Calibration of BK Virus Nucleic Acid Amplification Testing to the 1st WHO International Standard for BK Virus

PubMed Central

Tan, Susanna K.; Milligan, Stephen; Sahoo, Malaya K.; Taylor, Nathaniel

2017-01-01

ABSTRACT Significant interassay variability in the quantification of BK virus (BKV) DNA precludes establishing broadly applicable thresholds for the management of BKV infection in transplantation. The 1st WHO International Standard for BKV (primary standard) was introduced in 2016 as a common calibrator for improving the harmonization of BKV nucleic acid amplification testing (NAAT) and enabling comparisons of biological measurements worldwide. Here, we evaluated the Altona RealStar BKV assay (Altona) and calibrated the results to the international unit (IU) using the Exact Diagnostics BKV verification panel, a secondary standard traceable to the primary standard. The primary and secondary standards on Altona had nearly identical linear regression equations (primary standard, Y = 1.05X − 0.28, R2 = 0.99; secondary standard, Y = 1.04X − 0.26, R2 = 0.99) and conversion factors (primary standard, 1.11 IU/copy; secondary standard, 1.09 IU/copy). A comparison of Altona with a laboratory-developed BKV NAAT assay in IU/ml versus copies/ml using Passing-Bablok regression revealed similar regression lines, no proportional bias, and improvement in the systematic bias (95% confidence interval of intercepts: copies/ml, −0.52 to −1.01; IU/ml, 0.07 to −0.36). Additionally, Bland-Altman analyses revealed a clinically significant reduction of bias when results were reported in IU/ml (IU/ml, −0.10 log10; copies/ml, −0.70 log10). These results indicate that the use of a common calibrator improved the agreement between the two assays. As clinical laboratories worldwide use calibrators traceable to the primary standard to harmonize BKV NAAT results, we anticipate improved interassay comparisons with a potential for establishing broadly applicable quantitative BKV DNA load cutoffs for clinical practice. PMID:28053213

A mobile and web-based clinical decision support and monitoring system for diabetes mellitus patients in primary care: a study protocol for a randomized controlled trial.

PubMed

Kart, Özge; Mevsim, Vildan; Kut, Alp; Yürek, İsmail; Altın, Ayşe Özge; Yılmaz, Oğuz

2017-11-29

Physicians' guideline use rates for diagnosis, treatment and monitoring of diabetes mellitus (DM) is very low. Time constraints, patient overpopulation, and complex guidelines require alternative solutions for real time patient monitoring. Rapidly evolving e-health technology combined with clinical decision support and monitoring systems (CDSMS) provides an effective solution to these problems. The purpose of the study is to develop a user-friendly, comprehensive, fully integrated web and mobile-based Clinical Decision Support and Monitoring System (CDSMS) for the screening, diagnosis, treatment, and monitoring of DM diseases which is used by physicians and patients in primary care and to determine the effectiveness of the system. The CDSMS will be based on evidence-based guidelines for DM disease. A web and mobile-based application will be developed in which the physician will remotely monitor patient data through mobile applications in real time. The developed CDSMS will be tested in two stages. In the first stage, the usability, understandability, and adequacy of the application will be determined. Five primary care physicians will use the developed application for at least 16 DM patients. Necessary improvements will be made according to physician feedback. In the second phase, a parallel, single-blind, randomized controlled trial will be implemented. DM diagnosed patients will be recruited for the CDSMS trial by their primary care physicians. Ten physicians and their 439 patients will be involved in the study. Eligible participants will be assigned to intervention and control groups with simple randomization. The significance level will be accepted as p < 0.05. In the intervention group, the system will make recommendations on patient monitoring, diagnosis, and treatment. These recommendations will be implemented at the physician's discretion. Patients in the control group will be treated by physicians according to current DM treatment standards. Patients in both groups will be monitored for 6 months. Patient data will be compared between 0th and 6th month of the study. . Clinical and laboratory outcomes will be assessed in person while others will be self-assessed online. The developed system will be the first of its kind to utilize evidence based guidelines to provide health services to DM patients. ClinicalTrials.gov NCT02917226 . 28 September 2016.

Decision support and disease management: a logic engineering approach.

PubMed

Fox, J; Thomson, R

1998-12-01

This paper describes the development and application of PROforma, a unified technology for clinical decision support and disease management. Work leading to the implementation of PROforma has been carried out in a series of projects funded by European agencies over the past 13 years. The work has been based on logic engineering, a distinct design and development methodology that combines concepts from knowledge engineering, logic programming, and software engineering. Several of the projects have used the approach to demonstrate a wide range of applications in primary and specialist care and clinical research. Concurrent academic research projects have provided a sound theoretical basis for the safety-critical elements of the methodology. The principal technical results of the work are the PROforma logic language for defining clinical processes and an associated suite of software tools for delivering applications, such as decision support and disease management procedures. The language supports four standard objects (decisions, plans, actions, and enquiries), each of which has an intuitive meaning with well-understood logical semantics. The development toolset includes a powerful visual programming environment for composing applications from these standard components, for verifying consistency and completeness of the resulting specification and for delivering stand-alone or embeddable applications. Tools and applications that have resulted from the work are described and illustrated, with examples from specialist cancer care and primary care. The results of a number of evaluation activities are included to illustrate the utility of the technology.

Comparing the effectiveness of the BPMAP (Blood Pressure Management Application) and usual care in self-management of primary hypertension and adherence to treatment in patients aged 30-60 years: study protocol for a randomized controlled trial.

PubMed

Ashoorkhani, Mahnaz; Bozorgi, Ali; Majdzadeh, Reza; Hosseini, Hamed; Yoonessi, Ali; Ramezankhani, Ali; Eftekhar, Hassan

2016-10-21

Hypertension is one of the most important and well-known risk factors for cardiovascular diseases. Unfortunately, in spite of effective treatments, adherence to the regular use of drugs and other nondrug treatments, such as lifestyle improvement, is often poor. This study evaluates the effectiveness of an educational, supportive intervention - in the form of a Blood Pressure Management Application (BPMAP) - on self-management in patients with primary hypertension on controlling the determinant factors of hypertension, and on adherence to treatment. A two-arm, parallel-design randomized controlled clinical trial will be conducted on 30 to 60 year-old patients with primary hypertension who are attending the Tehran Heart Center. One hundred and thirty-two (132) patients will be randomly assigned to the intervention and control (usual method) groups. The most important inclusion criteria are, having primary hypertension and being pharmacologically treated for it, and not having developed the complications of hypertension, such as myocardial infarction, cerebral stroke and cardiac insufficiency. The participants should be able to read Persian and be able to use the application. The most important outcomes of the study include adherence to treatment, weight control, and regular monitoring of blood pressure which are assessed in the primary assessment (baseline data questionnaire) and again at the 8 th and 24 th weeks. The intervention is a mobile application that has capabilities such as reminders and scientific and supportive information. This application has been programmed to reduce many of the nonadherence factors of hypertension treatment. Therefore, the findings may contribute to a rise in adherence to treatment. If proven to have an appropriate impact, it may be extended for use in the national hypertension control plan. This study was registered in the Iran Randomized Clinical Trial Center under the number IRCT2015111712211N2 on 1 January 2016.

MO-A-BRC-00: TG167: Clinical Recommendations for Innovative Brachytherapy Devices and Applicators

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

NONE

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1)more » dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. NRC, FDA, Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, European Commission for CE Marking, and institutional review boards and radiation safety committees. Learning Objectives: Understand the necessary dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use. Evaluate risks and benefits from regulatory and safety perspectives. Identify necessary resources and create a plan for clinical introduction of innovative brachytherapy device or applications. Consultant for Theragenics Corp.; R. Nath, Consultant to Theragenics Corp.« less

Evaluating topic model interpretability from a primary care physician perspective.

PubMed

Arnold, Corey W; Oh, Andrea; Chen, Shawn; Speier, William

2016-02-01

Probabilistic topic models provide an unsupervised method for analyzing unstructured text. These models discover semantically coherent combinations of words (topics) that could be integrated in a clinical automatic summarization system for primary care physicians performing chart review. However, the human interpretability of topics discovered from clinical reports is unknown. Our objective is to assess the coherence of topics and their ability to represent the contents of clinical reports from a primary care physician's point of view. Three latent Dirichlet allocation models (50 topics, 100 topics, and 150 topics) were fit to a large collection of clinical reports. Topics were manually evaluated by primary care physicians and graduate students. Wilcoxon Signed-Rank Tests for Paired Samples were used to evaluate differences between different topic models, while differences in performance between students and primary care physicians (PCPs) were tested using Mann-Whitney U tests for each of the tasks. While the 150-topic model produced the best log likelihood, participants were most accurate at identifying words that did not belong in topics learned by the 100-topic model, suggesting that 100 topics provides better relative granularity of discovered semantic themes for the data set used in this study. Models were comparable in their ability to represent the contents of documents. Primary care physicians significantly outperformed students in both tasks. This work establishes a baseline of interpretability for topic models trained with clinical reports, and provides insights on the appropriateness of using topic models for informatics applications. Our results indicate that PCPs find discovered topics more coherent and representative of clinical reports relative to students, warranting further research into their use for automatic summarization. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Evaluating Topic Model Interpretability from a Primary Care Physician Perspective

PubMed Central

Arnold, Corey W.; Oh, Andrea; Chen, Shawn; Speier, William

2015-01-01

Background and Objective Probabilistic topic models provide an unsupervised method for analyzing unstructured text. These models discover semantically coherent combinations of words (topics) that could be integrated in a clinical automatic summarization system for primary care physicians performing chart review. However, the human interpretability of topics discovered from clinical reports is unknown. Our objective is to assess the coherence of topics and their ability to represent the contents of clinical reports from a primary care physician’s point of view. Methods Three latent Dirichlet allocation models (50 topics, 100 topics, and 150 topics) were fit to a large collection of clinical reports. Topics were manually evaluated by primary care physicians and graduate students. Wilcoxon Signed-Rank Tests for Paired Samples were used to evaluate differences between different topic models, while differences in performance between students and primary care physicians (PCPs) were tested using Mann-Whitney U tests for each of the tasks. Results While the 150-topic model produced the best log likelihood, participants were most accurate at identifying words that did not belong in topics learned by the 100-topic model, suggesting that 100 topics provides better relative granularity of discovered semantic themes for the data set used in this study. Models were comparable in their ability to represent the contents of documents. Primary care physicians significantly outperformed students in both tasks. Conclusion This work establishes a baseline of interpretability for topic models trained with clinical reports, and provides insights on the appropriateness of using topic models for informatics applications. Our results indicate that PCPs find discovered topics more coherent and representative of clinical reports relative to students, warranting further research into their use for automatic summarization. PMID:26614020

Teaching Evidence-Based Medicine in the Era of Point-of-Care Databases: The Case of the Giant Bladder Stone.

PubMed

Kash, Melissa J

2016-01-01

In an era where physicians rely on point-of-care databases that provide filtered, pre-appraised, and quickly accessible clinical information by smartphone applications, it is difficult to teach medical students the importance of knowing not only when it is appropriate to search the primary medical literature but also how to do it. This column will describe how librarians at an academic health sciences library use an unusual clinical case to make demonstrations of searching primary medical literature real and meaningful to medical students, and to illustrate vividly the importance of knowing what to do when the answer to a clinical question cannot be found in a point-of-care database.

Measurement of ocular aberrations in downward gaze using a modified clinical aberrometer

PubMed Central

Ghosh, Atanu; Collins, Michael J; Read, Scott A; Davis, Brett A; Iskander, D. Robert

2011-01-01

Changes in corneal optics have been measured after downward gaze. However, ocular aberrations during downward gaze have not been previously measured. A commercial Shack-Hartmann aberrometer (COAS-HD) was modified by adding a relay lens system and a rotatable beam splitter to allow on-axis aberration measurements in primary gaze and downward gaze with binocular fixation. Measurements with the modified aberrometer (COAS-HD relay system) in primary and downward gaze were validated against a conventional aberrometer. In human eyes, there were significant changes (p<0.05) in defocus C(2,0), primary astigmatism C(2,2) and vertical coma C(3,−1) in downward gaze (25 degrees) compared to primary gaze, indicating the potential influence of biomechanical forces on the optics of the eye in downward gaze. To demonstrate a further clinical application of this modified aberrometer, we measured ocular aberrations when wearing a progressive addition lens (PAL) in primary gaze (0 degree), 15 degrees downward gaze and 25 degrees downward gaze. PMID:21412451

Functional magnetic resonance imaging in clinical practice: State of the art and science.

PubMed

Barras, Christen D; Asadi, Hamed; Baldeweg, Torsten; Mancini, Laura; Yousry, Tarek A; Bisdas, Sotirios

2016-11-01

Functional magnetic resonance imaging (fMRI) has become a mainstream neuroimaging modality in the assessment of patients being evaluated for brain tumour and epilepsy surgeries. Thus, it is important for doctors in primary care settings to be well acquainted with the present and potential future applications, as well as limitations, of this modality. The objective of this article is to introduce the theoretical principles and state-of-the-art clinical applications of fMRI in brain tumour and epilepsy surgery, with a focus on the implications for clinical primary care. fMRI enables non-invasive functional mapping of specific cortical tasks (eg motor, language, memory-based, visual), revealing information about functional localisation, anatomical variation in cortical function, and disease effects and adaptations, including the fascinating phenomenon of brain plasticity. fMRI is currently ordered by specialist neurologists and neurosurgeons for the purposes of pre-surgical assessment, and within the context of an experienced multidisciplinary team to prepare, conduct and interpret the scan. With an increasing number of patients undergoing fMRI, general practitioners can expect questions about the current and emerging role of fMRI in clinical care from these patients and their families.

EVIDENT 3 Study: A randomized, controlled clinical trial to reduce inactivity and caloric intake in sedentary and overweight or obese people using a smartphone application

PubMed Central

Recio-Rodriguez, José I.; Gómez-Marcos, Manuel A.; Agudo-Conde, Cristina; Ramirez, Ignasi; Gonzalez-Viejo, Natividad; Gomez-Arranz, Amparo; Salcedo-Aguilar, Fernando; Rodriguez-Sanchez, Emiliano; Alonso-Domínguez, Rosario; Sánchez-Aguadero, Natalia; Gonzalez-Sanchez, Jesus; Garcia-Ortiz, Luis

2018-01-01

Abstract Introduction: Mobile technology, when included within multicomponent interventions, could contribute to more effective weight loss. The objective of this project is to assess the impact of adding the use of the EVIDENT 3 application, designed to promote healthy living habits, to traditional modification strategies employed for weight loss. Other targeted behaviors (walking, caloric-intake, sitting time) and outcomes (quality of life, inflammatory markers, measurements of arterial aging) will also be evaluated. Methods: Randomized, multicentre clinical trial with 2 parallel groups. The study will be conducted in the primary care setting and will include 700 subjects 20 to 65 years, with a body mass index (27.5–40 kg/m2), who are clinically classified as sedentary. The primary outcome will be weight loss. Secondary outcomes will include change in walking (steps/d), sitting time (min/wk), caloric intake (kcal/d), quality of life, arterial aging (augmentation index), and pro-inflammatory marker levels. Outcomes will be measured at baseline, after 3 months, and after 1 year. Participants will be randomly assigned to either the intervention group (IG) or the control group (CG). Both groups will receive the traditional primary care lifestyle counseling prior to randomization. The subjects in the IG will be lent a smartphone and a smartband for a 3-month period, corresponding to the length of the intervention. The EVIDENT 3 application integrates the information collected by the smartband on physical activity and the self-reported information by participants on daily food intake. Using this information, the application generates recommendations and personalized goals for weight loss. Discussion: There is a great diversity in the applications used obtaining different results on lifestyle improvement and weight loss. The populations studied are not homogeneous and generate different results. The results of this study will help our understanding of the efficacy of new technologies, combined with traditional counseling, towards reducing obesity and enabling healthier lifestyles. Ethics and dissemination: The study was approved by the Clinical Research Ethics Committee of the Health Area of Salamanca (“CREC of Health Area of Salamanca”) on April 2016. A SPIRIT checklist is available for this protocol. The trial was registered in ClinicalTrials.gov provided by the US National Library of Medicine-number NCT03175614. PMID:29480874

Clinical grade adult stem cell banking

PubMed Central

Thirumala, Sreedhar; Goebel, W Scott

2009-01-01

There has been a great deal of scientific interest recently generated by the potential therapeutic applications of adult stem cells in human care but there are several challenges regarding quality and safety in clinical applications and a number of these challenges relate to the processing and banking of these cells ex-vivo. As the number of clinical trials and the variety of adult cells used in regenerative therapy increases, safety remains a primary concern. This has inspired many nations to formulate guidelines and standards for the quality of stem cell collection, processing, testing, banking, packaging and distribution. Clinically applicable cryopreservation and banking of adult stem cells offers unique opportunities to advance the potential uses and widespread implementation of these cells in clinical applications. Most current cryopreservation protocols include animal serum proteins and potentially toxic cryoprotectant additives (CPAs) that prevent direct use of these cells in human therapeutic applications. Long term cryopreservation of adult stem cells under good manufacturing conditions using animal product free solutions is critical to the widespread clinical implementation of ex-vivo adult stem cell therapies. Furthermore, to avoid any potential cryoprotectant related complications, reduced CPA concentrations and efficient post-thaw washing to remove CPA are also desirable. The present review focuses on the current strategies and important aspects of adult stem cell banking for clinical applications. These include current good manufacturing practices (cGMPs), animal protein free freezing solutions, cryoprotectants, freezing & thawing protocols, viability assays, packaging and distribution. The importance and benefits of banking clinical grade adult stem cells are also discussed. PMID:20046678

Why is there variation in the practice of evidence-based medicine in primary care? A qualitative study

PubMed Central

Hisham, Ranita; Ng, Chirk Jenn; Liew, Su May; Hamzah, Nurazira; Ho, Gah Juan

2016-01-01

Objective To explore the factors, including barriers and facilitators, influencing the practice of evidence-based medicine (EBM) across various primary care settings in Malaysia based on the doctors’ views and experiences. Research design The qualitative study was used to answer the research question. 37 primary care physicians participated in six focus group discussions and six individual in-depth interviews. A semistructured topic guide was used to facilitate both the interviews and focus groups, which were audio recorded, transcribed verbatim, checked and analysed using a thematic approach. Participants 37 primary care doctors including medical officers, family medicine specialists, primary care lecturers and general practitioners with different working experiences and in different settings. Setting The study was conducted across three primary care settings—an academic primary care practice, private and public health clinics in Klang Valley, Malaysia. Results The doctors in this study were aware of the importance of EBM but seldom practised it. Three main factors influenced the implementation of EBM in the doctors’ daily practice. First, there was a lack of knowledge and skills in searching for and applying evidence. Second, workplace culture influenced doctors’ practice of EBM. Third, some doctors considered EBM as a threat to good clinical practice. They were concerned that rigid application of evidence compromised personalised patient care and felt that EBM did not consider the importance of clinical experience. Conclusions Despite being aware of and having a positive attitude towards EBM, doctors in this study seldom practised EBM in their routine clinical practice. Besides commonly cited barriers such as having a heavy workload and lack of training, workplace ‘EBM culture’ had an important influence on the doctors’ behaviour. Strategies targeting barriers at the practice level should be considered when implementing EBM in primary care. PMID:26962037

Using PACS and wavelet-based image compression in a wide-area network to support radiation therapy imaging applications for satellite hospitals

NASA Astrophysics Data System (ADS)

Smith, Charles L.; Chu, Wei-Kom; Wobig, Randy; Chao, Hong-Yang; Enke, Charles

1999-07-01

An ongoing PACS project at our facility has been expanded to include providing and managing images used for routine clinical operation of the department of radiation oncology. The intent of our investigation has been to enable out clinical radiotherapy service to enter the tele-medicine environment through the use of a PACS system initially implemented in the department of radiology. The backbone for the imaging network includes five CT and three MR scanners located across three imaging centers. A PC workstation in the department of radiation oncology was used to transmit CT imags to a satellite facility located approximately 60 miles from the primary center. Chest CT images were used to analyze network transmission performance. Connectivity established between the primary department and satellite has fulfilled all image criteria required by the oncologist. Establishing the link tot eh oncologist at the satellite diminished bottlenecking of imaging related tasks at the primary facility due to physician absence. A 30:1 compression ratio using a wavelet-based algorithm provided clinically acceptable images treatment planning. Clinical radiotherapy images can be effectively managed in a wide- area-network to link satellite facilities to larger clinical centers.

Cryotherapy with liquid nitrogen versus topical salicylic acid application for cutaneous warts in primary care: randomized controlled trial.

PubMed

Bruggink, Sjoerd C; Gussekloo, Jacobijn; Berger, Marjolein Y; Zaaijer, Krista; Assendelft, Willem J J; de Waal, Margot W M; Bavinck, Jan Nico Bouwes; Koes, Bart W; Eekhof, Just A H

2010-10-19

Cryotherapy is widely used for the treatment of cutaneous warts in primary care. However, evidence favours salicylic acid application. We compared the effectiveness of these treatments as well as a wait-and-see approach. Consecutive patients with new cutaneous warts were recruited in 30 primary care practices in the Netherlands between May 1, 2006, and Jan. 26, 2007. We randomly allocated eligible patients to one of three groups: cryotherapy with liquid nitrogen every two weeks, self-application of salicylic acid daily or a wait-and-see approach. The primary outcome was the proportion of participants whose warts were all cured at 13 weeks. Analysis was on an intention-to-treat basis. Secondary outcomes included treatment adherence, side effects and treatment satisfaction. Research nurses assessed outcomes during home visits at 4, 13 and 26 weeks. Of the 250 participants (age 4 to 79 years), 240 were included in the analysis at 13 weeks (loss to follow-up 4%). Cure rates were 39% (95% confidence interval [CI] 29%-51%) in the cryotherapy group, 24% (95% CI 16%-35%) in the salicylic acid group and 16% (95% CI 9.5%-25%) in the wait-and-see group. Differences in effectiveness were most pronounced among participants with common warts (n = 116): cure rates were 49% (95% CI 34%-64%) in the cryotherapy group, 15% (95% CI 7%-30%) in the salicylic acid group and 8% (95% CI 3%-21%) in the wait-and-see group. Cure rates among the participants with plantar warts (n = 124) did not differ significantly between treatment groups. For common warts, cryotherapy was the most effective therapy in primary care. For plantar warts, we found no clinically relevant difference in effectiveness between cryotherapy, topical application of salicylic acid or a wait-and-see approach after 13 weeks. (ClinicalTrial.gov registration no. ISRCTN42730629).

Cryotherapy with liquid nitrogen versus topical salicylic acid application for cutaneous warts in primary care: randomized controlled trial

PubMed Central

Bruggink, Sjoerd C.; Gussekloo, Jacobijn; Berger, Marjolein Y.; Zaaijer, Krista; Assendelft, Willem J.J.; de Waal, Margot W.M.; Bavinck, Jan Nico Bouwes; Koes, Bart W.; Eekhof, Just A.H.

2010-01-01

Background Cryotherapy is widely used for the treatment of cutaneous warts in primary care. However, evidence favours salicylic acid application. We compared the effectiveness of these treatments as well as a wait-and-see approach. Methods Consecutive patients with new cutaneous warts were recruited in 30 primary care practices in the Netherlands between May 1, 2006, and Jan. 26, 2007. We randomly allocated eligible patients to one of three groups: cryotherapy with liquid nitrogen every two weeks, self-application of salicylic acid daily or a wait-and-see approach. The primary outcome was the proportion of participants whose warts were all cured at 13 weeks. Analysis was on an intention-to-treat basis. Secondary outcomes included treatment adherence, side effects and treatment satisfaction. Research nurses assessed outcomes during home visits at 4, 13 and 26 weeks. Results Of the 250 participants (age 4 to 79 years), 240 were included in the analysis at 13 weeks (loss to follow-up 4%). Cure rates were 39% (95% confidence interval [CI] 29%–51%) in the cryotherapy group, 24% (95% CI 16%–35%) in the salicylic acid group and 16% (95% CI 9.5%–25%) in the wait-and-see group. Differences in effectiveness were most pronounced among participants with common warts (n = 116): cure rates were 49% (95% CI 34%–64%) in the cryotherapy group, 15% (95% CI 7%–30%) in the salicylic acid group and 8% (95% CI 3%–21%) in the wait-and-see group. Cure rates among the participants with plantar warts (n = 124) did not differ significantly between treatment groups. Interpretation For common warts, cryotherapy was the most effective therapy in primary care. For plantar warts, we found no clinically relevant difference in effectiveness between cryotherapy, topical application of salicylic acid or a wait-and-see approach after 13 weeks. (ClinicalTrial.gov registration no. ISRCTN42730629) PMID:20837684

Primary care research conducted in networks: getting down to business.

PubMed

Mold, James W

2012-01-01

This seventh annual practice-based research theme issue of the Journal of the American Board of Family Medicine highlights primary care research conducted in practice-based research networks (PBRNs). The issue includes discussion of (1) theoretical and methodological research, (2) health care research (studies addressing primary care processes), (3) clinical research (studies addressing the impact of primary care on patients), and (4) health systems research (studies of health system issues impacting primary care including the quality improvement process). We had a noticeable increase in submissions from PBRN collaborations, that is, studies that involved multiple networks. As PBRNs cooperate to recruit larger and more diverse patient samples, greater generalizability and applicability of findings lead to improved primary care processes.

The IND application.

PubMed

Ferkany, John W; Williams, Michael

2008-09-01

Translational biomedical research is often directed to the introduction of a new drug or biologic intended to treat unmet medical need in humans. This unit describes the timing and content of the investigational new drug (IND) application, the primary document required by the U.S. FDA for the initiation of clinical trials in humans with any new chemical entity (NCE) or biologic. The IND application contains all the information necessary for the FDA to make an assessment of the risks and benefits of the proposed clinical trials for the NCE/biologic, containing a detailed but succinct description of the biology, safety, toxicology, chemistry and manufacturing process, and the proposed clinical plan. This unit is geared for those with little or no experience with the IND process and is intended as a global introduction to this, the initial stage of the drug development process for drugs used in humans.

The Ottawa knee rules - a useful clinical decision tool.

PubMed

Yao, Kaihan; Haque, Tasneem

2012-04-01

Acute knee injuries are a common presentation in the primary care setting. The Ottawa knee rules provide guidance on how to identify which cases of knee injury require radiographic investigation. This article describes the Ottawa knee rules and outlines their sensitivity, reproducibility and application in the clinical setting. The Ottawa knee rules are a valuable tool for clinicians in the routine management of acute knee injuries. Studies show that they are highly sensitive at identifying patients with fractures of the knee and have a high degree of interobserver agreement and reproducible results. Application of the Ottawa knee rules in appropriate clinical scenarios may reduce the number of unnecessary radiographs ordered, streamlining patient throughput and allowing for significant cost savings. Although designed for use in adults, some studies have suggested that the Ottawa knee rules may also be applicable to the paediatric population.

Integrating preventive care and nursing standardized terminologies in nursing education: a case study.

PubMed

Burkhart, Lisa; Sommer, Sheryl

2007-01-01

This study investigated the development of a community-focused curriculum integrating primary, secondary, and tertiary prevention and nursing standardized terminologies as an organizing infrastructure. This is a case study of the curriculum redesign of the Marcella Niehoff School of Nursing, Loyola University Chicago. Faculty developed a conceptual framework integrating core concepts into curriculum design, course content, and clinical applications. A coherent curriculum was designed using a community-focused approach; primary, secondary, and tertiary prevention strategies; and standardized terminologies as the organizing infrastructure to teach and apply nursing practice. The curriculum provides a meaningful correlation between the classroom and clinical experience. Students journey with their patients throughout the health care experience, applying nursing concepts using standardized terminologies. Clinical experiences provide students with the opportunity to transfer knowledge to the health experiences of patients in their care. Patient encounters, whether at the primary, secondary, or tertiary level of prevention, are used to assist students in developing critical thinking skills through the use of standardized nursing terminologies.

Image-based multichannel vaginal cylinder brachytherapy for the definitive treatment of gynecologic malignancies in the vagina.

PubMed

Gebhardt, Brian J; Vargo, John A; Kim, Hayeon; Houser, Christopher J; Glaser, Scott M; Sukumvanich, Paniti; Olawaiye, Alexander B; Kelley, Joseph L; Edwards, Robert P; Comerci, John T; Courtney-Brooks, Madeleine; Beriwal, Sushil

2018-06-18

Brachytherapy is integral to vaginal cancer treatment and is typically delivered using an intracavitary single-channel vaginal cylinder (SCVC) or an interstitial brachytherapy (ISBT) applicator. Multi-channel vaginal cylinder (MCVC) applicators allow for improved organ-at-risk (OAR) sparing compared to SCVC while maintaining target coverage. We present clinical outcomes of patients treated with image-based high dose-rate (HDR) brachytherapy using a MCVC. Sixty patients with vaginal cancer (27% primary vaginal and 73% recurrence from other primaries) were treated with combination external beam radiotherapy (EBRT) and image-based HDR brachytherapy utilizing a MCVC if residual disease thickness was 7 mm or less after EBRT. All pts received 3D image-based BT to a total equivalent dose of 70-80 Gy. The median high-risk clinical target volume was 24.4 cm 3 (interquartile range [IQR], 14.1), with a median dose to 90% of 77.2 Gy (IQR, 2.8). After a median follow-up of 45 months (range, 11-78), the 4-year local-regional control, distant control, DFS, and OS rates were 92.6%, 76.1%, 64.0%, and 67.2%, respectively. The 4-year LRC rates were similar between the primary vaginal (92%) and recurrent (93%) groups (p = 0.290). Pts with lymph node positive disease had a lower rate of distant control at 4 years (22.7% vs. 89.0%, p < 0.001). There were no Grade 3 or higher acute complications. The 4-year rate of late Grade 3 or higher toxicity was 2.7%. Clinical outcomes of pts with primary and recurrent vaginal cancer treated definitively in a systematic manner with combination EBRT with image-guided HDR BT utilizing a MCVC applicator demonstrate high rates of local control and low rates of severe morbidity. The MCVC technique allows interstitial implantation to be avoided in select pts with ≤7 mm residual disease thickness following EBRT while maintaining excellent clinical outcomes with extended 4-year follow-up in this rare malignancy. Copyright © 2018. Published by Elsevier Inc.

One hundred and one over-the-scope-clip applications for severe gastrointestinal bleeding, leaks and fistulas.

PubMed

Wedi, Edris; Gonzalez, Susana; Menke, Detlev; Kruse, Elena; Matthes, Kai; Hochberger, Juergen

2016-02-07

To investigate the efficacy and clinical outcome of patients treated with an over-the-scope-clip (OTSC) system for severe gastrointestinal hemorrhage, perforations and fistulas. From 02-2009 to 10-2012, 84 patients were treated with 101 OTSC clips. 41 patients (48.8%) presented with severe upper-gastrointestinal (GI) bleeding, 3 (3.6%) patients with lower-GI bleeding, 7 patients (8.3%) underwent perforation closure, 18 patients (21.4%) had prevention of secondary perforation, 12 patients (14.3%) had control of secondary bleeding after endoscopic mucosal resection or endoscopic submucosal dissection (ESD) and 3 patients (3.6%) had an intervention on a chronic fistula. In 78/84 patients (92.8%), primary treatment with the OTSC was technically successful. Clinical primary success was achieved in 75/84 patients (89.28%). The overall mortality in the study patients was 11/84 (13.1%) and was seen in patients with life-threatening upper GI hemorrhage. There was no mortality in any other treatment group. In detail OTSC application lead to a clinical success in 35/41 (85.36%) patients with upper GI bleeding and in 3/3 patients with lower GI bleeding. Technical success of perforation closure was 100% while clinical success was seen in 4/7 cases (57.14%) due to attendant circumstances unrelated to the OTSC. Technical and clinic success was achieved in 18/18 (100%) patients for the prevention of bleeding or perforation after endoscopic mucosal resection and ESD and in 3/3 cases of fistula closure. Two application-related complications were seen (2%). This largest single center experience published so far confirms the value of the OTSC for GI emergencies and complications. Further clinical experience will help to identify optimal indications for its targeted and prophylactic use.

[Study on the application of value of digital medical technology in the operation on primary liver cancer].

PubMed

Fang, Chi-hua; Lu, Chao-min; Huang, Yan-peng; Li, Xiao-feng; Fan, Ying-fang; Yang, Jian; Xiang, Nan; Pan, Jia-hui

2009-04-01

To study the clinical application of digital medical in the operation on primary liver cancer. The patients (n=11) with primary hepatic carcinoma treated between February and July 2008, including 9 cases of hepatocellular carcinoma, 2 cases of cholangiocellular carcinoma, were scanned using 64 slices helicon computerized tomography (CT) and the datasets was collected. Segment and three-dimensional (3D) reconstruction of the CT image was carried out by the medical image processing system which was developed. And the 3D moulds were imported to the FreeForm Modeling System for smoothing. Then the hepatectomy in treatment of hepatoma and implanting of catheter were simulated with the force-feedback equipment (PHANToM). Finally, 3D models and results of simulation surgery were used for choosing mode of operation and comparing with the findings during the operation. The reconstructed models were true to life, and their spatial disposition and correlation were shown clearly; Blood supply of primary liver cancer could be seen easily. In the simulation surgery system, the process of virtual partial hepatectomy and implanting of catheter using simulation scalpel and catheter on 3D moulds with PHANToM was consistent with the clinical course of surgery. Life-like could be felt and power feeling can be touched during simulation operation. Digital medical benefited knowing the relationship between primary liver cancer and the intrahepatic pipe. It gave an advantage to complete primary liver cancer resection with more liver volume remained. It can improve the surgical effect and decrease the surgical risk and reduce the complication through demonstrating visualized operation before surgery.

Transcranial direct current stimulation in post stroke aphasia and primary progressive aphasia: Current knowledge and future clinical applications.

PubMed

Sebastian, Rajani; Tsapkini, Kyrana; Tippett, Donna C

2016-06-13

The application of transcranial direct current stimulation (tDCS) in chronic post stroke aphasia is documented in a substantial literature, and there is some new evidence that tDCS can augment favorable language outcomes in primary progressive aphasia. Anodal tDCS is most often applied to the left hemisphere language areas to increase cortical excitability (increase the threshold of activation) and cathodal tDCS is most often applied to the right hemisphere homotopic areas to inhibit over activation in contralesional right homologues of language areas. Outcomes usually are based on neuropsychological and language test performance, following a medical model which emphasizes impairment of function, rather than a model which emphasizes functional communication. In this paper, we review current literature of tDCS as it is being used as a research tool, and discuss future implementation of tDCS as an adjuvant treatment to behavioral speech-language pathology intervention. We review literature describing non-invasive brain stimulation, the mechanism of tDCS, and studies of tDCS in aphasia and neurodegenerative disorders. We discuss future clinical applications. tDCS is a promising adjunct to traditional speech-language pathology intervention to address speech-language deficits after stroke and in the neurodegenerative disease, primary progressive aphasia. Limited data are available regarding how performance on these types of specific tasks translates to functional communication outcomes.

Transcranial Direct Current Stimulation in Post Stroke Aphasia and Primary Progressive Aphasia: Current Knowledge and Future Clinical Applications

PubMed Central

Sebastian, Rajani; Tsapkini, Kyrana; Tippett, Donna C.

2016-01-01

BACKGROUND The application of transcranial direct current stimulation (tDCS) in chronic post stroke aphasia is documented in a substantial literature, and there is some new evidence that tDCS can augment favorable language outcomes in primary progressive aphasia. Anodal tDCS is most often applied to the left hemisphere language areas to increase cortical excitability (increase the threshold of activation) and cathodal tDCS is most often applied to the right hemisphere homotopic areas to inhibit over activation in contralesional right homologues of language areas. Outcomes usually are based on neuropsychological and language test performance, following a medical model which emphasizes impairment of function, rather than a model which emphasizes functional communication. OBJECTIVE In this paper, we review current literature of tDCS as it is being used as a research tool, and discuss future implementation of tDCS as an adjuvant treatment to behavioral speech-language pathology intervention. METHODS We review literature describing non-invasive brain stimulation, the mechanism of tDCS, and studies of tDCS in aphasia and neurodegenerative disorders. We discuss future clinical applications. RESULTS/CONCLUSIONS tDCS is a promising adjunct to traditional speech-language pathology intervention to address speech-language deficits after stroke and in the neurodegenerative disease, primary progressive aphasia. Limited data are available regarding how performance on these types of specific tasks translates to functional communication outcomes. PMID:27314871

Diagnostic and interventional musculoskeletal ultrasound: part 2. Clinical applications.

PubMed

Smith, Jay; Finnoff, Jonathan T

2009-02-01

Musculoskeletal ultrasound involves the use of high-frequency sound waves to image soft tissues and bony structures in the body for the purposes of diagnosing pathology or guiding real-time interventional procedures. Recently, an increasing number of physicians have integrated musculoskeletal ultrasound into their practices to facilitate patient care. Technological advancements, improved portability, and reduced costs continue to drive the proliferation of ultrasound in clinical medicine. This increased interest creates a need for education pertaining to all aspects of musculoskeletal ultrasound. The primary purpose of this article is to review diagnostic ultrasound technology and its potential clinical applications in the evaluation and treatment of patients with neurological and musculoskeletal disorders. After reviewing this article, physicians should be able to (1) list the advantages and disadvantages of ultrasound compared to other available imaging modalities; (2) describe how ultrasound machines produce images using sound waves; (3) discuss the steps necessary to acquire and optimize an ultrasound image; (4) understand the difference ultrasound appearances of tendons, nerves, muscles, ligaments, blood vessels, and bones; and (5) identify multiple applications for diagnostic and interventional musculoskeletal ultrasound. Part 2 of this 2-part article will focus on the clinical applications of musculoskeletal ultrasound in clinical practice, including the ultrasonographic appearance of normal and abnormal tissues as well as specific diagnostic and interventional applications in major body regions.

A retrospective study of a modified 1-minute formocresol pulpotomy technique part 1: clinical and radiographic findings.

PubMed

Kurji, Zahra A; Sigal, Michael J; Andrews, Paul; Titley, Keith

2011-01-01

The purpose of this study was to assess the clinical and radiographic outcomes of a 1-minute application of full-strength Buckley's formocresol with concurrent hemostasis using the medicated cotton pledget in human primary teeth. Using a retrospective chart review, clinical and radiographic data were available for 557 primary molars in 320 patients. Descriptive statistics and survival analysis were used to assess outcomes. Overall clinical success, radiographic success, and cumulative 5-year survival rates were approximately 99%, 90%, and 87%, respectively. Internal root resorption (∼5%) and pulp canal obliteration (∼2%) were the most frequently observed radiographic failures. Thirty-nine teeth were extracted due to clinical and or radiographic failure. Mandibular molars were 6 times more prone to radiographic failure than maxillary molars. Success rates for the modified technique are comparable to techniques that use the 5-minute diluted or full-strength solutions reported in the literature. This 1-minute full-strength formocresol technique is an acceptable alternative to published traditional techniques.

Proliferative human cell sources applied as biocomponent in bioartificial livers: a review.

PubMed

Nibourg, Geert A A; Chamuleau, Robert A F M; van Gulik, Thomas M; Hoekstra, Ruurdtje

2012-07-01

Bioartificial livers (BALs) are urgently needed to bridge severe liver failure patients to liver transplantation or liver regeneration. When based on primary hepatocytes, their efficacy has been shown in animal experiments and their safety was confirmed in clinical trials. However, a proliferative human cell source with therapeutic functionality is needed to secure availability and move BAL application forward. This review compares the performance of BALs based on proliferative human biocomponents and primary hepatocytes. This review evaluates relevant studies identified by searching the MEDLINE database until July 2011 and some of our own unpublished data. All the discussed hepatocyte-like biocomponents show deficiencies in their hepatic functionality compared with primary hepatocytes, particularly functions occurring late in liver development. Nonetheless, the HepaRG, HepG2-GS-CYP3A4, and mesenchymal stem cells show efficacy in a statistically well-powered animal model of acute liver failure, when applied in a BAL device. Various methods to gain higher functionality of BALs, including genetic modification, the usage of combinatory cell sources, and improvement of culture methods, have scarcely been applied, but may further pave the path for BAL application. Clinical implementation of a BAL based on a human proliferative biocomponent is still several years away.

MO-A-BRC-02: TG167 Report - Detailed Description

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

Rivard, M.

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1)more » dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. NRC, FDA, Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, European Commission for CE Marking, and institutional review boards and radiation safety committees. Learning Objectives: Understand the necessary dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use. Evaluate risks and benefits from regulatory and safety perspectives. Identify necessary resources and create a plan for clinical introduction of innovative brachytherapy device or applications. Consultant for Theragenics Corp.; R. Nath, Consultant to Theragenics Corp.« less

MO-A-BRC-01: TG167 Report - Introduction

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

Nath, R.

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1)more » dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. NRC, FDA, Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, European Commission for CE Marking, and institutional review boards and radiation safety committees. Learning Objectives: Understand the necessary dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use. Evaluate risks and benefits from regulatory and safety perspectives. Identify necessary resources and create a plan for clinical introduction of innovative brachytherapy device or applications. Consultant for Theragenics Corp.; R. Nath, Consultant to Theragenics Corp.« less

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.

Undergraduate nurses reflections on Whatsapp use in improving primary health care education.

PubMed

Willemse, Juliana J

2015-08-13

The global use of mobile devices with their connectivity capacity, and integrated with the affordances of social media networks, provides a resource-rich platform for innovative student-directed learning experiences. The objective of this study was to review the experiences of undergraduate nurses on the improvement of primary health care education at a School of Nursing at a University in the Western Cape, South Africa, through the incorporation of a social media application, WhatsApp. A qualitative, exploratory, descriptive, and contextual design was used to explore and describe data collected from a purposive sample of 21 undergraduate nursing students. The study population was engaged in a WhatsApp discussion group to enhance their integration of theory and clinical practice of the health assessment competency of the Primary Health Care Module. Participants submitted electronic reflections on their experiences in the WhatsApp discussion group via email on completion of the study. Thematic analysis of the qualitative data collected was done according to Tesch's (1990) steps of descriptive data analysis in order to identify the major themes in the study. The electronic reflections were analysed to explore their rich, reflective data. Seven themes were identified that included: positive experiences using the WhatsApp group; the usefulness of WhatsApp for integrating theory and clinical practice; the availability of resources for test preparation; opportunity for clarification; anonymity; exclusion of students as a result of the lack of an appropriate device, and the application caused the battery of the device to run flat quickly. The results of the experiences of students in the WhatsApp discussion group could be used to inform the use of social media applications in teaching and learning, with the purpose of enhancing the integration of the theory and clinical practice.

Application of Cox model in coagulation function in patients with primary liver cancer.

PubMed

Guo, Xuan; Chen, Mingwei; Ding, Li; Zhao, Shan; Wang, Yuefei; Kang, Qinjiong; Liu, Yi

2011-01-01

To analyze the distribution of coagulation parameters in patients with primary liver cancer; explore the relationship between clinical staging, survival, and coagulation parameters by using Coxproportional hazard model; and provide a parameter for clinical management and prognosis. Coagulation parameters were evaluated in 228 patients with primary liver cancer, 52 patients with common liver disease, and 52 normal healthy controls. The relationship between primary livercancer staging and coagulation parameters wasanalyzed. Follow-up examinations were performed. The Cox proportional hazard model was used to analyze the relationship between coagulationparameters and survival. The changes in the coagulation parameters in patients with primary liver cancer were significantly different from those in normal controls. The effect of the disease on coagulation function became more obvious as the severity of liver cancer increased (p<0.05). The levels of D-dimer, fibrinogen degradation products (FDP), fibrinogen (FIB), and platelets (PLT) were negatively correlated with the long-term survival of patients with advanced liver cancer. The stages of primary liver cancer are associated with coagulation parameters. Coagulation parameters are related to survival and risk factors. Monitoring of coagulation parameters may help ensure better surveillance and treatment for liver cancer patients.

Guidelines for hypertension treatment: applications for primary care practice--a review of the JNC VI report.

PubMed

Alexander, L M

1998-01-01

The Joint National Committee's report on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure was released in November 1997. With its release, an increased emphasis on "treating the patient, not just the number" has taken place. The report provides a comprehensive review of recent clinical evidence that helps guide clinical decision making in the care of the hypertensive patient. A new disease classification system entitled "risk stratification" is introduced and takes into account comorbid conditions that are present for many hypertensive individuals. This risk stratification is then linked to treatment strategies and provides a concise decision analysis framework to aid in clinical decision making. Community-based prevention strategies are also highlighted and should raise the awareness of clinicians to adopt these recommendations and integrate them more aggressively into daily practice. Increased emphasis on patient compliance to improve overall hypertension control rates is also presented. Maximum efficacy through once-daily dosing and fixed-dose combinations are reviewed in the report. The JNC report is a comprehensive resource for clinicians in primary care practice. Its evidenced-based approach is a wonderful teaching tool for those clinicians who also serve as clinical educators in primary care.

The Use of Bibliotherapy in Clinical Practice.

ERIC Educational Resources Information Center

Smith, Darrell; Burkhalter, Johnny K.

1987-01-01

Surveyed 158 members of American Academy of Psychotherapists in attempt to identify primary users of bibliotherapy, problems for which bibliotherapy seems most applicable, and reading resources that are being used effectively. Found that bibliotherapy was used often, particularly with childrearing skills and sexual dysfunctions. Years of…

[Quality and compliance with Clinical Practice Guidelines of Chronic Noncommunicable Diseases in primary care].

PubMed

Poblano-Verástegui, Ofelia; Vieyra-Romero, Waldo I; Galván-García, Ángel F; Fernández-Elorriaga, María; Rodríguez-Martínez, Antonia I; Saturno-Hernández, Pedro J

2017-01-01

To assess the quality and compliance of clinical practice guidelines (CPG) applicable to chronic non-communicable diseases (CNCD) in primary healthcare (CS), and views of staff on the barriers, facilitators and their use. 18 valued CPG with AGREEII, 3 are selected to develop indicators and assess compliance using lot quality acceptance sample (LQAS, standard 75 / 95% threshold 40 / 75% respectively, α:0. 05, β:0. 10) on 5 CS. 70 professionals surveyed about knowledge and use of CPG. Average quality of the CPG was 57.2%; low rating in domains: "Applicability" (<25%), "Stakeholder involvement" (43.5%) and "Rigour of development" (55.0%). Compliance in CS ranges from 39 to 53.4%. Professionals show uneven knowledge of CPG; 44 to 45% (according to CPG), they declare that they are not used, they identify as main barriers the lack of training, and their difficult accessibility and management. The quality and implementation of evaluated CPG is deficient constituting an opportunity of improvement in health services.

