years, 45% of the population was currently full-time or part- time employed. Patients with relapsing -remitting MS (RRMS) had higher employment rate than patients with secondary (SPMS) and primary progressive (PPMS). Higher educated MS patients with lower age at onset, shorter disease duration, less severe disability and less fatigue were most likely to be employed. Nearly half of all MS patients were still employed after almost two decades of having MS. Lower age at onset, shorter disease duration, higher education, less fatigue and less disability were independently associated with current employment. These key clinical and demographic factors are important to understand the reasons to work ability in MS. The findings highlight the need for environmental adjustments at the workplace to accommodate individual 's needs in order to improve working ability among MS patients.

An oracle: antituberculosis pharmacokinetics-pharmacodynamics, clinical correlation, and clinical trial simulations to predict the future.

PubMed

Pasipanodya, Jotam; Gumbo, Tawanda

2011-01-01

Antimicrobial pharmacokinetic-pharmacodynamic (PK/PD) science and clinical trial simulations have not been adequately applied to the design of doses and dose schedules of antituberculosis regimens because many researchers are skeptical about their clinical applicability. We compared findings of preclinical PK/PD studies of current first-line antituberculosis drugs to findings from several clinical publications that included microbiologic outcome and pharmacokinetic data or had a dose-scheduling design. Without exception, the antimicrobial PK/PD parameters linked to optimal effect were similar in preclinical models and in tuberculosis patients. Thus, exposure-effect relationships derived in the preclinical models can be used in the design of optimal antituberculosis doses, by incorporating population pharmacokinetics of the drugs and MIC distributions in Monte Carlo simulations. When this has been performed, doses and dose schedules of rifampin, isoniazid, pyrazinamide, and moxifloxacin with the potential to shorten antituberculosis therapy have been identified. In addition, different susceptibility breakpoints than those in current use have been identified. These steps outline a more rational approach than that of current methods for designing regimens and predicting outcome so that both new and older antituberculosis agents can shorten therapy duration.

Optimization-based reconstruction for reduction of CBCT artifact in IGRT

NASA Astrophysics Data System (ADS)

Xia, Dan; Zhang, Zheng; Paysan, Pascal; Seghers, Dieter; Brehm, Marcus; Munro, Peter; Sidky, Emil Y.; Pelizzari, Charles; Pan, Xiaochuan

2016-04-01

Kilo-voltage cone-beam computed tomography (CBCT) plays an important role in image guided radiation therapy (IGRT) by providing 3D spatial information of tumor potentially useful for optimizing treatment planning. In current IGRT CBCT system, reconstructed images obtained with analytic algorithms, such as FDK algorithm and its variants, may contain artifacts. In an attempt to compensate for the artifacts, we investigate optimization-based reconstruction algorithms such as the ASD-POCS algorithm for potentially reducing arti- facts in IGRT CBCT images. In this study, using data acquired with a physical phantom and a patient subject, we demonstrate that the ASD-POCS reconstruction can significantly reduce artifacts observed in clinical re- constructions. Moreover, patient images reconstructed by use of the ASD-POCS algorithm indicate a contrast level of soft-tissue improved over that of the clinical reconstruction. We have also performed reconstructions from sparse-view data, and observe that, for current clinical imaging conditions, ASD-POCS reconstructions from data collected at one half of the current clinical projection views appear to show image quality, in terms of spatial and soft-tissue-contrast resolution, higher than that of the corresponding clinical reconstructions.

Current nonclinical testing paradigm enables safe entry to First-In-Human clinical trials: The IQ consortium nonclinical to clinical translational database.

PubMed

Monticello, Thomas M; Jones, Thomas W; Dambach, Donna M; Potter, David M; Bolt, Michael W; Liu, Maggie; Keller, Douglas A; Hart, Timothy K; Kadambi, Vivek J

2017-11-01

The contribution of animal testing in drug development has been widely debated and challenged. An industry-wide nonclinical to clinical translational database was created to determine how safety assessments in animal models translate to First-In-Human clinical risk. The blinded database was composed of 182 molecules and contained animal toxicology data coupled with clinical observations from phase I human studies. Animal and clinical data were categorized by organ system and correlations determined. The 2×2 contingency table (true positive, false positive, true negative, false negative) was used for statistical analysis. Sensitivity was 48% with a 43% positive predictive value (PPV). The nonhuman primate had the strongest performance in predicting adverse effects, especially for gastrointestinal and nervous system categories. When the same target organ was identified in both the rodent and nonrodent, the PPV increased. Specificity was 84% with an 86% negative predictive value (NPV). The beagle dog had the strongest performance in predicting an absence of clinical adverse effects. If no target organ toxicity was observed in either test species, the NPV increased. While nonclinical studies can demonstrate great value in the PPV for certain species and organ categories, the NPV was the stronger predictive performance measure across test species and target organs indicating that an absence of toxicity in animal studies strongly predicts a similar outcome in the clinic. These results support the current regulatory paradigm of animal testing in supporting safe entry to clinical trials and provide context for emerging alternate models. Copyright © 2017 Elsevier Inc. All rights reserved.

Is the diagnostic threshold for bulimia nervosa clinically meaningful?

PubMed

Chapa, Danielle A N; Bohrer, Brittany K; Forbush, Kelsie T

2018-01-01

The DSM-5 differentiates full- and sub-threshold bulimia nervosa (BN) according to average weekly frequencies of binge eating and inappropriate compensatory behaviors. This study was the first to evaluate the modified frequency criterion for BN published in the DSM-5. The purpose of this study was to test whether community-recruited adults (N=125; 83.2% women) with current full-threshold (n=77) or sub-threshold BN (n=48) differed in comorbid psychopathology and eating disorder (ED) illness duration, symptom severity, and clinical impairment. Participants completed the Clinical Impairment Assessment and participated in semi-structured clinical interviews of ED- and non-ED psychopathology. Differences between the sub- and full-threshold BN groups were assessed using MANOVA and Chi-square analyses. ED illness duration, age-of-onset, body mass index (BMI), alcohol and drug misuse, and the presence of current and lifetime mood or anxiety disorders did not differ between participants with sub- and full-threshold BN. Participants with full-threshold BN had higher levels of clinical impairment and weight concern than those with sub-threshold BN. However, minimal clinically important difference analyses suggested that statistically significant differences between participants with sub- and full-threshold BN on clinical impairment and weight concern were not clinically significant. In conclusion, sub-threshold BN did not differ from full-threshold BN in clinically meaningful ways. Future studies are needed to identify an improved frequency criterion for BN that better distinguishes individuals in ways that will more validly inform prognosis and effective treatment planning for BN. Copyright © 2017 Elsevier Ltd. All rights reserved.

A Survey of the Current Situation of Clinical Biobanks in China.

PubMed

Li, Haiyan; Ni, Mingyu; Wang, Peng; Wang, Xiaomin

2017-06-01

The development of biomedical research urgently needs the support of a large number of high-quality clinical biospecimens. Therefore, human biobanks at different levels have been established successively in China and other countries at a significantly increasing pace in recent years. To better understand the general current state of clinical biobanks in China, we surveyed 42 clinical biobanks based in hospitals and collected information involving their management systems, sharing mechanisms, quality control systems, and informational management systems using closed questionnaire methods. Based on our current information, there has not been such a large-scale survey in China. An understanding of the status and challenges current clinical biobanks face will provide valuable insights for the construction and sustainable development of higher quality clinical biobanks.

The therapeutic impact of new migraine discoveries.

PubMed

Vécsei, Laszlo; Lukács, Melinda; Tajti, Janos; Fülöp, Ferenc; Toldi, Jozsef; Edvinsson, Lars

2018-05-29

Migraine is one the most disabling neurological conditions and associates with high socio-economic costs. Though certain aspects of the pathomechanism of migraine are still incompletely understood, the leading hypothesis implicates the role of the activation of the trigeminovascular system. Triptans are considered the current gold standard therapy for migraine attacks; however, their use in clinical practice is limited. Prophylactic treatment includes non-specific approaches for migraine prevention. All these support the need for future studies in order to develop innovative anti-migraine drugs. The present study is a review of the current literature regarding new therapeutic lines in migraine research. A systematic literature search in the database of PUBMED was conducted concerning therapeutic strategies in migraine published until July 2017. Ongoing clinical trials with 5-HT1F receptor agonists and glutamate receptor antagonists offer promising new aspects for acute migraine treatment. Monoclonal antibodies against CGRP and the CGRP receptor are revolutionary in preventive treatment; however, further long-term studies are needed to test their tolerability. Preclinical studies show positive results with PACAP- and kynurenic acid-related treatments. Other promising therapeutic strategies (such as those targeting TRPV1, substance P, NOS, or orexin) have failed to show efficacy in clinical trials. Due to their side-effects, current therapeutic approaches are not suitable for all migraine patients. Especially frequent episodic and chronic migraine represents a therapeutic challenge for researchers. Clinical and preclinical studies are needed to untangle the pathophysiology of migraine in order to develop new and migraine-specific therapies. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

The Clinical Use of Robots for Individuals with Autism Spectrum Disorders: A Critical Review

ERIC Educational Resources Information Center

Diehl, Joshua J.; Schmitt, Lauren M.; Villano, Michael; Crowell, Charles R.

2012-01-01

We examined peer-reviewed studies in order to understand the current status of empirically based evidence on the clinical applications of robots in the diagnosis and treatment of Autism Spectrum Disorders (ASD). Studies are organized into four broad categories: (a) the response of individuals with ASD to robots or robot-like behavior in comparison…

The role of barrier membranes for guided bone regeneration and restoration of large bone defects: current experimental and clinical evidence

PubMed Central

2012-01-01

Treatment of large bone defects represents a great challenge in orthopedic and craniomaxillofacial surgery. Although there are several methods for bone reconstruction, they all have specific indications and limitations. The concept of using barrier membranes for restoration of bone defects has been developed in an effort to simplify their treatment by offering a sinlge-staged procedure. Research on this field of bone regeneration is ongoing, with evidence being mainly attained from preclinical studies. The purpose of this review is to summarize the current experimental and clinical evidence on the use of barrier membranes for restoration of bone defects in maxillofacial and orthopedic surgery. Although there are a few promising preliminary human studies, before clinical applications can be recommended, future research should aim to establish the 'ideal' barrier membrane and delineate the need for additional bone grafting materials aiming to 'mimic' or even accelerate the normal process of bone formation. Reproducible results and long-term observations with barrier membranes in animal studies, and particularly in large animal models, are required as well as well-designed clinical studies to evaluate their safety, efficacy and cost-effectiveness. PMID:22834465

Pharmacogenetics and pharmacogenomics in psoriasis treatment: current challenges and future prospects.

PubMed

Sutherland, Alison; Power, Rebecca J; Rahman, Proton; O'Rielly, Darren D

2016-08-01

Topical, systemic, oral disease modifying, and biologic agents are part of the armamentarium to manage psoriatic disease. The choice of therapy depends upon disease severity, relevant co-morbidities and patient preference. There is great variability in patient response with these agents, and there is still no clear method of selecting the preferred therapeutic agent for efficacy or lack of adverse events. This article will review the pharmacogenetic and pharmacogenomic targets that are currently known with respect to psoriasis vulgaris, and the most frequent co-morbidity of psoriasis, psoriatic arthritis. Presently, no clinically actionable biomarker exists for any therapeutic agent used to treat psoriasis or psoriatic arthritis. The lack of validated outcome measures and conflicting results of open-label studies conducted may be attributed to a multitude of issues that confound discovery. Consequently, studies have been underpowered to identify genes or genetic variants worth translating to clinical practice. In order to achieve a pharmacogenetic/pharmacogenomic signature, improvements in study design of future investigations are required, including carefully designed prospective studies. It is imperative to combine known clinical, serological, and molecular markers with consistent outcomes and an adequate health economic evaluation before they can be adopted widely in clinical practice.

Factors Associated With Smoking Status among HIV-Positive Patients in Routine Clinical Care.

PubMed

Zyambo, Cosmas M; Willig, James H; Cropsey, Karen L; Carson, April P; Wilson, Craig; Tamhane, Ashutosh R; Westfall, Andrew O; Burkholder, Greer A

2015-07-01

Treatment-related reductions in morbidity and mortality among human immunodeficiency virus (HIV)-positive patients have been attenuated by cigarette smoking, which increases risk of cardiovascular, respiratory, and neoplastic diseases. This study investigated factors associated with smoking status among HIV-positive patients. This cross-sectional study included 2,464 HIV-positive patients attending the HIV Clinic at the University of Alabama at Birmingham between April 2008 and December 2013. Smoking status (current, former, never), psychosocial factors, and clinical characteristics were assessed. Multinomial logistic regression was used to obtain unadjusted and adjusted odds ratios (OR) and 95% confidence intervals (CI) for the association of the various factors with smoking status. Among HIV-positive patients (mean age 45 years, 75% male, 55% African-American), the majority reported a history of smoking (39% current and 22% former smokers). In adjusted models, patient characteristics associated with increased odds of current smoking were male gender (OR for heterosexual men, 1.8 [95% CI: 1.3-2.6]; for men who have sex with men, 1.5 [1.1-1.9]), history of respiratory diseases (1.5 [1.2-1.9]), unsuppressed HIV viral load (>50 copies/mL) (1.5 [1.1-1.9]), depression (1.6 [1.3-2.0]), anxiety (1.6 [1.2-2.1]), and prior and current substance abuse (4.7 [3.6-6.1] and 8.3 [5.3-13.3] respectively). Male gender, anxiety, and substance abuse were also associated with being a former smoker. Smoking was common among HIV-positive patients, with several psychosocial factors associated with current and former smoking. This suggests smoking cessation programs in HIV clinic settings may achieve greater impact by integrating interventions that also address illicit substance abuse and mental health.

Arab-American adolescent tobacco use: four pilot studies.

PubMed

Rice, Virginia Hill; Templin, Thomas; Kulwicki, Anahid

2003-11-01

Four pilot studies were conducted to determine the (1) current tobacco use patterns and predictors among 14- to 18-year-old Arab-American youths; (2) psychometric properties of study measures (English and Arabic); (3) cultural appropriateness of Project Toward No Tobacco (TNT) for intervention; (4) accessible population for a longitudinal study. Three studies were descriptive and one used a pretest-posttest design. From four Pilot Focus groups (N = 28 smokers) key tobacco use themes emerged along with information on study measures and the Project TNT intervention; Pilot Intervention tested the tailored Project TNT intervention with 9 Arab-American teens; Pilot Clinic (N = 44) determined the characteristics of the accessible teen health clinic population; and Pilot School (N = 119) obtained tobacco use data only. From Pilot Focus seven themes (being cool, "nshar ma'a al shabab" [hanging out with the guys], present [time] orientation, smoking feels and tastes good, keeps your mind off trouble, easy to get, and (many) "barriers to quitting") emerged from the data. In the Pilot Intervention a 37.5% cessation rate was found. In the Pilot Clinic study, 24% males and 17% females smoked. The current smoking rate in the Pilot School (N = 119) sample was 17%; 34% admitted to having ever smoked (even a puff). Significant predictors for current tobacco use included poor grades, stress, having many family members and peers who smoke, being exposed to many hours of smoking each day, receiving offers of tobacco products, advertising and mail, and believing that tobacco can help one to make friends. The four pilots contributed unique and essential knowledge for designing a longitudinal clinical trial on tobacco use by Arab-American adolescents.

Written feedback and continuity of learning in a geographically distributed medical education program.

PubMed

Harvey, Pam; Radomski, Natalie; O'Connor, Dennis

2013-12-01

The provision of effective feedback on clinical performance for medical students is important for their continued learning. Written feedback is an underutilised medium for linking clinical performances over time. The aim of this study is to investigate how clinical supervisors construct performance orientated written feedback and learning goals for medical students in a geographically distributed medical education (GDME) programme. This qualitative study uses textual analysis to examine the structure and content of written feedback statements in 1000 mini-CEX records from 33 Australian undergraduate medical students during their 36 week GDME programme. The students were in their second clinical year. Forty percent of mini-CEX records contained written feedback statements. Within these statements, 80% included comments relating to student clinical performance. The way in which written feedback statements were recorded varied in structure and content. Only 16% of the statements contained student learning goals focused on improving a student's clinical performance over time. Very few of the written feedback statements identified forward-focused learning goals. Training clinical supervisors in understanding how their feedback contributes to a student's continuity of learning across their GDME clinical placements will enable more focused learning experiences based on student need. To enhance student learning over time and place, effective written feedback should contain focused, coherent phrases that help reflection on current and future clinical performance. It also needs to provide enough detail for other GDME clinical supervisors to understand current student performance and plan future directions for their teaching.

Provision of oncology services in remote rural areas: a Scottish perspective.

PubMed

Smith, S M; Campbell, N C

2004-05-01

There is a paucity of research into rural health care services. In particular little is known about the provision of specialist cancer services for patients who live in remote rural areas of the UK. This study set out to investigate current models of medical and clinical oncology care in Scotland. A national survey with key health professionals was conducted to identify rural oncology schemes currently in operation. Detailed quantitative data about the schemes together with qualitative data on how health professionals view current models of care were collected by a computer-assisted telephone survey. Schemes that currently provide outpatient and chemotherapy oncology services for remote rural patients fell into three categories: central clinics (5); shared care outreach clinics with chemotherapy provision (11); and shared care outreach clinics without chemotherapy provision (7). All radiotherapy was conducted at central clinics (5). Widely varying practices in delivery of cancer care were found across the country. The main issues for professionals about current models of care involved expertise, travelling and accessibility (for patients), communication and expansion of the rural service. Nation-wide consistency in cancer care has still to be achieved. Travelling for treatment was seen to take its toll on all patients but particularly for the very remote, elderly and poor. Most professionals believe that an expansion of rural services would be of benefit to these patients. It is clear, however, that the proper infrastructure needs to be in place in terms of local expertise, ensured quality of care, and good communication links with cancer centres before this could happen.

A Clinical Approach to Antioxidant Therapy: Hypertonic Fluid Resuscitation Trial

DTIC Science & Technology

2003-06-01

5 2. Experimental Section...limited forward surgical care and delayed evacuation.[9] 1.1.1 Current Fluid Resuscitation Standard of Care By virtue of clinical experience , low cost...bleeding, thereby potentially increasing mortality. Indeed, evidence from experimental animal studies suggests that small-volume hypotensive

Clinical application of microsampling versus conventional sampling techniques in the quantitative bioanalysis of antibiotics: a systematic review.

PubMed

Guerra Valero, Yarmarly C; Wallis, Steven C; Lipman, Jeffrey; Stove, Christophe; Roberts, Jason A; Parker, Suzanne L

2018-03-01

Conventional sampling techniques for clinical pharmacokinetic studies often require the removal of large blood volumes from patients. This can result in a physiological or emotional burden, particularly for neonates or pediatric patients. Antibiotic pharmacokinetic studies are typically performed on healthy adults or general ward patients. These may not account for alterations to a patient's pathophysiology and can lead to suboptimal treatment. Microsampling offers an important opportunity for clinical pharmacokinetic studies in vulnerable patient populations, where smaller sample volumes can be collected. This systematic review provides a description of currently available microsampling techniques and an overview of studies reporting the quantitation and validation of antibiotics using microsampling. A comparison of microsampling to conventional sampling in clinical studies is included.

The current evidence base for the feasibility of 48-hour continuous subcutaneous infusions (CSCIs): A systematically-structured review

PubMed Central

Dickman, Andrew; Mason, Stephen; Ellershaw, John

2018-01-01

Background A continuous subcutaneous infusion (CSCI) is an effective method of multiple drug administration commonly encountered in end of life care when the oral route is compromised. At present, current practice is to limit syringe driver infusion time to a maximum of 24 hours as dictated by available chemical stability data. However, the ability to deliver prescribed medication by a CSCI over 48 hours may have numerous benefits in both patient care and health service resource utilisation. Aim To examine and present the current evidence base for the stability of 48-hour multiple-drug CSCIs in current clinical practice. Design A systematically-structured review following PRISMA guidelines. Data sources Three electronic databases and the grey literature were searched with no time limits. Empirical studies reporting data on the chemical stability of continuous subcutaneous infusions or solutions stored in polypropylene syringes were included. Results Twenty-one empirical studies were included in this review reporting chemical compatibility and stability of 32 discrete combinations of twenty-four drugs tested at a variety of different drug concentrations. The majority of combinations reported were assessed as being chemically compatible. The greatest risk of clinically significant chemical degradation was observed with midazolam. Only one study reported the microbiological stability of the solution examined. Conclusions There is currently limited evidence for the physical, chemical and microbiological stability of solutions for continuous subcutaneous infusion over a period of 48 hours. More stability data is required before the use of 48-hour CSCIs can be evaluated for use within clinical practice. PMID:29538455

Physicians' perceptions of capacity building for managing chronic disease in seniors using integrated interprofessional care models.

PubMed

Lee, Linda; Heckman, George; McKelvie, Robert; Jong, Philip; D'Elia, Teresa; Hillier, Loretta M

2015-03-01

To explore the barriers to and facilitators of adapting and expanding a primary care memory clinic model to integrate care of additional complex chronic geriatric conditions (heart failure, falls, chronic obstructive pulmonary disease, and frailty) into care processes with the goal of improving outcomes for seniors. Mixed-methods study using quantitative (questionnaires) and qualitative (interviews) methods. Ontario. Family physicians currently working in primary care memory clinic teams and supporting geriatric specialists. Family physicians currently working in memory clinic teams (n = 29) and supporting geriatric specialists(n = 9) were recruited as survey participants. Interviews were conducted with memory clinic lead physicians (n = 16).Statistical analysis was done to assess differences between family physician ratings and geriatric specialist ratings related to the capacity for managing complex chronic geriatric conditions, the role of interprofessional collaboration within primary care, and funding and staffing to support geriatric care. Results from both study methods were compared to identify common findings. Results indicate overall support for expanding the memory clinic model to integrate care for other complex conditions. However, the current primary care structure is challenged to support optimal management of patients with multiple comorbidities, particularly as related to limited funding and staffing resources. Structured training, interprofessional teams, and an active role of geriatric specialists within primary care were identified as important facilitators. The memory clinic model, as applied to other complex chronic geriatric conditions, has the potential to build capacity for high-quality primary care, improve health outcomes,promote efficient use of health care resources, and reduce healthcare costs.

Novel femoral artery terminology: integrating anatomy and clinical procedures leading to standardized intuitive nomenclature.

PubMed

Benninger, Brion

2014-10-01

The objective of this study is to investigate the terminology of the femoral artery and recommended alternative terminology that satisfies both anatomy and clinical arenas.The femoral artery (FA) is often defined as the continuation of the external iliac artery. Specifically, when the external iliac artery reaches directly beneath the inguinal ligament, it becomes the FA. Currently, Terminologia Anatomica (TA) records the profunda femoris or deep femoral as a terminal branch. Clinicians often use superficial femoral artery (SFA) rather than FA and profunda or deep FA. SFA is actually very deep and well protected for most of its journey. On observation, the terminology in current use is not intuitive. The objective of this study was to investigate the terminology associated with the anatomical and clinical anatomical interpretations of the FA and its terminal branches and to suggest a more appropriate terminology that addresses the points of view of the macro anatomist, as well as that of the clinician. Literature search was conducted regarding the nomenclature of the FA and its terminal branches. Dissection of 89 embalmed cadavers (49F, 40M, ages 47-89) was conducted to analyze the morphology of the FA and its branches. Perusal of the literature revealed a difference in terminology between anatomical and clinical textbooks/atlases/journals regarding the FA and its terminal branch. Our dissections suggested that the FA may be better defined vis-à-vis its relationship to the anterior and posterior compartments of the thigh. A difference in terminology exists between the anatomical and clinical arenas. A need for a standardized terminology is necessary because clinicians and their publishers have not adopted TA. This study suggests that the current FA be considered the common FA and the continuation of the FA, the SFA be renamed the anterior FA and the current profunda (the deep FA) be renamed the posterior FA, respectively. The proposed terminology mirrors the lower limb anterior/posterior tibial artery terminology. © 2014 Wiley Periodicals, Inc.

Visual Impairment/Intracranial Pressure Research Clinical Advisory Panel (RCAP) Meeting. [Summary Report

NASA Technical Reports Server (NTRS)

Villarreal, Jennifer

2014-01-01

The Visual Impairment/Intracranial Pressure (VIIP) Research and Clinical Advisory Panel convened on December 1, 2014 at the ISS Conference Facility in Houston. The panel members were provided updates to the current clinical cases and treatment plans along with the latest research activities (http://humanresearchroadmap.nasa.gov/Risks/?i=105) and preliminary study results. The following is a summary of this meeting.

Increased Clinical and Neurocognitive Impairment in Children with Autism Spectrum Disorders and Comorbid Bipolar Disorder

ERIC Educational Resources Information Center

Weissman, Adam S.; Bates, Marsha E.

2010-01-01

Bipolar (BD) symptomatology is prevalent in children with autism spectrum disorders (ASD) and may lead to increased impairment. The current study compared clinical and neurocognitive impairment in children (7-13 years) diagnosed with ASD (n=55), BD (n=34), ASD + BD (n=23), and a non-clinical control group (n=27). Relative to the ASD group, the ASD…

Sexual intercourse among adolescent daughters of mothers with depressive symptoms from minority families

PubMed Central

Cederbaum, Julie A.; Hurlburt, Michael S.

2016-01-01

This study investigated the association between maternal depressive symptoms and adolescent engagement in sexual intercourse in a non-clinical sample of mothers and their adolescent daughters from minority families. The current study explores ways in which maternal depression, family factors, and adolescent sex interact. Data were from a cross-sectional study of 176 mother-daughter dyads, including a subset of mothers with HIV. Logistic regression analyses revealed that among mothers who were not current marijuana users, more maternal depressive symptoms was associated with daughters’ engagement in sexual intercourse. Neither parent-child conflict nor parental involvement significantly mediated the relationship between maternal depressive symptoms and adolescent sex. This study provides the first empirical evidence that non-clinical depressive symptoms in mothers are associated with adolescent engagement in sexual intercourse. PMID:27326541

Economic impact of converting an interventional pain medicine physician office-based practice into a provider-based ambulatory pain practice.

PubMed

Grider, Jay S; Findley, Kelley A; Higdon, Courtney; Curtright, Jonathan; Clark, Don P

2014-01-01

One consequence of the shifting economic health care landscape is the growing trend of physician employment and practice acquisition by hospitals. These acquired practices are often converted into hospital- or provider-based clinics. This designation brings the increased services of the hospital, the accreditation of the hospital, and a new billing structure verses the private clinic (the combination of the facility and professional fee billing). One potential concern with moving to a provider-based designation is that this new structure might make the practice less competitive in a marketplace that may still be dominated by private physician office-based practices. The aim of the current study was to evaluate the impact of the provider-based/hospital fee structure on clinical volume. Determine the effect of transition to a hospital- or provider-based practice setting (with concomitant cost implications) on patient volume in the current practice milieu.   Community hospital-based academic interventional pain medicine practice. Economic analysis of effect of change in price structure on clinical volumes. The current study evaluates the effect of a change in designation with price implications on the demand for clinical services that accompany the transition to a hospital-based practice setting from a physician office setting in an academic community hospital. Clinical volumes of both procedures and clinic volumes increased in a mature practice setting following transition to a provider-based designation and the accompanying facility and professional fee structure. Following transition to a provider-based designation clinic visits were increased 24% while procedural volume demand did not change. Single practice entity and single geographic location in southeastern United States. The conversion to a hospital- or provider-based setting does not negatively impact clinical volume and referrals to community-based pain medicine practice. These results imply that factors other than price are a driver of patient choice.  

The immediate effects of lidocaine iontophoresis using interferential current on pressure sense threshold and tactile sensation.

PubMed

Yoosefinejad, Amin Kordi; Motealleh, Alireza; Abbasnia, Keramatollah

2016-01-01

Iontophoresis is the noninvasive delivery of ions using direct current. The direct current has some disadvantages such as skin burning. Interferential current is a kind of alternating current without limitations of direct current; so the purpose of this study is to investigate and compare the effects of lidocaine, interferential current and lidocaine iontophoresis using interferential current. 30 healthy women aged 20-24 years participated in this randomized clinical trial study. Pressure, tactile and pain thresholds were evaluated before and after the application of treatment methods. Pressure, tactile and pain sensitivity increased significantly after the application of lidocaine alone (p < 0.005) and lidocaine iontophoresis using interferential current (p < 0.0001). Lidocaine iontophoresis using interferential current can increase perception threshold of pain, tactile stimulus and pressure sense more significantly than lidocaine and interferential current alone.

Transcutaneous electrical nerve stimulation and interferential current demonstrate similar effects in relieving acute and chronic pain: a systematic review with meta-analysis.

PubMed

Almeida, Camila Cadena de; Silva, Vinicius Z Maldaner da; Júnior, Gerson Cipriano; Liebano, Richard Eloin; Durigan, Joao Luiz Quagliotti

2018-02-02

Transcutaneous electrical nerve stimulation and interferential current have been widely used in clinical practice. However, a systematic review comparing their effects on pain relief has not yet been performed. To investigate the effects of transcutaneous electrical nerve stimulation and interferential current on acute and chronic pain. We use Pubmed, Embase, LILACS, PEDro and Cochrane Central Register of Controlled Trials as data sources. Two independent reviewers that selected studies according to inclusion criteria, extracted information of interest and verified the methodological quality of the studies made study selection. The studies were selected if transcutaneous electrical nerve stimulation and interferential current were used as treatment and they had pain as the main outcome, as evaluated by a visual analog scale. Secondary outcomes were the Western Ontario Macmaster and Rolland Morris Disability questionnaires, which were added after data extraction. Eight studies with a pooled sample of 825 patients were included. The methodological quality of the selected studies was moderate, with an average of six on a 0-10 scale (PEDro). In general, both transcutaneous electrical nerve stimulation and interferential current improved pain and functional outcomes without a statistical difference between them. Transcutaneous electrical nerve stimulation and interferential current have similar effects on pain outcome The low number of studies included in this meta-analysis indicates that new clinical trials are needed. Copyright © 2018 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Use of Non-invasive Uterine Electromyography in the Diagnosis of Preterm Labour

PubMed Central

Lucovnik, M.; Novak-Antolic, Z.; Garfield, R.E.

2012-01-01

Predictive values of methods currently used in the clinics to diagnose preterm labour are low. This leads to missed opportunities to improve neonatal outcomes and, on the other hand, to unnecessary hospitalizations and treatments. In addition, research of new and potentially more effective preterm labour treatments is hindered by the inability to include only patients in true preterm labour into studies. Uterine electromyography (EMG) detects changes in cell excitability and coupling required for labour and has higher predictive values for preterm delivery than currently available methods. This methodology could also provide a better means to evaluate various therapeutic interventions for preterm labour. Our manuscript presents a review of uterine EMG studies examining the potential clinical value that this technology possesses over what is available to physicians currently. We also evaluated the impact that uterine EMG could have on investigation of preterm labour treatments by calculating sample sizes for studies using EMG vs. current methods to enrol women. Besides helping clinicians to make safer and more cost-effective decisions when managing patients with preterm contractions, implementation of uterine EMG for diagnosis of preterm labour would also greatly reduce sample sizes required for studies of treatments. PMID:24753891

The impact of prostate artery embolization (PAE) on the the physical history and pathophysiology of benign prostatic hyperplasia (BPH).

PubMed

Stamatiou, Konstantinos

2018-03-31

Prostate artery embolization (PAE) is a non invasive modality for the treatment of benign prostate hypertrophy (BPH) related lower urinary tract symptoms (LUTS). As a relatively new procedure, data determining the clinical success is somehow scarce. In the present article we examine the current clinical outcome measures in order to identify the most accurate. Current imaging outcome measures are consistent with clinical ones only in the group of patients with adenomatous- dominant BPH while are inconsistent in patients with small sized adenomas. Additional studies and/or evaluation tools are needed in order to provide accurate evaluation of clinical success in the subgroup of patients with non- adenomatous-dominant BPH while they may inspire new options and novel techniques for both BPH treatment and treatment-follow up.

Can corneal pannus with trachomatous inflammation--follicular be used in combination as an improved specific clinical sign for current ocular Chlamydia trachomatis infection?

PubMed

Derrick, Tamsyn; Holland, Martin J; Cassama, Eunice; Markham-David, Rod; Nabicassa, Meno; Marks, Michael; Bailey, Robin L; Last, Anna R

2016-01-27

Trachoma is a blinding disease caused by conjunctival infection with Chlamydia trachomatis (Ct). Mass drug administration (MDA) for trachoma control is administered based on the population prevalence of the clinical sign of trachomatis inflammation - follicular (TF). However, the prevalence of TF is often much higher than the prevalence of Ct infection. The addition of a clinical sign specific for current ocular Ct infection to TF could save resources by preventing unnecessary additional rounds of MDA. Study participants were aged between 1-9 years and resided on 7 islands of the Bijagos Archipelago, Guinea Bissau. Clinical grades for trachoma and corneal pannus and ocular swab samples were taken from 80 children with TF and from 81 matched controls without clinical evidence of trachoma. Ct infection testing was performed using droplet digital PCR. New pannus was significantly associated with Ct infection after adjustment for TF (P = 0.009, OR = 3.65 (1.4-9.8)). Amongst individuals with TF, individuals with new pannus had significantly more Ct infection than individuals with none or old pannus (75.0% vs 45.5%, Chi(2) P = 0.01). TF and new pannus together provide a highly specific (91.7%), but a poorly sensitive (51.9%) clinical diagnostic test for Ct infection. As we move towards trachoma elimination it may be desirable to use a combined clinical sign (new pannus in addition to TF) that is highly specific for current ocular Ct infection. This would allow national health systems to obtain a more accurate estimate of Ct population prevalence to inform further need for MDA without the expense of Ct molecular diagnostics, which are currently unaffordable in programmatic contexts.

Graphical Presentation of Patient-Treatment Interaction Elucidated by Continuous Biomarkers. Current Practice and Scope for Improvement.

PubMed

Shen, Yu-Ming; Le, Lien D; Wilson, Rory; Mansmann, Ulrich

2017-01-09

Biomarkers providing evidence for patient-treatment interaction are key in the development and practice of personalized medicine. Knowledge that a patient with a specific feature - as demonstrated through a biomarker - would have an advantage under a given treatment vs. a competing treatment can aid immensely in medical decision-making. Statistical strategies to establish evidence of continuous biomarkers are complex and their formal results are thus not easy to communicate. Good graphical representations would help to translate such findings for use in the clinical community. Although general guidelines on how to present figures in clinical reports are available, there remains little guidance for figures elucidating the role of continuous biomarkers in patient-treatment interaction (CBPTI). To combat the current lack of comprehensive reviews or adequate guides on graphical presentation within this topic, our study proposes presentation principles for CBPTI plots. In order to understand current practice, we review the development of CBPTI methodology and how CBPTI plots are currently used in clinical research. The quality of a CBPTI plot is determined by how well the presentation provides key information for clinical decision-making. Several criteria for a good CBPTI plot are proposed, including general principles of visual display, use of units presenting absolute outcome measures, appropriate quantification of statistical uncertainty, correct display of benchmarks, and informative content for answering clinical questions especially on the quantitative advantage for an individual patient with regard to a specific treatment. We examined the development of CBPTI methodology from the years 2000 - 2014, and reviewed how CBPTI plots were currently used in clinical research in six major clinical journals from 2013 - 2014 using the principle of theoretical saturation. Each CBPTI plot found was assessed for appropriateness of its presentation and clinical utility. In our review, a total of seven methodological papers and five clinical reports used CBPTI plots which we categorized into four types: those that distinguish the outcome effect for each treatment group; those that show the outcome differences between treatment groups (by either partitioning all individuals into subpopulations or modelling the functional form of the interaction); those that evaluate the proportion of population impact of the biomarker; and those that show the classification accuracy of the biomarker. The current practice of utilizing CBPTI plots in clinical reports suffers from methodological shortcomings: the lack of presentation of statistical uncertainty, the outcome measure scaled by relative unit instead of absolute unit, incorrect use of benchmarks, and being non-informative in answering clinical questions. There is considerable scope for improvement in the graphical representation of CBPTI in clinical reports. The current challenge is to develop instruments for high-quality graphical plots which not only convey quantitative concepts to readers with limited statistical knowledge, but also facilitate medical decision-making.

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

PubMed

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

2017-06-01

Various definitions for concussion have been proposed, each having its strengths and weaknesses. We reviewed and compared current definitions and identified criteria necessary for an operational definition of sports-related concussion (SRC) in preparation of the 5th Concussion Consensus Conference (Berlin, Germany). We also assessed the role of biomechanical studies in informing an operational definition of SRC. This is a systematic literature review. Data sources include MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Clinical Trials and SPORT Discus (accessed 14 September 2016). Eligibility criteria were studies reporting (clinical) criteria for diagnosing SRC and studies containing SRC impact data. Out of 1601 articles screened, 36 studies were included (2.2%), 14 reported on criteria for SRC definitions and 22 on biomechanical aspects of concussions. Six different operational definitions focusing on clinical findings and their dynamics were identified. Biomechanical studies were obtained almost exclusively on American football players. Angular and linear head accelerations linked to clinically confirmed concussions demonstrated considerable individual variation. SRC is a traumatic brain injury that is defined as a complex pathophysiological process affecting the brain, induced by biomechanical forces with several common features that help define its nature. Limitations identified include that the current criteria for diagnosing SRC are clinically oriented and that there is no gold/standard to assess their diagnostic properties. A future, more valid definition of SRC would better identify concussed players by demonstrating high predictive positive/negative values. Currently, the use of helmet-based systems to study the biomechanics of SRC is limited to few collision sports. New approaches need to be developed to provide objective markers for SRC. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Anxiety in Parkinson's disease: a critical review of experimental and clinical studies.

PubMed

Prediger, Rui D S; Matheus, Filipe C; Schwarzbold, Marcelo L; Lima, Marcelo M S; Vital, Maria A B F

2012-01-01

Parkinson's disease (PD) is the second most common neurodegenerative disorder affecting about 1% of the population older than 60 years. Classically, PD is considered as a movement disorder, and its diagnosis is based on the presence of a set of cardinal motor signs that are the consequence of a pronounced death of dopaminergic neurons in the substantia nigra pars compacta. There is now considerable evidence showing that the neurodegenerative processes leading to sporadic PD begin many years before the appearance of the characteristic motor symptoms, and that additional neuronal fields and neurotransmitter systems are also involved in PD, including olfactory structures, amygdala, caudal raphe nuclei, locus coeruleus, and hippocampus. Accordingly, adrenergic and serotonergic neurons are also lost, which seems to contribute to the anxiety in PD. Non-motor features of PD usually do not respond to dopaminergic medication and probably form the major current challenge in the clinical management of PD. Additionally, most studies performed with animal models of PD have investigated their ability to induce motor alterations associated with advanced phases of PD, and some studies begin to assess non-motor behavioral features of the disease. The present review attempts to examine results obtained from clinical and experimental studies to provide a comprehensive picture of the neurobiology and current and potential treatments for anxiety in PD. The data reviewed here indicate that, despite their high prevalence and impact on the quality of life, anxiety disorders are often under-diagnosed and under-treated in PD patients. Moreover, there are currently few clinical and pre-clinical studies underway to investigate new pharmacological agents for relieving these symptoms, and we hope that this article may inspire clinicians and researchers devote to the studies on anxiety in PD to change this scenario. This article is part of a Special Issue entitled 'Anxiety and Depression'. Copyright © 2011 Elsevier Ltd. All rights reserved.

Congenital Rubella: Clinical and Related Studies

ERIC Educational Resources Information Center

Menser, Margaret A.

1977-01-01

Briefly described are four studies currently being undertaken in Australia to determine the effectiveness of vaccination in the prevention of rubella and to examine the relationship between rubella and diabetes. (CL)

Design and Evaluation of Micellar Nanocarriers for 17-allyamino-17-demethoxygeldanamycin (17-AAG)

EPA Science Inventory

17-Allyamino-17-demethoxygeldanamycin (17-AAG) is a potent anticancer agent currently undergoing phases I and II clinical trials. However, the clinical development of 17-AAG has been hindered by its poor aqueous solubility and hepatotoxicity. This study aimed to devise novel mice...

Community-Clinic-Based Parent Intervention Addressing Noncompliance in Children with Attention-Deficit/Hyperactivity Disorder

ERIC Educational Resources Information Center

Canu, Will H.; Bearman, Sarah Kate

2011-01-01

The current study tested whether an abbreviated version of "Defiant Children" (Barkley, 1987), an efficacious parent training program to address the behavioral noncompliance often associated with disruptive behavior disorders, could be implemented successfully within a community mental health clinic setting by master's-level therapists. Ethnically…

Teacher-Child Interaction Training with an Urban Clinical Preschool Population

ERIC Educational Resources Information Center

Schaffner, Kristen F.; McGoey, Kara E.; Venesky, Lindsey

2016-01-01

The current study examined the impact of the relationship-enhancement phase of the Teacher-Child Interaction Training (TCIT) intervention on child behavior and teacher skill use within an urban therapeutic classroom milieu. Participants included four preschool children (mean age 4 years, 8 months) with clinical diagnoses attending a therapeutic…

Transcranial cerebellar direct current stimulation and transcutaneous spinal cord direct current stimulation as innovative tools for neuroscientists

PubMed Central

Priori, Alberto; Ciocca, Matteo; Parazzini, Marta; Vergari, Maurizio; Ferrucci, Roberta

2014-01-01

Two neuromodulatory techniques based on applying direct current (DC) non-invasively through the skin, transcranial cerebellar direct current stimulation (tDCS) and transcutaneous spinal DCS, can induce prolonged functional changes consistent with a direct influence on the human cerebellum and spinal cord. In this article we review the major experimental works on cerebellar tDCS and on spinal tDCS, and their preliminary clinical applications. Cerebellar tDCS modulates cerebellar motor cortical inhibition, gait adaptation, motor behaviour, and cognition (learning, language, memory, attention). Spinal tDCS influences the ascending and descending spinal pathways, and spinal reflex excitability. In the anaesthetised mouse, DC stimulation applied under the skin along the entire spinal cord may affect GABAergic and glutamatergic systems. Preliminary clinical studies in patients with cerebellar disorders, and in animals and patients with spinal cord injuries, have reported beneficial effects. Overall the available data show that cerebellar tDCS and spinal tDCS are two novel approaches for inducing prolonged functional changes and neuroplasticity in the human cerebellum and spinal cord, and both are new tools for experimental and clinical neuroscientists. PMID:24907311

Embolic Protection Devices During TAVI: Current Evidence and Uncertainties.

PubMed

Abdul-Jawad Altisent, Omar; Puri, Rishi; Rodés-Cabau, Josep

2016-10-01

Transcatheter aortic valve implantation (TAVI) is now the principal therapeutic option in patients with severe aortic stenosis deemed inoperable or at high surgical risk. Implementing TAVI in a lower risk profile population could be limited by relatively high cerebrovascular event rates related to the procedure. Diffusion-weighted magnetic resonance imaging studies have demonstrated the ubiquitous presence of silent embolic cerebral infarcts after TAVI, with some data relating these lesions to subsequent cognitive decline. Embolic protection devices provide a mechanical barrier against debris embolizing to the brain during TAVI. We review the current evidence and ongoing uncertainties faced with the 3 currently available devices (Embrella, TriGuard and Claret) in TAVI. Studies evaluated neurological damage at 3 levels: clinical, subclinical, and cognitive. Feasibility and safety were analyzed for the 3 devices. In terms of efficacy, all studies were exploratory, but none demonstrated significant reductions in clinical event rates. The Embrella and Claret devices demonstrated significant reductions of the total cerebral lesion volume on diffusion-weighted magnetic resonance imaging. Studies evaluating the effects on cognition were also somewhat inconclusive. In conclusion, despite embolic protection devices demonstrating reductions in the total cerebral lesion volume on diffusion-weighted magnetic resonance imaging, the clinical efficacy in terms of preventing stroke/cognitive decline requires confirmation in larger studies. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

The effect of cone beam CT (CBCT) on therapeutic decision-making in endodontics

PubMed Central

Knutsson, K; Flygare, L

2014-01-01

Objectives: The aim was to assess to what extent cone beam CT (CBCT) used in accordance with current European Commission guidelines in a normal clinical setting has an impact on therapeutic decisions in a population referred for endodontic problems. Methods: The study includes data of consecutively examined patients collected from October 2011 to December 2012. From 2 different endodontic specialist clinics, 57 patients were referred for a CBCT examination using criteria in accordance with current European guidelines. The CBCT examinations were performed using similar equipment and standardized among clinics. After a thorough clinical examination, but before CBCT, the examiner made a preliminary therapy plan which was recorded. After the CBCT examination, the same examiner made a new therapy plan. Therapy plans both before and after the CBCT examination were plotted for 53 patients and 81 teeth. As four patients had incomplete protocols, they were not included in the final analysis. Results: 4% of the patients referred to endodontic clinics during the study period were examined with CBCT. The most frequent reason for referral to CBCT examination was to differentiate pathology from normal anatomy, this was the case in 24 patients (45% of the cases). The primary outcome was therapy plan changes that could be attributed to CBCT examination. There were changes in 28 patients (53%). Conclusions: CBCT has a significant impact on therapeutic decision efficacy in endodontics when used in concordance with the current European Commission guidelines. PMID:24766060

Patients' attitudes and preferences about participation and recruitment strategies in clinical trials.

PubMed

Sood, Amit; Prasad, Kavita; Chhatwani, Laveena; Shinozaki, Eri; Cha, Stephen S; Loehrer, Laura L; Wahner-Roedler, Dietlind L

2009-03-01

To assess attitudes of patients about participation in clinical trials. This is a self-report survey of 400 patients who underwent general medical evaluations between September and November 2006 at a tertiary care academic medical center in Rochester, MN. We measured knowledge of access to clinical trials, attitudes toward participation, recruitment preferences, and beliefs about research integrity. Of 485 consecutive patients, 400 (82%) completed the survey. Previous participation in clinical trials was reported by 112 patients (28%). Most were unaware of online information about clinical trials (330 [82%]), were satisfied with their current knowledge (233 [58%]), expected their treating physician to inform them about current trials (304 [76%]), and showed equal interest in participating in conventional or complementary intervention trials (174 [44%]). Of the 400 respondents, 321 (80%) found it appropriate to be contacted by mail and 253 (63%) by telephone regarding study participation. Most patients (364 [91%]) wanted to be informed about research findings or else would not participate in future clinical trials (272 [68%]). The most frequently expected compensation was free parking (234 [58%]). Most thought that their safety (373 [93%]) and privacy (376 [94%]) would be guarded. Patients are interested in participating in clinical trials but commonly lack adequate information. If patients received more information (through their treating physicians), enrollment might improve. This single-site study has limited generalizability. Future studies involving a diverse group of patients from a broader geographic distribution will help provide more definitive results.

Feedback in clinical education, part I: Characteristics of feedback provided by approved clinical instructors.

PubMed

Nottingham, Sara; Henning, Jolene

2014-01-01

Providing students with feedback is an important component of athletic training clinical education; however, little information is known about the feedback that Approved Clinical Instructors (ACIs; now known as preceptors) currently provide to athletic training students (ATSs). To characterize the feedback provided by ACIs to ATSs during clinical education experiences. Qualitative study. One National Collegiate Athletic Association Division I athletic training facility and 1 outpatient rehabilitation clinic that were clinical sites for 1 entry-level master's degree program accredited by the Commission on Accreditation of Athletic Training Education. A total of 4 ACIs with various experience levels and 4 second-year ATSs. Extensive field observations were audio recorded, transcribed, and integrated with field notes for analysis. The constant comparative approach of open, axial, and selective coding was used to inductively analyze data and develop codes and categories. Member checking, triangulation, and peer debriefing were used to promote trustworthiness of the study. The ACIs gave 88 feedback statements in 45 hours and 10 minutes of observation. Characteristics of feedback categories included purpose, timing, specificity, content, form, and privacy. Feedback that ACIs provided included several components that made each feedback exchange unique. The ACIs in our study provided feedback that is supported by the literature, suggesting that ACIs are using current recommendations for providing feedback. Feedback needs to be investigated across multiple athletic training education programs to gain more understanding of certain areas of feedback, including frequency, privacy, and form.

Patients' Attitudes and Preferences About Participation and Recruitment Strategies in Clinical Trials

PubMed Central

Sood, Amit; Prasad, Kavita; Chhatwani, Laveena; Shinozaki, Eri; Cha, Stephen S.; Loehrer, Laura L.; Wahner-Roedler, Dietlind L.

2009-01-01

OBJECTIVE: To assess attitudes of patients about participation in clinical trials. PATIENTS AND METHODS: This is a self-report survey of 400 patients who underwent general medical evaluations between September and November 2006 at a tertiary care academic medical center in Rochester, MN. We measured knowledge of access to clinical trials, attitudes toward participation, recruitment preferences, and beliefs about research integrity. RESULTS: Of 485 consecutive patients, 400 (82%) completed the survey. Previous participation in clinical trials was reported by 112 patients (28%). Most were unaware of online information about clinical trials (330 [82%]), were satisfied with their current knowledge (233 [58%]), expected their treating physician to inform them about current trials (304 [76%]), and showed equal interest in participating in conventional or complementary intervention trials (174 [44%]). Of the 400 respondents, 321 (80%) found it appropriate to be contacted by mail and 253 (63%) by telephone regarding study participation. Most patients (364 [91%]) wanted to be informed about research findings or else would not participate in future clinical trials (272 [68%]). The most frequently expected compensation was free parking (234 [58%]). Most thought that their safety (373 [93%]) and privacy (376 [94%]) would be guarded. CONCLUSION: Patients are interested in participating in clinical trials but commonly lack adequate information. If patients received more information (through their treating physicians), enrollment might improve. This single-site study has limited generalizability. Future studies involving a diverse group of patients from a broader geographic distribution will help provide more definitive results. PMID:19252111

Surgical Treatment of Rotator Cuff Tears After 65 Years of Age: A Systematic Review.

PubMed

Silva, Bruno Mota; Cartucho, António; Sarmento, Marco; Moura, Nuno

2017-04-28

The objective of this study was to analyze current evidence regarding surgical management of rotator cuff tears in patients of 65 years of age and above. Our hypothesis was that surgical repair of rotator cuff tears, in patients older than 65 years, conveys good outcome scores. We have not found a similar systematic review in current literature. Medline®, PubMed, Scopus, and the Cochrane Register of Controlled Trials were searched from January 1999 unto December 2015 for studies, regardless of language, including the words 'rotator cuff' and '65 years' or '70 years'. Inclusion criteria were studies (level I to IV) that reported clinical outcomes in patients older than 65 years, having undertaken surgical repair of a symptomatic rotator cuff tears. Arthroscopic, mini open and open techniques were included. Exclusion criteria were: studies with patients younger than 65 years, studies that did not use validated outcome evaluation scores as primary assessment tools and those with follow up under one year. This work followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses - PRISMA guidelines. Data abstracted included patient demographics, tear pattern, surgical procedures, clinical and repair results. Outcome scores were converted to percentages, allowing comparison of data between studies. After deep analysis, 14 studies met the inclusion criteria: 11 level IV studies, 1 level III study and 2 level II studies. Seven studies found statistically significant outcome improvements between pre and postoperative evaluations. All studies reported good or excellent surgical outcomes. Better results would probably be achieved if all studies had rigorous and homogeneous patient selection criteria, but the fact is, that even though this was not the case, the clinical scores remained favorable, and with statistically significant outcome improvement in all studies with prospectively collected data. Based on current literature, rotator cuff repair in patients older than 65 years imparts favorable improvement in clinical outcome scores and overall patient satisfaction.

Oncolytic virus therapies.

PubMed

Buonaguro, Franco Maria; Tornesello, Maria Lina; Izzo, Francesco; Buonaguro, Luigi

2012-11-01

Oncolytic virus (OV) therapy currently represents one of the most promising approaches to cancer treatment for their dual anticancer mechanisms: direct lysis of cancer cells (oncolytic feature) and activation of the immunosystem (cancer vaccine aspect). The latter demonstrates the advantage of a multi-target approach against multiple tumor-associated antigens. Since the 2005 SFDA (the Chinese FDA) approval for the clinical use of Oncorine™, the first human OV-based cancer treatment, more than 200 patents have been filed worldwide and several Phase I/II studies have been conducted. This patent review analyzes patents and clinical studies of the most promising OV products to highlight the pros and cons of this innovative anticancer approach, which is currently being tested in several cancers (i.e., hepatocellular carcinoma, melanoma and glioblastoma) by systemic as well as intratumoral injection. Clinical results, although effective only for a limited period of time, are encouraging. Combined treatments with radio or chemotherapeutic protocols are also in progress.

Current and Future Clinical Applications of High-Intensity Focused Ultrasound (HIFU) for Pancreatic Cancer.

PubMed

Jang, Hyun Joo; Lee, Jae-Young; Lee, Don-Haeng; Kim, Won-Hong; Hwang, Joo Ha

2010-09-01

High-intensity focused ultrasound (HIFU) is a novel therapeutic modality that permits noninvasive treatment of various benign and malignant solid tumors, including prostatic cancer, uterine fibroids, hepatic tumors, renal tumors, breast cancers, and pancreatic cancers. Several preclinical and clinical studies have investigated the safety and efficacy of HIFU for treating solid tumors, including pancreatic cancer. The results of nonrandomized studies of HIFU therapy in patients with pancreatic cancer have suggested that HIFU treatment can effectively alleviate cancer-related pain without any significant complications. This noninvasive method of delivering ultrasound energy into the body has recently been evolving from a method for purely thermal ablation to harnessing the mechanical effects of HIFU to induce a systemic immune response and to enhance targeted drug delivery. This review provides a brief overview of HIFU, describes current clinical applications of HIFU for pancreatic cancer, and discusses future applications and challenges.

Current and Future Clinical Applications of High-Intensity Focused Ultrasound (HIFU) for Pancreatic Cancer

PubMed Central

Jang, Hyun Joo; Lee, Jae-Young; Lee, Don-Haeng; Kim, Won-Hong

2010-01-01

High-intensity focused ultrasound (HIFU) is a novel therapeutic modality that permits noninvasive treatment of various benign and malignant solid tumors, including prostatic cancer, uterine fibroids, hepatic tumors, renal tumors, breast cancers, and pancreatic cancers. Several preclinical and clinical studies have investigated the safety and efficacy of HIFU for treating solid tumors, including pancreatic cancer. The results of nonrandomized studies of HIFU therapy in patients with pancreatic cancer have suggested that HIFU treatment can effectively alleviate cancer-related pain without any significant complications. This noninvasive method of delivering ultrasound energy into the body has recently been evolving from a method for purely thermal ablation to harnessing the mechanical effects of HIFU to induce a systemic immune response and to enhance targeted drug delivery. This review provides a brief overview of HIFU, describes current clinical applications of HIFU for pancreatic cancer, and discusses future applications and challenges. PMID:21103296

Limited accessibility to designs and results of Japanese large-scale clinical trials for cardiovascular diseases.

PubMed

Sawata, Hiroshi; Ueshima, Kenji; Tsutani, Kiichiro

2011-04-14

Clinical evidence is important for improving the treatment of patients by health care providers. In the study of cardiovascular diseases, large-scale clinical trials involving thousands of participants are required to evaluate the risks of cardiac events and/or death. The problems encountered in conducting the Japanese Acute Myocardial Infarction Prospective (JAMP) study highlighted the difficulties involved in obtaining the financial and infrastructural resources necessary for conducting large-scale clinical trials. The objectives of the current study were: 1) to clarify the current funding and infrastructural environment surrounding large-scale clinical trials in cardiovascular and metabolic diseases in Japan, and 2) to find ways to improve the environment surrounding clinical trials in Japan more generally. We examined clinical trials examining cardiovascular diseases that evaluated true endpoints and involved 300 or more participants using Pub-Med, Ichushi (by the Japan Medical Abstracts Society, a non-profit organization), websites of related medical societies, the University Hospital Medical Information Network (UMIN) Clinical Trials Registry, and clinicaltrials.gov at three points in time: 30 November, 2004, 25 February, 2007 and 25 July, 2009. We found a total of 152 trials that met our criteria for 'large-scale clinical trials' examining cardiovascular diseases in Japan. Of these, 72.4% were randomized controlled trials (RCTs). Of 152 trials, 9.2% of the trials examined more than 10,000 participants, and 42.8% examined between 1,000 and 10,000 participants. The number of large-scale clinical trials markedly increased from 2001 to 2004, but suddenly decreased in 2007, then began to increase again. Ischemic heart disease (39.5%) was the most common target disease. Most of the larger-scale trials were funded by private organizations such as pharmaceutical companies. The designs and results of 13 trials were not disclosed. To improve the quality of clinical trials, all sponsors should register trials and disclose the funding sources before the enrolment of participants, and publish their results after the completion of each study.

Synthesis maps: visual knowledge translation for the CanIMPACT clinical system and patient cancer journeys.

PubMed

Jones, P H; Shakdher, S; Singh, P

2017-04-01

Salient findings and interpretations from the canimpact clinical cancer research study are visually represented in two synthesis maps for the purpose of communicating an integrated presentation of the study to clinical cancer researchers and policymakers. Synthesis maps integrate evidence and expertise into a visual narrative for knowledge translation and communication. A clinical system synthesis map represents the current Canadian primary care and cancer practice systems, proposed as a visual knowledge translation from the mixed-methods canimpact study to inform Canadian clinical research, policy, and practice discourses. Two synthesis maps, drawn together from multiple canimpact investigations and sources, were required to articulate critical differences between the clinical system and patient perspectives. The synthesis map of Canada-wide clinical cancer systems illustrates the relationships between primary care and the full cancer continuum. A patient-centred map was developed to represent the cancer (and primary care) journeys as experienced by breast and colorectal cancer patients.

Analyzing global trends of biomarker use in drug interventional clinical studies.

PubMed

Hayashi, K; Masuda, S; Kimura, H

2012-04-01

The trend of biomarker use in drug interventional clinical studies was analyzed using ClinicalTrials.gov to provide an overview of how biomarkers are used to streamline clinical studies and to examine regional differences. A total of 3,383 clinical study data was analyzed according to phase, region, sponsor, and therapeutic class. The number of clinical studies using biomarkers has been increasing constantly and is dependent on the number of Phase I and II studies. The majority of studies (58.5%) were sponsored by the United States, with the studies being conducted mainly in the sponsor's home region (80.3%). The use of biomarkers was prominent in the oncology area (37.1%). Although current data indicates some bias in the clinical use of biomarkers, it is expected that their use will increase in later phase studies or other therapeutic areas as biomarker development proceeds. In addition, limited regional use of biomarkers may lead to differences in biomarker use in drug development and in combination with political support may result in differences in competitiveness of drug development. Biomarkers would be a powerful tool against deteriorating research and development productivity when used more in appropriate clinical study conditions.

Sharing all types of clinical data and harmonizing journal standards.

PubMed

Barbui, Corrado

2016-04-03

Despite recent efforts to enforce policies requiring the sharing of data underlying clinical findings, current policies of biomedical journals remain largely heterogeneous. As this heterogeneity does not optimally serve the cause of data sharing, a first step towards better harmonization would be the requirement of a data sharing statement for all clinical studies and not simply for randomized studies. Although the publication of a data sharing statement does not imply that all data is made readily available, such a policy would swiftly implement a cultural change in the definition of scientific outputs. Currently, a scientific output only corresponds to a study report published in a medical journal, while in the near future it might consist of all materials described in the manuscript, including all relevant raw data. When such a cultural shift has been achieved, the logical conclusion would be for biomedical journals to require authors to make all data fully available without restriction as a condition for publication.

On the role of cystatin C in cancer progression.

PubMed

Leto, Gaetano; Crescimanno, Marilena; Flandina, Carla

2018-06-01

Cystatin C (Cyst C) is an endogenous inhibitor of lysosomal cysteine proteinases, which has been shown to play a role in several normal and pathological processes. Interestingly, a growing number of experimental and clinical studies suggest that this inhibitor also appears to be implicated in the malignant progression of various human tumors. However, the role of Cyst C in malignant diseases is still controversial as these studies have highlighted that this protein may function either as tumor suppressor or tumor promoter. The specific mechanisms underlying these opposing effects at present remain murky and are the subject of many current investigations. On the other hand, a complete knowledge of these mechanisms is of clinical interest in order to develop new, effective antitumor treatments based on the appropriate use of natural and/or synthetic cysteine proteinase inhibitors. This paper discusses the current findings regarding the role of Cyst C in cancer progression and the clinical implications emerging from these studies. Copyright © 2018 Elsevier Inc. All rights reserved.

Phage therapy.

PubMed

Housby, John N; Mann, Nicholas H

2009-06-01

There is a renaissance of interest in the antimicrobial potential of phages as more pathogens become multiply antibiotic resistant. Phage therapy is not a new concept, and it is important to ask why it is not part of the current repertoire of western medicine despite the fact that it has been continuously and extensively used in Eastern Europe for almost a century. Answering this question successfully will, largely, determine whether phage therapy can gain the credibility needed to overcome the scientific, financial and regulatory hurdles facing its adoption in mainstream clinical practice. Despite a paucity of such information from human studies, pharmacokinetic data and clinical outcomes from animal studies are currently providing convincing evidence for the safety and efficacy of phage therapy.

Some Non-FDA Approved Uses for Neuromodulation in Treating Autonomic Nervous System Disorders: A Discussion of the Preliminary Support.

PubMed

Lee, Samuel; Abd-Elsayed, Alaa

2016-12-01

Neuromodulation, including cavernous nerve stimulation, gastric electrical stimulation, deep brain stimulation, and vagus nerve stimulation, has been used with success in treating several functional disease conditions. The FDA has approved the use of neuromodulation for a few indications. We discuss in our review article the evidence of using neuromodulation for treating some important disorders involving the autonomic nervous system that are not currently FDA approved. This was a review article that included a systematic online web search for human clinical studies testing the efficacy of neuromodulation in treating erectile dysfunction, gastroparesis, gastroesophageal reflux disease, obesity, asthma, and heart failure. Our review includes all feasibility studies, nonrandomized clinical trials, and randomized controlled trials. Our systematic literature search found 3, 4, 5, 4, 1, and 4 clinical studies relating to erectile dysfunction, gastroparesis, gastroesophageal reflux disease, obesity, asthma, and heart failure, respectively. This review article shows preliminary support based on clinical studies that neuromodulation can be of benefit for patients with important autonomic nervous system disease conditions that are not currently approved by the FDA. All of these investigational uses are encouraging; further studies are necessary and warranted for all indications discussed in this review before achieving FDA approval. © 2016 International Neuromodulation Society.

Electrical Stimulation as a Means for Improving Vision.

PubMed

Sehic, Amer; Guo, Shuai; Cho, Kin-Sang; Corraya, Rima M; Chen, Dong F; Utheim, Tor P

2016-11-01

Evolving research has provided evidence that noninvasive electrical stimulation (ES) of the eye may be a promising therapy for either preserving or restoring vision in several retinal and optic nerve diseases. In this review, we focus on minimally invasive strategies for the delivery of ES and accordingly summarize the current literature on transcorneal, transorbital, and transpalpebral ES in both animal experiments and clinical studies. Various mechanisms are believed to underlie the effects of ES, including increased production of neurotrophic agents, improved chorioretinal blood circulation, and inhibition of proinflammatory cytokines. Different animal models have demonstrated favorable effects of ES on both the retina and the optic nerve. Promising effects of ES have also been demonstrated in clinical studies; however, all current studies have a lack of randomization and/or a control group (sham). There is thus a pressing need for a deeper understanding of the underlying mechanisms that govern clinical success and optimization of stimulation parameters in animal studies. In addition, such research should be followed by large, prospective, clinical studies to explore the full potential of ES. Through this review, we aim to provide insight to guide future research on ES as a potential therapy for improving vision. Copyright © 2016 American Society for Investigative Pathology. Published by Elsevier Inc. All rights reserved.

Therapeutic Use of Prebiotics, Probiotics, and Postbiotics to Prevent Necrotizing Enterocolitis: What is the Current Evidence?

PubMed Central

Patel, Ravi Mangal; Denning, Patricia Wei

2013-01-01

Synopsis Necrotizing enterocolitis (NEC) is a leading cause of neonatal morbidity and mortality and preventative therapies that are both effective and safe are urgently needed. Current evidence from therapeutic trials suggests that probiotics are effective in decreasing NEC in preterm infants and probiotics are currently the most promising therapy on the horizon for this devastating disease. However, concerns regarding safety and optimal dosing have limited the widespread adoption of routine clinical use of probiotics in preterm infants. In addition, prebiotics and postbiotics may be potential alternatives or adjunctive therapies to the administration of live microorganisms, although studies demonstrating their clinical efficacy in preventing NEC are lacking. This review summarizes the current evidence regarding the use of probiotics, prebiotics and postbiotics in the preterm infant, including its therapeutic role in preventing NEC. PMID:23415261

Evaluating the Effectiveness of Text Messaging and Phone Call Reminders to Minimize No Show at Pediatric Outpatient Clinics in Pakistan: Protocol for a Mixed-Methods Study.

PubMed

Saeed, Sana; Somani, Noureen; Sharif, Fatima; Kazi, Abdul Momin

2018-04-10

Missing health care appointments without canceling in advance results in a no show, a vacant appointment slot that cannot be offered to others. No show can be reduced by reminding patients about their appointment in advance. In this regard, mobile health (mHealth) strategy is to use text messaging (short message service, SMS), which is available on all cellular phones, including cheap low-end handsets. Nonattendance for appointments in health care results in wasted resources and disturbs the planned work schedules. The purpose of this study is to evaluate the efficacy of the current text messaging (SMS) and call-based reminder system and further explore how to improve the attendance at the pediatric outpatient clinics. The primary objectives are to (1) determine the efficacy of the current clinic appointment reminder service at pediatric outpatient clinics at Aga Khan University Hospital, (2) assess the mobile phone access and usage among caregivers visiting pediatrics consultant clinics, and (3) explore the perception and barriers of parents regarding the current clinic appointment reminder service at the pediatric outpatient clinics at Aga Khan University Hospital. The study uses a mixed-method design that consists of 3 components: (1) retrospective study (component A) which aims to determine the efficacy of text messaging (SMS) and phone call-based reminder service on patient's clinic attendance during January to June 2017 (N=58,517); (2) quantitative (component B) in which a baseline survey will be conducted to assess the mobile phone access and usage among parents/caregivers of children visiting pediatrics consultant clinics (n=300); and (3) qualitative (component C) includes in-depth interviews and focus group discussion with parents/caregivers of children visiting the pediatric consultancy clinic and with health care providers and administrative staff. Main constructs will be to explore perceptions and barriers related to existing clinic appointment reminder service. Ethics approval has been obtained from the Ethical Review Committee, Aga Khan University, Pakistan (4770-Ped-ERC-17). Results will be disseminated to pediatric quality public health and mHealth communities through scientific meetings and through publications, nationally and internationally. This study will provide insight regarding efficacy of using mHealth-based reminder services for patient's appointments in low- and middle-income countries setup. The finding of this study will be used to recommend further enhanced mHealth-based solutions to improve patient appointments and decrease no show. ©Sana Saeed, Noureen Somani, Fatima Sharif, Abdul Momin Kazi. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 10.04.2018.

A Comparison between Older Persons with Down Syndrome and a Control Group: Clinical Characteristics, Functional Status and Sensori-Motor Function

ERIC Educational Resources Information Center

Carmeli, Eli; Kessel, Shlomo; Merrick, Joav; Bar-Chad, Shmuel

2004-01-01

The increase in life expectancy within the general population has resulted in an increasing number of elderly adults with intellectual disability, and this is reflected in the increased life expectancy in persons with Down syndrome, currently about 56 years. The aim of this study was to study the clinical characteristics, the functional status and…

Clinical reasoning of nursing students on clinical placement: Clinical educators' perceptions.

PubMed

Hunter, Sharyn; Arthur, Carol

2016-05-01

Graduate nurses may have knowledge and adequate clinical psychomotor skills however they have been identified as lacking the clinical reasoning skills to deliver safe, effective care suggesting contemporary educational approaches do not always facilitate the development of nursing students' clinical reasoning. While nursing literature explicates the concept of clinical reasoning and develops models that demonstrate clinical reasoning, there is very little published about nursing students and clinical reasoning during clinical placements. Semi-structured interviews were conducted with ten clinical educators to gain an understanding of how they recognised, developed and appraised nursing students' clinical reasoning while on clinical placement. This study found variability in the clinical educators' conceptualisation, recognition, and facilitation of students' clinical reasoning. Although most of the clinical educators conceptualised clinical reasoning as a process those who did not demonstrated the greatest variability in the recognition and facilitation of students' clinical reasoning. The clinical educators in this study also described being unable to adequately appraise a student's clinical reasoning during clinical placement with the use of the current performance assessment tool. Copyright © 2016 Elsevier Ltd. All rights reserved.

Transcranial direct-current stimulation as treatment in epilepsy.

PubMed

Gschwind, Markus; Seeck, Margitta

2016-12-01

Neuromodulation (NM) is a complementary therapy for patients with drug-resistant epilepsy. Vagal nerve stimulation and deep brain stimulation of the anterior thalamus are established techniques and have shown their efficacy in lowering seizure frequency, but they are invasive and rarely render patients seizure-free. Non-invasive NM techniques are therefore increasingly investigated in a clinical context. Areas covered: Current knowledge about transcranial direct-current stimulation (tDCS) and other non-invasive NM in patients with epilepsy, based on the available animal and clinical studies from PubMed search. Expert commentary: tDCS modulates neuronal membrane potentials, and consequently alters cortical excitability. Cathodal stimulation leads to cortical inhibition, which is of particular importance in epilepsy treatment. The antiepileptic efficacy is promising but still lacks systematic studies. The beneficial effect, seen in ~20%, outlasts the duration of stimulation, indicating neuronal plasticity and is therefore of great interest to obtain long-term effects.

Laparoscopic sterilization with the spring clip: instrumentation development and current clinical experience.

PubMed

Hulka, J F; Omran, K; Lieberman, B A; Gordon, A G

1979-12-15

Since the original spring clip sterilization studies were reported, a number of clinically important modifications to the spring clip and applicator have been developed. The spring-loaded clip, manufactured by Richard Wolf Medical Instruments Corporation of Chicago, Illinois, and Rocket of London, Inc., London, England, and New York, New York can be applied with either a one- or two-incision applicator and the clips and applicators currently available incorporate improvements to the original prototypes in design, manufacture, and quality control. The two-incision applicator is associated with significantly fewer misapplications and the high pregnancy rates reported with the original clip and applicator have not occurred with the current designs. Comparative studies between the clip and band have revealed less operative bleeding and pain associated with the clip. The method is appropriate to all women requesting sterilization but especially to those in the younger age group who may subsequently request reversal because of divorce and remarriage.

Clinically Relevant Outcome Measures Following Limb Osseointegration; Systematic Review of the Literature.

PubMed

Al Muderis, Munjed M; Lu, William Y; Li, Jiao Jiao; Kaufman, Kenton; Orendurff, Michael; Highsmith, M Jason; Lunseth, Paul A; Kahle, Jason T

2018-02-01

The current standard of care for an amputee is a socket-based prostheses. An osseointegrated implant (OI) is an alternative for prosthetic attachment. Osseointegration addresses reported problems related to wearing a socket interface, such as skin issues, discomfort, diminished function, quality of life, prosthetic use, and abandonment. The purpose of this report is to systematically review current literature regarding OI to identify and categorize the reported clinically relevant outcome measures, rate the quality of available evidence, and synthesize the findings. A multidisciplinary team used PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methods. Search methodology was based on identifying clinically relevant articles. Three databases were searched: PubMed, CINAHL, and Web of Science. Clinical studies with aggregated data reporting at least 1 clinically relevant outcome measure were included. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criterion was used for critical appraisal and recommendations. This review identified 21 clinically relevant observational studies. Outcome measures were categorized into the following 9 categories: vibratory stimulation, complications, biomechanics, economics, patient-reported outcome measures, electromyography, x-ray, physical functional performance, and energy consumption. This systematic review consisted of Level III and IV observational studies. Homogeneous outcome measures with strong psychometric properties across prospective studies do not exist to date. Higher-level, prospective, randomized, long-term, clinically relevant trials are needed to prove efficacy of OI compared with socket prosthetic attachment. Osseointegration was at least equivalent to sockets in most studies. In some cases, it was superior. Osseointegration represents a promising alternative to socket prosthetic attachments for extremity amputees. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

MODULAR ANALYTICS: A New Approach to Automation in the Clinical Laboratory.

PubMed

Horowitz, Gary L; Zaman, Zahur; Blanckaert, Norbert J C; Chan, Daniel W; Dubois, Jeffrey A; Golaz, Olivier; Mensi, Noury; Keller, Franz; Stolz, Herbert; Klingler, Karl; Marocchi, Alessandro; Prencipe, Lorenzo; McLawhon, Ronald W; Nilsen, Olaug L; Oellerich, Michael; Luthe, Hilmar; Orsonneau, Jean-Luc; Richeux, Gérard; Recio, Fernando; Roldan, Esther; Rymo, Lars; Wicktorsson, Anne-Charlotte; Welch, Shirley L; Wieland, Heinrich; Grawitz, Andrea Busse; Mitsumaki, Hiroshi; McGovern, Margaret; Ng, Katherine; Stockmann, Wolfgang

2005-01-01

MODULAR ANALYTICS (Roche Diagnostics) (MODULAR ANALYTICS, Elecsys and Cobas Integra are trademarks of a member of the Roche Group) represents a new approach to automation for the clinical chemistry laboratory. It consists of a control unit, a core unit with a bidirectional multitrack rack transportation system, and three distinct kinds of analytical modules: an ISE module, a P800 module (44 photometric tests, throughput of up to 800 tests/h), and a D2400 module (16 photometric tests, throughput up to 2400 tests/h). MODULAR ANALYTICS allows customised configurations for various laboratory workloads. The performance and practicability of MODULAR ANALYTICS were evaluated in an international multicentre study at 16 sites. Studies included precision, accuracy, analytical range, carry-over, and workflow assessment. More than 700 000 results were obtained during the course of the study. Median between-day CVs were typically less than 3% for clinical chemistries and less than 6% for homogeneous immunoassays. Median recoveries for nearly all standardised reference materials were within 5% of assigned values. Method comparisons versus current existing routine instrumentation were clinically acceptable in all cases. During the workflow studies, the work from three to four single workstations was transferred to MODULAR ANALYTICS, which offered over 100 possible methods, with reduction in sample splitting, handling errors, and turnaround time. Typical sample processing time on MODULAR ANALYTICS was less than 30 minutes, an improvement from the current laboratory systems. By combining multiple analytic units in flexible ways, MODULAR ANALYTICS met diverse laboratory needs and offered improvement in workflow over current laboratory situations. It increased overall efficiency while maintaining (or improving) quality.

MODULAR ANALYTICS: A New Approach to Automation in the Clinical Laboratory

PubMed Central

Zaman, Zahur; Blanckaert, Norbert J. C.; Chan, Daniel W.; Dubois, Jeffrey A.; Golaz, Olivier; Mensi, Noury; Keller, Franz; Stolz, Herbert; Klingler, Karl; Marocchi, Alessandro; Prencipe, Lorenzo; McLawhon, Ronald W.; Nilsen, Olaug L.; Oellerich, Michael; Luthe, Hilmar; Orsonneau, Jean-Luc; Richeux, Gérard; Recio, Fernando; Roldan, Esther; Rymo, Lars; Wicktorsson, Anne-Charlotte; Welch, Shirley L.; Wieland, Heinrich; Grawitz, Andrea Busse; Mitsumaki, Hiroshi; McGovern, Margaret; Ng, Katherine; Stockmann, Wolfgang

2005-01-01

MODULAR ANALYTICS (Roche Diagnostics) (MODULAR ANALYTICS, Elecsys and Cobas Integra are trademarks of a member of the Roche Group) represents a new approach to automation for the clinical chemistry laboratory. It consists of a control unit, a core unit with a bidirectional multitrack rack transportation system, and three distinct kinds of analytical modules: an ISE module, a P800 module (44 photometric tests, throughput of up to 800 tests/h), and a D2400 module (16 photometric tests, throughput up to 2400 tests/h). MODULAR ANALYTICS allows customised configurations for various laboratory workloads. The performance and practicability of MODULAR ANALYTICS were evaluated in an international multicentre study at 16 sites. Studies included precision, accuracy, analytical range, carry-over, and workflow assessment. More than 700 000 results were obtained during the course of the study. Median between-day CVs were typically less than 3% for clinical chemistries and less than 6% for homogeneous immunoassays. Median recoveries for nearly all standardised reference materials were within 5% of assigned values. Method comparisons versus current existing routine instrumentation were clinically acceptable in all cases. During the workflow studies, the work from three to four single workstations was transferred to MODULAR ANALYTICS, which offered over 100 possible methods, with reduction in sample splitting, handling errors, and turnaround time. Typical sample processing time on MODULAR ANALYTICS was less than 30 minutes, an improvement from the current laboratory systems. By combining multiple analytic units in flexible ways, MODULAR ANALYTICS met diverse laboratory needs and offered improvement in workflow over current laboratory situations. It increased overall efficiency while maintaining (or improving) quality. PMID:18924721

The need for data-informed clinical supervision in substance use disorder treatment.

PubMed

Ramsey, Alex T; Baumann, Ana; Patterson Silver Wolf, David; Yan, Yan; Cooper, Ben; Proctor, Enola

2017-01-01

Effective clinical supervision is necessary for high-quality care in community-based substance use disorder treatment settings, yet little is known about current supervision practices. Some evidence suggests that supervisors and counselors differ in their experiences of clinical supervision; however, the impact of this misalignment on supervision quality is unclear. Clinical information monitoring systems may support supervision in substance use disorder treatment, but the potential use of these tools must first be explored. First, the current study examines the extent to which misaligned supervisor-counselor perceptions impact supervision satisfaction and emphasis on evidence-based treatments. This study also reports on formative work to develop a supervision-based clinical dashboard, an electronic information monitoring system and data visualization tool providing real-time clinical information to engage supervisors and counselors in a coordinated and data-informed manner, help align supervisor-counselor perceptions about supervision, and improve supervision effectiveness. Clinical supervisors and frontline counselors (N = 165) from five Midwestern agencies providing substance abuse services completed an online survey using Research Electronic Data Capture software, yielding a 75% response rate. Valid quantitative measures of supervision effectiveness were administered, along with qualitative perceptions of a supervision-based clinical dashboard. Through within-dyad analyses, misalignment between supervisor and counselor perceptions of supervision practices was negatively associated with satisfaction of supervision and reported frequency of discussing several important clinical supervision topics, including evidence-based treatments and client rapport. Participants indicated the most useful clinical dashboard functions and reported important benefits and challenges to using the proposed tool. Clinical supervision tends to be largely an informal and unstructured process in substance abuse treatment, which may compromise the quality of care. Clinical dashboards may be a well-targeted approach to facilitate data-informed clinical supervision in community-based treatment agencies.

Current Literature on Venereal Disease, 1972. Number Three. Abstracts and Bibliography.

ERIC Educational Resources Information Center

Lea, Mildred V., Ed.

Presented are abstracts of documents and research pertaining to the clinical description, laboratory diagnosis, management, and therapy of syphilis and gonorrhea. Abstracted case studies of other minor venereal and related diseases are also included, as are bibliographies on current research and evaluation, public health methods, and behavioral…

Current Literature on Venereal Disease, 1972. Number Two. Abstracts and Bibliography.

ERIC Educational Resources Information Center

Lea, Mildred V., Ed.

Presented are abstracts of documents and research pertaining to the clinical description, laboratory diagnosis, management, and therapy of syphilis and gonorrhea. Abstracted case studies of other minor venereal and related diseases are also included, as are bibliographies on current research and evaluation, public health methods, and behavioral…

Current Literature on Venereal Disease, 1972. Number One. Abstracts and Bibliography.

ERIC Educational Resources Information Center

Lea, Mildred V., Ed.

Presented are abstracts of documents and research pertaining to the clinical description, laboratory diagnosis, management, and therapy of syphilis and gonorrhea. Abstracted case studies of other minor venereal and related diseases are also included, as are bibliographies on current research and evaluation, public health methods, and behavioral…

Leisure Activity Participation of Elderly Individuals with Low Vision.

ERIC Educational Resources Information Center

Heinemann, Allen W.

1988-01-01

Studied low vision elderly clinic patients (N=63) who reported participation in six categories of leisure activities currently and at onset of vision loss. Found subjects reported significant declines in five of six activity categories. Found prior activity participation was related to current participation only for active crafts, participatory…

Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study

PubMed Central

Calle Rubio, Myriam; Alcázar Navarrete, Bernardino; Soriano, Joan B; Soler-Cataluña, Juan J; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; López-Campos, José Luis

2017-01-01

Background Chronic obstructive pulmonary disease (COPD) outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines. Methodology This is an observational study with prospective recruitment (May 2014–May 2015) of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent. Results A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7%) were eligible. Overall, 12.1% of COPD patients did not fulfill a diagnostic spirometry criteria. Considerable variability existed in the available resources and work organization of the hospitals, although the majority were university hospitals with respiratory inpatient units. There was insufficient implementation of clinical guidelines in preventive and educational matters. In contrast, quantitative evaluation of dyspnea grade (81.9%) and exacerbation history (70.9%) were more frequently performed. Only 12.4% had COPD severity calculated according to the Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity (BODE) index. Phenotype characteristics according to Spanish National Guideline for COPD were determined in 46.3% of the audited patients, and the risk evaluation according to Global initiative for chronic Obstructive Lung Disease was estimated only in 21.9%. Conclusion The EPOCONSUL study reports the current situation of medical care for COPD patients in outpatient clinics in Spain, revealing its variability, strengths, and weaknesses. This information has to be accounted for by health managers to define corrective strategies and maximize good clinical practice. PMID:28182155

Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study.

PubMed

Calle Rubio, Myriam; Alcázar Navarrete, Bernardino; Soriano, Joan B; Soler-Cataluña, Juan J; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; López-Campos, José Luis

2017-01-01

Chronic obstructive pulmonary disease (COPD) outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines. This is an observational study with prospective recruitment (May 2014-May 2015) of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent. A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7%) were eligible. Overall, 12.1% of COPD patients did not fulfill a diagnostic spirometry criteria. Considerable variability existed in the available resources and work organization of the hospitals, although the majority were university hospitals with respiratory inpatient units. There was insufficient implementation of clinical guidelines in preventive and educational matters. In contrast, quantitative evaluation of dyspnea grade (81.9%) and exacerbation history (70.9%) were more frequently performed. Only 12.4% had COPD severity calculated according to the Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity (BODE) index. Phenotype characteristics according to Spanish National Guideline for COPD were determined in 46.3% of the audited patients, and the risk evaluation according to Global initiative for chronic Obstructive Lung Disease was estimated only in 21.9%. The EPOCONSUL study reports the current situation of medical care for COPD patients in outpatient clinics in Spain, revealing its variability, strengths, and weaknesses. This information has to be accounted for by health managers to define corrective strategies and maximize good clinical practice.

[Post launch studies].

PubMed

Akaza, Hideyuki; Ohashi, Yasuo; Shimada, Yasuhiro; Ikeda, Tadashi; Saijo, Nagahiro; Isonishi, Seiji; Hirao, Yoshihiko; Tsuruo, Takashi; Tsukagoshi, Shigeru; Sone, Saburo; Nakamura, Seigo; Kato, Masuhiro; Mikami, Osamu; von Euler, Mikael; Blackledge, George; Milsted, Bob; Vose, Brent

2002-11-01

Evidence Based Medicine (EBM) is a growing concept in Japan as it is elsewhere. Central to improving the use of EBM is generation of data through well conducted controlled clinical studies. There are many problems associated with conduct of clinical studies after launch in Japan, and many initiatives are ongoing to improve the situation. Development of Clinical Research Coordinators (CRO) and central Data Management centers are key to improving the quality of clinical research in Japan. Currently Japan has an undeveloped legal system with regard to post-launch trials and off-label use of registered drugs. There is no reimbursement for off-label and various restrictions imposed on the recipients of the Ministry of Health, Labour and Welfare's (MHLW) funds. Maybe the biggest problem is the high cost of post-marketing studies sponsored by pharmaceutical manufacturers. A high quality system to support post launch clinical studies need a solid financial base. There is a need for a suitable review system for investigator initiated multi-centre studies, as the current IRB system is not sufficient. There are also challenges regarding the differences, perceived or real, in treatment practice and available registrations in Japan and in the West, causing problems in choosing suitable comparators and study designs. At the present time it is not clear whether investigator initiated trials will be acceptable for registration purposes in Japan. The agreed first priority is to build a suitable and strong infrastructure within the academic community to support researchers to investigate important questions with or without pharmaceutical company support. Despite all these issues, several groundbreaking projects are under way throughout Japan, in many different areas and by different collaborative groups, some with government support. In fact, researcher-initiated clinical trials achieved a rapid growth in Japan in the past year.

Improving Speech Perception in Noise with Current Focusing in Cochlear Implant Users

PubMed Central

Srinivasan, Arthi G.; Padilla, Monica; Shannon, Robert V.; Landsberger, David M.

2013-01-01

Cochlear implant (CI) users typically have excellent speech recognition in quiet but struggle with understanding speech in noise. It is thought that broad current spread from stimulating electrodes causes adjacent electrodes to activate overlapping populations of neurons which results in interactions across adjacent channels. Current focusing has been studied as a way to reduce spread of excitation, and therefore, reduce channel interactions. In particular, partial tripolar stimulation has been shown to reduce spread of excitation relative to monopolar stimulation. However, the crucial question is whether this benefit translates to improvements in speech perception. In this study, we compared speech perception in noise with experimental monopolar and partial tripolar speech processing strategies. The two strategies were matched in terms of number of active electrodes, microphone, filterbanks, stimulation rate and loudness (although both strategies used a lower stimulation rate than typical clinical strategies). The results of this study showed a significant improvement in speech perception in noise with partial tripolar stimulation. All subjects benefited from the current focused speech processing strategy. There was a mean improvement in speech recognition threshold of 2.7 dB in a digits in noise task and a mean improvement of 3 dB in a sentences in noise task with partial tripolar stimulation relative to monopolar stimulation. Although the experimental monopolar strategy was worse than the clinical, presumably due to different microphones, frequency allocations and stimulation rates, the experimental partial-tripolar strategy, which had the same changes, showed no acute deficit relative to the clinical. PMID:23467170

Treatment of depression in low-level residential care facilities for the elderly.

PubMed

George, Kuruvilla; Davison, Tanya E; McCabe, Marita; Mellor, David; Moore, Kathleen

2007-12-01

The rate of recognition and treatment of depressed older people in nursing homes is low. Data from the low-level residential care population have not been reported. This study aimed to collect information about the treatment of depression among older persons living in low-level residential care (hostels). The participants comprised 300 elderly residents from ten low-level residential care facilities from various suburbs in metropolitan Melbourne. The participants were interviewed by a trained clinical psychologist to determine the presence or absence of major or minor depressive disorder using the Structured Clinical Interview for DSM-IV Axis I Disorder (SCID-I). Each participant was also administered the Standardized Mini-mental State Examination (SMMSE) to determine level of cognitive function. The clinical psychologist then reviewed all cases in consultation with a geropsychiatrist experienced in the diagnosis of depression among older people, prior to assigning a diagnosis of depression. An important finding in this study was the low treatment for currently depressed residents, with less than half of those in the sample who were depressed receiving treatment. However, 61 of the 96 residents out of the sample of 300 who were on antidepressants were not currently depressed. There is an under recognition and under treatment of currently depressed older people in low-level residential care facilities (hostels) just as has been reported in studies in nursing homes. However, there are high numbers receiving antidepressants who are not currently depressed.

Movement of Genetic Counselors from Clinical to Non-clinical Positions: Identifying Driving Forces.

PubMed

Cohen, Stephanie A; Tucker, Megan E

2018-03-05

A previous study of genetic counselors (GCs) in the state of Indiana identified movement out of clinical positions within the past 2 years. The aims of this study were to determine if this trend is nationwide and identify reasons why GCs are leaving their positions and factors that might help employers attract and retain GCs. An email was sent to members of the American Board of Genetic Counseling with a link to an online confidential survey. There were 939 responses (23.5% response rate). Overall, 52% of GCs report being highly satisfied in their current position, although almost two thirds think about leaving and one third had changed jobs within the past 2 years. Of those who had changed jobs (n = 295), 74.9% had been working in a hospital/clinic setting but only 46.3% currently do, demonstrating a major shift out of the clinic (p < 0.001). The top three reasons cited for leaving a position were work environment/institutional climate, salary/benefits, and a lack of feeling valued/recognized as a professional. These results confirm that GCs are moving out of clinical positions and document elements of job satisfaction. We suggest points for employers to consider when trying to recruit or retain GCs.

Smoking behaviour and preferences for cessation support among clients of an Indigenous community-controlled health service.

PubMed

Cockburn, Nicole; Gartner, Coral; Ford, Pauline J

2018-03-02

Reducing smoking prevalence among Indigenous Australians is a vital part of closing the health gap between Indigenous and non-Indigenous Australians. Community-controlled health clinics are an important setting for delivering smoking cessation advice and assistance. This study measured tobacco and e-cigarette use, knowledge of smoking-related health effects, motivations to quit and interest in cessation aids. Clients of Aboriginal & Torres Strait Islander Community Health Service dental clinics in Southeast Queensland (n = 421) completed a brief written questionnaire while in the waiting room. Nearly half (n = 184, 47%) of the participants currently smoked daily, of which 9% (n = 7) currently used e-cigarettes. Few smokers (8%, n = 13) had no intention to quit smoking. For current smokers, previously used quit methods were abrupt cessation (42%, n = 78), nicotine replacement therapies (NRT; 25%, n = 45), prescription medications (23%, n = 43), e-cigarettes (9%, n = 17) and other methods (3%, n = 6). Current smokers were most interested in cutting down (85%, n = 110), abrupt cessation (75%, n = 98) and free NRT (72%, n = 101). Fewer (34%, n = 36) were interested in purchasing NRT for smoking cessation. Our study found there was interest in accessing smoking cessation aids among the clients of this community-controlled health clinic, particularly if provided free of charge. Embedding smoking cessation advice and assistance into a range of community-controlled health clinics could provide opportunities for addressing the high smoking prevalence among Indigenous Australians. © 2018 Australasian Professional Society on Alcohol and other Drugs.

Use of historical control data for assessing treatment effects in clinical trials.

PubMed

Viele, Kert; Berry, Scott; Neuenschwander, Beat; Amzal, Billy; Chen, Fang; Enas, Nathan; Hobbs, Brian; Ibrahim, Joseph G; Kinnersley, Nelson; Lindborg, Stacy; Micallef, Sandrine; Roychoudhury, Satrajit; Thompson, Laura

2014-01-01

Clinical trials rarely, if ever, occur in a vacuum. Generally, large amounts of clinical data are available prior to the start of a study, particularly on the current study's control arm. There is obvious appeal in using (i.e., 'borrowing') this information. With historical data providing information on the control arm, more trial resources can be devoted to the novel treatment while retaining accurate estimates of the current control arm parameters. This can result in more accurate point estimates, increased power, and reduced type I error in clinical trials, provided the historical information is sufficiently similar to the current control data. If this assumption of similarity is not satisfied, however, one can acquire increased mean square error of point estimates due to bias and either reduced power or increased type I error depending on the direction of the bias. In this manuscript, we review several methods for historical borrowing, illustrating how key parameters in each method affect borrowing behavior, and then, we compare these methods on the basis of mean square error, power and type I error. We emphasize two main themes. First, we discuss the idea of 'dynamic' (versus 'static') borrowing. Second, we emphasize the decision process involved in determining whether or not to include historical borrowing in terms of the perceived likelihood that the current control arm is sufficiently similar to the historical data. Our goal is to provide a clear review of the key issues involved in historical borrowing and provide a comparison of several methods useful for practitioners. Copyright © 2013 John Wiley & Sons, Ltd.