The detection of oral cancer using differential pathlength spectroscopy

NASA Astrophysics Data System (ADS)

Sterenborg, H. J. C. M.; Kanick, S.; de Visscher, S.; Witjes, M.; Amelink, A.

2010-02-01

The development of optical techniques for non-invasive diagnosis of cancer is an ongoing challenge to biomedical optics. For head and neck cancer we see two main fields of potential application 1) Screening for second primaries in patients with a history of oral cancer. This requires imaging techniques or an approach where a larger area can be scanned quickly. 2) Distinguishing potentially malignant visible primary lesions from benign ones. Here fiberoptic point measurements can be used as the location of the lesion is known. This presentation will focus on point measurement techniques. Various techniques for point measurements have been developed and investigated clinically for different applications. Differential Pathlength Spectroscopy is a recently developed fiberoptic point measurement technique that measures scattered light in a broad spectrum. Due to the specific fiberoptic geometry we measure only scattered photons that have travelled a predetermined pathlength. This allows us to analyse the spectrum mathematically and translate the measured curve into a set of parameters that are related to the microvasculature and to the intracellular morphology. DPS has been extensively evaluated on optical phantoms and tested clinically in various clinical applications. The first measurements in biopsy proven squamous cell carcinoma showed significant changes in both vascular and morphological parameters. Measurements on thick keratinized lesions however failed to generate any vascular signatures. This is related to the sampling depth of the standard optical fibers used. Recently we developed a fiberoptic probe with a ~1 mm sampling depth. Measurements on several leukoplakias showed that with this new probe we sample just below the keratin layer and can obtain vascular signatures. The results of a first set of clinical measurements will be presented and the significance for clinical diagnostics will be discussed.

Evaluation of consumer drug information databases.

PubMed

Choi, J A; Sullivan, J; Pankaskie, M; Brufsky, J

1999-01-01

To evaluate prescription drug information contained in six consumer drug information databases available on CD-ROM, and to make health care professionals aware of the information provided, so that they may appropriately recommend these databases for use by their patients. Observational study of six consumer drug information databases: The Corner Drug Store, Home Medical Advisor, Mayo Clinic Family Pharmacist, Medical Drug Reference, Mosby's Medical Encyclopedia, and PharmAssist. Not applicable. Not applicable. Information on 20 frequently prescribed drugs was evaluated in each database. The databases were ranked using a point-scale system based on primary and secondary assessment criteria. For the primary assessment, 20 categories of information based on those included in the 1998 edition of the USP DI Volume II, Advice for the Patient: Drug Information in Lay Language were evaluated for each of the 20 drugs, and each database could earn up to 400 points (for example, 1 point was awarded if the database mentioned a drug's mechanism of action). For the secondary assessment, the inclusion of 8 additional features that could enhance the utility of the databases was evaluated (for example, 1 point was awarded if the database contained a picture of the drug), and each database could earn up to 8 points. The results of the primary and secondary assessments, listed in order of highest to lowest number of points earned, are as follows: Primary assessment--Mayo Clinic Family Pharmacist (379), Medical Drug Reference (251), PharmAssist (176), Home Medical Advisor (113.5), The Corner Drug Store (98), and Mosby's Medical Encyclopedia (18.5); secondary assessment--The Mayo Clinic Family Pharmacist (8), The Corner Drug Store (5), Mosby's Medical Encyclopedia (5), Home Medical Advisor (4), Medical Drug Reference (4), and PharmAssist (3). The Mayo Clinic Family Pharmacist was the most accurate and complete source of prescription drug information based on the USP DI Volume II and would be an appropriate database for health care professionals to recommend to patients.

A qualitative study of clinic and community member perspectives on intervention toolkits: "Unless the toolkit is used it won't help solve the problem".

PubMed

Davis, Melinda M; Howk, Sonya; Spurlock, Margaret; McGinnis, Paul B; Cohen, Deborah J; Fagnan, Lyle J

2017-07-18

Intervention toolkits are common products of grant-funded research in public health and primary care settings. Toolkits are designed to address the knowledge translation gap by speeding implementation and dissemination of research into practice. However, few studies describe characteristics of effective intervention toolkits and their implementation. Therefore, we conducted this study to explore what clinic and community-based users want in intervention toolkits and to identify the factors that support application in practice. In this qualitative descriptive study we conducted focus groups and interviews with a purposive sample of community health coalition members, public health experts, and primary care professionals between November 2010 and January 2012. The transdisciplinary research team used thematic analysis to identify themes and a cross-case comparative analysis to explore variation by participant role and toolkit experience. Ninety six participants representing primary care (n = 54, 56%) and community settings (n = 42, 44%) participated in 18 sessions (13 focus groups, five key informant interviews). Participants ranged from those naïve through expert in toolkit development; many reported limited application of toolkits in actual practice. Participants wanted toolkits targeted at the right audience and demonstrated to be effective. Well organized toolkits, often with a quick start guide, with tools that were easy to tailor and apply were desired. Irrespective of perceived quality, participants experienced with practice change emphasized that leadership, staff buy-in, and facilitative support was essential for intervention toolkits to be translated into changes in clinic or public -health practice. Given the emphasis on toolkits in supporting implementation and dissemination of research and clinical guidelines, studies are warranted to determine when and how toolkits are used. Funders, policy makers, researchers, and leaders in primary care and public health are encouraged to allocate resources to foster both toolkit development and implementation. Support, through practice facilitation and organizational leadership, are critical for translating knowledge from intervention toolkits into practice.

Comparative sequencing analysis reveals high genomic concordance between matched primary and metastatic colorectal cancer lesions.

PubMed

Brannon, A Rose; Vakiani, Efsevia; Sylvester, Brooke E; Scott, Sasinya N; McDermott, Gregory; Shah, Ronak H; Kania, Krishan; Viale, Agnes; Oschwald, Dayna M; Vacic, Vladimir; Emde, Anne-Katrin; Cercek, Andrea; Yaeger, Rona; Kemeny, Nancy E; Saltz, Leonard B; Shia, Jinru; D'Angelica, Michael I; Weiser, Martin R; Solit, David B; Berger, Michael F

2014-08-28

Colorectal cancer is the second leading cause of cancer death in the United States, with over 50,000 deaths estimated in 2014. Molecular profiling for somatic mutations that predict absence of response to anti-EGFR therapy has become standard practice in the treatment of metastatic colorectal cancer; however, the quantity and type of tissue available for testing is frequently limited. Further, the degree to which the primary tumor is a faithful representation of metastatic disease has been questioned. As next-generation sequencing technology becomes more widely available for clinical use and additional molecularly targeted agents are considered as treatment options in colorectal cancer, it is important to characterize the extent of tumor heterogeneity between primary and metastatic tumors. We performed deep coverage, targeted next-generation sequencing of 230 key cancer-associated genes for 69 matched primary and metastatic tumors and normal tissue. Mutation profiles were 100% concordant for KRAS, NRAS, and BRAF, and were highly concordant for recurrent alterations in colorectal cancer. Additionally, whole genome sequencing of four patient trios did not reveal any additional site-specific targetable alterations. Colorectal cancer primary tumors and metastases exhibit high genomic concordance. As current clinical practices in colorectal cancer revolve around KRAS, NRAS, and BRAF mutation status, diagnostic sequencing of either primary or metastatic tissue as available is acceptable for most patients. Additionally, consistency between targeted sequencing and whole genome sequencing results suggests that targeted sequencing may be a suitable strategy for clinical diagnostic applications.

Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance.

PubMed

Huh, Warner K; Ault, Kevin A; Chelmow, David; Davey, Diane D; Goulart, Robert A; Garcia, Francisco A R; Kinney, Walter K; Massad, L Stewart; Mayeaux, Edward J; Saslow, Debbie; Schiffman, Mark; Wentzensen, Nicolas; Lawson, Herschel W; Einstein, Mark H

2015-02-01

In 2011, the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology updated screening guidelines for the early detection of cervical cancer and its precursors. Recommended screening strategies were cytology and cotesting (cytology in combination with hrHPV testing). These guidelines also addressed the use of hrHPV testing alone as a primary screening approach, which was not recommended for use at that time. There is now a growing body of evidence for screening with primary hrHPV testing, including a prospective US-based registration study. Thirteen experts including representatives from the Society of Gynecologic Oncology, American Society for Colposcopy and Cervical Pathology, American College of Obstetricians and Gynecologists, American Cancer Society, American Society of Cytopathology, College of American Pathologists, and the American Society for Clinical Pathology, convened to provide interim guidance for primary hrHPV screening. This guidance panel was specifically triggered by an application to the FDA for a currently marketed HPV test to be labeled for the additional indication of primary cervical cancer screening. Guidance was based on literature review and review of data from the FDA registration study, supplemented by expert opinion. This document aims to provide information for healthcare providers who are interested in primary hrHPV testing and an overview of the potential advantages and disadvantages of this strategy for screening as well as to highlight areas in need of further investigation. Copyright © 2015 Elsevier Inc. All rights reserved.

Effectiveness of a Smartphone application and wearable device for weight loss in overweight or obese primary care patients: protocol for a randomised controlled trial.

PubMed

Granado-Font, Esther; Flores-Mateo, Gemma; Sorlí-Aguilar, Mar; Montaña-Carreras, Xavier; Ferre-Grau, Carme; Barrera-Uriarte, Maria-Luisa; Oriol-Colominas, Eulàlia; Rey-Reñones, Cristina; Caules, Iolanda; Satué-Gracia, Eva-María

2015-06-04

To evaluate the effectiveness of an experimental intervention based on standard diet recommendations plus free Smartphone application (app) and wearable device for weight loss, compared with the standard diet intervention alone, in primary care patients aged 18 years or older who are overweight or obese. Multicentre randomized, controlled clinical trial. Primary health care centres in the city of Tarragona and surrounding areas. 70 primary care patients, aged 18 years or older, with body mass index of 25 g/m2 or greater who wish to lose weight. Description of the intervention: 12 months of standard diet recommendations without (n = 35) or with (n = 35) assistance of a free Smartphone app that allows the participant to maintain a record of dietary intake and a bracelet monitor that records physical activity. The outcomes will be weight loss at 12 months (primary outcome), changes in physical activity and cardiometabolic risk factors, frequency of app use, and participant satisfaction after 12 months. The results of our study will offer evidence of the effectiveness of an intervention using one of the most popular free apps and wearable devices in achieving weight loss among patients who are overweight or obese. If these new technologies are proven effective in our population, they could be readily incorporated into primary care interventions promoting healthy weight. The open design and study characteristics make it impossible for the participants and researchers to be blinded to study group assignment. Researchers responsible for data analysis will be blinded to participant allocation. Clinical Register: NCT02417623. Registered 26 March 2015.

Health Care Psychology: Prospects for the Well-Being of Children.

ERIC Educational Resources Information Center

Wright, Logan

1979-01-01

Health care psychology is distinguished from traditional child psychology in that it emphasizes clinical application and is concerned with primary mental health care. Diagnosis, classification, prediction, and treatment and control strategies in the field offer definite solutions to problems such as tracheotomy addiction, encopresis, psychogenic…

Comparing the application of Health Information Technology in primary care in Denmark and Andalucía, Spain.

PubMed

Protti, Denis; Johansen, Ib; Perez-Torres, Francisco

2009-04-01

It is generally acknowledged that Denmark is one, if not the, leading country in terms of the use of information technology by its primary care physicians. Other countries, notably excluding the United States and Canada, are also advanced in terms of electronic medical records in general practitioner offices and clinics. This paper compares the status of primary care physician office computing in Andalucía to that of Denmark by contrasting the functionality of electronic medical records (EMRs) and the ability to electronically communicate clinical information in both jurisdictions. A novel scoring system has been developed based on data gathered from databases held by the respective jurisdictional programs, and interviews with individuals involved in the deployment of the systems. The scoring methodology was applied for the first time in a comparison of the degree of automation in primary care physician offices in Denmark and the province of Alberta in Canada. It was also used to compare Denmark and New Zealand. This paper is the third offering of this method of scoring the adoption of electronic medical records in primary care office settings which hopefully may be applicable to other health jurisdictions at national, state, or provincial levels. Although similar in many respects, there are significant differences between these two relatively autonomous health systems which have led to the rates of uptake of physician office computing. Particularly notable is the reality that the Danish primary care physicians have individual "Electronic Medical Records" while in Andalucía, the primary care physicians share a common record which when secondary care is fully implemented will indeed be an "Electronic Health Record". It is clear that the diffusion of technology, within the primary care physician sector of the health care market, is subject to historical, financial, legal, cultural, and social factors. This tale of two places illustrates the issues, and different ways that they have been addressed.

A regional assessment of information technology sophistication in Missouri nursing homes.

PubMed

Alexander, Gregory L; Madsen, Richard; Wakefield, Douglas

2010-08-01

To provide a state profile of information technology (IT) sophistication in Missouri nursing homes. Primary survey data were collected from December 2006 to August 2007. A descriptive, exploratory cross-sectional design was used to investigate dimensions of IT sophistication (technological, functional, and integration) related to resident care, clinical support, and administrative processes. Each dimension was used to describe the clinical domains and demographics (ownership, regional location, and bed size). The final sample included 185 nursing homes. A wide range of IT sophistication is being used in administrative and resident care management processes, but very little in clinical support activities. Evidence suggests nursing homes in Missouri are expanding use of IT beyond traditional administrative and billing applications to patient care and clinical applications. This trend is important to provide support for capabilities which have been implemented to achieve national initiatives for meaningful use of IT in health care settings.

Micropulsed diode laser therapy: evolution and clinical applications.

PubMed

Sivaprasad, Sobha; Elagouz, Mohammed; McHugh, Dominic; Shona, Olajumoke; Dorin, Giorgio

2010-01-01

Many clinical trials have demonstrated the clinical efficacy of laser photocoagulation in the treatment of retinal vascular diseases, including diabetic retinopathy. There is, however, collateral iatrogenic retinal damage and functional loss after conventional laser treatment. Such side effects may occur even when the treatment is appropriately performed because of morphological damage caused by the visible endpoint, typically a whitening burn. The development of the diode laser with micropulsed emission has allowed subthreshold therapy without a visible burn endpoint. This greatly reduces the risk of structural and functional retinal damage, while retaining the therapeutic efficacy of conventional laser treatment. Studies using subthreshold micropulse laser protocols have reported successful outcomes for diabetic macular edema, central serous chorioretinopathy, macular edema secondary to retinal vein occlusion, and primary open angle glaucoma. The report includes the rationale and basic principles underlying micropulse diode laser therapy, together with a review of its current clinical applications. Copyright © 2010 Elsevier Inc. All rights reserved.

Clinical application of neurotrophic factors: the potential for primary auditory neuron protection

PubMed Central

Gillespie, Lisa N.; Shepherd, Robert K.

2007-01-01

Sensorineural hearing loss, as a result of damage to or destruction of the sensory epithelia within the cochlea, is a common cause of deafness. The subsequent degeneration of the neural elements within the inner ear may impinge upon the efficacy of the cochlear implant. Experimental studies have demonstrated that neurotrophic factors can prevent this degeneration in animal models of deafness, and can even provide functional benefits. Neurotrophic factor therapy may, therefore, provide similar protective effects in humans, resulting in improved speech perception outcomes among cochlear implant patients. There are, however, numerous issues pertaining to delivery techniques and treatment regimes which need to be addressed prior to any clinical application. This review considers these issues in view of the potential therapeutic application of neurotrophic factors within the auditory system. PMID:16262651

Clinical Practice Guidelines for the Management of Atopic Dermatitis 2016.

PubMed

Saeki, Hidehisa; Nakahara, Takeshi; Tanaka, Akio; Kabashima, Kenji; Sugaya, Makoto; Murota, Hiroyuki; Ebihara, Tamotsu; Kataoka, Yoko; Aihara, Michiko; Etoh, Takafumi; Katoh, Norito

2016-10-01

Atopic dermatitis (AD) is a disease characterized by relapsing eczema with pruritus as a primary lesion. Most patients have an atopic predisposition. The definitive diagnosis of AD requires the presence of all three features: (i) pruritus; (ii) typical morphology and distribution of the eczema; and (iii) chronic and chronically relapsing course. The current strategies to treat AD in Japan from the perspective of evidence-based medicine consist of three primary measures: (i) the use of topical corticosteroids and tacrolimus ointment as the main treatment for the inflammation; (ii) topical application of emollients to treat the cutaneous barrier dysfunction; and (iii) avoidance of apparent exacerbating factors, psychological counseling and advice about daily life. The guidelines present recommendations to review clinical research articles, evaluate the balance between the advantages and disadvantages of medical activities, and optimize medical activity-related patient outcomes with respect to several important points requiring decision-making in clinical practice. © 2016 Japanese Dermatological Association.

Clinical value of the Treponema pallidum haemagglutination test.

PubMed

Robertson, D H; McMillan, A

1975-04-01

In 1,129 patients attending the Department for Sexually Transmitted Diseases, the serum was examined by three screening tests (VDRL slide, RPCF, and TPHA) and twelve cases of syphilis (1 per cent. of patients attenting the clinic) were discovered. Six of these patients were considered to have latent syphilis (5 acquired, 1 congenital) and were detected only by the TPHA; all six cases were confirmed by the FTA-ABS, The TPHA failed to detect three of the remaining six cases (2 primary and 1 very early, the latter in a contact of a patient with primary syphilis). All six cases were, however, detected by the VDRL. In seven cases, the TPHA was positive in the absence of other evidence of present or previous syphilis. In these cases the FTA-ABS was also negative. The clinical application of the TPHA test in the detection of syphilis is discussed.

Weak Convergence of Bounded Influence Regression Estimates with Applications.

DTIC Science & Technology

1980-04-01

for bounded influence regression M-estimates and apply the results to sequential clinical trials , withI special reference to repeated significance...AUTHOR(s) S. CONTRACT O&GRANT NUIMBER(s) ,’ Raymond J. Carrol avv David/uppert v .. AFOSR-80-0 9. PERFORMING ORGANIZATION NAME AND ADDRESS PRO AM I...THIS PAGE (*%ten [)at& Eke 7") 2 1. Introduction. Our primary concern is the comparison of two treatments in a clinical setting, although our results

Creating an optical spectroscopy system for use in a primary care clinical setting (Conference Presentation)

NASA Astrophysics Data System (ADS)

Eshein, Adam; Nguyen, The-Quyen; Radosevich, Andrew J.; Gould, Bradley; Wu, Wenli; Konda, Vani; Yang, Leslie W.; Koons, Ann; Feder, Seth; Valuckaite, Vesta; Roy, Hemant K.; Backman, Vadim

2016-03-01

While there are a plethora of in-vivo spectroscopic techniques that have demonstrated the ability to detect a number of diseases in research trials, very few techniques have successfully become a fully realized clinical technology. This is primarily due to the stringent demands on a clinical device for widespread implementation. Some of these demands include: simple operation requiring minimal or no training, safe for in-vivo patient use, no disruption to normal clinic workflow, tracking of system performance, warning for measurement abnormality, and meeting all FDA guidelines for medical use. Previously, our group developed a fiber optic probe-based optical sensing technique known as low-coherence enhanced backscattering spectroscopy (LEBS) to quantify tissue ultrastructure in-vivo. Now we have developed this technique for the application of prescreening patients for colonoscopy in a primary care (PC) clinical setting. To meet the stringent requirements for a viable medical device used in a PC clinical setting, we developed several novel components including an automated calibration tool, optical contact sensor for signal acquisition, and a contamination sensor to identify measurements which have been affected by debris. The end result is a state-of-the-art medical device that can be realistically used by a PC physician to assess a person's risk for harboring colorectal precancerous lesions. The pilot study of this system shows great promise with excellent stability and accuracy in identifying high-risk patients. While this system has been designed and optimized for our specific application, the system and design concepts are universal to most in-vivo fiber optic based spectroscopic techniques.

Primary Care Physician Insights Into a Typology of the Complex Patient in Primary Care

PubMed Central

Loeb, Danielle F.; Binswanger, Ingrid A.; Candrian, Carey; Bayliss, Elizabeth A.

2015-01-01

PURPOSE Primary care physicians play unique roles caring for complex patients, often acting as the hub for their care and coordinating care among specialists. To inform the clinical application of new models of care for complex patients, we sought to understand how these physicians conceptualize patient complexity and to develop a corresponding typology. METHODS We conducted qualitative in-depth interviews with internal medicine primary care physicians from 5 clinics associated with a university hospital and a community health hospital. We used systematic nonprobabilistic sampling to achieve an even distribution of sex, years in practice, and type of practice. The interviews were analyzed using a team-based participatory general inductive approach. RESULTS The 15 physicians in this study endorsed a multidimensional concept of patient complexity. The physicians perceived patients to be complex if they had an exacerbating factor—a medical illness, mental illness, socioeconomic challenge, or behavior or trait (or some combination thereof)—that complicated care for chronic medical illnesses. CONCLUSION This perspective of primary care physicians caring for complex patients can help refine models of complexity to design interventions or models of care that improve outcomes for these patients. PMID:26371266

Primary care physician insights into a typology of the complex patient in primary care.

PubMed

Loeb, Danielle F; Binswanger, Ingrid A; Candrian, Carey; Bayliss, Elizabeth A

2015-09-01

Primary care physicians play unique roles caring for complex patients, often acting as the hub for their care and coordinating care among specialists. To inform the clinical application of new models of care for complex patients, we sought to understand how these physicians conceptualize patient complexity and to develop a corresponding typology. We conducted qualitative in-depth interviews with internal medicine primary care physicians from 5 clinics associated with a university hospital and a community health hospital. We used systematic nonprobabilistic sampling to achieve an even distribution of sex, years in practice, and type of practice. The interviews were analyzed using a team-based participatory general inductive approach. The 15 physicians in this study endorsed a multidimensional concept of patient complexity. The physicians perceived patients to be complex if they had an exacerbating factor-a medical illness, mental illness, socioeconomic challenge, or behavior or trait (or some combination thereof)-that complicated care for chronic medical illnesses. This perspective of primary care physicians caring for complex patients can help refine models of complexity to design interventions or models of care that improve outcomes for these patients. © 2015 Annals of Family Medicine, Inc.

Fluoride Varnish Application in the Primary Care Setting. A Clinical Study.

PubMed

Rolnick, S J; Jackson, J M; DeFor, T A; Flottemesch, T J

2015-01-01

The study objectives were twofold: 1. To examine how an intervention to apply fluoride varnish (FV) in a primary health setting to all young, low-income children was implemented and sustained and 2. To assess the feasibility of tracking medical care utilization in this population. The study included children age 1-5, insured through a government program, seen (7/1/2010-4/30/2012). Data on age, race, sex, clinic encounter, eligibility for and receipt of FV was obtained. The level of data in primary care, specialty care, urgent care and hospitalizations to assess feasibility of future patient tracking was also acquired.. Of 12,067 children, 85% received FV. Differences were found by age (youngest had highest rates). Small differences by race (81%-88%, highest in Blacks.) was found. No differences were found by sex. Ability to track over time was mixed. Approximately 50% had comprehensive data. However, primary care visit and hospitalization data was available on a larger percentage. FV programs can be introduced in the primary care setting and sustained. Further, long-term follow up is possible. Future study of such cohorts capturing health and cost benefits of oral health prevention efforts is needed.

Topical Vitamin C and the Skin: Mechanisms of Action and Clinical Applications.

PubMed

Al-Niaimi, Firas; Chiang, Nicole Yi Zhen

2017-07-01

OBJECTIVE: This review article details the main mechanisms of action and clinical applications of topical vitamin C on the skin, including its antioxidative, photoprotective, antiaging, and antipigmentary effects. DESIGN: A PubMed search for the relevant articles on vitamin C and the skin was conducted using the following key words: "vitamin C," "ascorbic acid," "ascorbyl-6-palmitate,"and "magnesium ascorbyl phosphate." RESULTS: As one of the most powerful antioxidants in the skin, vitamin C has been shown to protect against photoaging, ultraviolet-induced immunosuppression, and photocarcinogenesis. It also has an antiaging effect by increasing collagen synthesis, stabilizing collagen fibers, and decreasing collagen degradation. It decreases melanin formation, thereby reducing pigmentation. Vitamin C is the primary replenisher of vitamin E and works synergistically with vitamin E in the protection against oxidative damage. CONCLUSION: Topical vitamin C has a wide range of clinical applications, from antiaging and antipigmentary to photoprotective. Currently, clinical studies on the efficacy of topical formulations of vitamin C remain limited, and the challenge lies in finding the most stable and permeable formulation in achieving the optimal results.

Results of extracorporeal life support implementation in routine clinical practice: single center experience

PubMed Central

Biočina, Bojan; Petričević, Mate; Belina, Dražen; Gašparović, Hrvoje; Svetina, Lucija; Konosić, Sanja; White, Alexandra; Ivančan, Višnja; Kopjar, Tomislav; Miličić, Davor

2014-01-01

Aim To describe our experience in the clinical application of extracorporeal life support (ECLS) and analyze whether ECLS leads to acceptable clinical outcomes in patients with cardiac failure. Methods Data from clinical database of University Hospital Center Zagreb, Croatia, on 75 patients undergoing ECLS support from 2009 to 2014 due to cardiac failure were retrospectively analyzed. Outcomes were defined as procedural and clinical outcomes. ECLS as a primary procedure and ECLS as a postcardiotomy procedure due to inability to wean from cardiopulmonary bypass were analyzed. Results ECLS was used in 75 adult patients, and in 24 (32%) of those procedural success was noted. ECLS was implemented as a primary procedure in 36 patients and as a postcardiotomy procedure in 39 patients. Nine out of 39 (23.08%) patients had postcardiotomy ECLS after heart transplantation. Bleeding complications occurred in 30 (40%) patients, both in primary (11/36 patients) and postcardiotomy group (19/39 patients). ECLS was established by peripheral approach in 46 patients and by central cannulation in 27 patients. In 2 patients, combined cannulation was performed, with an inflow cannula placed into the right atrium and an outflow cannula placed into the femoral artery. Eleven patients treated with peripheral approach had ischemic complications. Conclusion ECLS is a useful tool in the treatment of patients with refractory cardiac failure and its results are encouraging in patients who otherwise have an unfavorable prognosis. PMID:25559831

[Gait, balance and independence rehabilitation program in elderly adults in a primary care unit].

PubMed

Espinosa-Cuervo, Gisela; López-Roldán, Verónica Miriam; Escobar-Rodríguez, David Alvaro; Conde-Embarcadero, Margarita; Trejo-León, Gerardo; González-Carmona, Beatriz

2013-01-01

to evaluate the effect of a supervised rehabilitation program to improve gait, balance and independence in elderly patients attending a family medicine unit. we conducted a quasi-experimental study over a period of four weeks in a group of 72 patients older than 65 years. a supervised program regarding the risk factors for falling, and balance, gait, coordination and oculovestibular system, the modalities to be done two or three times a week in the primary care unit or at home. An analysis of both tests was performed by "up and go," Tinetti scale and the Katz index. "intention to treat" and "by protocol." mean age was 72 ± 5 years, 67.8% were female and 81.9% of the patients completed the program. A significant clinical improvement with statistical level were evident for gait and balance (p = 0.001), independence showed only clinical improvement (p = 0.083). The efficacy for periodicity (two or three times/week) and performance place showed same clinical improvement and statistical level for gait and balance (p = 0.001 to 0.003) and independence showed only clinical improvement (p = 0.317 to 0.991). an integral rehabilitation program improved gait, balance and clinical independence significantly. The supervised program is applicable and can be reproduced at primary care unit or home for geriatric care and preventive actions.

I-Maculaweb: A Tool to Support Data Reuse in Ophthalmology

PubMed Central

Bonetto, Monica; Nicolò, Massimo; Gazzarata, Roberta; Fraccaro, Paolo; Rosa, Raffaella; Musetti, Donatella; Musolino, Maria; Traverso, Carlo E.

2016-01-01

This paper intends to present a Web-based application to collect and manage clinical data and clinical trials together in a unique tool. I-maculaweb is a user-friendly Web-application designed to manage, share, and analyze clinical data from patients affected by degenerative and vascular diseases of the macula. The unique and innovative scientific and technological elements of this project are the integration with individual and population data, relevant for degenerative and vascular diseases of the macula. Clinical records can also be extracted for statistical purposes and used for clinical decision support systems. I-maculaweb is based on an existing multilevel and multiscale data management model, which includes general principles that are suitable for several different clinical domains. The database structure has been specifically built to respect laterality, a key aspect in ophthalmology. Users can add and manage patient records, follow-up visits, treatment, diagnoses, and clinical history. There are two different modalities to extract records: one for the patient’s own center, in which personal details are shown and the other for statistical purposes, where all center’s anonymized data are visible. The Web-platform allows effective management, sharing, and reuse of information within primary care and clinical research. Clear and precise clinical data will improve understanding of real-life management of degenerative and vascular diseases of the macula as well as increasing precise epidemiologic and statistical data. Furthermore, this Web-based application can be easily employed as an electronic clinical research file in clinical studies. PMID:27170913

Educating residents in behavioral health care and collaboration: integrated clinical training of pediatric residents and psychology fellows.

PubMed

Pisani, Anthony R; leRoux, Pieter; Siegel, David M

2011-02-01

Pediatric residency practices face the challenge of providing both behavioral health (BH) training for pediatricians and psychosocial care for children. The University of Rochester School of Medicine and Dentistry and Rochester General Hospital developed a joint training program and continuity clinic infrastructure in which pediatric residents and postdoctoral psychology fellows train and practice together. The integrated program provides children access to BH care in a primary care setting and gives trainees the opportunity to integrate collaborative BH care into their regular practice routines. During 1998-2008, 48 pediatric residents and 8 psychology fellows trained in this integrated clinical environment. The program's accomplishments include longevity, faculty and fiscal stability, sustained support from pediatric leadership and community payers, the development in residents and faculty of greater comfort in addressing BH problems and collaborating with BH specialists, and replication of the model in two other primary care settings. In addition to quantitative program outcomes data, the authors present a case example that illustrates how the integrated program works and achieves its goals. They propose that educating residents and psychology trainees side by side in collaborative BH care is clinically and educationally valuable and potentially applicable to other settings. A companion report published in this issue provides results from a study comparing the perceptions of pediatric residents whose primary care continuity clinic took place in this integrated setting with those of residents from the same pediatric residency who had their continuity clinic training in a nonintegrated setting.

Effectiveness of a structured motivational intervention including smoking cessation advice and spirometry information in the primary care setting: the ESPITAP study.

PubMed

Martin-Lujan, Francisco; Piñol-Moreso, Josep L I; Martin-Vergara, Nuria; Basora-Gallisa, Josep; Pascual-Palacios, Irene; Sagarra-Alamo, Ramon; Llopis, Estefania Aparicio; Basora-Gallisa, Maria T; Pedret-Llaberia, Roser

2011-11-11

There is current controversy about the efficacy of smoking cessation interventions that are based on information obtained by spirometry. The objective of this study is to evaluate the effectiveness in the primary care setting of structured motivational intervention to achieve smoking cessation, compared with usual clinical practice. Multicentre randomized clinical trial with an intervention and a control group. 12 primary care centres in the province of Tarragona (Spain). 600 current smokers aged between 35 and 70 years with a cumulative habit of more than 10 packs of cigarettes per year, attended in primary care for any reason and who did not meet any of the exclusion criteria for the study, randomly assigned to structured intervention or standard clinical attention. Usual advice to quit smoking by a general practitioner as well as a 20-minute personalized visit to provide detailed information about spirometry results, during which FEV1, FVC, FEF 25-75% and PEF measurements were discussed and interpreted in terms of theoretical values. Additional information included the lung age index (defined as the average age of a non-smoker with the same FEV1 as the study participant), comparing this with the chronological age to illustrate the pulmonary deterioration that results from smoking. Spirometry during the initial visit. Structured interview questionnaire administered at the primary care centre at the initial visit and at 12-month follow-up. Telephone follow-up interview at 6 months. At 12-month follow-up, expired CO was measured in patients who claimed to have quit smoking. Smoking cessation at 12 months. Data will be analyzed on the basis of "intention to treat" and the unit of analysis will be the individual smoker. Among active smokers treated in primary care we anticipate significantly higher smoking cessation in the intervention group than in the control group. Application of a motivational intervention based on structured information about spirometry results, improved abstinence rates among smokers seen in actual clinical practice conditions in primary care. ClinicalTrial.gov, number NCT01194596.

Effectiveness of a structured motivational intervention including smoking cessation advice and spirometry information in the primary care setting: the ESPITAP study

PubMed Central

2011-01-01

Background There is current controversy about the efficacy of smoking cessation interventions that are based on information obtained by spirometry. The objective of this study is to evaluate the effectiveness in the primary care setting of structured motivational intervention to achieve smoking cessation, compared with usual clinical practice. Methods Design Multicentre randomized clinical trial with an intervention and a control group. Setting 12 primary care centres in the province of Tarragona (Spain). Subjects of study 600 current smokers aged between 35 and 70 years with a cumulative habit of more than 10 packs of cigarettes per year, attended in primary care for any reason and who did not meet any of the exclusion criteria for the study, randomly assigned to structured intervention or standard clinical attention. Intervention Usual advice to quit smoking by a general practitioner as well as a 20-minute personalized visit to provide detailed information about spirometry results, during which FEV1, FVC, FEF 25-75% and PEF measurements were discussed and interpreted in terms of theoretical values. Additional information included the lung age index (defined as the average age of a non-smoker with the same FEV1 as the study participant), comparing this with the chronological age to illustrate the pulmonary deterioration that results from smoking. Measurements Spirometry during the initial visit. Structured interview questionnaire administered at the primary care centre at the initial visit and at 12-month follow-up. Telephone follow-up interview at 6 months. At 12-month follow-up, expired CO was measured in patients who claimed to have quit smoking. Main variables Smoking cessation at 12 months. Analysis Data will be analyzed on the basis of "intention to treat" and the unit of analysis will be the individual smoker. Expected results Among active smokers treated in primary care we anticipate significantly higher smoking cessation in the intervention group than in the control group. Discussion Application of a motivational intervention based on structured information about spirometry results, improved abstinence rates among smokers seen in actual clinical practice conditions in primary care. Trial registration ClinicalTrial.gov, number NCT01194596. PMID:22078490

Review of U.S. registries for psoriasis.

PubMed

Amin, Mina; No, Daniel J; Wu, Jashin J

2017-12-01

Patient registries are databases comprised of standardized clinical data for a specific population of patients with a particular disease or medical condition. Information from patient registries allows clinicians to assess long-lasting outcomes in patients with a specific disease, such as psoriasis. Our primary objective was to identify available psoriasis registries in the United States (U.S.) and evaluate the application of patient registries compared to clinical trials. We searched Google, the Registry of Patient Registries, Orphanet and ClinicalTrials.gov to create a list of U.S. psoriasis registries. We also performed a literature review on the application of psoriasis registries using PubMed. We identified 6 psoriasis patient registries in the United States. Patient registries are frequently used for psoriasis in the U.S. and provide important information about the safety, efficacy and long-term effects of systemic therapies.

[Molecular Biology for Surgical Treatment of Lung Cancer].

PubMed

Suda, Kenichi; Mitsudomi, Tetsuya

2017-01-01

Progress in lung cancer research achieved during the last 10 years was summarized. These include identification of novel driver mutations and application of targeted therapies, resistance mechanisms to targeted therapies, and immunotherapy with immune checkpoint inhibitors. Molecular biology also affects the field of surgical treatment. Several molecular markers have been reported to predict benign/ malignant or stable/growing tumors, although far from clinical application. In perioperative period, there is a possibility of atrial natriuretic peptide to prevent cancer metastasis. As adjuvant settings, although biomarker-based cytotoxic therapies failed to show clinical efficacy, several trials are ongoing employing molecular targeted agents (EGFR-TKI or ALK-TKI) or immune checkpoint inhibitors. In clinical practice, mutational information is sometimes used to distinguish 2nd primary tumors from pulmonary metastases of previous cancers. Surgery also has important role for oligo-progressive disease during molecular targeted therapies.

Cardiovascular disease prevention and health promotion with the transcendental meditation program and Maharishi consciousness-based health care.

PubMed

Schneider, Robert H; Walton, Kenneth G; Salerno, John W; Nidich, Sanford I

2006-01-01

This article summarizes the background, rationale, and clinical research on a traditional system of natural health care that may be useful in the prevention of cardiovascular disease (CVD) and promotion of health. Results recently reported include reductions in blood pressure, psychosocial stress, surrogate markers for atherosclerotic CVD, and mortality. The randomized clinical trials conducted so far have involved applications to both primary and secondary prevention as well as to health promotion more generally. The results support the applicability of this approach for reducing ethnic health disparities associated with environmental and psychosocial stress. Proposed mechanisms for the effects of this traditional system include enhanced resistance to physiological and psychological stress and improvements in homeostatic and self-repair processes. This system may offer clinical and cost effectiveness advantages for health care, particularly in preventive cardiology.

Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance.

PubMed

Huh, Warner K; Ault, Kevin A; Chelmow, David; Davey, Diane D; Goulart, Robert A; Garcia, Francisco A R; Kinney, Walter K; Massad, L Stewart; Mayeaux, Edward J; Saslow, Debbie; Schiffman, Mark; Wentzensen, Nicolas; Lawson, Herschel W; Einstein, Mark H

2015-02-01

In 2011, the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology updated screening guidelines for the early detection of cervical cancer and its precursors. Recommended screening strategies were cytology or cotesting (cytology in combination with high-risk human papillomavirus [hrHPV] testing). These guidelines also addressed the use of hrHPV testing alone as a primary screening approach, which was not recommended for use at that time. There is now a growing body of evidence for screening with primary hrHPV testing, including a prospective U.S.-based registration study. Thirteen experts, including representatives from the Society of Gynecologic Oncology, the American Society for Colposcopy and Cervical Pathology, the American College of Obstetricians and Gynecologists, the American Cancer Society, the American Society of Cytopathology, the College of American Pathologists, and the American Society for Clinical Pathology, convened to provide interim guidance for primary hrHPV screening. This guidance panel was specifically triggered by an application to the U.S. Food and Drug Administration (FDA) for a currently marketed HPV test to be labeled for the additional indication of primary cervical cancer screening. Guidance was based on literature review and review of data from the FDA registration study, supplemented by expert opinion. This document aims to provide information for health care providers who are interested in primary hrHPV testing and an overview of the potential advantages and disadvantages of this strategy for screening as well as to highlight areas in need of further investigation.

Gelatin for purification and proliferation of primary keratinocyte culture for use in chronic wounds and burns.

PubMed

Rahsaz, Marjan; Geramizadeh, Bita; Kaviani, Maryam; Marzban, Saeed

2015-04-01

Human epidermal keratinocytes are currently established as a treatment for burns and wounds and have laboratory applications. Keratinocyte culture contamination by unwanted cells and inhibition of cell proliferation are barriers in primary keratinocyte culture. According to the recent literature, these cells are hard to culture. The present study was conducted to evaluate the efficacy of gelatin-coated surfaces in keratinocyte cultures. After enzymatic isolation of keratinocytes from normal epidermis by trypsin, the cells were cultured on gelatin-coated flasks in serum-free medium. Another group of cells were cultured as a control group without gelatin coating. We showed positive effects of surface coating with gelatin on the primary culture of keratinocytes. Culture of these cells on a gelatincoated surface showed better proliferation with suitable morphology. By using gelatin, adhesion of these cells to the surface was more efficient and without contamination by small round cells. Successful primary culture of keratinocytes on a gelatin-coated surface may provide better yield and optimal number of cells for research and clinical applications.

A review of signals used in sleep analysis

PubMed Central

Roebuck, A; Monasterio, V; Gederi, E; Osipov, M; Behar, J; Malhotra, A; Penzel, T; Clifford, GD

2014-01-01

This article presents a review of signals used for measuring physiology and activity during sleep and techniques for extracting information from these signals. We examine both clinical needs and biomedical signal processing approaches across a range of sensor types. Issues with recording and analysing the signals are discussed, together with their applicability to various clinical disorders. Both univariate and data fusion (exploiting the diverse characteristics of the primary recorded signals) approaches are discussed, together with a comparison of automated methods for analysing sleep. PMID:24346125

Recent Research on Emergent Verbal Behavior: Clinical Applications and Future Directions

ERIC Educational Resources Information Center

Grow, Laura L.; Kodak, Tiffany

2010-01-01

Previous research on the acquisition of verbal behavior in children with developmental disabilities has focused on teaching four primary verbal operants: (1) "mand"; (2) "tact"; (3) "echoic"; and (4) "intraverbal". In Skinner's (1957) analysis of verbal behavior, he stated that each verbal operant is maintained by unique antecedent and consequence…

Guidance on Performing Focused Ethnographies with an Emphasis on Healthcare Research

ERIC Educational Resources Information Center

Higginbottom, Gina M. A.; Pillay, Jennifer J.; Boadu, Nana Y.

2013-01-01

Focused ethnographies can have meaningful and useful application in primary care, community, or hospital healthcare practice, and are often used to determine ways to improve care and care processes. They can be pragmatic and efficient ways to capture data on a specific topic of importance to individual clinicians or clinical specialties. While…

[Present situation and future prospects of the certification system for medical technologists--from the viewpoint of the Japanese Society of Clinical Cytology].

PubMed

Hatakeyama, Shigeharu; Hirooka, Yasuaki

2012-06-01

The circumstances surrounding the certification examination for cytotechnologists in Japan are closely related with the history of the Japanese Society of Clinical Cytology. The examination for cytotechnologists is open only to medical technologists. The examination has two parts: primary and secondary. Qualification for candidacy for the secondary examination requires candidates to have passed the primary examination. The rate of successful applicants in the past 10 years was approximately 25-40%. Certified cytotechnologists are required to renew their qualifications every 4 years for their study and job history. I will present the purpose of the qualification update system, future themes, the reporting system for cytodiagnosis, and the possibility that the certification examination for cytotechnologists will become a national examination.

[The Jena Anxiety Monitoring List (JAMoL) - a tool for the evidence-based treatment of panic disorder with or without agoraphobia in primary care].

PubMed

Hiller, Thomas Stephan; Freytag, Antje; Breitbart, Jörg; Teismann, Tobias; Schöne, Elisabeth; Blank, Wolfgang; Schelle, Mercedes; Vollmar, Horst Christian; Margraf, Jürgen; Gensichen, Jochen

2018-04-01

Behavior therapy-oriented methods are recommended for treating anxiety disorders in primary care. The treatment of patients with long-term conditions can be improved by case management and structured clinical monitoring. The present paper describes the rationale, design and application of the 'Jena Anxiety Monitoring List' (JAMoL), a monitoring tool for the treatment of patients with panic disorder, with or without agoraphobia, in primary care. JAMoL's design was based on established clinical measures, the rationale of exposure-based anxiety treatment, and research on family practice-based case management. After piloting, the JAMoL was used in the clinical study 'Jena-PARADISE' (ISRCTN64669297), where non-physician practice staff monitored patients with panic disorder by telephone. Using semi-structured interviews in concomitant studies, study participants were asked about the instrument's functionality. The JAMoL assesses the severity of anxiety symptoms (6 items) as well as the patient's adherence to therapy (4 items) and fosters the case management-related information exchange (3 items). An integrated traffic light scheme facilitates the evaluation of monitoring results. Within the clinical study, non-physician practice staff carried out a total of 1,525 JAMoL-supported monitoring calls on 177 patients from 30 primary care practices (median calls per patient: 10 [interquartile range, 9-10]). Qualitative analyses revealed that most practice teams and patients rated the JAMoL as a practicable and treatment-relevant tool. The JAMoL enables primary care practice teams to continuously monitor anxiety symptoms and treatment adherence in patients with panic disorder with or without agoraphobia. Within the behavior therapy-oriented treatment program 'Jena-PARADISE', the JAMoL constitutes an important case management tool. Copyright © 2018. Published by Elsevier GmbH.

Obtaining the mean relative weights of the cost of care in Catalonia (Spain): retrospective application of the adjusted clinical groups case-mix system in primary health care.

PubMed

Sicras-Mainar, Antoni; Velasco-Velasco, Soledad; Navarro-Artieda, Ruth; Aguado Jodar, Alba; Plana-Ripoll, Oleguer; Hermosilla-Pérez, Eduardo; Bolibar-Ribas, Bonaventura; Prados-Torres, Alejandra; Violan-Fors, Concepción

2013-04-01

The study aims to obtain the mean relative weights (MRWs) of the cost of care through the retrospective application of the adjusted clinical groups (ACGs) in several primary health care (PHC) centres in Catalonia (Spain) in routine clinical practice. This is a retrospective study based on computerized medical records. All patients attended by 13 PHC teams in 2008 were included. The principle measurements were: demographic variables (age and sex), dependent variables (number of diagnoses and total costs), and case-mix or co-morbidity variables (International Classification of Primary Care). The costs model for each patient was established by differentiating the fix costs from the variable costs. In the bivariate analysis, the Student's t, analysis of variance, chi-squared, Pearson's linear correlation and Mann-Whitney-Wilcoxon tests were used. In order to compare the MRW of the present study with those of the United States (US), the concordance [intraclass correlation coefficient (ICC) and concordance correlation coefficient (CCC)] and the correlation (coefficient of determination: R²) were measured. The total number of patients studied was 227,235, and the frequentation was 5.9 visits/habitant/year) and with a mean diagnoses number of 4.5 (3.2). The distribution of costs was €148.7 million, of which 29.1% were fixed costs. The mean total cost per patient/year was €654.2 (851.7), which was considered to be the reference MRW. Relationship between study-MRW and US-MRW: ICC was 0.40 [confidential interval (CI) 95%: 0.21-0.60] and the CCC was 0.42 (CI 95%: 0.35-0.49). The correlation between the US MRW and the MRW of the present study can be seen; the adjusted R² value is 0.691. The explanatory power of the ACG classification was 36.9% for the total costs. The R² of the total cost without considering outliers was 56.9%. The methodology has been shown appropriate for promoting the calculation of the MRW for each category of the classification. The results provide a possible practical application in PHC clinical management. © 2012 Blackwell Publishing Ltd.

Results of a coordination and shared clinical information programme between primary care and nephrology.