WE-FG-BRA-07: Theranostic Nanoparticles Improve Clinical MR-Guided Radiation Therapy

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

Detappe, A; Institut Lumiere-Matiere, Lyon, FR; Kunjachan, S

Purpose: MR-guided radiation therapy is a current and emerging clinical reality. We have designed and tested a silica-based gadolinium chelates nanoparticle (AGuIX) for integration with MR-guided radiation therapy. The AGuIX nanoparticles used in this study are a dual-modality probe with radiosensitization properties and better MRI contrast than current FDA-approved gadolinium chelates. In advance of an approved Phase I clinical trial, we report on the efficacy and safety in multiple animal models and clinically relevant radiation conditions. By modeling our study on current clinic workflows, we show compatibility with modern patient care, thus heightening the translational significance of this research. Methods:more » The dual imaging and therapy functionality of AGuIX was investigated in mice with clinical radiation beams while safety was evaluated in mice, and nonhuman primates after systemic injection of 0.25 mg/g of nanoparticles. MRI/ICP-MS were used to measure tumor uptake and biodistribution. Due to their small size (2–3 nm), AGuIX have good renal clearance (t1/2=19min). We performed in vitro cell uptake quantification and radiosensitization studies (clonogenic assays and DNA damage quantification). In vivo radiation therapy studies were performed with both 6MV and 6MV-FFF clinical radiation beams. Histology was performed to measure the increase in DNA damage in the tumor and to evaluate the toxicity in healthy tissues. Results: In vitro and in vivo results demonstrate statistically significant increase (P < 0.01) in DNA damage, tumor growth supression and survival (+100 days) compared to radiation alone. Negligible toxicity was observed in all of the animal models. The combination of 6MV-FFF/AGuIX demonstrated a substantial dose enhancement compared to 6MV/AGuIX (DEF = 1.36 vs. 1.22) due to the higher proportion of low energy photons. Conclusion: With demonstrated efficacy and negligible toxicity in mice and non-human primates, AGuIX is a biocompatible nanoplatform with strong translational potential for MR-guided radiation therapy.« less

In defense of clinical conferences in clinical nursing education.

PubMed

Vezeau, Toni M

2016-01-01

Clinical conferencing has been a consistent feature of clinical education, but the current clinical education environment poses many challenges to its continuance. The paper raises concern regarding the current state of clinical conferencing as part of clinical practice education in nursing. This topic is of great concern, but has there is little direction for clinical educators. The paper reviews the literature on conferencing and recommends avenues for future research. Copyright © 2015 Elsevier Ltd. All rights reserved.

Primer: establishing a clinical trial unit--obtaining studies and patients.

PubMed

Fleischmann, Roy

2007-08-01

Rheumatologists with clinical expertise should perform clinical investigations of new molecules in an effort to discover therapies that could be of greater benefit or safety than those currently available for patients with chronic rheumatic diseases. Over the past few years, many studies have been conducted outside the United States and Europe because of the dearth of investigative sites in these countries. A clinician, whether in private practice or academia, who has the resources and desire to conduct clinical investigations, should be able to become involved in the process. The task of starting a new investigative unit is daunting, as it involves acquiring studies, hiring staff and obtaining space prior to any cash flow. If done properly, however, clinical investigation can be rewarding--both intellectually and financially.

An integrated review of the correlation between critical thinking ability and clinical decision-making in nursing.

PubMed

Lee, Daphne Sk; Abdullah, Khatijah Lim; Subramanian, Pathmawathi; Bachmann, Robert Thomas; Ong, Swee Leong

2017-12-01

To explore whether there is a correlation between critical thinking ability and clinical decision-making among nurses. Critical thinking is currently considered as an essential component of nurses' professional judgement and clinical decision-making. If confirmed, nursing curricula may be revised emphasising on critical thinking with the expectation to improve clinical decision-making and thus better health care. Integrated literature review. The integrative review was carried out after a comprehensive literature search using electronic databases Ovid, EBESCO MEDLINE, EBESCO CINAHL, PROQuest and Internet search engine Google Scholar. Two hundred and 22 articles from January 1980 to end of 2015 were retrieved. All studies evaluating the relationship between critical thinking and clinical decision-making, published in English language with nurses or nursing students as the study population, were included. No qualitative studies were found investigating the relationship between critical thinking and clinical decision-making, while 10 quantitative studies met the inclusion criteria and were further evaluated using the Quality Assessment and Validity Tool. As a result, one study was excluded due to a low-quality score, with the remaining nine accepted for this review. Four of nine studies established a positive relationship between critical thinking and clinical decision-making. Another five studies did not demonstrate a significant correlation. The lack of refinement in studies' design and instrumentation were arguably the main reasons for the inconsistent results. Research studies yielded contradictory results as regard to the relationship between critical thinking and clinical decision-making; therefore, the evidence is not convincing. Future quantitative studies should have representative sample size, use critical thinking measurement tools related to the healthcare sector and evaluate the predisposition of test takers towards their willingness and ability to think. There is also a need for qualitative studies to provide a fresh approach in exploring the relationship between these variables uncovering currently unknown contributing factors. This review confirmed that evidence to support the existence of relationships between critical thinking and clinical decision-making is still unsubstantiated. Therefore, it serves as a call for nurse leaders and nursing academics to produce quality studies in order to firmly support or reject the hypothesis that there is a statistically significant correlation between critical thinking and clinical decision-making. © 2017 John Wiley & Sons Ltd.

[Structural endpoints for glaucoma studies].

PubMed

Popa-Cherechenau, A; Schmidl, D; Garhöfer, G; Schmetterer, L

2018-03-06

Structural endpoints have been discussed as surrogate endpoints for the approval of neuroprotective drugs in glaucoma. Is the evidence strong enough to establish structural endpoints as surrogate endpoints? Review of current understanding between structure and function in glaucoma. The introduction of optical coherence tomography has revolutionized imaging in glaucoma patients. Clinically either the nerve fiber layer thickness can be measured along a circle centered in the optic nerve head or the ganglion cell layer thickness can be assessed in the macular region, the latter being quantified in combination with other inner retinal layers. On a microscopic level there is a strong correlation between structural and functional loss but this relation can only partially be described with currently available clinical methods. This is particularly true for longitudinal course of the disease in glaucoma patients. Novel imaging techniques that are not yet used clinically may have the potential to increase our understanding between structure and function in glaucoma but further research in this field is required. The current evidence does not allow the establishment of structural endpoints as surrogate endpoints for phase 3 studies in glaucoma. Neuroprotective drugs have to be approved on the basis of visual field data because this is the patient-relevant endpoint. Structural endpoints can, however, play an important role in phase 2 and proof of concept studies.

Metastasis of ovarian cancer to the breast: A report of two cases and a review of the literature

PubMed Central

TEMPFER, CLEMENS B.; EL FIZAZI, NARIMAN; ERGONENC, HASSAN; SOLASS, WIEBKE

2016-01-01

Metastasis of ovarian cancer to the breast (MOCB) is a rare event. Clinical presentations of MOCB vary and surgery is the mainstay of treatment. The current study presents two cases of MOCB in women with recurrent ovarian cancer first diagnosed in April 2011 and October 2013, respectively. The patients presented to the clinic with a localized, palpable, painful mass in the upper outer quadrant of the right breast and a centrally localized, palpable, painful mass of the left breast, respectively. Breast sonography and mammography showed a singular, round, homogenous tumor with irregular borders in each case. An ipsilateral enlarged axillary node was palpable in one case. Tumor biopsy revealed an undifferentiated adenocarcinoma of unknown origin in one case and a moderately-differentiated adenocarcinoma suspected to be breast cancer in the other case. Tumor cells were positive for estrogen receptor and paired box 8, and negative for GATA binding protein 3 in the two cases. Palliative mastectomy was performed in one case and lumpectomy with ipsilateral axillary sentinel node biopsy in the other case, and the final histology revealed MOCB in each. The post-operative course of the disease was uneventful and the patients continued with their ovarian cancer-specific chemotherapy. One patient succumbed to disease progression 2 months after breast surgery. The other patient remains alive and is currently undergoing systemic chemotherapy. The current study also presents a review of 110 cases of MOCB identified in a literature search of Pubmed. Data from these studies, including the clinical and histological characteristics of MOCB, and the clinical management and prognosis are discussed. Overall, MOCB is rare, with distinct clinical and histological features. The disease is usually treated with local surgical excision or mastectomy and has a poor prognosis. PMID:27313731

Challenges of implementing fibromyalgia treatment guidelines in current clinical practice.

PubMed

Arnold, Lesley M; Clauw, Daniel J

2017-09-01

The current diagnostic and treatment pathway for patients with fibromyalgia (FM) is lengthy, complex, and characterized by multiple physician visits with an average 2-year wait until diagnosis. It is clear that effective identification and appropriate treatment of FM remain a challenge in current clinical practice. Ideally, FM management involves a multidisciplinary approach with the preferable patient pathway originating in primary care but supported by a range of health care providers, including referral to specialist care when necessary. After the publication of individual clinical studies, high-quality reviews, and meta-analyses, recently published FM treatment guidelines have transitioned from an expert consensus to an evidence-based approach. Evidence-based guidelines provide a framework for ensuring early diagnosis and timely adoption of appropriate treatment. However, for successful outcomes, FM treatments must adopt a more holistic approach, which addresses more than just pain. Impact on the associated symptoms of fatigue and cognitive problems, sleep and mood disturbances, and lowered functional status are also important in judging the success of FM therapy. Recently published guidelines recommend the adoption of a symptom-based approach to guide pharmacologic treatment. Emerging treatment options for FM may be best differentiated on the basis of their effect on comorbid symptoms that are often associated with pain (e.g. sleep disturbance, mood, fatigue). The current review discusses the most recently published Canadian guidelines and the implications of the recent European League Against Rheumatism (EULAR) recommendations, with a focus on the challenges of implementing these guidelines in current clinical practice.

Relationship between Dispositional Mindfulness and Substance Use: Findings from a Clinical Sample

PubMed Central

Bowen, Sarah; Enkema, Matthew C.

2014-01-01

There has been rapidly increasing interest over the past decade in the potential of mindfulness-based approaches to psychological and medical treatment, including a recent growth in the area of substance abuse. Thus, the relationship between trait mindfulness and substance use has been explored in several studies. Results, however, have been mixed. While several studies of college student populations have evinced positive correlations between levels of trait mindfulness and substance use, the opposite seems to be true in clinical samples, with multiple studies showing a negative association. The current study reviews research in both non-treatment seeking college students and in clinical samples, and examines the relationship between trait mindfulness and substance dependence in a clinical sample (N = 281). Further, the study assesses the moderating effect of avoidant coping that might explain the disparate findings in the clinical versus nonclinical samples. PMID:24290208

Intracranial Pressure Monitoring—Review and Avenues for Development

PubMed Central

Dolmans, Rianne G. F.

2018-01-01

Intracranial pressure (ICP) monitoring is a staple of neurocritical care. The most commonly used current methods of monitoring in the acute setting include fluid-based systems, implantable transducers and Doppler ultrasonography. It is well established that management of elevated ICP is critical for clinical outcomes. However, numerous studies show that current methods of ICP monitoring cannot reliably define the limit of the brain’s intrinsic compensatory capacity to manage increases in pressure, which would allow for proactive ICP management. Current work in the field hopes to address this gap by harnessing live-streaming ICP pressure-wave data and a multimodal integration with other physiologic measures. Additionally, there is continued development of non-invasive ICP monitoring methods for use in specific clinical scenarios. PMID:29401746

[Review of current classification and terminology of vulvar disorders].

PubMed

Sláma, J

2012-08-01

To summarize current terminology and classification of vulvar disorders. Review article. Gynecologic oncology center, Department of Gynecology and Obstetrics, General Faculty Hospital and 1st Medical School of Charles University, Prague. Vulvar disorders include wide spectrum of different diagnoses. Multidisciplinary collaboration is frequently needed in diagnostical and therapeutical process. It is essential to use unified terminology using standard dermatological terms, and unified classification for comprehensible communication between different medical professions. Current classification, which is based on Clinical-pathological criteria, was established by International Society for the Study of Vulvovaginal Disease. Recently, there was introduced Clinical classification, which groups disorders according to main morphological finding. Adequate and unified classification and terminology are necessary for effective communication during the diagnostical process.

[Assessment of innovations in clinical research: strengths and potentials for improvement of research in Germany].

PubMed

Vollmar, Horst Christian; Georgieff, Peter; Bührlen, Bernhard

2010-01-01

Clinical research is a central link in the development chain of new treatment methods; scientifically, it belongs between basic science and health services research. It spans from the first application of a new substance or device in humans to the main proofs of its efficacy and safety. Economically speaking, it absorbs almost half of the total expenditures for the research and development of a new drug and represents a significant factor in the labour market for researchers and study personnel. Also, through participation in clinical trials, patients gain early access to new treatment methods, while on the other hand they are placed at higher risk for undesired side effects. Politics have taken significant steps to strengthen clinical research, but the pharmaceutical industry continues to complain about competitive disadvantages. Despite internationally recognised and, to a large extent, legally codified guidelines there are still significant national differences in implementation. In addition, traditional practices in clinical research are challenged by novel, mainly biotechnological therapeutic methods for which our current knowledge base is rather limited and which therefore entail a higher risk for patients or trial participants. The following paper summarises a report for the Office of Technology Assessment at the German Federal Parliament (TAB). Based on current regulations, scientific literature and expert interviews, current challenges and solution strategies for clinical research will be analysed in terms of an international comparison.

Targeting oncogenic vulnerabilities in triple negative breast cancer: biological bases and ongoing clinical studies

PubMed Central

Ocana, Alberto; Pandiella, Atanasio

2017-01-01

Triple negative breast cancer (TNBC) is still an incurable disease despite the great scientific effort performed during the last years. The huge heterogeneity of this disease has motivated the evaluation of a great number of therapies against different molecular alterations. In this article, we review the biological bases of this entity and how the known molecular evidence supports the current preclinical and clinical development of new therapies. Special attention will be given to ongoing clinical studies and potential options for future drug combinations. PMID:28108739

Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics.

PubMed

Li, Zhaoyang; Easton, Rachael

2018-01-01

The development of an injectable drug-device combination (DDC) product for biologics is an intricate and evolving process that requires substantial investments of time and money. Consequently, the commercial dosage form(s) or presentation(s) are often not ready when pivotal trials commence, and it is common to have drug product changes (manufacturing process or presentation) during clinical development. A scientifically sound and robust bridging strategy is required in order to introduce these changes into the clinic safely. There is currently no single developmental paradigm, but a risk-based hierarchical approach has been well accepted. The rigor required of a bridging package depends on the level of risk associated with the changes. Clinical pharmacokinetic/pharmacodynamic comparability or outcome studies are only required when important changes occur at a late stage. Moreover, an injectable DDC needs to be user-centric, and usability assessment in real-world clinical settings may be required to support the approval of a DDC. In this review, we discuss the common issues during the manufacturing process and presentation development of an injectable DDC and practical considerations in establishing a clinical strategy to address these issues, including key elements of clinical studies. We also analyze the current practice in the industry and review relevant and status of regulatory guidance in the DDC field.

Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics

PubMed Central

Easton, Rachael

2018-01-01

ABSTRACT The development of an injectable drug-device combination (DDC) product for biologics is an intricate and evolving process that requires substantial investments of time and money. Consequently, the commercial dosage form(s) or presentation(s) are often not ready when pivotal trials commence, and it is common to have drug product changes (manufacturing process or presentation) during clinical development. A scientifically sound and robust bridging strategy is required in order to introduce these changes into the clinic safely. There is currently no single developmental paradigm, but a risk-based hierarchical approach has been well accepted. The rigor required of a bridging package depends on the level of risk associated with the changes. Clinical pharmacokinetic/pharmacodynamic comparability or outcome studies are only required when important changes occur at a late stage. Moreover, an injectable DDC needs to be user-centric, and usability assessment in real-world clinical settings may be required to support the approval of a DDC. In this review, we discuss the common issues during the manufacturing process and presentation development of an injectable DDC and practical considerations in establishing a clinical strategy to address these issues, including key elements of clinical studies. We also analyze the current practice in the industry and review relevant and status of regulatory guidance in the DDC field. PMID:29035675

Echocardiographic strain and strain-rate imaging: a new tool to study regional myocardial function.

PubMed

D'hooge, Jan; Bijnens, Bart; Thoen, Jan; Van de Werf, Frans; Sutherland, George R; Suetens, Paul

2002-09-01

Ultrasonic imaging is the noninvasive clinical imaging modality of choice for diagnosing heart disease. At present, two-dimensional ultrasonic grayscale images provide a relatively cheap, fast, bedside method to study the morphology of the heart. Several methods have been proposed to assess myocardial function. These have been based on either grayscale or motion (velocity) information measured in real-time. However, the quantitative assessment of regional myocardial function remains an important goal in clinical cardiology. To do this, ultrasonic strain and strain-rate imaging have been introduced. In the clinical setting, these techniques currently only allow one component of the true three-dimensional deformation to be measured. Clinical, multidimensional strain (rate) information can currently thus only be obtained by combining data acquired using different transducer positions. Nevertheless, given the appropriate postprocessing, the clinical value of these techniques has already been shown. Moreover, multidimensional strain and strain-rate estimation of the heart in vivo by means of a single ultrasound acquisition has been shown to be feasible. In this paper, the new techniques of ultrasonic strain rate and strain imaging of the heart are reviewed in terms of definitions, data acquisition, strain-rate estimation, postprocessing, and parameter extraction. Their clinical validation and relevance will be discussed using clinical examples on relevant cardiac pathology. Based on these examples, suggestions are made for future developments of these techniques.

Evolving therapies for the management of chronic and acute decompensated heart failure.

PubMed

Cook, Jennifer C; Tran, Richard H; Patterson, J Herbert; Rodgers, Jo E

2016-11-01

The pharmacology, clinical efficacy, and safety profiles of evolving therapies for the management of chronic heart failure (HF) and acute decompensated heart failure (ADHF) are described. HF confers a significant financial burden despite the widespread use of traditional guideline-directed medical therapies such as angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, β-blockers, and aldosterone receptor antagonists, and the rates of HF-related mortality and hospitalization have remained unacceptably high. In response to a demand for novel pharmacologic agents, several therapeutic compounds have recently gained approval or are currently under review by the Food and Drug Administration. Sacubitril-valsartan has demonstrated benefit in reducing cardiovascular mortality and HF-related hospitalizations in clinical trials, while ivabradine and ferric carboxymaltose have proven efficacious in reducing HF-related hospitalizations. Lastly, the role of serelaxin in ADHF is currently under investigation in an ongoing Phase III study. While large, outcome-driven clinical trials are fundamental in informing the clinical application of these therapeutic agents, careful patient selection is imperative to ensuring similar outcomes postmarketing. In addition, optimization of current guideline-directed medical therapy remains essential as new therapies emerge and are incorporated into guideline recommendations. Additional therapeutic agents currently undergoing investigation include bucindolol hydrochloride, cimaglermin alfa, nitroxyl, omecamtiv mecarbil, TRV027, and ularitide. Clinical practitioners should remain abreast of emerging literature so that new therapeutic entities are optimally applied and positive patient outcomes are achieved. Recently introduced agents for the treatment of patients with HF include sacubitril-valsartan, ivabradine, and ferric carboxymaltose. Additional agents worthy of attention include serelaxin and other therapies currently under investigation. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Who uses multivitamins? A cross-sectional study in the Physicians' Health Study.

PubMed

Rautiainen, Susanne; Wang, Lu; Gaziano, J Michael; Sesso, Howard D

2014-06-01

The aim of this study was to examine the prevalence of self-reported multivitamin use in the Physicians' Health Study (PHS) cohort and its association with various lifestyle, clinical, and dietary factors to improve our understanding of who tends to use multivitamins. Among 18,040 middle-aged and older men, information on lifestyle and clinical factors was collected from a baseline enrollment questionnaire, and supplement use and dietary factors were assessed through a food-frequency questionnaire. Four categories of multivitamin use were considered: (1) no supplement use, (2) use of multivitamins only, (3) use of multivitamins with other individual vitamin/mineral supplements, and (4) use of other supplements only. We used logistic regression to calculate multivariate odds ratios and 95% confidence intervals of taking multivitamin supplements for various lifestyle, clinical and dietary factors. Overall, 36% of men reported current multivitamin use. Men who were older, current smokers, and currently using aspirin were 143, 43, and 74% more likely to use multivitamins only. Men having a history of hypercholesterolemia were 16% more likely to use multivitamins only. A 14, 24, and 26% greater likelihood of using multivitamins was also observed among men consuming more fruits and vegetables, whole grains, and tea, respectively. Similar associations were observed for the likelihood of using multivitamins with other supplements; however, men with higher physical activity, history of cancer, hypertension, higher consumption of nuts, and lower consumption of red meat and coffee were also more likely to use multivitamins with other supplements (all P < 0.05). Self-reported multivitamin use associated with lifestyle, clinical and dietary factors may be an indicator of healthy behaviors. These results provide important information for the interpretation of the recent findings from the PHS II trial and consideration of results from observational studies of multivitamin use and chronic disease.

Current Evidence Regarding the Diagnostic Methods for Pediatric Lumbar Spondylolisthesis: A Report From the Scoliosis Research Society Evidence Based Medicine Committee.

PubMed

Kim, Han Jo; Crawford, Charles H; Ledonio, Charles; Bess, Shay; Larson, A Noelle; Gates, Marilyn; Oetgen, Matthew; Sanders, James O; Burton, Douglas

Structured literature review. The Scoliosis Research Society (SRS) requested an assessment of the current state of peer-reviewed evidence regarding pediatric lumbar spondylolisthesis with the goal of identifying what is known and what gaps remain in further understanding the diagnostic methods for pediatric spondylolisthesis. Spondylolisthesis in the lumbar spine is common among children and adolescents and no formal synthesis of the published literature regarding diagnostic methods has been previously performed. A comprehensive literature search was performed. Abstracts were reviewed and data from included studies were analyzed by the committee. From 6600 initial citations with abstract, 663 articles underwent full-text review. The best available evidence for the clinical questions regarding diagnostic methods was provided by 26 included studies. Six of the studies were graded as Level III (retrospective comparative), and represent the current best available evidence whereas 20 of the studies were graded as Level IV (retrospective case series) evidence. No Level V (expert opinion) studies were included in the final list. None of the studies were graded as Level I or Level II. Plain radiography is the workhorse imaging modality for diagnosing spondylolisthesis. No association between radiologic grade of spondylolisthesis and clinical presentation were noted; however, grade III and IV slips more often required surgery, and increasing slip angles were associated with worse baseline outcome scores. There is Level III evidence that the Meyerding grade appears to be more accurate for measuring slip percentage whereas the Lonstein Slip angle and Dubousset Lumbosacral Kyphosis angles are the best for measuring lumbosacral kyphosis in spondylolisthesis. In addition, higher sacral table index, pelvic incidence, sacral slope, and lower sacral table angle were associated with spondylolisthesis. True incidence could not be determined by the current literature available. However, studies in adolescent athletes demonstrated an incidence of 6% to 7% across studies. The current "best available" evidence to guide the diagnosis and characterization of pediatric spondylolisthesis is presented. Future studies are needed to provide more high-quality evidence to answer these clinically relevant questions. Level III, review of Level III studies. Copyright © 2017 Scoliosis Research Society. Published by Elsevier Inc. All rights reserved.

Oncolytic Poxviruses

PubMed Central

Chan, Winnie M.; McFadden, Grant

2015-01-01

Current standard treatments of cancer can prolong survival of many cancer patients but usually do not effectively cure the disease. Oncolytic virotherapy is an emerging therapeutic for the treatment of cancer that exploits replication-competent viruses to selectively infect and destroy cancerous cells while sparing normal cells and tissues. Clinical and/or preclinical studies on oncolytic viruses have revealed that the candidate viruses being tested in trials are remarkably safe and offer potential for treating many classes of currently incurable cancers. Among these candidates are vaccinia and myxoma viruses, which belong to the family Poxviridae and possess promising oncolytic features. This article describes poxviruses that are being developed for oncolytic virotherapy and summarizes the outcomes of both clinical and preclinical studies. Additionally, studies demonstrating superior efficacy when poxvirus oncolytic virotherapy is combined with conventional therapies are described. PMID:25839047

Bcl-2 antisense therapy in B-cell malignant proliferative disorders.

PubMed

Chanan-Khan, Asher; Czuczman, Myron S

2004-08-01

Overexpression of Bcl-2 oncogene has been clinically associated with an aggressive clinical course, chemotherapy and radiotherapy resistance, and poor survival in patients with malignant B-cell disorders. Patients with relapsed or refractory chronic lymphocytic leukemia, multiple myeloma, or non-Hodgkin's lymphoma have limited therapeutic options. Preclinical and early clinical data have shown that Bcl-2 oncoprotein can be decreased by Bcl-2 antisense therapy. Also, downregulation of Bcl-2 protein can result in reversal of chemotherapy resistance and improved antitumor activity of biologic agents. Various clinical trials are evaluating the role of targeting Bcl-2 as a mechanism to enhance the antitumor potential of chemotherapy and immunotherapy. Early results from these clinical studies are encouraging and confirm the proof of principle for antisense therapy. As current data mature, these trials will hopefully validate preliminary results and establish Bcl-2 antisense as an important addition to the current armamentarium used in the treatment of patients with B-cell neoplasms.

Germline determinants of clinical outcome of cutaneous melanoma

PubMed Central

Vogelsang, Matjaz; Wilson, Melissa; Kirchhoff, Tomas

2016-01-01

Cutaneous melanoma (CM) is the most lethal form of skin cancer. Despite the constant increase of melanoma incidence, which is in part due to incremental advances in early diagnostic modalities, mortality rates have not improved over the last decade and for advanced stages remain steadily high. While conventional prognostic biomarkers currently in use find significant utility for predicting overall general survival probabilities, they are not sensitive enough for a more personalized clinical assessment on an individual level. In recent years, the advent of genomic technologies has brought the promise of identification of germline DNA alterations that may associate with CM outcomes and hence represent novel biomarkers for clinical utilization. This review attempts to summarize the current state of knowledge of germline genetic factors studied for their impact on melanoma clinical outcomes. We also discuss ongoing problems and hurdles in validating such surrogates, and we also project future directions in discovery of more powerful germline genetic factors with clinical utility in melanoma prognostication. PMID:26342156

Integrating functional genomics to accelerate mechanistic personalized medicine.

PubMed

Tyner, Jeffrey W

2017-03-01

The advent of deep sequencing technologies has resulted in the deciphering of tremendous amounts of genetic information. These data have led to major discoveries, and many anecdotes now exist of individual patients whose clinical outcomes have benefited from novel, genetically guided therapeutic strategies. However, the majority of genetic events in cancer are currently undrugged, leading to a biological gap between understanding of tumor genetic etiology and translation to improved clinical approaches. Functional screening has made tremendous strides in recent years with the development of new experimental approaches to studying ex vivo and in vivo drug sensitivity. Numerous discoveries and anecdotes also exist for translation of functional screening into novel clinical strategies; however, the current clinical application of functional screening remains largely confined to small clinical trials at specific academic centers. The intersection between genomic and functional approaches represents an ideal modality to accelerate our understanding of drug sensitivities as they relate to specific genetic events and further understand the full mechanisms underlying drug sensitivity patterns.

Urological complications of uterine leiomyoma: a review of literature.

PubMed

Dagur, Gautam; Suh, Yiji; Warren, Kelly; Singh, Navjot; Fitzgerald, John; Khan, Sardar A

2016-06-01

Uterine leiomyomas are common gynecologic tumor in reproductive-aged women, by age 50, diagnosis shared by urologist, gynecologists and radiologists. The goal of this article is to review the current literature, study the impact of leiomyoma on female lower urinary tract, examine the cause female sexual dysfunction and provide a comprehensive review of current diagnostic, imaging studies, and current treatment of leiomyoma. Clinical leiomyoma studies published from 1956 through 2015 were identified using the PubMed search engines and the key words leiomyoma, fibroid in the current literature. Impact of leiomyoma on the lower urinary tract including female sexual dysfunction was reviewed with terms of "urinary retention", "bladder", "urethra", "dyspareunia", "incontinence", "incomplete bladder emptying", "female sexual dysfunction", and "lower urinary tract" to study the urological and sexual effects of leiomyoma. Literature related to leiomyoma was reviewed from 1965 to present. Women with uterine leiomyomata complained of pelvic pain, menstrual irregularities, infertility, lower urinary tract symptoms and sexual dysfunction. Leiomyoma is a common tumor of the uterus that often clinically impacts on the lower urinary tract and results in urological and sexual symptoms. Leiomyoma can compress and grow into and become adherent to the bladder and surrounding pelvic organs or metastasize into peritoneal organs. Leiomyoma can enlarge and compress the urinary bladder, urethra, and lower end of the ureters. Leiomyoma can cause embarrassing sexual dysfunction in females. Current literature of non-surgical and surgical therapy of leiomyoma is described.

Quantitative Pulmonary Imaging Using Computed Tomography and Magnetic Resonance Imaging

PubMed Central

Washko, George R.; Parraga, Grace; Coxson, Harvey O.

2011-01-01

Measurements of lung function, including spirometry and body plethesmography, are easy to perform and are the current clinical standard for assessing disease severity. However, these lung functional techniques do not adequately explain the observed variability in clinical manifestations of disease and offer little insight into the relationship of lung structure and function. Lung imaging and the image based assessment of lung disease has matured to the extent that it is common for clinical, epidemiologic, and genetic investigation to have a component dedicated to image analysis. There are several exciting imaging modalities currently being used for the non-invasive study of lung anatomy and function. In this review we will focus on two of them, x-ray computed tomography and magnetic resonance imaging. Following a brief introduction of each method we detail some of the most recent work being done to characterize smoking-related lung disease and the clinical applications of such knowledge. PMID:22142490

Transcranial direct current stimulation in psychiatric disorders

PubMed Central

Tortella, Gabriel; Casati, Roberta; Aparicio, Luana V M; Mantovani, Antonio; Senço, Natasha; D’Urso, Giordano; Brunelin, Jerome; Guarienti, Fabiana; Selingardi, Priscila Mara Lorencini; Muszkat, Débora; Junior, Bernardo de Sampaio Pereira; Valiengo, Leandro; Moffa, Adriano H; Simis, Marcel; Borrione, Lucas; Brunoni, André R

2015-01-01

The interest in non-invasive brain stimulation techniques is increasing in recent years. Among these techniques, transcranial direct current stimulation (tDCS) has been the subject of great interest among researchers because of its easiness to use, low cost, benign profile of side effects and encouraging results of research in the field. This interest has generated several studies and randomized clinical trials, particularly in psychiatry. In this review, we provide a summary of the development of the technique and its mechanism of action as well as a review of the methodological aspects of randomized clinical trials in psychiatry, including studies in affective disorders, schizophrenia, obsessive compulsive disorder, child psychiatry and substance use disorder. Finally, we provide an overview of tDCS use in cognitive enhancement as well as a discussion regarding its clinical use and regulatory and ethical issues. Although many promising results regarding tDCS efficacy were described, the total number of studies is still low, highlighting the need of further studies aiming to replicate these findings in larger samples as to provide a definite picture regarding tDCS efficacy in psychiatry. PMID:25815258

Challenges in the clinical development of new antiepileptic drugs.

PubMed

Franco, Valentina; French, Jacqueline A; Perucca, Emilio

2016-01-01

Despite the current availability in the market of over two dozen antiepileptic drugs (AEDs), about one third of people with epilepsy fail to achieve complete freedom from seizures with existing medications. Moreover, currently available AEDs have significant limitations in terms of safety, tolerability and propensity to cause or be a target for clinically important adverse drug interactions. A review of the evidence shows that there are many misperceptions about the viability of investing into new therapies for epilepsy. In fact, there are clear incentives to develop newer and more efficacious medications. Developing truly innovative drugs requires a shift in the paradigms for drug discovery, which is already taking place by building on greatly expanded knowledge about the mechanisms involved in epileptogenesis, seizure generation, seizure spread and development of co-morbidities. AED development can also benefit by a review of the methodology currently applied in clinical AED development, in order to address a number of ethical and scientific concerns. As discussed in this article, many processes of clinical drug development, from proof-of-concept-studies to ambitious programs aimed at demonstrating antiepileptogenesis and disease-modification, can be facilitated by a greater integration of preclinical and clinical science, and by application of knowledge acquired during decades of controlled epilepsy trials. Copyright © 2015 Elsevier Ltd. All rights reserved.

Brain MRI atrophy quantification in MS

PubMed Central

Rocca, Maria A.; Battaglini, Marco; Benedict, Ralph H.B.; De Stefano, Nicola; Geurts, Jeroen J.G.; Henry, Roland G.; Horsfield, Mark A.; Jenkinson, Mark; Pagani, Elisabetta

2017-01-01

Patients with the main clinical phenotypes of multiple sclerosis (MS) manifest varying degrees of brain atrophy beyond that of normal aging. Assessment of atrophy helps to distinguish clinically and cognitively deteriorating patients and predicts those who will have a less-favorable clinical outcome over the long term. Atrophy can be measured from brain MRI scans, and many technological improvements have been made over the last few years. Several software tools, with differing requirements on technical ability and levels of operator intervention, are currently available and have already been applied in research or clinical trial settings. Despite this, the measurement of atrophy in routine clinical practice remains an unmet need. After a short summary of the pathologic substrates of brain atrophy in MS, this review attempts to guide the clinician towards a better understanding of the methods currently used for quantifying brain atrophy in this condition. Important physiologic factors that affect brain volume measures are also considered. Finally, the most recent research on brain atrophy in MS is summarized, including whole brain and various compartments thereof (i.e., white matter, gray matter, selected CNS structures). Current methods provide sufficient precision for cohort studies, but are not adequate for confidently assessing changes in individual patients over the scale of months or a few years. PMID:27986875

Employment among Patients with Multiple Sclerosis-A Population Study

PubMed Central

Bøe Lunde, Hanne Marie; Telstad, Wenche; Grytten, Nina; Kyte, Lars; Aarseth, Jan; Myhr, Kjell-Morten; Bø, Lars

2014-01-01

Objective To investigate demographic and clinical factors associated with employment in MS. Methods The study included 213 (89.9%) of all MS patients in Sogn and Fjordane County, Western Norway at December 31st 2010. The patients underwent clinical evaluation, structured interviews and completed self-reported questionnaires. Demographic and clinical factors were compared between patients being employed versus patients being unemployed and according to disease course of MS. Logistic regression analysis was used to identify factors independently associated with current employment. Results After a mean disease duration of almost 19 years, 45% of the population was currently full-time or part- time employed. Patients with relapsing –remitting MS (RRMS) had higher employment rate than patients with secondary (SPMS) and primary progressive (PPMS). Higher educated MS patients with lower age at onset, shorter disease duration, less severe disability and less fatigue were most likely to be employed. Conclusions Nearly half of all MS patients were still employed after almost two decades of having MS. Lower age at onset, shorter disease duration, higher education, less fatigue and less disability were independently associated with current employment. These key clinical and demographic factors are important to understand the reasons to work ability in MS. The findings highlight the need for environmental adjustments at the workplace to accommodate individual ’s needs in order to improve working ability among MS patients. PMID:25054972

Clinical Relevance of Coronary Fractional Flow Reserve: Art-of-state

PubMed Central

Adiputra, Yohanes; Chen, Shao-Liang

2015-01-01

Objective: The objective was to delineate the current knowledge of fractional flow reserve (FFR) in terms of definition, features, clinical applications, and pitfalls of measurement of FFR. Data Sources: We searched database for primary studies published in English. The database of National Library of Medicine (NLM), MEDLINE, and PubMed up to July 2014 was used to conduct a search using the keyword term “FFR”. Study Selection: The articles about the definition, features, clinical application, and pitfalls of measurement of FFR were identified, retrieved, and reviewed. Results: Coronary pressure-derived FFR rapidly assesses the hemodynamic significance of individual coronary artery lesions and can readily be performed in the catheterization laboratory. The use of FFR has been shown to effectively guide coronary revascularization procedures leading to improved patient outcomes. Conclusions: FFR is a valuable tool to determine the functional significance of coronary stenosis. It combines physiological and anatomical information, and can be followed immediately by percutaneous coronary intervention (PCI) if necessary. The technique of FFR measurement can be performed easily, rapidly, and safely in the catheterization laboratory. By systematic use of FFR in dubious stenosis and multi-vessel disease, PCI can be made an even more effective and better treatment than it is currently. The current clinical evidence for FFR should encourage cardiologists to use this tool in the catheterization laboratory. PMID:25963364

The global pipeline of new medicines for the control and elimination of malaria

PubMed Central

2012-01-01

Over the past decade, there has been a transformation in the portfolio of medicines to combat malaria. New fixed-dose artemisinin combination therapy is available, with four different types having received approval from Stringent Regulatory Authorities or the World Health Organization (WHO). However, there is still scope for improvement. The Malaria Eradication Research agenda identified several gaps in the current portfolio. Simpler regimens, such as a single-dose cure are needed, compared with the current three-day treatment. In addition, new medicines that prevent transmission and also relapse are needed, but with better safety profiles than current medicines. There is also a big opportunity for new medicines to prevent reinfection and to provide chemoprotection. This study reviews the global portfolio of new medicines in development against malaria, as of the summer of 2012. Cell-based phenotypic screening, and ‘fast followers’ of clinically validated classes, mean that there are now many new classes of molecules starting in clinical development, especially for the blood stages of malaria. There remain significant gaps for medicines blocking transmission, preventing relapse, and long-duration molecules for chemoprotection. The nascent pipeline of new medicines is significantly stronger than five years ago. However, there are still risks ahead in clinical development and sustainable funding of clinical studies is vital if this early promise is going to be delivered. PMID:22958514

Psychiatric Syndromes in Adolescents with Marijuana Abuse and Dependency in Outpatient Treatment

ERIC Educational Resources Information Center

Diamond, Guy; Panichelli-Mindel, Susan M.; Shera, David; Dennis, Mike; Tims, Frank; Ungemack, Jane

2006-01-01

Objective: The purpose of the current study to assist in understanding the prevalence and clinical correlates of psychiatric distress in adolescents seeking outpatient services for marijuana abuse or dependency. Methods: In a multi-site randomized clinical trial, 600 adolescents and their parents were assessed at intake using the Global Appraisals…

Clinically Significant Change to Establish Benchmarks in Residential Drug and Alcohol Treatment Services

ERIC Educational Resources Information Center

Billingham, Daniel D.; Kelly, Peter J.; Deane, Frank P.; Crowe, Trevor P.; Buckingham, Mark S.; Craig, Fiona L.

2012-01-01

There is increasing emphasis on the use routine outcome assessment measures to inform quality assurance initiatives. The calculation of reliable and clinically significant change indices is one strategy that organizations could use to develop both internal and externally focused benchmarking processes. The current study aimed to develop reliable…

An Evaluation of the Development of MFT Competencies and the Influence of the Supervisory Relationship

ERIC Educational Resources Information Center

Burke, Jay Evan

2017-01-01

Practicum training is an essential part of The Chicago School of Professional Psychology (TCSPP) Marriage and Family Therapy (MFT) Master's degree program, and the cornerstone for preparing students for clinical practice. To characterize the development across clinical competency areas, the current study examined midpoint and final evaluation data…

Clinical Supervision Model in Teaching Practice: Does It Make a Difference in Supervisors' Performance?

ERIC Educational Resources Information Center

Gürsoy, Esim; Kesner, John Edward; Salihoglu, Umut Muharrem

2016-01-01

In search for better practices there has been a plethora of research in preservice teacher training. To contribute to the literature, the current study aims at investigating teacher trainees' and cooperating teachers' views about the performance and contribution of supervisors during teaching practice after using Clinical Supervision Model.…

Prenatal Pregnancy Complications and Psychiatric Symptoms: Children with ASD versus Clinic Controls

ERIC Educational Resources Information Center

Tudor, Megan E.; DeVincent, Carla J.; Gadow, Kenneth D.

2012-01-01

The current study examined the association between prenatal pregnancy complications (PPC) and childhood psychiatric symptoms in children with an autism spectrum disorder (ASD) and non-ASD children who were referred to a psychiatric clinic (Controls). Parents completed a "DSM-IV"-referenced rating scale and developmental history questionnaire.…

Building a Bridge or Digging a Pipeline? Clinical Data Mining in Evidence-Informed Knowledge Building

ERIC Educational Resources Information Center

Epstein, Irwin

2015-01-01

Challenging the "bridge metaphor" theme of this conference, this article contends that current practice-research integration strategies are more like research-to-practice "pipelines." The purpose of this article is to demonstrate the potential of clinical data-mining studies conducted by practitioners, practitioner-oriented PhD…

Trends in Handheld Computing Among Medical Students

PubMed Central

Grasso, Michael A.; Yen, M. Jim; Mintz, Matthew L.

2005-01-01

The purpose of this study was to identify trends in the utilization and acceptance of handheld computers (personal digital assistants) among medical students during preclinical and clinical training. These results can be used to identify differences between preclinical and clinical users, differences between current use and idealized use, and perceived limitations of these devices. PMID:16779255

Physicians’ perceptions of capacity building for managing chronic disease in seniors using integrated interprofessional care models

PubMed Central

Lee, Linda; Heckman, George; McKelvie, Robert; Jong, Philip; D’Elia, Teresa; Hillier, Loretta M.

2015-01-01

Abstract Objective To explore the barriers to and facilitators of adapting and expanding a primary care memory clinic model to integrate care of additional complex chronic geriatric conditions (heart failure, falls, chronic obstructive pulmonary disease, and frailty) into care processes with the goal of improving outcomes for seniors. Design Mixed-methods study using quantitative (questionnaires) and qualitative (interviews) methods. Setting Ontario. Participants Family physicians currently working in primary care memory clinic teams and supporting geriatric specialists. Methods Family physicians currently working in memory clinic teams (n = 29) and supporting geriatric specialists (n = 9) were recruited as survey participants. Interviews were conducted with memory clinic lead physicians (n = 16). Statistical analysis was done to assess differences between family physician ratings and geriatric specialist ratings related to the capacity for managing complex chronic geriatric conditions, the role of interprofessional collaboration within primary care, and funding and staffing to support geriatric care. Results from both study methods were compared to identify common findings. Main findings Results indicate overall support for expanding the memory clinic model to integrate care for other complex conditions. However, the current primary care structure is challenged to support optimal management of patients with multiple comorbidities, particularly as related to limited funding and staffing resources. Structured training, interprofessional teams, and an active role of geriatric specialists within primary care were identified as important facilitators. Conclusion The memory clinic model, as applied to other complex chronic geriatric conditions, has the potential to build capacity for high-quality primary care, improve health outcomes, promote efficient use of health care resources, and reduce health care costs. PMID:25932482

Cognitive effects of transcranial direct current stimulation in depression: Results from the SELECT-TDCS trial and insights for further clinical trials.

PubMed

Brunoni, André Russowsky; Tortella, Gabriel; Benseñor, Isabela Martins; Lotufo, Paulo Andrade; Carvalho, André Ferrer; Fregni, Felipe

2016-09-15

Cognitive dysfunction treatment remains an unmet clinical need in major depressive disorder (MDD). Transcranial direct current stimulation (tDCS) may improve cognitive symptoms in MDD. Our aim was to investigate the cognitive effects of tDCS in the Sertraline vs. Electric Current Therapy for Treating Depression Clinical Study (SELECT-TDCS). We also explored whether tDCS could have mood-independent cognitive effects. One hundred twenty MDD patients aged from 18 to 65 years received 12 sessions of active/sham tDCS (2mA for 30min) and real/placebo 50mg/d sertraline over 6 weeks in a factorial trial. We analyzed whether changes in performance of neuropsychological tests (Trail Making, Digit Span, Stroop Task, Mini-Mental Status Exam and Montreal Cognitive Assessment) occurred over time, according to treatment group and depression improvement. Exploratory analyses were carried out to verify the influence of clinical and demographic variables on the outcomes. Cognitive improvement was showed in most tests used, although they occurred regardless of intervention type and depression improvement. Further exploratory analyses revealed that clinical response and education level could have mediated pro-cognitive tDCS effects on some of the tests used. The neuropsychological battery used might not have been sensitive to detect tDCS-induced effects on cognition. Lack of simultaneous cognitive training during application may have also limited its cognitive effects. We found no evidence of beneficial or deleterious cognitive effects of tDCS as a treatment for depression. We discussed clinical trial design considerations for further tDCS studies assessing cognitive effects, including sample and outcomes considerations. Copyright © 2016 Elsevier B.V. All rights reserved.

Cell Seeding Densities in Autologous Chondrocyte Implantation Techniques for Cartilage Repair.

PubMed

Foldager, Casper Bindzus; Gomoll, Andreas H; Lind, Martin; Spector, Myron

2012-04-01

Cartilage repair techniques have been among the most intensively investigated treatments in orthopedics for the past decade, and several different treatment modalities are currently available. Despite the extensive research effort within this field, the generation of hyaline cartilage remains a considerable challenge. There are many parameters attendant to each of the cartilage repair techniques that can affect the amount and types of reparative tissue generated in the cartilage defect, and some of the most fundamental of these parameters have yet to be fully investigated. For procedures in which in vitro-cultured autologous chondrocytes are implanted under a periosteal or synthetic membrane cover, or seeded onto a porous membrane or scaffold, little is known about how the number of cells affects the clinical outcome. Few published clinical studies address the cell seeding density that was employed. The principal objective of this review is to provide an overview of the cell seeding densities used in cell-based treatments currently available in the clinic for cartilage repair. Select preclinical studies that have informed the use of specific cell seeding densities in the clinic are also discussed.

Availability of a fetal goat tongue cell line ZZ-R 127 for isolation of Foot-and-mouth disease virus (FMDV) from clinical samples collected from animals experimentally infected with FMDV.

PubMed

Fukai, Katsuhiko; Onozato, Hiroyuki; Kitano, Rie; Yamazoe, Reiko; Morioka, Kazuki; Yamada, Manabu; Ohashi, Seiichi; Yoshida, Kazuo; Kanno, Toru

2013-11-01

The availability of the fetal goat tongue cell line ZZ-R 127 for the isolation of Foot-and-mouth disease virus (FMDV) has not been evaluated using clinical samples other than epithelial suspensions. Therefore, in the current study, the availability of ZZ-R 127 cells for the isolation of FMDV was evaluated using clinical samples (e.g., sera, nasal swabs, saliva, feces, and oropharyngeal fluids) collected from animals experimentally infected with an FMDV isolate. Virus isolation rates for the ZZ-R 127 cells were statistically higher than those for the porcine kidney cell line (IB-RS-2) in experimental infections using cattle, goats, and pigs (P < 0.01). Virus titers in the ZZ-R 127 cells were also statistically higher than those in the IB-RS-2 cells. The availability of ZZ-R 127 cells for the isolation of FMDV not only from epithelial suspensions but also from other clinical samples was confirmed in the current study.

New therapeutic solutions for Behçet's syndrome.

PubMed

Vitale, Antonio; Rigante, Donato; Lopalco, Giuseppe; Emmi, Giacomo; Bianco, Maria Teresa; Galeazzi, Mauro; Iannone, Florenzo; Cantarini, Luca

2016-07-01

Behçet's syndrome (BS) is a systemic inflammatory disorder characterized by a wide range of potential clinical manifestations with no gold-standard therapy. However, the recent classification of BS at a crossroads between autoimmune and autoinflammatory syndromes has paved the way to new further therapeutic opportunities in addition to anti-tumor necrosis factor agents. This review provides a digest of all current experience and evidence about pharmacological agents recently described as having a role in the treatment of BS, including interleukin (IL)-1 inhibitors, tocilizumab, rituximab, alemtuzumab, ustekinumab, interferon-alpha-2a, and apremilast. IL-1 inhibitors currently represent the most studied agents among the latest treatment options for BS, proving to be effective, safe and with an acceptable retention on treatment. However, since BS is a peculiar disorder with clinical features responding to certain treatments that in turn can worsen other manifestations, identifying new treatment options for patients unresponsive to the current drug armamentarium is of great relevance. A number of agents have been studied in the last decade showing changing fortunes in some cases and promising results in others. The latter will potentially provide their contribution for better clinical management of BS, improving patients' quality of life and long-term outcome.

Safety and acceptability of transcranial direct current stimulation for the acute treatment of major depressive episodes: Analysis of individual patient data.

PubMed

Moffa, Adriano H; Brunoni, André R; Fregni, Felipe; Palm, Ulrich; Padberg, Frank; Blumberger, Daniel M; Daskalakis, Zafiris J; Bennabi, Djamila; Haffen, Emmanuel; Alonzo, Angelo; Loo, Colleen K

2017-10-15

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation modality that has been increasingly used for major depressive disorder (MDD) treatment. Although studies in healthy volunteers showed that the technique is well-tolerated, tDCS safety and acceptability have not been sufficiently explored in patients with MDD. We collected individual patient data from 6 randomized clinical trials that had been previously identified in a systematic review and meta-analysis. Primary outcomes were safety (rate of adverse events) and acceptability (rate of dropouts). Secondary outcomes were clinical, demographic and treatment predictors of the primary outcomes. Dropout rates between active (8.8%) and sham (12%) groups were not significantly different (OR= 0.7, p=0.38). Adverse event rates between active (73.5%) and sham (68.3%) groups were not significantly different (OR= 1.4, p= 0.23). Higher current densities were associated with lower adverse event rates. Dropout reasons were not systematically reported and adverse events were not collected using questionnaires standardized across studies. Active tDCS is as acceptable and safe as sham tDCS, as found in randomized clinical trials of MDD. Copyright © 2017. Published by Elsevier B.V.

Systematic review of emergency medicine clinical practice guidelines: Implications for research and policy.

PubMed

Venkatesh, Arjun K; Savage, Dan; Sandefur, Benjamin; Bernard, Kenneth R; Rothenberg, Craig; Schuur, Jeremiah D

2017-01-01

Over 25 years, emergency medicine in the United States has amassed a large evidence base that has been systematically assessed and interpreted through ACEP Clinical Policies. While not previously studied in emergency medicine, prior work has shown that nearly half of all recommendations in medical specialty practice guidelines may be based on limited or inconclusive evidence. We sought to describe the proportion of clinical practice guideline recommendations in Emergency Medicine that are based upon expert opinion and low level evidence. Systematic review of clinical practice guidelines (Clinical Policies) published by the American College of Emergency Physicians from January 1990 to January 2016. Standardized data were abstracted from each Clinical Policy including the number and level of recommendations as well as the reported class of evidence. Primary outcomes were the proportion of Level C equivalent recommendations and Class III equivalent evidence. The primary analysis was limited to current Clinical Policies, while secondary analysis included all Clinical Policies. A total of 54 Clinical Policies including 421 recommendations and 2801 cited references, with an average of 7.8 recommendations and 52 references per guideline were included. Of 19 current Clinical Policies, 13 of 141 (9.2%) recommendations were Level A, 57 (40.4%) Level B, and 71 (50.4%) Level C. Of 845 references in current Clinical Policies, 67 (7.9%) were Class I, 272 (32.3%) Class II, and 506 (59.9%) Class III equivalent. Among all Clinical Policies, 200 (47.5%) recommendations were Level C equivalent, and 1371 (48.9%) of references were Class III equivalent. Emergency medicine clinical practice guidelines are largely based on lower classes of evidence and a majority of recommendations are expert opinion based. Emergency medicine appears to suffer from an evidence gap that should be prioritized in the national research agenda and considered by policymakers prior to developing future quality standards.

Treatment Readiness as a Determinant of Treatment Participation in a Prison-Based Rehabilitation Program: An Exploratory Study.

PubMed

Bosma, Anouk Q; Kunst, Maarten J J; Dirkzwager, Anja J E; Nieuwbeerta, Paul

2017-06-01

The current study had three aims. First, it measured treatment readiness among offenders who entered the Prevention of Recidivism program. This is a prison-based rehabilitation program in the Netherlands that aims to lower re-offending rates among offenders with a prison sentence of at least for months and that is carried out during the final months of incarceration. Second, the study evaluated whether treatment readiness was associated with treatment participation. Third, the study examined whether treatment readiness measured with a validated instrument predicted treatment participation above and beyond a clinical assessment of treatment readiness, currently used as a criterion to include offenders in rehabilitation programs. To address these aims, data were used from the fourth wave of a research project studying the effects of imprisonment on the life of detainees in the Netherlands. Results indicated that treatment readiness as measured with a validated instrument was a significant predictor of treatment participation. Also, the current study showed that treatment readiness measured with a validated instrument improved the prediction of treatment participation above and beyond a clinical assessment of treatment readiness. Outcomes were discussed in light of study limitations and implications.

Using "clinical trial diaries" to track patterns of participation for serial healthy volunteers in U.S. phase I studies.

PubMed

Edelblute, Heather B; Fisher, Jill A

2015-02-01

Phase I testing of investigational drugs relies on healthy volunteers as research participants. Many U.S. healthy volunteers enroll repeatedly in clinical trials for the financial compensation. Serial participants are incentivized to ignore restrictions on their participation, and no centralized clinical trial registry prevents dual enrollment. Little is currently known about how healthy volunteers participate in studies over time, hampering the development of policies to protect this group. We detail a methodology developed as part of a longitudinal study to track in real-time healthy volunteers' Phase I participation. Illustrating these data through three case studies, we document how healthy volunteers use strategies, such as qualifying for studies at more than one clinic and traveling significant distances, to maximize their participation. Our findings suggest that "clinical trial diaries" can generate critical information about serial research participation and point to ethical issues unique to healthy volunteers' involvement in Phase I clinical trials. © The Author(s) 2015.

Biomarkers of tolerance: searching for the hidden phenotype.

PubMed

Perucha, Esperanza; Rebollo-Mesa, Irene; Sagoo, Pervinder; Hernandez-Fuentes, Maria P

2011-08-01

Induction of transplantation tolerance remains the ideal long-term clinical and logistic solution to the current challenges facing the management of renal allograft recipients. In this review, we describe the recent studies and advances made in identifying biomarkers of renal transplant tolerance, from study inceptions, to the lessons learned and their implications for current and future studies with the same goal. With the age of biomarker discovery entering a new dimension of high-throughput technologies, here we also review the current approaches, developments, and pitfalls faced in the subsequent statistical analysis required to identify valid biomarker candidates.

[The Coordinating Centers for Clinical Trials (KKS) and the KKS Network: competence for clinical research].

PubMed

Ohmann, Christian; Bruns, Insa; Wolff, Stephanie

2010-01-01

The Network of the Coordination Centers for Clinical Trials (CTCs; Koordinierungszentren für Klinische Studien(KKS)) comprises 17 institutions working as scientific service provider for universities, study groups, the pharmaceutical and medical devices industry as well as additional clients associated with clinical research. The CTCs have established planning and conduct of clinical trials according to Good Clinical Practice (GCP) guidelines,with a wide range of study support in academia. One focus according to indications is cancer. Expertise in hematological/oncological research can be requested nationwide and cross-institutional. The KKS network currently cooperates with medical societies and other, even European networks in 20 countries and has been established as a strong platform for oncological trials. Copyright © 2010 S. Karger AG, Basel.

Two Sides of the Same Coin: Cannabis Dependence and Mental Health Problems in Help-Seeking Adolescent and Young Adult Outpatients

ERIC Educational Resources Information Center

Norberg, Melissa M.; Battisti, Robert A.; Copeland, Jan; Hermens, Daniel F.; Hickie, Ian B.

2012-01-01

The aim of the current study was to delineate the psychiatric profile of cannabis dependent young people (14-29 years old) with mental health problems (N = 36) seeking treatment via a research study. To do so, the Structured Clinical Interview for DSM-IV-TR Axis I Disorders and the Structured Clinical Interview for DSM-IV Childhood Diagnoses were…

The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: summary and recommendations.

PubMed

Denicoff, Andrea M; McCaskill-Stevens, Worta; Grubbs, Stephen S; Bruinooge, Suanna S; Comis, Robert L; Devine, Peggy; Dilts, David M; Duff, Michelle E; Ford, Jean G; Joffe, Steven; Schapira, Lidia; Weinfurt, Kevin P; Michaels, Margo; Raghavan, Derek; Richmond, Ellen S; Zon, Robin; Albrecht, Terrance L; Bookman, Michael A; Dowlati, Afshin; Enos, Rebecca A; Fouad, Mona N; Good, Marjorie; Hicks, William J; Loehrer, Patrick J; Lyss, Alan P; Wolff, Steven N; Wujcik, Debra M; Meropol, Neal J

2013-11-01

Many challenges to clinical trial accrual exist, resulting in studies with inadequate enrollment and potentially delaying answers to important scientific and clinical questions. The National Cancer Institute (NCI) and the American Society of Clinical Oncology (ASCO) cosponsored the Cancer Trial Accrual Symposium: Science and Solutions on April 29-30, 2010 to examine the state of accrual science related to patient/community, physician/provider, and site/organizational influences, and identify new interventions to facilitate clinical trial enrollment. The symposium featured breakout sessions, plenary sessions, and a poster session including 100 abstracts. Among the 358 attendees were clinical investigators, researchers of accrual strategies, research administrators, nurses, research coordinators, patient advocates, and educators. A bibliography of the accrual literature in these three major areas was provided to participants in advance of the meeting. After the symposium, the literature in these areas was revisited to determine if the symposium recommendations remained relevant within the context of the current literature. Few rigorously conducted studies have tested interventions to address challenges to clinical trials accrual. Attendees developed recommendations for improving accrual and identified priority areas for future accrual research at the patient/community, physician/provider, and site/organizational levels. Current literature continues to support the symposium recommendations. A combination of approaches addressing both the multifactorial nature of accrual challenges and the characteristics of the target population may be needed to improve accrual to cancer clinical trials. Recommendations for best practices and for future research developed from the symposium are provided.

Motivational interviewing and the clinical science of Carl Rogers.

PubMed

Miller, William R; Moyers, Theresa B

2017-08-01

The clinical method of motivational interviewing (MI) evolved from the person-centered approach of Carl Rogers, maintaining his pioneering commitment to the scientific study of therapeutic processes and outcomes. The development of MI pertains to all 3 of the 125th anniversary themes explored in this special issue. Applications of MI have spread far beyond clinical psychology into fields including health care, rehabilitation, public health, social work, dentistry, corrections, coaching, and education, directly impacting the lives of many people. The public relevance and impact of clinical psychology are illustrated in the similarity of MI processes and outcomes across such diverse fields and the inseparability of human services from the person who provides them, in that both relational and technical elements of MI predict client outcomes. Within the history of clinical psychology MI is a clear product of clinical science, arising from the seminal work of Carl Rogers whose own research grounded clinical practice in empirical science. As with Rogers' work 70 years ago, MI began as an inductive empirical approach, observing clinical practice to develop and test hypotheses about what actually promotes change. Research on MI bridges the current divide between evidence-based practice and the well-established importance of therapeutic relationship. Research on training and learning of MI further questions the current model of continuing professional education through self-study and workshops as a way of improving practice behavior and client outcomes. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Rostral Anterior Cingulate Cortex Theta Current Density and Response to Antidepressants and Placebo in Major Depression

PubMed Central

Korb, Alexander S.; Hunter, Aimee M.; Cook, Ian A.; Leuchter, Andrew F.

2009-01-01

Objective To assess whether pretreatment theta current density in the rostral anterior cingulate (rACC) and medial orbitofrontal cortex (mOFC) differentiates responders from non-responders to antidepressant medication or placebo in a double-blinded study. Methods Pretreatment EEGs were collected from 72 subjects with Major Depressive Disorder (MDD) who participated in one of three placebo-controlled trials. Subjects were randomized to receive treatment with fluoxetine, venlafaxine, or placebo. Low-resolution brain electromagnetic tomography (LORETA) was used to assess theta current density in the rACC and mOFC. Results Medication responders showed elevated rACC and mOFC theta current density compared to medication non-responders (rACC: p=0.042; mOFC: p=0.039). There was no significant difference in either brain region between placebo responders and placebo non-responders. Conclusions Theta current density in the rACC and mOFC may be useful as a biomarker for prediction of response to antidepressant medication. Significance This is the first double-blinded treatment study to examine pretreatment rACC and mOFC theta current density in relation to antidepressant response and placebo response. Results support the potential clinical utility of this approach for predicting clinical outcome to antidepressant treatments in MDD. PMID:19539524

Pregabalin Modulation of Neurotransmitter Release Is Mediated by Change in Intrinsic Activation/Inactivation Properties of Cav2.1 Calcium ChannelsS⃞

PubMed Central

Di Guilmi, Mariano N.; Urbano, Francisco J.; Inchauspe, Carlota Gonzalez

2011-01-01

In this work, we studied the effects of the anticonvulsant and analgesic drug pregabalin (PGB) on excitatory postsynaptic currents (EPSCs) at principal neurons of the mouse medial nucleus of the trapezoid body and on presynaptic calcium currents at the calyx of Held. We found that the acute application of PGB reduced the amplitude of EPSCs in a dose-dependent manner with a maximal blocking effect of approximately 30%. A clinical high-concentration dose of PGB (e.g., 500 μM) blocked Cav2.1 channel-mediated currents and decreased their facilitation during a 100-Hz train, without changing their voltage-dependent activation. Furthermore, PGB also removed the inactivation of Cav2.1 channels at a clinically relevant low concentration of 100 μM. These results suggest novel modulatory mechanisms mediated by the acute administration of PGB on fast excitatory synaptic transmission and might contribute to better understanding PGB anticonvulsant/analgesic clinical effects. PMID:21177783

Advances in Progenitor Cell Therapy Using Scaffolding Constructs for Central Nervous System Injury

PubMed Central

Walker, Peter A.; Aroom, Kevin R.; Jimenez, Fernando; Shah, Shinil K.; Harting, Matthew T.; Gill, Brijesh S.

2010-01-01

Traumatic brain injury (TBI) is a major cause of morbidity and mortality in the United States. Current clinical therapy is focused on optimization of the acute/subacute intracerebral milieu, minimizing continued cell death, and subsequent intense rehabilitation to ameliorate the prolonged physical, cognitive, and psychosocial deficits that result from TBI. Adult progenitor (stem) cell therapies have shown promise in pre-clinical studies and remain a focus of intense scientific investigation. One of the fundamental challenges to successful translation of the large body of pre-clinical work is the delivery of progenitor cells to the target location/organ. Classically used vehicles such as intravenous and intra arterial infusion have shown low engraftment rates and risk of distal emboli. Novel delivery methods such as nanofiber scaffold implantation could provide the structural and nutritive support required for progenitor cell proliferation, engraftment, and differentiation. The focus of this review is to explore the current state of the art as it relates to current and novel progenitor cell delivery methods. PMID:19644777

Role of imaging in testicular cancer: current and future practice.

PubMed

Barrisford, Glen W; Kreydin, Evgeniy I; Preston, Mark A; Rodriguez, Dayron; Harisighani, Mukesh G; Feldman, Adam S

2015-09-01

The article provides a summary of the epidemiologic and clinical aspects of testicular malignancy. Current standard imaging and novel techniques are reviewed. Present data and clinical treatment trends have favored surveillance protocols over adjuvant radiation or chemotherapy for low-stage testicular malignancy. This has resulted in increasing numbers of imaging studies and the potential for increased long-term exposure risks. Understanding imaging associated risks as well as strategies to minimize these risks is of increasing importance. The development, validation and incorporation of alternative lower risk highly efficacious and cost-effective imaging techniques is essential.

A window on disease pathogenesis and potential therapeutic strategies: molecular imaging for arthritis

PubMed Central

2011-01-01

Novel molecular imaging techniques are at the forefront of both preclinical and clinical imaging strategies. They have significant potential to offer visualisation and quantification of molecular and cellular changes in health and disease. This will help to shed light on pathobiology and underlying disease processes and provide further information about the mechanisms of action of novel therapeutic strategies. This review explores currently available molecular imaging techniques that are available for preclinical studies with a focus on optical imaging techniques and discusses how current and future advances will enable translation into the clinic for patients with arthritis. PMID:21345267

Regenerative Chemical Biology: Current Challenges and Future Potential

PubMed Central

Ao, Ada; Hao, Jijun; Hong, Charles C.

2011-01-01

The enthusiasm surrounding the clinical potential of embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs) is tempered by the fact that key issues regarding their safety, efficacy, and long-term benefits have thus far been suboptimal. Small molecules can potentially relieve these problems at major junctions of stem cell biology and regenerative therapy. In this review, we will introduce recent advances in these important areas and the first-generation of small molecules used in the regenerative context. Current chemical biology studies will provide the archetype for future interdisciplinary collaborations, and improve clinical benefits of cell-based therapies. PMID:21513877

Use of platelet-rich plasma in the treatment of rotator cuff pathology. What has been scientifically proven?

PubMed

Miranda, I; Sánchez-Alepuz, E; Lucas, F J; Carratalá, V; González-Jofre, C A

To analyze the current scientific and/or clinical evidence supporting the use of platelet-rich plasma (PRP) in the treatment of rotator cuff pathology. After a systematic review in PubMed, studies assessing PRP efficacy in the treatment of rotator cuff pathology published since 2013 to date were identified. Data were grouped based on type of study (laboratory, clinical or meta-analysis); accordingly study design, pathology treated and clinical outcomes were summarized. Thirty five articles have been analyzed: 10 laboratory studies, 17 clinical assays and 8 meta-analyses. While laboratory studies report positive or partially positive results for the use of PRP, 70.6% of clinical studies and 75% of meta-analysis found no statistically significant differences between the PRP group and the control group. The positive results of laboratory studies do not translate well to clinical practice. There is no concordance among the few positive results reported in the clinical studies, and even some contradictory effects have been reported. There is no solid scientific and/or clinical evidence supporting the use of PRP in the treatment of rotator cuff pathology in routine clinical practice. Copyright © 2017 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.

Safety pharmacology — Current and emerging concepts

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

Hamdam, Junnat; Sethu, Swaminathan; Smith, Trevor

2013-12-01

Safety pharmacology (SP) is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials. SP studies are described in the International Conference on Harmonisation (ICH) S7A and S7B guidelines. The core battery and supplemental SP studies evaluate effects of a new chemical entity (NCE) at both anticipated therapeutic and supra-therapeutic exposures on major organ systems, including cardiovascular, central nervous, respiratory, renal and gastrointestinal. This review outlines the current practices and emerging concepts in SP studies including frontloading, parallel assessment of core battery studies, use of non-standard species, biomarkers, and combiningmore » toxicology and SP assessments. Integration of the newer approaches to routine SP studies may significantly enhance the scope of SP by refining and providing mechanistic insight to potential adverse effects associated with test compounds. - Highlights: • SP — mandatory non-clinical risk assessments performed during drug development. • SP organ system studies ensure the safety of clinical participants in FiH trials. • Frontloading in SP facilitates lead candidate drug selection. • Emerging trends: integrating SP-Toxicological endpoints; combined core battery tests.« less

How current Clinical Practice Guidelines for low back pain reflect Traditional Medicine in East Asian Countries: a systematic review of Clinical Practice Guidelines and systematic reviews.

PubMed

Cho, Hyun-Woo; Hwang, Eui-Hyoung; Lim, Byungmook; Heo, Kwang-Ho; Liu, Jian-Ping; Tsutani, Kiichiro; Lee, Myeong Soo; Shin, Byung-Cheul

2014-01-01

The aims of this study were to investigate whether there is a gap between evidence of traditional medicine (TM) interventions in East-Asian countries from the current Clinical Practice Guidelines (CPGs) and evidence from current systematic reviews and meta-analyses (SR-MAs) and to analyze the impact of this gap on present CPGs. We examined 5 representative TM interventions in the health care systems of East-Asian countries. We searched seven relevant databases for CPGs to identify whether core CPGs included evidence of TM interventions, and we searched 11 databases for SR-MAs to re-evaluate current evidence on TM interventions. We then compared the gap between the evidence from CPGs and SR-MAs. Thirteen CPGs and 22 SR-MAs met our inclusion criteria. Of the 13 CPGs, 7 CPGs (54%) mentioned TM interventions, and all were for acupuncture (only one was for both acupuncture and acupressure). However, the CPGs did not recommend acupuncture (or acupressure). Of 22 SR-MAs, 16 were for acupuncture, 5 for manual therapy, 1 for cupping, and none for moxibustion and herbal medicine. Comparing the evidence from CPGs and SR-MAs, an underestimation or omission of evidence for acupuncture, cupping, and manual therapy in current CPGs was detected. Thus, applying the results from the SR-MAs, we moderately recommend acupuncture for chronic LBP, but we inconclusively recommend acupuncture for (sub)acute LBP due to the limited current evidence. Furthermore, we weakly recommend cupping and manual therapy for both (sub)acute and chronic LBP. We cannot provide recommendations for moxibustion and herbal medicine due to a lack of evidence. The current CPGs did not fully reflect the evidence for TM interventions. As relevant studies such as SR-MAs are conducted and evidence increases, the current evidence on acupuncture, cupping, and manual therapy should be rigorously considered in the process of developing or updating the CPG system.

Advanced Practice Registered Nurses and Physician Assistants in Sleep Centers and Clinics: A Survey of Current Roles and Educational Background

PubMed Central

Colvin, Loretta; Cartwright, Ann; Collop, Nancy; Freedman, Neil; McLeod, Don; Weaver, Terri E.; Rogers, Ann E.

2014-01-01

Study Objectives: To survey Advanced Practice Registered Nurse (APRN) and Physician Assistant (PA) utilization, roles and educational background within the field of sleep medicine. Methods: Electronic surveys distributed to American Academy of Sleep Medicine (AASM) member centers and APRNs and PAs working within sleep centers and clinics. Results: Approximately 40% of responding AASM sleep centers reported utilizing APRNs or PAs in predominantly clinical roles. Of the APRNs and PAs surveyed, 95% reported responsibilities in sleep disordered breathing and more than 50% in insomnia and movement disorders. Most APRNs and PAs were prepared at the graduate level (89%), with sleep-specific education primarily through “on the job” training (86%). All APRNs surveyed were Nurse Practitioners (NPs), with approximately double the number of NPs compared to PAs. Conclusions: APRNs and PAs were reported in sleep centers at proportions similar to national estimates of NPs and PAs in physicians' offices. They report predominantly clinical roles, involving common sleep disorders. Given current predictions that the outpatient healthcare structure will change and the number of APRNs and PAs will increase, understanding the role and utilization of these professionals is necessary to plan for the future care of patients with sleep disorders. Surveyed APRNs and PAs reported a significant deficiency in formal and standardized sleep-specific education. Efforts to provide formal and standardized educational opportunities for APRNs and PAs that focus on their clinical roles within sleep centers could help fill a current educational gap. Citation: Colvin L, Cartwright Ann, Collop N, Freedman N, McLeod D, Weaver TE, Rogers AE. Advanced practice registered nurses and physician assistants in sleep centers and clinics: a survey of current roles and educational background. J Clin Sleep Med 2014;10(5):581-587. PMID:24812545

The AMIGO Clinical Study: Attrition Rates Among Military Beneficiaries Undergoing Intensive Group Outpatient Pre-Diabetes Care

DTIC Science & Technology

2013-11-11

or lactating  Patients with untreated hypothyroidism or previously diagnosed Cushing’s syndrome  Patients currently taking metformin or...screening  Age គ years old  Women who are currently (or within past 6-weeks) pregnant or lactating  Patients with untreated hypothyroidism or

Potential effects of current drug therapies on cognitive impairment in patients with type 2 diabetes.

PubMed

Palleria, Caterina; Leporini, Christian; Maida, Francesca; Succurro, Elena; De Sarro, Giovambattista; Arturi, Franco; Russo, Emilio

2016-07-01

Type 2 diabetes mellitus is a complex metabolic disease that can cause serious damage to various organs. Among the best-known complications, an important role is played by cognitive impairment. Impairment of cognitive functioning has been reported both in type 1 and 2 diabetes mellitus. While this comorbidity has long been known, no major advances have been achieved in clinical research; it is clear that appropriate control of blood glucose levels represents the best current (although unsatisfactory) approach in the prevention of cognitive impairment. We have focused our attention on the possible effect on the brain of antidiabetic drugs, despite their effects on blood glucose levels, giving a brief rationale on the mechanisms (e.g. GLP-1, BDNF, ghrelin) that might be involved. Indeed, GLP-1 agonists are currently clinically studied in other neurodegenerative diseases (i.e. Parkinson's and Alzheimer's disease); furthermore, also other antidiabetic drugs have proven efficacy in preclinical studies. Overall, promising results are already available and finding new intervention strategies represents a current need in this field of research. Copyright © 2016 Elsevier Inc. All rights reserved.

Multidisciplinary acute care research organization (MACRO): if you build it, they will come.

PubMed

Early, Barbara J; Huang, David T; Callaway, Clifton W; Zenati, Mazen; Angus, Derek C; Gunn, Scott R; Yealy, Donald M; Unikel, Daniel; Billiar, Timothy R; Peitzman, Andrew B; Sperry, Jason L

2013-07-01

Clinical research will increasingly play a core role in the evolution and growth of acute care surgery program development across the country. What constitutes an efficient and effective clinical research infrastructure in the current fiscal and academic environment remains obscure. We sought to characterize the effects of implementation of a multidisciplinary acute care research organization (MACRO) at a busy tertiary referral university setting. In 2008, to minimize redundancy and cost as well as to maximize existing resources promoting acute care research, MACRO was created, unifying clinical research infrastructure among the Departments of Critical Care Medicine, Emergency Medicine, and Surgery. During the periods 2008 to 2012, we performed a retrospective analysis and determined volume of clinical studies, patient enrollment for both observational and interventional trials, and staff growth since MACRO's origination and characterized changes over time. From 2008 to 2011, the volume of patients enrolled in clinical studies, which MACRO facilitates has significantly increased more than 300%. The percentage of interventional/observational trials has remained stable during the same period (50-60%). Staff has increased from 6 coordinators to 10, with an additional 15 research associates allowing 24/7 service. With this significant growth, MACRO has become financially self-sufficient, and additional outside departments now seek MACRO's services. Appropriate organization of acute care clinical research infrastructure minimizes redundancy and can promote sustainable, efficient growth in the current academic environment. Further studies are required to determine if similar models can be successful at other acute care surgery programs.

Participant verification: prevention of co-enrolment in clinical trials in South Africa.

PubMed

Harichund, C; Haripersad, K; Ramjee, R

2013-05-15

As KwaZulu-Natal Province is the epicentre of the HIV epidemic in both South Africa (SA) and globally, it is an ideal location to conduct HIV prevention and therapeutic trials. Numerous prevention trials are currently being conducted here; the potential for participant co-enrolment may compromise the validity of these studies and is therefore of great concern. To report the development and feasibility of a digital, fingerprint-based participant identification method to prevent co-enrolment at multiple clinical trial sites. The Medical Research Council (MRC) HIV Prevention Research Unit (HPRU) developed the Biometric Co-enrolment Prevention System (BCEPS), which uses fingerprint-based biometric technology to identify participants. A trial website was used to determine the robustness and usability of the system. After successful testing, the BCEPS was piloted in July 2010 across 7 HPRU clinical research sites. The BCEPS was pre-loaded with study names and clinical trial sites, with new participant information loaded at first visit to a trial site. We successfully implemented the BCEPS at the 7 HPRU sites. Using the BCEPS, we performed real-time 'flagging' of women who were already enrolled in another study as they entered a trial at an HPRU site and, where necessary, excluded them from participation on site. This system has promise in reducing co-enrolment in clinical trials and represents a valuable tool for future implementation by all groups conducting trials. The MRC is currently co-ordinating this effort with clinical trial sites nationally.

Feedback in Clinical Education, Part I: Characteristics of Feedback Provided by Approved Clinical Instructors

PubMed Central

Nottingham, Sara; Henning, Jolene

2014-01-01

Context Providing students with feedback is an important component of athletic training clinical education; however, little information is known about the feedback that Approved Clinical Instructors (ACIs; now known as preceptors) currently provide to athletic training students (ATSs). Objective To characterize the feedback provided by ACIs to ATSs during clinical education experiences. Design Qualitative study. Setting One National Collegiate Athletic Association Division I athletic training facility and 1 outpatient rehabilitation clinic that were clinical sites for 1 entry-level master's degree program accredited by the Commission on Accreditation of Athletic Training Education. Patients or Other Participants A total of 4 ACIs with various experience levels and 4 second-year ATSs. Data Collection and Analysis Extensive field observations were audio recorded, transcribed, and integrated with field notes for analysis. The constant comparative approach of open, axial, and selective coding was used to inductively analyze data and develop codes and categories. Member checking, triangulation, and peer debriefing were used to promote trustworthiness of the study. Results The ACIs gave 88 feedback statements in 45 hours and 10 minutes of observation. Characteristics of feedback categories included purpose, timing, specificity, content, form, and privacy. Conclusions Feedback that ACIs provided included several components that made each feedback exchange unique. The ACIs in our study provided feedback that is supported by the literature, suggesting that ACIs are using current recommendations for providing feedback. Feedback needs to be investigated across multiple athletic training education programs to gain more understanding of certain areas of feedback, including frequency, privacy, and form. PMID:24143902

Adjuvant bisphosphonate treatment for breast cancer: Where are we heading and can the pre-clinical literature help us get there?

PubMed

Russell, Kent; Clemons, Mark; Costa, Luis; Addison, Christina L

2012-06-01

Bisphosphonates have demonstrated anti-tumour activity in preclinical studies of bone metastatic disease, thus it was natural to transition these agents into the adjuvant cancer therapy setting. Surprisingly, the results of adjuvant breast cancer trials have shown either modest to no benefit or even harm. We sought to explore whether the preclinical results supporting bisphosphonate use provided clues to help explain the current clinical data. Interestingly, the majority of preclinical data suggested that bisphosphonate treatment was more efficacious when administered after the establishment of osseous metastases. This is similar to the findings of one clinical study whereby patients with biopsy evidence of osseous micrometastases derive greater survival benefit from bisphosphonate treatment. Another clinical study found bisphosphonates were associated with increased incidence of visceral metastases, similar to what has been previously published in preclinical models using "preventative" dosing strategies. While the current clinical data suggest bisphosphonates may be more efficacious in post-menopausal or oestrogen depleted patients, or those with hormone receptor positive tumours, to date no appropriately designed preclinical studies have evaluated these effects. Furthermore, putative mechanisms that regulate response to bisphosphonates in other tumour types remain to be evaluated in breast cancer. Despite the initial optimism regarding adjuvant bisphosphonate therapy, the conflicting clinical results from large trials suggest that we should return to the bench to further investigate factors that may influence response to bisphosphonate treatment or identify appropriate characteristics that would indicate the sub-groups of patients most likely to benefit from bisphosphonate treatment.

Graduate admissions in clinical neuropsychology: the importance of undergraduate training.

PubMed

Karazsia, Bryan T; Stavnezer, Amy Jo; Reeves, Jonathan W

2013-11-01

Discussions of and recommendations for the training of clinical neuropsychologists exist at the doctoral, internship, and post-doctoral level. With few exceptions, the literature on undergraduate preparations in clinical neuropsychology is sparse and lacks empirical evidence. In the present study, graduate-level faculty and current trainees completed surveys about graduate school preparations. Faculty expectations of minimum and ideal undergraduate training were highest for research methods, statistics, and assessment. Preferences for "goodness of fit" also emerged as important admissions factors. These results offer evidence for desirable undergraduate preparations for advanced study in clinical neuropsychology. Although undergraduate training in psychology is intentionally broad, results from this study suggest that students who desire advanced study in clinical neuropsychology need to tailor their experiences to be competitive in the application process. The findings have implications for prospective graduate students, faculty who train and mentor undergraduates, and faculty who serve on admissions committees.

Patient characteristics driving clinical utility in psychiatric pharmacogenetics: a reanalysis from the AB-GEN multicentric trial.

PubMed

Menchón, J M; Espadaler, J; Tuson, M; Saiz-Ruiz, J; Bobes, J; Vieta, E; Álvarez, E; Pérez, V

2018-05-04

Clinical utility of commercial multi-gene pharmacogenetic tests in depression is starting to be studied with some promising results on efficacy and tolerability. Among the next steps is the definition of the patient profile that is most likely to benefit from testing. Here we present a reanalysis of data from the AB-GEN randomized clinical trial showing that clinical utility of pharmacogenetic testing can be markedly influenced by patient characteristics such as age, baseline severity and duration of current depressive episode.Trial registration ClinicalTrials.gov NCT02529462.

Robotics in invasive cardiac electrophysiology.

PubMed

Shurrab, Mohammed; Schilling, Richard; Gang, Eli; Khan, Ejaz M; Crystal, Eugene

2014-07-01

Robotic systems allow for mapping and ablation of different arrhythmia substrates replacing hand maneuvering of intracardiac catheters with machine steering. Currently there are four commercially available robotic systems. Niobe magnetic navigation system (Stereotaxis Inc., St Louis, MO) and Sensei robotic navigation system (Hansen Medical Inc., Mountain View, CA) have an established platform with at least 10 years of clinical studies looking at their efficacy and safety. AMIGO Remote Catheter System (Catheter Robotics, Inc., Mount Olive, NJ) and Catheter Guidance Control and Imaging (Magnetecs, Inglewood, CA) are in the earlier phases of implementations with ongoing feasibility and some limited clinical studies. This review discusses the advantages and limitations related to each existing system and highlights the ideal futuristic robotic system that may include the most promising features of the current ones.

Transcatheter Aortic Valve Implantation: Experience with the CoreValve Device.

PubMed

Asgar, Anita W; Bonan, Raoul

2012-01-01

The field of transcatheter aortic valve implantation has been rapidly evolving. The Medtronic CoreValve first emerged on the landscape in 2004 with initial first human studies, and it is currently being studied in the Pivotal US trial. This article details the current experience with the self-expanding aortic valve with a focus on clinical results and ongoing challenges. Copyright © 2012 Elsevier Inc. All rights reserved.

Management of Current Psychiatric Disorders

PubMed Central

Carbonnel, François; David, Michel; Norton, Joanna; Bourrel, Gérard; Boulenger, Jean-Philippe; Capdevielle, Delphine

2016-01-01

Objective: Describe and analyse the experience of family physicians in managing current psychiatric disorders to obtain a better understanding of the underlying reasons of under-detection and inadequate prescribing identified in studies. Methods: A qualitative study using in-depth interviews. Sample of 15 practicing family physicians, recruited by telephone from a precedent cohort (Sesame1) with a maximum variation: sex, age, single or group practice, urban or rural. Qualitative method is inspired by the completed grounded theory of a verbatim semiopragmatic analysis from 2 experts in this approach. Results: Family physicians found that current psychiatric disorders were related to psychological symptoms in reaction to life events. Their role was to make patients aware of a psychiatric symptom rather than establish a diagnosis. Their management responsibility was considered in contrasting ways: it was claimed or endured. They defined their position as facilitating compliance to psychiatrist consultations, while assuring a complementary psychotherapeutic approach. Prescribing medication was not a priority for them. Conclusions: The identified under-detection is essentially due to inherent frontline conditions and complexity of clinical forms. The family physician role, facilitating compliance to psychiatrist consultations while assuring a support psychotherapy is the main result of this study. More studies should be conducted to define more accurately the clinical reality, management and course of current psychiatric disorders in primary care.

Cutaneous T cell lymphoma: Current practices in blood assessment and the utility of T-cell receptor Vβ chain restriction

PubMed Central

Gibson, Juliet F; Huang, Jing; Liu, Kristina J; Carlson, Kacie R; Foss, Francine; Choi, Jaehyuk; Edelson, Richard; Hussong, Jerry W.; Mohl, Ramsey; Hill, Sally; Girardi, Sally

2016-01-01

Background Accurate quantification of malignant cells in the peripheral blood of patients with cutaneous T cell lymphoma (CTCL) is important for early detection, prognosis, and monitoring disease burden. Objective Determine the spectrum of current clinical practices; critically evaluate elements of current ISCL B1 and B2 staging criteria; and assess the potential role of TCR-Vβ analysis by flow cytometry. Methods We assessed current clinical practices by survey, and performed a retrospective analysis of 161 patients evaluated at Yale (2011-2014) to compare the sensitivity, specificity, PPV, and NPV of parameters for ISCL B2 staging. Results There was heterogeneity in clinical practices among institutions. ISCL B1 criteria did not capture five Yale cohort patients with immunophenotypic abnormalities who later progressed. TCR-Vβ testing was more specific than PCR and aided diagnosis in detecting clonality, but was of limited benefit in quantification of tumor burden. Limitations Because of limited follow-up involving a single center, further investigation will be necessary to conclude whether our proposed diagnostic algorithm is of general clinical benefit. Conclusion We propose further study of “modified B1 criteria”: CD4/CD8 ratio ≥5, %CD4+/CD26- ≥ 20%, %CD4+/CD7- ≥ 20%, with evidence of clonality. TCR-Vβ testing should be considered in future diagnostic and staging algorithms. PMID:26874819

The impact of sperm DNA damage in assisted conception and beyond: recent advances in diagnosis and treatment.

PubMed

Lewis, Sheena E M; John Aitken, R; Conner, Sarah J; Iuliis, Geoffry De; Evenson, Donald P; Henkel, Ralph; Giwercman, Aleksander; Gharagozloo, Parviz

2013-10-01

Sperm DNA damage is a useful biomarker for male infertility diagnosis and prediction of assisted reproduction outcomes. It is associated with reduced fertilization rates, embryo quality and pregnancy rates, and higher rates of spontaneous miscarriage and childhood diseases. This review provides a synopsis of the most recent studies from each of the authors, all of whom have major track records in the field of sperm DNA damage in the clinical setting. It explores current laboratory tests and the accumulating body of knowledge concerning the relationship between sperm DNA damage and clinical outcomes. The paper proceeds to discuss the strengths, weaknesses and clinical applicability of current sperm DNA tests. Next, the biological significance of DNA damage in the male germ line is considered. Finally, as sperm DNA damage is often the result of oxidative stress in the male reproductive tract, the potential contribution of antioxidant therapy in the clinical management of this condition is discussed. DNA damage in human spermatozoa is an important attribute of semen quality. It should be part of the clinical work up and properly controlled trials addressing the effectiveness of antioxidant therapy should be undertaken as a matter of urgency. Sperm DNA damage is a useful biomarker for male infertility diagnosis and prediction of assisted reproduction outcomes. It is associated with reduced fertilization rates, embryo quality and pregnancy rates, and higher rates of spontaneous miscarriage and childhood diseases. With all of these fertility check points, it shows more promise than conventional semen parameters from a diagnostic perspective. Despite this, few infertility clinics use it routinely. This review provides a synopsis of the most recent studies from each of the authors, all of whom have major track records in the field of sperm DNA damage in the clinical setting. It explores current laboratory tests and the accumulating body of knowledge concerning the relationship between sperm DNA damage and clinical outcomes. The paper proceeds to discuss the strengths and weaknesses and clinical applicability of current sperm DNA fragmentation tests. Next, the biological significance of DNA damage in the male germ line is considered. Finally, as sperm DNA damage is often the result of increased oxidative stress in the male reproductive tract, the potential contribution of antioxidant therapy in the clinical management of this condition is discussed. As those working in this field of clinical research, we conclude that DNA damage in human spermatozoa is an important attribute of semen quality which should be carefully assessed in the clinical work up of infertile couples and that properly controlled trials addressing the effectiveness of antioxidant therapy should be undertaken as a matter of urgency. Copyright © 2013 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Alzheimer’s Disease Drug Development in 2008 and Beyond: Problems and Opportunities

PubMed Central

Becker, Robert E.; Greig, Nigel H.

2008-01-01

Recently, a number of Alzheimer’s disease (AD) multi-center clinical trials (CT) have failed to provide statistically significant evidence of drug efficacy. To test for possible design or execution flaws we analyzed in detail CTs for two failed drugs that were strongly supported by preclinical evidence and by proven CT AD efficacy for other drugs in their class. Studies of the failed commercial trials suggest that methodological flaws may contribute to the failures and that these flaws lurk within current drug development practices ready to impact other AD drug development [1]. To identify and counter risks we considered the relevance to AD drug development of the following factors: (1) effective dosing of the drug product, (2) reliable evaluations of research subjects, (3) effective implementation of quality controls over data at research sites, (4) resources for practitioners to effectively use CT results in patient care, (5) effective disease modeling, (6) effective research designs. New drugs currently under development for AD address a variety of specific mechanistic targets. Mechanistic targets provide AD drug development opportunities to escape from many of the factors that currently undermine AD clinical pharmacology, especially the problems of inaccuracy and imprecision associated with using rated outcomes. In this paper we conclude that many of the current problems encountered in AD drug development can be avoided by changing practices. Current problems with human errors in clinical trials make it difficult to differentiate drugs that fail to evidence efficacy from apparent failures due to Type II errors. This uncertainty and the lack of publication of negative data impede researchers’ abilities to improve methodologies in clinical pharmacology and to develop a sound body of knowledge about drug actions. We consider the identification of molecular targets as offering further opportunities for overcoming current failures in drug development. PMID:18690832

Clinical potential of implantable wireless sensors for orthopedic treatments.

PubMed

Karipott, Salil Sidharthan; Nelson, Bradley D; Guldberg, Robert E; Ong, Keat Ghee

2018-04-01

Implantable wireless sensors have been used for real-time monitoring of chemicals and physical conditions of bones, tendons and muscles to diagnose and study orthopedic diseases and injuries. Due to the importance of these sensors in orthopedic care, a critical review, which not only analyzes the underlying technologies but also their clinical implementations and challenges, will provide a landscape view on their current state and their future clinical role. Areas covered: By conducting an extensive literature search and following the leaders of orthopedic implantable wireless sensors, this review covers the battery-powered and battery-free wireless implantable sensor technologies, and describes their implementation for hips, knees, spine, and shoulder stress/strain monitoring. Their advantages, limitations, and clinical challenges are also described. Expert commentary: Currently, implantable wireless sensors are mostly limited for scientific investigations and demonstrative experiments. Although rapid advancement in sensors and wireless technologies will push the reliability and practicality of these sensors for clinical realization, regulatory constraints and financial viability in medical device industry may curtail their continuous adoption for clinical orthopedic applications. In the next five years, these sensors are expected to gain increased interest from researchers, but wide clinical adoption is still unlikely.

Practices in habilitation of pediatric recipients of cochlear implants in India: A survey.

PubMed

Jeyaraman, Janani

2013-01-01

Cochlear implant (CI) (re)habilitation programs are long-term processes, with many factors contributing to the overall success. The clinics in India that are working toward pediatric CI habilitation vary in their team philosophy, clinical practices, and service delivery. It is important to explore their clinical perspectives and practices to appreciate their current state and suggest directions for improvement in the future. The objective of the study was to characterize the current status and clinical practices of the pediatric CI programs in India. Twenty-two clinics involved in the pediatric CI habilitation program across India participated in the survey. The heads of the CI teams of the participant clinics completed a validated survey questionnaire containing multiple-choice and open-ended questions on the details of the CI habilitation team, assessment and therapy protocols used, and other related clinical services. The categorical data obtained were analyzed using descriptive statistical measures. The interpretation of results indicated a need to focus future discussions on early identification and management of hearing impairment, funding for CIs, continuing education programs for professionals, decision processes for providing CIs for children with multiple concerns, choice of language(s) of instruction, assessment protocols used, and outreach/consultation services.

The current status of clinical trials focusing on nasopharyngeal carcinoma: A comprehensive analysis of ClinicalTrials.gov database.