PubMed

García García, Manuel; Valenzuela Mújica, Mari Pau; Martínez Ocaña, Juan Carlos; Otero López, María del Sol; Ponz Clemente, Esther; López Alba, Thaïs; Gálvez Hernández, Enrique

2011-01-01

The high prevalence of chronic kidney disease (CKD) in the general population has created a need to coordinate specialised nephrology care and primary care. Although several systems have been developed to coordinate this process, published results are scarce and contradictory. To present the results of the application of a coordinated programme between nephrology care and primary care through consultations and a system of shared clinical information to facilitate communication and improve the criteria for referring patients. Elaboration of a coordinated care programme by the primary care management team and the nephrology department, based on the SEN-SEMFYC consensus document and a protocol for the study and management of arterial hypertension (AHT). Explanation and implementation in primary health care units. A directory of specialists’ consultations was created, both in-person and via e-mail. A continuous training programme in kidney disease and arterial hypertension was implemented in the in-person consultation sessions. The programme was progressively implemented over a three-year period (2007-2010) in an area of 426,000 inhabitants with 230 general practitioners. Use of a clinical information system named Salut en Xarxa that allows access to clinical reports, diagnoses, prescriptions, test results and clinical progression. Improved referral criteria between primary care and specialised nephrology service. Improved prioritisation of visits. Progressive increase in referrals denied by specialists (28.5% in 2009), accompanied by an explanatory report including suggestions for patient management. Decrease in first nephrology outpatient visits that have been referred from primary care (15% in 2009). Family doctors were generally satisfied with the improvement in communication and the continuous training programme. The main causes for denying referral requests were: patients >70 years with stage 3 CKD (44.15%); patients <70 years with stage 3a CKD (19.15%); albumin/creatinine ratio <500 mg/g (12.23%); non-secondary, non-refractory, essential AHT (11.17%). The general practitioners included in the programme showed great interest and no complaints were registered. The consultations improve adequacy and prioritisation of nephrology visits, allow for better communication between different levels of the health system, and offer systematic training for general practitioners to improve the management of nephrology patients. This process allows for referring nephrology patients with the most complex profiles to nephrology outpatient clinics.

Immune response to functionalized mesoporous silica nanoparticles for targeted drug delivery

NASA Astrophysics Data System (ADS)

Heidegger, Simon; Gößl, Dorothée; Schmidt, Alexandra; Niedermayer, Stefan; Argyo, Christian; Endres, Stefan; Bein, Thomas; Bourquin, Carole

2015-12-01

Multifunctional mesoporous silica nanoparticles (MSN) have attracted substantial attention with regard to their high potential for targeted drug delivery. For future clinical applications it is crucial to address safety concerns and understand the potential immunotoxicity of these nanoparticles. In this study, we assess the biocompatibility and functionality of multifunctional MSN in freshly isolated, primary murine immune cells. We show that the functionalized silica nanoparticles are rapidly and efficiently taken up into the endosomal compartment by specialized antigen-presenting cells such as dendritic cells. The silica nanoparticles showed a favorable toxicity profile and did not affect the viability of primary immune cells from the spleen in relevant concentrations. Cargo-free MSN induced only very low immune responses in primary cells as determined by surface expression of activation markers and release of pro-inflammatory cytokines such as Interleukin-6, -12 and -1β. In contrast, when surface-functionalized MSN with a pH-responsive polymer capping were loaded with an immune-activating drug, the synthetic Toll-like receptor 7 agonist R848, a strong immune response was provoked. We thus demonstrate that MSN represent an efficient drug delivery vehicle to primary immune cells that is both non-toxic and non-inflammagenic, which is a prerequisite for the use of these particles in biomedical applications.Multifunctional mesoporous silica nanoparticles (MSN) have attracted substantial attention with regard to their high potential for targeted drug delivery. For future clinical applications it is crucial to address safety concerns and understand the potential immunotoxicity of these nanoparticles. In this study, we assess the biocompatibility and functionality of multifunctional MSN in freshly isolated, primary murine immune cells. We show that the functionalized silica nanoparticles are rapidly and efficiently taken up into the endosomal compartment by specialized antigen-presenting cells such as dendritic cells. The silica nanoparticles showed a favorable toxicity profile and did not affect the viability of primary immune cells from the spleen in relevant concentrations. Cargo-free MSN induced only very low immune responses in primary cells as determined by surface expression of activation markers and release of pro-inflammatory cytokines such as Interleukin-6, -12 and -1β. In contrast, when surface-functionalized MSN with a pH-responsive polymer capping were loaded with an immune-activating drug, the synthetic Toll-like receptor 7 agonist R848, a strong immune response was provoked. We thus demonstrate that MSN represent an efficient drug delivery vehicle to primary immune cells that is both non-toxic and non-inflammagenic, which is a prerequisite for the use of these particles in biomedical applications. Electronic supplementary information (ESI) available. See DOI: 10.1039/c5nr06122a

Molekulare Diagnostik der HPV Infektion

PubMed Central

Wentzensen, PD Dr. med. Nicolas

2014-01-01

Carcinogenic human papillomaviruses (HPV) cause the majority of cervical cancers and other anogentical cancers. Large randomized trials have shown that HPV testing can be efficiently used for primary cervical cancer screening. Other applications include the triage of abnormal cytology results and the follow-up of women after treatment. Many assays have been developed to measure DNA, RNA, and proteins of HPV. The various tests can have very different applications. It is important to validate HPV assays before they are implemented in screening or clinical care. PMID:21845360

Barriers to implementing the "2008 Mexican Clinical Practice Guideline recommendations for the management of hip and knee osteoarthritis" in primary healthcare practice.

PubMed

Loyola-Sanchez, Adalberto; Richardson, Julie; Pelaez-Ballestas, Ingris; Sánchez, José Guadalupe; González, Martha Alicia; Sánchez-Cruz, Juan; Jiménez-Baez, María Valeria; Nolasco-Alonso, Nancy; Alvarado, Idolina; Rodríguez-Amado, Jacqueline; Alvarez-Nemegyei, José; Wilson, Mike G

2014-01-01

To evaluate the implementability of the "2008 Mexican Clinical Practice Guideline for the management of hip and knee osteoarthritis at the primary level of care" within primary healthcare of three Mexican regions using the Guideline Implementability Appraisal methodology version 2 (GLIA.v2). Six family physicians, representing the South, North, and Central Mexico, and one Mexican physiatrist evaluated the 45 recommendations stated by the Mexican guideline. The GLIA.v2 methodology includes the execution of qualitative and semi-quantitative techniques. Reviewers' agreement was between moderate to near complete in most cases. Sixty-nine percent of the recommendations were considered difficult to implement within clinical practice. Eight recommendations did not have an appropriate format. Only 6 recommendations were judged as able to be consistently applied to clinical practice. Barriers related to the context of one or more institutions/regions were identified in 25 recommendations. These barriers are related to health providers/patients' beliefs, processes of care within each institution, and availability of some treatments recommended by the guideline. The guideline presented problems of conciseness and clarity that negatively affect its application within the Mexican primary healthcare context. We identified individual, organizational and system characteristics, which are common to the 3 institutions/regions studied and constitute barriers for implementing the guideline to clinical practice. It is recommended that the 2008-Mexican-CPG-OA be thoroughly revised and restructured to improve the clarity of the actions implied by each recommendation. We propose some strategies to accomplish this and to overcome some of the identified regional/institutional barriers. Copyright © 2013 Elsevier España, S.L.U. All rights reserved.

Clinical audit of diabetes management can improve the quality of care in a resource-limited primary care setting.

PubMed

Govender, Indira; Ehrlich, Rodney; Van Vuuren, Unita; De Vries, Elma; Namane, Mosedi; De Sa, Angela; Murie, Katy; Schlemmer, Arina; Govender, Strini; Isaacs, Abdul; Martell, Rob

2012-12-01

To determine whether clinical audit improved the performance of diabetic clinical processes in the health district in which it was implemented. Patient folders were systematically sampled annually for review. Primary health-care facilities in the Metro health district of the Western Cape Province in South Africa. Health-care workers involved in diabetes management. Clinical audit and feedback. The Skillings-Mack test was applied to median values of pooled audit results for nine diabetic clinical processes to measure whether there were statistically significant differences between annual audits performed in 2005, 2007, 2008 and 2009. Descriptive statistics were used to illustrate the order of values per process. A total of 40 community health centres participated in the baseline audit of 2005 that decreased to 30 in 2009. Except for two routine processes, baseline medians for six out of nine processes were below 50%. Pooled audit results showed statistically significant improvements in seven out of nine clinical processes. The findings indicate an association between the application of clinical audit and quality improvement in resource-limited settings. Co-interventions introduced after the baseline audit are likely to have contributed to improved outcomes. In addition, support from the relevant government health programmes and commitment of managers and frontline staff contributed to the audit's success.

The potential impact of bone tissue engineering in the clinic

PubMed Central

Mishra, Ruchi; Bishop, Tyler; Valerio, Ian L; Fisher, John P; Dean, David

2016-01-01

Bone tissue engineering (BTE) intends to restore structural support for movement and mineral homeostasis, and assist in hematopoiesis and the protective functions of bone in traumatic, degenerative, cancer, or congenital malformation. While much effort has been put into BTE, very little of this research has been translated to the clinic. In this review, we discuss current regenerative medicine and restorative strategies that utilize tissue engineering approaches to address bone defects within a clinical setting. These approaches involve the primary components of tissue engineering: cells, growth factors and biomaterials discussed briefly in light of their clinical relevance. This review also presents upcoming advanced approaches for BTE applications and suggests a probable workpath for translation from the laboratory to the clinic. PMID:27549369

DEVELOPING AN IPAD® APPLICATION FOR DATA COLLECTION IN A RHEUMATOLOGY RESEARCH CLINIC.

PubMed

Kaka, Hussam; Ayearst, Renise; Tran, Maithy; Touma, Zahi; Bagovich, Maria; Vinik, Ophir; Somaily, Mansour; Haddad, Amir; Gladman, Dafna D; Chandran, Vinod

2015-01-01

Clinical research data are often collected on paper and later inputted onto an electronic database. This method is time consuming and potentially introduces errors. Therefore, to make primary data collection more efficient and less error prone we aimed to develop a touch-screen application for data collection in a psoriatic arthritis research clinic and compared it with the pre-existing paper-based system. We developed a Web application using Java and optimized it for the iPad®. It highlights missing fields for physicians in real time, and only permits submission of data collection form after corrections are made. For its evaluation, seven physicians participated, and before each patient visit they were randomly assigned paper or iPad® data entry. Number of errors, length of visit, and time between clinic visit and completion of data entry were measured. A total of 106 patients seen in the clinic who agreed to participate were randomly assigned to be evaluated by clinic physicians using the iPad® (fifty-three patients) or a paper protocol (fifty-three patients). On average, 3.34 omissions were found per paper form, of which 2.24 would have been detected on the iPad®. The iPad® increased the mean patient encounter time from 37.2 minutes to 46.5 minutes, but eliminated delay between a clinic visit and its data entry. Entering data using the iPad® application makes the patient encounter slightly longer, but reduces "missing fields." It also eliminates the delay between clinic visit and data entry thus improving the efficiency of clinical data capture in a research setting.

Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.

PubMed

Koonrungsesomboon, Nut; Tharavanij, Thipaporn; Phiphatpatthamaamphan, Kittichet; Vilaichone, Ratha-Korn; Manuwong, Sudsayam; Curry, Parichat; Siramolpiwat, Sith; Punchaipornpon, Thanachai; Kanitnate, Supakit; Tammachote, Nattapol; Yamprasert, Rodsarin; Chanvimalueng, Waipoj; Kaewkumpai, Ruchirat; Netanong, Soiphet; Kitipawong, Peerapong; Sritipsukho, Paskorn; Karbwang, Juntra

2017-02-01

This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

Elevating Oral Health Interprofessional Practice Among Pediatricians Through a Statewide Quality Improvement Learning Collaborative.

PubMed

Nelson, Joni D; Spencer, Sharon M; Blake, Christine E; Moore, Justin B; Martin, Amy B

Because of persistent effects of early childhood caries and impacts of dental health professional shortages areas, the integration of oral health in primary care settings is a public health priority. In this study, we explored oral health interprofessional practice (OHIP) as an integrative pathway to reduce oral health disparities. OHIP can include performing oral health risk assessments, describing the importance of fluoride in the drinking water, implementing fluoride varnish application, and referring patients to a dental home. To conduct a formative evaluation of how 15 pediatric primary care practices implemented the adoption of OHIP in their clinical settings. Using an ecological framework, we conducted a qualitative process evaluation to measure the factors that inhibited and facilitated OHIP adoption into pediatric settings. Document review analysis and qualitative interviews were conducted with pediatric practices to contextualize challenges and facilitators to OHIP adoption. A total of 15 Children's Health Insurance Program Reauthorization Act pediatric practices located in 13 South Carolina counties participated in this study. Outcomes of interest were the facilitators and challenges of OHIP adoption into pediatric primary care practices. Thematic analysis revealed challenges for OHIP adoption including limited resources and capacity, role delineation for clinical and administrative staff, communication, and family receptiveness. OHIP training for clinical practitioners and staff and responsiveness from clinical staff and local dentists were facilitators of OHIP adoption. Twelve key recommendations emerged on the basis of participant experiences within OHIP, with developing an active dental referral network and encouraging buy-in from clinical staff for OHIP adoption as primary recommendations. We demonstrated the effectiveness of a learning collaborative meeting among pediatric primary care providers to adopt OHIPs. This work reveals an actionable pathway to support oral health equity advancement for children through an additional access point of preventive oral care, reinforcement of positive oral health behaviors, and interaction between parent and child for overall health and wellness of the family.

Emerging Issues and Future Developments in Capsule Endoscopy

PubMed Central

Slawinski, Piotr R.; Obstein, Keith L.; Valdastri, Pietro

2015-01-01

Capsule endoscopy (CE) has transformed from a research venture into a widely used clinical tool and the primary means for diagnosing small bowel pathology. These orally administered capsules traverse passively through the gastrointestinal tract via peristalsis and are used in the esophagus, stomach, small bowel, and colon. The primary focus of CE research in recent years has been enabling active CE manipulation and extension of the technology to therapeutic functionality; thus, widening the scope of the procedure. This review outlines clinical standards of the technology as well as recent advances in CE research. Clinical capsule applications are discussed with respect to each portion of the gastrointestinal tract. Promising research efforts are presented with an emphasis on enabling active capsule locomotion. The presented studies suggest, in particular, that the most viable solution for active capsule manipulation is actuation of a capsule via exterior permanent magnet held by a robot. Developing capsule procedures adhering to current healthcare standards, such as enabling a tool channel or irrigation in a therapeutic device, is a vital phase in the adaptation of CE in the clinical setting. PMID:26028956

Review of the clinical applications and technological advances of circulating tumor DNA in cancer monitoring.

PubMed

Chang, Yi; Tolani, Bhairavi; Nie, Xiuhong; Zhi, Xiuyi; Hu, Mu; He, Biao

2017-01-01

Circulating cell-free DNA (cfDNA) released by tumor cells, termed ctDNA, closely reflects the heterogeneity of primary cancers and their metastases. As a noninvasive, real-time monitoring biomarker, ctDNA is a promising tool for detecting driver gene mutations, assessing tumor burden and acquired resistance, and early diagnosis. However, isolation and enrichment of cfDNA is a big challenge due to the high degree of DNA fragmentation and its relatively low abundance in the bloodstream. This review aims to provide insights into the recent technological advances in acquisition of optimal quality cfDNA, the use of preservatives, isolation methods, processing timelines, and detection techniques. It also describes clinical applications of ctDNA in cancer patient management.

Medical imaging: examples of clinical applications

NASA Astrophysics Data System (ADS)

Meinzer, H. P.; Thorn, M.; Vetter, M.; Hassenpflug, P.; Hastenteufel, M.; Wolf, I.

Clinical routine is currently producing a multitude of diagnostic digital images but only a few are used in therapy planning and treatment. Medical imaging is involved in both diagnosis and therapy. Using a computer, existing 2D images can be transformed into interactive 3D volumes and results from different modalities can be merged. Furthermore, it is possible to calculate functional areas that were not visible in the primary images. This paper presents examples of clinical applications that are integrated into clinical routine and are based on medical imaging fundamentals. In liver surgery, the importance of virtual planning is increasing because surgery is still the only possible curative procedure. Visualisation and analysis of heart defects are also gaining in significance due to improved surgery techniques. Finally, an outlook is provided on future developments in medical imaging using navigation to support the surgeon's work. The paper intends to give an impression of the wide range of medical imaging that goes beyond the mere calculation of medical images.

Femtosecond lasers in ophthalmology: clinical applications in anterior segment surgery

NASA Astrophysics Data System (ADS)

Juhasz, Tibor; Nagy, Zoltan; Sarayba, Melvin; Kurtz, Ronald M.

2010-02-01

The human eye is a favored target for laser surgery due to its accessibility via the optically transparent ocular tissue. Femtosecond lasers with confined tissue effects and minimized collateral tissue damage are primary candidates for high precision intraocular surgery. The advent of compact diode-pumped femtosecond lasers, coupled with computer controlled beam delivery devices, enabled the development of high precision femtosecond laser for ophthalmic surgery. In this article, anterior segment femtosecond laser applications currently in clinical practice and investigation are reviewed. Corneal procedures evolved first and remain dominant due to easy targeting referenced from a contact surface, such as applanation lenses placed on the eye. Adding a high precision imaging technique, such as optical coherence tomography (OCT), can enable accurate targeting of tissue beyond the cornea, such as the crystalline lens. Initial clinical results of femtosecond laser cataract surgery are discussed in detail in the latter portion part of the article.

Cardiovascular Disease Prevention and Health Promotion with the Transcendental Meditation Program and Maharishi Consciousness-Based Health Care

PubMed Central

Schneider, Robert H.; Walton, Kenneth G.; Salerno, John W.; Nidich, Sanford I.

2008-01-01

This article summarizes the background, rationale, and clinical research on a traditional system of natural health care that may be useful in the prevention of cardiovascular disease (CVD) and promotion of health. Results recently reported indude reductions in blood pressure, psychosocial stress, surrogate markers for atherosclerotic CVD, and mortality. The randomized clinical trials conducted so far have involved applications to both primary and secondary prevention as well as to health promotion more generally. The results support the applicability of this approach for reducing ethnic health disparities associated with environmental and psychosocial stress. Proposed mechanisms for the effects of this traditional system include enhanced resistance to physiological and psychological stress and improvements in homeostatic and self-repair processes. This system may offer clinical and cost effectiveness advantages for health care, particularly in preventive cardiology. PMID:16938913

Hidden Treasures and Secret Pitfalls: Application of the Capability Approach to ParkinsonNet.

PubMed

Canoy, Marcel; Faber, Marjan J; Munneke, Marten; Oortwijn, Wija; Nijkrake, Maarten J; Bloem, Bastiaan R

2015-01-01

In the Netherlands, the largest health technology assessment (HTA) program funds mainly (cost-)effectiveness studies and implementation research. The cost-effectiveness studies are usually controlled clinical trials which simultaneously collect cost data. The success of a clinical trial typically depends on the effect size for the primary outcome, such as health gains or mortality rates. A drawback is that in case of a negative primary outcome, relevant other (and perhaps more implicit) benefits might be missed. Conversely, positive trials can contain adverse outcomes that may also remain hidden. The capability approach (developed by Nobel Prize winner and philosopher Sen) is an instrument that may reveal such "hidden treasures and secret pitfalls" that lie embedded within clinical trials, beyond the more traditional outcomes. Here, we exemplify the possible merits of the capability approach using a large clinical trial (funded by the HTA program in the Netherlands) that aimed to evaluate the ParkinsonNet concept, an innovative network approach for Parkinson patients. This trial showed no effects for the primary outcome, but the ParkinsonNet concept tested in this study was nevertheless met with great enthusiasm and was rapidly implemented throughout an entire country, and meanwhile also internationally. We applied the capability approach to the ParkinsonNet concept, and this analysis yielded additional benefits within several capability domains. These findings seems to substantiate the claim that richer policy debates may ensue by applying the capability approach to clinical trial data, in addition to traditional outcomes.

Clinical stage, therapy, and prognosis in canine anal sac gland carcinoma.

PubMed

Polton, Gerry A; Brearley, Malcolm J

2007-01-01

Reports of canine anal sac gland carcinoma (ASGC) describe varied clinical presentations and management and differing responses to therapy. A unifying approach to clinical stage determination and management of this disease has yet to be presented. An ordinal clinical staging scheme for canine ASGC can be devised on the basis of responses to therapy for a retrospective cohort of affected dogs. 130 dogs with naturally occurring ASGC. A simplified clinical stage system and a management algorithm for canine ASGC were derived from retrospective evaluation of a cohort of 80 dogs; applicability of both was then prospectively evaluated in a cohort of 50 dogs. Retrospective evaluation revealed 4 statistically significant negative prognostic indicators for survival: lack of therapy, presence of distant metastases, presence of lymph node metastases, and primary tumor size. Lymph node extirpation was a statistically significant positive prognostic indicator by bivariate analysis. In both retrospective and prospective analyses, the modified clinical stage scheme revealed a significant association with survival time. The clinical staging scheme permits differentiation between groups in terms of prognosis and, therefore, decisions on therapy. This will facilitate application of appropriate therapy and enhanced communication and collaboration in further investigations of ASGC.

Making Personalized Health Care Even More Personalized: Insights From Activities of the IOM Genomics Roundtable.

PubMed

David, Sean P; Johnson, Samuel G; Berger, Adam C; Feero, W Gregory; Terry, Sharon F; Green, Larry A; Phillips, Robert L; Ginsburg, Geoffrey S

2015-01-01

Genomic research has generated much new knowledge into mechanisms of human disease, with the potential to catalyze novel drug discovery and development, prenatal and neonatal screening, clinical pharmacogenomics, more sensitive risk prediction, and enhanced diagnostics. Genomic medicine, however, has been limited by critical evidence gaps, especially those related to clinical utility and applicability to diverse populations. Genomic medicine may have the greatest impact on health care if it is integrated into primary care, where most health care is received and where evidence supports the value of personalized medicine grounded in continuous healing relationships. Redesigned primary care is the most relevant setting for clinically useful genomic medicine research. Taking insights gained from the activities of the Institute of Medicine (IOM) Roundtable on Translating Genomic-Based Research for Health, we apply lessons learned from the patient-centered medical home national experience to implement genomic medicine in a patient-centered, learning health care system. © 2015 Annals of Family Medicine, Inc.

Chronic heart failure management in Australia -- time for general practice centred models of care?

PubMed

Scott, Ian; Jackson, Claire

2013-05-01

Chronic heart failure (CHF) is an increasingly prevalent problem within ageing populations and accounts for thousands of hospitalisations and deaths annually in Australia. Disease management programs for CHF (CHF-DMPs) aim to optimise care, with the predominant model being cardiologist led, hospital based multidisciplinary clinics with cardiac nurse outreach. However, findings from contemporary observational studies and clinical trials raise uncertainty around the effectiveness and sustainability of traditional CHF-DMPs in real-world clinical practice. To suggest an alternative model of care that involves general practitioners with a special interest in CHF liaising with, and being up-skilled by, specialists within community based, multidisciplinary general practice settings. Preliminary data from trials evaluating primary care based CHF-DMPs are encouraging, and further studies are underway comparing this model of care with traditional hospital based, specialist led CHF-DMPs. Results of studies of similar primary care models targeting diabetes and other chronic diseases suggest potential for its application to CHF.

Clinical excellence: evidence on the assessment of senior doctors' applications to the UK Advisory Committee on Clinical Excellence Awards. Analysis of complete national data set

PubMed Central

Campbell, John L; Abel, Gary

2016-01-01

Objectives To inform the rational deployment of assessor resource in the evaluation of applications to the UK Advisory Committee on Clinical Excellence Awards (ACCEA). Setting ACCEA are responsible for a scheme to financially reward senior doctors in England and Wales who are assessed to be working over and above the standard expected of their role. Participants Anonymised applications of consultants and senior academic GPs for awards were considered by members of 14 regional subcommittees and 2 national assessing committees during the 2014–2015 round of applications. Design It involved secondary analysis of complete anonymised national data set. Primary and secondary outcome measures We analysed scores for each of 1916 applications for a clinical excellence award across 4 levels of award. Scores were provided by members of 16 subcommittees. We assessed the reliability of assessments and described the variance in the assessment of scores. Results Members of regional subcommittees assessed 1529 new applications and 387 renewal applications. Average scores increased with the level of application being made. On average, applications were assessed by 9.5 assessors. The highest contributions to the variance in individual assessors' assessments of applications were attributable to assessors or to residual variance. The applicant accounted for around a quarter of the variance in scores for new bronze applications, with this proportion decreasing for higher award levels. Reliability in excess of 0.7 can be attained where 4 assessors score bronze applications, with twice as many assessors being required for higher levels of application. Conclusions Assessment processes pertaining in the competitive allocation of public funds need to be credible and efficient. The present arrangements for assessing and scoring applications are defensible, depending on the level of reliability judged to be required in the assessment process. Some relatively minor reconfiguration in approaches to scoring might usefully be considered in future rounds of assessment. PMID:27256095

A Study of Clinical Coding Accuracy in Surgery: Implications for the Use of Administrative Big Data for Outcomes Management.

PubMed

Nouraei, S A R; Hudovsky, A; Frampton, A E; Mufti, U; White, N B; Wathen, C G; Sandhu, G S; Darzi, A

2015-06-01

Clinical coding is the translation of clinical activity into a coded language. Coded data drive hospital reimbursement and are used for audit and research, and benchmarking and outcomes management purposes. We undertook a 2-center audit of coding accuracy across surgery. Clinician-auditor multidisciplinary teams reviewed the coding of 30,127 patients and assessed accuracy at primary and secondary diagnosis and procedure levels, morbidity level, complications assignment, and financial variance. Postaudit data of a randomly selected sample of 400 cases were reaudited by an independent team. At least 1 coding change occurred in 15,402 patients (51%). There were 3911 (13%) and 3620 (12%) changes to primary diagnoses and procedures, respectively. In 5183 (17%) patients, the Health Resource Grouping changed, resulting in income variance of £3,974,544 (+6.2%). The morbidity level changed in 2116 (7%) patients (P < 0.001). The number of assigned complications rose from 2597 (8.6%) to 2979 (9.9%) (P < 0.001). Reaudit resulted in further primary diagnosis and procedure changes in 8.7% and 4.8% of patients, respectively. The coded data are a key engine for knowledge-driven health care provision. They are used, increasingly at individual surgeon level, to benchmark performance. Surgical clinical coding is prone to subjectivity, variability, and error (SVE). Having a specialty-by-specialty understanding of the nature and clinical significance of informatics variability and adopting strategies to reduce it, are necessary to allow accurate assumptions and informed decisions to be made concerning the scope and clinical applicability of administrative data in surgical outcomes improvement.

Topical Vitamin C and the Skin: Mechanisms of Action and Clinical Applications

PubMed Central

Al-Niaimi, Firas

2017-01-01

OBJECTIVE: This review article details the main mechanisms of action and clinical applications of topical vitamin C on the skin, including its antioxidative, photoprotective, antiaging, and antipigmentary effects. DESIGN: A PubMed search for the relevant articles on vitamin C and the skin was conducted using the following key words: “vitamin C,” “ascorbic acid,” “ascorbyl-6-palmitate,”and “magnesium ascorbyl phosphate.” RESULTS: As one of the most powerful antioxidants in the skin, vitamin C has been shown to protect against photoaging, ultraviolet-induced immunosuppression, and photocarcinogenesis. It also has an antiaging effect by increasing collagen synthesis, stabilizing collagen fibers, and decreasing collagen degradation. It decreases melanin formation, thereby reducing pigmentation. Vitamin C is the primary replenisher of vitamin E and works synergistically with vitamin E in the protection against oxidative damage. CONCLUSION: Topical vitamin C has a wide range of clinical applications, from antiaging and antipigmentary to photoprotective. Currently, clinical studies on the efficacy of topical formulations of vitamin C remain limited, and the challenge lies in finding the most stable and permeable formulation in achieving the optimal results. PMID:29104718

Using program evaluation to support knowledge translation in an interprofessional primary care team: a case study.

PubMed

Donnelly, Catherine; Shulha, Lyn; Klinger, Don; Letts, Lori

2016-10-06

Evaluation is a fundamental component in building quality primary care and is ideally situated to support individual, team and organizational learning by offering an accessible form of participatory inquiry. The evaluation literature has begun to recognize the unique features of KT evaluations and has described attributes to consider when evaluating KT activities. While both disciplines have focused on the evaluation of KT activities neither has explored the role of evaluation in KT. The purpose of the paper is to examine how participation in program evaluation can support KT in a primary care setting. A mixed methods case study design was used, where evaluation was conceptualized as a change process and intervention. A Memory Clinic at an interprofessional primary care clinic was the setting in which the study was conducted. An evaluation framework, Pathways of Influence provided the theoretical foundation to understand how program evaluation can facilitate the translation of knowledge at the level of the individual, inter-personal (Memory Clinic team) and the organization. Data collection included questionnaires, interviews, evaluation log and document analysis. Questionnaires and interviews were administered both before and after the evaluation: Pattern matching was used to analyze the data based on predetermined propositions. Individuals gained program knowledge that resulted in changes to both individual and program practices. One of the key themes was the importance clinicians placed on local, program based knowledge. The evaluation had less influence on the broader health organization. Program evaluation facilitated individual, team and organizational learning. The use of evaluation to support KT is ideally suited to a primary care setting by offering relevant and applicable knowledge to primary care team members while being sensitive to local context.

Principles and clinical applications of liquid chromatography - tandem mass spectrometry for the determination of adrenal and gonadal steroid hormones.

PubMed

Kulle, A E; Welzel, M; Holterhus, P-M; Riepe, F G

2011-10-01

Liquid-chromatography - tandem mass spectrometry (LC-MS/MS) is becoming the method of choice for clinical steroid analysis. In most instances, it has the advantage of higher sensitivity, better reproducibility and greater specificity than commercial immunoassay techniques. The method requires only minimal sample preparation and a small sample volume. Furthermore, it has the potential to analyze multiple steroids simultaneously. Modern instruments guarantee high throughput, allowing an affordable price for the individual assay. All this makes LC-MS/MS an attractive method for use in a clinical setting. Reliable reference ranges for the detected analytes are the pre-requisite for their clinical use. If these are available, LC-MS/MS can find application in congenital disorders of steroid metabolism, such as congenital adrenal hyperplasia, disorders of sex development and disorders of salt homeostasis, as well as in acquired disorders of steroid metabolism, such as primary aldosteronism, Cushing's disease, Addison's disease, and hyperandrogenemia, as well as in psychiatric disease states such as depression or anxiety disorders. The principles of LC-MS/MS for steroid measurement, the pros and cons of LC-MS/MS compared with conventional immunoassays and the possible applications in clinical routine, with a special focus on pediatric endocrinology needs, are discussed here.

Ozone therapy in periodontics

PubMed Central

Gupta, G; Mansi, B

2012-01-01

Gingival and Periodontal diseases represent a major concern both in dentistry and medicine. The majority of the contributing factors and causes in the etiology of these diseases are reduced or treated with ozone in all its application forms (gas, water, oil). The beneficial biological effects of ozone, its anti-microbial activity, oxidation of bio-molecules precursors and microbial toxins implicated in periodontal diseases and its healing and tissue regeneration properties, make the use of ozone well indicated in all stages of gingival and periodontal diseases. The primary objective of this article is to provide a general review about the clinical applications of ozone in periodontics. The secondary objective is to summarize the available in vitro and in vivo studies in Periodontics in which ozone has been used. This objective would be of importance to future researchers in terms of what has been tried and what the potentials are for the clinical application of ozone in Periodontics. PMID:22574088

Ozone therapy in periodontics.

PubMed

Gupta, G; Mansi, B

2012-02-22

Gingival and Periodontal diseases represent a major concern both in dentistry and medicine. The majority of the contributing factors and causes in the etiology of these diseases are reduced or treated with ozone in all its application forms (gas, water, oil). The beneficial biological effects of ozone, its anti-microbial activity, oxidation of bio-molecules precursors and microbial toxins implicated in periodontal diseases and its healing and tissue regeneration properties, make the use of ozone well indicated in all stages of gingival and periodontal diseases. The primary objective of this article is to provide a general review about the clinical applications of ozone in periodontics. The secondary objective is to summarize the available in vitro and in vivo studies in Periodontics in which ozone has been used. This objective would be of importance to future researchers in terms of what has been tried and what the potentials are for the clinical application of ozone in Periodontics.

[Adequate application of quantitative and qualitative statistic analytic methods in acupuncture clinical trials].

PubMed

Tan, Ming T; Liu, Jian-ping; Lao, Lixing

2012-08-01

Recently, proper use of the statistical methods in traditional Chinese medicine (TCM) randomized controlled trials (RCTs) has received increased attention. Statistical inference based on hypothesis testing is the foundation of clinical trials and evidence-based medicine. In this article, the authors described the methodological differences between literature published in Chinese and Western journals in the design and analysis of acupuncture RCTs and the application of basic statistical principles. In China, qualitative analysis method has been widely used in acupuncture and TCM clinical trials, while the between-group quantitative analysis methods on clinical symptom scores are commonly used in the West. The evidence for and against these analytical differences were discussed based on the data of RCTs assessing acupuncture for pain relief. The authors concluded that although both methods have their unique advantages, quantitative analysis should be used as the primary analysis while qualitative analysis can be a secondary criterion for analysis. The purpose of this paper is to inspire further discussion of such special issues in clinical research design and thus contribute to the increased scientific rigor of TCM research.

Impact of electronic clinical decision support on adherence to guideline-recommended treatment for hyperlipidaemia, atrial fibrillation and heart failure: protocol for a cluster randomised trial

PubMed Central

Kessler, Maya Elizabeth; Cook, David A; Kor, Daryl Jon; McKie, Paul M; Pencille, Laurie J; Scheitel, Marianne R; Chaudhry, Rajeev

2017-01-01

Introduction Clinical practice guidelines facilitate optimal clinical practice. Point of care access, interpretation and application of such guidelines, however, is inconsistent. Informatics-based tools may help clinicians apply guidelines more consistently. We have developed a novel clinical decision support tool that presents guideline-relevant information and actionable items to clinicians at the point of care. We aim to test whether this tool improves the management of hyperlipidaemia, atrial fibrillation and heart failure by primary care clinicians. Methods/analysis Clinician care teams were cluster randomised to receive access to the clinical decision support tool or passive access to institutional guidelines on 16 May 2016. The trial began on 1 June 2016 when access to the tool was granted to the intervention clinicians. The trial will be run for 6 months to ensure a sufficient number of patient encounters to achieve 80% power to detect a twofold increase in the primary outcome at the 0.05 level of significance. The primary outcome measure will be the percentage of guideline-based recommendations acted on by clinicians for hyperlipidaemia, atrial fibrillation and heart failure. We hypothesise care teams with access to the clinical decision support tool will act on recommendations at a higher rate than care teams in the standard of care arm. Ethics and dissemination The Mayo Clinic Institutional Review Board approved all study procedures. Informed consent was obtained from clinicians. A waiver of informed consent and of Health Insurance Portability and Accountability Act (HIPAA) authorisation for patients managed by clinicians in the study was granted. In addition to publication, results will be disseminated via meetings and newsletters. Trial registration number NCT02742545. PMID:29208620

Measuring mechanisms for quality assurance in primary care systems in transition: test of a new instrument in Slovenia and Uzbekistan.

PubMed

Kringos, Dionne Sofia; Boerma, Wienke; Pellny, Martina

2009-01-01

This World Health Organization (WHO) study aimed to develop and field test an instrument to assess the availability of structures and mechanisms for managing quality in primary care in countries in transition. The instrument is based on a literature study, consensus meetings with experts, and observations in these countries. It consists of three parts: a semi-structured questionnaire on national policies and mechanisms; a structured questionnaire for general practitioners (GPs); and a structured questionnaire for use with managers of primary care facilities. The instrument has been field tested in 2007 in Slovenia and Uzbekistan. In Slovenia, leadership on quality improvement was weak and local managers reported few incentives and resources to control quality. There was a lack of external support for quality improvement activities. Availability and use of clinical guidelines for GPs were not optimal. GPs found teamwork and communication with patients inadequate. In Uzbekistan, primary care quality and standards in health centres were extensively regulated and laid down in numerous manuals, instructions and other documents. Managers, however, indicated the need for more financial and non-financial levers for quality improvement and they wanted to know more about modern healthcare management. GPs reported strong involvement in activities such as peer review and clinical audit, and reported frequent use of clinical guidelines. Overall, the information gathered with the provisional instrument has resulted in policy recommendations. At the same time, the pilot resulted in improvements to the instrument. Application of the instrument helps decision makers to identify improvement areas in the infrastructure for managing the quality of primary care.

Dental student attitudes towards communication skills instruction and clinical application.

PubMed

McKenzie, Carly T

2014-10-01

This study investigated dental students' attitudes towards communication skills instruction and clinical application and explored the impact of a one-semester course and year in school on students' attitudes, measured by the Communication Skills Attitude Scale. Demographic characteristics and self-assessment of communication skills were also analyzed. The study employed a pretest-posttest survey design combined with cross-sectional data. Participants were first- and fourth-year students at a U.S. dental school. Out of a possible 120 students, 106 (fifty-seven D1 and forty-nine D4) participated in the pretest, an 88 percent response rate; out of a possible 121 students, 115 (fifty-seven D1 and fifty-eight D4) participated in the posttest, a 95 percent response rate. In the results, D4 students consistently demonstrated less positive attitudes towards communication skills instruction and more negative attitudes regarding the importance of interpersonal skills in clinical encounters than did their D1 counterparts. A single communications course had no discernible effect on attitudes or self-assessments for either cohort. Females reported more positive attitudes towards clinical application of interpersonal skills than did males. Gender significantly interacted with two demographic variables: primary language and parent as health care professional. Female children of health care professionals reported poorer attitudes towards clinical communication skills training and application than did their male counterparts. Generally, parental occupation in health care moderated the decrease in positive attitudes over time towards clinical usefulness of communication skills. The D4 students rated their communication skills higher than did the D1 students. Students who demonstrated more positive attitudes towards communication skills training and application were more likely to say their own skills needed improvement.

No evidence of obstetrical adverse events after hyperimmune globulin application for primary cytomegalovirus infection in pregnancy: experience from a single centre.

PubMed

Chiaie, Loredana Delle; Neuberger, Patrick; Vochem, Matthias; Lihs, Angela; Karck, Ulrich; Enders, Martin

2018-06-01

To determine the frequency of obstetrical adverse events and clinical outcome in infants following antenatal hyperimmune globulin (HIG) treatment for primary cytomegalovirus (CMV) infection in pregnancy. Data from 50 women including three twin pregnancies were retrospectively evaluated. Primary infection was defined by seroconversion or the presence of CMV-specific IgM and low IgG avidity. All women received two or more infusions of HIG (200 U/kg). Congenital CMV (cCMV) infection was diagnosed by detection of CMV in amniotic fluid and/or neonatal urine. We compared gestational age (GA) at birth, head circumference (HC) and birth weight (BW) of infants in our study cohort with those of live-born infants delivered in our clinic between 2015 and 2016. Median gestational age at time of maternal CMV diagnosis was 13 weeks. One-hundred-forty-one maternal HIG doses were given. No HIG-related severe adverse reactions occurred. Preterm birth rate was 4.2% (2/47) in singleton pregnancies. None of the neonates had birth weight or head circumference < 3rd percentile (< 3P) for gestational age. There was no statistically significant difference regarding GA, BW and HC between our study cohort and the total population of live-born infants. The frequency of CMV-related sequelae in infants with cCMV infection was 10.5% (2/19) (one with bilateral hearing loss and one with mild motoric delay), both cases following first trimester maternal infection. Antenatal HIG treatment was well tolerated and not associated with prematurity or decreased birth weight. HIG application might have a favorable effect on the clinical course of congenital CMV infection.

Adoptive Immunotherapy for Cancer or Viruses

PubMed Central

Maus, Marcela V.; Fraietta, Joseph A.; Levine, Bruce L.; Kalos, Michael; Zhao, Yangbing; June, Carl H.

2015-01-01

Adoptive immunotherapy, or the infusion of lymphocytes, is a promising approach for the treatment of cancer and certain chronic viral infections. The application of the principles of synthetic biology to enhance T cell function has resulted in substantial increases in clinical efficacy. The primary challenge to the field is to identify tumor-specific targets to avoid off-tissue, on-target toxicity. Given recent advances in efficacy in numerous pilot trials, the next steps in clinical development will require multicenter trials in order to establish adoptive immunotherapy as a mainstream technology. PMID:24423116

Clinical Nononcologic Applications of PET/CT and PET/MRI in Musculoskeletal, Orthopedic, and Rheumatologic Imaging.

PubMed

Gholamrezanezhad, Ali; Basques, Kyle; Batouli, Ali; Matcuk, George; Alavi, Abass; Jadvar, Hossein

2018-06-01

With improvements in PET/CT and PET/MRI over the last decade, as well as increased understanding of the pathophysiology of musculoskeletal diseases, there is an emerging potential for PET as a primary or complementary modality in the management of rheumatologic and orthopedic conditions. We discuss the role of PET/CT and PET/MRI in nononcologic musculoskeletal disorders, including inflammatory and infectious conditions and postoperative complications. There is great potential for an increased role for PET to serve as a primary or complementary modality in the management of orthopedic and rheumatologic disorders.

Spirometry in primary care

PubMed Central

Coates, Allan L; Graham, Brian L; McFadden, Robin G; McParland, Colm; Moosa, Dilshad; Provencher, Steeve; Road, Jeremy

2013-01-01

Canadian Thoracic Society (CTS) clinical guidelines for asthma and chronic obstructive pulmonary disease (COPD) specify that spirometry should be used to diagnose these diseases. Given the burden of asthma and COPD, most people with these diseases will be diagnosed in the primary care setting. The present CTS position statement was developed to provide guidance on key factors affecting the quality of spirometry testing in the primary care setting. The present statement may also be used to inform and guide the accreditation process for spirometry in each province. Although many of the principles discussed are equally applicable to pulmonary function laboratories and interpretation of tests by respirologists, they are held to a higher standard and are outside the scope of the present statement. PMID:23457669

Establishment, maintenance and in vitro and in vivo applications of primary human glioblastoma multiforme (GBM) xenograft models for translational biology studies and drug discovery.

PubMed

Carlson, Brett L; Pokorny, Jenny L; Schroeder, Mark A; Sarkaria, Jann N

2011-03-01

Development of clinically relevant tumor model systems for glioblastoma multiforme (GBM) is important for advancement of basic and translational biology. One model that has gained wide acceptance in the neuro-oncology community is the primary xenograft model. This model entails the engraftment of patient tumor specimens into the flank of nude mice and subsequent serial passage of these tumors in the flank of mice. These tumors are then used to establish short-term explant cultures or intracranial xenografts. This unit describes detailed procedures for establishment, maintenance, and utilization of a primary GBM xenograft panel for the purpose of using them as tumor models for basic or translational studies.

A mobile phone application for the assessment and management of youth mental health problems in primary care: health service outcomes from a randomised controlled trial of mobiletype.

PubMed

Reid, Sophie C; Kauer, Sylvia D; Hearps, Stephen J C; Crooke, Alexander H D; Khor, Angela S; Sanci, Lena A; Patton, George C

2013-06-19

GPs detect at best 50c of mental health problems in young people. Barriers to detecting mental health problems include lack of screening tools, limited appointment times and young people's reluctance to report mental health symptoms to GPs. The mobiletype program is a mobile phone mental health assessment and management application which monitors mood, stress and everyday activities then transmits this information to general practitioners (GPs) via a secure website in summary format for medical review. The current aims were to examine: (i) mobiletype as a clinical assistance tool, ii) doctor-patient rapport and, iii) pathways to care. We conducted a randomised controlled trial in primary care with patients aged 14 to 24 years recruited from rural and metropolitan general practices. GPs identified and referred eligible participants (those with mild or more mental health concerns) who were randomly assigned to either the intervention group (where mood, stress and daily activities were monitored) or the attention-comparison group (where only daily activities were monitored). Both groups self-monitored for 2 to 4 weeks and reviewed the monitoring data with their GP. GPs, participants and researchers were blind to group allocation at randomisation. GPs assessed the mobiletype program as a clinical assistant tool. Doctor-patient rapport was assessed using the General Practice Assessment Questionnaire Communication and Enablement subscales, and the Trust in Physician Scale (TPS). Pathways to care was measured using The Party Project's Exit Interview. Of the 163 participants assessed for eligibility, 118 were randomised and 114 participants were included in analyses (intervention n = 68, attention-comparison n = 46). T-tests showed that the intervention program increased understanding of patient mental health, assisted in decisions about medication/referral and helped in diagnosis when compared to the attention-comparison program. Mixed model analysis showed no differences in GP-patient rapport nor in pathways to care. We conducted the first RCT of a mobile phone application in the mental health assessment and management of youth mental health in primary care. This study suggests that mobiletype has much to offer GPs in the often difficult and time-consuming task of assessment and management of youth mental health problems in primary care. ClinicalTrials.gov NCT00794222.

Designing Colorectal Cancer Screening Decision Support: A Cognitive Engineering Enterprise.

PubMed

Militello, Laura G; Saleem, Jason J; Borders, Morgan R; Sushereba, Christen E; Haverkamp, Donald; Wolf, Steven P; Doebbeling, Bradley N

2016-03-01

Adoption of clinical decision support has been limited. Important barriers include an emphasis on algorithmic approaches to decision support that do not align well with clinical work flow and human decision strategies, and the expense and challenge of developing, implementing, and refining decision support features in existing electronic health records (EHRs). We applied decision-centered design to create a modular software application to support physicians in managing and tracking colorectal cancer screening. Using decision-centered design facilitates a thorough understanding of cognitive support requirements from an end user perspective as a foundation for design. In this project, we used an iterative design process, including ethnographic observation and cognitive task analysis, to move from an initial design concept to a working modular software application called the Screening & Surveillance App. The beta version is tailored to work with the Veterans Health Administration's EHR Computerized Patient Record System (CPRS). Primary care providers using the beta version Screening & Surveillance App more accurately answered questions about patients and found relevant information more quickly compared to those using CPRS alone. Primary care providers also reported reduced mental effort and rated the Screening & Surveillance App positively for usability.

Designing Colorectal Cancer Screening Decision Support: A Cognitive Engineering Enterprise

PubMed Central

Militello, Laura G.; Saleem, Jason J.; Borders, Morgan R.; Sushereba, Christen E.; Haverkamp, Donald; Wolf, Steven P.; Doebbeling, Bradley N.

2016-01-01

Adoption of clinical decision support has been limited. Important barriers include an emphasis on algorithmic approaches to decision support that do not align well with clinical work flow and human decision strategies, and the expense and challenge of developing, implementing, and refining decision support features in existing electronic health records (EHRs). We applied decision-centered design to create a modular software application to support physicians in managing and tracking colorectal cancer screening. Using decision-centered design facilitates a thorough understanding of cognitive support requirements from an end user perspective as a foundation for design. In this project, we used an iterative design process, including ethnographic observation and cognitive task analysis, to move from an initial design concept to a working modular software application called the Screening & Surveillance App. The beta version is tailored to work with the Veterans Health Administration’s EHR Computerized Patient Record System (CPRS). Primary care providers using the beta version Screening & Surveillance App more accurately answered questions about patients and found relevant information more quickly compared to those using CPRS alone. Primary care providers also reported reduced mental effort and rated the Screening & Surveillance App positively for usability. PMID:26973441

Primary and persistent negative symptoms: Concepts, assessments and neurobiological bases.

PubMed

Mucci, Armida; Merlotti, Eleonora; Üçok, Alp; Aleman, André; Galderisi, Silvana

2017-08-01

Primary and persistent negative symptoms (PPNS) represent an unmet need in the care of people with schizophrenia. They have an unfavourable impact on real-life functioning and do not respond to available treatments. Underlying etiopathogenetic mechanisms of PPNS are still unknown. The presence of primary and enduring negative symptoms characterizes deficit schizophrenia (DS), proposed as a separate disease entity with respect to non-deficit schizophrenia (NDS). More recently, to reduce the heterogeneity of negative symptoms by using criteria easily applicable in the context of clinical trials, the concept of persistent negative symptoms (PNS) was developed. Both PNS and DS constructs include enduring negative symptoms (at least 6months for PNS and 12months for DS) that do not respond to available treatments. PNS exclude secondary negative symptoms based on a cross-sectional evaluation of severity thresholds on commonly used rating scales for positive symptoms, depression and extrapyramidal side effects; the DS diagnosis, instead, excludes all potential sources of secondary negative symptoms based on a clinical longitudinal assessment. In this paper we review the evolution of concepts and assessment modalities relevant to PPNS, data on prevalence of DS and PNS, as well as studies on clinical, neuropsychological, brain imaging electrophysiological and psychosocial functioning aspects of DS and PNS. Copyright © 2016 Elsevier B.V. All rights reserved.

Veterans Affairs Geriatric Scholars Program: Enhancing Existing Primary Care Clinician Skills in Caring for Older Veterans.

PubMed

Kramer, B Josea; Creekmur, Beth; Howe, Judith L; Trudeau, Scott; Douglas, Joseph R; Garner, Kimberly; Bales, Connie; Callaway-Lane, Carol; Barczi, Steven

2016-11-01

The Veterans Affairs Geriatric Scholars Program (GSP) is a continuing professional development program to integrate geriatrics into the clinical practices of primary care providers and select associated health professions that support primary care teams. GSP uses a blended program educational format, and the minimal requirements are to attend an intensive course in geriatrics, participate in an interactive workshop on quality improvement (QI), and initiate a local QI project to demonstrate application of new knowledge to benefit older veterans. Using a retrospective post/pre survey design, the effect of GSP on clinical practices and behaviors and variation of that effect on clinicians working in rural and nonrural settings were evaluated. Significant improvement was found in the frequency of using evidence-based brief standardized assessments, clinical decision-making, and standards of care. Significant subgroup differences were observed in peer-to-peer information sharing between rural and nonrural clinicians. Overall, 77% of the sample reported greater job satisfaction after participating in GSP. The program is a successful model for advancing postgraduate education in geriatrics and a model that might be replicated to increase access to quality health care, particularly in rural areas. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.

Application of ultrasound in periodontics: Part I

PubMed Central

Bains, Vive K.; Mohan, Ranjana; Bains, Rhythm

2008-01-01

Ultrasonic is a branch of acoustics concerned with sound vibrations in frequency ranges above audible level. Ultrasound uses the transmission and reflection of acoustic energy. A pulse is propagated and its reflection is received, both by the transducer. For clinical purposes ultrasound is generated by transducers, which converts electrical energy into ultrasonic waves. This is usually achieved by magnetostriction or piezoelectricity. Primary effects of ultrasound are thermal, mechanical (cavitation and microstreaming), and chemical (sonochemicals). Knowledge of the basic and other secondary effects of ultrasound is essential for the development of techniques of application. PMID:20142941

Havery Mudd 2014-2015 Computer Science Conduit Clinic Final Report

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

Aspesi, G; Bai, J; Deese, R

2015-05-12

Conduit, a new open-source library developed at Lawrence Livermore National Laboratories, provides a C++ application programming interface (API) to describe and access scientific data. Conduit’s primary use is for inmemory data exchange in high performance computing (HPC) applications. Our team tested and improved Conduit to make it more appealing to potential adopters in the HPC community. We extended Conduit’s capabilities by prototyping four libraries: one for parallel communication using MPI, one for I/O functionality, one for aggregating performance data, and one for data visualization.

Funding source and primary outcome changes in clinical trials registered on ClinicalTrials.gov are associated with the reporting of a statistically significant primary outcome: a cross-sectional study.

PubMed

Ramagopalan, Sreeram V; Skingsley, Andrew P; Handunnetthi, Lahiru; Magnus, Daniel; Klingel, Michelle; Pakpoor, Julia; Goldacre, Ben

2015-01-01

We and others have shown a significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. The objectives of this study were to investigate whether changes made to primary outcomes are associated with the likelihood of reporting a statistically significant primary outcome on ClinicalTrials.gov. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 20 November 2014 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. 13,238 completed interventional trials were registered with ClinicalTrials.gov that also had study results posted on the website. 2555 (19.3%) had one or more statistically significant primary outcomes. Statistical analysis showed that registration year, funding source and primary outcome change after trial completion were associated with reporting a statistically significant primary outcome .  Funding source and primary outcome change after trial completion are associated with a statistically significant primary outcome report on clinicaltrials.gov.

[Development and evolution of a balanced scorecard in primary health care: Lessons learned].

PubMed

Bartolomé-Benito, E; Jiménez-Carramiñana, J; Sánchez-Perruca, L; Bartolomé-Casado, M S; Dominguez-Mandueño, A B; Marti-Argandoña, M; Hernández-Pascual, M; Miquel-Gómez, A

To describe the design, implementation, and monitoring of eSOAP (Primary Health Care Balanced Scorecard) and its role in the deployment of strategic objectives and clinical management, as well as to show the lessons learned during six years of follow-up. Descriptive study areas: methodology (conceptual framework, strategic matrix, strategic map, and processes map), technology and standardisation. As of December 2014, 9,046 (78%) professionals are registered in eSOAP. A total of 381 indicators were measured from 16 data sources, of which 36% were of results (EFQM model), 39.1% of clinical management, and 20% were included in the Program Centre Contract. The Balanced Scorecard has enabled to deploy all strategic lines of Primary Health Care, and has enabled the healthcare professionals to evaluate the evolution of results over time, and at patient level (e.g. 16% increase in control of diabetic patients). A total of 295,779 reports were generated and 13,080 professionals were evaluated by goals. There was an increased use of the eSOAP application by the professionals. The Balanced Scorecard was the key in deploying Primary Health Care strategies. It has helped clinical management and improved relevant indicators (health, patient experience, and costs), such as the management models that we used as references (EFQM Kaplan and Norton), and new emerging scenarios (Triple aim). Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

Assessment of residents' loss of interest in academic careers and identification of correctable factors.

PubMed

Reck, Samuel J; Stratman, Erik J; Vogel, Curt; Mukesh, Bickol N

2006-07-01

To quantify interest in an academic career at the dermatology resident and residency applicant level. Cross-sectional survey. Dermatology residents attending a basic science course and residency applicants applying to a single residency program. Self-reported level of interest in an academic dermatology career, reasons for losing interest in academics, and area of desired primary academic contribution. One hundred nine of 230 dermatology applicants and 130 of 190 dermatology residents completed the survey. Seventy-nine applicants (72.5%) and 48 residents (36.9%) were interested in an academic career. Thirty-three of 47 residents (70.2%) and 63 of 79 applicants (79.8%) interested in an academic career hoped to make their primary academic contribution as teacher-clinicians, while only 7 residents (14.9%) and 15 applicants (19.0%) planned to primarily contribute through basic or clinical research. Thirty-eight resident respondents (29.2%) reported losing interest in academics for the following primary reasons: bureaucracy, 24 (63.2%); salary differential/financial issues, 20 (52.6%); lack of effective mentorship, role model, or professional guidance, 19 (50.0%); and location or practice environment, 10 (26.3%). Many residents report losing interest in pursuing a career in academic dermatology. Many reasons for this are not easy to correct. However, half of those residents primarily lose interest because of a lack of mentors, role models, and career guidance. Methods to improve this perception and experience should be sought. Strategies should also be developed to cultivate future teacher-clinicians, where most of the interest lies.

Effective treatment options for musculoskeletal pain in primary care: A systematic overview of current evidence

PubMed Central

Hill, Jonathan C.; Foster, Nadine E.; Protheroe, Joanne

2017-01-01

Background & aims Musculoskeletal pain, the most common cause of disability globally, is most frequently managed in primary care. People with musculoskeletal pain in different body regions share similar characteristics, prognosis, and may respond to similar treatments. This overview aims to summarise current best evidence on currently available treatment options for the five most common musculoskeletal pain presentations (back, neck, shoulder, knee and multi-site pain) in primary care. Methods A systematic search was conducted. Initial searches identified clinical guidelines, clinical pathways and systematic reviews. Additional searches found recently published trials and those addressing gaps in the evidence base. Data on study populations, interventions, and outcomes of intervention on pain and function were extracted. Quality of systematic reviews was assessed using AMSTAR, and strength of evidence rated using a modified GRADE approach. Results Moderate to strong evidence suggests that exercise therapy and psychosocial interventions are effective for relieving pain and improving function for musculoskeletal pain. NSAIDs and opioids reduce pain in the short-term, but the effect size is modest and the potential for adverse effects need careful consideration. Corticosteroid injections were found to be beneficial for short-term pain relief among patients with knee and shoulder pain. However, current evidence remains equivocal on optimal dose, intensity and frequency, or mode of application for most treatment options. Conclusion This review presents a comprehensive summary and critical assessment of current evidence for the treatment of pain presentations in primary care. The evidence synthesis of interventions for common musculoskeletal pain presentations shows moderate-strong evidence for exercise therapy and psychosocial interventions, with short-term benefits only from pharmacological treatments. Future research into optimal dose and application of the most promising treatments is needed. PMID:28640822

Enhancing spatial resolution of (18)F positron imaging with the Timepix detector by classification of primary fired pixels using support vector machine.

PubMed

Wang, Qian; Liu, Zhen; Ziegler, Sibylle I; Shi, Kuangyu

2015-07-07

Position-sensitive positron cameras using silicon pixel detectors have been applied for some preclinical and intraoperative clinical applications. However, the spatial resolution of a positron camera is limited by positron multiple scattering in the detector. An incident positron may fire a number of successive pixels on the imaging plane. It is still impossible to capture the primary fired pixel along a particle trajectory by hardware or to perceive the pixel firing sequence by direct observation. Here, we propose a novel data-driven method to improve the spatial resolution by classifying the primary pixels within the detector using support vector machine. A classification model is constructed by learning the features of positron trajectories based on Monte-Carlo simulations using Geant4. Topological and energy features of pixels fired by (18)F positrons were considered for the training and classification. After applying the classification model on measurements, the primary fired pixels of the positron tracks in the silicon detector were estimated. The method was tested and assessed for [(18)F]FDG imaging of an absorbing edge protocol and a leaf sample. The proposed method improved the spatial resolution from 154.6   ±   4.2 µm (energy weighted centroid approximation) to 132.3   ±   3.5 µm in the absorbing edge measurements. For the positron imaging of a leaf sample, the proposed method achieved lower root mean square error relative to phosphor plate imaging, and higher similarity with the reference optical image. The improvements of the preliminary results support further investigation of the proposed algorithm for the enhancement of positron imaging in clinical and preclinical applications.

Enhancing spatial resolution of 18F positron imaging with the Timepix detector by classification of primary fired pixels using support vector machine

NASA Astrophysics Data System (ADS)

Wang, Qian; Liu, Zhen; Ziegler, Sibylle I.; Shi, Kuangyu

2015-07-01

Position-sensitive positron cameras using silicon pixel detectors have been applied for some preclinical and intraoperative clinical applications. However, the spatial resolution of a positron camera is limited by positron multiple scattering in the detector. An incident positron may fire a number of successive pixels on the imaging plane. It is still impossible to capture the primary fired pixel along a particle trajectory by hardware or to perceive the pixel firing sequence by direct observation. Here, we propose a novel data-driven method to improve the spatial resolution by classifying the primary pixels within the detector using support vector machine. A classification model is constructed by learning the features of positron trajectories based on Monte-Carlo simulations using Geant4. Topological and energy features of pixels fired by 18F positrons were considered for the training and classification. After applying the classification model on measurements, the primary fired pixels of the positron tracks in the silicon detector were estimated. The method was tested and assessed for [18F]FDG imaging of an absorbing edge protocol and a leaf sample. The proposed method improved the spatial resolution from 154.6   ±   4.2 µm (energy weighted centroid approximation) to 132.3   ±   3.5 µm in the absorbing edge measurements. For the positron imaging of a leaf sample, the proposed method achieved lower root mean square error relative to phosphor plate imaging, and higher similarity with the reference optical image. The improvements of the preliminary results support further investigation of the proposed algorithm for the enhancement of positron imaging in clinical and preclinical applications.

A systematic review of diagnostic criteria for psoriasis in adults and children: evidence from studies with a primary aim to develop or validate diagnostic criteria.

PubMed

Burden-Teh, E; Phillips, R C; Thomas, K S; Ratib, S; Grindlay, D; Murphy, R

2017-11-06

The diagnosis of psoriasis in adults and children is made clinically, for both patient management and the selection of participants in research. Diagnostic criteria provide a structure for clinical assessment, which in turn helps standardize patient recruitment into clinical trials and case definitions in observational studies. The aim of this systematic review was to identify and critically appraise the published studies to date that had a primary research aim to develop or validate diagnostic criteria for psoriasis. A search of Ovid MEDLINE and Ovid Embase was conducted in October 2016. The primary objective was to record the sensitivity and specificity of diagnostic criteria for psoriasis. Secondary objectives included diagnostic recommendations, applicability to children and study characteristics. Diagnostic accuracy studies were critically appraised for risk of bias using the QUADAS-2 tool. Twenty-three studies met the inclusion criteria. None detailed clinical examination-based diagnostic criteria. The included criteria varied from genetic and molecular diagnostic models to skin imaging, histopathology, and questionnaire-based, computer-aided and traditional Chinese medicine criteria. High sensitivity and specificity (> 90%) were reported in many studies. However, the study authors often did not specify how the criteria would be used clinically or in research. This review identified studies with varying risk of bias, and due to each study developing separate criteria meta-analysis was not possible. Clinical examination-based diagnostic criteria are currently lacking for psoriasis. Future research could follow an international collaborative approach and employ study designs allowing high-quality diagnostic accuracy testing. Existing and newly developed criteria require validation. © 2017 British Association of Dermatologists.

A retrospective study of a modified 1-minute formocresol pulpotomy technique part 2: effect on exfoliation times and successors.

PubMed

Kurji, Zahra A; Sigal, Michael J; Andrews, Paul; Titley, Keith

2011-01-01

The purposes of this study were to evaluate the: effect of a 1-minute application of full-strength Buckley's formocresol with concur- rent hemostasis using the medicated cotton pledget in human primary teeth on their successors; and exfoliation times compared to the contralateral nonpulpotomized tooth. Using a retrospective chart review, clinical and radiographic data were available for 557 primary molars in 320 patients. There was no difference between treated and control teeth in the number of enamel defects of succedaneous teeth (P<.45). Approximately 66% exfoliated at the same time as their contralateral counterpart and approximately 29% exfoliated earlier (P<.001). This 1-minute technique showed a tendency toward early exfoliation, but no effect on clinical management, and no increase in incidence of defects on succedaneous teeth was observed. The 1-minute full-strength formocresol technique may be considered an acceptable alternative to the 5-minute formocresol pulpotomy.

Alpharetroviral self-inactivating vectors produced by a superinfection-resistant stable packaging cell line allow genetic modification of primary human T lymphocytes.

PubMed

Labenski, Verena; Suerth, Julia D; Barczak, Elke; Heckl, Dirk; Levy, Camille; Bernadin, Ornellie; Charpentier, Emmanuelle; Williams, David A; Fehse, Boris; Verhoeyen, Els; Schambach, Axel

2016-08-01

Primary human T lymphocytes represent an important cell population for adoptive immunotherapies, including chimeric-antigen and T-cell receptor applications, as they have the capability to eliminate non-self, virus-infected and tumor cells. Given the increasing numbers of clinical immunotherapy applications, the development of an optimal vector platform for genetic T lymphocyte engineering, which allows cost-effective high-quality vector productions, remains a critical goal. Alpharetroviral self-inactivating vectors (ARV) have several advantages compared to other vector platforms, including a more random genomic integration pattern and reduced likelihood for inducing aberrant splicing of integrated proviruses. We developed an ARV platform for the transduction of primary human T lymphocytes. We demonstrated functional transgene transfer using the clinically relevant herpes-simplex-virus thymidine kinase variant TK.007. Proof-of-concept of alpharetroviral-mediated T-lymphocyte engineering was shown in vitro and in a humanized transplantation model in vivo. Furthermore, we established a stable, human alpharetroviral packaging cell line in which we deleted the entry receptor (SLC1A5) for RD114/TR-pseudotyped ARVs to prevent superinfection and enhance genomic integrity of the packaging cell line and viral particles. We showed that superinfection can be entirely prevented, while maintaining high recombinant virus titers. Taken together, this resulted in an improved production platform representing an economic strategy for translating the promising features of ARVs for therapeutic T-lymphocyte engineering. Copyright © 2016 Elsevier Ltd. All rights reserved.

New insights into molecular diagnostic pathology of primary liver cancer: Advances and challenges.

PubMed

Cong, Wen-Ming; Wu, Meng-Chao

2015-11-01

Primary liver cancer (PLC) is one of the most common malignancies worldwide with increasing incidence and accounts for the third leading cause of cancer-related mortality. Traditional morphopathology primarily emphasizes qualitative diagnosis of PLC, which is not sufficient to resolve the major concern of increasing the long-term treatment efficacy of PLC in clinical management for the modern era. Since the beginning of the 21st century, molecular pathology has played an active role in the investigation of the evaluation of the metastatic potential of PLC, detection of drug targets, prediction of recurrence risks, analysis of clonal origins, evaluation of the malignancy trend of precancerous lesions, and determination of clinical prognosis. As a result, many new progresses have been obtained, and new strategies of molecular-pathological diagnosis have been formed. Moreover, the new types of pathobiological diagnosis indicator systems for PLC have been preliminarily established. These achievements provide valuable molecular pathology-based guide for clinical formulation of individualized therapy programs for PLC. This review article briefly summarizes some relevant progresses of molecular-pathological diagnosis of PLC from the perspective of clinical translational application other than basic experimental studies. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Zirconia in dentistry: part 2. Evidence-based clinical breakthrough.

PubMed

Koutayas, Spiridon Oumvertos; Vagkopoulou, Thaleia; Pelekanos, Stavros; Koidis, Petros; Strub, Jörg Rudolf

2009-01-01

An ideal all-ceramic restoration that conforms well and demonstrates enhanced biocompatibility, strength, fit, and esthetics has always been desirable in clinical dentistry. However, the inherent brittleness, low flexural strength, and fracture toughness of conventional glass and alumina ceramics have been the main obstacles for extensive use. The recent introduction of zirconia-based ceramics as a restorative dental material has generated considerable interest in the dental community, which has been expressed with extensive industrial, clinical, and research activity. Contemporary zirconia powder technology contributes to the fabrication of new biocompatible all-ceramic restorations with improved physical properties for a wide range of promising clinical applications. Especially with the development of computer-aided design (CAD)/computer-aided manufacturing (CAM) systems, high-strength zirconia frameworks can be viable for the fabrication of full and partial coverage crowns, fixed partial dentures, veneers, posts and/or cores, primary double crowns, implant abutments, and implants. Data from laboratory and clinical studies are promising regarding their performance and survival. However, clinical data are considered insufficient and the identified premature complications should guide future research. In addition, different zirconia-based dental auxiliary components (i.e., cutting burs and surgical drills, extra-coronal attachments and orthodontic brackets) can also be technologically feasible. This review aims to present and discuss zirconia manufacturing methods and their potential for successful clinical application in dentistry.

Immunomodulatory Nature and Site Specific Affinity of Mesenchymal Stem Cells: a Hope in Cell Therapy

PubMed Central

Lotfinegad, Parisa; Shamsasenjan, karim; Movassaghpour, Aliakbar; Majidi, Jafar; Baradaran, Behzad

2014-01-01

Immunosuppressive ability of mesenchymal stem cells (MSCs), their differentiation properties to various specialized tissue types, ease of in vitro and in vivo expansion and specific migration capacity, make them to be tested in different clinical trials for the treatment of various diseases. The immunomodulatory effects of MSCs are less identified which probably has high clinically significance. The clinical trials based on primary research will cause better understanding the ability of MSCs in immunomodulatory applications and site specific migration in the optimization of therapy. So, this review focus on MSCs functional role in modulating immune responses, their ability in homing to tumor, their potency as delivery vehicle and their medical importance. PMID:24409403

Clinical application of pharmacogenetics: focusing on practical issues.

PubMed

Chang, Matthew T; McCarthy, Jeanette J; Shin, Jaekyu

2015-01-01

Recent large-scale genetic-based studies have transformed the field of pharmacogenetics to identify, characterize and leverage genetic information to inform patient care. Genetic testing can be used to alter drug selection, optimize drug dosing and prevent unnecessary adverse events. As precision medicine becomes the mainstay in the clinic, it becomes critical for clinicians to utilize pharmacogenetics to guide patient care. One primary challenge is identifying patients where genetic tests that can potentially impact patient care. To address this challenge, our review highlights many practical issues clinicians may encounter: identifying candidate patients and clinical laboratories for pharmacogenetic testing, selecting highly curated resources to help asses test validity, reimbursing costs of pharmacogenetic tests, and interpreting of pharmacogenetic test results.

Antibodies to watch in 2018.

PubMed

Kaplon, Hélène; Reichert, Janice M

The pace of antibody therapeutics development accelerated in 2017, and this faster pace is projected to continue through 2018. Notably, the annual number of antibody therapeutics granted a first approval in either the European Union (EU) or United States (US) reached double-digits (total of 10) for the first time in 2017. The 10 antibodies granted approvals are: brodalumab, dupilumab, sarilumab, guselkumab, benralizumab, ocrelizumab, inotuzumab ozogamicin, avelumab, duvalumab, and emicizumab. Brodalumab, however, had already been approved in Japan in 2016. As of December 1, 2017, nine antibody therapeutics (ibalizumab, burosumab, tildrakizumab, caplacizumab, erenumab, fremanezumab, galcanezumab, romosozumab, mogamulizumab) were in regulatory review in the EU or US, and regulatory actions on their marketing applications are expected by the end of 2018. Based on company announcements and estimated clinical study primary completion dates, and assuming the study results are positive, marketing applications for at least 12 antibody therapeutics that are now being evaluated in late-stage clinical studies may be submitted by the end of 2018. Of the 12 candidates, 8 are for non-cancer indications (lanadelumab, crizanlizumab, ravulizumab, eptinezumab, risankizumab, satralizumab, brolucizumab, PRO140) and 4 are for cancer (sacituzumab govitecan, moxetumomab pasudotox, cemiplimab, ublituximab). Additional antibody therapeutics to watch in 2018 include 19 mAbs undergoing evaluation in late-stage studies with primary completion dates in late 2017 or during 2018. Of these mAbs, 9 are for non-cancer indications (lampalizumab, roledumab, emapalumab, fasinumab, tanezumab, etrolizumab, NEOD001, gantenerumab, anifrolumab) and 10 are for cancer indications (tremelimumab, isatuximab, BCD-100, carotuximab, camrelizumab, IBI308, glembatumumab vedotin, mirvetuximab soravtansine, oportuzumab monatox, L19IL2/L19TNF). Positive clinical study results may enable marketing application submissions in 2018. Brief summaries of these antibody therapeutics are provided in this installment of the 'Antibodies to watch' article series.

Antibodies to watch in 2018

PubMed Central

Kaplon, Hélène; Reichert, Janice M.

2018-01-01

ABSTRACT The pace of antibody therapeutics development accelerated in 2017, and this faster pace is projected to continue through 2018. Notably, the annual number of antibody therapeutics granted a first approval in either the European Union (EU) or United States (US) reached double-digits (total of 10) for the first time in 2017. The 10 antibodies granted approvals are: brodalumab, dupilumab, sarilumab, guselkumab, benralizumab, ocrelizumab, inotuzumab ozogamicin, avelumab, duvalumab, and emicizumab. Brodalumab, however, had already been approved in Japan in 2016. As of December 1, 2017, nine antibody therapeutics (ibalizumab, burosumab, tildrakizumab, caplacizumab, erenumab, fremanezumab, galcanezumab, romosozumab, mogamulizumab) were in regulatory review in the EU or US, and regulatory actions on their marketing applications are expected by the end of 2018. Based on company announcements and estimated clinical study primary completion dates, and assuming the study results are positive, marketing applications for at least 12 antibody therapeutics that are now being evaluated in late-stage clinical studies may be submitted by the end of 2018. Of the 12 candidates, 8 are for non-cancer indications (lanadelumab, crizanlizumab, ravulizumab, eptinezumab, risankizumab, satralizumab, brolucizumab, PRO140) and 4 are for cancer (sacituzumab govitecan, moxetumomab pasudotox, cemiplimab, ublituximab). Additional antibody therapeutics to watch in 2018 include 19 mAbs undergoing evaluation in late-stage studies with primary completion dates in late 2017 or during 2018. Of these mAbs, 9 are for non-cancer indications (lampalizumab, roledumab, emapalumab, fasinumab, tanezumab, etrolizumab, NEOD001, gantenerumab, anifrolumab) and 10 are for cancer indications (tremelimumab, isatuximab, BCD-100, carotuximab, camrelizumab, IBI308, glembatumumab vedotin, mirvetuximab soravtansine, oportuzumab monatox, L19IL2/L19TNF). Positive clinical study results may enable marketing application submissions in 2018. Brief summaries of these antibody therapeutics are provided in this installment of the ‘Antibodies to watch’ article series. PMID:29300693

Factors Affecting the Development and Sustainability of Communities of Practice Among Primary Care Physicians in Hong Kong.

PubMed

Poon, Man Kay; Lam, Tai Pong

2017-01-01

Primary care physicians (PCPs) maintain high standards of medical care by partaking in continuous learning. The learning model of communities of practice (COPs) is increasingly being used in the field of health care. This study explores the establishment and maintenance of COPs among PCPs in Hong Kong. Sequential, semi-structured individual interview and focus group interview were conducted to explore the purposes for partaking in continuous learning, as well as barriers and facilitators for attendance among private nonspecialist PCPs in Hong Kong. Data were drawn from the discourses related to COPs. Thematic analysis with constant comparison was performed until data saturation was reached. PCPs voluntarily established COPs to solve clinical problems from the existing networks. Clinical interest, practice orientation, and recruitment of new members through endorsement by the existing members fostered group coherence. Conversation and interaction among members generated the "best" practice with knowledge that was applicable in specific clinical scenarios in primary care setting. COPs rejected commercial sponsorship to minimize corporate influences on learning. Updating medical knowledge, solving clinical problems, maintaining openness, engendering a sense of trust and ownership among members, and fulfilling psychosocial needs were integral to sustainability. Seeking secretariat support to aid in the logistics of meetings, enhancing external learning resources, and facilitation skills training of facilitators from professional bodies may further incentivize members to maintain COPs. Autonomy of group learning activities, recruiting specialists and allied health professionals, training facilitators, and undertaking discussion in multimedia may achieve the sustainability of COPs.

A modified varying-stage adaptive phase II/III clinical trial design.

PubMed

Dong, Gaohong; Vandemeulebroecke, Marc

2016-07-01

Conventionally, adaptive phase II/III clinical trials are carried out with a strict two-stage design. Recently, a varying-stage adaptive phase II/III clinical trial design has been developed. In this design, following the first stage, an intermediate stage can be adaptively added to obtain more data, so that a more informative decision can be made. Therefore, the number of further investigational stages is determined based upon data accumulated to the interim analysis. This design considers two plausible study endpoints, with one of them initially designated as the primary endpoint. Based on interim results, another endpoint can be switched as the primary endpoint. However, in many therapeutic areas, the primary study endpoint is well established. Therefore, we modify this design to consider one study endpoint only so that it may be more readily applicable in real clinical trial designs. Our simulations show that, the same as the original design, this modified design controls the Type I error rate, and the design parameters such as the threshold probability for the two-stage setting and the alpha allocation ratio in the two-stage setting versus the three-stage setting have a great impact on the design characteristics. However, this modified design requires a larger sample size for the initial stage, and the probability of futility becomes much higher when the threshold probability for the two-stage setting gets smaller. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Clinical applications of immunoglobulin: update

PubMed Central

Novaretti, Marcia Cristina Zago; Dinardo, Carla Luana

2011-01-01

Human immunoglobulin is the most used blood product in the clinical practice. Immunoglobulin applications have increased quickly since the elucidation of its immunomodulatory and antiinflammatory properties which turned this blood product into a precious tool in the treatment of numerous diseases that present with humoral immune deficiency or that cause immune system dysfunction. Currently, the approved indications for Ig are: primary immunodeficiencies, secondary immunodeficiencies (multiple myeloma or chronic lymphoid leukemia), Kawasaki syndrome, immune thrombocytopenic purpura, Guillain Barré syndrome, graft-versus-host disease following bone marrow transplantation and repeat infections in HIV children. On the other hand, there are numerous "off-label" indications of immunoglobulin, which represent 20-60% of all clinical applications of this drug. It is important to study all these indications and, above all, the scientific evidence for its use, in order to provide patients with a new therapeutic option without burdening the health system. This review results from a wide selection of papers identified in the Pubmed and Lilacs scientific electronic databases. A group of descriptors were used from human immunoglobulin to the names of each disease that immunoglobulin is clinically applied. Our main objective is to list the numerous indications of immunoglobulin, both authorized and "off-label" and to analyze these indications in the light of the most recent scientific evidence. PMID:23049300

Peering beneath the surface: novel imaging techniques to noninvasively select gametes and embryos for ART.

PubMed

Jasensky, Joshua; Swain, Jason E

2013-10-01

Embryo imaging has long been a critical tool for in vitro fertilization laboratories, aiding in morphological assessment of embryos, which remains the primary tool for embryo selection. With the recent emergence of clinically applicable real-time imaging systems to assess embryo morphokinetics, a renewed interest has emerged regarding noninvasive methods to assess gamete and embryo development as a means of inferring quality. Several studies exist that utilize novel imaging techniques to visualize or quantify intracellular components of gametes and embryos with the intent of correlating localization of organelles or molecular constitution with quality or outcome. However, the safety of these approaches varies due to the potential detrimental impact of light exposure or other variables. Along with complexity of equipment and cost, these drawbacks currently limit clinical application of these novel microscopes and imaging techniques. However, as evidenced by clinical incorporation of some real-time imaging devices as well as use of polarized microscopy, some of these imaging approaches may prove to be useful. This review summarizes the existing literature on novel imaging approaches utilized to examine gametes and embryos. Refinement of some of these imaging systems may permit clinical application and serve as a means to offer new, noninvasive selection tools to improve outcomes for various assisted reproductive technology procedures.

iPad applications that required a range of motor skills promoted motor coordination in children commencing primary school.

PubMed

Axford, Caitlin; Joosten, Annette V; Harris, Courtenay

2018-04-01

Children are reported to spend less time engaged in outdoor activity and object-related play than in the past. The increased use and mobility of technology, and the ease of use of tablet devices are some of the factors that have contributed to these changes. Concern has been raised that the use of such screen and surface devices in very young children is reducing their fine motor skill development. We examined the effectiveness of iPad applications that required specific motor skills designed to improve fine motor skills. We conducted a two-group non-randomised controlled trial with two pre-primary classrooms (53 children; 5-6 years) in an Australian co-educational school, using a pre- and post-test design. The effectiveness of 30 minutes daily use of specific iPad applications for 9 weeks was compared with a control class. Children completed the Beery Developmental Test of Visual Motor Integration (VMI) and observation checklist, the Shore Handwriting Screen, and self-care items from the Hawaii Early Learning Profile. On post testing, the experimental group made a statistically and clinically significant improvement on the VMI motor coordination standard scores with a moderate clinical effect size (P < 0.001; d = 0.67). Children's occupational performance in daily tasks also improved. Preliminary evidence was gained for using the iPad, with these motor skill-specific applications as an intervention in occupational therapy practice and as part of at home or school play. © 2018 Occupational Therapy Australia.

Glass Fibre-Reinforced Composite Post and Core Used in Decayed Primary Anterior Teeth: A Case Report

PubMed Central

Verma, Leena; Passi, Sidhi

2011-01-01

Aesthetic requirement of severely mutilated primary anterior teeth in the case of early childhood caries has been a challenge to pediatric dentist. Among restorative treatment options, prefabricated crown and biological and resin composite restoration either by means of direct or indirect technique are mentioned in the literature. This paper presents the clinical sequence of rehabilitation of maxillary anterior primary teeth. Endodontic treatment was followed by the placement of a glass fibre-reinforced composite resin post. The crown reconstruction was done with composite restoration. Resin glass fibre post has best properties in elasticity, translucency, adaptability, tenaciousness, and resistance to traction and to impact. Along with ease of application, fiber can be used as an alternative to traditionally used materials in the management of early childhood caries. PMID:22567447

Small Molecule Protection of Bone Marrow Hematopoietic Stem Cells

DTIC Science & Technology

2016-10-01

early phase clinical trials of metformin in Fanconi anemia patients. – What was the impact on other disciplines? The fields of DNA damage...patent applications, study questionnaires, and surveys , etc. Reminder: Pages shall be consecutively numbered throughout the report. DO NOT RENUMBER...crosslinks, which impede replication and transcription.2,3 The primary cause of early morbidity and mortality for FA patients is bone marrow failure.4

A comparison of revisional and primary bariatric surgery

PubMed Central

Fulton, Courtney; Sheppard, Caroline; Birch, Daniel; Karmali, Shazeer; de Gara, Christopher

2017-01-01

Background Revisional surgery is an important component of addressing weight regain and complications following primary bariatric surgery. Owing to provincial need and the complexity of this patient population, a specialized multidisciplinary revision clinic was developed. We sought to characterize patients who undergo revision surgery and compare their outcomes with primary bariatric surgery clinic data. Methods We completed a retrospective chart review of bariatric revision clinic patients compared with primary bariatric surgery patients from December 2009 to June 2014. Results We reviewed the charts of 2769 primary bariatric clinic patients, 886 of whom had bariatric surgery, and 534 revision bariatric clinic patients, 83 of whom had revision surgery. Fewer revision clinic patients underwent surgery than primary clinic patients (22% v. 32%). The mean preoperative body mass index (BMI) was 44.7 ± 9.5 in revision patients compared with 45.7 ± 7.6 in primary bariatric surgery patients. Most revision patients had a prior vertical banded gastroplasty (VBG; 48%) or a laparoscopic adjustable gastric band (LAGB; 24%). Bands were removed in 36% of all LAGB patients presenting to clinic. Of the 134 procedures performed in the revision clinic, 83 were bariatric weight loss surgeries, and 51 were band removals. Revision clinic patients experienced a significant decrease in BMI (from 44.7 ± 9.5 to 33.8 ± 7.5, p < 0.001); their BMI at 12-month follow-up was similar to that of primary clinic patients (34.5 ± 7.0, p = 0.7). Complications were significantly more frequent in revision patients than primary patients (41% v. 15%, p < 0.001). Conclusion A bariatric revision clinic manages a wide variety of complex patients distinct from those seen in a primary clinic. Operative candidates at the revision clinic are chosen based on favourable medical, anatomic and psychosocial factors, keeping in mind the resource constraints of a public health care system. PMID:28570215

A comparison of revisional and primary bariatric surgery.

PubMed

Fulton, Courtney; Sheppard, Caroline; Birch, Daniel; Karmali, Shazeer; de Gara, Christopher

2017-06-01

Revisional surgery is an important component of addressing weight regain and complications following primary bariatric surgery. Owing to provincial need and the complexity of this patient population, a specialized multidisciplinary revision clinic was developed. We sought to characterize patients who undergo revision surgery and compare their outcomes with primary bariatric surgery clinic data. We completed a retrospective chart review of bariatric revision clinic patients compared with primary bariatric surgery patients from December 2009 to June 2014. We reviewed the charts of 2769 primary bariatric clinic patients, 886 of whom had bariatric surgery, and 534 revision bariatric clinic patients, 83 of whom had revision surgery. Fewer revision clinic patients underwent surgery than primary clinic patients (22% v. 32%). The mean preoperative body mass index (BMI) was 44.7 ± 9.5 in revision patients compared with 45.7 ± 7.6 in primary bariatric surgery patients. Most revision patients had a prior vertical banded gastroplasty (VBG; 48%) or a laparoscopic adjustable gastric band (LAGB; 24%). Bands were removed in 36% of all LAGB patients presenting to clinic. Of the 134 procedures performed in the revision clinic, 83 were bariatric weight loss surgeries, and 51 were band removals. Revision clinic patients experienced a significant decrease in BMI (from 44.7 ± 9.5 to 33.8 ± 7.5, p < 0.001); their BMI at 12-month follow-up was similar to that of primary clinic patients (34.5 ± 7.0, p = 0.7). Complications were significantly more frequent in revision patients than primary patients (41% v. 15%, p < 0.001). A bariatric revision clinic manages a wide variety of complex patients distinct from those seen in a primary clinic. Operative candidates at the revision clinic are chosen based on favourable medical, anatomic and psychosocial factors, keeping in mind the resource constraints of a public health care system.

Assessing primary care data quality.

PubMed

Lim, Yvonne Mei Fong; Yusof, Maryati; Sivasampu, Sheamini

2018-04-16

Purpose The purpose of this paper is to assess National Medical Care Survey data quality. Design/methodology/approach Data completeness and representativeness were computed for all observations while other data quality measures were assessed using a 10 per cent sample from the National Medical Care Survey database; i.e., 12,569 primary care records from 189 public and private practices were included in the analysis. Findings Data field completion ranged from 69 to 100 per cent. Error rates for data transfer from paper to web-based application varied between 0.5 and 6.1 per cent. Error rates arising from diagnosis and clinical process coding were higher than medication coding. Data fields that involved free text entry were more prone to errors than those involving selection from menus. The authors found that completeness, accuracy, coding reliability and representativeness were generally good, while data timeliness needs to be improved. Research limitations/implications Only data entered into a web-based application were examined. Data omissions and errors in the original questionnaires were not covered. Practical implications Results from this study provided informative and practicable approaches to improve primary health care data completeness and accuracy especially in developing nations where resources are limited. Originality/value Primary care data quality studies in developing nations are limited. Understanding errors and missing data enables researchers and health service administrators to prevent quality-related problems in primary care data.

[The alpha-herpesviridae in dermatology : Herpes simplex virus types I and II. German version].

PubMed

El Hayderi, L; Rübben, A; Nikkels, A F

2017-03-01

This review on herpes simplex virus type I and type II (HSV-I, HSV-II) summarizes recent developments in clinical manifestations and treatment interventions for primary and recurrent orolabial and genital herpes, as well as those regarding vaccination issues. Among the clinical presentations, the relationship between pyogenic granuloma and chronic HSV-I infection; HSV-related folliculitis; verrucous HSV-I and HSV-II lesions; the role of recurrent HSV-I infection in burning mouth syndrome; HSV-I and HSV-II infection of the periareolar area; zosteriform HSV; the "knife-cut sign"; and the preferential colonization and infection of preexisting dermatoses by HSV-I or HSV-II are discussed. The usual antiviral treatment regimens for primary and recurrent orolabial and genital herpes are compared to short-term and one-day treatment options. New anti-HSV-I and anti-HSV-II agents include amenavir, pritelivir, brincidofovir, valomaciclovir, and FV-100. Therapeutic or preventive vaccination against HSV-I and HSV-II infections still remains a highly desirable treatment aim, which, unfortunately, has no clinically relevant applications to date.

Adoptive T Cell Immunotherapy for Patients with Primary Immunodeficiency Disorders.

PubMed

McLaughlin, Lauren P; Bollard, Catherine M; Keller, Michael

2017-01-01

Primary immunodeficiency disorders (PID) are a group of inborn errors of immunity with a broad range of clinical severity but often associated with recurrent and serious infections. While hematopoietic stem cell transplantation (HSCT) can be curative for some forms of PID, chronic and/or refractory viral infections remain a cause of morbidity and mortality both before and after HSCT. Although antiviral pharmacologic agents exist for many viral pathogens, these are associated with significant costs and toxicities and may not be effective for increasingly drug-resistant pathogens. Thus, the emergence of adoptive immunotherapy with virus-specific T lymphocytes (VSTs) is an attractive option for addressing the underlying impaired T cell immunity in many PID patients. VSTs have been utilized for PID patients following HSCT in many prior phase I trials, and may potentially be beneficial before HSCT in patients with chronic viral infections. We review the various methods of generating VSTs, clinical experience using VSTs for PID patients, and current limitations as well as potential ways to broaden the clinical applicability of adoptive immunotherapy for PID patients.

A dynamic model for tumour growth and metastasis formation.

PubMed

Haustein, Volker; Schumacher, Udo

2012-07-05

A simple and fast computational model to describe the dynamics of tumour growth and metastasis formation is presented. The model is based on the calculation of successive generations of tumour cells and enables one to describe biologically important entities like tumour volume, time point of 1st metastatic growth or number of metastatic colonies at a given time. The model entirely relies on the chronology of these successive events of the metastatic cascade. The simulation calculations were performed for two embedded growth models to describe the Gompertzian like growth behaviour of tumours. The initial training of the models was carried out using an analytical solution for the size distribution of metastases of a hepatocellular carcinoma. We then show the applicability of our models to clinical data from the Munich Cancer Registry. Growth and dissemination characteristics of metastatic cells originating from cells in the primary breast cancer can be modelled thus showing its ability to perform systematic analyses relevant for clinical breast cancer research and treatment. In particular, our calculations show that generally metastases formation has already been initiated before the primary can be detected clinically.

A dynamic model for tumour growth and metastasis formation

PubMed Central

2012-01-01

A simple and fast computational model to describe the dynamics of tumour growth and metastasis formation is presented. The model is based on the calculation of successive generations of tumour cells and enables one to describe biologically important entities like tumour volume, time point of 1st metastatic growth or number of metastatic colonies at a given time. The model entirely relies on the chronology of these successive events of the metastatic cascade. The simulation calculations were performed for two embedded growth models to describe the Gompertzian like growth behaviour of tumours. The initial training of the models was carried out using an analytical solution for the size distribution of metastases of a hepatocellular carcinoma. We then show the applicability of our models to clinical data from the Munich Cancer Registry. Growth and dissemination characteristics of metastatic cells originating from cells in the primary breast cancer can be modelled thus showing its ability to perform systematic analyses relevant for clinical breast cancer research and treatment. In particular, our calculations show that generally metastases formation has already been initiated before the primary can be detected clinically. PMID:22548735

Short-term intensive insulin therapy at diagnosis in type 2 diabetes: plan for filling the gaps.

PubMed

Weng, Jianping; Retnakaran, Ravi; Ariachery C, Ammini; Ji, Linong; Meneghini, Luigi; Yang, Wenying; Woo, Jeong-Taek

2015-09-01

Short-term intensive insulin therapy is unique amongst therapies for type 2 diabetes because it offers the potential to preserve and improve beta-cell function without additional pharmacological treatment. On the basis of clinical experience and the promising results of a series of studies in newly diagnosed patients, mostly in Asian populations, an expert workshop was convened to assess the available evidence and the potential application of short-term intensive insulin therapy should it be advocated for inclusion in clinical practice. Participants included primary care physicians and endocrinologists. We endorse the concept of short-term intensive insulin therapy as an option for some patients with type 2 diabetes at the time of diagnosis and have identified the following six areas where additional knowledge could help clarify optimal use in clinical practice: (1) generalizability to primary care, (2) target population and biomarkers, (3) follow-up treatment, (4) education of patients and providers, (5) relevance of ethnicity, and (6) health economics. © 2014 The Authors. Diabetes Metabolism Research and Reviews published by John Wiley & Sons, Ltd.

Strategies for Isolation and Molecular Profiling of Circulating Tumor Cells.

PubMed

Chen, Jia-Yang; Chang, Ying-Chih

2017-01-01

Cancer is the leading cause of death by disease worldwide, and metastasis is responsible for more than 90% of the mortality of cancer patients. Metastasis occurs when tumor cells leave the primary tumor, travel through the blood stream as circulating tumor cells (CTCs), and then colonize secondary tumors at sites distant from the primary tumor. The capture, identification, and analysis of CTCs offer both scientific and clinical benefits. On the scientific side, the analysis of CTCs could help elucidate possible genetic alterations and signaling pathway aberrations during cancer progression, which could then be used to find new methods to stop cancer progression. On the clinical side, non-invasive testing of a patient's blood for CTCs can be used for patient diagnosis and prognosis, as well as subsequent monitoring of treatment efficacy in routine clinical practice. Additionally, investigation of CTCs early in the progression of cancer may reveal targets for initial cancer detection and for anti-cancer treatment. This chapter will evaluate strategies and devices used for the isolation and identification of CTCs directly from clinical samples of blood. Recent progress in the understanding of the significance of both single CTCs and circulating tumor microemboli will be discussed. Also, advancements in the use of CTC-based liquid biopsy in clinical diagnosis and the potential of CTC-based molecular characterization for use in clinical applications will be summarized.