PubMed

Peng, Hao; Chen, Lei; Chen, Yu-Pei; Li, Wen-Fei; Tang, Ling-Long; Lin, Ai-Hua; Sun, Ying; Ma, Jun

2018-01-01

Clinical Trials have emerged as the main force in driving the development of medicine. However, little is known about the current status of clinical trials regarding nasopharyngeal carcinoma (NPC). This study aimed at providing a comprehensive landscape of NPC-related trials on the basis of ClinicalTrials.gov database. We used the keyword "nasopharyngeal carcinoma" to search the ClinicalTrials.gov database and assessed the characteristics of these trials. Up to December 30, 2016, 462 eligible trials in total were identified, of which 222 (48.0%) recruited only NPC (NPC trials) and the other 240 (52.0%) recruited both NPC and other cancers (multiple cancer trials). Moreover, 47 (10.2%) were Epstein-Barr virus (EBV)-related trials and 267 (57.8%) focused on metastatic/recurrent disease. Compared with NPC trials, the multiple cancer trials had a higher percentage of phase 1 (26.7% vs. 6.7%, P < 0.001) studies and more patients with metastatic/recurrent disease (72.5% vs. 41.9%, P < 0.001). Notably, non-EBV trials had more phase 2 or 3 (78.4% vs. 48.8%, P < 0.001) and interventional studies (89.5% vs. 70.7%, P = 0.002) than EBV trials. Obviously, more phase 2/3 or 3 trials were conducted in patients with non-metastatic/recurrent disease (29.4% vs. 4.9%, P < 0.001); however, metastatic/recurrent trials were more likely to be anticancer (94.6% vs. 63.6%, P < 0.001). The role of plasma EBV DNA in clinical trials is underestimated, and high-level randomized clinical trials should be performed for patients with metastatic/recurrent disease.

Perceived knowledge and clinical comfort with genetics among Taiwanese nurses enrolled in a RN-to-BSN program.

PubMed

Hsiao, Chiu-Yueh; Lee, Shu-Hsin; Chen, Suh-Jen; Lin, Shu-Chin

2013-08-01

Advances in genetics have had a profound impact on health care. Yet, many nurses, as well as other health care providers, have limited genetic knowledge and feel uncomfortable integrating genetics into their practice. Very little is known about perceived genetic knowledge and clinical comfort among Taiwanese nurses enrolled in a Registered Nurse to Bachelor of Science in Nursing program. To examine perceived knowledge and clinical comfort with genetics among Taiwanese nurses enrolled in a Registered Nurse to Bachelor of Science in Nursing program and to assess how genetics has been integrated into their past and current nursing programs. The study also sought to examine correlations among perceived knowledge, integration of genetics into the nursing curriculum, and clinical comfort with genetics. A descriptive, cross-sectional study. Taiwanese nurses enrolled in a Registered Nurse to Bachelor of Science in Nursing program were recruited. A total of 190 of 220 nurses returned the completed survey (86.36% response rate). Descriptive statistics and the Pearson product-moment correlation were used for data analysis. Most nurses indicated limited perceived knowledge and clinical comfort with genetics. Curricular hours focused on genetics in a current nursing program were greater than those in past nursing programs. The use of genetic materials, attendance at genetic workshops and conferences, and clinically relevant genetics in nursing practice significantly related with perceived knowledge and clinical comfort with genetics. However, there were no correlations between prior genetic-based health care, perceived knowledge, and clinical comfort with genetics. This study demonstrated the need for emphasizing genetic education and practice to ensure health-related professionals become knowledgeable about genetic information. Given the rapidly developing genetic revolution, nurses and other health care providers need to utilize genetic discoveries to optimize health outcomes. Copyright © 2012 Elsevier Ltd. All rights reserved.

Current and Emerging Technology Approaches in Genomics

PubMed Central

Conley, Yvette P.; Biesecker, Leslie G.; Gonsalves, Stephen; Merkle, Carrie J.; Kirk, Maggie; Aouizerat, Bradley E.

2013-01-01

Purpose To introduce current and emerging approaches that are being utilized in the field of genomics so the reader can conceptually evaluate the literature and appreciate how these approaches are advancing our understanding of health-related issues. Organizing Construct Each approach is described and includes information related to how it is advancing research, its potential clinical utility, exemplars of current uses, challenges related to technologies used for these approaches, and when appropriate information related to understanding the evidence base for clinical utilization of each approach is provided. Web-based resources are included for the reader who would like more in-depth information and to provide opportunity to stay up to date with these approaches and their utility. Conclusions The chosen approaches– genome sequencing, genome-wide association studies, epigenomics, and gene expression– are extremely valuable approaches for collecting research data to help us better understand the pathophysiology of a variety of health-related conditions, but they are also gaining in utility for clinical assessment and testing purposes. Clinical Relevance Our increased understanding of the molecular underpinnings of disease will assist with better development of screening tests, diagnostic tests, tests that allow us to prognosticate, tests that allow for individualized treatments, and tests to facilitate post-treatment surveillance. PMID:23294727

Physicians' Current Practices and Opportunities for DNA Banking of Dying Patients With Cancer

PubMed Central

Quillin, John M.; Bodurtha, Joann N.; Siminoff, Laura A.; Smith, Thomas J.

2011-01-01

Purpose: The availability of genetic tests for cancer susceptibility is increasing. Current tests, however, have limited clinical sensitivity. Even when clinically valid tests are available, the genetic counseling and informed consent process might not be feasible for dying patients with cancer. DNA banking preserves the opportunity for future research or clinical testing and may provide critical opportunities for surviving relatives. This study explored the current practices and potential for DNA banking for cancer susceptibility among oncologists specializing in palliative care. Methods: Palliative care oncologists actively providing clinical care for dying patients with cancer were recruited for an online survey. Descriptive statistics for DNA banking practices, perceived qualification to recommend banking, and potential predictors were assessed. Results: Data were collected from 49 physicians (37% recruitment rate). Eighty percent reported assessing at least some patients for genetic cancer susceptibility in the past 12 months. No participants reported banking DNA for patients in the past 12 months. Only 5% reported feeling at least somewhat qualified to order DNA banking. A Web-based risk assessment tool and genetic counselor on staff were perceived as the most helpful potential resources. Conclusion: Despite its potential, DNA banking is not being used by palliative care oncologists. PMID:21886501

Photodynamic therapy (PDT) and photodiagnosis (PD) using endogenous photosensitization induced by 5-aminolevulinic acid (ALA): current clinical and development status

NASA Astrophysics Data System (ADS)

Marcus, Stuart L.; Sobel, Russel S.; Golub, Allyn L.; Carroll, Ronald L.; Lundahl, Scott L.; Shulman, D. Geoffrey

1996-04-01

Exogenous provision of ALA to many tissues results in the accumulation of sufficient quantities of the endogenous photosensitizer protoporphyrin IX, (PpIX), to produce a photodynamic effect. Therefore, ALA may be considered the only current PDT agent in clinical development which is a biochemical precursor of a photosensitizer. Topical ALA application, followed by exposure to activating light (ALA PDT), has been reported effective for the treatment of a variety of dermatologic diseases including cutaneous T-cell lymphoma, superficial basal cell carcinoma, Bowen's disease, and actinic (solar) keratoses, and is also being examined for treatment of acne and hirsutism. PpIX induced by ALA application also may serve as a fluorescence detection marker for photodiagnosis (PD) of malignant and pre- malignant conditions of the urinary bladder and other organs. Local internal application of ALA has also been used for selective endometrial ablation in animal model systems and is beginning to be examined in human clinical studies. Systemic, oral administration of ALA has been used for ALA PDT of superficial head and neck cancer, various gastrointestinal cancers, and the condition known as Barrett's esophagus. This brief paper reviews the current clinical and development status of ALA PDT.

Reference intervals: current status, recent developments and future considerations.

PubMed

Ozarda, Yesim

2016-01-01

Reliable and accurate reference intervals (RIs) for laboratory analyses are an integral part of the process of correct interpretation of clinical laboratory test results. RIs given in laboratory reports have an important role in aiding the clinician in interpreting test results in reference to values for healthy populations. Since the 1980s, the International Federation of Clinical Chemistry (IFCC) has been proactive in establishing recommendations to clarify the true significance of the term 'RIs, to select the appropriate reference population and statistically analyse the data. The C28-A3 guideline published by the Clinical and Laboratory Standards Institute (CLSI) and IFCC is still the most widely-used source of reference in this area. In recent years, protocols additional to the Guideline have been published by the IFCC, Committee on Reference Intervals and Decision Limits (C-RIDL), including all details of multicenter studies on RIs to meet the requirements in this area. Multicentric RIs studies are the most important development in the area of RIs. Recently, the C-RIDL has performed many multicentric studies to obtain common RIs. Confusion of RIs and clinical decision limits (CDLs) remains an issue and pediatric and geriatric age groups are a significant problem. For future studies of RIs, the genetic effect would seem to be the most challenging area. 
The aim of the review is to present the current theory and practice of RIs, with special emphasis given to multicenter RIs studies, RIs studies for pediatric and geriatric age groups, clinical decision limits and partitioning by genetic effects on RIs.

Reference intervals: current status, recent developments and future considerations

PubMed Central

Ozarda, Yesim

2016-01-01

Reliable and accurate reference intervals (RIs) for laboratory analyses are an integral part of the process of correct interpretation of clinical laboratory test results. RIs given in laboratory reports have an important role in aiding the clinician in interpreting test results in reference to values for healthy populations. Since the 1980s, the International Federation of Clinical Chemistry (IFCC) has been proactive in establishing recommendations to clarify the true significance of the term ‘RIs, to select the appropriate reference population and statistically analyse the data. The C28-A3 guideline published by the Clinical and Laboratory Standards Institute (CLSI) and IFCC is still the most widely-used source of reference in this area. In recent years, protocols additional to the Guideline have been published by the IFCC, Committee on Reference Intervals and Decision Limits (C-RIDL), including all details of multicenter studies on RIs to meet the requirements in this area. Multicentric RIs studies are the most important development in the area of RIs. Recently, the C-RIDL has performed many multicentric studies to obtain common RIs. Confusion of RIs and clinical decision limits (CDLs) remains an issue and pediatric and geriatric age groups are a significant problem. For future studies of RIs, the genetic effect would seem to be the most challenging area.
The aim of the review is to present the current theory and practice of RIs, with special emphasis given to multicenter RIs studies, RIs studies for pediatric and geriatric age groups, clinical decision limits and partitioning by genetic effects on RIs. PMID:26981015

Nursing Students' Opinion on the Use of Smartphone Applications (Apps) in Clinical Education and Training: A Study Protocol.

PubMed

O'Connor, Siobhan; Andrews, Tom

2016-01-01

Nurse educators are exploring different mobile technologies to provide additional support to nursing students in clinical practice. However, the view of nursing students on the use of smartphone applications (apps) to enhance clinical education has not been explored. This proposed study will use a self-reported questionnaire to examine the opinions of nursing students on the current and potential use of smartphone apps when training in clinical settings. Descriptive and inferential statistics will be performed on the quantitative data. Qualitative data from open ended questions will be thematically analysed using the framework approach. This will be the first study to examine the use of smartphone apps as a support in clinical teaching from a students' perspective. Their opinion is vital if the right mobile technology is to be designed and implemented.

Practical Considerations for Clinical PET/MR Imaging.

PubMed

Galgano, Samuel; Viets, Zachary; Fowler, Kathryn; Gore, Lael; Thomas, John V; McNamara, Michelle; McConathy, Jonathan

2018-01-01

Clinical PET/MR imaging is currently performed at a number of centers around the world as part of routine standard of care. This article focuses on issues and considerations for a clinical PET/MR imaging program, focusing on routine standard-of-care studies. Although local factors influence how clinical PET/MR imaging is implemented, the approaches and considerations described here intend to apply to most clinical programs. PET/MR imaging provides many more options than PET/computed tomography with diagnostic advantages for certain clinical applications but with added complexity. A recurring theme is matching the PET/MR imaging protocol to the clinical application to balance diagnostic accuracy with efficiency. Copyright © 2017 Elsevier Inc. All rights reserved.

[Progress in methodological characteristics of clinical practice guideline for osteoarthritis].

PubMed

Xing, D; Wang, B; Lin, J H

2017-06-01

At present, several clinical practice guidelines for the treatment of osteoarthritis have been developed by institutes or societies. The ultimate purpose of developing clinical practice guidelines is to formulate the process in the treatment of osteoarthritis effectively. However, the methodologies used in developing clinical practice guidelines may place an influence on the transformation and application of that in treating osteoarthritis. The present study summarized the methodological features of individual clinical practice guideline and presented the tools for quality evaluation of clinical practice guideline. The limitations of current osteoarthritis guidelines of China are also indicated. The review article might help relevant institutions improve the quality in developing guide and clinical transformation.

Practical Considerations for Clinical PET/MR Imaging.

PubMed

Galgano, Samuel; Viets, Zachary; Fowler, Kathryn; Gore, Lael; Thomas, John V; McNamara, Michelle; McConathy, Jonathan

2017-05-01

Clinical PET/MR imaging is currently performed at a number of centers around the world as part of routine standard of care. This article focuses on issues and considerations for a clinical PET/MR imaging program, focusing on routine standard-of-care studies. Although local factors influence how clinical PET/MR imaging is implemented, the approaches and considerations described here intend to apply to most clinical programs. PET/MR imaging provides many more options than PET/computed tomography with diagnostic advantages for certain clinical applications but with added complexity. A recurring theme is matching the PET/MR imaging protocol to the clinical application to balance diagnostic accuracy with efficiency. Copyright © 2016 Elsevier Inc. All rights reserved.

Learning about an Undiagosed Condition in an Adult

MedlinePlus

... of the public with current information on clinical research studies. For example, the study entitled "Studies of Children with Metabolic and Other Genetic Diseases" evaluates individuals of all ages (despite its title) with known or suspected genetic diseases. You can ...

Aged erythrocytes: a fine wine or sour grapes?

PubMed

Cohen, B; Matot, I

2013-12-01

Blood transfusion saves many lives but carries significant risk of injury. Currently, red blood cell (RBC) concentrates can be stored up to 42 days. Concerns have recently been raised about the safety and efficacy of transfusing stored RBCs. Refrigerated storage results in a 'storage lesion' that is reflected by metabolic derangements, RBC shape modification, rheological changes, oxidative injury to lipids and proteins, alterations in oxygen affinity and delivery, increased adhesion of RBCs to endothelial cells, and accumulation of bioactive substances in storage media. In animal models, transfusion of aged, but not fresh, RBCs induces organ injury, inflammation, coagulopathy, and impaired oxygen delivery. A number of clinical studies, mostly observational or retrospective and from a single centre, have reported an association between transfusion of older RBCs and increased clinically significant outcomes, such as increased morbidity and mortality in certain patient populations, including trauma, critical care, and cardiac surgery. Others, however, have failed to indicate an influence of RBC age on outcome. The quality of evidence is currently too poor to make recommendations to change current transfusion practice; however, the transfusion community looks forward to the results of randomized trials currently addressing the long-standing question regarding the effects of RBC storage on clinically significant outcomes.

Modulation of Brain Activity with Noninvasive Transcranial Direct Current Stimulation (tDCS): Clinical Applications and Safety Concerns

PubMed Central

Zhao, Haichao; Qiao, Lei; Fan, Dongqiong; Zhang, Shuyue; Turel, Ofir; Li, Yonghui; Li, Jun; Xue, Gui; Chen, Antao; He, Qinghua

2017-01-01

Transcranial direct current stimulation (tDCS) is a widely-used tool to induce neuroplasticity and modulate cortical function by applying weak direct current over the scalp. In this review, we first introduce the underlying mechanism of action, the brief history from discovery to clinical scientific research, electrode positioning and montages, and parameter setup of tDCS. Then, we review tDCS application in clinical samples including people with drug addiction, major depression disorder, Alzheimer's disease, as well as in children. This review covers the typical characteristics and the underlying neural mechanisms of tDCS treatment in such studies. This is followed by a discussion of safety, especially when the current intensity is increased or the stimulation duration is prolonged. Given such concerns, we provide detailed suggestions regarding safety procedures for tDCS operation. Lastly, future research directions are discussed. They include foci on the development of multi-tech combination with tDCS such as with TMS and fMRI; long-term behavioral and morphological changes; possible applications in other research domains, and more animal research to deepen the understanding of the biological and physiological mechanisms of tDCS stimulation. PMID:28539894

Agreement in reporting between trial publications and current clinical trial registry in high impact journals: A methodological review.

PubMed

Kosa, Sarah Daisy; Mbuagbaw, Lawrence; Borg Debono, Victoria; Bhandari, Mohit; Dennis, Brittany B; Ene, Gabrielle; Leenus, Alvin; Shi, Daniel; Thabane, Michael; Valvasori, Sara; Vanniyasingam, Thuva; Ye, Chenglin; Yranon, Elgene; Zhang, Shiyuan; Thabane, Lehana

2018-02-01

The primary objective of this systematic survey was to examine the percentage of studies in which there was agreement in the reporting of the primary outcome between the currently updated version of the clinical trial registry and the published paper. We also investigated the factors associated with agreement in reporting of the primary outcome. We searched PubMed for all randomized control trials (RCT)s published in 2012-2015 in the top five general medicine journals (based on the 2014 impact factor). Two hundred abstracts (50 from each year) were randomly selected for data extraction. Agreement in reporting of 11 key study conduct items (e.g., sample size) and study characteristics (e.g., funding, number of sites) were extracted by two independent reviewers. Descriptive analyses were conducted to determine the proportion of studies on which there was agreement in reporting of key study conduct items. Generalized estimating equations were used to explore factors associated with agreement in reporting of the primary outcome. Of the 200 included studies, 87% had agreement in reporting of the primary outcome. After adjusting for other covariates, having greater than 50 sites was associated with an increased likelihood of agreement in reporting of the primary outcome (odds ratio=7.1, 95% confidence interval=1.39, 36.27, p=0.018). We identified substantive disagreement in reporting between publications and current clinical trial registry, which were associated with several study characteristics. Further measures are needed to improve reporting given the potential threats to the quality and integrity of scientific research. Copyright © 2017 Elsevier Inc. All rights reserved.

Add-on treatment with N-acetylcysteine for bipolar depression: a 24-week randomized double-blind parallel group placebo-controlled multicentre trial (NACOS-study protocol).

PubMed

Ellegaard, Pernille Kempel; Licht, Rasmus Wentzer; Poulsen, Henrik Enghusen; Nielsen, René Ernst; Berk, Michael; Dean, Olivia May; Mohebbi, Mohammadreza; Nielsen, Connie Thuroee

2018-04-05

Oxidative stress and inflammation may be involved in the development and progression of mood disorders, including bipolar disorder. Currently, there is a scarcity of useful treatment options for bipolar depressive episodes, especially compared with the efficacy of treatment for acute mania. N-Acetylcysteine (NAC) has been explored for psychiatric disorders for some time given its antioxidant and anti-inflammatory properties. The current trial aims at testing the clinical effects of adjunctive NAC treatment (compared to placebo) for bipolar depression. We will also explore the biological effects of NAC in this context. We hypothesize that adjunctive NAC treatment will reduce symptoms of depression, which will be reflected by changes in selected markers of oxidative stress. In the study, we will include adults diagnosed with bipolar disorder, in a currently depressive episode. Participants will undertake a 20-week, adjunctive, randomized, double-blinded, parallel group placebo-controlled trial comparing 3 grams of adjunctive NAC daily with placebo. The primary outcome is the mean change over time from baseline to end of study on the Montgomery-Asberg Depression Rating Scale (MADRS). Among the secondary outcomes are mean changes from baseline to end of study on the Bech-Rafaelsen Melancholia Scale (MES), the Young Mania Rating Scale (YMRS), the WHO-Five Well-being Index (WHO-5), the Global Assessment of Functioning scale (GAF-F), the Global Assessment of Symptoms scale (GAF-S) and the Clinical Global Impression-Severity scale (CGI-S). The potential effects on oxidative stress by NAC treatment will be measured through urine and blood samples. DNA will be examined for potential polymorphisms related to oxidative defences. Registered at The European Clinical Trials Database, ClinicalTrials.gov: NCT02294591 and The Danish Data Protection Agency: 2008-58-0035.

A Clinician-Centered Evaluation of the Usability of AHLTA and Automated Clinical Practice Guidelines at TAMC

DTIC Science & Technology

2011-03-31

evidence based medicine into clinical practice. It will decrease costs and enable multiple stakeholders to work in an open content/source environment to exchange clinical content, develop and test technology and explore processes in applied CDS. Design: Comparative study between the KMR infrastructure and capabilities developed as an open source, vendor agnostic solution for aCPG execution within AHLTA and the current DoD/MHS standard evaluating: H1: An open source, open standard KMR and Clinical Decision Support Engine can enable organizations to share domain

Growth factor delivery vehicles for tendon injuries: Mesenchymal stem cells and Platelet Rich Plasma

PubMed Central

Guevara-Alvarez, Alberto; Schmitt, Andreas; Russell, Ryan P.; Imhoff, Andreas B.; Buchmann, Stefan

2014-01-01

Summary Background: tendon tissue shows limited regeneration potential with formation of scar tissue and inferior mechanical properties. The capacity of several growth factors to improve the healing response and decrease scar formation is described in different preclinical studies. Besides the application of isolated growth factors, current research focuses on two further strategies to improve the healing response in tendon injuries: platelet rich plasma (PRP) and mesenchymal stem cells (MSCs). Objective: the present review focuses on these two options and describes their potential to improve tendon healing. Results: in vitro experiments and animal studies showed promising results for the use of PRP, however clinical controlled studies have shown a tendency of reduced pain related symptoms but no significant differences in overall clinical scores. On the other hand MSCs are not totally arrived in clinical use so that there is still a lack of randomized controlled trials. In basic research experiments they show an extraordinary paracrine activity, anti-inflammatory effect and the possibility to differentiate in tenocytes when different activating-factors are added. Conclusion: preclinical studies have shown promising results in improving tendon remodeling but the comparability of current literature is difficult due to different compositions. PRP and MSCs can act as efficient growth factor vehicles, however further studies should be performed in order to adequate investigate their clinical benefits in different tendon pathologies. PMID:25489557

Sex Differences in Stroke Therapies

PubMed Central

Sohrabji, Farida; Park, Min Jung; Mahnke, Amanda H

2016-01-01

Stroke is the 5th leading cause of death and acquired disability in aged populations. Women are disproportionally affected by stroke, having a higher incidence and worse outcomes than men. Numerous preclinical studies have discovered novel therapies for the treatment of stroke, but almost all of these were found to be unsuccessful in clinical trials. Despite known sex differences in occurrence and severity of stroke, few therapeutics, both preclinically and clinically, take into account possible sex differences in treatment. Reanalysis of data from the only currently FDA-approved stroke therapy, tPA, has shown to not only improve stroke outcomes for both sexes, but to also show sexual dimorphism by more robust improvement in stroke outcome in females. Experimental evidence supports the inclusion of sex as a variable in the study of a number of novel stroke drugs and therapies, including preclinical studies of anti-inflammatory drugs (minocycline), stimulators of cell survival (IGF-1), and inhibitors of cell death pathways (pharmacological inhibition of PARP-1, NO production, and caspase activation), as well as in current clinical trials of stem cell therapy and cortical stimulation. Overall, study design and analyses in clinical trials, as well as in preclinical studies, must include both sexes equally, consider possible sex differences in the analyses, and report the differences/similarities in more systemized/structured way to translate promising therapies to both sexes and increase stroke recovery. PMID:27870437

Beyond the Dedicated Education Unit: Using Cognitive Load Theory to Guide Clinical Placement.

PubMed

Mulcock, Pamela McPhie; Grassley, Jane; Davis, Michael; White, Kathryn

2017-02-01

Navigating multiple instructors and clinical agencies can impair students' learning by increasing their cognitive load and perceived stress. This study used cognitive load theory to guide the home base clinical model (HBCM), which assigned students to the same faculty and hospital unit for two consecutive medical-surgical clinical courses. The study used a quasi-experimental three-group design to evaluate the effects of the HBCM on students' perceived stress, compared with groups who changed hospital or instructor. A 10-point visual analog scale measured students' perceived stress on nine clinical tasks. The study recruited 140 participants. Reductions in mean stress were greater for the HBCM groups than the other two groups. The study findings challenge the current practice of placing students with changing faculty and facilities. The HBCM demonstrates potential as an effective model for increasing students' ability to learn by decreasing their cognitive load and subsequent stress in their clinical placements. [J Nurs Educ. 2017;56(2):105-109.]. Copyright 2017, SLACK Incorporated.

Membrane transporters in drug development

PubMed Central

2011-01-01

Membrane transporters can be major determinants of the pharmacokinetic, safety and efficacy profiles of drugs. This presents several key questions for drug development, including which transporters are clinically important in drug absorption and disposition, and which in vitro methods are suitable for studying drug interactions with these transporters. In addition, what criteria should trigger follow-up clinical studies, and which clinical studies should be conducted if needed. In this article, we provide the recommendations of the International Transporter Consortium on these issues, and present decision trees that are intended to help guide clinical studies on the currently recognized most important drug transporter interactions. The recommendations are generally intended to support clinical development and filing of a new drug application. Overall, it is advised that the timing of transporter investigations should be driven by efficacy, safety and clinical trial enrolment questions (for example, exclusion and inclusion criteria), as well as a need for further understanding of the absorption, distribution, metabolism and excretion properties of the drug molecule, and information required for drug labeling. PMID:20190787

The Broader Autism Phenotype and Friendships in Non-Clinical Dyads

ERIC Educational Resources Information Center

Wainer, Allison L.; Block, Nicole; Donnellan, M. Brent; Ingersoll, Brooke

2013-01-01

The broader autism phenotype (BAP) is a set of subclinical traits qualitatively similar to those observed in autism spectrum disorders. The current study sought to elucidate the association between self- and informant-reports of the BAP and friendships, in a non-clinical sample of college student dyads. Self-informant agreement of the BAP and…

Validity of the WISC-IV Spanish for a Clinically Referred Sample of Hispanic Children

ERIC Educational Resources Information Center

San Miguel Montes, Liza E.; Allen, Daniel N.; Puente, Antonio E.; Neblina, Cris

2010-01-01

The Wechsler Intelligence Scale for Children (WISC) is the most commonly used intelligence test for children. Five years ago, a Spanish version of the WISC-IV was published (WISC-IV Spanish; Wechsler, 2005), but a limited amount of published information is available regarding its utility when assessing clinical samples. The current study included…

Characteristics and Clinical Practices of Marriage and Family Therapists: A National Survey

ERIC Educational Resources Information Center

Northey, William F., Jr.

2002-01-01

This report presents data from a telephone survey of a randomly selected sample of 292 marriage and family therapists (MFTs) who were Clinical Members of the American Association for Marriage and Family Therapy. The study, designed to better understand the current state of the field of MFT, provides descriptive data on the demographic…

Study Designs and Statistical Analyses for Biomarker Research

PubMed Central

Gosho, Masahiko; Nagashima, Kengo; Sato, Yasunori

2012-01-01

Biomarkers are becoming increasingly important for streamlining drug discovery and development. In addition, biomarkers are widely expected to be used as a tool for disease diagnosis, personalized medication, and surrogate endpoints in clinical research. In this paper, we highlight several important aspects related to study design and statistical analysis for clinical research incorporating biomarkers. We describe the typical and current study designs for exploring, detecting, and utilizing biomarkers. Furthermore, we introduce statistical issues such as confounding and multiplicity for statistical tests in biomarker research. PMID:23012528

The Characteristics of TCM Clinical Trials: A Systematic Review of ClinicalTrials.gov.

PubMed

Chen, Junchao; Huang, Jihan; Li, Jordan V; Lv, Yinghua; He, Yingchun; Zheng, Qingshan

2017-01-01

The aim of this review is to characterize current status of global TCM clinical trials registered in ClinicalTrials.gov. We examined all the trials registered within ClinicalTrials.gov up to 25 September 2015, focusing on study interventions to identify TCM-related trials, and extracted 1,270 TCM trials from the data set. Overall, 691 (54.4%) trials were acupuncture, and 454 (35.8%) trials were herbal medicines. Differences in TCM trial intervention types were also evident among the specific therapeutic areas. Among all trials, 55.7% that were small studies enrolled <100 subjects, and only 8.7% of completed studies had reported results of trials. As for the location, the United States was second to China in conducting the most TCM trials. This review is the first snapshot of the landscape of TCM clinical trials registered in ClinicalTrials.gov, providing the basis for treatment and prevention of diseases within TCM and offering useful information that will guide future research on TCM.

The Characteristics of TCM Clinical Trials: A Systematic Review of ClinicalTrials.gov

PubMed Central

Huang, Jihan; Li, Jordan V.; Lv, Yinghua; He, Yingchun

2017-01-01

Objective The aim of this review is to characterize current status of global TCM clinical trials registered in ClinicalTrials.gov. Methods We examined all the trials registered within ClinicalTrials.gov up to 25 September 2015, focusing on study interventions to identify TCM-related trials, and extracted 1,270 TCM trials from the data set. Results Overall, 691 (54.4%) trials were acupuncture, and 454 (35.8%) trials were herbal medicines. Differences in TCM trial intervention types were also evident among the specific therapeutic areas. Among all trials, 55.7% that were small studies enrolled <100 subjects, and only 8.7% of completed studies had reported results of trials. As for the location, the United States was second to China in conducting the most TCM trials. Conclusion This review is the first snapshot of the landscape of TCM clinical trials registered in ClinicalTrials.gov, providing the basis for treatment and prevention of diseases within TCM and offering useful information that will guide future research on TCM. PMID:29138646

Access, interest, and attitudes toward electronic communication for health care among patients in the medical safety net.

PubMed

Schickedanz, Adam; Huang, David; Lopez, Andrea; Cheung, Edna; Lyles, C R; Bodenheimer, Tom; Sarkar, Urmimala

2013-07-01

Electronic and internet-based tools for patient-provider communication are becoming the standard of care, but disparities exist in their adoption among patients. The reasons for these disparities are unclear, and few studies have looked at the potential communication technologies have to benefit vulnerable patient populations. To characterize access to, interest in, and attitudes toward internet-based communication in an ethnically, economically, and linguistically diverse group of patients from a large urban safety net clinic network. Observational, cross-sectional study Adult patients (≥ 18 years) in six resource-limited community clinics in the San Francisco Department of Public Health (SFDPH) MAIN MEASURES: Current email use, interest in communicating electronically with health care professionals, barriers to and facilitators of electronic health-related communication, and demographic data-all self-reported via survey. Sixty percent of patients used email, 71 % were interested in using electronic communication with health care providers, and 19 % reported currently using email informally with these providers for health care. Those already using any email were more likely to express interest in using it for health matters. Most patients agreed electronic communication would improve clinic efficiency and overall communication with clinicians. A significant majority of safety net patients currently use email, text messaging, and the internet, and they expressed an interest in using these tools for electronic communication with their medical providers. This interest is currently unmet within safety net clinics that do not offer a patient portal or secure messaging. Tools such as email encounters and electronic patient portals should be implemented and supported to a greater extent in resource-poor settings, but this will require tailoring these tools to patients' language, literacy level, and experience with communication technology.

Occupational outcome in bipolar disorder is not predicted by premorbid functioning and intelligence.

PubMed

Schoeyen, Helle K; Melle, Ingrid; Sundet, Kjetil; Aminoff, Sofie R; Hellvin, Tone; Auestad, Bjoern H; Morken, Gunnar; Andreassen, Ole A

2013-05-01

Bipolar disorder (BD), over the long term, can manifest a variety of outcomes depending on a number of different conditions. There is a need for further knowledge regarding preventive factors as well as predictors of the disabling course of the disorder. Studies regarding the impact on functional outcome of premorbid and current general intellectual function [intelligence quotient (IQ)] and premorbid functioning in BD patients are sparse. The present study addressed the role of premorbid functioning [assessed with the Premorbid Adjustment Scale (PAS)], intelligence, course of illness, and sociodemographics on occupational outcome in BD. Bipolar disorder patients were recruited consecutively from psychiatric units (outpatient and inpatient) in four major hospitals in Oslo, Norway [(N = 226: 64.4% bipolar I disorder (BD-I); 30.1% bipolar II disorder (BD-II); 5.5% bipolar disorder not otherwise specified (BD-NOS); 38.6% males]. The associations between current IQ, premorbid IQ [assessed using the National Adult Reading Test (NART)], PAS, clinical and sociodemographic characteristics, and receipt of disability benefit were analysed using descriptive statistics and logistic regression analyses. The number of hospitalizations for depressive episodes and illness duration was associated with a higher risk of receipt of disability benefit. PAS, premorbid and current IQ, as well as decline in IQ, did not explain the higher risk of receipt of disability benefits. Severe clinical course of BD was associated with receipt of disability benefit. Occupational outcome was unrelated to PAS, premorbid and current IQ, as well as decline in IQ. This suggests that the persistence of severe clinical symptoms, rather than global cognitive functioning, determines occupational outcome in BD and emphasizes the protective potential of early and continuous clinical treatment. © 2013 John Wiley and Sons A/S. Published by Blackwell Publishing Ltd.

Current Status and Prospects for Cannabidiol Preparations as New Therapeutic Agents.

PubMed

Fasinu, Pius S; Phillips, Sarah; ElSohly, Mahmoud A; Walker, Larry A

2016-07-01

States and the federal government are under growing pressure to legalize the use of cannabis products for medical purposes in the United States. Sixteen states have legalized (or decriminalized possession of) products high in cannabidiol (CBD) and with restricted ∆(9) -tetrahydrocannabinol (∆(9) -THC) content. In most of these states, the intent is for use in refractory epileptic seizures in children, but in a few states, the indications are broader. This review provides an overview of the pharmacology and toxicology of CBD; summarizes some of the regulatory, safety, and cultural issues relevant to the further exploitation of its antiepileptic or other pharmacologic activities; and assesses the current status and prospects for clinical development of CBD and CBD-rich preparations for medical use in the United States. Unlike Δ(9) -THC, CBD elicits its pharmacologic effects without exerting any significant intrinsic activity on the cannabinoid receptors, whose activation results in the psychotropic effects characteristic of Δ(9) -THC, and CBD possesses several pharmacologic activities that give it a high potential for therapeutic use. CBD exhibits neuroprotective, antiepileptic, anxiolytic, antipsychotic, and antiinflammatory properties. In combination with Δ(9) -THC, CBD has received regulatory approvals in several European countries and is currently under study in trials registered by the U.S. Food and Drug Administration in the United States. A number of states have passed legislation to allow for the use of CBD-rich, limited Δ(9) -THC-content preparations of cannabis for certain pathologic conditions. CBD is currently being studied in several clinical trials and is at different stages of clinical development for various medical indications. Judging from clinical findings reported so far, CBD and CBD-enriched preparations have great potential utility, but uncertainties regarding sourcing, long-term safety, abuse potential, and regulatory dilemmas remain. © 2016 Pharmacotherapy Publications, Inc.

Current and experimental treatments of Parkinson disease: A guide for neuroscientists.

PubMed

Oertel, Wolfgang; Schulz, Jörg B

2016-10-01

Over a period of more than 50 years, the symptomatic treatment of the motor symptoms of Parkinson disease (PD) has been optimized using pharmacotherapy, deep brain stimulation, and physiotherapy. The arsenal of pharmacotherapies includes L-Dopa, several dopamine agonists, inhibitors of monoamine oxidase (MAO)-B and catechol-o-methyltransferase (COMT), and amantadine. In the later course of the disease, motor complications occur, at which stage different oral formulations of L-Dopa or dopamine agonists with long half-life, a transdermal application or parenteral pumps for continuous drug supply can be subscribed. Alternatively, the patient is offered deep brain stimulation of the subthalamic nucleus (STN) or the internal part of the globus pallidus (GPi). For a more efficacious treatment of motor complications, new formulations of L-Dopa, dopamine agonists, and amantadine as well as new MAO-B and COMT inhibitors are currently tested in clinical trials, and some of them already yielding positive results in phase 3 trials. In addition, non-dopaminergic agents have been tested in the early clinical phase for the treatment of motor fluctuations and dyskinesia, including adenosine A2A antagonists (istradefylline, preladenant, and tozadenant) and modulators of the metabolic glutamate receptor 5 (mGluR5 - mavoglurant) and serotonin (eltoprazine) receptors. Recent clinical trials testing coenzyme Q10, the dopamine agonist pramipexole, creatine monohydrate, pioglitazone, or AAV-mediated gene therapy aimed at increasing expression of neurturin, did not prove efficacious. Treatment with nicotine, caffeine, inosine (a precursor of urate), and isradipine (a dihydropyridine calcium channel blocker), as well as active and passive immunization against α-synuclein and inhibitors or modulators of α-synuclein-aggregation are currently studied in clinical trials. However, to date, no disease-modifying treatment is available. We here review the current status of treatment options for motor and non-motor symptoms, and discuss current investigative strategies for disease modification. This review provides basic insights, mainly addressing basic scientists and non-specialists. It stresses the need to intensify therapeutic PD research and points out reasons why the translation of basic research to disease-modifying therapies has been unsuccessful so far. The symptomatic treatment of the motor symptoms of Parkinson disease (PD) has been constantly optimized using pharmacotherapy (L-Dopa, several dopamine agonists, inhibitors of monoamine oxidase (MAO)-B and catechol-o-methyltransferase (COMT), and amantadine), deep brain stimulation, and physiotherapy. For a more efficacious treatment of motor complications, new formulations of L-Dopa, dopamine agonists, and amantadine as well as new MAO-B and COMT inhibitors are currently tested in clinical trials. Non-dopaminergic agents have been tested in the early clinical phase for the treatment of motor fluctuations and dyskinesia. Recent clinical trials testing coenzyme Q10, the dopamine agonist pramipexole, creatine monohydrate, pioglitazone, or AAV-mediated gene therapy aimed at increasing expression of neurturin, did not prove efficacious. Treatment with nicotine, caffeine, and isradipine - a dihydropyridine calcium channel blocker - as well as active and passive immunization against α-synuclein and inhibitors of α-synuclein-aggregation are currently studied in clinical trials. However, to date, no disease-modifying treatment is available for PD. We here review the current status of treatment options and investigative strategies for both motor and non-motor symptoms. This review stresses the need to intensify therapeutic PD research and points out reasons why the translation of basic research to disease-modifying therapies has been unsuccessful so far. This article is part of a special issue on Parkinson disease. © 2016 International Society for Neurochemistry.

Improving speech perception in noise with current focusing in cochlear implant users.

PubMed

Srinivasan, Arthi G; Padilla, Monica; Shannon, Robert V; Landsberger, David M

2013-05-01

Cochlear implant (CI) users typically have excellent speech recognition in quiet but struggle with understanding speech in noise. It is thought that broad current spread from stimulating electrodes causes adjacent electrodes to activate overlapping populations of neurons which results in interactions across adjacent channels. Current focusing has been studied as a way to reduce spread of excitation, and therefore, reduce channel interactions. In particular, partial tripolar stimulation has been shown to reduce spread of excitation relative to monopolar stimulation. However, the crucial question is whether this benefit translates to improvements in speech perception. In this study, we compared speech perception in noise with experimental monopolar and partial tripolar speech processing strategies. The two strategies were matched in terms of number of active electrodes, microphone, filterbanks, stimulation rate and loudness (although both strategies used a lower stimulation rate than typical clinical strategies). The results of this study showed a significant improvement in speech perception in noise with partial tripolar stimulation. All subjects benefited from the current focused speech processing strategy. There was a mean improvement in speech recognition threshold of 2.7 dB in a digits in noise task and a mean improvement of 3 dB in a sentences in noise task with partial tripolar stimulation relative to monopolar stimulation. Although the experimental monopolar strategy was worse than the clinical, presumably due to different microphones, frequency allocations and stimulation rates, the experimental partial-tripolar strategy, which had the same changes, showed no acute deficit relative to the clinical. Copyright © 2013 Elsevier B.V. All rights reserved.

The performance implications of pharmacy information system at the university teaching hospitals of Shiraz, Iran: Cluster approach

PubMed Central

Bayati, Saeede; Bastani, Peivand; Sagheb, Zahra Mahmoodzade; Jamalabadi, Sara; Samadbeik, Mahnaz

2017-01-01

Pharmacy information system (PIS) is becoming vital in assisting pharmacists to do their responsibilities. The aim of this study was to identify the current PIS implications in teaching hospitals affiliated with Shiraz University of Medical Science. This cross-sectional study was conducted in teaching hospitals affiliated with Shiraz University of Medical Science over the year 2016. Data were collected by observing the PIS as well as interviewing its users based on the researcher-made checklist. The checklist was prepared based on reviewing the Persian and English literature and its content validity was approved by the experts. To determine the reliability of the checklist, inter-rater reliability was used. Data were analyzed using SPSS16, and hospitals were clustered using SK-means method. In this study, the least conformity to the standards was shown in smart clinical features (4.54%), pharmaceutical companies' relationship (32.6%), and optimization of drug therapy (34.6%). In contrast, the highest conformity to the standards was shown in reporting capabilities (77.3%) and entry information and input (70.4%). Medication stock checking and optimization of drug therapy were effective features that have made a distinction between hospitals and lead to 95% variance between clusters. Based on the results, the current PIS design pays less attention to clinical features. Besides, clinical information for pharmacists and outside organization relationship were not provided by the current system. Thus, emphasis should be placed on the implementation of corrective actions to eliminate the current system's deficiencies. PMID:29184843

Sexual intercourse among adolescent daughters of mothers with depressive symptoms from minority families.

PubMed

Sang, Jina; Cederbaum, Julie A; Hurlburt, Michael S

2016-08-01

This study investigated the association between maternal depressive symptoms and adolescent engagement in sexual intercourse in a non-clinical sample of mothers and their adolescent daughters from minority families. The current study explores ways in which maternal depression, family factors, and adolescent sex interact. Data were from a cross-sectional study of 176 mother-daughter dyads, including a subset of mothers with HIV. Logistic regression analyses revealed that among mothers who were not current marijuana users, more maternal depressive symptoms was associated with daughters' engagement in sexual intercourse. Neither parent-child conflict nor parental involvement significantly mediated the relationship between maternal depressive symptoms and adolescent sex. This study provides the first empirical evidence that non-clinical depressive symptoms in mothers are associated with adolescent engagement in sexual intercourse. Copyright © 2016 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

Statin use and incident frailty in women aged 65 years or older: prospective findings from the Women's Health Initiative Observational Study.

PubMed

LaCroix, Andrea Z; Gray, Shelly L; Aragaki, Aaron; Cochrane, Barbara B; Newman, Anne B; Kooperberg, Charles L; Black, Henry; Curb, J David; Greenland, Philip; Woods, Nancy F

2008-04-01

Inflammatory biomarkers have shown consistent associations with disability and frailty in older adults. Statin medications may reduce the incidence the frailty because of their anti-inflammatory effects. This study examines associations between current use, duration, and potency of statin medications and incident frailty in initially nonfrail women 65 years old or older. The authors conducted a prospective analysis of data from the Women's Health Initiative Observational Study (WHI-OS) conducted at 40 clinical centers in the United States. Eligible women were nonfrail and 65-79 years old at baseline (n = 25,378). Current statin use at baseline was ascertained through direct inspection of medicine containers during clinic visits. Frailty was ascertained through self-reported indicators and physical measurements at baseline and 3-year clinic contacts. Components of frailty included self-reported low physical function, exhaustion, low physical activity, and unintended weight loss. Multinomial logistic regression models were used to adjust for covariates predicting incident frailty. Among the 25,378 eligible women, 3453 (13.6%) developed frailty by the 3-year follow-up contact. Current statin use had no association with incident frailty (multivariate-adjusted odds ratio [OR] = 1.00; 95% confidence interval [CI], 0.85-1.16). Duration and potency of statin use were also not significantly associated with incident frailty. Among low potency statin users, longer duration of use was associated with reduced risk of frailty (p for trend =.02). A similar pattern of results was observed when frailty was studied in the absence of intervening, incident cardiovascular events. Overall, incidence of frailty was similar in current statin users and nonusers.

Childhood fever in well-child clinics: a focus group study among doctors and nurses.

PubMed

Peetoom, Kirsten K B; Ploum, Luc J L; Smits, Jacqueline J M; Halbach, Nicky S J; Dinant, Geert-Jan; Cals, Jochen W L

2016-07-08

Fever is common in children aged 0-4 years old and often leads to parental worries and in turn, high use of healthcare services. Educating parents may have beneficial effects on their sense of coping and fever management. Most parents receive information when their child is ill but it might be more desirable to educate parents in the setting of well-child clinics prior to their child becoming ill, in order to prepare parents for future illness management. This study aims to explore experiences of well-child clinic professionals when dealing with childhood fever and current practices of fever information provision to identify starting points for future interventions. We held four focus group discussions based on naturalistic enquiry among 22 well-child clinic professionals. Data was analysed using the constant comparative technique. Well-child clinic professionals regularly received questions from parents about childhood fever and felt that parental worries were the major driving factor behind these contacts. These worries were assumed to be driven by: (1) lack of knowledge (2) experiences with fever (3) educational level and size social network (4) inconsistencies in paracetamol administration advice among healthcare professionals. Well-child clinic professionals perceive current information provision as limited and stated a need for improvement. For example, information should be consistent, easy to find and understand. Fever-related questions are common in well-child care and professionals perceive that most of the workload is driven by parental worries. The focus group discussions revealed a desire to optimise the current limited information provision for childhood fever. Future interventions aimed at improving information provision for fever in well-child clinics should consider parental level of knowledge, experience, educational level and social network and inconsistencies among healthcare providers. Future fever information provision should focus on improving fever management and practical skills.

Concepts for NASA longitudinal health studies

NASA Technical Reports Server (NTRS)

Nicogossian, A. E.; Pool, S. L.; Leach, C. S.; Moseley, E.; Rambaut, P. C.

1983-01-01

Clinical data collected from a 15-year study of the homogenous group of pre-Shuttle astronauts have revealed no significant long-term effects from spaceflight. The current hypothesis suggests that repeated exposures to the space environment in the Shuttle era will similarly have no long-term health effects. However, a much more heterogenous group of astronauts and non-astronaut scientists will fly in Shuttle, and data on this group's adaptation to the space environment and readaptation to earth are currently sparse. In addition, very little information is available concerning the short- and long-term medical consequences of long duration exposure to space and subsequent readaptation to the earth environment. In this paper, retrospective clinical information on astronauts is reviewed and concepts for conducting epidemiological studies examining long-term health effects of spaceflight on humans, including associated occupational risks factors, are presented.

Portable recording in the assessment of obstructive sleep apnea. ASDA standards of practice.