ε-Aminocaproic acid and clinical value in cardiac anesthesia.

PubMed

Raghunathan, Karthik; Connelly, Neil Roy; Kanter, Gary J

2011-02-01

The primary aim was to compare the "clinical value" of tranexamic acid (TXA) with ε-aminocaproic acid (EACA) when used for blood conservation during high-risk cardiac surgery. Data previously reported by the Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART) study investigators were reanalyzed independently after appropriate statistical adjustment. The authors compared TXA with EACA for important primary and secondary outcomes and applied the "clinical value" equation to this comparison. BART, the largest blinded multicenter study on this topic to date, compared all 3 commonly used antifibrinolytics head-to-head in a randomized dose-equivalent fashion during high-risk cardiac surgery. Comparisons of TXA with EACA with application of the clinical value equation was not performed specifically by the BART investigators. One thousand five hundred fifty patients enrolled in 2 of the 3 arms of the BART study were included in the analysis (TXA, n= 770 and EACA, n = 780, with data reported by the investigators in the New England Journal of Medicine). The major finding was that there were no significant differences in overall safety and clinically important efficacy between TXA and EACA. Considering the substantial difference in costs and with the increasing volume of high-risk cardiac surgery, EACA has increased "clinical value" when compared with TXA. EACA should be the antifibrinolytic medication of choice for high-risk cardiac surgery. Copyright © 2011 Elsevier Inc. All rights reserved.

Primary cerebral lymphoma: clinical and aeromedical considerations.

PubMed

Storms, Patrick R

2007-04-01

Cancer, and the complications of cancer therapy, can present significant obstacles to the airman wishing to return to flying status. If found to be free of recurrent lymphoma and to be neurologically intact after completion of therapy, applicants can be considered for a time-limited medical certificate, provided that they are otherwise qualified. Long-term follow up of patients must include not only disease-free survival time, but also serial neuropsychometric evaluation and quality-of-life assessments. This case illustrates the aeromedical considerations and certification issues for a patient presenting with performance issues progressing to discreet neurological findings, culminating in the diagnosis and treatment of primary central nervous system (CNS) lymphoma.

Consultation clinics for complementary and alternative medicine at Japanese university hospitals: An analysis at Tokushima University Hospital

PubMed Central

YANAGAWA, HIROAKI; TERAO, JUNJI; TAKEDA, EIJI; TAKAISHI, YOSHIHISA; KASHIWADA, YOSHIKI; KAWAZOE, KAZUYOSHI; FUSHITANI, SHUJI; TSUCHIYA, KOICHIRO; YAMAUCHI, AIKO; SATO, CHIHO; IRAHARA, MINORU

2010-01-01

Here, we report on a Consultation Clinic for Complementary and Alternative Medicine (CAM) which we established at Tokushima University Hospital in July of 2007 with the aim of providing person-to-person information on CAM, though not CAM therapy itself. In December of 2008, we received 55 applications for consultation, 37% concerning health foods, 37% Japanese herbal medicine (Kampo), and 26% various other topics. The consultants (nutritionists and pharmacists) communicated individually with 38 applicants; malignancies (26%) and cardiovascular disease (24%) were the main underlying concerns. To promote the quality of consultation, data was collected by means of focus group interviews concerning the perspective of the consultants. Safe and effective use of CAM requires a network of communication linking individuals, consultation teams, physicians, primary care institutions and university hospitals. To advance this goal, we plan to broaden the efforts described herein. Our findings indicate that the specific role of the consultation clinic in promoting the scientific use of CAM merits further study. PMID:22993564

Clinical Applications of Hallucinogens: A Review

PubMed Central

Garcia-Romeu, Albert; Kersgaard, Brennan; Addy, Peter H.

2016-01-01

Hallucinogens fall into several different classes, as broadly defined by pharmacological mechanism of action, and chemical structure. These include psychedelics, entactogens, dissociatives, and other atypical hallucinogens. Although these classes do not share a common primary mechanism of action, they do exhibit important similarities in their ability to occasion temporary but profound alterations of consciousness, involving acute changes in somatic, perceptual, cognitive, and affective processes. Such effects likely contribute to their recreational use. However, a growing body of evidence indicates that these drugs may have therapeutic applications beyond their potential for abuse. This review will present data on several classes of hallucinogens with a particular focus on psychedelics, entactogens, and dissociatives, for which clinical utility has been most extensively documented. Information on each class is presented in turn, tracing relevant historical insights, highlighting similarities and differences between the classes from the molecular to the behavioral level, and presenting the most up-to-date information on clinically oriented research with these substances, with important ramifications for their potential therapeutic value. PMID:27454674

Strategies for Preparing Albumin-based Nanoparticles for Multifunctional Bioimaging and Drug Delivery

PubMed Central

An, Fei-Fei; Zhang, Xiao-Hong

2017-01-01

Biosafety is the primary concern in clinical translation of nanomedicine. As an intrinsic ingredient of human blood without immunogenicity and encouraged by its successful clinical application in Abraxane, albumin has been regarded as a promising material to produce nanoparticles for bioimaging and drug delivery. The strategies for synthesizing albumin-based nanoparticles could be generally categorized into five classes: template, nanocarrier, scaffold, stabilizer and albumin-polymer conjugate. This review introduces approaches utilizing albumin in the preparation of nanoparticles and thereby provides scientists with knowledge of goal-driven design on albumin-based nanomedicine. PMID:29109768

Prevalence of primary outcome changes in clinical trials registered on ClinicalTrials.gov: a cross-sectional study.

PubMed

Ramagopalan, Sreeram; Skingsley, Andrew P; Handunnetthi, Lahiru; Klingel, Michelle; Magnus, Daniel; Pakpoor, Julia; Goldacre, Ben

2014-01-01

An important principle in the good conduct of clinical trials is that a summary of the trial protocol, with a pre-defined primary outcome, should be freely available before the study commences. The clinical trials registry ClinicalTrials.gov provides one method of doing this, and once the trial is registered, any changes made to the primary outcome are documented. The objectives of this study were: to assess the proportion of registered trials on ClinicalTrials.gov that had the primary outcome changed; to assess when the primary outcome was changed in relation to the listed study start and end dates and to assess whether the primary outcome change had any relation to the study sponsor. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 25 October 2012 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. Our analysis showed that 28229 of 89204 (31.7%) registered studies had their primary outcome changed.  Industry funding was associated with all primary outcome changes, odds ratio (OR)= 1.36, 95% confidence interval (CI)=1.31-1.41, p<0.001; with primary outcome changes after study start date OR=1.37, 95% CI=1.32-1.42, p<0.001; with primary outcome changes after primary completion date OR=1.84, 95% CI=1.75-1.94, p<0.001 and with primary outcome changes after study completion date OR=1.82, 95% CI=1.73-1.91, p<0.001.  Conclusions A significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. These changes are associated with funding source.

A transposon and transposase system for human application.

PubMed

Hackett, Perry B; Largaespada, David A; Cooper, Laurence J N

2010-04-01

The stable introduction of therapeutic transgenes into human cells can be accomplished using viral and nonviral approaches. Transduction with clinical-grade recombinant viruses offers the potential of efficient gene transfer into primary cells and has a record of therapeutic successes. However, widespread application for gene therapy using viruses can be limited by their initially high cost of manufacture at a limited number of production facilities as well as a propensity for nonrandom patterns of integration. The ex vivo application of transposon-mediated gene transfer now offers an alternative to the use of viral vectors. Clinical-grade DNA plasmids can be prepared at much reduced cost and with lower immunogenicity, and the integration efficiency can be improved by the transient coexpression of a hyperactive transposase. This has facilitated the design of human trials using the Sleeping Beauty (SB) transposon system to introduce a chimeric antigen receptor (CAR) to redirect the specificity of human T cells. This review examines the rationale and safety implications of application of the SB system to genetically modify T cells to be manufactured in compliance with current good manufacturing practice (cGMP) for phase I/II trials.

Magnetic fingerprints of rolling cells for quantitative flow cytometry in whole blood

NASA Astrophysics Data System (ADS)

Reisbeck, Mathias; Helou, Michael Johannes; Richter, Lukas; Kappes, Barbara; Friedrich, Oliver; Hayden, Oliver

2016-09-01

Over the past 50 years, flow cytometry has had a profound impact on preclinical and clinical applications requiring single cell function information for counting, sub-typing and quantification of epitope expression. At the same time, the workflow complexity and high costs of such optical systems still limit flow cytometry applications to specialized laboratories. Here, we present a quantitative magnetic flow cytometer that incorporates in situ magnetophoretic cell focusing for highly accurate and reproducible rolling of the cellular targets over giant magnetoresistance sensing elements. Time-of-flight analysis is used to unveil quantitative single cell information contained in its magnetic fingerprint. Furthermore, we used erythrocytes as a biological model to validate our methodology with respect to precise analysis of the hydrodynamic cell diameter, quantification of binding capacity of immunomagnetic labels, and discrimination of cell morphology. The extracted time-of-flight information should enable point-of-care quantitative flow cytometry in whole blood for clinical applications, such as immunology and primary hemostasis.

[Application of mini-septopal in surgery of the hand].

PubMed

Zimmer, K

1992-01-01

Successful application of the Septopal in treatment of osteomyelitis has created the demand for this form of drug available for implantation into the small operation field, e.c. in the hand. The Chair and Clinic for Traumatology of the Medical Academy in Wrocław has been chosen to cooperate in the clinical trial on application of the Septopal-minichains in surgery of hand. There were 76 patients treated with the Mini-Septopal implantation. In 18 cases the osteomyelitis or active bacterial soft tissue infection gave indications for this type of treatment. In 58 cases Mini-Septopal was implanted because of high risk of infection in contaminated wounds. In both groups bacteriological examinations have been performed and statistical study revealed successful results even in primary resistant for gentamicin bacteries. Very good results of treatment let us estimate very high the usefulness of Mini-Septopal in bone and soft-tissue infections treatment, if the proper surgical procedures are performed to clean the focus of infection.

Sentinel lymph node navigation surgery for early stage gastric cancer.

PubMed

Mitsumori, Norio; Nimura, Hiroshi; Takahashi, Naoto; Kawamura, Masahiko; Aoki, Hiroaki; Shida, Atsuo; Omura, Nobuo; Yanaga, Katsuhiko

2014-05-21

We attempted to evaluate the history of sentinel node navigation surgery (SNNS), technical aspects, tracers, and clinical applications of SNNS using Infrared Ray Electronic Endoscopes (IREE) combined with Indocyanine Green (ICG). The sentinel lymph node (SLN) is defined as a first lymph node (LN) which receives cancer cells from a primary tumor. Reports on clinical application of SNNS for gastric cancers started to appear since early 2000s. Two prospective multicenter trials of SNNS for gastric cancer have also been accomplished in Japan. Kitagawa et al reported that the endoscopic dual (dye and radioisotope) tracer method for SN biopsy was confirmed acceptable and effective when applied to the early-stage gastric cancer (EGC). We have previously reported the usefulness of SNNS in gastrointestinal cancer using ICG as a tracer, combined with IREE (Olympus Optical, Tokyo, Japan) to detect SLN. LN metastasis rate of EGC is low. Hence, clinical application of SNNS for EGC might lead us to avoid unnecessary LN dissection, which could preserve the patient's quality of life after operation. The most ideal method of SNNS should allow secure and accurate detection of SLN, and real time observation of lymphatic flow during operation.

Sentinel lymph node navigation surgery for early stage gastric cancer

PubMed Central

Mitsumori, Norio; Nimura, Hiroshi; Takahashi, Naoto; Kawamura, Masahiko; Aoki, Hiroaki; Shida, Atsuo; Omura, Nobuo; Yanaga, Katsuhiko

2014-01-01

We attempted to evaluate the history of sentinel node navigation surgery (SNNS), technical aspects, tracers, and clinical applications of SNNS using Infrared Ray Electronic Endoscopes (IREE) combined with Indocyanine Green (ICG). The sentinel lymph node (SLN) is defined as a first lymph node (LN) which receives cancer cells from a primary tumor. Reports on clinical application of SNNS for gastric cancers started to appear since early 2000s. Two prospective multicenter trials of SNNS for gastric cancer have also been accomplished in Japan. Kitagawa et al reported that the endoscopic dual (dye and radioisotope) tracer method for SN biopsy was confirmed acceptable and effective when applied to the early-stage gastric cancer (EGC). We have previously reported the usefulness of SNNS in gastrointestinal cancer using ICG as a tracer, combined with IREE (Olympus Optical, Tokyo, Japan) to detect SLN. LN metastasis rate of EGC is low. Hence, clinical application of SNNS for EGC might lead us to avoid unnecessary LN dissection, which could preserve the patient’s quality of life after operation. The most ideal method of SNNS should allow secure and accurate detection of SLN, and real time observation of lymphatic flow during operation. PMID:24914329

Appropriate Use Criteria for Echocardiography: Evolving Applications in the Era of Value-Based Healthcare

PubMed Central

Singh, Amita

2017-01-01

The current climate in healthcare is increasingly emphasizing a value-based approach to diagnostic testing. Cardiac imaging, including echocardiography, has been a primary target of ongoing reforms in healthcare delivery and reimbursement. The Appropriate Use Criteria (AUC) for echocardiography is a physician-derived tool intended to guide utilization in optimal patient care. To date, the AUC have primarily been employed solely as justification for reimbursement, though evolving broader applications to guide clinical decision-making suggest a far more valuable role in the delivery of high-quality and high-value healthcare. PMID:27553788

[Design and validation of an instrument to assess families at risk for health problems].

PubMed

Puschel, Klaus; Repetto, Paula; Solar, María Olga; Soto, Gabriela; González, Karla

2012-04-01

There is a paucity of screening instruments with a high clinical predictive value to identify families at risk and therefore, develop focused interventions in primary care. To develop an easy to apply screening instrument with a high clinical predictive value to identify families with a higher health vulnerability. In the first stage of the study an instrument with a high content validity was designed through a review of existent instruments, qualitative interviews with families and expert opinions following a Delphi approach of three rounds. In the second stage, concurrent validity was tested through a comparative analysis between the pilot instrument and a family clinical interview conducted to 300 families randomly selected from a population registered at a primary care clinic in Santiago. The sampling was blocked based on the presence of diabetes, depression, child asthma, behavioral disorders, presence of an older person or the lack of previous conditions among family members. The third stage, was directed to test the clinical predictive validity of the instrument by comparing the baseline vulnerability obtained by the instrument and the change in clinical status and health related quality of life perceptions of the family members after nine months of follow-up. The final SALUFAM instrument included 13 items and had a high internal consistency (Cronbach's alpha: 0.821), high test re-test reproducibility (Pearson correlation: 0.84) and a high clinical predictive value for clinical deterioration (Odds ratio: 1.826; 95% confidence intervals: 1.101-3.029). SALUFAM instrument is applicable, replicable, has a high content validity, concurrent validity and clinical predictive value.

Applications and safety considerations of Lactobacillus salivarius as a probiotic in animal and human health.

PubMed

Chaves, B D; Brashears, M M; Nightingale, K K

2017-03-03

The goals of this review are to summarize the current knowledge on the application of Lactobacillus salivarius as a probiotic in animals and humans, and to address safety concerns with its use on live hosts. Overall, several strains of L. salivarius are well established probiotics with multiple applications in animal health, particularly to reduce colonization by gastrointestinal pathogens, and to a lesser extent, as a production and quality aid. In humans, L. salivarius has been used to prevent and treat a variety of chronic diseases, including asthma, cancer, atopic dermatitis and halitosis, and to a much limited extent, to prevent or treat infections. Based on the results from primary research evidence, it seems that L. salivarius does not pose a health risk to animals or humans in the doses currently used for a variety of applications; however, there is a systematic lack of studies assuring the safety of many of the strains intended for clinical use. This review provides researchers in the field with up-to-date information regarding applications and safety of L. salivarius. Furthermore, it helps researchers identify knowledge gaps and potential opportunities for microbiological and clinical research. © 2017 The Society for Applied Microbiology.

CISUS: an integrated 3D ultrasound system for IGT using a modular tracking API

NASA Astrophysics Data System (ADS)

Boctor, Emad M.; Viswanathan, Anand; Pieper, Steve; Choti, Michael A.; Taylor, Russell H.; Kikinis, Ron; Fichtinger, Gabor

2004-05-01

Ultrasound has become popular in clinical/surgical applications, both as the primary image guidance modality and also in conjunction with other modalities like CT or MRI. Three dimensional ultrasound (3DUS) systems have also demonstrated usefulness in image-guided therapy (IGT). At the same time, however, current lack of open-source and open-architecture multi-modal medical visualization systems prevents 3DUS from fulfilling its potential. Several stand-alone 3DUS systems, like Stradx or In-Vivo exist today. Although these systems have been found to be useful in real clinical setting, it is difficult to augment their functionality and integrate them in versatile IGT systems. To address these limitations, a robotic/freehand 3DUS open environment (CISUS) is being integrated into the 3D Slicer, an open-source research tool developed for medical image analysis and surgical planning. In addition, the system capitalizes on generic application programming interfaces (APIs) for tracking devices and robotic control. The resulting platform-independent open-source system may serve as a valuable tool to the image guided surgery community. Other researchers could straightforwardly integrate the generic CISUS system along with other functionalities (i.e. dual view visualization, registration, real-time tracking, segmentation, etc) to rapidly create their medical/surgical applications. Our current driving clinical application is robotically assisted and freehand 3DUS-guided liver ablation, which is fully being integrated under the CISUS-3D Slicer. Initial functionality and pre-clinical feasibility are demonstrated on phantom and ex-vivo animal models.

Views of general practitioners on the use of STOPP&START in primary care: a qualitative study.

PubMed

Dalleur, O; Feron, J-M; Spinewine, A

2014-08-01

STOPP (Screening Tool of Older Person's Prescriptions) and START (Screening Tool to Alert Doctors to Right Treatment) criteria aim at detecting potentially inappropriate prescribing in older people. The objective was to explore general practitioners' (GPs) perceptions regarding the use of the STOPP&START tool in their practice. We conducted three focus groups which were conveniently sampled. Vignettes with clinical cases were provided for discussion as well as a full version of the STOPP&START tool. Knowledge, strengths and weaknesses of the tool and its implementation were discussed. Two researchers independently performed content analysis, classifying quotes and creating new categories for emerging themes. Discussions highlighted incentives (e.g. systematic procedure for medication review) and barriers (e.g. time-consuming application) influencing the use of STOPP&START in primary care. Usefulness, comprehensiveness, and relevance of the tool were also questioned. Another important category emerging from the content analysis was the projected use of the tool. The GPs imagined key elements for the implementation in daily practice: computerized clinical decision support system, education, and multidisciplinary collaborations, especially at care transitions and in nursing homes. Despite variables views on the usefulness, comprehensiveness, and relevance of STOPP&START, GPs suggest the implementation of this tool in primary care within computerized clinical decision support systems, through education, and used as part of multidisciplinary collaborations.

Clinic Services for Persons with AIDS

PubMed Central

Markson, Leona E; Turner, Barbara J; Cocroft, Jim; Houchens, Robert; Fanning, Thomas R

1997-01-01

OBJECTIVE To profile characteristics of clinics caring for persons with advanced HIV infection. DESIGN AND SETTING Survey of clinic directors in New York State. PARTICIPANTS Newly diagnosed Medicaid-enrolled AIDS patients in New York state in federal fiscal years 1987–1992 (n = 6,184) managed by 62 HIV specialty, 53 hospital-based general medicine/primary care, 36 community-based primary care, and 28 other clinics. MEASUREMENTS AND MAIN RESULTS Telephone survey about clinic hours, emphasis on HIV, staffing, procedures, and directors’ rating of care. Estimates of the number of newly diagnosed, Medicaid-enrolled AIDS patients treated in surveyed clinics were obtained from claims data. We found that community-based clinics were significantly more likely to have longer hours, a physician on call, or to accommodate unscheduled care than were hospital-based general medicine/primary care or other types of clinics. Compared with HIV specialty clinics, general medicine/primary care clinics were less likely to have HIV-specific care attributes such as a director of HIV care (98% vs 72%), multidisciplinary conferences on HIV care (83% vs 32%), or a standard initial HIV workup (90% vs 70%). Of general medicine/primary care clinics, most (83%) were staffed by residents and fellows compared with only 68% of HIV or 25% of community-based clinics (p < .001). General medicine/primary care clinics were less likely than community-based clinics to perform Pap smears (75% vs 94%) or to have case managers on payroll (21% vs 81%). CONCLUSIONS In this sample of clinics, hospital-based general medicine/primary care clinics managing the care of Medicaid enrollees with AIDS appeared to have more limited hours and availability of specific services than HIV specialty or community-based clinics.

Rural Doctors' Views on and Experiences with Evidence-Based Medicine: The FrEEDoM Qualitative Study.

PubMed

Hisham, Ranita; Liew, Su May; Ng, Chirk Jenn; Mohd Nor, Kamaliah; Osman, Iskandar Firzada; Ho, Gah Juan; Hamzah, Nurazira; Glasziou, Paul

2016-01-01

Evidence-based medicine is the integration of individual clinical expertise, best external evidence and patient values which was introduced more than two decades ago. Yet, primary care physicians in Malaysia face unique barriers in accessing scientific literature and applying it to their clinical practice. This study aimed to explore the views and experiences of rural doctors' about evidence-based medicine in their daily clinical practice in a rural primary care setting. Qualitative methodology was used. The interviews were conducted in June 2013 in two rural health clinics in Malaysia. The participants were recruited using purposive sampling. Four focus group discussions with 15 medical officers and three individual in-depth interviews with family medicine specialists were carried out. All interviews were conducted using a topic guide and were audio-recorded, transcribed verbatim, checked and analyzed using a thematic approach. Key themes identified were: (1) doctors viewed evidence-based medicine mainly as statistics, research and guidelines, (2) reactions to evidence-based medicine were largely negative, (3) doctors relied on specialists, peers, guidelines and non-evidence based internet sources for information, (4) information sources were accessed using novel methods such as mobile applications and (5) there are several barriers to evidence-based practice, including doctor-, evidence-based medicine-, patient- and system-related factors. These included inadequacies in knowledge, attitude, management support, time and access to evidence-based information sources. Participants recommended the use of online services to support evidence-based practice in the rural settings. The level of evidence-based practice is low in the rural setting due to poor awareness, knowledge, attitude and resources. Doctors use non-evidence based sources and access them through new methods such as messaging applications. Further research is recommended to develop and evaluate interventions to overcome the identified barriers.

Statistical controversies in clinical research: comparison of primary outcomes in protocols, public clinical-trial registries and publications: the example of oncology trials.

PubMed

Perlmutter, A S; Tran, V-T; Dechartres, A; Ravaud, P

2017-04-01

Protocols are often unavailable to peer-reviewers and readers. To detect outcome reporting bias (ORB), readers usually have to resort to publicly available descriptions of study design such as public clinical trial registries. We compared primary outcomes in protocols, ClinicalTrials.gov and publications of oncology trials and evaluated the use of ClinicalTrials.gov as compared with protocols in detecting discrepancies between planned and published outcomes. We searched for phase III oncology trials registered in ClinicalTrials.gov and published in the Journal of Clinical Oncology and New England Journal of Medicine between January 2014 and June 2015. We extracted primary outcomes reported in the protocol, ClinicalTrials.gov and the publication. First, we assessed the quality of primary outcome descriptions by using a published framework. Second, we evaluated modifications of primary outcomes between each source. Finally, we evaluated the agreement, specificity and sensitivity of detecting modifications between planned and published outcomes by using protocols or ClinicalTrials.gov. We included 65 trials, with 81 primary outcomes common among the 3 sources. The proportion of primary outcomes reporting all items from the framework was 73%, 22%, and 75% for protocols, ClinicalTrials.gov and publications, respectively. Eight (12%) trials presented a discrepancy between primary outcomes reported in the protocol and in the publication. Twelve (18.5%) trials presented a discrepancy between primary outcomes registered at ClinicalTrials.gov and in publications. We found a moderate agreement in detecting discrepant reporting of outcomes by using protocols or ClinicalTrials.gov [κ = 0.53, 95% confidence interval (0.25-0.81)]. Using ClinicalTrials.gov to detect discrepant reporting of outcomes showed high specificity (89.5%) but lacked sensitivity (75%) as compared with use of protocols. In oncology trials, primary outcome descriptions in ClinicalTrials.gov are often of low quality and may not reflect what is in the protocol, thus limiting the detection of modifications between planned and published outcomes. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Monte Carlo modeling of light propagation in the human head for applications in sinus imaging

PubMed Central

Cerussi, Albert E.; Mishra, Nikhil; You, Joon; Bhandarkar, Naveen; Wong, Brian

2015-01-01

Abstract. Sinus blockages are a common reason for physician visits, affecting one out of seven people in the United States, and often require medical treatment. Diagnosis in the primary care setting is challenging because symptom criteria (via detailed clinical history) plus objective imaging [computed tomography (CT) or endoscopy] are recommended. Unfortunately, neither option is routinely available in primary care. We previously demonstrated that low-cost near-infrared (NIR) transillumination correlates with the bulk findings of sinus opacity measured by CT. We have upgraded the technology, but questions of source optimization, anatomical influence, and detection limits remain. In order to begin addressing these questions, we have modeled NIR light propagation inside a three-dimensional adult human head constructed via CT images using a mesh-based Monte Carlo algorithm (MMCLAB). In this application, the sinus itself, which when healthy is a void region (e.g., nonscattering), is the region of interest. We characterize the changes in detected intensity due to clear (i.e., healthy) versus blocked sinuses and the effect of illumination patterns. We ran simulations for two clinical cases and compared simulations with measurements. The simulations presented herein serve as a proof of concept that this approach could be used to understand contrast mechanisms and limitations of NIR sinus imaging. PMID:25781310

Monte Carlo modeling of light propagation in the human head for applications in sinus imaging

NASA Astrophysics Data System (ADS)

Cerussi, Albert E.; Mishra, Nikhil; You, Joon; Bhandarkar, Naveen; Wong, Brian

2015-03-01

Sinus blockages are a common reason for physician visits, affecting one out of seven people in the United States, and often require medical treatment. Diagnosis in the primary care setting is challenging because symptom criteria (via detailed clinical history) plus objective imaging [computed tomography (CT) or endoscopy] are recommended. Unfortunately, neither option is routinely available in primary care. We previously demonstrated that low-cost near-infrared (NIR) transillumination correlates with the bulk findings of sinus opacity measured by CT. We have upgraded the technology, but questions of source optimization, anatomical influence, and detection limits remain. In order to begin addressing these questions, we have modeled NIR light propagation inside a three-dimensional adult human head constructed via CT images using a mesh-based Monte Carlo algorithm (MMCLAB). In this application, the sinus itself, which when healthy is a void region (e.g., nonscattering), is the region of interest. We characterize the changes in detected intensity due to clear (i.e., healthy) versus blocked sinuses and the effect of illumination patterns. We ran simulations for two clinical cases and compared simulations with measurements. The simulations presented herein serve as a proof of concept that this approach could be used to understand contrast mechanisms and limitations of NIR sinus imaging.

The effect of self-administered superficial local hot and cold application methods on pain, functional status and quality of life in primary knee osteoarthritis patients.

PubMed

Aciksoz, Semra; Akyuz, Aygul; Tunay, Servet

2017-12-01

To investigate the effect of the self-administered superficial local hot and cold applications on pain, and the functional status and the quality of life in primary knee osteoarthritis patients. Superficial local hot and cold application is used as a nonpharmacological method for the treatment of knee osteoarthritis. However, various guidelines for the management of knee osteoarthritis have conflicting recommendation for hot and cold therapy. A randomised clinical trial design. The sample consisted of patients (n = 96) who were diagnosed with primary knee osteoarthritis. During the application stage, patients were designated to the hot and cold application groups and administered hot and cold application twice a day for 3 weeks together with standard osteoarthritis treatment. The control group only used standard osteoarthritis treatment. The data were collected with a Descriptive Information Form, a Pain Scale, the WOMAC Osteoarthritis Index, the Nottingham Health Profile (NHP) and a Patient Satisfaction Evaluation Form. Outcome measures included pain intensity, functional status and quality of life. We found decreased primary measurement pain scores and improved functional status scores and quality of life scores after the application programme compared to the pre-application stage in both the hot and cold application groups. Once the application was completed, the pain scores, functional status scores and quality-of-life scores on the second measurements were found to be still statistically lower than the pre-application scores but higher than the first measurement ([p < .001, χ 2  = 48.000; p < .001, χ 2  = 34.000], [p < .001, χ 2  = 22.000; p = .001 χ 2 =14.000] and [p = .005, χ 2  = 16.000; p = .001, χ 2  = 12.500]). There was no difference in the perceived pain, functional status and quality of life between the pre-application, postapplication and 2 weeks postapplication periods of the individuals in three groups (p > .05). It was found that both hot and cold application resulted in a mild improvement in pain, functional status and quality of life, but this improvement was not sufficient to create a significant difference between the groups. This study contributes to the literature on hot and cold application methods as self-management strategies for patients with knee osteoarthritis. © 2017 John Wiley & Sons Ltd.

A historical overview of magnetic resonance imaging, focusing on technological innovations.

PubMed

Ai, Tao; Morelli, John N; Hu, Xuemei; Hao, Dapeng; Goerner, Frank L; Ager, Bryan; Runge, Val M

2012-12-01

Magnetic resonance imaging (MRI) has now been used clinically for more than 30 years. Today, MRI serves as the primary diagnostic modality for many clinical problems. In this article, historical developments in the field of MRI will be discussed with a focus on technological innovations. Topics include the initial discoveries in nuclear magnetic resonance that allowed for the advent of MRI as well as the development of whole-body, high field strength, and open MRI systems. Dedicated imaging coils, basic pulse sequences, contrast-enhanced, and functional imaging techniques will also be discussed in a historical context. This article describes important technological innovations in the field of MRI, together with their clinical applicability today, providing critical insights into future developments.

A review of evidence of health benefit from artificial neural networks in medical intervention.

PubMed

Lisboa, P J G

2002-01-01

The purpose of this review is to assess the evidence of healthcare benefits involving the application of artificial neural networks to the clinical functions of diagnosis, prognosis and survival analysis, in the medical domains of oncology, critical care and cardiovascular medicine. The primary source of publications is PUBMED listings under Randomised Controlled Trials and Clinical Trials. The rĵle of neural networks is introduced within the context of advances in medical decision support arising from parallel developments in statistics and artificial intelligence. This is followed by a survey of published Randomised Controlled Trials and Clinical Trials, leading to recommendations for good practice in the design and evaluation of neural networks for use in medical intervention.

Mental Imagery: Functional Mechanisms and Clinical Applications

PubMed Central

Pearson, Joel; Naselaris, Thomas; Holmes, Emily A.; Kosslyn, Stephen M.

2015-01-01

Mental imagery research has weathered both disbelief of the phenomenon and inherent methodological limitations. Here we review recent behavioral, brain imaging, and clinical research that has reshaped our understanding of mental imagery. Research supports the claim that visual mental imagery is a depictive internal representation that functions like a weak form of perception. Brain imaging work has demonstrated that neural representations of mental and perceptual images resemble one another as early as the primary visual cortex (V1). Activity patterns in V1 encode mental images and perceptual images via a common set of low-level depictive visual features. Recent translational and clinical research reveals the pivotal role that imagery plays in many mental disorders and suggests how clinicians can utilize imagery in treatment. PMID:26412097

Marine-derived angiogenesis inhibitors for cancer therapy.

PubMed

Wang, Ying-Qing; Miao, Ze-Hong

2013-03-15

Angiogenesis inhibitors have been successfully used for cancer therapy in the clinic. Many marine-derived natural products and their analogues have been reported to show antiangiogenic activities. Compared with the drugs in the clinic, these agents display interesting characteristics, including diverse sources, unique chemical structures, special modes of action, and distinct activity and toxicity profiles. This review will first provide an overview of the current marine-derived angiogenesis inhibitors based on their primary targets and/or mechanisms of action. Then, the marine-derived antiangiogenic protein kinase inhibitors will be focused on. And finally, the clinical trials of the marine-derived antiangiogenic agents will be discussed, with special emphasis on their application potentials, problems and possible coping strategies in their future development as anticancer drugs.

Provider perceptions of an integrated primary care quality improvement strategy: The PPAQ toolkit.

PubMed

Beehler, Gregory P; Lilienthal, Kaitlin R

2017-02-01

The Primary Care Behavioral Health (PCBH) model of integrated primary care is challenging to implement with high fidelity. The Primary Care Behavioral Health Provider Adherence Questionnaire (PPAQ) was designed to assess provider adherence to essential model components and has recently been adapted into a quality improvement toolkit. The aim of this pilot project was to gather preliminary feedback on providers' perceptions of the acceptability and utility of the PPAQ toolkit for making beneficial practice changes. Twelve mental health providers working in Department of Veterans Affairs integrated primary care clinics participated in semistructured interviews to gather quantitative and qualitative data. Descriptive statistics and qualitative content analysis were used to analyze data. Providers identified several positive features of the PPAQ toolkit organization and structure that resulted in high ratings of acceptability, while also identifying several toolkit components in need of modification to improve usability. Toolkit content was considered highly representative of the (PCBH) model and therefore could be used as a diagnostic self-assessment of model adherence. The toolkit was considered to be high in applicability to providers regardless of their degree of prior professional preparation or current clinical setting. Additionally, providers identified several system-level contextual factors that could impact the usefulness of the toolkit. These findings suggest that frontline mental health providers working in (PCBH) settings may be receptive to using an adherence-focused toolkit for ongoing quality improvement. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Assessing Impacts on Unplanned Hospitalisations of Care Quality and Access Using a Structural Equation Method: With a Case Study of Diabetes

PubMed Central

Congdon, Peter

2016-01-01

Background: Enhanced quality of care and improved access are central to effective primary care management of long term conditions. However, research evidence is inconclusive in establishing a link between quality of primary care, or access, and adverse outcomes, such as unplanned hospitalisation. Methods: This paper proposes a structural equation model for quality and access as latent variables affecting adverse outcomes, such as unplanned hospitalisations. In a case study application, quality of care (QOC) is defined in relation to diabetes, and the aim is to assess impacts of care quality and access on unplanned hospital admissions for diabetes, while allowing also for socio-economic deprivation, diabetes morbidity, and supply effects. The study involves 90 general practitioner (GP) practices in two London Clinical Commissioning Groups, using clinical quality of care indicators, and patient survey data on perceived access. Results: As a single predictor, quality of care has a significant negative impact on emergency admissions, and this significant effect remains when socio-economic deprivation and morbidity are allowed. In a full structural equation model including access, the probability that QOC negatively impacts on unplanned admissions exceeds 0.9. Furthermore, poor access is linked to deprivation, diminished QOC, and larger list sizes. Conclusions: Using a Bayesian inference methodology, the evidence from the analysis is weighted towards negative impacts of higher primary care quality and improved access on unplanned admissions. The methodology of the paper is potentially applicable to other long term conditions, and relevant when care quality and access cannot be measured directly and are better regarded as latent variables. PMID:27598184

Assessing Impacts on Unplanned Hospitalisations of Care Quality and Access Using a Structural Equation Method: With a Case Study of Diabetes.

PubMed

Congdon, Peter

2016-09-01

Enhanced quality of care and improved access are central to effective primary care management of long term conditions. However, research evidence is inconclusive in establishing a link between quality of primary care, or access, and adverse outcomes, such as unplanned hospitalisation. This paper proposes a structural equation model for quality and access as latent variables affecting adverse outcomes, such as unplanned hospitalisations. In a case study application, quality of care (QOC) is defined in relation to diabetes, and the aim is to assess impacts of care quality and access on unplanned hospital admissions for diabetes, while allowing also for socio-economic deprivation, diabetes morbidity, and supply effects. The study involves 90 general practitioner (GP) practices in two London Clinical Commissioning Groups, using clinical quality of care indicators, and patient survey data on perceived access. As a single predictor, quality of care has a significant negative impact on emergency admissions, and this significant effect remains when socio-economic deprivation and morbidity are allowed. In a full structural equation model including access, the probability that QOC negatively impacts on unplanned admissions exceeds 0.9. Furthermore, poor access is linked to deprivation, diminished QOC, and larger list sizes. Using a Bayesian inference methodology, the evidence from the analysis is weighted towards negative impacts of higher primary care quality and improved access on unplanned admissions. The methodology of the paper is potentially applicable to other long term conditions, and relevant when care quality and access cannot be measured directly and are better regarded as latent variables.

Knowledge flow and exchange in interdisciplinary primary health care teams (PHCTs): an exploratory study

PubMed Central

Sibbald, Shannon L.; Wathen, C. Nadine; Kothari, Anita; Day, Adam M. B.

2013-01-01

Objective: Improving the process of evidence-based practice in primary health care requires an understanding of information exchange among colleagues. This study explored how clinically oriented research knowledge flows through multidisciplinary primary health care teams (PHCTs) and influences clinical decisions. Methods: This was an exploratory mixed-methods study with members of six PHCTs in Ontario, Canada. Quantitative data were collected using a questionnaire and analyzed with social network analysis (SNA) using UCINet. Qualitative data were collected using semi-structured interviews and analyzed with content analysis procedures using NVivo8. Results: It was found that obtaining research knowledge was perceived to be a shared responsibility among team members, whereas its application in patient care was seen as the responsibility of the team leader, usually the senior physician. PHCT members acknowledged the need for resources for information access, synthesis, interpretation, or management. Conclusion: Information sharing in interdisciplinary teams is a complex and multifaceted process. Specific interventions need to be improved such as formalizing modes of communication, better organizing knowledge-sharing activities, and improving the active use of allied health professionals. Despite movement toward team-based models, senior physicians are often gatekeepers of uptake of new evidence and changes in practice. PMID:23646028

Social, ethical and legal barriers to e-health.

PubMed

Anderson, James G

2007-01-01

Information technology such as electronic medical records (EMRs), electronic prescribing and decision support systems are recognized as essential tools in Europe, the U.S., Canada, Australia, and New Zealand. But significant barriers impede wide-scale adoption of these tools, especially EMR systems. The objectives of this study were to investigate the present status of information technology in health care, the perceived benefits and barriers by primary care physicians. Literature analysis and survey data from primary care physicians on adoption of information technology are reviewed. The U.S. trails European countries as well as Canada, Australia and New Zealand in the use of information technology in primary care. The results of the study indicate that physicians in general perceive benefits to information technology, but also cite major barriers to its implementation in their practices. These barriers include lack of access to capital by health care providers, complex systems and lack of data standards that permit exchange of clinical data, privacy concerns and legal barriers. Overcoming these barriers will require subsidies and performance incentives by payers and government; certification and standardization of vendor applications that permit clinical data exchange; removal of legal barriers; and greater security of medical data to convince practitioners and patients of the value of EMRs.

The Child Health Care System of Serbia.

PubMed

Bogdanović, Radovan; Lozanović, Dragana; Pejović Milovančević, Milica; Sokal Jovanović, Ljiljana

2016-10-01

The health care system in Serbia is based on a network of public health institutions funded by the National Health Insurance and from the state budget. Access to public health institutions is free. Preventive and curative services are provided at the local level in primary health care centers. Over the past 5-7 years, the number of pediatricians in primary health care centers decreased because of reduced number of applicants for pediatric training, which endangers the maintenance of the traditional model of pediatric care. Secondary medical care is offered in pediatric departments of local and regional general hospitals or outpatient clinics, and in specialized hospitals for children or adults. Tertiary medical care is provided by inpatient or outpatient subspecialty services in 5 major university children's clinics. The health reforms undertaken in the recent 10 years have aimed at strengthening preventive health care and reducing the overall costs for pediatric care. Current initiatives of the Ministry of Health and national pediatric associations are aimed at reestablishing and strengthening the capacity of the primary pediatric health care model by increasing the number of physicians and developing new processes of care. Copyright © 2016 Elsevier Inc. All rights reserved.

Maximizing the clinical utility of antimüllerian hormone testing in women's health

PubMed Central

Leader, Benjamin; Baker, Valerie L.

2014-01-01

Purpose of review To provide an update on the latest clinical applications of serum antimüllerian hormone (AMH) testing with practical approaches to mitigate the impact of significant variability in AMH results. Recent findings Recent studies continue to demonstrate that AMH is the best single serum test for ovarian response management with, at most, a weak-to-moderate age-independent association with live-birth rate and time to conception. Data confirm serum AMH levels improve menopause prediction, monitoring of ovarian damage, and identification of women at risk for several ovary-related disorders such as polycystic ovary syndrome and premature or primary ovarian insufficiency. However, it is now recognized that serum AMH results can have dramatic variability due to common, biologic fluctuations within some individuals, use of hormonal contraceptives or other medications, certain surgical procedures, specimen treatment, assay changes, and laboratory calibration differences. Practical guidelines are provided to minimize the impact of variability in AMH results and maximize the accuracy of clinical decision-making. Summary AMH is an ovarian biomarker of central importance which improves the clinical management of women's health. However, with the simultaneous rapid expansion of AMH clinical applications and recognition of variability in AMH results, consensus regarding the clinical cutpoints is increasingly difficult. Therefore, a careful approach to AMH measurement and interpretation in clinical care is essential. PMID:24978853

Impact of Eating Attitude and Impairment of Physical Quality of Life Between Tertiary Clinic and Primary Clinic Functional Dyspepsia Outpatients in Japan

PubMed Central

Shimpuku, Mayumi; Futagami, Seiji; Tajima, Natsuki; Yamawaki, Hiroshi; Maruki, Yuuta; Kodaka, Yasuhiro; Nagoya, Hiroyuki; Gudis, Katya; Kawagoe, Tetsuro; Sakamoto, Choitsu

2014-01-01

Background/Aims There is no available data on factors associated with healthcare-seeking behavior for functional dyspepsia (FD) symptoms at either tertiary or primary clinics in Japan. Therefore, we aimed to compare clinical symptoms and life styles such as sleep disorders and eating attitude in FD patients visiting general practitioners at primary clinics with those consulting gastroenterologists at tertiary clinics to clarify healthcare-seeking patterns in Japanese patients. Methods Fifty-one FD outpatients in a tertiary clinic (college hospital), 50 FD outpatients visiting primary clinics and 50 healthy volunteers were enrolled. Clinical symptoms, quality of life, sleep disorders, eating attitude and anxiety were estimated using the Gastrointestinal Symptom Rating Scale (GSRS), Social Functioning-8 (SF-8) test, Pittsburg Sleep Quality Index (PSQI) test and State-Trait Anxiety Inventory (STAI) for FD outpatients and healthy volunteers. Results FD outpatients exhibited higher mean scores of GSRS than healthy volunteers. The SF-8 physical component summary scores in the tertiary clinic group were significantly lower than those in the primary clinic group. GSRS scores were significantly (P < 0.001, P = 0.002) associated with global PSQI scores in FD outpatients as well as with STAI-trait scores (P = 0.006, P = 0.001) compared to healthy volunteers. The frequency of eating between meals in the primary clinic group was significantly (P < 0.05) higher than that in the tertiary clinic group. Conclusions It may be important for clarification of healthcare-seeking behavior to determine the difference in both impairment of physical quality of life and eating attitudes between tertiary clinic and primary clinic FD outpatients in Japan. PMID:25273121

Some controversial multiple testing problems in regulatory applications.

PubMed

Hung, H M James; Wang, Sue-Jane

2009-01-01

Multiple testing problems in regulatory applications are often more challenging than the problems of handling a set of mathematical symbols representing multiple null hypotheses under testing. In the union-intersection setting, it is important to define a family of null hypotheses relevant to the clinical questions at issue. The distinction between primary endpoint and secondary endpoint needs to be considered properly in different clinical applications. Without proper consideration, the widely used sequential gate keeping strategies often impose too many logical restrictions to make sense, particularly to deal with the problem of testing multiple doses and multiple endpoints, the problem of testing a composite endpoint and its component endpoints, and the problem of testing superiority and noninferiority in the presence of multiple endpoints. Partitioning the null hypotheses involved in closed testing into clinical relevant orderings or sets can be a viable alternative to resolving the illogical problems requiring more attention from clinical trialists in defining the clinical hypotheses or clinical question(s) at the design stage. In the intersection-union setting there is little room for alleviating the stringency of the requirement that each endpoint must meet the same intended alpha level, unless the parameter space under the null hypothesis can be substantially restricted. Such restriction often requires insurmountable justification and usually cannot be supported by the internal data. Thus, a possible remedial approach to alleviate the possible conservatism as a result of this requirement is a group-sequential design strategy that starts with a conservative sample size planning and then utilizes an alpha spending function to possibly reach the conclusion early.

A Case Series of the Probability Density and Cumulative Distribution of Laryngeal Disease in a Tertiary Care Voice Center.

PubMed

de la Fuente, Jaime; Garrett, C Gaelyn; Ossoff, Robert; Vinson, Kim; Francis, David O; Gelbard, Alexander

2017-11-01

To examine the distribution of clinic and operative pathology in a tertiary care laryngology practice. Probability density and cumulative distribution analyses (Pareto analysis) was used to rank order laryngeal conditions seen in an outpatient tertiary care laryngology practice and those requiring surgical intervention during a 3-year period. Among 3783 new clinic consultations and 1380 operative procedures, voice disorders were the most common primary diagnostic category seen in clinic (n = 3223), followed by airway (n = 374) and swallowing (n = 186) disorders. Within the voice strata, the most common primary ICD-9 code used was dysphonia (41%), followed by unilateral vocal fold paralysis (UVFP) (9%) and cough (7%). Among new voice patients, 45% were found to have a structural abnormality. The most common surgical indications were laryngotracheal stenosis (37%), followed by recurrent respiratory papillomatosis (18%) and UVFP (17%). Nearly 55% of patients presenting to a tertiary referral laryngology practice did not have an identifiable structural abnormality in the larynx on direct or indirect examination. The distribution of ICD-9 codes requiring surgical intervention was disparate from that seen in clinic. Application of the Pareto principle may improve resource allocation in laryngology, but these initial results require confirmation across multiple institutions.

Plasticity and stability of visual field maps in adult primary visual cortex

PubMed Central

Wandell, Brian A.; Smirnakis, Stelios M.