PubMed

Ferber, R; Millman, R; Coppola, M; Fleetham, J; Murray, C F; Iber, C; McCall, V; Nino-Murcia, G; Pressman, M; Sanders, M

1994-06-01

The objective assessment of patients with a presumptive diagnosis of obstructive sleep apnea (OSA) has primarily used attended polysomnographic study. Recent technologic advances and issues of availability, convenience and cost have led to a rapid increase in the use of portable recording devices. However, limited scientific information has been published regarding the evaluation of the efficacy, accuracy, validity, utility, cost effectiveness and limitations of this portable equipment. Attaining a clear assessment of the role of portable devices is complicated by the multiplicity of recording systems and the variability of clinical settings in which they have been analyzed. This paper reviews the current knowledge base regarding portable recording in the assessment of OSA, including technical considerations, validation studies, potential advantages and disadvantages, issues of safety, current clinical usage and areas most in need of further study.

Atomoxetine pharmacogenetics: associations with pharmacokinetics, treatment response and tolerability.

PubMed

Brown, Jacob T; Bishop, Jeffrey R

2015-01-01

Atomoxetine is indicated for the treatment of attention deficit hyperactivity disorder and is predominantly metabolized by the CYP2D6 enzyme. Differences in pharmacokinetic parameters as well as clinical treatment outcomes across CYP2D6 genotype groups have resulted in dosing recommendations within the product label, but clinical studies supporting the use of genotype guided dosing are currently lacking. Furthermore, pharmacokinetic and clinical studies have primarily focused on extensive as compared with poor metabolizers, with little information known about other metabolizer categories as well as genes involved in the pharmacodynamics of atomoxetine. This review describes the pharmacogenetic associations with atomoxetine pharmacokinetics, treatment response and tolerability with considerations for the clinical utility of this information.

How Researchers Define Vulnerable Populations in HIV/AIDS Clinical Trials

PubMed Central

Lo, Bernard; Strauss, Ronald P.; Eron, Joseph; Gifford, Allen L.

2010-01-01

In this study, we interviewed researchers, asking them to define vulnerable populations in HIV/AIDS clinical trials, and provide feedback on the federal regulations for three vulnerable populations. Interview data informed a conceptual framework, and were content analyzed to identify acceptability or disagreement with the regulations. Beginning with several characteristics of vulnerable enrollees identified by researchers, the conceptual framework illustrates possible scenarios of how enrollees could be considered vulnerable in clinical research. Content analysis identified barriers affecting HIV/AIDS researchers’ ability to conduct clinical trials with pregnant women, prisoners, and children, for which the regulations specify additional protections. This study challenges current thinking about federal regulations’ group-based approach to defining vulnerable populations. PMID:20721614

Software Toolbox for Low-Frequency Conductivity and Current Density Imaging Using MRI.

PubMed

Sajib, Saurav Z K; Katoch, Nitish; Kim, Hyung Joong; Kwon, Oh In; Woo, Eung Je

2017-11-01

Low-frequency conductivity and current density imaging using MRI includes magnetic resonance electrical impedance tomography (MREIT), diffusion tensor MREIT (DT-MREIT), conductivity tensor imaging (CTI), and magnetic resonance current density imaging (MRCDI). MRCDI and MREIT provide current density and isotropic conductivity images, respectively, using current-injection phase MRI techniques. DT-MREIT produces anisotropic conductivity tensor images by incorporating diffusion weighted MRI into MREIT. These current-injection techniques are finding clinical applications in diagnostic imaging and also in transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), and electroporation where treatment currents can function as imaging currents. To avoid adverse effects of nerve and muscle stimulations due to injected currents, conductivity tensor imaging (CTI) utilizes B1 mapping and multi-b diffusion weighted MRI to produce low-frequency anisotropic conductivity tensor images without injecting current. This paper describes numerical implementations of several key mathematical functions for conductivity and current density image reconstructions in MRCDI, MREIT, DT-MREIT, and CTI. To facilitate experimental studies of clinical applications, we developed a software toolbox for these low-frequency conductivity and current density imaging methods. This MR-based conductivity imaging (MRCI) toolbox includes 11 toolbox functions which can be used in the MATLAB environment. The MRCI toolbox is available at http://iirc.khu.ac.kr/software.html . Its functions were tested by using several experimental datasets, which are provided together with the toolbox. Users of the toolbox can focus on experimental designs and interpretations of reconstructed images instead of developing their own image reconstruction softwares. We expect more toolbox functions to be added from future research outcomes. Low-frequency conductivity and current density imaging using MRI includes magnetic resonance electrical impedance tomography (MREIT), diffusion tensor MREIT (DT-MREIT), conductivity tensor imaging (CTI), and magnetic resonance current density imaging (MRCDI). MRCDI and MREIT provide current density and isotropic conductivity images, respectively, using current-injection phase MRI techniques. DT-MREIT produces anisotropic conductivity tensor images by incorporating diffusion weighted MRI into MREIT. These current-injection techniques are finding clinical applications in diagnostic imaging and also in transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), and electroporation where treatment currents can function as imaging currents. To avoid adverse effects of nerve and muscle stimulations due to injected currents, conductivity tensor imaging (CTI) utilizes B1 mapping and multi-b diffusion weighted MRI to produce low-frequency anisotropic conductivity tensor images without injecting current. This paper describes numerical implementations of several key mathematical functions for conductivity and current density image reconstructions in MRCDI, MREIT, DT-MREIT, and CTI. To facilitate experimental studies of clinical applications, we developed a software toolbox for these low-frequency conductivity and current density imaging methods. This MR-based conductivity imaging (MRCI) toolbox includes 11 toolbox functions which can be used in the MATLAB environment. The MRCI toolbox is available at http://iirc.khu.ac.kr/software.html . Its functions were tested by using several experimental datasets, which are provided together with the toolbox. Users of the toolbox can focus on experimental designs and interpretations of reconstructed images instead of developing their own image reconstruction softwares. We expect more toolbox functions to be added from future research outcomes.

Attributes of clinical leadership in contemporary nursing: an integrative review.

PubMed

Mannix, Judy; Wilkes, Lesley; Daly, John

2013-08-01

Effective clinical leadership is offered as the key to healthy, functional and supportive work environments for nurses and other health professionals. However, as a concept it lacks a standard definition and is poorly understood. This paper reports on an integrative review undertaken to uncover current understandings of defining attributes of contemporary clinical leadership in nursing. Data collection involved a search of relevant electronic databases for a 10-year period. Keywords for the search were 'clinical leadership' and 'nursing'. Ten research papers met the inclusion criteria for the integrative review. Analysis of these studies indicated clinical leadership attributes had a clinical focus, a follower/team focus or a personal qualities focus; attributes necessary to sustain supportive workplaces and build the capacity and resilience of nursing workforces. The small number of research-based studies yielded for the review indicates the need for further research in the area of clinical leadership.

Lifetime eating disorder comorbidity associated with delayed depressive recovery in bipolar disorder.

PubMed

Balzafiore, Danielle R; Rasgon, Natalie L; Yuen, Laura D; Shah, Saloni; Kim, Hyun; Goffin, Kathryn C; Miller, Shefali; Wang, Po W; Ketter, Terence A

2017-12-01

Although eating disorders (EDs) are common in bipolar disorder (BD), little is known regarding their longitudinal consequences. We assessed prevalence, clinical correlates, and longitudinal depressive severity in BD patients with vs. without EDs. Outpatients referred to Stanford University BD Clinic during 2000-2011 were assessed with the Systematic Treatment Enhancement Program for BD (STEP-BD) affective disorders evaluation, and while receiving naturalistic treatment for up to 2 years, were monitored with the STEP-BD clinical monitoring form. Patients with vs. without lifetime EDs were compared with respect to prevalence, demographic and unfavorable illness characteristics/current mood symptoms and psychotropic use, and longitudinal depressive severity. Among 503 BD outpatients, 76 (15.1%) had lifetime EDs, which were associated with female gender, and higher rates of lifetime comorbid anxiety, alcohol/substance use, and personality disorders, childhood BD onset, episode accumulation (≥10 prior mood episodes), prior suicide attempt, current syndromal/subsyndromal depression, sadness, anxiety, and antidepressant use, and earlier BD onset age, and greater current overall BD severity. Among currently depressed patients, 29 with compared to 124 without lifetime EDs had significantly delayed depressive recovery. In contrast, among currently recovered (euthymic ≥8 weeks) patients, 10 with compared to 95 without lifetime EDs had only non-significantly hastened depressive recurrence. Primarily Caucasian, insured, suburban, American specialty clinic-referred sample limits generalizability. Small number of recovered patients with EDs limited statistical power to detect relationships between EDs and depressive recurrence. Further studies are warranted to explore the degree to which EDs impact longitudinal depressive illness burden in BD.

Improving the clinical evidence of bone graft substitute technology in lumbar spine surgery.

PubMed

Hsu, Wellington K; Nickoli, M S; Wang, J C; Lieberman, J R; An, H S; Yoon, S T; Youssef, J A; Brodke, D S; McCullough, C M

2012-12-01

Bone graft substitutes have been used routinely for spine fusion for decades, yet clinical evidence establishing comparative data remains sparse. With recent scrutiny paid to the outcomes, complications, and costs associated with osteobiologics, a need to improve available data guiding efficacious use exists. We review the currently available clinical literature, studying the outcomes of various biologics in posterolateral lumbar spine fusion, and establish the need for a multicenter, independent osteobiologics registry.

Improving the Clinical Evidence of Bone Graft Substitute Technology in Lumbar Spine Surgery

PubMed Central

Hsu, Wellington K.; Nickoli, M. S.; Wang, J. C.; Lieberman, J. R.; An, H. S.; Yoon, S. T.; Youssef, J. A.; Brodke, D. S.; McCullough, C. M.

2012-01-01

Bone graft substitutes have been used routinely for spine fusion for decades, yet clinical evidence establishing comparative data remains sparse. With recent scrutiny paid to the outcomes, complications, and costs associated with osteobiologics, a need to improve available data guiding efficacious use exists. We review the currently available clinical literature, studying the outcomes of various biologics in posterolateral lumbar spine fusion, and establish the need for a multicenter, independent osteobiologics registry. PMID:24353975

Combining novel technologies with improved logistics to reduce hemodialysis vascular access dysfunction.

PubMed

Roy-Chaudhury, P; Lee, T; Duncan, H; El-Khatib, M

2009-01-01

Hemodialysis (HD) vascular access dysfunction is currently a huge clinical problem for which there are no effective therapies. There are, however, a number of promising technologies that are currently at the experimental or clinical trial stage. We believe that the application of these novel technologies in combination with better clinical protocols for vascular access care could significantly reduce the current problems associated with HD vascular access.

The diagnostic management of upper extremity deep vein thrombosis: A review of the literature.

PubMed

Kraaijpoel, Noémie; van Es, Nick; Porreca, Ettore; Büller, Harry R; Di Nisio, Marcello

2017-08-01

Upper extremity deep vein thrombosis (UEDVT) accounts for 4% to 10% of all cases of deep vein thrombosis. UEDVT may present with localized pain, erythema, and swelling of the arm, but may also be detected incidentally by diagnostic imaging tests performed for other reasons. Prompt and accurate diagnosis is crucial to prevent pulmonary embolism and long-term complications as the post-thrombotic syndrome of the arm. Unlike the diagnostic management of deep vein thrombosis (DVT) of the lower extremities, which is well established, the work-up of patients with clinically suspected UEDVT remains uncertain with limited evidence from studies of small size and poor methodological quality. Currently, only one prospective study evaluated the use of an algorithm, similar to the one used for DVT of the lower extremities, for the diagnostic workup of clinically suspected UEDVT. The algorithm combined clinical probability assessment, D-dimer testing and ultrasonography and appeared to safely and effectively exclude UEDVT. However, before recommending its use in routine clinical practice, external validation of this strategy and improvements of the efficiency are needed, especially in high-risk subgroups in whom the performance of the algorithm appeared to be suboptimal, such as hospitalized or cancer patients. In this review, we critically assess the accuracy and efficacy of current diagnostic tools and provide clinical guidance for the diagnostic management of clinically suspected UEDVT. Copyright © 2017 Elsevier Ltd. All rights reserved.

Withdrawal symptoms in internet gaming disorder: A systematic review.

PubMed

Kaptsis, Dean; King, Daniel L; Delfabbro, Paul H; Gradisar, Michael

2016-02-01

Internet gaming disorder (IGD) is currently positioned in the appendix of the DSM-5 as a condition requiring further study. The aim of this review was to examine the state of current knowledge of gaming withdrawal symptomatology, given the importance of withdrawal in positioning the disorder as a behavioral addiction. A total of 34 studies, including 10 qualitative studies, 17 research reports on psychometric instruments, and 7 treatment studies, were evaluated. The results indicated that the available evidence on Internet gaming withdrawal is very underdeveloped. Internet gaming withdrawal is most consistently referred to as 'irritability' and 'restlessness' following cessation of the activity. There exists a concerning paucity of qualitative studies that provide detailed clinical descriptions of symptoms arising from cessation of internet gaming. This has arguably compromised efforts to quantify withdrawal symptoms in empirical studies of gaming populations. Treatment studies have not reported on the natural course of withdrawal and/or withdrawal symptom trajectory following intervention. It is concluded that many more qualitative clinical studies are needed, and should be prioritised, to develop our understanding of gaming withdrawal. This should improve clinical descriptions of problematic internet gaming and in turn improve the quantification of IGD withdrawal and thus treatments for harmful internet gaming. Copyright © 2015 Elsevier Ltd. All rights reserved.

Introduction: the goals of antimicrobial therapy.

PubMed

Song, Jae-Hoon

2003-03-01

Antimicrobial agents are generally evaluated in preclinical studies assessing in vitro activity, animal models demonstrating in vivo bacteriologic efficacy, and clinical trials primarily investigating safety and clinical efficacy. However, large sample sizes are required to detect any differences in outcomes between antimicrobials in clinical trials, and, generally, studies are powered to show only clinical equivalence. In addition, diagnosis is often based on clinical symptoms, rather than microbiological evidence of bacterial infection, and the patients most likely to have resistant pathogens are often excluded. Clinical efficacy can be achieved in some bacterial infections in which antimicrobials are suboptimal or even not prescribed. However, bacterial eradication maximizes clinical efficacy and may also reduce the development and spread of resistant organisms. The goal of antimicrobial therapy is, therefore, to eradicate bacteria at the site of infection. Bacterial eradication is not usually assessed as a primary endpoint within the limits of currently recommended clinical trial design. However, pharmacokinetic (PK) (serum concentration profiles, penetration to site of infection) and pharmacodynamic (PD) (susceptibility, concentration- versus time-dependent killing, post-antimicrobial effects) criteria can be used to predict bacteriologic efficacy. PK/PD predictions should be confirmed during all phases of antimicrobial development and throughout clinical use in response to changing patterns of resistance. A clear rationale for dose recommendations can be determined preclinically based on PK/PD parameters, and correlated with efficacy, safety and resistance endpoints in clinical trials. The duration of treatment and dose should be the shortest that will reliably eradicate the pathogen(s), and that is safe and well tolerated. Currently available agents vary significantly in their ability to achieve PK/PD parameters necessary for bacteriologic eradication. Recommendations for appropriate antimicrobial therapy should be based on PK/PD parameters, with the aim of achieving the maximum potential for eradication of both existing and emerging resistant pathogens.

The International College of Neuro-Psychopharmacology (CINP) Treatment Guidelines for Bipolar Disorder in Adults (CINP-BD-2017), Part 3: The Clinical Guidelines.

PubMed

Fountoulakis, Konstantinos N; Grunze, Heinz; Vieta, Eduard; Young, Allan; Yatham, Lakshmi; Blier, Pierre; Kasper, Siegfried; Moeller, Hans Jurgen

2017-02-01

The current paper introduces the actual International College of Neuro-Psychopharmacology clinical guidelines for the treatment of bipolar disorder. The current clinical guidelines are based on evidence-based data, but they also intend to be clinically useful, while a rigid algorithm was developed on the basis of firm evidence alone. Monotherapy was prioritized over combination therapy. There are separate recommendations for each of the major phases of bipolar disorder expressed as a 5-step algorithm. The current International College of Neuro-Psychopharmacology clinical guidelines for the treatment of bipolar disorder are the most up-to-date guidance and are as evidence based as possible. They also include recommendations concerning the use of psychotherapeutic interventions, again on the basis of available evidence. This adherence of the workgroup to the evidence in a clinically oriented way helped to clarify the role of specific antidepressants and traditional agents like lithium, valproate, or carbamazepine. The additional focus on specific clinical characteristics, including predominant polarity, mixed features, and rapid cycling, is also a novel approach. Many issues need further studies, data are sparse and insufficient, and many questions remain unanswered. The most important and still unmet need is to merge all the guidelines that concern different phases of the illness into a single one and in this way consider BD as a single unified disorder, which is the real world fact. However, to date the research data do not permit such a unified approach. © The Author 2016. Published by Oxford University Press on behalf of CINP.

Relevance of MICA and other non-HLA antibodies in clinical transplantation.

PubMed

Sumitran-Holgersson, Suchitra

2008-10-01

The clinical importance of HLA-specific antibodies for organ allograft outcome is well established. In the past few years, there has been an increasing interest in non-HLA antigens as targets of injury in organ transplant recipients. This increased interest has been spurred by the fact that HLA-identical kidney transplants also undergo immunological rejections. Polymorphisms within non-HLA genes associated with evoking an immune response to alloantigens are currently being studied for their association with transplant outcome. Non-HLA antigens, such as the polymorphic MHC class I-related chain A (MICA), expressed on endothelial cells have been implicated in the pathogenesis of hyperacute, acute and chronic organ allograft rejections. Use of endothelial cells as targets may clarify the specificities of other clinically relevant non-HLA antibodies in graft rejections. This review summarizes past and current knowledge of the clinical importance and specificities of non-HLA antibodies, and mechanisms by which these antibodies may contribute to graft destruction in clinical transplantation. The aims of current research into the role of non-HLA antigens and their genetics in predicting outcome are to develop an improved insight into the basic science of transplantation and to develop a risk or prognostic index for use in the clinical setting. Non-HLA antibody responses are receiving increasing interest in acute and chronic rejection and specificity, affinity, and pathogenicity need to be investigated to estimate their contribution. Undoubtedly, this will continue to be an area of interest in terms of fully understanding the role of non-HLA antigens as targets of immune-mediated injury and the potential for clinical intervention.

Cost-benefit assessment of using electronic health records data for clinical research versus current practices: Contribution of the Electronic Health Records for Clinical Research (EHR4CR) European Project.

PubMed

Beresniak, Ariel; Schmidt, Andreas; Proeve, Johann; Bolanos, Elena; Patel, Neelam; Ammour, Nadir; Sundgren, Mats; Ericson, Mats; Karakoyun, Töresin; Coorevits, Pascal; Kalra, Dipak; De Moor, Georges; Dupont, Danielle

2016-01-01

The widespread adoption of electronic health records (EHR) provides a new opportunity to improve the efficiency of clinical research. The European EHR4CR (Electronic Health Records for Clinical Research) 4-year project has developed an innovative technological platform to enable the re-use of EHR data for clinical research. The objective of this cost-benefit assessment (CBA) is to assess the value of EHR4CR solutions compared to current practices, from the perspective of sponsors of clinical trials. A CBA model was developed using an advanced modeling approach. The costs of performing three clinical research scenarios (S) applied to a hypothetical Phase II or III oncology clinical trial workflow (reference case) were estimated under current and EHR4CR conditions, namely protocol feasibility assessment (S1), patient identification for recruitment (S2), and clinical study execution (S3). The potential benefits were calculated considering that the estimated reduction in actual person-time and costs for performing EHR4CR S1, S2, and S3 would accelerate time to market (TTM). Probabilistic sensitivity analyses using Monte Carlo simulations were conducted to manage uncertainty. Should the estimated efficiency gains achieved with the EHR4CR platform translate into faster TTM, the expected benefits for the global pharmaceutical oncology sector were estimated at €161.5m (S1), €45.7m (S2), €204.5m (S1+S2), €1906m (S3), and up to €2121.8m (S1+S2+S3) when the scenarios were used sequentially. The results suggest that optimizing clinical trial design and execution with the EHR4CR platform would generate substantial added value for pharmaceutical industry, as main sponsors of clinical trials in Europe, and beyond. Copyright © 2015 Elsevier Inc. All rights reserved.

A review of clinical decision making: models and current research.

PubMed

Banning, Maggi

2008-01-01

The aim of this paper was to review the current literature clinical decision-making models and the educational application of models to clinical practice. This was achieved by exploring the function and related research of the three available models of clinical decision making: information-processing model, the intuitive-humanist model and the clinical decision-making model. Clinical decision making is a unique process that involves the interplay between knowledge of pre-existing pathological conditions, explicit patient information, nursing care and experiential learning. Historically, two models of clinical decision making are recognized from the literature; the information-processing model and the intuitive-humanist model. The usefulness and application of both models has been examined in relation the provision of nursing care and care related outcomes. More recently a third model of clinical decision making has been proposed. This new multidimensional model contains elements of the information-processing model but also examines patient specific elements that are necessary for cue and pattern recognition. Literature review. Evaluation of the literature generated from MEDLINE, CINAHL, OVID, PUBMED and EBESCO systems and the Internet from 1980 to November 2005. The characteristics of the three models of decision making were identified and the related research discussed. Three approaches to clinical decision making were identified, each having its own attributes and uses. The most recent addition to the clinical decision making is a theoretical, multidimensional model which was developed through an evaluation of current literature and the assessment of a limited number of research studies that focused on the clinical decision-making skills of inexperienced nurses in pseudoclinical settings. The components of this model and the relative merits to clinical practice are discussed. It is proposed that clinical decision making improves as the nurse gains experience of nursing patients within a specific speciality and with experience, nurses gain a sense of saliency in relation to decision making. Experienced nurses may use all three forms of clinical decision making both independently and concurrently to solve nursing-related problems. It is suggested that O'Neill's clinical decision-making model could be tested by educators and experienced nurses to assess the efficacy of this hybrid approach to decision making.

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.

COMPUTERIZED TRAINING OF CRYOSURGERY – A SYSTEM APPROACH

PubMed Central

Keelan, Robert; Yamakawa, Soji; Shimada, Kenji; Rabin, Yoed

2014-01-01

The objective of the current study is to provide the foundation for a computerized training platform for cryosurgery. Consistent with clinical practice, the training process targets the correlation of the frozen region contour with the target region shape, using medical imaging and accepted criteria for clinical success. The current study focuses on system design considerations, including a bioheat transfer model, simulation techniques, optimal cryoprobe layout strategy, and a simulation core framework. Two fundamentally different approaches were considered for the development of a cryosurgery simulator, based on a finite-elements (FE) commercial code (ANSYS) and a proprietary finite-difference (FD) code. Results of this study demonstrate that the FE simulator is superior in terms of geometric modeling, while the FD simulator is superior in terms of runtime. Benchmarking results further indicate that the FD simulator is superior in terms of usage of memory resources, pre-processing, parallel processing, and post-processing. It is envisioned that future integration of a human-interface module and clinical data into the proposed computer framework will make computerized training of cryosurgery a practical reality. PMID:23995400

Event-related potentials in impulsively aggressive juveniles: a retrospective chart-review study.

PubMed

Fisher, William; Ceballos, Natalie; Matthews, Dan; Fisher, Larry

2011-05-30

The assessment, treatment and management of aggressive youth represent a major clinical challenge facing pediatric mental health professionals today. Although a number of studies have examined physiological differences among aggressive patients vs. controls, the current literature lacks a comprehensive examination of the electroencephalographic activity of impulsively aggressive juveniles. The current study was designed to fill this void in the literature via a retrospective chart review of 80 male and female juveniles undergoing inpatient treatment for pathologically impulsive aggression. Clinical reports for mid- and late-latency event-related potentials (ERPs) were examined to determine their correlations with aggression characteristics, as well as any differential predictive utility of hemispheric differences and auditory vs. visual potentials. Results indicated that decrements of mid-latency potentials and ERPs evoked by auditory stimuli (vs. late-latency components and visual ERPs) were more highly predictive of aggressive behavior. No significant hemispheric differences were noted. Taken together, these results have theoretical significance for the etiology of impulsive aggression, and perhaps also clinical relevance for the treatment of this condition. Copyright © 2011 Elsevier Ltd. All rights reserved.

Psychiatric comorbidity in patients with spasmodic dysphonia: a controlled study

PubMed Central

Gündel, H; Busch, R; Ceballos‐Baumann, A; Seifert, E

2007-01-01

Objectives To study the prevalence of psychiatric comorbidity assessed by a structured clinical interview in patients with spasmodic dysphonia (SD) compared with patients suffering from vocal fold paralysis (VFP). Methods In 48 patients with SD and 27 patients with VFP, overall psychiatric comorbidity was studied prospectively using the Structured Clinical Interview for DSM‐IV Axis I disorders. Physical disability and psychometric variables were assessed with standardised self‐rating questionnaires. Results 41.7% of SD subjects and 19.5% of the control group met DSM‐IV clinical criteria for current psychiatric comorbidity (p<0.05). Significant predictors of psychiatric comorbidity in SD were severity of voice impairment and subjective assessment of “satisfaction with health”. As a limitation, the severity of voice impairment in patients with SD was nearly twice as high, and their illness had lasted nearly twice as long. Conclusions We found a high prevalence of psychiatric comorbidity in patients with SD. The significant correlation between current psychiatric comorbidity and the extent of voice pathology may point to an especially strong interaction between somatic and psychiatric complaints in SD. PMID:17615166

Central pathology review for phase III clinical trials: the enabling effect of virtual microscopy.

PubMed

Mroz, Pawel; Parwani, Anil V; Kulesza, Piotr

2013-04-01

Central pathology review (CPR) was initially designed as a quality control measure. The potential of CPR in clinical trials was recognized as early as in the 1960s and quickly became embedded as an integral part of many clinical trials since. To review the current experience with CPR in clinical trials, to summarize current developments in virtual microscopy, and to discuss the potential advantages and disadvantages of this technology in the context of CPR. A PubMed (US National Library of Medicine) search for published studies was conducted, and the relevant articles were reviewed, accompanied by the authors' experience at their practicing institution. The review of the available literature strongly suggests the growing importance of CPR both in the clinical trial setting as well as in second opinion cases. However, the currently applied approach significantly impedes efficient transfer of slides and patient data. Recent advances in imaging, digital microscopy, and Internet technologies suggest that the CPR process may be dramatically streamlined in the foreseeable future to allow for better diagnosis and quality assurance than ever before. In particular, whole slide imaging may play an important role in this process and result in a substantial reduction of the overall turnaround time required for slide review at the central location. Above all, this new approach may benefit the large clinical trials organized by oncology cooperative groups, since most of those trials involve complicated logistics owing to enrollment of large number of patients at several remotely located participating institutions.

Randomized, sham-controlled trial based on transcranial direct current stimulation and wrist robot-assisted integrated treatment on subacute stroke patients: Intermediate results.

PubMed

Mazzoleni, Stefano; Tran, Vi Do; Iardella, Laura; Dario, Paolo; Posteraro, Federico

2017-07-01

The main goal of this study is to analyse the effects of combined transcranial direct current stimulation (tDCS) and wrist robot-assisted therapy in subacute stroke patients. Twenty-four patients were included in this study and randomly assigned to the experimental (EG) or control group (CG). All participants performed wrist robot-assisted training a) in conjunction with tDCS (real stimulation for patients in EG) or b) without tDCS (sham stimulation for patients in CG). Clinical scales and kinematic parameters recorded by the robot were used for the assessment. Clinical outcome measures show a significant decrease in motor impairment after the treatment in both groups. Kinematic data show several significant improvements after the integrated therapy in both groups. However, no significant differences in both clinical outcome measures and kinematic parameters was found between two groups. The potential advantages of combined tDCS and wrist robot-assisted therapy in subacute stroke patients are still unclear.

Automatic analysis of nuclear-magnetic-resonance-spectroscopy clinical research data

NASA Astrophysics Data System (ADS)

Scott, Katherine N.; Wilson, David C.; Bruner, Angela P.; Lyles, Teresa A.; Underhill, Brandon; Geiser, Edward A.; Ballinger, J. Ray; Scott, James D.; Stopka, Christine B.

1998-03-01

A major problem of P-31 nuclear magnetic spectroscopy (MRS) in vivo applications is that when large data sets are acquired, the time invested in data reduction and analysis with currently available technologies may totally overshadow the time required for data acquisition. An example is out MRS monitoring of exercise therapy for patients with peripheral vascular disease. In these, the spectral acquisition requires 90 minutes per patient study, whereas data analysis and reduction requires 6-8 hours. Our laboratory currently uses the proprietary software SA/GE developed by General Electric. However, other software packages have similar limitations. When data analysis takes this long, the researcher does not have the rapid feedback required to ascertain the quality of data acquired nor the result of the study. This highly undesirable even in a research environment, but becomes intolerable in the clinical setting. The purpose of this report is to outline progress towards the development of an automated method for eliminating the spectral analysis burden on the researcher working in the clinical setting.

A Multifaceted Approach to RSV Vaccination.

PubMed

Blanco, Jorge C G; Boukhvalova, Marina S; Morrison, Trudy G; Vogel, Stefanie N

2018-05-17

Respiratory Syncytial Virus (RSV) is the leading cause of pneumonia and bronchiolitis in infants, resulting in significant morbidity and mortality worldwide. In addition, RSV infections occur throughout different ages, thus, maintaining the virus in circulation, and increasing health risk to more susceptible populations such as infants, the elderly, and the immunocompromised. To date, there is no vaccine approved to prevent RSV infection or minimize symptoms of infection. Current clinical trials for vaccines against RSV are being carried out in four very different populations. There are vaccines that target two different pediatric populations, infants 2 to 6 month of age and seropositive children over 6 months of age, as well as women (non-pregnant or pregnant in their third trimester). There are vaccines that target adult and elderly populations. In this review, we will present and discuss RSV vaccine candidates currently in clinical trials. We will describe the preclinical studies instrumental for their advancement, with the goal of introducing new preclinical models that may more accurately predict the outcome of clinical vaccine studies.

Why do we do as we do? Factors influencing clinical reasoning and decision-making among physiotherapists in an acute setting.

PubMed

Holdar, Ulrika; Wallin, Lars; Heiwe, Susanne

2013-12-01

Despite the current movement for health-care to become more informed by evidence, knowledge on effective implementation of evidence-based practice is scarce. To improve research application among physiotherapists, the process of implementation and clinical reasoning needs to be scrutinized. The aim of this study was to identify various experiences of factors that influence the physiotherapist's clinical reasoning in specialist care. A phenomenographic approach was chosen. Eleven physiotherapists at two acute care hospitals in nn. Data was obtained by observations and interviews. Phenomenographic data analysis identified various experiences of clinical decision-making. The Ethical Review Board of the nn approved the study. The observations and the interviews enabled identification of various experiences that influenced clinical decision-making. The physiotherapists' clinical reasoning was perceived to be constrained by contextual factors. The physiotherapists collected current information on the patient by using written and verbal information exchange and used this to generate an inner picture of the patient. By creating hypotheses that were accepted or rejected, they made decisions in advance of their interventions. The decisions were influenced by the individual characteristics of the physiotherapist, his/her knowledge and patient perceptions. Clinical reasoning is a complex and constantly evolving process. Contextual factors such as economy and politics are not easily changed, but factors such as the patient and the physiotherapist as a person are more tangible. Copyright © 2013 John Wiley & Sons, Ltd.

Interprofessional education in the clinical setting: A qualitative look at the preceptor's perspective in training advanced practice nursing students.

PubMed

Chen, Angel K; Rivera, Josette; Rotter, Nicole; Green, Emily; Kools, Susan

2016-11-01

With the shift towards interprofessional education to promote collaborative practice, clinical preceptors are increasingly working with trainees from various professions to provide patient care. It is unclear whether and how preceptors modify their existing precepting approach when working with trainees from other professions. There is little information on strategies for this type of precepting, and how preceptors may foster or impede interprofessional collaboration. The purpose of this qualitative description pilot study was to identify current methods preceptors use to teach trainees from other professions in the clinical setting, particularly advanced practice nursing and medical trainees, and to identify factors that support or impede this type of precepting. Data collected through observations and interviews were analyzed by the research team using thematic analysis procedures. Three major themes were identified: 1) a variety of teaching approaches and levels of engagement with trainees of different professions, 2) preceptor knowledge gaps related to curricula, goals, and scope of practice of trainees from other professions, and 3) administrative, structural and logistical elements that impact the success of precepting trainees from different professions in the clinical setting. This study has implications for faculty development and evaluation of current precepting practices in clinical settings. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

An integrative model for in-silico clinical-genomics discovery science.

PubMed

Lussier, Yves A; Sarkar, Indra Nell; Cantor, Michael

2002-01-01

Human Genome discovery research has set the pace for Post-Genomic Discovery Research. While post-genomic fields focused at the molecular level are intensively pursued, little effort is being deployed in the later stages of molecular medicine discovery research, such as clinical-genomics. The objective of this study is to demonstrate the relevance and significance of integrating mainstream clinical informatics decision support systems to current bioinformatics genomic discovery science. This paper is a feasibility study of an original model enabling novel "in-silico" clinical-genomic discovery science and that demonstrates its feasibility. This model is designed to mediate queries among clinical and genomic knowledge bases with relevant bioinformatic analytic tools (e.g. gene clustering). Briefly, trait-disease-gene relationships were successfully illustrated using QMR, OMIM, SNOMED-RT, GeneCluster and TreeView. The analyses were visualized as two-dimensional dendrograms of clinical observations clustered around genes. To our knowledge, this is the first study using knowledge bases of clinical decision support systems for genomic discovery. Although this study is a proof of principle, it provides a framework for the development of clinical decision-support-system driven, high-throughput clinical-genomic technologies which could potentially unveil significant high-level functions of genes.

Economic evaluation of nurse practitioner and clinical nurse specialist roles: A methodological review.

PubMed

Lopatina, Elena; Donald, Faith; DiCenso, Alba; Martin-Misener, Ruth; Kilpatrick, Kelley; Bryant-Lukosius, Denise; Carter, Nancy; Reid, Kim; Marshall, Deborah A

2017-07-01

Advanced practice nurses (e.g., nurse practitioners and clinical nurse specialists) have been introduced internationally to increase access to high quality care and to tackle increasing health care expenditures. While randomised controlled trials and systematic reviews have demonstrated the effectiveness of nurse practitioner and clinical nurse specialist roles, their cost-effectiveness has been challenged. The poor quality of economic evaluations of these roles to date raises the question of whether current economic evaluation guidelines are adequate when examining their cost-effectiveness. To examine whether current guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles. Our methodological review was informed by a qualitative synthesis of four sources of information: 1) narrative review of literature reviews and discussion papers on economic evaluation of advanced practice nursing roles; 2) quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials; 3) review of guidelines for economic evaluation; and, 4) input from an expert panel. The narrative literature review revealed several challenges in economic evaluations of advanced practice nursing roles (e.g., complexity of the roles, variability in models and practice settings where the roles are implemented, and impact on outcomes that are difficult to measure). The quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials identified methodological limitations of these studies. When we applied the Guidelines for the Economic Evaluation of Health Technologies: Canada to the identified challenges and limitations, discussed those with experts and qualitatively synthesized all findings, we concluded that standard guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles and should be routinely followed. However, seven out of 15 current guideline sections (describing a decision problem, choosing type of economic evaluation, selecting comparators, determining the study perspective, estimating effectiveness, measuring and valuing health, and assessing resource use and costs) may require additional role-specific considerations to capture costs and effects of these roles. Current guidelines for economic evaluation should form the foundation for economic evaluations of nurse practitioner and clinical nurse specialist roles. The proposed role-specific considerations, which clarify application of standard guidelines sections to economic evaluation of nurse practitioner and clinical nurse specialist roles, may strengthen the quality and comprehensiveness of future economic evaluations of these roles. Copyright © 2017 Elsevier Ltd. All rights reserved.

Nuclear medicine in clinical urology and nephrology

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

Tauxe, W.N.; Dubousky, E.V.

This book presents explanations of current procedures involving the kidney with information of the performance of each test, its rationale, and interpretation. The information covers all currently used radiopharmaceuticals, radiation dosimetry, instrumentation, test protocols, and mathematical principles of pathophysiology as they relate to nuclear medicine studies. Information is provided on which radiopharmaceutical, instrument, or computer application to use, and when.

Models for truth-telling in physician-patient encounters: what can we learn from Yoruba concept of Ooto?

PubMed

Ewuoso, Cornelius

2017-09-29

Empirical studies have now established that many patients make clinical decisions based on models other than Anglo American model of truth-telling and patient autonomy. Some scholars also add that current medical ethics frameworks and recent proposals for enhancing communication in health professional-patient relationship have not adequately accommodated these models. In certain clinical contexts where health professional and patients are motivated by significant cultural and religious values, these current frameworks cannot prevent communication breakdown, which can, in turn, jeopardize patient care, cause undue distress to a patient in certain clinical contexts or negatively impact his/her relationship with the community. These empirical studies have now recommended that additional frameworks developed around other models of truth-telling; and which take very seriously significant value-differences which sometimes exist between health professional and patients, as well as patient's cultural/religious values or relational capacities, must be developed. This paper contributes towards the development of one. Specifically, this study proposes a framework for truth-telling developed around African model of truth-telling by drawing insights from the communitarian concept of ootọ́ amongst the Yoruba people of south west Nigeria. I am optimistic that if this model is incorporated into current medical ethics codes and curricula, it will significantly enhance health professional-patient communication. © 2017 John Wiley & Sons Ltd.

A review of clinical trials of oxytocin in Prader-Willi syndrome.

PubMed

Rice, Lauren J; Einfeld, Stewart L; Hu, Nan; Carter, C Sue

2018-03-01

PWS is a severe developmental disability for which there is no known treatment. The oxytocin system is currently a primary target for intervention. The aim of this article is to review the evidence for the efficacy of intranasal oxytocin in PWS. To date, there have been five clinical trials of oxytocin in PWS. Four of these studies reported that oxytocin improved behaviors. However, each of these studies suffered important limitations that likely influenced the findings. For example, one study did not include a control group. Another study did not statistically analyze the effects of oxytocin on behavior. The final two studies used study-specific measures for which psychometric properties have not been assessed. Because of these limitations, the most appropriate conclusion to draw from the existing studies is that there is currently no convincing evidence that intranasal oxytocin improves symptoms of PWS. However, this does not mean that oxytocin is not involved in PWS. Rather, it suggests that further work is needed to understand the nature of the PWS oxytocin abnormality.

Efficiency improvement of dentistry clinics: introducing an intervening package for dentistry clinics, isfahan, iran.

PubMed

Alaghemandan, Hamed; Yarmohammadian, Mohammad H; Khorasani, Elahe; Rezaee, Sobhan

2014-02-01

In Isfahan, the second metropolitan in Iran, there are 1448 dentistry treatment centers that most of them are inefficient. Today, efficiency is the most important issue in health care centers as well as dentistry clinics. The goal of this research is to investigate the affordability and efficiency of dentistry clinics in Isfahan province, Iran. The current work is a quantitative research, designed in three methodological steps, including two surveys and experimental studies, for understanding current deficiencies of Iranian dentistry clinics. First, we ran a survey. Then, we analyzed the results of the questionnaires which guided us to find a particular intervening package to improve the efficiency of the clinics. At the second step, we chose an inefficient clinic named Mohtasham (Iran, Isfahan) to evaluate our intervening package. Based on what the interviewees answered, we mention the most important issues to be considered for improving the efficiency of dental clinics in Isfahan. By considering mentioned problematic issues, an intervening package was designed. This intervening package was applied in Mohtasham clinic, since June 2010. It improved the clinic's income from 16328 US$ with 4125 clients in 2010, to 420,000 US$ with 14784 patients in 2012. The proposed intervening package changed this clinic to an efficient and economic one. Its income increased 5.08 times and its patient's numbers grew 4.01 times simultaneously. In other words, Mohtasham's experience demonstrates the reliability of the package and its potentiality to be applied in macro level to improve other dentistry clinics.

Hemorrhage Control for Major Traumatic Vascular Injuries

DTIC Science & Technology

2017-10-01

subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. PLEASE DO...aims: 1) Determine current practice patterns for the treatment of patients with NCTH among 4 clinical sites using a retrospective study design (Phase...competency, and training issues for catheter-based hemorrhage control (Phase 1b); 3) Conduct a prospective 4-site observational study to test the hypothesis

Bone disease in multiple myeloma and precursor disease: novel diagnostic approaches and implications on clinical management

PubMed Central

Kristinsson, Sigurdur Y; Minter, Alex R; Korde, Neha; Tan, Esther; Landgren, Ola

2011-01-01

The manifestations of bone involvement in patients with multiple myeloma (MM) can have devastating clinical effects and increase mortality. Recent studies demonstrate that patients with the precursor conditions smoldering MM (SMM) and monoclonal gammopathy of undetermined significance (MGUS) show evidence of bone disease and increased risk of fractures. The understanding of the pathogenesis of bone disease in MM has expanded in recent years. The traditional skeletal survey will probably be replaced by newer and more sensitive imaging techniques, which may have a prognostic impact and change our definition of MGUS and SMM. Bisphosphonates are recommended to prevent skeletal events in patients with MM, and have also been studied in SMM and MGUS. This article summarizes the current knowledge of bone disease in plasma cell disorders, and discusses the current standard and future role of novel imaging techniques, as well as the evidence and current guidelines for bisphosphonates in MM, SMM and MGUS. PMID:21745013

The Current Studies of Education for a Traditional and Complementary Medicine in Malaysia

PubMed Central

Kim, Yun Jin

2017-01-01

The aim of this study is to understand the current tradition and complementary medicine (T&CM) education in Malaysia. We referred to literature regarding to traditional medicine education in Malaysia, and collected the information via website or interview with faculty of T&CM in universities/colleges and Division of T&CM, Ministry of Health, Malaysia. T&CM education in Malaysia has been following China’s T&CM systems for 50 years. Currently, Division of T&CM, Ministry of Health; and Ministry of Higher Education has approved 11 institutions to offer T&CM education. Students may major in Chinese herbal medicine, acupuncture, or other T&CM subjects. Generally, clinical training programs in China, Taiwan, or Australia include substantial proportion of clinical training. We report on the general information of T&CM education in Malaysia. This result would be the first-stage information for the establishment of a strategy regarding the enhancement of T&CM education in Malaysia. PMID:28853309

Fluctuation between grandiose and vulnerable narcissism.

PubMed

Gore, Whitney L; Widiger, Thomas A

2016-10-01

Current literature on narcissistic personality disorder has emphasized a distinction between grandiose and vulnerable narcissism. Some researchers have further suggested that narcissistic persons fluctuate between grandiose and vulnerable narcissism. However, this perception has been confined largely to clinical experience with no systematic research testing the hypothesis. Clinicians and clinical psychology professors in the current study identified 143 persons who fit a description of either a grandiose or a vulnerable narcissist and indicated the extent to which these persons ever demonstrated traits of the complementary variant. The results supported the fluctuation hypothesis, particularly for episodes of vulnerable narcissism in persons identified as a grandiose narcissist. Correlations of the grandiose and vulnerable narcissism traits with a brief five-factor model measure corroborated past trait descriptions of the 2 respective variants of narcissism. The results of the current study are compared with existing cross-sectional and longitudinal research, and suggestions for future research are provided. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Paternal history of mental illness associated with posttraumatic stress disorder among veterans.

PubMed

Shepherd-Banigan, Megan; Kelley, Michelle L; Katon, Jodie G; Curry, John F; Goldstein, Karen M; Brancu, Mira; Wagner, H Ryan; Fecteau, Teresa E; Van Houtven, Courtney H

2017-10-01

This study examined the association between parent and family reported history of non-PTSD mental illness (MI), PTSD specifically, and substance use problems, and participant clinical diagnosis of PTSD. Participants were drawn from the US Department of Veterans Affairs Mid-Atlantic Mental Illness Research, Education and Clinical Center (MIRECC) Post-Deployment Mental Health (PDMH) study (n = 3191), an ongoing multi-site cohort study of US Afghanistan and Iraq conflict era veterans. Participants who recalled a father history of PTSD had a 26-percentage point higher likelihood of meeting criteria for PTSD; while participants reporting any family history of PTSD had a 15-percentage point higher probability of endorsing symptoms consistent with PTSD. Mother history of substance use problems was associated with Veteran current PTSD, but results were sensitive to model specification. Current PTSD was not associated with family/parent history of non-PTSD mental illness, mother history of PTSD, or family/father history of substance use problems. Family history of PTSD may increase PTSD risk among veterans exposed to trauma, particularly when a father history is reported. Knowledge of family history could improve clinical decision-making for trauma-exposed individuals and allow for more effective targeting of programs and clinical services. Published by Elsevier B.V.

The relationship between lifestyle factors and clinical symptoms of bipolar disorder patients in a Chinese population.

PubMed

Huang, Jia; Yuan, Cheng Mei; Xu, Xian Rong; Wang, Yong; Hong, Wu; Wang, Zuo Wei; Su, You Song; Hu, Ying Yan; Cao, Lan; Wang, Yu; Chen, Jun; Fang, Yi Ru

2018-05-06

There is evidence that bipolar disorder (BD) patients with an unhealthy lifestyle have a worse course of illness. This study was designed to examine the extent to which lifestyle could influence the severity of clinical symptoms associated with BD. A total of 113 BD patients were recruited in this study. The lifestyle information including data on dietary patterns, physical activity, and sleep quality were collected using a self-rated questionnaire. The results showed that the consumption of whole grain, seafood, and dairy products were significantly negatively correlated with the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score. The consumption of sugar, soft drinks, and alcohol as well as being a current smoker were positively correlated with the severity of clinical symptoms. Multiple linear regression and binary logistic regression analyses demonstrated an independent negative correlation between both whole grain and dairy product consumption with the HAMD-17 score. The results from the current study suggested that lifestyle factors, especially dietary patterns, might be associated with clinical symptoms of BD. The association between the consumption of specific foods and severity of depressive symptoms may offer some useful information and further understanding of the role of lifestyle factors in the development of BD. Copyright © 2018. Published by Elsevier B.V.

Current status of endoscopic submucosal dissection for early gastric cancer in Korea: role and benefits.