2010-01-01

Preface It is important to understand the balance between cortical plasticity and stability in various systems and spatial scales in the adult brain. We review measurements of adult plasticity in primary visual cortex (V1), a structure that has a key role in distributing visual information. There are claims of plasticity at multiple spatial scales in adult V1, but many inconsistencies in the data raise questions about the extent and nature of such plasticity. Understanding is further limited by a lack of quantitative models to guide the interpretation of the data. These problems limit efforts to translate research findings about adult cortical plasticity into significant clinical, educational and policy applications. PMID:19904279

Rapid and accurate reversed-phase high-performance liquid chromatographic determination of conjugated bile acids in human bile for routine clinical applications. Therapeutic control during gallstone dissolution therapy.

PubMed

Swobodnik, W; Klüppelberg, U; Wechsler, J G; Volz, M; Normandin, G; Ditschuneit, H

1985-05-03

This paper introduces a new method to detect the taurine and glycine conjugates of five different bile acids (cholic acid, deoxycholic acid, chenodeoxycholic acid, ursodeoxycholic acid and lithocholic acid) in human bile. Advantages of this method are sufficient separation of compounds within a short period of time and a high rate of reproducibility. Using a mobile phase gradient of acetonitrile and water, modified with tetrabutylammonium hydrogen sulphate (0.0075 mol/l), we were able to maximize the differentiation between ursodeoxycholic acid and lithocholic acid, which is of primary interest during conservative gallstone dissolution therapy. Use of this gradient reduced analysis time to less than 0.5 h. Recovery rates for this modified method ranged from 94% to 100%, and reproducibility was 98%, sufficient for routine clinical applications.

The clinical application of anterolateral thigh flap.

PubMed

Lee, Yao-Chou; Chiu, Haw-Yen; Shieh, Shyh-Jou

2011-01-01

The anterolateral thigh flap can provide a large skin paddle nourished by a long and large-caliber pedicle and can be harvested by two-team work. Most importantly, the donor-site morbidity is minimal. However, the anatomic variations decreased its popularity. By adapting free-style flap concepts, such as preoperative mapping of the perforators and being familiar with retrograde perforator dissection, this disadvantage had been overcome gradually. Furthermore, several modifications widen its clinical applications: the fascia lata can be included for sling or tendon reconstruction, the bulkiness could be created by including vastus lateralis muscle or deepithelization of skin flap, the pliability could be increased by suprafascial dissection or primary thinning, the pedicle length could be lengthening by proximally eccentric placement of the perforator, and so forth. Combined with these technical and conceptual advancements, the anterolateral thigh flap has become the workhorse flap for soft-tissue reconstructions from head to toe.

The Clinical Application of Anterolateral Thigh Flap

PubMed Central

Lee, Yao-Chou; Chiu, Haw-Yen; Shieh, Shyh-Jou

2011-01-01

The anterolateral thigh flap can provide a large skin paddle nourished by a long and large-caliber pedicle and can be harvested by two-team work. Most importantly, the donor-site morbidity is minimal. However, the anatomic variations decreased its popularity. By adapting free-style flap concepts, such as preoperative mapping of the perforators and being familiar with retrograde perforator dissection, this disadvantage had been overcome gradually. Furthermore, several modifications widen its clinical applications: the fascia lata can be included for sling or tendon reconstruction, the bulkiness could be created by including vastus lateralis muscle or deepithelization of skin flap, the pliability could be increased by suprafascial dissection or primary thinning, the pedicle length could be lengthening by proximally eccentric placement of the perforator, and so forth. Combined with these technical and conceptual advancements, the anterolateral thigh flap has become the workhorse flap for soft-tissue reconstructions from head to toe. PMID:22567234

PACAP receptor pharmacology and agonist bias: analysis in primary neurons and glia from the trigeminal ganglia and transfected cells

PubMed Central

Walker, C S; Sundrum, T; Hay, D L

2014-01-01

Background and Purpose A major challenge in the development of new medicines targeting GPCRs is the ability to quantify drug action in physiologically relevant models. Primary cell models that closely resemble the clinically relevant in vivo site of drug action are important translational tools in drug development. However, pharmacological studies in these models are generally very limited due to the methodology used. Experimental Approach We used a neuropeptide system to demonstrate the applicability of using highly sensitive signalling assays in primary cells. We quantified the action of pituitary adenylate cyclase-activating peptide (PACAP)-38, PACAP-27 and vasoactive intestinal polypeptide in primary cultures of neurons and glia derived from rat trigeminal ganglia (TG), comparing our observations to transfected cells. Key Results PACAP-responsive receptors in rat trigeminal neurons, glia and transfected PAC1n receptors were pharmacologically distinct. PACAP-38, but not PACAP-27, activated ERK in glia, while both forms stimulated cellular cAMP production. PACAP(6–38) also displayed cell-type-dependent, agonist-specific, antagonism. Conclusions and Implications The complexity of PACAP pharmacology in the TG may help to direct, more effectively, the development of disease treatments targeting the PACAP receptor. We suggest that these methodologies are broadly applicable to other primary cell types of human or animal origin, and that our approach may allow more thorough characterization of ligand properties in physiologically relevant cell types. PMID:24303997

Internalized homophobia in men: wanting in the first person singular, hating in the first person plural.

PubMed

Moss, Donald

2002-01-01

This paper focuses on the expression of internalized homophobia in men, arguing that the most powerful clinical use of this term depends upon its applicability to any man, without limitation to those whose primary object choice is homosexual. A number of dynamic situations are described to which the term might apply, elaborated by examples from contemporary culture and clinical practice. A central dynamic elucidated here is the move from an anxiety-ridden, first person singular voice to the promised safety of a first person plural voice--that is, from the dangerous position of "I want" to the more protected "we hate."

Application of special diagnostic techniques in the management of nodular goitre.

PubMed Central

Walfish, P. G.; Miskin, M.; Rosen, I. B.; Strawbridge, H. T.

1976-01-01

The primary challenge in the management of nodular goitre is to establish which thyroid nodules are malignant. Since selection of patients for operation on the basis of palpation of nodules alone gives a low yield of malignant disease, physicians have sought criteria for selection that combine the information obtained from special laboratory procedures with thoughtful clinical appraisal. Such special procedures, which include radioisotope scintiscanning, echography by B-mode ultrasonography, and either large- or fine-needle aspiration and cytologic examination of the aspirate, are considered valuable in a proposed clinical approach to the management of thyroid nodules. Images FIG. 1 FIG. 2 FIG. 3 PMID:1277058

The chemistry of PET imaging with zirconium-89.

PubMed

Dilworth, Jonathan R; Pascu, Sofia I

2018-04-23

This Tutorial Review aims to provide an overview of the use of zirconium-89 complexes in biomedical imaging. Over the past decade there have been many new papers in this field, ranging from chemistry through to preclinical and clinical applications. Here we attempt to summarise the main developments that have occurred in this period. The primary focus is on coordination chemistry but other aspects such as isotope production, isotope properties, handling and radiochemical techniques and characterisation of cold and labelled complexes are included. Selected results from animal and human clinical studies are presented in the context of the stabilities and properties of the labelled bioconjugates.

Enter the reverend: introduction to and application of Bayes' theorem in clinical ophthalmology.

PubMed

Thomas, Ravi; Mengersen, Kerrie; Parikh, Rajul S; Walland, Mark J; Muliyil, Jayprakash

2011-12-01

Ophthalmic practice utilizes numerous diagnostic tests, some of which are used to screen for disease. Interpretation of test results and many clinical management issues are actually problems in inverse probability that can be solved using Bayes' theorem. Use two-by-two tables to understand Bayes' theorem and apply it to clinical examples. Specific examples of the utility of Bayes' theorem in diagnosis and management. Two-by-two tables are used to introduce concepts and understand the theorem. The application in interpretation of diagnostic tests is explained. Clinical examples demonstrate its potential use in making management decisions. Positive predictive value and conditional probability. The theorem demonstrates the futility of testing when prior probability of disease is low. Application to untreated ocular hypertension demonstrates that the estimate of glaucomatous optic neuropathy is similar to that obtained from the Ocular Hypertension Treatment Study. Similar calculations are used to predict the risk of acute angle closure in a primary angle closure suspect, the risk of pupillary block in a diabetic undergoing cataract surgery, and the probability that an observed decrease in intraocular pressure is due to the medication that has been started. The examples demonstrate how data required for management can at times be easily obtained from available information. Knowledge of Bayes' theorem helps in interpreting test results and supports the clinical teaching that testing for conditions with a low prevalence has a poor predictive value. In some clinical situations Bayes' theorem can be used to calculate vital data required for patient management. © 2011 The Authors. Clinical and Experimental Ophthalmology © 2011 Royal Australian and New Zealand College of Ophthalmologists.

A scoping review of the potential for chart stimulated recall as a clinical research method.

PubMed

Sinnott, Carol; Kelly, Martina A; Bradley, Colin P

2017-08-22

Chart-stimulated recall (CSR) is a case-based interviewing technique, which is used in the assessment of clinical decision-making in medical education and professional certification. Increasingly, clinical decision-making is a concern for clinical research in primary care. In this study, we review the prior application and utility of CSR as a technique for research interviews in primary care. Following Arksey & O'Malley's method for scoping reviews, we searched seven databases, grey literature, reference lists, and contacted experts in the field. We excluded studies on medical education or competence assessment. Retrieved citations were screened by one reviewer and full texts were ordered for all potentially relevant abstracts. Two researchers independently reviewed full texts and performed data extraction and quality appraisal if inclusion criteria were met. Data were collated and summarised using a published framework on the reporting of qualitative interview techniques, which was chosen a priori. The preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines informed the review report. From an initial list of 789 citations, eight studies using CSR in research interviews were included in the review: six from North America, one from the Netherlands, and one from Ireland. The most common purpose of included studies was to examine the influence of guidelines on physicians' decisions. The number of interviewees ranged from seven to twenty nine, while the number of charts discussed per interview ranged from one to twelve. CSR gave insights into physicians' reasoning for actions taken or not taken; the unrecorded social and clinical influences on decisions; and discrepancies between physicians' real and perceived practice. Ethical concerns and the training and influence of the researcher were poorly discussed in most of the studies. Potential pitfalls included the risk of recall, selection and observation biases. Despite the proven validity, reliability and acceptability of CSR in assessment interviews in medical education, its use in clinical research is limited. Application of CSR in qualitative research brings interview data closer to the reality of practice. Although further development of the approach is required, we recommend a role for CSR in research interviews on decision-making in clinical practice.

Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: methods of a decision-maker-researcher partnership systematic review.

PubMed

Haynes, R Brian; Wilczynski, Nancy L

2010-02-05

Computerized clinical decision support systems are information technology-based systems designed to improve clinical decision-making. As with any healthcare intervention with claims to improve process of care or patient outcomes, decision support systems should be rigorously evaluated before widespread dissemination into clinical practice. Engaging healthcare providers and managers in the review process may facilitate knowledge translation and uptake. The objective of this research was to form a partnership of healthcare providers, managers, and researchers to review randomized controlled trials assessing the effects of computerized decision support for six clinical application areas: primary preventive care, therapeutic drug monitoring and dosing, drug prescribing, chronic disease management, diagnostic test ordering and interpretation, and acute care management; and to identify study characteristics that predict benefit. The review was undertaken by the Health Information Research Unit, McMaster University, in partnership with Hamilton Health Sciences, the Hamilton, Niagara, Haldimand, and Brant Local Health Integration Network, and pertinent healthcare service teams. Following agreement on information needs and interests with decision-makers, our earlier systematic review was updated by searching Medline, EMBASE, EBM Review databases, and Inspec, and reviewing reference lists through 6 January 2010. Data extraction items were expanded according to input from decision-makers. Authors of primary studies were contacted to confirm data and to provide additional information. Eligible trials were organized according to clinical area of application. We included randomized controlled trials that evaluated the effect on practitioner performance or patient outcomes of patient care provided with a computerized clinical decision support system compared with patient care without such a system. Data will be summarized using descriptive summary measures, including proportions for categorical variables and means for continuous variables. Univariable and multivariable logistic regression models will be used to investigate associations between outcomes of interest and study specific covariates. When reporting results from individual studies, we will cite the measures of association and p-values reported in the studies. If appropriate for groups of studies with similar features, we will conduct meta-analyses. A decision-maker-researcher partnership provides a model for systematic reviews that may foster knowledge translation and uptake.

Human keratinocytes are efficiently immortalized by a Rho kinase inhibitor

PubMed Central

Chapman, Sandra; Liu, Xuefeng; Meyers, Craig; Schlegel, Richard; McBride, Alison A.

2010-01-01

Primary human keratinocytes are useful for studying the pathogenesis of many different diseases of the cutaneous and mucosal epithelia. In addition, they can form organotypic tissue equivalents in culture that can be used as epidermal autografts for wound repair as well as for the delivery of gene therapy. However, primary keratinocytes have a finite lifespan in culture that limits their proliferative capacity and clinical use. Here, we report that treatment of primary keratinocytes (originating from 3 different anatomical sites) with Y-27632, a Rho kinase inhibitor, greatly increased their proliferative capacity and resulted in efficient immortalization without detectable cell crisis. More importantly, the immortalized cells displayed characteristics typical of primary keratinocytes; they had a normal karyotype and an intact DNA damage response and were able to differentiate into a stratified epithelium. This is the first example to our knowledge of a defined chemical compound mediating efficient cell immortalization, and this finding could have wide-ranging and profound investigational and medical applications. PMID:20516646

How PET/MR Can Add Value For Children With Cancer.

PubMed

Daldrup-Link, Heike

2017-03-01

To review how PET/MR technology could add value for pediatric cancer patients. Since many primary tumors in children are evaluated with MRI and metastases are detected with PET/CT, integrated PET/MR can be a time-efficient and convenient solution for pediatric cancer staging. 18 F-FDG PET/MR can assess primary tumors and the whole body in one imaging session, avoid repetitive anesthesia and reduce radiation exposure compared to 18 F-FDG PET/CT. This article lists 10 action points, which might improve the clinical value of PET/MR for children with cancer. However, even if PET/MR proves valuable, it cannot enter mainstream applications if it is not accessible to the majority of pediatric cancer patients. Therefore, innovations are needed to make PET/MR scanners affordable and increase patient throughput. PET/MR offers opportunities for more efficient, accurate and safe diagnoses of pediatric cancer patients. The impact on patient management and outcomes has to be substantiated by large-scale prospective clinical trials.

Host–Environment Medicine

PubMed Central

Rabinowitz, Peter M; Poljak, Alex

2003-01-01

Rapid developments in genomic and proteomic testing promise to impact the way in which clinicians assess disease risk and drug selection in their patients. Because most diseases result from host–environment interactions, however, primary care providers will need to avoid the trap of biological determinism by examining the important role of environmental factors in their clinical assessments and interventions. This article discusses the application of host–environment concepts to recent developments in the areas of genomics and proteomics. PMID:12648255

Documenting clinical pharmacist intervention before and after the introduction of a web-based tool.

PubMed

Nurgat, Zubeir A; Al-Jazairi, Abdulrazaq S; Abu-Shraie, Nada; Al-Jedai, Ahmed

2011-04-01

To develop a database for documenting pharmacist intervention through a web-based application. The secondary endpoint was to determine if the new, web-based application provides any benefits with regards to documentation compliance by clinical pharmacists and ease of calculating cost savings compared with our previous method of documenting pharmacist interventions. A tertiary care hospital in Saudi Arabia. The documentation of interventions using a web-based documentation application was retrospectively compared with previous methods of documentation of clinical pharmacists' interventions (multi-user PC software). The number and types of interventions recorded by pharmacists, data mining of archived data, efficiency, cost savings, and the accuracy of the data generated. The number of documented clinical interventions increased from 4,926, using the multi-user PC software, to 6,840 for the web-based application. On average, we observed 653 interventions per clinical pharmacist using the web-based application, which showed an increase compared to an average of 493 interventions using the old multi-user PC software. However, using a paired Student's t-test there was no statistical significance difference between the two means (P = 0.201). Using a χ² test, which captured management level and the type of system used, we found a strong effect of management level (P < 2.2 × 10⁻¹⁶) on the number of documented interventions. We also found a moderately significant relationship between educational level and the number of interventions documented (P = 0.045). The mean ± SD time required to document an intervention using the web-based application was 66.55 ± 8.98 s. Using the web-based application, 29.06% of documented interventions resulted in cost-savings, while using the multi-user PC software only 4.75% of interventions did so. The majority of cost savings across both platforms resulted from the discontinuation of unnecessary drugs and a change in dosage regimen. Data collection using the web-based application was consistently more complete when compared to the multi-user PC software. The web-based application is an efficient system for documenting pharmacist interventions. Its flexibility and accessibility, as well as its detailed report functionality is a useful tool that will hopefully encourage other primary and secondary care facilities to adopt similar applications.

Combination of photodynamic therapy and immunotherapy - evolving role in dermatology

NASA Astrophysics Data System (ADS)

Wang, Xiu-Li; Wang, Hong-Wei; Huang, Zheng

2008-02-01

Photodynamic therapy (PDT) is a promising treatment modality. It offers alternative options in the treatment of cancer and vascular diseases. In cancer treatment, PDT has been used primarily for localized superficial or endoluminal malignant and premalignant conditions. More recently, its application has also been expanded to solid tumors. However, its antitumor efficacy remains debatable and its acceptance still variable. Pre-clinical studies demonstrate that, in addition to the primary local cytotoxicity, PDT might induce secondary host immune responses, which may further enhance PDT's therapeutic effects on primary tumor as well as metastasis. Therefore, PDT-induced local and systemic antitumor immune response might play an important role in successful control of malignant diseases. Furthermore, PDT's antitumor efficacy might also be enhanced through an effective immunoadjuvant or immunomodulator. Our recent clinical data also indicate that improved clinical outcomes can be obtained by a combination of PDT and immunomodulation therapy for the treatment of pre-malignant skin diseases. For instance, the combination of topical ALA-PDT and Imiquimod is effective for the treatment of genital bowenoid papulosis. This presentation will also report our preliminary data in developing combination approaches of PDT and immunotherapy for actinic keratosis (AK), basal cell carcinomas (BCCs) and Bowen's disease.

Development and pilot test of a process to identify research needs from a systematic review.

PubMed

Saldanha, Ian J; Wilson, Lisa M; Bennett, Wendy L; Nicholson, Wanda K; Robinson, Karen A

2013-05-01

To ensure appropriate allocation of research funds, we need methods for identifying high-priority research needs. We developed and pilot tested a process to identify needs for primary clinical research using a systematic review in gestational diabetes mellitus. We conducted eight steps: abstract research gaps from a systematic review using the Population, Intervention, Comparison, Outcomes, and Settings (PICOS) framework; solicit feedback from the review authors; translate gaps into researchable questions using the PICOS framework; solicit feedback from multidisciplinary stakeholders at our institution; establish consensus among multidisciplinary external stakeholders on the importance of the research questions using the Delphi method; prioritize outcomes; develop conceptual models to highlight research needs; and evaluate the process. We identified 19 research questions. During the Delphi method, external stakeholders established consensus for 16 of these 19 questions (15 with "high" and 1 with "medium" clinical benefit/importance). We pilot tested an eight-step process to identify clinically important research needs. Before wider application of this process, it should be tested using systematic reviews of other diseases. Further evaluation should include assessment of the usefulness of the research needs generated using this process for primary researchers and funders. Copyright © 2013 Elsevier Inc. All rights reserved.

Clinical applications of somatostatin analogs for growth hormone-secreting pituitary adenomas

PubMed Central

Wang, Ji-wen; Li, Ying; Mao, Zhi-gang; Hu, Bin; Jiang, Xiao-bing; Song, Bing-bing; Wang, Xin; Zhu, Yong-hong; Wang, Hai-jun

2014-01-01

Excessive growth hormone (GH) is usually secreted by GH-secreting pituitary adenomas and causes gigantism in juveniles or acromegaly in adults. The clinical complications involving cardiovascular, respiratory, and metabolic systems lead to elevated morbidity in acromegaly. Control of serum GH and insulin-like growth factor (IGF) 1 hypersecretion by surgery or pharmacotherapy can decrease morbidity. Current pharmacotherapy includes somatostatin analogs (SAs) and GH receptor antagonist; the former consists of lanreotide Autogel (ATG) and octreotide long-acting release (LAR), and the latter refers to pegvisomant. As primary medical therapy, lanreotide ATG and octreotide LAR can be supplied in a long-lasting formulation to achieve biochemical control of GH and IGF-1 by subcutaneous injection every 4–6 weeks. Lanreotide ATG and octreotide LAR provide an effective medical treatment, whether as a primary or secondary therapy, for the treatment of GH-secreting pituitary adenoma; however, to maximize benefits with the least cost, several points should be emphasized before the application of SAs. A comprehensive assessment, especially of the observation of clinical predictors and preselection of SA treatment, should be completed in advance. A treatment process lasting at least 3 months should be implemented to achieve a long-term stable blood concentration. More satisfactory surgical outcomes for noninvasive macroadenomas treated with presurgical SA may be achieved, although controversy of such adjuvant therapy exists. Combination of SA and pegvisomant or cabergoline shows advantages in some specific cases. Thus, an individual treatment program should be established for each patient under a full evaluation of the risks and benefits. PMID:24421637

Clinical response and safety of malathion shampoo for treatment of head lice in a primary school.

PubMed

Wananukul, Siriwan; Chatproedprai, Susheera; Tempark, Therdpong; Wananukul, Winai

2011-04-01

Help eradicate or at least alleviating head lice in a primary school with malathion shampoo and to study clinical response and safety of malathion shampoo. All students were examined by using a fine-toothed lice comb to help detect live lice. Direct visual examination and the collection of nits for microscopic examination were performed to differentiate viable nits from empty nits. Diagnosis of head lice was made by the presence of lice. All students that had lice and/or nits were treated with malathion shampoo. Malathion shampoo was also provided for all family members. Pediculocidal efficacy was by the presence or absence of live lice. Blood for red blood cell cholinesterase activity was drawn in 32 volunteers before treatment and after the second treatment. At the first visit, 629 students were examined and 48 students had live head lice. The infestation rate was 13% in girls and 1.3% in boys. The cure rate was 93% after the first treatment. The reported side effects were nausea, a burning sensation, and irritation that was found in five (4%), 10 (7%) and three (2%) students respectively. The mean of RBC cholinesterase activity before and after two applications showed significant changes (p = 0.03). It was -7.5 +/- 4.1% reduction from the initial, but all were in the normal range. There was no report of clinical manifestation of malathion toxicity. Malathion shampoo is safe and effective in the treatment of head lice. There is significant skin absorption so a scalp examination for head lice should be done before subsequent application to avoid unnecessary exposure.

Advances in gene therapy for heart failure.

PubMed

Fish, Kenneth M; Ishikawa, Kiyotake

2015-04-01

Chronic heart failure is expected to increase its social and economic burden as a consequence of improved survival in patients with acute cardiac events. Cardiac gene therapy holds significant promise in heart failure treatment for patients with currently very limited or no treatment options. The introduction of adeno-associated virus (AAV) gene vector changed the paradigm of cardiac gene therapy, and now it is the primary vector of choice for chronic heart failure gene therapy in clinical and preclinical studies. Recently, there has been significant progress towards clinical translation in this field spearheaded by AAV-1 mediated sarcoplasmic reticulum Ca2+ ATPase (SERCA2a) gene therapy targeting chronic advanced heart failure patients. Meanwhile, several independent laboratories are reporting successful gene therapy approaches in clinically relevant large animal models of heart failure and some of these approaches are expected to enter clinical trials in the near future. This review will focus on gene therapy approaches targeting heart failure that is in clinical trials and those close to its initial clinical trial application.

Clinical managers in the primary care sector: do the benefits stack up?

PubMed

O'Riordan, Chris; McDermott, Aoife

2012-01-01

The purpose of this paper is to explore the nature and value of the clinical management role undertaken by primary care doctors in Ireland. To date, a majority of research has focused on clinical management roles in the acute sector. The paper presents a sub-set of data from a mixed methods study. In total, 14 semi-structured interviews are drawn upon to identify the nature and value of the clinical management role in primary care. Comparison with acute sector research identifies considerable differences in the nature of the clinical management role across sectors--and in the associated value proposition. Structural and role-related contingencies affecting the potential value of clinical management roles in Irish primary care are discussed. Structural influences include the private ownership structure, low complexity and limited requirement for cross-professional coordination. Role-related influences include the primacy of the clinical identity, time constraints and lack of managerial training. The findings provide a limited basis for generalisation, premised on 14 interviews in one national context. However, given the international shift towards the provision of health services in primary care, they provide a research agenda for an important healthcare context. The findings draw attention to the need for policy consideration of the value of the clinical manager role in primary care; how policy can support effective primary care management; and the need for specialised management training, which takes account of the small-firm context. The paper identifies that primary-care clinical-management roles focus on operational management and oversight and discusses the structural and role-related factors which affect their efficacy.

Modelling Conditions and Health Care Processes in Electronic Health Records: An Application to Severe Mental Illness with the Clinical Practice Research Datalink.

PubMed

Olier, Ivan; Springate, David A; Ashcroft, Darren M; Doran, Tim; Reeves, David; Planner, Claire; Reilly, Siobhan; Kontopantelis, Evangelos

2016-01-01

The use of Electronic Health Records databases for medical research has become mainstream. In the UK, increasing use of Primary Care Databases is largely driven by almost complete computerisation and uniform standards within the National Health Service. Electronic Health Records research often begins with the development of a list of clinical codes with which to identify cases with a specific condition. We present a methodology and accompanying Stata and R commands (pcdsearch/Rpcdsearch) to help researchers in this task. We present severe mental illness as an example. We used the Clinical Practice Research Datalink, a UK Primary Care Database in which clinical information is largely organised using Read codes, a hierarchical clinical coding system. Pcdsearch is used to identify potentially relevant clinical codes and/or product codes from word-stubs and code-stubs suggested by clinicians. The returned code-lists are reviewed and codes relevant to the condition of interest are selected. The final code-list is then used to identify patients. We identified 270 Read codes linked to SMI and used them to identify cases in the database. We observed that our approach identified cases that would have been missed with a simpler approach using SMI registers defined within the UK Quality and Outcomes Framework. We described a framework for researchers of Electronic Health Records databases, for identifying patients with a particular condition or matching certain clinical criteria. The method is invariant to coding system or database and can be used with SNOMED CT, ICD or other medical classification code-lists.

Dosimetry and first clinical evaluation of the new 18F-radiolabeled bombesin analogue BAY 864367 in patients with prostate cancer.

PubMed

Sah, Bert-Ram; Burger, Irene A; Schibli, Roger; Friebe, Matthias; Dinkelborg, Ludger; Graham, Keith; Borkowski, Sandra; Bacher-Stier, Claudia; Valencia, Ray; Srinivasan, Ananth; Hany, Thomas F; Mu, Linjing; Wild, Peter J; Schaefer, Niklaus G

2015-03-01

The aim of this first-in-man study was to demonstrate the feasibility, safety, and tolerability, as well as provide dosimetric data and evaluate the imaging properties, of the bombesin analogue BAY 864367 for PET/CT in a small group of patients with primary and recurrent prostate cancer (PCa). Ten patients with biopsy-proven PCa (5 with primary PCa and 5 with prostate-specific antigen recurrence after radical prostatectomy) were prospectively selected for this exploratory clinical trial with BAY 864367, a new (18)F-labeled bombesin analogue. PET scans were assessed at 6 time points, up to 110 min after intravenous administration of 302 ± 11 MBq of BAY 864367. Imaging results were compared with (18)F-fluorocholine PET/CT scans. Dosimetry was calculated using the OLINDA/EXM software. Three of 5 patients with primary disease showed positive tumor delineation in the prostate, and 2 of 5 patients with biochemical relapse showed a lesion suggestive of recurrence on the BAY 864367 scan. Tumor-to-background ratio averaged 12.9 ± 7.0. The ratio of malignant prostate tissue to normal prostate tissue was 4.4 ± 0.6 in 3 patients with tracer uptake in the primary PCa. Mean effective dose was 4.3 ± 0.3 mSv/patient (range, 3.7-4.9 mSv). BAY 864367, a novel (18)F-labeled bombesin tracer, was successfully investigated in a first-in-man clinical trial of PCa and showed favorable dosimetric values. Additionally, the application was safe and well tolerated. The tracer delineated tumors in a subset of patients, demonstrating the potential of gastrin-releasing-peptide receptor imaging. © 2015 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

Improving substance abuse screening and intervention in a primary care clinic.

PubMed

Neushotz, Lori A; Fitzpatrick, Joyce J

2008-04-01

Despite recent efforts to educate primary care providers in the identification and management of patients presenting with substance abuse problems, many opportunities to identify and intervene with these patients are overlooked. This project was designed to identify factors that interfere with rates of screening and brief intervention (SBI) of substance abuse problems in a primary care clinic in a major academic medical center in New York City. Six informants representing the disciplines of medicine, nursing, and social work in the primary care clinic provided information regarding SBI. Analysis was focused on substantiation of the need for enhanced diffusion of knowledge related to screening for substance abuse problems to improve rates of SBI in primary care. Recommendations for improvement included continued promotion of SBI by influential role models and opinion leaders, improvement in primary care providers' perceptions of the perceived characteristics of SBI to improve rates of adoption, implementation of interdisciplinary educational initiatives toward the goal of improving rates of SBI in the primary care clinic, and initiation of translational research at the clinic supporting SBI in primary care.

Quantitative evaluation of photoplethysmographic artifact reduction for pulse oximetry

NASA Astrophysics Data System (ADS)

Hayes, Matthew J.; Smith, Peter R.

1999-01-01

Motion artefact corruption of pulse oximeter output, causing both measurement inaccuracies and false alarm conditions, is a primary restriction in the current clinical practice and future applications of this useful technique. Artefact reduction in photoplethysmography (PPG), and therefore by application in pulse oximetry, is demonstrated using a novel non-linear methodology recently proposed by the authors. The significance of these processed PPG signals for pulse oximetry measurement is discussed, with particular attention to the normalization inherent in the artefact reduction process. Quantitative experimental investigation of the performance of PPG artefact reduction is then utilized to evaluate this technology for application to pulse oximetry. While the successfully demonstrated reduction of severe artefacts may widen the applicability of all PPG technologies and decrease the occurrence of pulse oximeter false alarms, the observed reduction of slight artefacts suggests that many such effects may go unnoticed in clinical practice. The signal processing and output averaging used in most commercial oximeters can incorporate these artefact errors into the output, while masking the true PPG signal corruption. It is therefore suggested that PPG artefact reduction should be incorporated into conventional pulse oximetry measurement, even in the absence of end-user artefact problems.

Antimicrobial resistance dashboard application for mapping environmental occurrence and resistant pathogens

PubMed Central

Stedtfeld, Robert D.; Williams, Maggie R.; Fakher, Umama; Johnson, Timothy A.; Stedtfeld, Tiffany M.; Wang, Fang; Khalife, Walid T.; Hughes, Mary; Etchebarne, Brett E.; Tiedje, James M.; Hashsham, Syed A.

2016-01-01

An antibiotic resistance (AR) Dashboard application is being developed regarding the occurrence of antibiotic resistance genes (ARG) and bacteria (ARB) in environmental and clinical settings. The application gathers and geospatially maps AR studies, reported occurrence and antibiograms, which can be downloaded for offline analysis. With the integration of multiple data sets, the database can be used on a regional or global scale to identify hot spots for ARGs and ARB; track and link spread and transmission, quantify environmental or human factors influencing presence and persistence of ARG harboring organisms; differentiate natural ARGs from those distributed via human or animal activity; cluster and compare ARGs connections in different environments and hosts; and identify genes that can be used as proxies to routinely monitor anthropogenic pollution. To initially populate and develop the AR Dashboard, a qPCR ARG array was tested with 30 surface waters, primary influent from three waste water treatment facilities, ten clinical isolates from a regional hospital and data from previously published studies including river, park soil and swine farm samples. Interested users are invited to download a beta version (available on iOS or Android), submit AR information using the application, and provide feedback on current and prospective functionalities. PMID:26850162

The use of behavior change theory in Internet-based asthma self-management interventions: a systematic review.

PubMed

Al-Durra, Mustafa; Torio, Monika-Bianca; Cafazzo, Joseph A

2015-04-02

The high prevalence rate of asthma represents a major societal burden. Advancements in information technology continue to affect the delivery of patient care in all areas of medicine. Internet-based solutions, social media, and mobile technology could address some of the problems associated with increasing asthma prevalence. This review evaluates Internet-based asthma interventions that were published between 2004 and October 2014 with respect to the use of behavioral change theoretical frameworks, applied clinical guidelines, and assessment tools. The search term (Asthma AND [Online or Internet or Mobile or Application or eHealth or App]) was applied to six bibliographic databases (Ovid MEDLINE, PubMed, BioMed Central, ProQuest Computing, Web of Knowledge, and ACM Digital Library) including only English-language articles published between 2004 and October 2014. In total, 3932 articles matched the priori search terms and were reviewed by the primary reviewer based on their titles, index terms, and abstracts. The matching articles were then screened by the primary reviewer for inclusion or exclusion based on their abstract, study type, and intervention objectives with respect to the full set of priori inclusion and exclusion criteria; 331 duplicates were identified and removed. A total of 85 articles were included for in-depth review and the remaining 3516 articles were excluded. The primary and secondary reviewer independently reviewed the complete content of the 85 included articles to identify the applied behavioral change theories, clinical guidelines, and assessment tools. Findings and any disagreement between reviewers were resolved by in-depth discussion and through a consolidation process for each of the included articles. The reviewers identified 17 out of 85 interventions (20%) where at least one model, framework, and/or construct of a behavioral change theory were applied. The review identified six clinical guidelines that were applied across 30 of the 85 interventions (35%) as well as a total of 21 assessment tools that were applied across 32 of the 85 interventions (38%). The findings of this literature review indicate that the majority of published Internet-based interventions do not use any documented behavioral change theory, clinical guidelines, and/or assessment tools to inform their design. Further, it was found that the application of clinical guidelines and assessment tools were more salient across the reviewed interventions. A consequence, as such, is that many Internet-based asthma interventions are designed in an ad hoc manner, without the use of any notable evidence-based theoretical frameworks, clinical guidelines, and/or assessment tools.

Part 2: Screening, Brief Intervention and Referral to Treatment Plus Recovery Management: A Proposed Model for Recovery-Oriented Primary Care.

PubMed

Fornili, Katherine S

2016-01-01

Part 1 of this two-part series (The Theoretical Basis for Recovery-Oriented Management of Substance Use Disorders in the Primary Care) explored the theoretical foundations for evidence-based substance Screening, Brief Intervention and Referral to Treatment (SBIRT) services. The aim was to produce possible explanations for why traditional SBIRT works well for individuals with unhealthy alcohol use but not as well for individuals who have more serious substance use disorders, including drug use and alcohol/drug dependence. Building on that analysis, through meaningful application of recovery management (RM) concepts within an integrated primary care/behavioral health context, a new, theory-based, recovery-oriented framework for primary care SBIRT is now introduced in Part 2. The proposed SBIRT Plus Recovery Management (SBIRT + RM) model moves traditional SBIRT from its original, limited, and narrow focus only on substance detection, brief intervention, and referral to its rightful, structured placement within a comprehensive, multidimensional, recovery-oriented system of care clinical practice environment. SBIRT+RM describes relevant strategies for improving recovery outcomes for individuals identified through primary care substance screening and defines primary care provider roles and responsibilities for sustained recovery support and long-term recovery maintenance.

Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

PubMed

Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

2017-06-01

The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

Clinical applications of hallucinogens: A review.

PubMed

Garcia-Romeu, Albert; Kersgaard, Brennan; Addy, Peter H

2016-08-01

Hallucinogens fall into several different classes, as broadly defined by pharmacological mechanism of action, and chemical structure. These include psychedelics, entactogens, dissociatives, and other atypical hallucinogens. Although these classes do not share a common primary mechanism of action, they do exhibit important similarities in their ability to occasion temporary but profound alterations of consciousness, involving acute changes in somatic, perceptual, cognitive, and affective processes. Such effects likely contribute to their recreational use. However, a growing body of evidence indicates that these drugs may have therapeutic applications beyond their potential for abuse. This review will present data on several classes of hallucinogens with a particular focus on psychedelics, entactogens, and dissociatives, for which clinical utility has been most extensively documented. Information on each class is presented in turn, tracing relevant historical insights, highlighting similarities and differences between the classes from the molecular to the behavioral level, and presenting the most up-to-date information on clinically oriented research with these substances, with important ramifications for their potential therapeutic value. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Recent Advances in Conjugated Polymer Materials for Disease Diagnosis.

PubMed

Lv, Fengting; Qiu, Tian; Liu, Libing; Ying, Jianming; Wang, Shu

2016-02-10

The extraordinary optical amplification and light-harvesting properties of conjugated polymers impart sensing systems with higher sensitivity, which meets the primary demands of early cancer diagnosis. Recent advances in the detection of DNA methylation and mutation with polyfluorene derivatives based fluorescence resonance energy transfer (FRET) as a means to modulate fluorescent responses attest to the great promise of conjugated polymers as powerful tools for the clinical diagnosis of diseases. To facilitate the ever-changing needs of diagnosis, the development of detection approaches and FRET signal analysis are highlighted in this review. Due to their exceptional brightness, excellent photostability, and low or absent toxicity, conjugated polymers are verified as superior materials for in-vivo imaging, and provide feasibility for future clinical molecular-imaging applications. The integration of conjugated polymers with clinical research has shown profound effects on diagnosis for the early detection of disease-related biomarkers, as well as in-vivo imaging, which leads to a multidisciplinary scientific field with perspectives in both basic research and application issues. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Imaging outcome measures for progressive multiple sclerosis trials

PubMed Central

Moccia, Marcello; de Stefano, Nicola; Barkhof, Frederik

2017-01-01

Imaging markers that are reliable, reproducible and sensitive to neurodegenerative changes in progressive multiple sclerosis (MS) can enhance the development of new medications with a neuroprotective mode-of-action. Accordingly, in recent years, a considerable number of imaging biomarkers have been included in phase 2 and 3 clinical trials in primary and secondary progressive MS. Brain lesion count and volume are markers of inflammation and demyelination and are important outcomes even in progressive MS trials. Brain and, more recently, spinal cord atrophy are gaining relevance, considering their strong association with disability accrual; ongoing improvements in analysis methods will enhance their applicability in clinical trials, especially for cord atrophy. Advanced magnetic resonance imaging (MRI) techniques (e.g. magnetization transfer ratio (MTR), diffusion tensor imaging (DTI), spectroscopy) have been included in few trials so far and hold promise for the future, as they can reflect specific pathological changes targeted by neuroprotective treatments. Position emission tomography (PET) and optical coherence tomography have yet to be included. Applications, limitations and future perspectives of these techniques in clinical trials in progressive MS are discussed, with emphasis on measurement sensitivity, reliability and sample size calculation. PMID:29041865

Telehealth Applications to Enhance CKD Knowledge and Awareness Among Patients and Providers.

PubMed

Tuot, Delphine S; Boulware, L Ebony

2017-01-01

CKD affects 13% of the US adult population, causes excess mortality, and is associated with significant sociodemographic disparities. Optimal CKD management slows progression of disease and reduces cardiovascular-related outcomes. Resources for patients and primary care providers, major stakeholders in preventive CKD care, are critically needed to enhance understanding of the disease and to optimize CKD health, particularly because of the asymptomatic nature of kidney disease. Telehealth is defined as the use of electronic communication and telecommunications technology to support long-distance clinical health care, patient and professional health-related education, and public health and health administration. It provides new opportunities to enhance awareness and understanding among these important stakeholders. This review will examine the role of telehealth within existing educational theories, identify telehealth applications that can enhance CKD knowledge and behavior change among patients and primary care providers, and examine the advantages and disadvantages of telehealth vs usual modalities for education. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Attention deficits and hyperactivity–impulsivity: What have we learned, what next?

PubMed Central

NIGG, JOEL T.

2015-01-01

The domains of self-regulation, self-control, executive function, inattention, and impulsivity cut across broad swathes of normal and abnormal development. Attention-deficit/hyperactivity disorder is a common syndrome that encompasses a portion of these domains. In the past 25 years research on attention-deficit/hyperactivity disorder has been characterized by dramatic advances in genetic, neural, and neuropsychological description of the syndrome as well as clarification of its multidimensional phenotypic structure. The limited clinical applicability of these research findings poses the primary challenge for the next generation. It is likely that clinical breakthroughs will require further refinement in describing heterogeneity or clinical/biological subgroups, renewed focus on the environment in the form of etiological events as well as psychosocial contexts of development, and integration of both with biological understanding. PMID:24342852

Application of laser Raman spectroscopy in concentration measurements of multiple analytes in human body fluids

NASA Astrophysics Data System (ADS)

Qu, Jianan Y.; Suria, David; Wilson, Brian C.

1998-05-01

The primary goal of these studies was to demonstrate that NIR Raman spectroscopy is feasible as a rapid and reagentless analytic method for clinical diagnostics. Raman spectra were collected on human serum and urine samples using a 785 nm excitation laser and a single-stage holographic spectrometer. A partial east squares method was used to predict the analyte concentrations of interest. The actual concentrations were determined by a standard clinical chemistry. The prediction accuracy of total protein, albumin, triglyceride and glucose in human sera ranged from 1.5 percent to 5 percent which is greatly acceptable for clinical diagnostics. The concentration measurements of acetaminophen, ethanol and codeine inhuman urine have demonstrated the potential of NIR Raman technology in screening of therapeutic drugs and substances of abuse.

Health information technology in primary health care in developing countries: a literature review.

PubMed Central

Tomasi, Elaine; Facchini, Luiz Augusto; Maia, Maria de Fatima Santos

2004-01-01

This paper explores the debate and initiatives concerning the use of information technology (IT) in primary health care in developing countries. The literature from 1992-2002 was identified from searches of the MEDLINE, Latin American and Caribbean Health Science Literature Database (LILACS), Cochrane Library and Web of Science databases. The search identified 884 references, 350 of which were classified according to the scheme described by the Pan American Health Organization (PAHO). For the analysis of advantages, problems and perspectives of IT applications and systems, 52 articles were selected according to their potential contribution to the primary health-care processes in non-developed countries. These included: 10 on electronic patient registries (EPR), 22 on process and programmatic action evaluation and management systems (PPAEM) and 20 on clinical decision-support systems (CDS). The main advantages, limitations and perspectives are discussed. PMID:15640923

The Clinical Application of Mastectomy With Single Incision Followed by Immediate Laparoscopic-Assisted Breast Reconstruction With Latissimus Dorsi Muscle Flap.

PubMed

Yuan, Huozhong; Xie, Donghua; Xiao, Xigang; Huang, Xingwei

2017-08-01

To explore the clinical application of mastectomy with single incision followed by immediate laparoscopic-assisted breast reconstruction with latissimus dorsi muscle flap. Fifteen women with primary early breast cancer, 3 women with breast ductal carcinoma in situ, and 7 women with severe plasma cell mastitis were treated with partial mastectomy or total mastectomy, sentinel lymph node biopsy, or axillary lymph node dissection through a breast lateral transverse incision. Subsequent breast reconstruction with latissimus dorsi muscle flap was assisted by laparoscopy. The patient's position, time used in dissecting latissimus dorsi muscle flap, size of latissimus dorsi muscle flap, postoperative complications, and the cosmetic results after reconstruction were assessed. All the operations were well done through the breast lateral transverse incision and assistance of laparoscopy. The patient's position was changed only once during the operation. It took 1.5 to 2 hours to dissect latissimus dorsi muscle flap. The sizes of the latissimus dorsi muscle flap were 5 to 8 × 12 to 16 cm. There were no serious postoperative complications noted. The patients were satisfied with the appearance of the breasts and the small surgical scar. The surgical approach introduced is minimally invasive with concealed scar and outstanding cosmetic results. It is worth promoting in clinical application.

Efficacy of leukocyte- and platelet-rich fibrin in wound healing: a randomized controlled clinical trial.

PubMed

Chignon-Sicard, Bérengère; Georgiou, Charalambos A; Fontas, Eric; David, Sylvain; Dumas, Pierre; Ihrai, Tarik; Lebreton, Elisabeth

2012-12-01

Application of platelet concentrates to wounds could speed healing. Leukocyte- and platelet-rich fibrin, a relatively recent development, stands out from the other preparations. This prospective, randomized, controlled clinical trial studied the rate of healing of postoperative hand wounds after a single application of leukocyte- and platelet-rich fibrin. Eligible patients were healthy individuals older than 18 years who had been scheduled for elective McCash (open palm) surgery for Dupuytren disease at the Plastic and Hand Surgery Department of Nice's University Hospital between August of 2007 and February of 2010. The control group received the reference care of petroleum jelly mesh (Vaselitulle), and test patients had leukocyte- and platelet-rich fibrin applied. The primary endpoint was healing delay measured in postoperative days. Secondary endpoints included pain, bleeding, and wound exudate. The trial was carried out as a single-blind trial. Among the 68 randomized patients, 33 patients in the leukocyte- and platelet-rich fibrin group and 31 in the Vaselitulle group were analyzed. Primary endpoint analysis showed a median healing delay of 24 days (interquartile range, 18 to 28 days) for the fibrin group and 29 days (interquartile range, 26 to 35 days) for the Vaselitulle group (p = 0.014, log-rank test). Postoperative pain assessment, bleeding, and exudate were always lower for the fibrin group, but not significantly so. The authors trial demonstrates that a single leukocyte- and platelet-rich fibrin application on fresh postoperative hand wounds shows a median improvement of 5 days in comparison with the standard treatment. Therapeutic, II.

How much is not enough? Human resources requirements for primary health care: a case study from South Africa.

PubMed

Daviaud, Emmanuelle; Chopra, Mickey

2008-01-01

To quantify staff requirements in primary health care facilities in South Africa through an adaptation of the WHO workload indicator of staff needs tool. We use a model to estimate staffing requirements at primary health care facilities. The model integrates several empirically-based assumptions including time and type of health worker required for each type of consultation, amount of management time required, amount of clinical support required and minimum staff requirements per type of facility. We also calculate the number of HIV-related consultations per district. The model incorporates type of facility, monthly travelling time for mobile clinics, opening hours per week, yearly activity and current staffing and calculates the expected staffing per category of staff per facility and compares it to the actual staffing. Across all the districts there is either an absence of doctors visiting clinics or too few doctors to cover the opening times of community health centres. Overall the number of doctors is only 7% of the required amount. There is 94% of the required number of professional nurses but with wide variations between districts, with a few districts having excesses while most have shortages. The number of enrolled nurses is 60% of what it should be. There are 17% too few enrolled nurse assistants. Across all districts there is wide variation in staffing levels between facilities leading to inefficient use of professional staff. The application of an adapted WHO workload tool identified important human resource planning issues.

Modeling Predictors of Duties Not Including Flying Status.

PubMed

Tvaryanas, Anthony P; Griffith, Converse

2018-01-01

The purpose of this study was to reuse available datasets to conduct an analysis of potential predictors of U.S. Air Force aircrew nonavailability in terms of being in "duties not to include flying" (DNIF) status. This study was a retrospective cohort analysis of U.S. Air Force aircrew on active duty during the period from 2003-2012. Predictor variables included age, Air Force Specialty Code (AFSC), clinic location, diagnosis, gender, pay grade, and service component. The response variable was DNIF duration. Nonparametric methods were used for the exploratory analysis and parametric methods were used for model building and statistical inference. Out of a set of 783 potential predictor variables, 339 variables were identified from the nonparametric exploratory analysis for inclusion in the parametric analysis. Of these, 54 variables had significant associations with DNIF duration in the final model fitted to the validation data set. The predicted results of this model for DNIF duration had a correlation of 0.45 with the actual number of DNIF days. Predictor variables included age, 6 AFSCs, 7 clinic locations, and 40 primary diagnosis categories. Specific demographic (i.e., age), occupational (i.e., AFSC), and health (i.e., clinic location and primary diagnosis category) DNIF drivers were identified. Subsequent research should focus on the application of primary, secondary, and tertiary prevention measures to ameliorate the potential impact of these DNIF drivers where possible.Tvaryanas AP, Griffith C Jr. Modeling predictors of duties not including flying status. Aerosp Med Hum Perform. 2018; 89(1):52-57.

Effect of human patient plasma ex vivo treatment on gene expression and progenitor cell activation of primary human liver cells in multi-compartment 3D perfusion bioreactors for extra-corporeal liver support.

PubMed

Schmelzer, Eva; Mutig, Kerim; Schrade, Petra; Bachmann, Sebastian; Gerlach, Jörg C; Zeilinger, Katrin

2009-07-01

Cultivation of primary human liver cells in innovative 3D perfusion multi-compartment capillary membrane bioreactors using decentralized mass exchange and integral oxygenation provides in vitro conditions close to the physiologic environment in vivo. While a few scale-up bioreactors were used clinically, inoculated liver progenitors in these bioreactors were not investigated. Therefore, we characterized regenerative processes and expression patterns of auto- and paracrine mediators involved in liver regeneration in bioreactors after patient treatment. Primary human liver cells containing parenchymal and non-parenchymal cells co-cultivated in bioreactors were used for clinical extra-corporeal liver support to bridge to liver transplantation. 3D tissue re-structuring in bioreactors was studied; expression of proteins and genes related to regenerative processes and hepatic progenitors was analyzed. Formation of multiple bile ductular networks and colonies of putative progenitors were observed within parenchymal cell aggregates. HGF was detected in scattered cells located close to vascular-like structures, expression of HGFA and c-Met was assigned to biliary cells and hepatocytes. Increased expression of genes associated to hepatic progenitors was detected following clinical application. The results confirm auto- and paracrine interactions between co-cultured cells in the bioreactor. The 3D bioreactor provides a valuable tool to study mechanisms of progenitor activation and hepatic regeneration ex vivo under patient plasma treatment. (c) 2009 Wiley Periodicals, Inc.

Effectiveness of plasma lyso-Gb3 as a biomarker for selecting high-risk patients with Fabry disease from multispecialty clinics for genetic analysis.

PubMed

Maruyama, Hiroki; Miyata, Kaori; Mikame, Mariko; Taguchi, Atsumi; Guili, Chu; Shimura, Masaru; Murayama, Kei; Inoue, Takeshi; Yamamoto, Saori; Sugimura, Koichiro; Tamita, Koichi; Kawasaki, Toshihiro; Kajihara, Jun; Onishi, Akifumi; Sugiyama, Hitoshi; Sakai, Teiko; Murata, Ichijiro; Oda, Takamasa; Toyoda, Shigeru; Hanawa, Kenichiro; Fujimura, Takeo; Ura, Shigehisa; Matsumura, Mimiko; Takano, Hideki; Yamashita, Satoshi; Matsukura, Gaku; Tazawa, Ryushi; Shiga, Tsuyoshi; Ebato, Mio; Satoh, Hiroshi; Ishii, Satoshi

2018-03-15

PurposePlasma globotriaosylsphingosine (lyso-Gb3) is a promising secondary screening biomarker for Fabry disease. Here, we examined its applicability as a primary screening biomarker for classic and late-onset Fabry disease in males and females.MethodsBetween 1 July 2014 and 31 December 2015, we screened 2,360 patients (1,324 males) referred from 169 Japanese specialty clinics (cardiology, nephrology, neurology, and pediatrics), based on clinical symptoms suggestive of Fabry disease. We used the plasma lyso-Gb3 concentration, α-galactosidase A (α-Gal A) activity, and analysis of the α-Gal A gene (GLA) for primary and secondary screens, respectively.ResultsOf 8 males with elevated lyso-Gb3 levels (≥2.0 ng ml -1 ) and low α-Gal A activity (≤4.0 nmol h -1  ml -1 ), 7 presented a GLA mutation (2 classic and 5 late-onset). Of 15 females with elevated lyso-Gb3, 7 displayed low α-Gal A activity (5 with GLA mutations; 4 classic and 1 late-onset) and 8 exhibited normal α-Gal A activity (1 with a classic GLA mutation and 3 with genetic variants of uncertain significance).ConclusionPlasma lyso-Gb3 is a potential primary screening biomarker for classic and late-onset Fabry disease probands.Genet Med advance online publication, 15 March 2018; doi:10.1038/gim.2018.31.

The brain's emotional foundations of human personality and the Affective Neuroscience Personality Scales.

PubMed

Davis, Kenneth L; Panksepp, Jaak

2011-10-01

Six of the primary-process subcortical brain emotion systems - SEEKING, RAGE, FEAR, CARE, GRIEF and PLAY - are presented as foundational for human personality development, and hence as a potentially novel template for personality assessment as in the Affective Neurosciences Personality Scales (ANPS), described here. The ANPS was conceptualized as a potential clinical research tool, which would help experimentalists and clinicians situate subjects and clients in primary-process affective space. These emotion systems are reviewed in the context of a multi-tiered framing of consciousness spanning from primary affect, which encodes biological valences, to higher level tertiary (thought mediated) processing. Supporting neuroscience research is presented along with comparisons to Cloninger's Temperament and Character Inventory and the Five Factor Model (FFM). Suggestions are made for grounding the internal structure of the FFM on the primal emotional systems recognized in affective neuroscience, which may promote substantive dialog between human and animal research traditions. Personality is viewed in the context of Darwinian "continuity" with the inherited subcortical brain emotion systems being foundational, providing major forces for personality development in both humans and animals, and providing an affective infrastructure for an expanded five factor descriptive model applying to normal and clinical human populations as well as mammals generally. Links with ontogenetic and epigenetic models of personality development are also presented. Potential novel clinical applications of the CARE maternal-nurturance system and the PLAY system are also discussed. Copyright © 2011 Elsevier Ltd. All rights reserved.

Proteomics of ovarian cancer: functional insights and clinical applications

DOE PAGES

Elzek, Mohamed A.; Rodland, Karin D.

2015-03-04

In the past decade, there has been an increasing interest in applying proteomics to assist in understanding the pathogenesis of ovarian cancer, elucidating the mechanism of drug resistance, and in the development of biomarkers for early detection of ovarian cancer. Although ovarian cancer is a spectrum of different diseases, the strategies for diagnosis and treatment with surgery and adjuvant therapy are similar across ovarian cancer types, increasing the general applicability of discoveries made through proteomics research. While proteomic experiments face many difficulties which slow the pace of clinical applications, recent advances in proteomic technology contribute significantly to the identification ofmore » aberrant proteins and networks which can serve as targets for biomarker development and individualized therapies. This review provides a summary of the literature on proteomics’ contributions to ovarian cancer research and highlights the current issues, future directions, and challenges. In conclusion, we propose that protein-level characterization of primary lesion in ovarian cancer can decipher the mystery of this disease, improve diagnostic tools, and lead to more effective screening programs.« less

Guidelines from the Canadian Association of Pathologists for establishing a telepathology service for anatomic pathology using whole-slide imaging

PubMed Central

Bernard, Chantal; Chandrakanth, S. A.; Cornell, Ian Scott; Dalton, James; Evans, Andrew; Garcia, Bertha M.; Godin, Chris; Godlewski, Marek; Jansen, Gerard H.; Kabani, Amin; Louahlia, Said; Manning, Lisa; Maung, Raymond; Moore, Lisa; Philley, Joanne; Slatnik, Jack; Srigley, John; Thibault, Alain; Picard, Donald Daniel; Cracower, Hanah; Tetu, Bernard

2014-01-01

The use of telepathology for clinical applications in Canada has steadily become more attractive over the last 10 years, driven largely by its potential to provide rapid pathology consulting services throughout the country regardless of the location of a particular institution. Based on this trend, the president of the Canadian Association of Pathologists asked a working group consisting of pathologists, technologists, and healthcare administrators from across Canada to oversee the development of guidelines to provide Canadian pathologists with basic information on how to implement and use this technology. The guidelines were systematically developed, based on available medical literature and the clinical experience of early adopters of telepathology in Canada. While there are many different modalities and applications of telepathology, this document focuses specifically on whole-slide imaging as applied to intraoperative pathology consultation (frozen section), primary diagnosis, expert or second opinions and quality assurance activities. Applications such as hematopathology, microbiology, tumour boards, education, research and technical and/or standard-related issues are not covered. PMID:24843826

Details for Manuscript Number SSM-D-07-00339R2 “When there is no doctor: Reasons for the disappearance of primary care physicians in the US during the early 21st century”

PubMed Central

McKinlay, John; Marceau, Lisa

2008-01-01

Primary care doctoring in the USA today (2007) bears little resemblance to what existed just 25 years ago. We focus on what is likely to unfold in the U.S. over the next several decades and suggest that by about 2025, primary care doctoring in the U.S. could be rare, possibly unrecognizable and even nonexistent. Seven reasons for the probable disappearance of primary care doctoring are identified. The most important reason is medicine’s loss of state sponsorship: the U.S. state has shifted from a pluralistic orientation to a New Right approach. With less state protection medicine has become even more attractive for private interests. Six additional reasons include: • The epidemiological transition (chronic diseases reduce doctors to a palliative role and monitoring of incurable conditions); • The overcrowded health care playing field (non–physician clinicians are supplanting primary care doctors); • The unintended consequences of clinical guidelines (the art of doctoring is reduced to formulaic tasks, easily codified and performed by non-physician clinicians); • The demise of the in-person examination (in-person examination is being replaced by impersonal testing); • Primary care doctoring is becoming unattractive (physicians are dissatisfied, alienated and experiencing income declines. Applications by U.S. graduates to primary care programs continue to decline); • Patients are not what they used to be (internet access and direct-to-consumer advertising are changing the doctor-patient relationship). By 2025, many everyday illnesses in the U.S. will be managed via the internet or by non-physician clinicians working out of retail clinics. Some medical problems will still require a physician’s attention, but this will be provided by specialists rather than by primary care doctors (general practitioners). PMID:18701201

Candidate-based proteomics in the search for biomarkers of cardiovascular disease

PubMed Central

Anderson, Leigh

2005-01-01

The key concept of proteomics (looking at many proteins at once) opens new avenues in the search for clinically useful biomarkers of disease, treatment response and ageing. As the number of proteins that can be detected in plasma or serum (the primary clinical diagnostic samples) increases towards 1000, a paradoxical decline has occurred in the number of new protein markers approved for diagnostic use in clinical laboratories. This review explores the limitations of current proteomics protein discovery platforms, and proposes an alternative approach, applicable to a range of biological/physiological problems, in which quantitative mass spectrometric methods developed for analytical chemistry are employed to measure limited sets of candidate markers in large sets of clinical samples. A set of 177 candidate biomarker proteins with reported associations to cardiovascular disease and stroke are presented as a starting point for such a ‘directed proteomics’ approach. PMID:15611012

Challenges in translating vascular tissue engineering to the pediatric clinic.

PubMed

Duncan, Daniel R; Breuer, Christopher K

2011-10-14

The development of tissue-engineered vascular grafts for use in cardiovascular surgery holds great promise for improving outcomes in pediatric patients with complex congenital cardiac anomalies. Currently used synthetic grafts have a number of shortcomings in this setting but a tissue engineering approach has emerged in the past decade as a way to address these limitations. The first clinical trial of this technology showed that it is safe and effective but the primary mode of graft failure is stenosis. A variety of murine and large animal models have been developed to study and improve tissue engineering approaches with the hope of translating this technology into routine clinical use, but challenges remain. The purpose of this report is to address the clinical problem and review recent advances in vascular tissue engineering for pediatric applications. A deeper understanding of the mechanisms of neovessel formation and stenosis will enable rational design of improved tissue-engineered vascular grafts.

Gene Therapy with the Sleeping Beauty Transposon System.

PubMed

Kebriaei, Partow; Izsvák, Zsuzsanna; Narayanavari, Suneel A; Singh, Harjeet; Ivics, Zoltán

2017-11-01

The widespread clinical implementation of gene therapy requires the ability to stably integrate genetic information through gene transfer vectors in a safe, effective, and economical manner. The latest generation of Sleeping Beauty (SB) transposon vectors fulfills these requirements, and may overcome limitations associated with viral gene transfer vectors and transient nonviral gene delivery approaches that are prevalent in ongoing clinical trials. The SB system enables high-level stable gene transfer and sustained transgene expression in multiple primary human somatic cell types, thereby representing a highly attractive gene transfer strategy for clinical use. Here, we review the most important aspects of using SB for gene therapy, including vectorization as well as genomic integration features. We also illustrate the path to successful clinical implementation by highlighting the application of chimeric antigen receptor (CAR)-modified T cells in cancer immunotherapy. Copyright © 2017 Elsevier Ltd. All rights reserved.

Promoting Bedside Nurse-Led Research Through a Dedicated Neuroscience Nursing Research Fellowship.

PubMed

Stutzman, Sonja; Olson, DaiWai; Supnet, Charlene; Harper, Caryn; Brown-Cleere, Shelley; McCulley, Becky; Goldberg, Mark

2016-12-01

We hypothesized that nurses would benefit from the fellowship model traditionally used to engage physicians in clinical research. The Neuroscience Nursing Research Center (NNRC) fellowship program was created as a model for engaging nurses at all levels of clinical practice to become active in clinical research. The NNRC was established in 2013 as a novel approach to promote bedside nurses as primary investigators in clinical research. The NNRC developed 4 pathways to nursing research success: research fellowship, student-nurse internship, didactic training, and research consultation. Fellows have enrolled more than 900 participants in 14 studies. Nurses have presented more than 20 abstracts at 12 conferences and submitted 11 manuscripts for publication. The NNRC has provided research training to more than 150 nurses. The NNRC program is successful in engaging nurses in research. It shows promise to continue to develop nursing research that is applicable to clinicians and thus improve patient care.

Antibiotic prescribing for respiratory infections at retail clinics, physician practices, and emergency departments.

PubMed

Mehrotra, Ateev; Gidengil, Courtney A; Setodji, Claude M; Burns, Rachel M; Linder, Jeffrey A

2015-04-01

To compare antibiotic prescribing among retail clinics, primary care practices, and emergency departments (EDs) for acute respiratory infections (ARIs): antibiotics-may-be-appropriate ARIs (eg, sinusitis) and antibiotics-never-appropriate ARIs (eg, acute bronchitis). We analyzed retail clinic data from the electronic health records of the 3 largest retail clinic chains in the United States, and data on visits to primary care practices and EDs from the nationally representative National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey. Using multivariate models, we estimated an adjusted antibiotic prescribing rate for each site of care, controlling for differences in patient characteristics and diagnosis. From 2007 to 2009 in the United States, there were 3 million, 167 million, and 29 million ARI visits at retail clinics, primary care practices, and EDs, respectively. For all ARI visits, the adjusted antibiotic prescribing rate at retail clinics (58%) was similar to the rate at primary care practices (62%; P=.09) and EDs (59%; P=.48). For antibiotics-may-be-appropriate ARI visits, the adjusted antibiotic prescribing rate (95%) at retail clinics was higher than at primary care practices (85%; P<.01) and EDs (83%; P<.01). For antibiotics-never-appropriate ARI visits, the adjusted antibiotic prescribing rate (34%) at retail clinics was lower than at primary care practices (51%; P<.01) and EDs (48%; P<.01). Compared with primary care practices and EDs, there was no difference at retail clinics in overall ARI antibiotic prescribing. At retail clinics, antibiotic prescribing was more diagnosis-appropriate.

Randomized controlled trial of the efficacy and safety of self-adhesive low-level light therapy in women with primary dysmenorrhea.

PubMed

Hong, Gi-Youn; Shin, Byung-Cheul; Park, Seong-Nam; Gu, Yun-Hee; Kim, Nam-Gyun; Park, Kyoung-Jun; Kim, Soo-Yeon; Shin, Yong-Il

2016-04-01

To evaluate the efficacy and safety of low-level light therapy in women with primary dysmenorrhea. A multicenter prospective, randomized, double-blind, placebo-controlled clinical trial including patients 18-35 years of age with primary dysmenorrhea was undertaken at two university hospitals in South Korea between October 2011 and September 2012. Patients were randomized using a computer-generated sequence to receive low-level light therapy using the Color DNA-WSF device or to receive placebo treatment with a dummy device. The severity of menstrual pain, assessed using a visual analog scale, was the primary outcome and was evaluated at baseline and during every menstrual cycle for 3 months following treatment. Patients who received more than one application of treatment (with a Color DNA-WSF or placebo device) were included in analyses. Patients and investigators were masked to the treatment assignments. Overall, 44 patients were assigned to each group. At the final study visit, the reduction in scores using a visual analog scale was significantly greater in patients who received low-level light therapy (n=41; 4.34±2.22) than among those in the control group (n=38; 1.79±1.73; P<0.001 when adjusted for age) No serious adverse events occurred. Low-level light therapy could be an effective, safe treatment modality for women with primary dysmenorrhea. Clinical Trials.gov: NCT02026206. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Does the Primary Care Behavioral Health Model Reduce Emergency Department Visits?

PubMed

Serrano, Neftali; Prince, Ronald; Fondow, Meghan; Kushner, Kenneth

2018-04-16

To examine the impact of integrating behavioral health services using the primary care behavioral health (PCBH) model on emergency department (ED) utilization. Utilization data from three Dane County, Wisconsin hospitals and four primary care clinics from 2003 to 2011. We used a retrospective, quasi-experimental, controlled, pre-post study design. Starting in 2007, two clinics began integrating behavioral health into their primary care practices with a third starting in 2010. A fourth, nonimplementing, community clinic served as control. Change in emergency department and primary care utilization (number of visits) for patients diagnosed with mood and anxiety disorders was the outcomes of interest. Retrospective data were obtained from electronic patient records from the three main area hospitals along with primary care data from participating clinics. Following the introduction of the PCBH model, one clinic experienced a statistically significant (p < .01, 95 percent CI 6.3-16.3 percent), 11.3 percent decrease in the ratio of ED visits to primary care encounters, relative to a control site, but two other intervention clinics did not. The PCBH model may be associated with a reduction in ED utilization, but better-controlled studies are needed to confirm this result. © Health Research and Educational Trust.

Ultrasound-Guided Application of Percutaneous Electrolysis as an Adjunct to Exercise and Manual Therapy for Subacromial Pain Syndrome: a Randomized Clinical Trial.

PubMed

de-Miguel-Valtierra, Lorena; Salom-Moreno, Jaime; Fernández-de-Las-Peñas, César; Cleland, Joshua A; Arias-Buría, José L

2018-05-16

This randomized clinical trial compared the effects of adding US-guided percutaneous electrolysis into a program consisting of manual therapy and exercise on pain, related-disability, function and pressure sensitivity in subacromial pain syndrome. Fifty patients with subacromial pain syndrome were randomized into manual therapy and exercise or percutaneous electrolysis group. All patients received the same manual therapy and exercise program, one session per week for 5 consecutive weeks. Patients assigned to the electrolysis group also received the application of percutaneous electrolysis at each session. The primary outcome was Disabilities of the Arm, Shoulder and Hand (DASH). Secondary outcomes included pain, function (Shoulder Pain and Disability Index-SPADI) pressure pain thresholds (PPTs) and Global Rating of Change (GROC). They were assessed at baseline, post-treatment, and 3, and 6 months after treatment. Both groups showed similar improvements in the primary outcome (DASH) at all follow-ups (P=0.051). Subjects receiving manual therapy, exercise, and percutaneous electrolysis showed significantly greater changes in shoulder pain (P<0.001) and SPADI (P<0.001) than those receiving manual therapy and exercise alone at all follow-ups. Effect sizes were large (SMD>0.91) for shoulder pain and function at 3 and 6 months in favour of the percutaneous electrolysis group. No between-groups differences in PPT were found. The current clinical trial found that the inclusion of US-guided percutaneous electrolysis in combination with manual therapy and exercise resulted in no significant differences for related-disability (DASH) than the application of manual therapy and exercise alone in patients with subacromial pain syndrome. Nevertheless, differences were reported for some secondary outcomes such as shoulder pain and function (SPADI). Whether or not these effects are reliable should be addressed in future studies Perspective This study found that the inclusion of US-guided percutaneous electrolysis into a manual therapy and exercise program resulted in no significant differences for disability and pressure pain sensitivity than the application of manual therapy and exercise alone in patients with subacromial pain syndrome. Copyright © 2018. Published by Elsevier Inc.

What is the actual epidemiology of familial hypercholesterolemia in Italy? Evidence from a National Primary Care Database.

PubMed

Guglielmi, Valeria; Bellia, Alfonso; Pecchioli, Serena; Medea, Gerardo; Parretti, Damiano; Lauro, Davide; Sbraccia, Paolo; Federici, Massimo; Cricelli, Iacopo; Cricelli, Claudio; Lapi, Francesco

2016-11-15

There are some inconsistencies on prevalence estimates of familial hypercholesterolemia (FH) in general population across Europe due to variable application of its diagnostic criteria. We aimed to investigate the FH epidemiology in Italy applying the Dutch Lipid Clinical Network (DLCN) score, and two alternative diagnostic algorithms to a primary care database. We performed a retrospective population-based study using the Health Search IMS Health Longitudinal Patient Database (HSD) and including active (alive and currently registered with their general practitioners (GPs)) patients on December 31, 2014. Cases of FH were identified by applying DLCN score. Two further algorithms, based on either ICD9CM coding for FH or some clinical items adopted by the DLCN, were tested towards DLCN itself as gold standard. We estimated a prevalence of 0.01% for "definite" and 0.18% for "definite" plus "probable" cases as per the DLCN. Algorithms 1 and 2 reported a FH prevalence of 0.9 and 0.13%, respectively. Both algorithms resulted in consistent specificity (1: 99.10%; 2: 99.9%) towards DLCN, but Algorithm 2 considerably better identified true positive (sensitivity=85.90%) than Algorithm 1 (sensitivity=10.10%). The application of DLCN or valid diagnostic alternatives in the Italian primary care setting provides estimates of FH prevalence consistent with those reported in other screening studies in Caucasian population. These diagnostic criteria should be therefore fostered among GPs. In the perspective of FH new therapeutic options, the epidemiological picture of FH is even more relevant to foresee the costs and to plan affordable reimbursement programs in Italy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Effectiveness of a multifactorial intervention based on an application for smartphones, heart-healthy walks and a nutritional workshop in patients with type 2 diabetes mellitus in primary care (EMID): study protocol for a randomised controlled trial

PubMed Central

Alonso-Domínguez, Rosario; Gómez-Marcos, Manuel A; Patino-Alonso, Maria C; Sánchez-Aguadero, Natalia; Agudo-Conde, Cristina; Castaño-Sánchez, Carmen; García-Ortiz, Luis; Recio-Rodríguez, José I

2017-01-01

Introduction New information and communication technologies (ICTs) may promote lifestyle changes, but no adequate evidence is available on their combined effect of ICTs with multifactorial interventions aimed at improving diet and increasing physical activity in patients with type 2 diabetes mellitus (DM2). The primary objective of this study is to assess the effect of a multifactorial intervention to increase physical activity and adherence to Mediterranean diet in DM2. Methods and analysis Study scope and population: The study will be conducted at ‘La Alamedilla’ primary care research unit in Salamanca (Spain). 200 patients with DM2 of both sexes, aged 25–70 years and who meet the inclusion criteria and sign the informed consent will be recruited. Each participant will attend the clinic at baseline and 3 and 12 months after intervention. Intervention Both groups will be given short advice on diet and physical activity. The intervention group will also take five heart-healthy walks and attend a group session on diet education and will be trained on use of an application for smartphone (EVIDENT II) for 3 months. Variables and measurement instruments The main study endpoints will be changes in physical activity, as assessed by a pedometer and the International Physical Activity Questionnaire, and adherence to the Mediterranean diet, as evaluated by an adherence questionnaire and the Diet Quality Index. Anthropometric parameters and laboratory values, lifestyles and quality of life will also be assessed. Ethics and dissemination It was approved by the Clinical Research Ethics Committee of Salamanca on 28/11/2016. Trial registration NCT02991079; Pre-results. PMID:28912193

Development of a Primary Care-Based Clinic to Support Adults With a History of Childhood Cancer: The Tactic Clinic.

PubMed

Overholser, Linda S; Moss, Kerry M; Kilbourn, Kristin; Risendal, Betsy; Jones, Alison F; Greffe, Brian S; Garrington, Timothy; Leonardi-Warren, Kristin; Yamashita, Traci E; Kutner, Jean S

2015-01-01

Describe the development and evolution of a primary-care-based, multidisciplinary clinic to support the ongoing care of adult survivors of childhood cancer. A consultative clinic for adult survivors of childhood cancer has been developed that is located in an adult, academic internal medicine setting and is based on a long-term follow-up clinic model available at Children's Hospital Colorado. The clinic opened in July 2008. One hundred thirty-five patients have been seen as of April 2014. Referrals and clinic capacity have gradually increased over time, and a template has been developed in the electronic medical record to help facilitate completion of individualized care plan letters. A primary care-based, multidisciplinary consultative clinic for adults with a history of childhood cancer survivor is feasible and actively engages adult primary care resources to provide risk-based care for long-term pediatric cancer survivors. This model of care planning can help support adult survivors of pediatric cancer and their primary care providers in non-academic, community settings as well. Copyright © 2015 Elsevier Inc. All rights reserved.

Reticulated vitreous carbon: a useful material for cell adhesion and tissue invasion.

PubMed

Pec, M K; Reyes, R; Sánchez, E; Carballar, D; Delgado, A; Santamaría, J; Arruebo, M; Evora, C

2010-10-06

Diverse carbon materials have been used for tissue engineering and clinical implant applications with varying success. In this study, commercially available reticulated vitreous carbon (RVC) foams were tested in vitro and in vivo for compatibility with primary cell adhesion and tissue repair. Pores sizes were determined as 279 ± 98 μm. No hydroxyapatite deposition was detected after immersion of the foams in simulated body fluid. Nonetheless, RVC provided an excellent support for adhesion of mesenchymal stem cells (MSCs) as well as primary chondrocytes without any surface pre-treatment. Live cell quantification revealed neutral behaviour of the material with plastic adhered chondrocytes but moderate cytotoxicity with MSCs. Yet, rabbit implanted foams exhibited good integration in subcutaneous pockets and most importantly, total defect repair in bone. Probably due to the stiffness of the material, incompatibility with cartilage regeneration was found. Interestingly and in contrast to several other carbon materials, we observed a total lack of foreign body reactions. Our results and its outstanding porous interconnectivity and availability within a wide range of pore sizes convert RVC into an attractive candidate for tissue engineering applications in a variety of bone models and for ex vivo cell expansion for regenerative medical applications.

40 CFR 421.300 - Applicability: Description of the primary and secondary titanium subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... primary and secondary titanium subcategory. 421.300 Section 421.300 Protection of Environment... POINT SOURCE CATEGORY Primary and Secondary Titanium Subcategory § 421.300 Applicability: Description of the primary and secondary titanium subcategory. The provisions of this subpart are applicable to...

40 CFR 421.300 - Applicability: Description of the primary and secondary titanium subcategory.

Code of Federal Regulations, 2012 CFR

2012-07-01

... primary and secondary titanium subcategory. 421.300 Section 421.300 Protection of Environment... POINT SOURCE CATEGORY Primary and Secondary Titanium Subcategory § 421.300 Applicability: Description of the primary and secondary titanium subcategory. The provisions of this subpart are applicable to...

40 CFR 421.300 - Applicability: Description of the primary and secondary titanium subcategory.

Code of Federal Regulations, 2013 CFR

2013-07-01

... primary and secondary titanium subcategory. 421.300 Section 421.300 Protection of Environment... POINT SOURCE CATEGORY Primary and Secondary Titanium Subcategory § 421.300 Applicability: Description of the primary and secondary titanium subcategory. The provisions of this subpart are applicable to...

40 CFR 421.300 - Applicability: Description of the primary and secondary titanium subcategory.

Code of Federal Regulations, 2011 CFR

2011-07-01

... primary and secondary titanium subcategory. 421.300 Section 421.300 Protection of Environment... POINT SOURCE CATEGORY Primary and Secondary Titanium Subcategory § 421.300 Applicability: Description of the primary and secondary titanium subcategory. The provisions of this subpart are applicable to...

40 CFR 421.300 - Applicability: Description of the primary and secondary titanium subcategory.

Code of Federal Regulations, 2014 CFR

2014-07-01

... primary and secondary titanium subcategory. 421.300 Section 421.300 Protection of Environment... POINT SOURCE CATEGORY Primary and Secondary Titanium Subcategory § 421.300 Applicability: Description of the primary and secondary titanium subcategory. The provisions of this subpart are applicable to...

40 CFR 421.80 - Applicability: Description of the primary zinc subcategory.

Code of Federal Regulations, 2011 CFR

2011-07-01

... primary zinc subcategory. 421.80 Section 421.80 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Zinc Subcategory § 421.80 Applicability: Description of the primary zinc subcategory. The provisions of this subpart are applicable to discharges resulting from the production of primary zinc by either...

40 CFR 421.80 - Applicability: Description of the primary zinc subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... primary zinc subcategory. 421.80 Section 421.80 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Zinc Subcategory § 421.80 Applicability: Description of the primary zinc subcategory. The provisions of this subpart are applicable to discharges resulting from the production of primary zinc by either...

40 CFR 421.70 - Applicability: Description of the primary lead subcategory.

Code of Federal Regulations, 2011 CFR

2011-07-01

... primary lead subcategory. 421.70 Section 421.70 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Lead Subcategory § 421.70 Applicability: Description of the primary lead subcategory. The provisions of this subpart are applicable to discharges resulting from the production of lead at primary lead...

40 CFR 421.70 - Applicability: Description of the primary lead subcategory.

Code of Federal Regulations, 2014 CFR

2014-07-01

... primary lead subcategory. 421.70 Section 421.70 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Lead Subcategory § 421.70 Applicability: Description of the primary lead subcategory. The provisions of this subpart are applicable to discharges resulting from the production of lead at primary lead...

40 CFR 421.70 - Applicability: Description of the primary lead subcategory.

Code of Federal Regulations, 2013 CFR

2013-07-01

... primary lead subcategory. 421.70 Section 421.70 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Lead Subcategory § 421.70 Applicability: Description of the primary lead subcategory. The provisions of this subpart are applicable to discharges resulting from the production of lead at primary lead...

40 CFR 421.70 - Applicability: Description of the primary lead subcategory.

Code of Federal Regulations, 2012 CFR

2012-07-01

... primary lead subcategory. 421.70 Section 421.70 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Lead Subcategory § 421.70 Applicability: Description of the primary lead subcategory. The provisions of this subpart are applicable to discharges resulting from the production of lead at primary lead...

40 CFR 421.330 - Applicability: Description of the primary zirconium and hafnium subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... primary zirconium and hafnium subcategory. 421.330 Section 421.330 Protection of Environment ENVIRONMENTAL... CATEGORY Primary Zirconium and Hafnium Subcategory § 421.330 Applicability: Description of the primary zirconium and hafnium subcategory. The provisions of this subpart are applicable to discharges resulting...

40 CFR 421.70 - Applicability: Description of the primary lead subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... primary lead subcategory. 421.70 Section 421.70 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Lead Subcategory § 421.70 Applicability: Description of the primary lead subcategory. The provisions of this subpart are applicable to discharges resulting from the production of lead at primary lead...

40 CFR 421.210 - Applicability: Description of the primary molybdenum and rhenium subcategory.

Code of Federal Regulations, 2013 CFR

2013-07-01

... primary molybdenum and rhenium subcategory. 421.210 Section 421.210 Protection of Environment... POINT SOURCE CATEGORY Primary Molybdenum and Rhenium Subcategory § 421.210 Applicability: Description of the primary molybdenum and rhenium subcategory. The provisions of this subpart are applicable to...

40 CFR 421.210 - Applicability: Description of the primary molybdenum and rhenium subcategory.

Code of Federal Regulations, 2012 CFR

2012-07-01

... primary molybdenum and rhenium subcategory. 421.210 Section 421.210 Protection of Environment... POINT SOURCE CATEGORY Primary Molybdenum and Rhenium Subcategory § 421.210 Applicability: Description of the primary molybdenum and rhenium subcategory. The provisions of this subpart are applicable to...

40 CFR 421.210 - Applicability: Description of the primary molybdenum and rhenium subcategory.

Code of Federal Regulations, 2014 CFR

2014-07-01

... primary molybdenum and rhenium subcategory. 421.210 Section 421.210 Protection of Environment... POINT SOURCE CATEGORY Primary Molybdenum and Rhenium Subcategory § 421.210 Applicability: Description of the primary molybdenum and rhenium subcategory. The provisions of this subpart are applicable to...

40 CFR 421.210 - Applicability: Description of the primary molybdenum and rhenium subcategory.

Code of Federal Regulations, 2011 CFR

2011-07-01

... primary molybdenum and rhenium subcategory. 421.210 Section 421.210 Protection of Environment... POINT SOURCE CATEGORY Primary Molybdenum and Rhenium Subcategory § 421.210 Applicability: Description of the primary molybdenum and rhenium subcategory. The provisions of this subpart are applicable to...

40 CFR 421.210 - Applicability: Description of the primary molybdenum and rhenium subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... primary molybdenum and rhenium subcategory. 421.210 Section 421.210 Protection of Environment... POINT SOURCE CATEGORY Primary Molybdenum and Rhenium Subcategory § 421.210 Applicability: Description of the primary molybdenum and rhenium subcategory. The provisions of this subpart are applicable to...

Clinical pharmacy cardiac risk service for managing patients with coronary artery disease in a health maintenance organization.

PubMed

Sandhoff, Brian G; Nies, Leslie K; Olson, Kari L; Nash, James D; Rasmussen, Jon R; Merenich, John A

2007-01-01

A clinical pharmacy service for managing the treatment of coronary artery disease in a health maintenance organization is described. Despite the proven benefits of aggressive risk factor modification for patients with coronary artery disease (CAD), there remains a treatment gap between consensus- and evidence-based recommendations and their application in patient care. In 1998, Kaiser Permanente of Colorado developed the Clinical Pharmacy Cardiac Risk Service (CPCRS) to focus on the long-term management of patients with CAD to improve clinical outcomes. The primary goals of the CPCRS are to increase the number of CAD patients on lipid-lowering therapy, manage medications shown to decrease the risk of future CAD-related events, assist in the monitoring and control of other diseases that increase cardiovascular risk, provide patient education and recommendations for nonpharmacologic therapy, and act as a CAD information resource for physicians and other health care providers. Using an electronic medical record and tracking database, the service works in close collaboration with primary care physicians, cardiologists, cardiac rehabilitation nurses, and other health care providers to reduce cardiac risk in the CAD population. Particular attention is given to dyslipidemia, blood pressure, diabetes mellitus, and tobacco cessation. Treatment with evidence-based regimens is initiated and adjusted as necessary. Over 11,000 patients are currently being followed by the CPCRS. A clinical pharmacy service in a large health maintenance organization provides cardiac risk reduction for patients with CAD and helps close treatment gaps that may exist for these patients.

Psychiatric Consultation in Community Clinics: A Decade of Experience in the Community Clinics in Jerusalem.

PubMed

Avny, Ohad; Teitelbaum, Tatiana; Simon, Moshe; Michnick, Tatiana; Siman-Tov, Maya

2016-01-01

A consultation model between primary care physicians and psychiatrists that has been in operation for 12 years in the Jerusalem district of the Clalit Health Services in Israel is evaluated. In this model psychiatrists provide consultations twice a month at the primary care clinic. All patients are referred by their family physicians. Communication between the psychiatric consultant and the referring physician is carried out by telephone, correspondence and staff meetings. Evaluation of the psychiatric care consultation model in which a psychiatrist consults at the primary care clinic. A questionnaire-based survey distributed to 17 primary care physicians in primary care clinics in Jerusalem in which a psychiatric consultant is present. Almost all of the doctors (93%) responded that the consultation model was superior to the existing model of referral to a secondary psychiatric clinic alone and reduced the workload in caring for the referred patients. The quality of psychiatric care was correlated with the depression prevalence among patients referred for consultation at their clinic (r=0.530, p=0.035). In addition, correlation was demonstrated between primary care physicians impression of alleviation of care of patients and their impression of extent of the patients' cooperation with the consulting psychiatrist (r=0.679, p = 0.015) Conclusions: Very limited conclusions may be drawn from this questionnaire distributed to primary care physicians who were asked to assess psychiatric consultation in their clinic. Our conclusion could be influenced by the design and the actual distribution of the questionnaires by the consulting psychiatrist. Nevertheless answers to the questionnaire might imply that the consultation model of care between a psychiatric consultant and the primary care physician, where the patient's primary care physician takes a leading role in his psychiatric care, is perceived by family physicians as a good alternative to referral to a psychiatric clinic, especially when treating patients suffering from depression.

Clinical utility of measures of breathlessness.

PubMed

Cullen, Deborah L; Rodak, Bernadette

2002-09-01

The clinical utility of measures of dyspnea has been debated in the health care community. Although breathlessness can be evaluated with various instruments, the most effective dyspnea measurement tool for patients with chronic lung disease or for measuring treatment effectiveness remains uncertain. Understanding the evidence for the validity and reliability of these instruments may provide a basis for appropriate clinical application. Evaluate instruments designed to measure breathlessness, either as single-symptom or multidimensional instruments, based on psychometrics foundations such as validity, reliability, and discriminative and evaluative properties. Classification of each dyspnea measurement instrument will recommend clinical application in terms of exercise, benchmarking patients, activities of daily living, patient outcomes, clinical trials, and responsiveness to treatment. Eleven dyspnea measurement instruments were selected. Each instrument was assessed as discriminative or evaluative and then analyzed as to its psychometric properties and purpose of design. Descriptive data from all studies were described according to their primary patient application (ie, chronic obstructive pulmonary disease, asthma, or other patient populations). The Borg Scale and the Visual Analogue Scale are applicable to exertion and thus can be applied to any cardiopulmonary patient to determine dyspnea. All other measures were determined appropriate for chronic obstructive pulmonary disease, whereas the Shortness of Breath Questionnaire can be applied to cystic fibrosis and lung transplant patients. The most appropriate utility for all instruments was measuring the effects on activities of daily living and for benchmarking patient progress. Instruments that quantify function and health-related quality of life have great utility for documenting outcomes but may be limited as to documenting treatment responsiveness in terms of clinically important changes. The dyspnea measurement instruments we studied meet important standards of validity and reliability. Discriminative measures have limited clinical utility and, when used for populations or conditions for which they are not designed or validated, the data collected may not be clinically relevant. Evaluative measures have greater clinical utility and can be applied for outcome purposes. Measures should be applied to the populations and conditions for which they were designed. The relationship between clinical therapies and the measurement of dyspnea as an outcome can develop as respiratory therapists become more comfortable with implementing dyspnea measurement instruments and use the data to improve patient treatment. Dyspnea evaluation should be considered for all clinical practice guidelines and care pathways.

40 CFR 421.270 - Applicability: Description of the primary rare earth metals subcategory.

Code of Federal Regulations, 2014 CFR

2014-07-01

... primary rare earth metals subcategory. 421.270 Section 421.270 Protection of Environment ENVIRONMENTAL... CATEGORY Primary Rare Earth Metals Subcategory § 421.270 Applicability: Description of the primary rare earth metals subcategory. The provisions of this subpart are applicable to discharges resulting from the...

40 CFR 421.270 - Applicability: Description of the primary rare earth metals subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... primary rare earth metals subcategory. 421.270 Section 421.270 Protection of Environment ENVIRONMENTAL... CATEGORY Primary Rare Earth Metals Subcategory § 421.270 Applicability: Description of the primary rare earth metals subcategory. The provisions of this subpart are applicable to discharges resulting from the...

40 CFR 421.270 - Applicability: Description of the primary rare earth metals subcategory.

Code of Federal Regulations, 2012 CFR

2012-07-01

... primary rare earth metals subcategory. 421.270 Section 421.270 Protection of Environment ENVIRONMENTAL... CATEGORY Primary Rare Earth Metals Subcategory § 421.270 Applicability: Description of the primary rare earth metals subcategory. The provisions of this subpart are applicable to discharges resulting from the...

40 CFR 421.270 - Applicability: Description of the primary rare earth metals subcategory.

Code of Federal Regulations, 2011 CFR

2011-07-01

... primary rare earth metals subcategory. 421.270 Section 421.270 Protection of Environment ENVIRONMENTAL... CATEGORY Primary Rare Earth Metals Subcategory § 421.270 Applicability: Description of the primary rare earth metals subcategory. The provisions of this subpart are applicable to discharges resulting from the...

40 CFR 421.270 - Applicability: Description of the primary rare earth metals subcategory.

Code of Federal Regulations, 2013 CFR

2013-07-01

... primary rare earth metals subcategory. 421.270 Section 421.270 Protection of Environment ENVIRONMENTAL... CATEGORY Primary Rare Earth Metals Subcategory § 421.270 Applicability: Description of the primary rare earth metals subcategory. The provisions of this subpart are applicable to discharges resulting from the...

Simple method to distinguish between primary and secondary C3 deficiencies.

PubMed

Pereira de Carvalho Florido, Marlene; Ferreira de Paula, Patrícia; Isaac, Lourdes

2003-03-01

Due to the increasing numbers of reported clinical cases of complement deficiency in medical centers, clinicians are now more aware of the role of the complement system in the protection against infections caused by microorganisms. Therefore, clinical laboratories are now prepared to perform a number of diagnostic tests of the complement system other than the standard 50% hemolytic component assay. Deficiencies of alternative complement pathway proteins are related to severe and recurrent infections; and the application of easy, reliable, and low-cost methods for their detection and distinction are always welcome, notably in developing countries. When activation of the alternative complement pathway is evaluated in hemolytic agarose plates, some but not all human sera cross-react to form a late linear lysis. Since the formation of this linear lysis is dependent on C3 and factor B, it is possible to use late linear lysis to routinely screen for the presence of deficiencies of alternative human complement pathway proteins such as factor B. Furthermore, since linear lysis is observed between normal human serum and primary C3-deficient serum but not between normal human serum and secondary C3-deficient serum caused by the lack of factor H or factor I, this assay may also be used to discriminate between primary and secondary C3 deficiencies.

Photodynamic application in neurosurgery: present and future

NASA Astrophysics Data System (ADS)

Kostron, Herwig

2009-06-01

Photodynamic techniques such as photodynamic diagnosis (PDD), fluorescence guided tumor resection (FGR) and photodynamic therapy (PDT) are currently undergoing intensive clinical investigations as adjunctive treatment for malignant brain tumours. This review provides an overview on the current clinical data and trials as well as on photosensitisers, technical developments and indications for photodynamic application in Neurosurgery. Furthermore new developments and clinical significance of FGR for neurosurgery will be discussed. Over 1000 patients were enrolled in various clinical phase I/II trials for PDT for malignant brain tumours. Despite various treatment protocols, variation of photosensitisers and light dose there is a clear trend towards prolonging median survival after one single PDT as compared to conventional therapeutic modalities. The median survival after PDT for primary glioblastoma multiforme WHO IV was 19 months and for recurrent GBM 9 months as compared to standard convential treatment which is 15 months and 3 months, respectively. FGR in combination with adjunctive radiation was significantly superior to standard surgical resection followed by radiation. The combination of FGR/PDD and intraoperative PDT increased significantly survival in recurrent glioblastoma patients. The combination of PDD/ FGR and PDT offers an exciting approach to the treatment of malignant brain tumours "to see and to treat." PDT was generally well tolerated and side effects consisted of occasionally increased intracranial pressure and prolonged skin sensitivity against direct sunlight. This review covers the current available data and draws the future potential of PDD and PDT for its application in neurosurgery.

Immediate and long-term efficacy and safety of photodynamic therapy with Photolon (Fotolon): a seven-year clinical experience

NASA Astrophysics Data System (ADS)

Istomin, Yuri P.; Kaplan, Michael A.; Shliakhtsin, Siarhei V.; Lapzevich, Tatsiana P.; Cerkovsky, Dmitriy A.; Marchanka, Ludmila N.; Fedulov, Alexander S.; Trukhachova, Tatsiana V.

2009-06-01

The purpose of the present study was to summarize data on the long-term efficacy of photodynamic therapy (PDT) with Photolon in patients with malignant tumors of various types and localizations. The data obtained show that PDT with Photolon is a highly effective therapeutic modality for the treatment of skin tumors, cervical intraepithelial neoplasias, lung cancers, disseminated forms of melanoma, primary and metastatic brain tumors, several ophthalmologic diseases. This paper provides a review of most illustrative studies of the application of PDT with Photolon for the treatment of different oncological and non-oncological diseases performed in leading clinical centers of the Republic of Belarus and Russia.

Determinants for successful marketing authorisation of orphan medicinal products in the EU.