PubMed

Kim, Sang Gyun; Lyu, Da Hyun; Park, Chan Mi; Lee, Na Rae; Kim, Jiyoung; Cha, Youngju; Jung, Hwoon-Yong

2018-06-21

This study was aimed to investigate the current clinical status of endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) in Korea based on a National Health Insurance (NHI) database between 2011 and 2014. The claims data of ESD for EGC in Korean NHI were reviewed using material codes of Health Insurance Review and Assessment Service between November 2011 and December 2014. The current clinical status was analyzed in terms of treatment pattern, in-hospital length of stay (LOS), total medical costs, and en bloc resection rate according to the hospital type. A total of 23,828 cases of ESD for EGC were evaluated. ESD was performed in 67.4% of cases in tertiary care hospitals, 31.8% in general hospitals, and 0.8% in hospitals, respectively. The median LOS was 5 days, and total median medical costs was approximately 1,300 US dollars. En bloc resection rate was 99%; 8.5% of cases underwent additional treatment within 90 days ESD, and 5.5% in 91 to 365 days after ESD. The clinical status was not significantly different according to the year and hospital type. A majority of ESD for EGC were performed in tertiary care hospitals in Korea. The clinical status showed excellent clinical outcomes and did not differ by the year and between the types of hospitals in Korea.

Perception survey on the introduction of clinical performance examination as part of the national nursing licensing examination in Korea.

PubMed

Shin, Su Jin; Kim, Yeong Kyeong; Suh, Soon-Rim; Jung, Duk Yoo; Kim, Yunju; Yim, Mi Kyoung

2017-01-01

The purpose of this study was to analyze opinions about the action plan for implementation of clinical performance exam as part of the national nursing licensing examination and presents the expected effects of the performance exam and aspects to consider regarding its implementation. This study used a mixed-methods design. Quantitative data were collected by a questionnaire survey, while qualitative data were collected by focus group interviews with experts. The survey targeted 200 nursing professors and clinical nurses with more than 5 years of work experience, and the focus group interviews were conducted with 28 of professors, clinical instructors, and nurses at hospitals. First, nursing professors and clinical specialists agreed that the current written tests have limitations in evaluating examinees' ability, and that the introduction of a clinical performance exam will yield positive results. Clinical performance exam is necessary to evaluate and improve nurses' work ability, which means that the implementation of a performance exam is advisable if its credibility and validity can be verified. Second, most respondents chose direct performance exams using simulators or standardized patients as the most suitable format of the test. In conclusion, the current national nursing licensing exam is somewhat limited in its ability to identify competent nurses. Thus, the time has come for us to seriously consider the introduction of a performance exam. The prerequisites for successfully implementing clinical performance exam as part of the national nursing licensing exam are a professional training process and forming a consortium to standardize practical training.

The National Cancer Institute–American Society of Clinical Oncology Cancer Trial Accrual Symposium: Summary and Recommendations

PubMed Central

Denicoff, Andrea M.; McCaskill-Stevens, Worta; Grubbs, Stephen S.; Bruinooge, Suanna S.; Comis, Robert L.; Devine, Peggy; Dilts, David M.; Duff, Michelle E.; Ford, Jean G.; Joffe, Steven; Schapira, Lidia; Weinfurt, Kevin P.; Michaels, Margo; Raghavan, Derek; Richmond, Ellen S.; Zon, Robin; Albrecht, Terrance L.; Bookman, Michael A.; Dowlati, Afshin; Enos, Rebecca A.; Fouad, Mona N.; Good, Marjorie; Hicks, William J.; Loehrer, Patrick J.; Lyss, Alan P.; Wolff, Steven N.; Wujcik, Debra M.; Meropol, Neal J.

2013-01-01

Introduction: Many challenges to clinical trial accrual exist, resulting in studies with inadequate enrollment and potentially delaying answers to important scientific and clinical questions. Methods: The National Cancer Institute (NCI) and the American Society of Clinical Oncology (ASCO) cosponsored the Cancer Trial Accrual Symposium: Science and Solutions on April 29-30, 2010 to examine the state of accrual science related to patient/community, physician/provider, and site/organizational influences, and identify new interventions to facilitate clinical trial enrollment. The symposium featured breakout sessions, plenary sessions, and a poster session including 100 abstracts. Among the 358 attendees were clinical investigators, researchers of accrual strategies, research administrators, nurses, research coordinators, patient advocates, and educators. A bibliography of the accrual literature in these three major areas was provided to participants in advance of the meeting. After the symposium, the literature in these areas was revisited to determine if the symposium recommendations remained relevant within the context of the current literature. Results: Few rigorously conducted studies have tested interventions to address challenges to clinical trials accrual. Attendees developed recommendations for improving accrual and identified priority areas for future accrual research at the patient/community, physician/provider, and site/organizational levels. Current literature continues to support the symposium recommendations. Conclusions: A combination of approaches addressing both the multifactorial nature of accrual challenges and the characteristics of the target population may be needed to improve accrual to cancer clinical trials. Recommendations for best practices and for future research developed from the symposium are provided. PMID:24130252

Perception survey on the introduction of clinical performance examination as part of the national nursing licensing examination in Korea

PubMed Central

2017-01-01

Purpose The purpose of this study was to analyze opinions about the action plan for implementation of clinical performance exam as part of the national nursing licensing examination and presents the expected effects of the performance exam and aspects to consider regarding its implementation. Methods This study used a mixed-methods design. Quantitative data were collected by a questionnaire survey, while qualitative data were collected by focus group interviews with experts. The survey targeted 200 nursing professors and clinical nurses with more than 5 years of work experience, and the focus group interviews were conducted with 28 of professors, clinical instructors, and nurses at hospitals. Results First, nursing professors and clinical specialists agreed that the current written tests have limitations in evaluating examinees’ ability, and that the introduction of a clinical performance exam will yield positive results. Clinical performance exam is necessary to evaluate and improve nurses’ work ability, which means that the implementation of a performance exam is advisable if its credibility and validity can be verified. Second, most respondents chose direct performance exams using simulators or standardized patients as the most suitable format of the test. Conclusion In conclusion, the current national nursing licensing exam is somewhat limited in its ability to identify competent nurses. Thus, the time has come for us to seriously consider the introduction of a performance exam. The prerequisites for successfully implementing clinical performance exam as part of the national nursing licensing exam are a professional training process and forming a consortium to standardize practical training. PMID:29129904

PARP Inhibitors in Ovarian Cancer.

PubMed

Mittica, Gloria; Ghisoni, Eleonora; Giannone, Gaia; Genta, Sofia; Aglietta, Massimo; Sapino, Anna; Valabrega, Giorgio

2018-03-05

Treatment of Epithelial Ovarian Cancer (EOC), historically based on surgery and platinum doublet chemotherapy, is associated with high risk of relapse and poor prognosis for recurrent disease. In this landscape, the innovative treatment with PARP inhibitors (PARPis) demonstrated an outstanding activity in EOC, and is currently changing clinical practice in BRCA mutant patients. To highlight the mechanism of action, pharmacokinetics, clinical activity, indications and current strategies of development of Olaparib, Niraparib, Rucaparib, Talazoparib and Veliparib, the 5 most relevant PARPis. We performed a review on Pubmed using 'ovarian cancer' and the name of each PARPi (PARP inhibitor) discussed in the review as Medical Subject Headings (MeSH) keywords. The same search was performed on "clinicaltrial.gov" to identify ongoing clinical trials and on "google.com/patents" and "uspto.gov" for recent patents exploring PARPIs in ovarian cancer. Olaparib, Niraparib and Rucaparib are already approved for treatment of recurrent EOC and their indications are partially overlapping. Talazoparib and Veliparib are promising PARPis, but currently under investigation in early phase trials. Several studies are evaluating PARPis in monotherapy or in associations, in a wide range of settings (i.e. first line, neoadjuvant, platinum-sensitive and resistant disease). PARPis are valuable options in patients with recurrent ovarian cancer with promising activity in different stages of this disease. Further studies are required to better define optimal clinical settings, predictors of response beyond BRCA mutations and strategies to overcome secondary resistance of PARPis therapy in EOC. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Weight management interventions in adults with intellectual disabilities and obesity: a systematic review of the evidence.

PubMed

Spanos, Dimitrios; Melville, Craig Andrew; Hankey, Catherine Ruth

2013-09-23

To evaluate the clinical effectiveness of weight management interventions in adults with intellectual disabilities (ID) and obesity using recommendations from current clinical guidelines for the first line management of obesity in adults. Full papers on lifestyle modification interventions published between 1982 to 2011 were sought by searching the Medline, Embase, PsycINFO and CINAHL databases. Studies were evaluated based on (1) intervention components, (2) methodology, (3) attrition rate (4) reported weight loss and (5) duration of follow up. Twenty two studies met the inclusion criteria. The interventions were classified according to inclusion of the following components: behaviour change alone, behaviour change plus physical activity, dietary advice or physical activity alone, dietary plus physical activity advice and multi-component (all three components). The majority of the studies had the same methodological limitations: no sample size justification, small heterogeneous samples, no information on randomisation methodologies. Eight studies were classified as multi-component interventions, of which one study used a 600 kilocalorie (2510 kilojoule) daily energy deficit diet. Study durations were mostly below the duration recommended in clinical guidelines and varied widely. No study included an exercise program promoting 225-300 minutes or more of moderate intensity physical activity per week but the majority of the studies used the same behaviour change techniques. Three studies reported clinically significant weight loss (≥ 5%) at six months post intervention. Current data indicate weight management interventions in those with ID differ from recommended practice and further studies to examine the effectiveness of multi-component weight management interventions for adults with ID and obesity are justified.

Weight management interventions in adults with intellectual disabilities and obesity: a systematic review of the evidence

PubMed Central

2013-01-01

To evaluate the clinical effectiveness of weight management interventions in adults with intellectual disabilities (ID) and obesity using recommendations from current clinical guidelines for the first line management of obesity in adults. Full papers on lifestyle modification interventions published between 1982 to 2011 were sought by searching the Medline, Embase, PsycINFO and CINAHL databases. Studies were evaluated based on 1) intervention components, 2) methodology, 3) attrition rate 4) reported weight loss and 5) duration of follow up. Twenty two studies met the inclusion criteria. The interventions were classified according to inclusion of the following components: behaviour change alone, behaviour change plus physical activity, dietary advice or physical activity alone, dietary plus physical activity advice and multi-component (all three components). The majority of the studies had the same methodological limitations: no sample size justification, small heterogeneous samples, no information on randomisation methodologies. Eight studies were classified as multi-component interventions, of which one study used a 600 kilocalorie (2510 kilojoule) daily energy deficit diet. Study durations were mostly below the duration recommended in clinical guidelines and varied widely. No study included an exercise program promoting 225–300 minutes or more of moderate intensity physical activity per week but the majority of the studies used the same behaviour change techniques. Three studies reported clinically significant weight loss (≥ 5%) at six months post intervention. Current data indicate weight management interventions in those with ID differ from recommended practice and further studies to examine the effectiveness of multi-component weight management interventions for adults with ID and obesity are justified. PMID:24060348

Validation of next generation sequencing technologies in comparison to current diagnostic gold standards for BRAF, EGFR and KRAS mutational analysis.

PubMed

McCourt, Clare M; McArt, Darragh G; Mills, Ken; Catherwood, Mark A; Maxwell, Perry; Waugh, David J; Hamilton, Peter; O'Sullivan, Joe M; Salto-Tellez, Manuel

2013-01-01

Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical diagnosis and therapeutic decision-making in oncology owing to its enhanced sensitivity in DNA mutation detection, fast-turnaround of samples in comparison to current gold standard methods and the potential to sequence a large number of cancer-driving genes at the one time. We aim to test the diagnostic accuracy of current NGS technology in the analysis of mutations that represent current standard-of-care, and its reliability to generate concomitant information on other key genes in human oncogenesis. Thirteen clinical samples (8 lung adenocarcinomas, 3 colon carcinomas and 2 malignant melanomas) already genotyped for EGFR, KRAS and BRAF mutations by current standard-of-care methods (Sanger Sequencing and q-PCR), were analysed for detection of mutations in the same three genes using two NGS platforms and an additional 43 genes with one of these platforms. The results were analysed using closed platform-specific proprietary bioinformatics software as well as open third party applications. Our results indicate that the existing format of the NGS technology performed well in detecting the clinically relevant mutations stated above but may not be reliable for a broader unsupervised analysis of the wider genome in its current design. Our study represents a diagnostically lead validation of the major strengths and weaknesses of this technology before consideration for diagnostic use.

Outcome Measures in Spinal Cord Injury

PubMed Central

Alexander, Marcalee S.; Anderson, Kim; Biering-Sorensen, Fin; Blight, Andrew R.; Brannon, Ruth; Bryce, Thomas; Creasey, Graham; Catz, Amiram; Curt, Armin; Donovan, William; Ditunno, John; Ellaway, Peter; Finnerup, Nanna B.; Graves, Daniel E.; Haynes, Beth Ann; Heinemann, Allen W.; Jackson, Amie B.; Johnston, Mark; Kalpakjian, Claire Z.; Kleitman, Naomi; Krassioukov, Andrei; Krogh, Klaus; Lammertse, Daniel; Magasi, Susan; Mulcahey, MJ; Schurch, Brigitte; Sherwood, Arthur; Steeves, John D.; Stiens, Steven; Tulsky, David S.; van Hedel, Hubertus J.A.; Whiteneck, Gale

2009-01-01

Study Design review by the Spinal Cord Outcomes Partnership Endeavor (SCOPE), which is a broad-based international consortium of scientists and clinical researchers representing academic institutions, industry, government agencies, not-for-profit organizations and foundations. Objectives assessment of current and evolving tools for evaluating human spinal cord injury (SCI) outcomes for both clinical diagnosis and clinical research studies. Methods a framework for the appraisal of evidence of metric properties was used to examine outcome tools or tests for accuracy, sensitivity, reliability and validity for human SCI. Results imaging, neurological, functional, autonomic, sexual health, bladder/bowel, pain, and psycho-social tools were evaluated. Several specific tools for human SCI studies have or are being developed to allow the more accurate determination for a clinically meaningful benefit (improvement in functional outcome or quality of life) being achieved as a result of a therapeutic intervention. Conclusion significant progress has been made, but further validation studies are required to identify the most appropriate tools for specific targets in a human SCI study or clinical trial. PMID:19381157

Pituitary dysfunction following traumatic brain injury: clinical perspectives

PubMed Central

Tanriverdi, Fatih; Kelestimur, Fahrettin

2015-01-01

Traumatic brain injury (TBI) is a well recognized public health problem worldwide. TBI has previously been considered as a rare cause of hypopituitarism, but an increased prevalence of neuroendocrine dysfunction in patients with TBI has been reported during the last 15 years in most of the retrospective and prospective studies. Based on data in the current literature, approximately 15%–20% of TBI patients develop chronic hypopituitarism, which clearly suggests that TBI-induced hypopituitarism is frequent in contrast with previous assumptions. This review summarizes the current data on TBI-induced hypopituitarism and briefly discusses some clinical perspectives on post-traumatic anterior pituitary hormone deficiency. PMID:26251600

[Personalised treatment of disorders in the use of alcohol and nicotine].

PubMed

Dom, G; van den Brink, W; Schellekens, A

There is an increasing interest in personalised treatment based on the individual characteristics of the patient in the field of addiction care. To summarise the present state of staging and profiling possibilities within addiction care. A literature review highlighting the current scientific findings and proposing a theoretical model. There are currently an insufficient number of studies to allow for a fully data driven model. However, research identifying biomarkers is growing and some clinically implementable findings can be put forward. a personalised approach in addiction care holds promise. There is an urgent need for better and larger datasets to empirically support models aimed for clinical use.

Characteristics of erythrocyte-derived microvesicles and its relation with atherosclerosis.

PubMed

Li, Kai-Yin; Zheng, Lei; Wang, Qian; Hu, Yan-Wei

2016-12-01

Microvesicles are formed under many circumstances, especially in atheromatous plaques. Erythrocyte-derived microvesicles (ErMVs) have been proved to promote atherosclerosis by promoting hypercoagulation, mediating inflammation and inducing cell adhesion. Several clinical studies have reported potential roles of ErMVs in cardiovascular disease diagnosis, but the current understanding of ErMVs remains insufficient. In this paper, we will review current research on the formation and degradation of ErMVs and the possible effects of ErMVs in atherosclerosis, discuss potential clinical applications in cardiovascular disease, and hope to raise awareness of the relation with atherosclerosis. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

A systematic review on pharmacogenetics in cardiovascular disease: is it ready for clinical application?

PubMed

Verschuren, Jeffrey J W; Trompet, Stella; Wessels, Judith A M; Guchelaar, Henk-Jan; de Maat, Moniek P M; Simoons, Maarten L; Jukema, J Wouter

2012-01-01

Pharmacogenetics is the search for heritable genetic polymorphisms that influence responses to drug therapy. The most important application of pharmacogenetics is to guide choosing agents with the greatest potential of efficacy and smallest risk of adverse drug reactions. Many studies focusing on drug-gene interactions have been published in recent years, some of which led to adaptation of FDA recommendations, indicating that we are on the verge of the clinical application of genetic information in drug therapy. This systematic review provides a comprehensive overview of the current knowledge on pharmacogenetics of all major drug classes currently used in the treatment of cardiovascular diseases.

CT myocardial perfusion imaging: current status and future perspectives.

PubMed

Yang, Dong Hyun; Kim, Young-Hak

2017-07-01

Computed tomography myocardial perfusion (CTP) combined with coronary computed tomography angiography (CCTA) may constitute a "1-stop shop" for the noninvasive diagnosis of hemodynamically significant coronary stenosis during a single CT examination. CTP shows high diagnostic performance and provides incremental value over CCTA for the detection of hemodynamically significant coronary stenosis in patients with a high Agatston calcium score or coronary artery stents. Future studies should determine the optimal protocol and clinical value of CTP for guiding revascularization strategy and prognostication. In this article, we review the current status and future perspectives of CTP, focusing on technical considerations, clinical applications, and future research topics.

Gene Editing: Regulatory and Translation to Clinic.

PubMed

Ando, Dale; Meyer, Kathleen

2017-10-01

The clinical application and regulatory strategy of genome editing for ex vivo cell therapy is derived from the intersection of two fields of study: viral vector gene therapy trials; and clinical trials with ex vivo purification and engraftment of CD34 +  hematopoietic stem cells, T cells, and tumor cell vaccines. This article covers the regulatory and translational preclinical activities needed for a genome editing clinical trial modifying hematopoietic stem cells and the genesis of this current strategy based on previous clinical trials using genome-edited T cells. The SB-728 zinc finger nuclease platform is discussed because this is the most clinically advanced genome editing technology. Copyright © 2017 Elsevier Inc. All rights reserved.

A Review of Clinical Data for Currently Approved Hysteroscopic Sterilization Procedures

PubMed Central

Basinski, Cindy M

2010-01-01

Two hysteroscopic permanent sterilization procedures are approved for use in the United States: Essure® Permanent Birth Control System (Conceptus Incorporated, Mountain View, CA) and Adiana® Permanent Contraception (Hologic, Inc., Bedford, MA). This review compares the clinical trial data for these procedures. A notable difference is the resultant clinical pregnancy risk. The clinical trials for the Essure procedure have reported no pregnancies in 643 relying women in the 9 years since initiation of the studies. The clinical trial for the Adiana procedure has reported 12 pregnancies in 570 relying women in nearly 5 years of collected data. Other clinical outcome parameters concerning Essure and Adiana are examined in this review. PMID:21364861

Dual-Energy CT: New Horizon in Medical Imaging

PubMed Central

Goo, Jin Mo

2017-01-01

Dual-energy CT has remained underutilized over the past decade probably due to a cumbersome workflow issue and current technical limitations. Clinical radiologists should be made aware of the potential clinical benefits of dual-energy CT over single-energy CT. To accomplish this aim, the basic principle, current acquisition methods with advantages and disadvantages, and various material-specific imaging methods as clinical applications of dual-energy CT should be addressed in detail. Current dual-energy CT acquisition methods include dual tubes with or without beam filtration, rapid voltage switching, dual-layer detector, split filter technique, and sequential scanning. Dual-energy material-specific imaging methods include virtual monoenergetic or monochromatic imaging, effective atomic number map, virtual non-contrast or unenhanced imaging, virtual non-calcium imaging, iodine map, inhaled xenon map, uric acid imaging, automatic bone removal, and lung vessels analysis. In this review, we focus on dual-energy CT imaging including related issues of radiation exposure to patients, scanning and post-processing options, and potential clinical benefits mainly to improve the understanding of clinical radiologists and thus, expand the clinical use of dual-energy CT; in addition, we briefly describe the current technical limitations of dual-energy CT and the current developments of photon-counting detector. PMID:28670151

Sex differences in stroke therapies.

PubMed

Sohrabji, Farida; Park, Min Jung; Mahnke, Amanda H

2017-01-02

Stroke is the fifth leading cause of death and acquired disability in aged populations. Women are disproportionally affected by stroke, having a higher incidence and worse outcomes than men. Numerous preclinical studies have discovered novel therapies for the treatment of stroke, but almost all of these have been shown to be unsuccessful in clinical trials. Despite known sex differences in occurrence and severity of stroke, few preclinical or clinical therapeutics take into account possible sex differences in treatment. Reanalysis of data from studies of tissue plasminogen activator (tPA), the only currently FDA-approved stroke therapy, has shown that tPA improves stroke outcomes for both sexes and also shows sexual dimorphism by more robust improvement in stroke outcome in females. Experimental evidence supports the inclusion of sex as a variable in the study of a number of novel stroke drugs and therapies, including preclinical studies of anti-inflammatory drugs (minocycline), stimulators of cell survival (insulin-like growth factor-1), and inhibitors of cell death pathways (pharmacological inhibition of poly[ADP-ribose] polymerase-1, nitric oxide production, and caspase activation) as well as in current clinical trials of stem cell therapy and cortical stimulation. Overall, study design and analysis in clinical trials as well as in preclinical studies must include both sexes equally, consider possible sex differences in the analyses, and report the differences/similarities in more systematic/structured ways to allow promising therapies for both sexes and increase stroke recovery. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Detecting Breech Presentation Before Labour: Lessons From a Low-Risk Maternity Clinic.

PubMed

Ressl, Bill; O'Beirne, Maeve

2015-08-01

Evaluation of fetal position is an important part of prenatal care. A woman with a breech presentation may need referral for external cephalic version, for assisted breech delivery, or to schedule a Caesarean section. In many centres, a breech presentation undetected until labour will result in an emergency Caesarean section, a less desirable alternative for both the mother and the health care system. The anecdotal reports of undiagnosed breech presentations at a busy maternity clinic prompted a study to quantify the missed breech presentations and to evaluate the effectiveness of the current detection process, with the aim of allowing no more than 1% of breech presentations to remain undetected until labour. We performed a retrospective analysis of 102 breech deliveries over a 14 month period to quantify missed breech presentations, and used a prospective physician survey documenting how fetal presentation was determined at 186 prenatal visits over four months to analyze the current detection process. We found that approximately 8% of breech presentations were undetected until labour. We concluded that within the limitations of the small sample size evaluated, the current practice of using a vaginal examination to verify fetal presentation determined by abdominal palpation (Leopold's manoeuvres) may not be more accurate than abdominal palpation alone. The current detection process resulted in an unacceptably high rate of missed breech presentations. The results of this study prompted the clinic's acquisition of bedside ultrasound capability to assess fetal position.

Benefits of dietary fiber in clinical nutrition.

PubMed

Klosterbuer, Abby; Roughead, Zamzam Fariba; Slavin, Joanne

2011-10-01

Dietary fiber is widely recognized as an important part of a healthy diet and is a common addition to enteral nutrition (EN) formulas. Fiber sources differ in characteristics such as solubility, fermentability, and viscosity, and it is now well known that different types of fiber exert varying physiological effects in the body. Clinical studies suggest fiber can exert a wide range of benefits in areas such as bowel function, gut health, immunity, blood glucose control, and serum lipid levels. Although early clinical nutrition products contained fiber from a single source, it is now thought that blends of fiber from multiple sources more closely resemble a regular diet and may provide a greater range of benefits for the patient. Current recommendations support the use of dietary fiber in clinical nutrition when no contraindications exist, but little information exists about which types and combinations of fibers provide the relevant benefit in certain patient populations. This article summarizes the different types of fiber commonly added to EN products and reviews the current literature on the use of fiber blends in clinical nutrition.

Studying the effects of classic hallucinogens in the treatment of alcoholism: rationale, methodology, and current research with psilocybin.

PubMed

Bogenschutz, Michael P

2013-03-01

Recent developments in the study of classic hallucinogens, combined with a re-appraisal of the older literature, have led to a renewal of interest in possible therapeutic applications for these drugs, notably their application in the treatment of addictions. This article will first provide a brief review of the research literature providing direct and indirect support for the possible therapeutic effects of classic hallucinogens such as psilocybin and lysergic acid diethylamide (LSD) in the treatment of addictions. Having provided a rationale for clinical investigation in this area, we discuss design issues in clinical trials using classic hallucinogens, some of which are unique to this class of drug. We then discuss the current status of this field of research and design considerations in future randomized trials.

Effect of ion implantation on the tribology of metal-on-metal hip prostheses.

PubMed

Bowsher, John G; Hussain, Azad; Williams, Paul; Nevelos, Jim; Shelton, Julia C

2004-12-01

Nitrogen ion implantation (which considerably hardens the surface of the bearing) may represent one possible method of reducing the wear of metal-on-metal (MOM) hip bearings. Currently there are no ion-implanted MOM bearings used clinically. Therefore a physiological hip simulator test was undertaken using standard test conditions, and the results compared to previous studies using the same methods. N2-ion implantation of high carbon cast Co-Cr-Mo-on-Co-Cr-Mo hip prostheses increased wear by 2-fold during the aggressive running-in phase compared to untreated bearing surfaces, plus showing no wear reductions during steady-state conditions. Although 2 specimens were considered in the current study, it would appear that ion implantation has no clinical benefit for MOM.

Advances of high intensity focused ultrasound (HIFU) for pancreatic cancer.

PubMed

Xiaoping, Li; Leizhen, Zheng

2013-11-01

High intensity focused ultrasound (HIFU) is a novel therapeutic modality. Several preclinical and clinical studies have investigated the safety and efficacy of HIFU for treating solid tumours, including pancreatic cancer. Preliminary studies suggest that HIFU may be useful for the palliative therapy of cancer-related pain in patients with unresectable pancreatic cancer. This review provides a brief overview of HIFU, describes current clinical applications of HIFU for pancreatic cancer, and discusses future applications and challenges.

The Use of Mobile Phone and Medical Apps among General Practitioners in Hangzhou City, Eastern China.

PubMed

Liu, Ying; Ren, Wen; Qiu, Yan; Liu, Juanjuan; Yin, Pei; Ren, Jingjing

2016-05-24

Mobile phones and mobile phone apps have expanded new forms of health professionals' work. There are many studies on the use of mobile phone apps for different specialists. However, there are no studies on the current use of mobile phone apps among general practitioners (GPs). The objective of the study was to investigate the extent to which GPs own smartphones with apps and use them to aid their clinical activities. A questionnaire survey of GPs was undertaken in Hangzhou, Eastern China. Data probing GPs' current use of medical apps in their clinical activities and factors influencing app use were collected and analyzed 125 GPs participated in the survey. 90.4% of GPs owned a mobile phone, with 48.7% owning an iPhone and 47.8% owning an Android phone. Most mobile phone owners had 1-3 medical-related apps, with very few owning more than 4. There was no difference in number of apps between iPhone and Android owners (χ(2)=1.388, P=0.846). 36% of GPs reported using medical-related apps on a daily basis. The majority of doctors reported using apps to aid clinical activities less than 30 minutes per day. A high level of mobile phone ownership and usage among GPs was found in this study, but few people chose medical-related apps to support their clinical practice.

Regenerative medicine in Brazil: small but innovative.

PubMed

McMahon, Dominique S; Singer, Peter A; Daar, Abdallah S; Thorsteinsdóttir, Halla

2010-11-01

Although Brazil has received attention for conducting one of the world's largest stem cell clinical trials for heart disease, little has been published regarding Brazil's regenerative medicine (RM) sector. Here we present a comprehensive case study of RM in Brazil, including analysis of the current activity, the main motivations for engaging in RM and the remaining challenges to development in this field. Our case study is primarily based on semi-structured interviews with experts on RM in Brazil, including researchers, policymakers, clinicians, representatives of firms and regulators. Driven by domestic health needs and strategic government support, Brazil is producing innovative RM research, particularly for clinical research in cardiology, orthopedics, diabetes and neurology. We describe the main RM research currently taking place in Brazil, as well as some of the economic, regulatory and policy events that have created a favorable environment for RM development. Brazilian RM researchers need to overcome several formidable challenges to research: research funding is inconsistent, importation of materials is costly and slow, and weak linkages between universities, hospitals and industry impede translational research. Although Brazil's contribution to the RM sector is small, its niche emphasis on clinical applications may become of global importance, particularly if Brazil manages to address the challenges currently impinging on RM innovation.

Recommendations for research priorities in breast cancer by the Coalition of Cancer Cooperative Groups Scientific Leadership Council: systemic therapy and therapeutic individualization.

PubMed

Sparano, Joseph A; Hortobagyi, Gabriel N; Gralow, Julie R; Perez, Edith A; Comis, Robert L

2010-02-01

Over 9,000 women with breast cancer are enrolled annually on clinical trials sponsored by the National Cancer Institute (NCI), accounting for about one-third of all patients enrolled on NCI-sponsored trials. Thousands are also enrolled on pharmaceutical-sponsored studies. Although breast cancer mortality rates have recently declined for the first time in part due to systemic therapeutic advances, coordinated efforts will be necessary to maintain this trend. The Coalition of Cancer Cooperative Groups convened the Scientific Leadership Council in breast cancer (BC), an expert panel, to identify priorities for future research and current trials with greatest practice-changing potential. Panelists formed a consensus on research priorities for chemoprevention, development and application of molecular markers for predicting therapeutic benefit and toxicity, intermediate markers predictive of therapeutic effect, pathogenesis-based therapeutic approaches, utilization of adaptive designs requiring fewer patients to achieve objectives, special and minority populations, and effects of BC and treatment on patients and families. Panelists identified 13 ongoing studies as High Priority and identified gaps in the current trial portfolio. We propose priorities for current and future clinical breast cancer research evaluating systemic therapies that may serve to improve the efficiency of clinical trials, identify individuals most likely to derive therapeutic benefit, and prioritize therapeutic strategies.

Current practices for evaluation of resonance disorders in North America.

PubMed

Stelck, Elizabeth Huebert; Boliek, Carol A; Hagler, Paul H; Rieger, Jana M

2011-02-01

Improving treatment outcomes for people with resonance problems (due to velopharyngeal disorders) is a priority for many speech-language pathologists (SLPs), but there exists a limited understanding of the practices SLPs are using to assess and monitor therapeutic effects in this population. The current study was designed to answer the following questions: (1) What are current clinical practices versus best practices for assessing resonance disorders, tracking therapeutic effects, and determining discharge criteria? (2) What assessment practices would SLPs prefer to use with clients who have resonance disorders? (3) What are barriers to SLPs' use of best practices? and (4) What effects do SLP demographics have on clinical practices? Thirty-eight SLPs, specializing in the treatment of resonance disorders, participated in the study. Responses were compared with best practice recommendations derived from the literature. Most clinicians were using low-tech assessment tools, often because they lacked access to high-tech tools. Demographics and training did not affect clinical assessment practices. There is a need to increase the availability of high-tech assessment tools to SLPs practicing in the area of resonance disorders, as consistent use of sophisticated assessment devices would exemplify contemporary thinking about the transfer of knowledge to practice in this area. © Thieme Medical Publishers.

Can time-averaged flow boundary conditions be used to meet the clinical timeline for Fontan surgical planning?

PubMed

Wei, Zhenglun Alan; Trusty, Phillip M; Tree, Mike; Haggerty, Christopher M; Tang, Elaine; Fogel, Mark; Yoganathan, Ajit P

2017-01-04

Cardiovascular simulations have great potential as a clinical tool for planning and evaluating patient-specific treatment strategies for those suffering from congenital heart diseases, specifically Fontan patients. However, several bottlenecks have delayed wider deployment of the simulations for clinical use; the main obstacle is simulation cost. Currently, time-averaged clinical flow measurements are utilized as numerical boundary conditions (BCs) in order to reduce the computational power and time needed to offer surgical planning within a clinical time frame. Nevertheless, pulsatile blood flow is observed in vivo, and its significant impact on numerical simulations has been demonstrated. Therefore, it is imperative to carry out a comprehensive study analyzing the sensitivity of using time-averaged BCs. In this study, sensitivity is evaluated based on the discrepancies between hemodynamic metrics calculated using time-averaged and pulsatile BCs; smaller discrepancies indicate less sensitivity. The current study incorporates a comparison between 3D patient-specific CFD simulations using both the time-averaged and pulsatile BCs for 101 Fontan patients. The sensitivity analysis involves two clinically important hemodynamic metrics: hepatic flow distribution (HFD) and indexed power loss (iPL). Paired demographic group comparisons revealed that HFD sensitivity is significantly different between single and bilateral superior vena cava cohorts but no other demographic discrepancies were observed for HFD or iPL. Multivariate regression analyses show that the best predictors for sensitivity involve flow pulsatilities, time-averaged flow rates, and geometric characteristics of the Fontan connection. These predictors provide patient-specific guidelines to determine the effectiveness of analyzing patient-specific surgical options with time-averaged BCs within a clinical time frame. Copyright © 2016 Elsevier Ltd. All rights reserved.

Family History, Gender, and Eating and Body Image Concerns in University Students Seeking Counseling Services

ERIC Educational Resources Information Center

Cavallini, Adriane Q.; Erekson, David M.; Steinberg, Rachel M.; Clayson, Rachelle A.; Albright, Dallin D.

2018-01-01

Family history events have been shown to be reliable predictors of eating and body image concerns; however, little is known regarding how family history events compare in a clinical sample, or if these events differ by gender. The current study addresses this paucity, focusing on 3,129 university students seeking clinical services. Having a family…

A Parent-Mediated Intervention that Targets Responsive Parental Behaviors Increases Attachment Behaviors in Children with ASD: Results from a Randomized Clinical Trial

ERIC Educational Resources Information Center

Siller, Michael; Swanson, Meghan; Gerber, Alan; Hutman, Ted; Sigman, Marian

2014-01-01

The current study is a randomized clinical trial evaluating the efficacy of Focused Playtime Intervention (FPI) in a sample of 70 children with Autism Spectrum Disorder. This parent-mediated intervention has previously been shown to significantly increase responsive parental communication (Siller et al. in "J Autism Dev Disord"…

Incremental Criterion Validity of the WJ-III COG Clinical Clusters: Marginal Predictive Effects beyond the General Factor

ERIC Educational Resources Information Center

McGill, Ryan J.

2015-01-01

The current study examined the incremental validity of the clinical clusters from the Woodcock-Johnson III Tests of Cognitive Abilities (WJ-III COG) for predicting scores on the Woodcock-Johnson III Tests of Achievement (WJ-III ACH). All participants were children and adolescents (N = 4,722) drawn from the nationally representative WJ-III…

How Do Students with Dyslexia Perform in Extended Matching Questions, Short Answer Questions and Observed Structured Clinical Examinations?

ERIC Educational Resources Information Center

Gibson, Sandra; Leinster, Samuel

2011-01-01

There are an increasing number of students with learning difficulties attending university, and currently much debate about the suitability and ability of students with dyslexia at both medical school and once they graduate into clinical practice. In this study we describe the performance of students with dyslexia compared to fellow students in…

Co-Occurrence of Conduct Disorder and Depression in a Clinic-Based Sample of Boys with ADHD

ERIC Educational Resources Information Center

Drabick, Deborah A. G.; Gadow, Kenneth D.; Sprafkin, Joyce

2006-01-01

Background: Children with attention-deficit/hyperactivity disorder (ADHD) are at risk for the development of comorbid conduct disorder (CD) and depression. The current study examined potential psychosocial risk factors for CD and depression in a clinic-based sample of 203 boys (aged 6-10 years) with ADHD. Methods: The boys and their mothers…

MREIT experiments with 200 µA injected currents: a feasibility study using two reconstruction algorithms, SMM and harmonic B(Z).

PubMed

Arpinar, V E; Hamamura, M J; Degirmenci, E; Muftuler, L T

2012-07-07

Magnetic resonance electrical impedance tomography (MREIT) is a technique that produces images of conductivity in tissues and phantoms. In this technique, electrical currents are applied to an object and the resulting magnetic flux density is measured using magnetic resonance imaging (MRI) and the conductivity distribution is reconstructed using these MRI data. Currently, the technique is used in research environments, primarily studying phantoms and animals. In order to translate MREIT to clinical applications, strict safety standards need to be established, especially for safe current limits. However, there are currently no standards for safe current limits specific to MREIT. Until such standards are established, human MREIT applications need to conform to existing electrical safety standards in medical instrumentation, such as IEC601. This protocol limits patient auxiliary currents to 100 µA for low frequencies. However, published MREIT studies have utilized currents 10-400 times larger than this limit, bringing into question whether the clinical applications of MREIT are attainable under current standards. In this study, we investigated the feasibility of MREIT to accurately reconstruct the relative conductivity of a simple agarose phantom using 200 µA total injected current and tested the performance of two MREIT reconstruction algorithms. These reconstruction algorithms used are the iterative sensitivity matrix method (SMM) by Ider and Birgul (1998 Elektrik 6 215-25) with Tikhonov regularization and the harmonic B(Z) proposed by Oh et al (2003 Magn. Reason. Med. 50 875-8). The reconstruction techniques were tested at both 200 µA and 5 mA injected currents to investigate their noise sensitivity at low and high current conditions. It should be noted that 200 µA total injected current into a cylindrical phantom generates only 14.7 µA current in imaging slice. Similarly, 5 mA total injected current results in 367 µA in imaging slice. Total acquisition time for 200 µA and 5 mA experiments was about 1 h and 8.5 min, respectively. The results demonstrate that conductivity imaging is possible at low currents using the suggested imaging parameters and reconstructing the images using iterative SMM with Tikhonov regularization, which appears to be more tolerant to noisy data than harmonic B(Z).

Complex posttraumatic stress disorder: The need to consolidate a distinct clinical syndrome or to reevaluate features of psychiatric disorders following interpersonal trauma?

PubMed

Giourou, Evangelia; Skokou, Maria; Andrew, Stuart P; Alexopoulou, Konstantina; Gourzis, Philippos; Jelastopulu, Eleni

2018-03-22

Complex posttraumatic stress disorder (Complex PTSD) has been recently proposed as a distinct clinical entity in the WHO International Classification of Diseases, 11 th version, due to be published, two decades after its first initiation. It is described as an enhanced version of the current definition of PTSD, with clinical features of PTSD plus three additional clusters of symptoms namely emotional dysregulation, negative self-cognitions and interpersonal hardship, thus resembling the clinical features commonly encountered in borderline personality disorder (BPD). Complex PTSD is related to complex trauma which is defined by its threatening and entrapping context, generally interpersonal in nature. In this manuscript, we review the current findings related to traumatic events predisposing the above-mentioned disorders as well as the biological correlates surrounding them, along with their clinical features. Furthermore, we suggest that besides the present distinct clinical diagnoses (PTSD; Complex PTSD; BPD), there is a cluster of these comorbid disorders, that follow a continuum of trauma and biological severity on a spectrum of common or similar clinical features and should be treated as such. More studies are needed to confirm or reject this hypothesis, particularly in clinical terms and how they correlate to clinical entities' biological background, endorsing a shift from the phenomenologically only classification of psychiatric disorders towards a more biologically validated classification.

Ultrasonography in diagnosing clinically occult groin hernia: systematic review and meta-analysis.

PubMed

Kwee, Robert M; Kwee, Thomas C

2018-05-14

To provide an updated systematic review on the performance of ultrasonography (US) in diagnosing clinically occult groin hernia. A systematic search was performed in MEDLINE and Embase. Methodological quality of included studies was assessed. Accuracy data of US in detecting clinically occult groin hernia were extracted. Positive predictive value (PPV) was pooled with a random effects model. For studies investigating the performance of US in hernia type classification (inguinal vs femoral), correctly classified proportion was assessed. Sixteen studies were included. In the two studies without verification bias, sensitivities were 29.4% [95% confidence interval (CI), 15.1-47.5%] and 90.9% (95% CI, 70.8-98.9%); specificities were 90.0% (95% CI, 80.5-95.9%) and 90.6% (95% CI, 83.0-95.6%). Verification bias or a variation of it (i.e. study limited to only subjects with definitive proof of disease status) was present in all other studies. Sensitivity, specificity, and negative predictive value (NPV) were not pooled. PPV ranged from 58.8 to 100%. Pooled PPV, based on data from ten studies with low risk of bias and no applicability concerns with respect to patient selection, was 85.6% (95% CI, 76.5-92.7%). Proportion of correctly classified hernias, based on data from four studies, ranged between 94.4% and 99.1%. Sensitivity, specificity and NPV of US in detecting clinically occult groin hernia cannot reliably be determined based on current evidence. Further studies are necessary. Accuracy may strongly depend on the examiner's skills. PPV is high. Inguinal and femoral hernias can reliably be differentiated by US. • Sensitivity, specificity and NPV of ultrasound in detecting clinically occult groin hernia cannot reliably be determined based on current evidence. • Accuracy may strongly depend on the examiner's skills. • PPV of US in detection of clinically occult groin hernia is high [pooled PPV of 85.6% (95% confidence interval, 76.5-92.7%)]. • US has very high performance in correctly differentiating between clinically occult inguinal and femoral hernia (correctness of 94.4- 99.1%).

The RooPfs study to assess whether improved housing provides additional protection against clinical malaria over current best practice in The Gambia: study protocol for a randomized controlled study and ancillary studies.

PubMed

Pinder, Margaret; Conteh, Lesong; Jeffries, David; Jones, Caroline; Knudsen, Jakob; Kandeh, Balla; Jawara, Musa; Sicuri, Elisa; D'Alessandro, Umberto; Lindsay, Steve W

2016-06-03

In malaria-endemic areas, residents of modern houses have less malaria than those living in traditional houses. This study will determine if modern housing provides incremental protection against clinical malaria over the current best practice of long-lasting insecticidal nets (LLINs) and prompt treatment in The Gambia, determine the incremental cost-effectiveness of the interventions, and analyze the housing market in The Gambia. A two-armed, household, cluster-randomized, controlled study will be conducted to assess whether improved housing and LLINs combine to provide better protection against clinical malaria in children than LLINs alone in The Gambia. The unit of randomization will be the household, defined as a house and its occupants. A total of 800 households will be enrolled and will receive LLINs, and 400 will receive improved housing before clinical follow-up. One child aged 6 months to 13 years will be enrolled from each household and followed for clinical malaria using active case detection to estimate malaria incidence for two malaria transmission seasons. Episodes of clinical malaria will be the primary endpoint. Study children will be surveyed at the end of each transmission season to estimate the prevalence of Plasmodium falciparum infection, parasite density, and the prevalence of anemia. Exposure to malaria parasites will be assessed using light traps, followed by detection of Anopheles gambiae species and sporozoite infection. Ancillary economic and social science studies will undertake a cost-effectiveness analysis and use qualitative and participatory methods to explore the acceptability of the housing modifications and to design strategies for scaling-up housing interventions. The study is the first of its kind to measure the efficacy of housing on reducing clinical malaria, assess the incremental cost-effectiveness of improved housing, and identify mechanisms for scaling up housing interventions. Trial findings will help inform policy makers on improved housing for malaria control in sub-Saharan Africa. ISRCTN Registry, ISRCTN02622179 . Registered on 23 September 2014.

Analysis of neurodegenerative Mendelian genes in clinically diagnosed Alzheimer Disease

PubMed Central

Fernández, Maria Victoria; Kim, Jong Hun; Budde, John P.; Black, Kathleen; Medvedeva, Alexandra; Saef, Ben; Del-Aguila, Jorge; Ibañez, Laura; Dube, Umber; Harari, Oscar; Norton, Joanne; Chasse, Rachel; Morris, John C.; Goate, Alison

2017-01-01

Alzheimer disease (AD), Frontotemporal lobar degeneration (FTD), Amyotrophic lateral sclerosis (ALS) and Parkinson disease (PD) have a certain degree of clinical, pathological and molecular overlap. Previous studies indicate that causative mutations in AD and FTD/ALS genes can be found in clinical familial AD. We examined the presence of causative and low frequency coding variants in the AD, FTD, ALS and PD Mendelian genes, in over 450 families with clinical history of AD and over 11,710 sporadic cases and cognitive normal participants from North America. Known pathogenic mutations were found in 1.05% of the sporadic cases, in 0.69% of the cognitively normal participants and in 4.22% of the families. A trend towards enrichment, albeit non-significant, was observed for most AD, FTD and PD genes. Only PSEN1 and PINK1 showed consistent association with AD cases when we used ExAC as the control population. These results suggest that current study designs may contain heterogeneity and contamination of the control population, and that current statistical methods for the discovery of novel genes with real pathogenic variants in complex late onset diseases may be inadequate or underpowered to identify genes carrying pathogenic mutations. PMID:29091718

Challenges in cryopreservation of regulatory T cells (Tregs) for clinical therapeutic applications.

PubMed

Golab, Karolina; Leveson-Gower, Dennis; Wang, Xiao-Jun; Grzanka, Jakub; Marek-Trzonkowska, Natalia; Krzystyniak, Adam; Millis, J Michael; Trzonkowski, Piotr; Witkowski, Piotr

2013-07-01

Promising results of initial studies applying ex-vivo expanded regulatory T cell (Treg) as a clinical intervention have increased interest in this type of the cellular therapy and several new clinical trials involving Tregs are currently on the way. Methods of isolation and expansion of Tregs have been studied and optimized to the extent that such therapy is feasible, and allows obtaining sufficient numbers of Tregs in the laboratory following Good Manufacturing Practice (GMP) guidelines. Nevertheless, Treg therapy could even more rapidly evolve if Tregs could be efficiently cryopreserved and stored for future infusion or expansions rather than utilization of only freshly isolated and expanded cells as it is preferred now. Currently, our knowledge regarding the impact of cryopreservation on Treg recovery, viability, and functionality is still limited. Based on experience with cryopreserved peripheral blood mononuclear cells (PBMCs), cryopreservation may have a detrimental effect on Tregs, can decrease Treg viability, cause abnormal cytokine secretion, and compromise expression of surface markers essential for proper Treg function and processing. Therefore, optimal strategies and conditions for Treg cryopreservation in conjunction with cell culture, expansion, and processing for clinical application still need to be investigated and defined. Copyright © 2013 Elsevier B.V. All rights reserved.

Human leptospirosis in Croatia: current status of epidemiology and clinical characteristics.

PubMed

Topic, Mirjana Balen; Habus, Josipa; Milas, Zoran; Tosev, Elvira Celjuska; Stritof, Zrinka; Turk, Nenad

2010-03-01

This study presents the current status of human leptospirosis in Croatia from an epidemiological and clinical viewpoint. Data from annual reports of the Croatian Institute for Public Health as well as archives of the University Hospital for Infectious Diseases 'Dr Fran Mihaljevic' (UHID) in Zagreb were used in this retrospective cohort analysis. The mean yearly incidence of leptospirosis from 1990 to 2007 was 1.83/100 000 inhabitants, with an incidence >2.5/100 000 inhabitants recorded approximately every 3-4 years, making Croatia one of the countries with the highest incidence of human leptospirosis in Europe. In addition to the majority of sporadic cases, two minor outbreaks were recorded. The clinical burden and more detailed epidemiology of 130 patients hospitalised at UHID in the period 1997-2007 were also studied. Clinical presentations were as expected, with an overall case fatality rate (CFR) of 0.77%. The most commonly established infective serovars were Australis followed by Saxkoebing and Grippotyphosa. In comparison with previous periods, the mean yearly number of patients with leptospirosis hospitalised at UHID decreased, but among them a rather higher rate of patients with Weil's disease and a higher CFR was observed.

Recent developments in clopidogrel pharmacology and their relation to clinical outcomes.

PubMed

Gurbel, Paul A; Antonino, Mark J; Tantry, Udaya S

2009-08-01

Oral antiplatelet therapy with clopidogrel and aspirin is an important and widely prescribed strategy to prevent ischemic events in patients with cardiovascular diseases. However, the occurrence of thrombotic events including stent thrombosis is still high (> 10%). Current practice guidelines are mainly based on large-scale trials focusing on clinical endpoints and 'one size fits all' strategies of treating all patients with the same clopidogrel doses. Pharmacodynamic studies have demonstrated that the latter strategy is associated with wide response variability where a substantial percentage of patients show nonresponsivenes. Translational research studies have established the relation between clopidogrel nonresponsivenes or high on-treatment platelet reactivity to adverse clinical events, thereby establishing clopidogrel nonresponsivenes as an important emerging clinical entity. Clopidogrel response variability is primarily a pharmacokinetic phenomenon associated with insufficient active metabolite generation that is secondary to i) limited intestinal absorption affected by an ABCB1 gene polymorphism; ii) functional variability in P450 isoenzyme activity; and iii) a genetic polymorphism of CYP450 isoenzymes. Personalized antiplatelet treatment with higher clopidogrel doses in selected patients or with newer more potent P2Y(12) receptor blockers based on individual platelet function measurement can overcome some of the limitations of current clopidogrel treatment.

Effort-Based Decision-Making Paradigms for Clinical Trials in Schizophrenia: Part 1—Psychometric Characteristics of 5 Paradigms

PubMed Central

Reddy, L. Felice; Horan, William P.; Barch, Deanna M.; Buchanan, Robert W.; Dunayevich, Eduardo; Gold, James M.; Lyons, Naomi; Marder, Stephen R.; Treadway, Michael T.; Wynn, Jonathan K.; Young, Jared W.; Green, Michael F.

2015-01-01

Impairments in willingness to exert effort contribute to the motivational deficits characteristic of the negative symptoms of schizophrenia. The current study evaluated the psychometric properties of 5 new or adapted paradigms to determine their suitability for use in clinical trials of schizophrenia. This study included 94 clinically stable participants with schizophrenia and 40 healthy controls. The effort-based decision-making battery was administered twice to the schizophrenia group (baseline, 4-week retest) and once to the control group. The 5 paradigms included 1 that assesses cognitive effort, 1 perceptual effort, and 3 that assess physical effort. Each paradigm was evaluated on (1) patient vs healthy control group differences, (2) test-retest reliability, (3) utility as a repeated measure (ie, practice effects), and (4) tolerability. The 5 paradigms showed varying psychometric strengths and weaknesses. The Effort Expenditure for Rewards Task showed the best reliability and utility as a repeated measure, while the Grip Effort Task had significant patient-control group differences, and superior tolerability and administration duration. The other paradigms showed weaker psychometric characteristics in their current forms. These findings highlight challenges in adapting effort and motivation paradigms for use in clinical trials. PMID:26142081

Parents' attitudes toward oral rehydration therapy in children with mild-to-moderate dehydration.

PubMed

Nir, Vered; Nadir, Erez; Schechter, Yaffa; Kline-Kremer, Adi

2013-01-01

According to current guidelines, the first line of treatment for mild-to-moderate dehydration is oral rehydration; the second line is rehydration through a nasogastric tube. Both methods are widely underused. This study was conducted to evaluate parents' attitudes towards rehydration methods used in pediatric emergency departments. 100 questionnaires were distributed to parents of children who visited emergency room due to gastroenteritis and suspected dehydration. 75 of the parents expected their child to get IV fluids. 49 of them would refuse to consider oral rehydration. 75 of the parents would refuse to consider insertion of nasogastric tube. Parents whose children were previously treated intravenously tended to be less likely to agree to oral treatment. Parents were more prone to decline oral rehydration if the main measurement of dehydration was the child's clinical appearance, clinical appearance with vomiting, or child's refusal to drink and were more likely to agree if the main measurement was diarrhea, diarrhea with clinical appearance, or clinical personnel opinion. This is the first study to examine parents' expectations. We found that in the majority of cases, parents' expectations contradict current guidelines. Efforts should be taken to educate parents in order to allow full implementation of the guidelines.

[Transcranial direct current stimulation (tDCS) for depression: Results of nearly a decade of clinical research].

PubMed

Palm, U; Ayache, S S; Padberg, F; Lefaucheur, J-P

2016-02-01

Since 2006 transcranial direct current stimulation (tDCS) has been investigated in the treatment of depression. In this review, we discuss the implications and clinical perspectives that tDCS may have as a therapeutic tool in depression from the results reported in this domain. A comprehensive literature review has found nearly thirty articles - all in English - on this topic, corresponding to clinical studies, placebo-controlled or not, case reports and reviews. Several meta-analyses showed that the antidepressant effects of active tDCS are significant against placebo, but variable, mainly due to the heterogeneity of the patients included in the studies, for example regarding the resistance to antidepressant treatment. Specific recommendations for the use of tDCS in treating depression may not yet be available, but some elements of good practice can be highlighted. Of particular note is that anodal tDCS of the left prefrontal cortex at 2mA for 20 minutes per day has a potential therapeutic value without risk of significant side effects: tDCS offers safe conditions for clinical use in the treatment of depression. Copyright © 2015 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

Analysis of neurodegenerative Mendelian genes in clinically diagnosed Alzheimer Disease.

PubMed

Fernández, Maria Victoria; Kim, Jong Hun; Budde, John P; Black, Kathleen; Medvedeva, Alexandra; Saef, Ben; Deming, Yuetiva; Del-Aguila, Jorge; Ibañez, Laura; Dube, Umber; Harari, Oscar; Norton, Joanne; Chasse, Rachel; Morris, John C; Goate, Alison; Cruchaga, Carlos

2017-11-01

Alzheimer disease (AD), Frontotemporal lobar degeneration (FTD), Amyotrophic lateral sclerosis (ALS) and Parkinson disease (PD) have a certain degree of clinical, pathological and molecular overlap. Previous studies indicate that causative mutations in AD and FTD/ALS genes can be found in clinical familial AD. We examined the presence of causative and low frequency coding variants in the AD, FTD, ALS and PD Mendelian genes, in over 450 families with clinical history of AD and over 11,710 sporadic cases and cognitive normal participants from North America. Known pathogenic mutations were found in 1.05% of the sporadic cases, in 0.69% of the cognitively normal participants and in 4.22% of the families. A trend towards enrichment, albeit non-significant, was observed for most AD, FTD and PD genes. Only PSEN1 and PINK1 showed consistent association with AD cases when we used ExAC as the control population. These results suggest that current study designs may contain heterogeneity and contamination of the control population, and that current statistical methods for the discovery of novel genes with real pathogenic variants in complex late onset diseases may be inadequate or underpowered to identify genes carrying pathogenic mutations.

Symptoms and Etiological Attribution: A Cross-Sectional Study in Mexican Outpatients with Psychosis and Their Relatives.

PubMed

Gómez-de-Regil, Lizzette; Ros-Morente, Agnès; Rodríguez-Hansen, Gisela

2016-01-01

This cross-sectional study aimed at identifying the most common attributions of their mental disorder in a Mexican patients who have experienced psychosis and their relatives and exploring how having experienced or not characteristic psychotic symptoms and their present clinical status might affect their etiological attributions. Past and current symptom profiles of 66 patients were as assessed with the SCID-I (Structured Clinical Interview for DSM-IV Axis I Disorders) and the PANSS (Positive and Negative Syndrome Scale), respectively. The etiological attribution of psychosis of patients (n = 62) and the relatives (n = 65) was assessed with the Angermeyer and Klusmann scale comprising 30 items into five categories: biology, personality, family, society, and esoteric. Patients and relatives attribute psychosis mainly to social factors. Relatives' attributions were not influenced by clinical profile of patients, whereas in the case of patients it was only current clinical status that showed a difference, with those in nonremission scoring higher personality and family factors. Acknowledging patients' and relatives' beliefs about mental disorders at onset and later on is particularly important in psychosis, a mental condition with severe and/or persistent symptoms, in order to promote better involvement in treatment and in consequence efficacy and recovery.

[Asperger syndrome: evolution of the concept and current clinical data].

PubMed

Aussilloux, C; Baghdadli, A

2008-05-01

Although Asperger syndrome is described by international classifications as a category of pervasive developmental disorder (PDD), its validity as a specific entity distinct from autistic disorders remains controversial. The syndrome, first described by Hans Asperger, could not be distinguished from high functioning autism (onset, symptoms, outcome...). However, international classifications propose a distinction between the two syndromes based on a delayed onset, the absence of speech delay, the presence of motor disorders and a better outcome in Asperger syndrome. This categorical differentiation is not confirmed by current studies and in the absence of biological markers, no clinical, neuropsychological or epidemiological criteria makes it possible to distinguish high functioning autism from Asperger syndrome. From a clinical perspective, it is nevertheless of interest to isolate Asperger syndrome from other autistic disorders to propose specific assessment and therapy.

Current status and future perspectives in laparoendoscopic single-site and natural orifice transluminal endoscopic urological surgery.

PubMed

Autorino, Riccardo; Stein, Robert J; Lima, Estevão; Damiano, Rocco; Khanna, Rakesh; Haber, Georges-Pascal; White, Michael A; Kaouk, Jihad H

2010-05-01

Objective of this study is to provide an evidence-based analysis of the current status and future perspectives of scarless urological surgery. A PubMed search has been performed for all relevant urological literature regarding natural orifice transluminal endoscopic surgery (NOTES) and laparoendoscopic single-site surgery (LESS). In addition, experience with LESS and NOTES at our own institution has been considered. All clinical and investigative reports for LESS and NOTES procedures in the urological literature have been considered. A wide variety of clinical procedures in urology have been successfully completed by using LESS techniques. Thus far, experience with NOTES has largely been investigational, although early clinical reports are emerging. Further development of instrumentation and platforms is necessary for both techniques to become more widely adopted throughout the urological community.

Magnetoencephalography in Stroke Recovery and Rehabilitation

PubMed Central

Paggiaro, Andrea; Birbaumer, Niels; Cavinato, Marianna; Turco, Cristina; Formaggio, Emanuela; Del Felice, Alessandra; Masiero, Stefano; Piccione, Francesco

2016-01-01

Magnetoencephalography (MEG) is a non-invasive neurophysiological technique used to study the cerebral cortex. Currently, MEG is mainly used clinically to localize epileptic foci and eloquent brain areas in order to avoid damage during neurosurgery. MEG might, however, also be of help in monitoring stroke recovery and rehabilitation. This review focuses on experimental use of MEG in neurorehabilitation. MEG has been employed to detect early modifications in neuroplasticity and connectivity, but there is insufficient evidence as to whether these methods are sensitive enough to be used as a clinical diagnostic test. MEG has also been exploited to derive the relationship between brain activity and movement kinematics for a motor-based brain–computer interface. In the current body of experimental research, MEG appears to be a powerful tool in neurorehabilitation, but it is necessary to produce new data to confirm its clinical utility. PMID:27065338

Evaluation of LOINC for Representing Constitutional Cytogenetic Test Result Reports

PubMed Central

Heras, Yan Z.; Mitchell, Joyce A.; Williams, Marc S.; Brothman, Arthur R.; Huff, Stanley M.

2009-01-01

Genetic testing is becoming increasingly important to medical practice. Integrating genetics and genomics data into electronic medical records is crucial in translating genetic discoveries into improved patient care. Information technology, especially Clinical Decision Support Systems, holds great potential to help clinical professionals take full advantage of genomic advances in their daily medical practice. However, issues relating to standard terminology and information models for exchanging genetic testing results remain relatively unexplored. This study evaluates whether the current LOINC standard is adequate to represent constitutional cytogenetic test result reports using sample result reports from ARUP Laboratories. The results demonstrate that current standard terminology is insufficient to support the needs of coding cytogenetic test results. The terminology infrastructure must be developed before clinical information systems will be able to handle the high volumes of genetic data expected in the near future. PMID:20351857

Evaluation of LOINC for representing constitutional cytogenetic test result reports.

PubMed

Heras, Yan Z; Mitchell, Joyce A; Williams, Marc S; Brothman, Arthur R; Huff, Stanley M

2009-11-14

Genetic testing is becoming increasingly important to medical practice. Integrating genetics and genomics data into electronic medical records is crucial in translating genetic discoveries into improved patient care. Information technology, especially Clinical Decision Support Systems, holds great potential to help clinical professionals take full advantage of genomic advances in their daily medical practice. However, issues relating to standard terminology and information models for exchanging genetic testing results remain relatively unexplored. This study evaluates whether the current LOINC standard is adequate to represent constitutional cytogenetic test result reports using sample result reports from ARUP Laboratories. The results demonstrate that current standard terminology is insufficient to support the needs of coding cytogenetic test results. The terminology infrastructure must be developed before clinical information systems will be able to handle the high volumes of genetic data expected in the near future.

Gait Analysis Using Wearable Sensors

PubMed Central

Tao, Weijun; Liu, Tao; Zheng, Rencheng; Feng, Hutian

2012-01-01

Gait analysis using wearable sensors is an inexpensive, convenient, and efficient manner of providing useful information for multiple health-related applications. As a clinical tool applied in the rehabilitation and diagnosis of medical conditions and sport activities, gait analysis using wearable sensors shows great prospects. The current paper reviews available wearable sensors and ambulatory gait analysis methods based on the various wearable sensors. After an introduction of the gait phases, the principles and features of wearable sensors used in gait analysis are provided. The gait analysis methods based on wearable sensors is divided into gait kinematics, gait kinetics, and electromyography. Studies on the current methods are reviewed, and applications in sports, rehabilitation, and clinical diagnosis are summarized separately. With the development of sensor technology and the analysis method, gait analysis using wearable sensors is expected to play an increasingly important role in clinical applications. PMID:22438763

Nurse leaders' perceptions of the ethical recruitment of study subjects in clinical research.

PubMed

Nurmi, Sanna-Maria; Pietilä, Anna-Maija; Kangasniemi, Mari; Halkoaho, Arja

2015-11-01

The aim of this study was to describe nurse leaders' perceptions of ethical recruitment in clinical research. Nurse leaders are expected to get involved in clinical research, but there are few studies that focus on their role, particularly the ethical issues. Qualitative data were collected from ten nurse leaders using thematic one-to-one interviews and analysed with content analysis. Nurse leaders considered clinical research at their workplace in relation to the key issues that enabled ethical recruitment of study subjects in clinical research. These were: early information and collaboration for incorporating clinical research in everyday work, an opportune and peaceful recruitment moment and positive research culture. Getting involved in clinical research is part of the nurse leader's professional responsibility in current health care. They have an essential role to play in ensuring that recruitment is ethical and that the dignity of study subjects is maintained. The duty of nurse leaders is to maintain good contact with other collaborators and to ensure good conditions for implementing clinical research at their site. This requires a comprehensive understanding of the overall situation on their wards. Implementing clinical research requires careful planning, together with educating, supporting and motivating nursing staff. © 2014 John Wiley & Sons Ltd.

Adult human neural stem cell therapeutics: Current developmental status and prospect.

PubMed

Nam, Hyun; Lee, Kee-Hang; Nam, Do-Hyun; Joo, Kyeung Min

2015-01-26

Over the past two decades, regenerative therapies using stem cell technologies have been developed for various neurological diseases. Although stem cell therapy is an attractive option to reverse neural tissue damage and to recover neurological deficits, it is still under development so as not to show significant treatment effects in clinical settings. In this review, we discuss the scientific and clinical basics of adult neural stem cells (aNSCs), and their current developmental status as cell therapeutics for neurological disease. Compared with other types of stem cells, aNSCs have clinical advantages, such as limited proliferation, inborn differentiation potential into functional neural cells, and no ethical issues. In spite of the merits of aNSCs, difficulties in the isolation from the normal brain, and in the in vitro expansion, have blocked preclinical and clinical study using aNSCs. However, several groups have recently developed novel techniques to isolate and expand aNSCs from normal adult brains, and showed successful applications of aNSCs to neurological diseases. With new technologies for aNSCs and their clinical strengths, previous hurdles in stem cell therapies for neurological diseases could be overcome, to realize clinically efficacious regenerative stem cell therapeutics.

Investigational drugs for the treatment of endometriosis, an update on recent developments.

PubMed

Barra, Fabio; Scala, Carolina; Mais, Valerio; Guerriero, Stefano; Ferrero, Simone

2018-05-01

Endometriosis is a hormone-dependent benign chronic disease that requires a chronic medical therapy. Although currently available drugs are efficacious in treating endometriosis-related pain, some women experience partial or no improvement. Moreover, the recurrence of symptoms is expected after discontinuation of the therapies. Currently, new drugs are under intense clinical investigation for the treatment of endometriosis. Areas covered: This review aims to offer the reader a complete and updated overview on new investigational drugs and early molecular targets for the treatment of endometriosis. The authors describe the pre-clinical and clinical development of these agents. Expert opinion: Among the drugs under investigation, late clinical trials on gonadotropin-releasing hormone antagonists (GnRH-ant) showed the most promising results for the treatment of endometriosis. Aromatase inhibitors (AIs) are efficacious in treating endometriosis related pain symptoms but they cause significant adverse effects that limit their long-term use. New targets have been identified to produce drugs for the treatment of endometriosis, but the majority of these new compounds have only been investigated in laboratory studies or early clinical trials. Thus, further clinical research is required in order to elucidate their efficacy and safety in human.

Early Experience with a Brief, Multimodal, Multidisciplinary Treatment Program for Fibromyalgia

PubMed Central

Vincent, Ann; Whipple, Mary O.; Oh, Terry H.; Guderian, Janet A.; Barton, Debra L.; Luedtke, Connie A.

2014-01-01

Fibromyalgia is a complex, heterogeneous disorder for which a multidisciplinary individualized approach is currently advocated. We executed a 1 week multidisciplinary fibromyalgia clinical program with 7 patients, based on our previous experience with our existing 1.5 day multidisciplinary fibromyalgia program that has demonstrated both short- and long-term benefits. The current expanded program was not designed as a clinical study, but rather as a clinical feasibility assessment and was multidisciplinary in nature, with cognitive behavioral therapy, activity pacing and graded exercise therapy as major components. We assessed changes in individual patients at 1 week and 3 months following the program utilizing validated self-report measures of pain, fatigue, and self-efficacy. All patients indicated at least small improvements in pain and physical symptoms both at 1 week and 3 months and all but one patient showed improvement in self-efficacy at 1 week and 3 months. Similar trends were observed for fatigue. Based on our early clinical experience, we conclude that the 1 week multidisciplinary fibromyalgia program is logistically feasible and has potential for clinical efficacy. Further research is needed and is planned to test the clinical efficacy of this program and compare it with other interventions. PMID:24315246

Toward a therapy for mitochondrial disease

PubMed Central

Viscomi, Carlo

2016-01-01

Mitochondrial disorders are a group of genetic diseases affecting the energy-converting process of oxidative phosphorylation. The extreme variability of symptoms, organ involvement, and clinical course represent a challenge to the development of effective therapeutic interventions. However, new possibilities have recently been emerging from studies in model organisms and awaiting verification in humans. I will discuss here the most promising experimental approaches and the challenges we face to translate them into the clinics. The current clinical trials will also be briefly reviewed. PMID:27911730

[The quality of epidemiological research on pediatric refractive error and amblyopia in China needs to be improved].

PubMed

He, M G

2017-01-11

Over the past decade, great progress has been made in the clinical and epidemiological studies on refractive error and amblyopia in children with research findings published in international peer reviewed journals. This article reviews some of the essential publications so that the research findings could be learnt extensively, understood critically and objectively, and applied effectively to clinical practice. We aim to address the current limitations and shed light on clinical practice. (Chin J Ophthalmol, 2017, 53: 3-6) .

Challenges and lessons learned in conducting comparative-effectiveness trials.

PubMed

Herrick, Linda M; Locke, G Richard; Zinsmeister, Alan R; Talley, Nicholas J

2012-05-01

The current health-care environment is demanding evidence-based medicine that relies on clinical trials as the basis for decisions. Clinician investigators are more often finding that they are personally responsible for coordinating large, multisite trials. We present strategies for successful implementation and management of multisite clinical trials and knowledge gained through an international, multisite randomized clinical trial. Topics include team composition, regulatory requirements, study organization and governance, communication strategies, recruitment and retention efforts, budget, technology transfer, and publication.

Challenges and Lessons Learned in Conducting Comparative-Effectiveness Trials

PubMed Central

Herrick, Linda M.; Locke, G. Richard; Zinsmeister, Alan R.; Talley, Nicholas J.

2014-01-01

The current health-care environment is demanding evidence-based medicine that relies on clinical trials as the basis for decisions. Clinician investigators are more often finding that they are personally responsible for coordinating large, multisite trials. We present strategies for successful implementation and management of multisite clinical trials and knowledge gained through an international, multisite randomized clinical trial. Topics include team composition, regulatory requirements, study organization and governance, communication strategies, recruitment and retention efforts, budget, technology transfer, and publication. PMID:22552235

Evidence-based medicine in the treatment of peritoneal carcinomatosis: Past, present, and future.

PubMed

Nissan, Aviram; Stojadinovic, Alexander; Garofalo, Alfredo; Esquivel, Jesus; Piso, Pompiliu

2009-09-15

The current treatment of peritoneal surface malignancies (PSMs) is moving from a nihilistic approach, into a combined modality approach offering selected patients long-term survival. As primary PSM are rare, extrapolation of data from clinical trials of related disease is necessary to develop treatment guidelines. Secondary PSM are more common, and therefore, treatment guidelines should be developed based on prospective clinical trials. We reviewed the published and ongoing clinical trials studying the treatment of PSM. (c) 2009 Wiley-Liss, Inc.

Sex selection for non-medical indications: a survey of current pre-implantation genetic screening practices among U.S. ART clinics.

PubMed

Capelouto, Sarah M; Archer, Sydney R; Morris, Jerrine R; Kawwass, Jennifer F; Hipp, Heather S

2018-03-01

This study aimed to determine the current percentage of United States (U.S.) assisted reproductive technology (ART) clinics offering sex selection via pre-implantation genetic screening (PGS) for non-medical purposes. The authors conducted website review and telephone interview survey of 493 U.S. ART clinics performing in vitro fertilization (IVF) in 2017. Main outcome measures were pre-implantation genetic screening (PGS)/pre-implantation genetic diagnosis (PGD) practices and non-medical sex selection practices including family balancing. Of the 493 ART clinics in the USA, 482 clinics (97.8%) responded to our telephone interview survey. Among all U.S. ART clinics, 91.9% (n = 449) reported offering PGS and/or PGD. Furthermore, 476 clinics responded to survey questions about sex selection practices. Of those ART clinics, 72.7% (n = 346) reported offering sex selection. More specifically among those clinics offering sex selection, 93.6% (n = 324) reported performing sex selection for family balancing, and 81.2% (n = 281) reported performing for elective purposes (patient preference, regardless of rationale for the request). For couples without infertility, 83.5% (n = 289) of clinics offer sex selection for family balancing and 74.6% (n = 258) for non-specific elective reasons. The majority of U.S. ART clinics offer non-medical sex selection, a percentage that has increased substantially since last reported in 2006.

Collection of annotated data in a clinical validation study for alarm algorithms in intensive care--a methodologic framework.

PubMed

Siebig, Sylvia; Kuhls, Silvia; Imhoff, Michael; Langgartner, Julia; Reng, Michael; Schölmerich, Jürgen; Gather, Ursula; Wrede, Christian E

2010-03-01

Monitoring of physiologic parameters in critically ill patients is currently performed by threshold alarm systems with high sensitivity but low specificity. As a consequence, a multitude of alarms are generated, leading to an impaired clinical value of these alarms due to reduced alertness of the intensive care unit (ICU) staff. To evaluate a new alarm procedure, we currently generate a database of physiologic data and clinical alarm annotations. Data collection is taking place at a 12-bed medical ICU. Patients with monitoring of at least heart rate, invasive arterial blood pressure, and oxygen saturation are included in the study. Numerical physiologic data at 1-second intervals, monitor alarms, and alarm settings are extracted from the surveillance network. Bedside video recordings are performed with network surveillance cameras. Based on the extracted data and the video recordings, alarms are clinically annotated by an experienced physician. The alarms are categorized according to their technical validity and clinical relevance by a taxonomy system that can be broadly applicable. Preliminary results showed that only 17% of the alarms were classified as relevant, and 44% were technically false. The presented system for collecting real-time bedside monitoring data in conjunction with video-assisted annotations of clinically relevant events is the first allowing the assessment of 24-hour periods and reduces the bias usually created by bedside observers in comparable studies. It constitutes the basis for the development and evaluation of "smart" alarm algorithms, which may help to reduce the number of alarms at the ICU, thereby improving patient safety. Copyright 2010 Elsevier Inc. All rights reserved.

Review at a multidisciplinary tumor board impacts critical management decisions of pediatric patients with cancer.

PubMed

Thenappan, Arun; Halaweish, Ihab; Mody, Rajen J; Smith, Ethan A; Geiger, James D; Ehrlich, Peter F; Jasty Rao, Rama; Hutchinson, Raymond; Yanik, Gregory; Rabah, Raja M; Heider, Amer; Stoll, Tammy; Newman, Erika A

2017-02-01

Optimal cancer care requires a multidisciplinary approach. The purpose of the current study was to evaluate the impact of a multidisciplinary tumor board on the treatment plans of children with solid tumors. The records of 158 consecutive patients discussed at a formal multidisciplinary pediatric tumor board between July 2012 and April 2014 were reviewed. Treatment plans were based on clinical practice guidelines and on current Children's Oncology Group protocols. Alterations in radiologic, pathologic, surgical, and medical interpretations were analyzed to determine the impact on changes in recommendations for clinical management. Overall, 55 of 158 children (35%) had alterations in radiologic, pathologic, medical, or surgical interpretation of clinical data following multidisciplinary discussion. Of these, 64% had changes to the initial recommendation for clinical management. Review of imaging studies resulted in interpretation changes in 30 of 158 patients studied (19%), with 12 clinical management changes. Six of 158 patients (3.9%) had changes in pathologic interpretation, with four patients (2.5%) requiring treatment changes. In eight patients (5%), a change in medical management was recommended, while in 11 patients (7%) there were changes in surgical management that were based solely on discussion and not on interpretation of imaging or pathology. Formal multidisciplinary review led to alterations in interpretation of clinical data in 35% of patients, and the majority led to changes in recommendations for treatment. Comprehensive multidisciplinary tumor board incorporated into the care of children with cancer provides additional perspectives for families and care providers when delineating optimal treatment plans. © 2016 Wiley Periodicals, Inc.

Cardiovascular Magnetic Resonance Imaging-Incremental Value in a Series of 361 Patients Demonstrating Cost Savings and Clinical Benefits: An Outcome-Based Study.

PubMed

Hegde, Vinayak A; Biederman, Robert Ww; Mikolich, J Ronald

2017-01-01

This study was designed to assess the clinical impact and cost-benefit of cardiovascular magnetic resonance imaging (CMR). In the face of current health care cost concerns, cardiac imaging modalities have come under focused review. Data related to CMR clinical impact and cost-benefit are lacking. Retrospective review of 361 consecutive patients (pts) who underwent CMR exams was conducted. Indications for CMR were tabulated for appropriateness criteria. Components of the CMR exam were identified along with evidence of clinical impact. The cost of each CMR exam was ascertained along with cost savings attributable to the CMR exam for calculation of an incremental cost-effectiveness ratio. A total of 354 of 361 pts (98%) had diagnostic quality studies. Of the 361 pts, 350 (97%) had at least 1 published Appropriateness Criterion for CMR. A significant clinical impact attributable to CMR exam results was observed in 256 of 361 pts (71%). The CMR exam resulted in a new diagnosis in 69 of 361 (27%) pts. Cardiovascular magnetic resonance imaging results avoided invasive procedures in 38 (11%) pts and prevented additional diagnostic testing in 26 (7%) pts. Comparison of health care savings using CMR as opposed to current standards of care showed a net cost savings of $833 037, ie, per patient cost savings of $2308. Cardiovascular magnetic resonance imaging provides diagnostic image quality in >98% of cases. Cardiovascular magnetic resonance imaging findings have documentable clinical impact on patient management in 71% of pts undergoing the exam, in a cost beneficial manner.

Cardiovascular Magnetic Resonance Imaging—Incremental Value in a Series of 361 Patients Demonstrating Cost Savings and Clinical Benefits: An Outcome-Based Study

PubMed Central

Hegde, Vinayak A; Biederman, Robert WW; Mikolich, J Ronald

2017-01-01

BACKGROUND This study was designed to assess the clinical impact and cost-benefit of cardiovascular magnetic resonance imaging (CMR). In the face of current health care cost concerns, cardiac imaging modalities have come under focused review. Data related to CMR clinical impact and cost-benefit are lacking. METHODS AND RESULTS Retrospective review of 361 consecutive patients (pts) who underwent CMR exams was conducted. Indications for CMR were tabulated for appropriateness criteria. Components of the CMR exam were identified along with evidence of clinical impact. The cost of each CMR exam was ascertained along with cost savings attributable to the CMR exam for calculation of an incremental cost-effectiveness ratio. A total of 354 of 361 pts (98%) had diagnostic quality studies. Of the 361 pts, 350 (97%) had at least 1 published Appropriateness Criterion for CMR. A significant clinical impact attributable to CMR exam results was observed in 256 of 361 pts (71%). The CMR exam resulted in a new diagnosis in 69 of 361 (27%) pts. Cardiovascular magnetic resonance imaging results avoided invasive procedures in 38 (11%) pts and prevented additional diagnostic testing in 26 (7%) pts. Comparison of health care savings using CMR as opposed to current standards of care showed a net cost savings of $833 037, ie, per patient cost savings of $2308. CONCLUSIONS Cardiovascular magnetic resonance imaging provides diagnostic image quality in >98% of cases. Cardiovascular magnetic resonance imaging findings have documentable clinical impact on patient management in 71% of pts undergoing the exam, in a cost beneficial manner. PMID:28579858

High-Definition transcranial direct current stimulation in early onset epileptic encephalopathy: a case study.

PubMed

Meiron, Oded; Gale, Rena; Namestnic, Julia; Bennet-Back, Odeya; David, Jonathan; Gebodh, Nigel; Adair, Devin; Esmaeilpour, Zeinab; Bikson, Marom

2018-01-01

Early onset epileptic encephalopathy is characterized by high daily seizure-frequency, multifocal epileptic discharges, severe psychomotor retardation, and death at infancy. Currently, there are no effective treatments to alleviate seizure frequency and high-voltage epileptic discharges in these catastrophic epilepsy cases. The current study examined the safety and feasibility of High-Definition transcranial direct current stimulation (HD-tDCS) in reducing epileptiform activity in a 30-month-old child suffering from early onset epileptic encephalopathy. HD-tDCS was administered over 10 intervention days spanning two weeks including pre- and post-intervention video-EEG monitoring. There were no serious adverse events or side effects related to the HD-tDCS intervention. Frequency of clinical seizures was not significantly reduced. However, interictal sharp wave amplitudes were significantly lower during the post-intervention period versus baseline. Vital signs and blood biochemistry remained stable throughout the entire study. These exploratory findings support the safety and feasibility of 4 × 1 HD-tDCS in early onset epileptic encephalopathy and provide the first evidence of HD-tDCS effects on paroxysmal EEG features in electroclinical cases under the age of 36 months. Extending HD-tDCS treatment may enhance electrographic findings and clinical effects.

Current treatment trends and the need for better predictive tools in the management of ductal carcinoma in situ of the breast.

PubMed

Martínez-Pérez, Carlos; Turnbull, Arran K; Ekatah, Gregory E; Arthur, Laura M; Sims, Andrew H; Thomas, Jeremy S; Dixon, J Michael

2017-04-01

Ductal carcinoma in situ (DCIS) of the breast represents a group of heterogeneous non-invasive lesions the incidence of which has risen dramatically since the advent of mammography screening. In this review we summarise current treatment trends and up-to-date results from clinical trials studying surgery and adjuvant therapy alternatives, including the recent consensus on excision margin width and its role in decision-making for post-excision radiotherapy. The main challenge in the clinical management of DCIS continues to be the tailoring of treatment to individual risk, in order to avoid the over-treatment of low-risk lesions or under-treatment of DCIS with higher risk of recurring or progressing into invasion. While studies estimate that only about 40% of DCIS would become invasive if untreated, heterogeneity and complex natural history have prevented adequate identification of these higher-risk lesions. Here we discuss attempts to develop prognostic tools for the risk stratification of DCIS lesions and their limitations. Early results of a UK-wide audit of DCIS management (the Sloane Project) have also demonstrated a lack of consistency in treatment. In this review we offer up-to-date perspectives on current treatment and prediction of DCIS, highlighting the pressing clinical need for better prognostic indices. Tools integrating both clinical and histopathological factors together with molecular biomarkers may hold potential for adequate stratification of DCIS according to risk. This could help develop standardised practices for optimal management of patients with DCIS, improving clinical outcomes while providing only the amount of therapy required for each individual patient. Copyright © 2017 Elsevier Ltd. All rights reserved.

Psychopathology and parenting: An examination of perceived and observed parenting in mothers with depression and PTSD

PubMed Central

Muzik, Maria; Morelen, Diana; Hruschak, Jessica; Rosenblum, Katherine Lisa; Bocknek, Erika; Beeghly, Marjorie

2016-01-01

Background The postpartum period represents a major transition in the lives of many women, a time when women are at increased risk for the emergence of psychopathology including depression and PTSD. The current study aimed to better understand the unique contributions of clinically significant postpartum depression, PTSD, and comorbid PTSD/depression on mother–infant bonding and observed maternal parenting behaviors (i.e., behavioral sensitivity, negative affect, positive affect) at 6 months postpartum. Methods Mothers (n=164; oversampled for history of childhood maltreatment given parent study's focus on perinatal mental health in women with trauma histories) and infants participated in 6-month home visit during which dyads engaged in interactional tasks varying in level of difficulties. Mothers also reported on their childhood abuse histories, current depression/PTSD symptoms, and bonding with the infant using standardized and validated instruments. Results Mothers with clinically significant depression had the most parenting impairment (self-report and observed). Mothers with clinically significant PTSD alone (due to interpersonal trauma that occurred predominately in childhood) showed similar interactive behaviors to those who were healthy controls or trauma-exposed but resilient (i.e., no postpartum psychopathology). Childhood maltreatment in the absence of postpartum psychopathology did not infer parenting risk. Limitations Findings are limited by (1) small cell sizes per clinical group, limiting power, (2) sample size and sample demographics prohibited examination of third variables that might also impact parenting (e.g., income, education), (3) self-report of symptoms rather than use of psychiatric interviews. Conclusions Findings show that in the context of child abuse history and/or current PTSD, clinically significant maternal depression was the most salient factor during infancy that was associated with parenting impairment at this level of analysis. PMID:27732922

Evaluating the effect of a third-party implementation of resolution recovery on the quality of SPECT bone scan imaging using visual grading regression.

PubMed

Hay, Peter D; Smith, Julie; O'Connor, Richard A

2016-02-01

The aim of this study was to evaluate the benefits to SPECT bone scan image quality when applying resolution recovery (RR) during image reconstruction using software provided by a third-party supplier. Bone SPECT data from 90 clinical studies were reconstructed retrospectively using software supplied independent of the gamma camera manufacturer. The current clinical datasets contain 120×10 s projections and are reconstructed using an iterative method with a Butterworth postfilter. Five further reconstructions were created with the following characteristics: 10 s projections with a Butterworth postfilter (to assess intraobserver variation); 10 s projections with a Gaussian postfilter with and without RR; and 5 s projections with a Gaussian postfilter with and without RR. Two expert observers were asked to rate image quality on a five-point scale relative to our current clinical reconstruction. Datasets were anonymized and presented in random order. The benefits of RR on image scores were evaluated using ordinal logistic regression (visual grading regression). The application of RR during reconstruction increased the probability of both observers of scoring image quality as better than the current clinical reconstruction even where the dataset contained half the normal counts. Type of reconstruction and observer were both statistically significant variables in the ordinal logistic regression model. Visual grading regression was found to be a useful method for validating the local introduction of technological developments in nuclear medicine imaging. RR, as implemented by the independent software supplier, improved bone SPECT image quality when applied during image reconstruction. In the majority of clinical cases, acquisition times for bone SPECT intended for the purposes of localization can safely be halved (from 10 s projections to 5 s) when RR is applied.

Current perspectives on the role of the pharmacist in heart failure management

PubMed Central

Cheng, Judy WM

2017-01-01

Pharmacists play an important role within a multidisciplinary health care team in the care of patients with heart failure (HF). It has been evaluated and documented that pharmacists providing medication reconciliation especially during transition of care, educating patients on their medications, and providing collaborative medication management lead to positive changes in the patient outcomes, including but not limited to decreasing in hospitalizations and read-missions. It is foreseeable that pharmacist roles will continue to expand as new treatment and innovative care are developed for HF patients. I reviewed published role of pharmacists in the care of HF patients. MEDLINE and Current Content database (both from 1966 – December 31, 2017) were utilized to identify peer-reviewed clinical trials, descriptive studies, and review articles published in English using the following search terms: pharmacists, clinical pharmacy, HF, and cardiomyopathy. Citations from available articles were also reviewed for additional references. Preliminary search revealed 31 studies and 55 reviews. They were further reviewed by title and abstract as well as full text to remove irrelevant articles. At the end, 24 of these clinical trials and systematic reviews are described in the following text and Table 1 summarizes 16 pertinent clinical trials. Some roles that are currently being explored include medication management in patients with mechanical circulatory support for end-stage HF, where pharmacokinetics and pharmacodynamics of medications can change, medication management in ambulatory intravenous diuretic clinics, and comprehensive medication management in patients’ home settings. Pharmacists should continue to explore and prospectively evaluate their role in the care of this patient population, including documenting their interventions, and impact to economic and patient outcomes. PMID:29594034

Systematic review of interventional sickle cell trials registered in ClinicalTrials.gov.

PubMed

Lebensburger, Jeffrey D; Hilliard, Lee M; Pair, Lauren E; Oster, Robert; Howard, Thomas H; Cutter, Gary R

2015-12-01

The registry ClinicalTrials.gov was created to provide investigators and patients an accessible database of relevant clinical trials. To understand the state of sickle cell disease clinical trials, a comprehensive review of all 174 "closed," "interventional" sickle cell trials registered at ClinicalTrials.gov was completed in January 2015. The majority of registered sickle cell disease clinical trials listed an academic center as the primary sponsor and were an early phase trial. The primary outcome for sickle cell disease trials focused on pain (23%), bone marrow transplant (BMT) (13%), hydroxyurea (8%), iron overload (8%), and pulmonary hypertension (8%). A total of 52 trials were listed as terminated or withdrawn, including 25 (14% of all trials) terminated for failure to enroll participants. At the time of this review, only 19 trials uploaded results and 29 trials uploaded a manuscript in the ClinicalTrials.gov database. A systematic review of pubmed.gov revealed that only 35% of sickle cell studies completed prior to 2014 resulted in an identified manuscript. In comparison, of 80 thalassemia trials registered in ClinicalTrials.gov, four acknowledged failure to enroll participants as a reason for trial termination or withdrawal, and 48 trials (60%) completed prior to 2014 resulted in a currently identified manuscript. ClinicalTrials.gov can be an important database for investigators and patients with sickle cell disease to understand the current available research trials. To enhance the validity of the website, investigators must update their trial results and upload trial manuscripts into the database. This study, for the first time, quantifies outcomes of sickle cell disease trials and provides support to the belief that barriers exist to successful completion, publication, and dissemination of sickle cell trial results. © The Author(s) 2015.

A Doctor's Name as a Brand: A Nationwide Survey on Registered Clinic Names in Taiwan.

PubMed

Chu, Feng-Yuan; Dai, Ying-Xiu; Liu, Jui-Yao; Chen, Tzeng-Ji; Chou, Li-Fang; Hwang, Shinn-Jang

2018-06-01

In countries where the private clinics of physicians can be freely named, registering a clinic with a physician's name is one way to make patients familiar with the physician. No previous study had investigated how clinics make use of this method of personal branding. Therefore, the current study analyzed 10,847 private physician Western medicine clinics in Taiwan. Of those clinics, 31.0% ( n = 3363) were named with a physician's full name, 8.9% ( n = 960) with a surname, and 8.1% ( n = 884) with a given name. The proportion of clinics registered with a physician's name was lower in rural areas (37.3%) than in urban (48.5%) and suburban areas (49.2%), respectively. Among clinics with only one kind of specialist, a physician's name was used most frequently in clinics of obstetrics and gynecology (64.9%), otorhinolaryngology (64.1%), and dermatology (63.4%). In Taiwan, fewer than half of clinics used a physician's name as a brand. The sociocultural or strategic factors and real benefits of doing so could be further studied in the future for a better understanding of healthcare services management.

Hepatic veno-occlusive disease after hematopoietic stem cell transplantation: update on defibrotide and other current investigational therapies.

PubMed

Ho, V T; Revta, C; Richardson, P G

2008-02-01

Hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), remains one of the most serious and common complications after myeloablative hematopoietic stem cell transplantation (HSCT). Clinical diagnosis of hepatic VOD is based on the clinical triad of (1) painful hepatomegaly, (2) hyperbilirubinemia and (3) unexplained fluid retention. While milder cases usually resolve spontaneously, severe VOD is associated with a grim prognosis. Defibrotide (DF), a polydisperse mixture of single-stranded oligonucleotide with antithrombotic and fibrinolytic effects on microvascular endothelium, has emerged as an effective and safe therapy for patients with severe VOD. Multiple studies, including a recent large international multicenter phase II clinical trial, have demonstrated 30-60% complete remission rates with DF, even among patients with severe VOD and multiorgan failure. This article will review our current understanding of hepatic VOD, and update the clinical trial experience with DF and other potential therapies for this feared transplant complication.

Triglycerides: A reappraisal.

PubMed

Wiesner, Philipp; Watson, Karol E

2017-08-01

Elevated cholesterol levels are clearly independently associated with adverse cardiovascular events. Another class of lipid particles, triglycerides, is also abundant in the human body and has been found in atherosclerotic plaques. Recent observational studies have demonstrated an association between elevated triglyceride levels and increased risk for future cardiovascular events. With this knowledge and the discovery of effective agents to lower triglyceride levels, the management of triglycerides is currently undergoing a renaissance. Unfortunately, no randomized, controlled clinical trials have been completed to date, proving that lowering triglycerides will reduce cardiovascular events. In this review we highlight some of the evidence that led to this stage and discuss the current data on pharmacologic intervention of triglyceride levels and the effect on clinical outcomes. Lastly, we want to give the reader insight on what the most recent lipid guidelines state about clinical triglyceride management, mention new pharmacological agents, and highlight the clinical evidence for safe and effective lowering of triglycerides levels with life style modification. Copyright © 2017. Published by Elsevier Inc.

Knowledge management strategies: Enhancing knowledge transfer to clinicians and patients.

PubMed

Roemer, Lorrie K; Rocha, Roberto A; Del Fiol, Guilherme; Bradshaw, Richard L; Hanna, Timothy P; Hulse, Nathan C

2006-01-01

At Intermountain Healthcare (Intermountain), executive clinical content experts are responsible for disseminating consistent evidence-based clinical content throughout the enterprise at the point-of-care. With a paper-based system it was difficult to ensure that current information was received and was being used in practice. With electronic information systems multiple applications were supplying similar, but different, vendor-licensed and locally-developed content. These issues influenced the consistency of clinical practice within the enterprise, jeopardized patient and clinician safety, and exposed the enterprise and its employees to potential financial penalties. In response to these issues Intermountain is developing a knowledge management infrastructure providing tools and services to support clinical content development, deployment, maintenance, and communication. The Intermountain knowledge management philosophy includes strategies guiding clinicians and consumers of health information to relevant best practice information with the intention of changing behaviors. This paper presents three case studies describing different information management problems identified within Intermountain, methods used to solve the problems, implementation challenges, and the current status of each project.