PubMed

Putzeist, Michelle; Heemstra, Harald E; Garcia, Jordi Llinares; Mantel-Teeuwisse, Aukje K; Gispen-De Wied, Christine C; Hoes, Arno W; Leufkens, Hubert G M

2012-04-01

In 2010, the European Regulation for Orphan Medicinal Products (OMPs) was in force for ten years. In this study we assessed possible determinants of applications for OMPs in the EU since 2000 that are associated with a successful marketing authorisation. Our analysis shows that clinical trial characteristics such as demonstrating convincing evidence of a beneficial effect on the primary endpoint, the selection of a clinically relevant endpoint, providing RCT data as pivotal study evidence and the submission of sound dose finding data are critical success factors. In addition, high medical need seems to counterweigh uncertainties about the scientific evidence in the benefit-risk assessment of OMPs. Copyright © 2011 Elsevier Ltd. All rights reserved.

General Information about Primary CNS Lymphoma

MedlinePlus

... Primary CNS Lymphoma Treatment (PDQ®)–Patient Version General Information About Primary CNS Lymphoma Go to Health Professional ... the PDQ Adult Treatment Editorial Board . Clinical Trial Information A clinical trial is a study to answer ...

Changing Patterns of Mental Health Care Use: The Role of Integrated Mental Health Services in Veteran Affairs Primary Care.

PubMed

Leung, Lucinda B; Yoon, Jean; Rubenstein, Lisa V; Post, Edward P; Metzger, Maureen E; Wells, Kenneth B; Sugar, Catherine A; Escarce, José J

2018-01-01

Aiming to foster timely, high-quality mental health care for Veterans, VA's Primary Care-Mental Health Integration (PC-MHI) embeds mental health specialists in primary care and promotes care management for depression. PC-MHI and patient-centered medical home providers work together to provide the bulk of mental health care for primary care patients with low-to-moderate-complexity mental health conditions. This study examines whether increasing primary care clinic engagement in PC-MHI services is associated with changes in patient health care utilization and costs. We performed a retrospective longitudinal cohort study of primary care patients with identified mental health needs in 29 Southern California VA clinics from October 1, 2008 to September 30, 2013, using electronic administrative data (n = 66,638). We calculated clinic PC-MHI engagement as the proportion of patients receiving PC-MHI services among all primary care clinic patients in each year. Capitalizing on variation in PC-MHI engagement across clinics, our multivariable regression models predicted annual patient use of 1) non-primary care based mental health specialty (MHS) visits, 2) total mental health visits (ie, the sum of MHS and PC-MHI visits), and 3) health care utilization and costs. We controlled for year- and clinic-fixed effects, other clinic interventions, and patient characteristics. Median clinic PC-MHI engagement increased by 8.2 percentage points over 5 years. At any given year, patients treated at a clinic with 1 percentage-point higher PC-MHI engagement was associated with 0.5% more total mental health visits (CI, 0.18% to 0.90%; P = .003) and 1.0% fewer MHS visits (CI, -1.6% to -0.3%; P = .002); this is a substitution rate, at the mean, of 1.5 PC-MHI visits for each MHS visit. There was no PC-MHI effect on other health care utilization and costs. As intended, greater clinic engagement in PC-MHI services seems to increase realized accessibility to mental health care for primary care patients, substituting PC-MHI for MHS visits, without increasing acute care use or total costs. Thus, PC-MHI services within primary care clinics may improve mental health care value at the patient population level. More research is needed to understand the relationship between clinic PC-MHI engagement and clinical quality of mental health care. © Copyright 2018 by the American Board of Family Medicine.

An mHealth App for Decision-Making Support in Wound Dressing Selection (WounDS): Protocol for a User-Centered Feasibility Study.

PubMed

Jordan, Scott; McSwiggan, Jane; Parker, Joanne; Halas, Gayle A; Friesen, Marcia

2018-04-24

Primary care health professionals, especially family physicians, see a variety of wounds, and yet-despite the frequency of providing wound care-many family physicians do not feel confident in wound care management. This is partly due to a lack of formal wound education in Family Medicine programs. While there are numerous electronic wound care resources available in the UK and North America, none were identified that address the specific need in supporting clinical decision-making in wound dressing selection. At the same time, healthcare providers are increasingly using technology in personal and professional contexts, and a logical extension is to use technology for knowledge translation strategies. This work developed a prototype mobile health software application named WounDS, designed to support clinical decision-making in selecting wound dressings. This article presents the development and evaluation plan for the WounDS app. WounDS has been developed on the iOS platform. The primary specification included ease of use, in that one of the primary influences in user adoption would be the ability to receive a wound dressing recommendation in under 30 seconds and under 5 taps on the screen. The WounDS app guides users through a series of binary decisions for assessing the wound and provides a wound dressing recommendation. The selection algorithm is based in best practices using the Wound Bed Preparation Paradigm. Current work is underway to examine the implementation needs for WounDS to be most effectively utilized and to pilot test its feasibility and use in clinical care. Data will be collected through user trials, focus groups, and user metadata will be collected within the app. Optimizing these preconditions will enable a subsequent phase of study to determine effects on clinical decision-making and clinical outcomes. WounDS is designed for knowledge translation, use of technology in clinical decision-making, and continuity of care. The benefits of WounDS include the potential to improve healthcare providers' competency in wound management and to improve wound healing through better alignment with evidence-based best practices in wound dressing selection, consistency in care from primary to community care, and subsequent downstream impacts in quality of life for patients. ©Scott Jordan, Jane McSwiggan, Joanne Parker, Gayle A. Halas, Marcia Friesen. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 24.04.2018.

Alcohol Devitalization and Replantation for Primary Malignant Bone Tumors of the Knee Joint

PubMed Central

ZHANG, Xihai; CHEN, Ge; WANG, Jun; TANG, Lian; YIN, Yiran

2017-01-01

Background: This paper is aimed at studying the therapeutic effects of in situ replantation of alcohol-devitalized bone segments to treat malignant bone tumors of the knee joint. Methods: We retrospectively analyzed clinical data for 45 patients from January 2013 to January 2016 who underwent replantation following alcohol-devitalization of bone segments and 40 who underwent prosthesis implantation. The two groups were comparable in basal clinical biometric data, including gender, age, tumor type and location, Enneking staging, and maximum tumor diameter. Radical tumor resection was combined with neoadjuvant chemotherapy following the two-implantation procedures. Results: The median follow-up time was 25 months, and the outcomes were compared. We found no differences in the length of bone lesions, surgery time, intraoperative blood loss, amount of postoperative drainage, and perioperative complications, which were just three for each method. We also found no significant differences in limb function scores, internal fixation imaging scores, tumor-free survival rate, and overall survival rate between the two groups. Replantation following alcohol-devitalization of tumor-bearing bone segment demonstrated similar clinical outcomes compared with prosthesis implantation in the treatment of primary malignant bone tumors of the knee joint. Conclusion: Both therapies enjoy good application safety and effectiveness. Because alcohol devitalization is inexpensive and easy to apply in the clinic, it should be considered a preferred method in the treatment of bone tumors. PMID:29308374

Characteristics of antimicrobial studies registered in the USA through ClinicalTrials.Gov

PubMed Central

Stockmann, Chris; Sherwin, Catherine M.T.; Ampofo, Krow; Hersh, Adam L.; Pavia, Andrew T.; Byington, Carrie L.; Ward, Robert M.; Spigarelli, Michael G.

2013-01-01

Increasing rates of antimicrobial-resistant infections and the dwindling pipeline of new agents necessitate judicious, evidence-based antimicrobial prescribing. Clinical trials represent a vital resource for establishing evidence of safety and efficacy, which are crucial to guiding antimicrobial treatment decisions. The objective of this study was to comprehensively evaluate the characteristics of antimicrobial research studies registered in ClinicalTrials.gov. Primary outcome measures, funding sources, inclusion criteria and the reporting of study results were evaluated for 16 055 antimicrobial studies registered in ClinicalTrials.gov as of mid 2012. Interventional studies accounted for 93% of registered antimicrobial studies. Clinical trials of drugs (82%) and biologics (9%) were most common. Antibacterial, antiviral and antifungal studies accounted for 43%, 41% and 16% of drug trials, respectively. Among interventional drug trials, 73% featured randomised allocation to study arms and 71% included measures of safety and/or efficacy as primary endpoints. Children were eligible for enrolment in 26% of studies. Among the studies, 60% were sponsored primarily by non-profit organisations, 30% by industry and 10% by the federal government. Only 7% of studies reported results; however, 71% of these were sponsored primarily by industry. Antimicrobial studies commonly incorporated elements of high-quality trial design, including randomisation and safety/efficacy endpoints. Publication of study results and updating of ClinicalTrials.gov should be encouraged for all studies, with particular attention paid to research sponsored by non-profit organisations and governmental agencies. Leveraging the application of these data to guide the careful selection of antimicrobial agents will be essential to preserve their utility for years to come. PMID:23726436

The selective estrogen receptor modulators in breast cancer prevention.

PubMed

Li, Fangxuan; Dou, Jinli; Wei, Lijuan; Li, Shixia; Liu, Juntian

2016-05-01

Persistently increased blood levels of estrogens are associated with an increased risk of breast cancer. Selective estrogen receptor modulators (SERMs) are a class of compounds that act on the estrogen receptor (ER). Several clinical trials have demonstrated the effectiveness of its prophylactic administration. Incidence of invasive ER-positive breast cancer was reduced by SERMs treatment, especially for those women with high risk of developing breast cancer. In this study, we reviewed the clinical application of SERMs in breast cancer prevention. To date, four prospective randomized clinical trials had been performed to test the efficacy of tamoxifen for this purpose. Concerning on the benefit and cost of tamoxifen, various studies from different countries demonstrated that chemoprevention with tamoxifen seemed to be cost-effective for women with a high risk of invasive breast cancer. Based above, tamoxifen was approved for breast cancer prevention by the US Food and Drug Administration in 1998. Raloxifene was also approved for postmenopausal women in 2007 for breast cancer prevention which reduces the risk of invasive breast cancer with a lower risk of unwanted stimulation of endometrium. Thus, raloxifene is considered to have a better clinical possesses as prophylactic agent. Several other agents, such as arzoxifene and lasofoxifene, are currently being investigated in clinic. The American Society of Clinical Oncology and National Comprehensive Cancer Network had published guidelines on breast cancer chemoprevention by SERMs. However, use of tamoxifen and raloxifene for primary breast cancer prevention was still low. A broader educational effort is needed to alert women and primary care physicians that SERMs are available to reduce breast cancer risk.

Hospital quality of care: does information technology matter? The relationship between information technology adoption and quality of care.

PubMed

Menachemi, Nir; Chukmaitov, Askar; Saunders, Charles; Brooks, Robert G

2008-01-01

Hospitals have been slow to adopt information technology (IT) largely because of a lack of generalizable evidence of the value associated with such adoption. To explore the relationship between IT adoption and quality of care in acute-care hospitals. Primary data on hospital IT adoption were combined with secondary hospital discharge data. Regression analyses were used to examine the relationship between various measures of IT adoption and several quality indicators after controlling for confounders. Adoption of IT was measured using a previously validated method that considers clinical, administrative, and strategic IT capabilities of acute-care hospitals. Quality measures included the Inpatient Quality Indicators developed by the Agency for Healthcare Research and Quality. Data from 98 hospitals were available for analyses. Hospitals adopted an average of 11.3 (45.2%) clinical IT applications, 15.7 (74.8%) administrative IT applications, and 5 (50%) strategic IT applications. In multivariate regression analyses, hospitals that adopted a greater number of IT applications were significantly more likely to have desirable quality outcomes on seven Inpatient Quality Indicator measures, including risk-adjusted mortality from percutaneous transluminal coronary angioplasty, gastrointestinal hemorrhage, and acute myocardial infarction. An increase in clinical IT applications was also inversely correlated with utilization of incidental appendectomy, and an increase in the adoption of strategic IT applications was inversely correlated with risk-adjusted mortality from craniotomy and laparoscopic cholecystectomy. Hospital adoption of IT is associated with desirable quality outcomes across hospitals in Florida. These findings will assist hospital leaders interested in understanding better the effect of costly IT adoption on quality of care in their institutions.

[Implications in primary health care of medical genetics and genomic in type 2 diabetes mellitus].

PubMed

Ramirez-Garcia, Sergio Alberto; Cabrera-Pivaral, Carlos E; Huacuja-Ruiz, Luis; Flores-Alvarado, Luis Javier; Pérez-García, Guillermo; González-Rico, José Luis; López-Velázquez, Alma; Topete-González, Luz Rosalba; Rosales-Góme, Roberto Carlos; Candelario-Mejía, Gerardo; Villa-Ruano, Nemesio

2013-01-01

Type 2 diabetes mellitus is a complex disease and a global health problem. Therefore, the first level of health care should handle the approaches of medical genetics and genomics to reduce its incidence. The aim is to present perspectives analyzed by our group in two areas of genetics and its clinical application. Emphasis is placed on the coexistence of several genetic forms clinically detectable in patients with diabetes, missing heritability associated with low penetrance, and epigenomics mechanism. It is discussed the effect of genetic variation associated with resistance to insulin, beta-cell dysfunction, shaft incretin, and other points of interest, such as thrifty genotype hypothesis, conformational disease, genetically unknown foods, phenocopies as clinically silent hypercortisolism, molecular phytopharmacology in the clinical management. Finally, the result was displayed in the Mexican population from genetic studies and new findings of clinical importance, such as involvement of melatonin and effect of variations in the number of copies in a genomic region.

Site-Specific Expression of Polycomb-Group Genes Encoding the HPC-HPH/PRC1 Complex in Clinically Defined Primary Nodal and Cutaneous Large B-Cell Lymphomas

PubMed Central

Raaphorst, Frank M.; Vermeer, Maarten; Fieret, Elly; Blokzijl, Tjasso; Dukers, Danny; Sewalt, Richard G.A.B.; Otte, Arie P.; Willemze, Rein; Meijer, Chris J.L.M.

2004-01-01

Polycomb-group (PcG) genes preserve cell identity by gene silencing, and contribute to regulation of lymphopoiesis and malignant transformation. We show that primary nodal large B-cell lymphomas (LBCLs), and secondary cutaneous deposits from such lymphomas, abnormally express the BMI-1, RING1, and HPH1 PcG genes in cycling neoplastic cells. By contrast, tumor cells in primary cutaneous LBCLs lacked BMI-1 expression, whereas RING1 was variably detected. Lack of BMI-1 expression was characteristic for primary cutaneous LBCLs, because other primary extranodal LBCLs originating from brain, testes, and stomach were BMI-1-positive. Expression of HPH1 was rarely detected in primary cutaneous LBCLs of the head or trunk and abundant in primary cutaneous LBCLs of the legs, which fits well with its earlier recognition as a distinct clinical pathological entity with different clinical behavior. We conclude that clinically defined subclasses of primary LBCLs display site-specific abnormal expression patterns of PcG genes of the HPC-HPH/PRC1 PcG complex. Some of these patterns (such as the expression profile of BMI-1) may be diagnostically relevant. We propose that distinct expression profiles of PcG genes results in abnormal formation of HPC-HPH/PRC1 PcG complexes, and that this contributes to lymphomagenesis and different clinical behavior of clinically defined LBCLs. PMID:14742259

Evaluating clinic and community-based lifestyle interventions for obesity reduction in a low-income Latino neighborhood: Vivamos Activos Fair Oaks Program.

PubMed

Drieling, Rebecca L; Ma, Jun; Stafford, Randall S

2011-02-14

Obesity exerts an enormous health impact through its effect on coronary heart disease and its risk factors. Primary care-based and community-based intensive lifestyle counseling may effectively promote weight loss. There has been limited implementation and evaluation of these strategies, particularly the added benefit of community-based intervention, in low-income Latino populations. The Vivamos Activos Fair Oaks project is a randomized clinical trial designed to evaluate the clinical and cost-effectiveness of two obesity reduction lifestyle interventions: clinic-based intensive lifestyle counseling, either alone (n = 80) or combined with community health worker support (n = 80), in comparison to usual primary care (n = 40). Clinic-based counseling consists of 15 group and four individual lifestyle counseling sessions provided by health educators targeting behavior change in physical activity and dietary practices. Community health worker support includes seven home visits aimed at practical implementation of weight loss strategies within the person's home and neighborhood. The interventions use a framework based on Social Cognitive Theory, the Transtheoretical Model of behavior change, and techniques from previously tested lifestyle interventions. Application of the framework was culturally tailored based on past interventions in the same community and elsewhere, as well as a community needs and assets assessment. The interventions include a 12-month intensive phase followed by a 12-month maintenance phase. Participants are obese Spanish-speaking adults with at least one cardiovascular risk factor recruited from a community health center in a low-income neighborhood of San Mateo County, California. Follow-up assessments occur at 6, 12, and 24 months for the primary outcome of percent change in body mass index at 24 months. Secondary outcomes include specific cardiovascular risk factors, particularly blood pressure and fasting glucose levels. If successful, this study will provide evidence for broad implementation of obesity interventions in minority populations and guidance about the selection of strategies involving clinic-based case management and community-based community health worker support. ClinicalTrials.gov: NCT01242683.

Continuity of care: an Italian clinical experience.

PubMed

Tarquini, Roberto; Coletta, Davide; Mazzoccoli, Gianluigi; Gensini, Gian Franco

2013-10-01

Recently, there is a growing interest in the concept of "continuity of care," since patients, being older and more complex, are increasingly seen by an array of providers in a wide variety of organizations and places. Different models of continuity of care have been proposed, yet no single model of care coordination has been proven to be universally applicable across patient (and disease) populations. In the present paper, we introduce a novel model of continuity of care, the Ospedale Santa Verdiana, in Castelfiorentino (Tuscany, Italy), and its first period (1 year) of implementation, since January 2010. There are two main cornerstones: (a) the clinical and urgent need to bridge the gap between primary care and hospital care; and (b) the development and implementation of a model of continuity and coordination of care, which target the so-called complex patient. It is not specific for a single disease but it works "across diseases." There are three driving forces: (a) "primary care" since one of the two Hospital Coordinators is a primary care physician; (b) "hospital care" since patients in the decompensated phase often require hospitalization; and (c) the "University of Florence", which is the "glue". The duties of the Hospital Coordinator, who is an assistant professor at University of Florence, are to guarantee an efficacious and dynamic communication between primary care physicians and hospitalists, and by creating a school for practitioners of the continuity and coordination of care, to make this model exportable.

Inhibitory effect of mitomycin C on proliferation of primary cultured fibroblasts from human airway granulation tissues.

PubMed

Chen, Nan; Zhang, Jie; Xu, Min; Wang, Yu Ling; Pei, Ying Hua

2013-01-01

Airway granulation tissue and scar formation pose a challenge because of the high incidence of recurrence after treatment. As an emerging treatment modality, topical application of mitomycin C has potential value in delaying the recurrence of airway obstruction. Several animal and clinical studies have already proven its feasibility and efficacy. However, the ideal dosage has still not been determined. To establish a novel method for culturing primary fibroblasts isolated from human airway granulation tissue, and to investigate the dose-effect of mitomycin C on the fibroblast proliferation in vitro, so as to provide an experimental reference for clinical practitioners. Granulation tissues were collected during the routine bronchoscopy at our department. The primary fibroblasts were obtained by culturing the explanted tissues. The cells were treated with different concentrations of mitomycin C (0.1, 0.2, 0.4, 0.8 and 1.6 mg/ml) for 5 min followed by additional 48-hour culture before an MTT assay was performed to measure cell viability. MTT assay showed that mitomycin C reduced cell viability at all tested concentrations. The inhibitory ratios were 10.26, 26.77, 32.88, 64.91 and 80.45% for cells treated with mitomycin C at 0.1, 0.2, 0.4, 0.8 and 1.6 mg/ml, respectively. Explant culture is a reliable method for culturing primary fibroblasts from human airway granulation tissue, and mitomycin C can inhibit proliferation of the fibroblasts in vitro. Copyright © 2013 S. Karger AG, Basel.

Using ClinicalTrials.gov to supplement information in ophthalmology conference abstracts about trial outcomes: a comparison study.

PubMed

Scherer, Roberta W; Huynh, Lynn; Ervin, Ann-Margret; Dickersin, Kay

2015-01-01

Including results from unpublished randomized controlled trials (RCTs) in a systematic review may ameliorate the effect of publication bias in systematic review results. Unpublished RCTs are sometimes described in abstracts presented at conferences, included in trials registers, or both. Trial results may not be available in a trials register and abstracts describing RCT results often lack study design information. Complementary information from a trials register record may be sufficient to allow reliable inclusion of an unpublished RCT only available as an abstract in a systematic review. We identified 496 abstracts describing RCTs presented at the 2007 to 2009 Association for Research in Vision and Ophthalmology (ARVO) meetings; 154 RCTs were registered in ClinicalTrials.gov. Two persons extracted verbatim primary and non-primary outcomes reported in the abstract and ClinicalTrials.gov record. We compared each abstract outcome with all ClinicalTrials.gov outcomes and coded matches as complete, partial, or no match. We identified 800 outcomes in 152 abstracts (95 primary [51 abstracts] and 705 [141 abstracts] non-primary outcomes). No outcomes were reported in 2 abstracts. Of 95 primary outcomes, 17 (18%) agreed completely, 53 (56%) partially, and 25 (26%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among 705 non-primary outcomes, 56 (8%) agreed completely, 205 (29%) agreed partially, and 444 (63%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among the 258 outcomes partially agreeing, we found additional information on the time when the outcome was measured more often in ClinicalTrials.gov than in the abstract (141/258 (55%) versus 55/258 (21%)). We found no association between the presence of non-matching "new" outcomes and year of registration, time to registry update, industry sponsorship, or multi-center status. Conference abstracts may be a valuable source of information about results for outcomes of unpublished RCTs that have been registered in ClinicalTrials.gov. Complementary additional descriptive information may be present for outcomes reported in both sources. However, ARVO abstract authors also present outcomes not reported in ClinicalTrials.gov and these may represent analyses not originally planned.

A Prospective, Randomized, Multicenter Clinical Trial on the Safety and Efficacy of a Ready-to-Use Fibrin Sealant as an Adjunct to Hemostasis during Vascular Surgery.

PubMed

Chetter, Ian; Stansby, Gerard; Sarralde, José Aurelio; Riambau, Vicente; Giménez-Gaibar, Antonio; MacKenzie, Kent; Acín, Francisco; Navarro-Puerto, Jordi

2017-11-01

Anastomotic or "stitch hole" bleeding is common during vascular surgery with synthetic material such as Dacron or polytetrafluoroethylene. Hemostatic adjuncts such as fibrin sealant (FS) may reduce blood loss and operating time in such circumstances. We evaluated the safety and the hemostatic effectiveness of a ready-to-use human plasma-derived FS in vascular surgery. Patients with mild/moderate suture line bleeding during elective, open, vascular surgery using synthetic grafts or patches were studied. In an initial Exploratory Study, all patients were treated with FS Grifols, and in a subsequent Primary Study were randomized in a 2:1 ratio to FS Grifols or manual compression (MC). The primary efficacy end point was time to hemostasis (TTH), assessed at defined intervals from the start of treatment application, during a 10-min observational period. Safety end points (in Exploratory + Primary Studies) included adverse events (AEs), vital signs, physical assessments, common clinical laboratory tests (coagulation, complete blood count, serum clinical chemistry parameters, microscopic urinalysis), viral markers, and immunogenicity. In the Primary Study, the proportion of patients who achieved hemostasis at the 3-min time point was higher in the FS Grifols group (46.4%, n = 51/110) than in the MC group (26.3%, n = 15/57) (P < 0.05). The benefit was maintained at successive time intervals: 69 FS Grifols patients (62.7%) and 18 MC patients (31.6%) at 4 min; 82 FS Grifols patients (74.5%) and 28 MC patients (49.1%) at 5 min. The differences between the groups persisted for TTH ≤ 7 min and TTH ≤ 10 min. Treatment failure was reported for 13 FS Grifols patients (11.8%) and 16 MC patients (28.1%). TTH was shorter after FS Grifols application than after MC application. Differences were statistically significant in favor of FS Grifols for each TTH category and for the overall comparison (P < 0.001) as well as for each TTH category (cumulative) and for treatment failure (P = 0.016). Overall, AE experience and types of AEs reported were those expected in this patient population and were similar between the 2 treatment groups. The most frequently reported AEs were procedural pain (59.9% and 69.2% of patients in the FS Grifols [n = 72 + 111] and MC [n = 57] groups, respectively) and nausea (23.5% and 19.2% of patients, respectively). FS Grifols was efficacious and safe as an adjunct to anastomotic hemostasis in patients undergoing arterial surgery using prosthetic material with mild to moderate bleeding. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Functional neuroimaging applications for assessment and rehabilitation planning in patients with disorders of consciousness.

PubMed

Giacino, Joseph T; Hirsch, Joy; Schiff, Nicholas; Laureys, Steven

2006-12-01

To describe the theoretic framework, design, and potential clinical applications of functional neuroimaging protocols in patients with disorders of consciousness. Recent published literature and authors' own work. Studies using functional neuroimaging techniques to investigate cognitive processing in patients diagnosed with vegetative and minimally conscious state. Not applicable. Positron-emission tomography activation studies suggest that the vegetative state represents a global disconnection syndrome in which higher order association cortices are functionally disconnected from primary cortical areas. In contrast, patterns of activation in functional magnetic resonance imaging studies of patients in the minimally conscious state show preservation of large-scale cortical networks associated with language and visual processing. Novel applications of functional neuroimaging in patients with disorders of consciousness may aid in differential diagnosis, prognostic assessment and identification of pathophysiologic mechanisms. Improvements in patient characterization may, in turn, provide new opportunities for restoration of function through interventional neuromodulation.

International Classification of Primary Care-2 coding of primary care data at the general out-patients' clinic of General Hospital, Lagos, Nigeria.

PubMed

Olagundoye, Olawunmi Abimbola; van Boven, Kees; van Weel, Chris

2016-01-01

Primary care serves as an integral part of the health systems of nations especially the African continent. It is the portal of entry for nearly all patients into the health care system. Paucity of accurate data for health statistics remains a challenge in the most parts of Africa because of inadequate technical manpower and infrastructure. Inadequate quality of data systems contributes to inaccurate data. A simple-to-use classification system such as the International Classification of Primary Care (ICPC) may be a solution to this problem at the primary care level. To apply ICPC-2 for secondary coding of reasons for encounter (RfE), problems managed and processes of care in a Nigerian primary care setting. Furthermore, to analyze the value of selected presented symptoms as predictors of the most common diagnoses encountered in the study setting. Content analysis of randomly selected patients' paper records for data collection at the end of clinic sessions conducted by family physicians at the general out-patients' clinics. Contents of clinical consultations were secondarily coded with the ICPC-2 and recorded into excel spreadsheets with fields for sociodemographic data such as age, sex, occupation, religion, and ICPC elements of an encounter: RfE/complaints, diagnoses/problems, and interventions/processes of care. Four hundred and one encounters considered in this study yielded 915 RfEs, 546 diagnoses, and 1221 processes. This implies an average of 2.3 RfE, 1.4 diagnoses, and 3.0 processes per encounter. The top 10 RfE, diagnoses/common illnesses, and processes were determined. Through the determination of the probability of the occurrence of certain diseases beginning with a RfE/complaint, the top five diagnoses that resulted from each of the top five RfE were also obtained. The top five RfE were: headache, fever, pain general/multiple sites, visual disturbance other and abdominal pain/cramps general. The top five diagnoses were: Malaria, hypertension uncomplicated, visual disturbance other, peptic ulcer, and upper respiratory infection. From the determination of the posterior probability given the top five RfE, malaria, hypertension, upper respiratory infection, refractive error, and conjuctivitis were the five most frequent diagnoses that resulted from a complaint of a headache. The study demonstrated that ICPC-2 can be applied to primary care data in the Nigerian context to generate information about morbidity and services provided. It also provided an empirical basis to support diagnosis and prognostication in a primary care setting. In developing countries where the transition to electronic health records is still evolving and fraught with limitations, more reliable data collection can be achieved from paper records through the application of the ICPC-2.

Primary Care-Based Memory Clinics: Expanding Capacity for Dementia Care.

PubMed

Lee, Linda; Hillier, Loretta M; Heckman, George; Gagnon, Micheline; Borrie, Michael J; Stolee, Paul; Harvey, David

2014-09-01

The implementation in Ontario of 15 primary-care-based interprofessional memory clinics represented a unique model of team-based case management aimed at increasing capacity for dementia care at the primary-care level. Each clinic tracked referrals; in a subset of clinics, charts were audited by geriatricians, clinic members were interviewed, and patients, caregivers, and referring physicians completed satisfaction surveys. Across all clinics, 582 patients were assessed, and 8.9 per cent were referred to a specialist. Patients and caregivers were very satisfied with the care received, as were referring family physicians, who reported increased capacity to manage dementia. Geriatricians' chart audits revealed a high level of agreement with diagnosis and management. This study demonstrated acceptability, feasibility, and preliminary effectiveness of the primary-care memory clinic model. Led by specially trained family physicians, it provided timely access to high-quality collaborative dementia care, impacting health service utilization by more-efficient use of scarce geriatric specialist resources.

Is it just religious practice? Exploring patients' reasons for choosing a faith-based primary health clinic over their local public sector primary health clinic.

PubMed

Porter, James D; Bresick, Graham

2017-06-29

Person-centred, re-engineered primary health care (PHC) is a national and global priority. Faith-based health care is a significant provider of PHC in sub-Saharan Africa, but there is limited published data on the reasons for patient choice of faith-based health care, particularly in South Africa. The primary objective was to determine and explore the reasons for patient choice of a faith-based primary care clinic over their local public sector primary care clinic, and secondarily to determine to what extent these reasons were influenced by demography. The study was conducted at Jubilee Health Centre (JHC), a faith-based primary care clinic attached to Jubilee Community Church in Cape Town, South Africa. Focus groups, using the nominal group technique, were conducted with JHC patients and used to generate ranked reasons for attending the clinic. These were collated into the top 15 reasons and incorporated into a quantitative questionnaire which was administered to adult patients attending JHC. A total of 164 patients were surveyed (a response rate of 92.4%) of which 68.3% were female and 57.9% from the Democratic Republic of the Congo (DRC). Of patients surveyed, 98.2% chose to attend JHC because 'the staff treat me with respect', 96.3% because 'the staff are friendly' and 96.3% because 'the staff take time to listen to me'. The reason 'it is a Christian clinic' was chosen by 70.1% of patients. 'The staff speak my home language' was given as a reason by 61.1% of DRC patients and 37.1% of South African patients. 'The clinic is close to me' was chosen by 66.6% of Muslims and 40.8% of Christians. Patients chose to attend JHC (a faith-based primary care clinic) because of the quality of care received. They emphasised the staff-patient relationship and patient-centredness rather than the clinic's religious practices (prayer with patients). These findings may be important in informing efforts to improve public sector primary care.

Modelling Conditions and Health Care Processes in Electronic Health Records: An Application to Severe Mental Illness with the Clinical Practice Research Datalink

PubMed Central

Olier, Ivan; Springate, David A.; Ashcroft, Darren M.; Doran, Tim; Reeves, David; Planner, Claire; Reilly, Siobhan; Kontopantelis, Evangelos

2016-01-01

Background The use of Electronic Health Records databases for medical research has become mainstream. In the UK, increasing use of Primary Care Databases is largely driven by almost complete computerisation and uniform standards within the National Health Service. Electronic Health Records research often begins with the development of a list of clinical codes with which to identify cases with a specific condition. We present a methodology and accompanying Stata and R commands (pcdsearch/Rpcdsearch) to help researchers in this task. We present severe mental illness as an example. Methods We used the Clinical Practice Research Datalink, a UK Primary Care Database in which clinical information is largely organised using Read codes, a hierarchical clinical coding system. Pcdsearch is used to identify potentially relevant clinical codes and/or product codes from word-stubs and code-stubs suggested by clinicians. The returned code-lists are reviewed and codes relevant to the condition of interest are selected. The final code-list is then used to identify patients. Results We identified 270 Read codes linked to SMI and used them to identify cases in the database. We observed that our approach identified cases that would have been missed with a simpler approach using SMI registers defined within the UK Quality and Outcomes Framework. Conclusion We described a framework for researchers of Electronic Health Records databases, for identifying patients with a particular condition or matching certain clinical criteria. The method is invariant to coding system or database and can be used with SNOMED CT, ICD or other medical classification code-lists. PMID:26918439

Evaluation of Voice Acoustics as Predictors of Clinical Depression Scores.

PubMed

Hashim, Nik Wahidah; Wilkes, Mitch; Salomon, Ronald; Meggs, Jared; France, Daniel J

2017-03-01

The aim of the present study was to determine if acoustic measures of voice, characterizing specific spectral and timing properties, predict clinical ratings of depression severity measured in a sample of patients using the Hamilton Depression Rating Scale (HAMD) and Beck Depression Inventory (BDI-II). This is a prospective study. Voice samples and clinical depression scores were collected prospectively from consenting adult patients who were referred to psychiatry from the adult emergency department or primary care clinics. The patients were audio-recorded as they read a standardized passage in a nearly closed-room environment. Mean Absolute Error (MAE) between actual and predicted depression scores was used as the primary outcome measure. The average MAE between predicted and actual HAMD scores was approximately two scores for both men and women, and the MAE for the BDI-II scores was approximately one score for men and eight scores for women. Timing features were predictive of HAMD scores in female patients while a combination of timing features and spectral features was predictive of scores in male patients. Timing features were predictive of BDI-II scores in male patients. Voice acoustic features extracted from read speech demonstrated variable effectiveness in predicting clinical depression scores in men and women. Voice features were highly predictive of HAMD scores in men and women, and BDI-II scores in men, respectively. The methodology is feasible for diagnostic applications in diverse clinical settings as it can be implemented during a standard clinical interview in a normal closed room and without strict control on the recording environment. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

A clinical study to evaluate the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics cream for pain reduction of venipuncture in children.

PubMed

Eichenfield, Lawrence F; Funk, Ann; Fallon-Friedlander, Sheila; Cunningham, Bari B

2002-06-01

A double-randomized, blinded crossover trial was performed to assess the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics (EMLA) for pain relief during pediatric venipuncture procedures. Safety was assessed by evaluation for topical or systemic effects and measurement of serum lidocaine concentrations. A total of 120 children who were scheduled for repeat venipuncture for non-study-related reasons at 2 sites participated in the study. Patients were doubly randomized to treatment regimen (study medication application time of either 30 or 60 minutes) and to the order of application of the topical anesthetics for each venipuncture. The primary outcome measures were the child's rating of pain immediately after the venipuncture procedures using a 100-mm visual analog scale (VAS) tool and the parent's and blinded research observer's Observed Behavioral Distress scores. Both ELA-Max and EMLA seemed to alleviate venipuncture pain. There was no clinically or statistically significant difference in the patient VAS scores within the 30-minute or 60-minute treatment groups, and there was no clinical or statistical difference in VAS scores between the 30-minute ELA-Max treatment without occlusion and the 60-minute EMLA treatment with occlusion. There were no clinically or statistically significant differences between treatment with ELA-Max and EMLA in parental or blinded researcher Observed Behavioral Distress scores, the most frequent response at any observation time being "no distress." This study demonstrates that a 30-minute application of ELA-Max without occlusion is as safe and as effective for ameliorating pain associated with venipuncture as a 60-minute application of the prescription product EMLA requiring occlusion.

The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI): Revision for Clinical Use, Content Validation, and Inter-rater Reliability.

PubMed

Rosenson, Robert S; Miller, Kate; Bayliss, Martha; Sanchez, Robert J; Baccara-Dinet, Marie T; Chibedi-De-Roche, Daniela; Taylor, Beth; Khan, Irfan; Manvelian, Garen; White, Michelle; Jacobson, Terry A

2017-04-01

The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) is a method for assessing the likelihood that a patient's muscle symptoms (e.g., myalgia or myopathy) were caused or worsened by statin use. The objectives of this study were to prepare the SAMS-CI for clinical use, estimate its inter-rater reliability, and collect feedback from physicians on its practical application. For content validity, we conducted structured in-depth interviews with its original authors as well as with a panel of independent physicians. Estimation of inter-rater reliability involved an analysis of 30 written clinical cases which were scored by a sample of physicians. A separate group of physicians provided feedback on the clinical use of the SAMS-CI and its potential utility in practice. Qualitative interviews with providers supported the content validity of the SAMS-CI. Feedback on the clinical use of the SAMS-CI included several perceived benefits (such as brevity, clear wording, and simple scoring process) and some possible concerns (workflow issues and applicability in primary care). The inter-rater reliability of the SAMS-CI was estimated to be 0.77 (confidence interval 0.66-0.85), indicating high concordance between raters. With additional provider feedback, a revised SAMS-CI instrument was created suitable for further testing, both in the clinical setting and in prospective validation studies. With standardized questions, vetted language, easily interpreted scores, and demonstrated reliability, the SAMS aims to estimate the likelihood that a patient's muscle symptoms were attributable to statins. The SAMS-CI may support better detection of statin-associated muscle symptoms in clinical practice, optimize treatment for patients experiencing muscle symptoms, and provide a useful tool for further clinical research.

Biomarkers in Cardiology - Part 2: In Coronary Heart Disease, Valve Disease and Special Situations

PubMed Central

2015-01-01

Cardiovascular diseases are the main causes of mortality and morbidity in Brazil. Their primary and secondary preventions are a priority for the health system and require multiple approaches for increased effectiveness. Biomarkers are tools used to identify with greater accuracy high-risk individuals, establish a faster diagnosis, guide treatment, and determine prognosis. This review aims to highlight the importance of biomarkers in clinical cardiology practice and raise relevant points regarding their application and perspectives for the next few years. This document was divided into two parts. This second part addresses the application of biomarkers in coronary heart disease, valvular diseases, cardio-oncology, pulmonary embolism, and cardiorenal syndrome. PMID:26083777

DICOM image quantification secondary capture (DICOM IQSC) integrated with numeric results, regions, and curves: implementation and applications in nuclear medicine

NASA Astrophysics Data System (ADS)

Cao, Xinhua; Xu, Xiaoyin; Voss, Stephan

2017-03-01

In this paper, we describe an enhanced DICOM Secondary Capture (SC) that integrates Image Quantification (IQ) results, Regions of Interest (ROIs), and Time Activity Curves (TACs) with screen shots by embedding extra medical imaging information into a standard DICOM header. A software toolkit of DICOM IQSC has been developed to implement the SC-centered information integration of quantitative analysis for routine practice of nuclear medicine. Primary experiments show that the DICOM IQSC method is simple and easy to implement seamlessly integrating post-processing workstations with PACS for archiving and retrieving IQ information. Additional DICOM IQSC applications in routine nuclear medicine and clinic research are also discussed.

Part II: Functional delivery of a neurotherapeutic gene to neural stem cells using minicircle DNA and nanoparticles: Translational advantages for regenerative neurology.

PubMed

Fernandes, Alinda R; Chari, Divya M

2016-09-28

Both neurotrophin-based therapy and neural stem cell (NSC)-based strategies have progressed to clinical trials for treatment of neurological diseases and injuries. Brain-derived neurotrophic factor (BDNF) in particular can confer neuroprotective and neuro-regenerative effects in preclinical studies, complementing the cell replacement benefits of NSCs. Therefore, combining both approaches by genetically-engineering NSCs to express BDNF is an attractive approach to achieve combinatorial therapy for complex neural injuries. Current genetic engineering approaches almost exclusively employ viral vectors for gene delivery to NSCs though safety and scalability pose major concerns for clinical translation and applicability. Magnetofection, a non-viral gene transfer approach deploying magnetic nanoparticles and DNA with magnetic fields offers a safe alternative but significant improvements are required to enhance its clinical application for delivery of large sized therapeutic plasmids. Here, we demonstrate for the first time the feasibility of using minicircles with magnetofection technology to safely engineer NSCs to overexpress BDNF. Primary mouse NSCs overexpressing BDNF generated increased daughter neuronal cell numbers post-differentiation, with accelerated maturation over a four-week period. Based on our findings we highlight the clinical potential of minicircle/magnetofection technology for therapeutic delivery of key neurotrophic agents. Copyright © 2016 Elsevier B.V. All rights reserved.

Clinical Resting-state fMRI in the Preoperative Setting

PubMed Central

Lee, Megan H.; Miller-Thomas, Michelle M.; Benzinger, Tammie L.; Marcus, Daniel S.; Hacker, Carl D.; Leuthardt, Eric C.; Shimony, Joshua S.

2017-01-01

The purpose of this manuscript is to provide an introduction to resting-state functional magnetic resonance imaging (RS-fMRI) and to review the current application of this new and powerful technique in the preoperative setting using our institute’s extensive experience. RS-fMRI has provided important insights into brain physiology and is an increasingly important tool in the clinical setting. As opposed to task-based functional MRI wherein the subject performs a task while being scanned, RS-fMRI evaluates low-frequency fluctuations in the blood oxygen level dependent (BOLD) signal while the subject is at rest. Multiple resting state networks (RSNs) have been identified, including the somatosensory, language, and visual networks, which are of primary importance for presurgical planning. Over the past 4 years, we have performed over 300 RS-fMRI examinations in the clinical setting and these have been used to localize eloquent somatosensory and language cortices before brain tumor resection. RS-fMRI is particularly useful in this setting for patients who are unable to cooperate with the task-based paradigm, such as young children or those who are sedated, paretic, or aphasic. Although RS-fMRI is still investigational, our experience indicates that this method is ready for clinical application in the presurgical setting. PMID:26848556

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

PubMed

Adiputra, Yohanes; Chen, Shao-Liang

2015-05-20

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. 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". The articles about the definition, features, clinical application, and pitfalls of measurement of FFR were identified, retrieved, and reviewed. 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. 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.

About the necessity to manage events coded with MedDRA prior to statistical analysis: proposal of a strategy with application to a randomized clinical trial, ANRS 099 ALIZE.

PubMed

Journot, Valérie; Tabuteau, Sophie; Collin, Fidéline; Molina, Jean-Michel; Chene, Geneviève; Rancinan, Corinne

2008-03-01

Since 2003, the Medical Dictionary for Regulatory Activities (MedDRA) is the regulatory standard for safety report in clinical trials in the European Community. Yet, we found no published example of a practical experience for a scientifically oriented statistical analysis of events coded with MedDRA. We took advantage of a randomized trial in HIV-infected patients with MedDRA-coded events to explain the difficulties encountered during the events analysis and the strategy developed to report events consistently with trial-specific objectives. MedDRA has a rich hierarchical structure, which allows the grouping of coded terms into 5 levels, the highest being "System Organ Class" (SOC). Each coded term may be related to several SOCs, among which one primary SOC is defined. We developed a new general 5-step strategy to select a SOC as trial primary SOC, consistently with trial-specific objectives for this analysis. We applied it to the ANRS 099 ALIZE trial, where all events were coded with MedDRA version 3.0. We compared the MedDRA and the ALIZE primary SOCs. In the ANRS 099 ALIZE trial, 355 patients were recruited, and 3,722 events were reported and documented, among which 35% had multiple SOCs (2 to 4). We applied the proposed 5-step strategy. Altogether, 23% of MedDRA primary SOCs were modified, mainly from MedDRA primary SOCs "Investigations" (69%) and "Ear and labyrinth disorders" (6%), for the ALIZE primary SOCs "Hepatobiliary disorders" (35%), "Musculoskeletal and connective tissue disorders" (21%), and "Gastrointestinal disorders" (15%). MedDRA largely enhanced in size and complexity with versioning and the development of Standardized MedDRA Queries. Yet, statisticians should not systematically rely on primary SOCs proposed by MedDRA to report events. A simple general 5-step strategy to re-classify events consistently with the trial-specific objectives might be useful in HIV trials as well as in other fields.

National Institutes of Health eliminates funding for national architecture linking primary care research.

PubMed

Peterson, Kevin A

2007-01-01

With the ending of the National Electronic Clinical Trial and Research Network (NECTAR) pilot programs and the abridgement of Clinical Research Associate initiative, the National Institutes of Health Roadmap presents a strategic shift for practice-based research networks from direct funding of a harmonized national infrastructure of cooperating research networks to a model of local engagement of primary care clinics performing practice-based research under the aegis of regional academic health centers through Clinical and Translational Science Awards. Although this may present important opportunities for partnering between community practices and large health centers, for primary care researchers, the promise of a transformational change that brings a unified national primary care community into the clinical research enterprise seems likely to remain unfulfilled.

Increasing the Capacity of Primary Care Through Enabling Technology.

PubMed

Young, Heather M; Nesbitt, Thomas S

2017-04-01

Primary care is the foundation of effective and high-quality health care. The role of primary care clinicians has expanded to encompass coordination of care across multiple providers and management of more patients with complex conditions. Enabling technology has the potential to expand the capacity for primary care clinicians to provide integrated, accessible care that channels expertise to the patient and brings specialty consultations into the primary care clinic. Furthermore, technology offers opportunities to engage patients in advancing their health through improved communication and enhanced self-management of chronic conditions. This paper describes enabling technologies in four domains (the body, the home, the community, and the primary care clinic) that can support the critical role primary care clinicians play in the health care system. It also identifies challenges to incorporating these technologies into primary care clinics, care processes, and workflow.

General Information about Metastatic Squamous Neck Cancer with Occult Primary

MedlinePlus

... Occult Primary Treatment (Adult) (PDQ®)–Patient Version General Information About Metastatic Squamous Neck Cancer with Occult Primary ... the PDQ Adult Treatment Editorial Board . Clinical Trial Information A clinical trial is a study to answer ...

Collaborative Social and Medical Service System

PubMed Central

Petermann, Cynthia A.; Bobroff, Risa B.; Moore, Dwight M.; Gilson, Hillary S.; Li, Yizhen; Dargahi, Ross; Classen, David W.; Fowler, Jerry; Moreau, Dennis R.; Beck, J. Robert; Buffone, Gregory J.

1994-01-01

This paper describes the Collaborative Social and Medical Services System, a robust information infrastructure for integrated social and medical care. The Collaborative Social and Medical Services System design and architecture address the primary goals of creating a readily extensible social and ambulatory care system. Our initial step toward reaching this goal is the delivery of an application supporting the operations of the Baylor Teen Health Clinics. This paper discusses our protoype experiences, system architecture, components, and the standards we are addressing. PMID:7950001

Application of principal component analysis to multispectral imaging data for evaluation of pigmented skin lesions

NASA Astrophysics Data System (ADS)

Jakovels, Dainis; Lihacova, Ilze; Kuzmina, Ilona; Spigulis, Janis

2013-11-01

Non-invasive and fast primary diagnostics of pigmented skin lesions is required due to frequent incidence of skin cancer - melanoma. Diagnostic potential of principal component analysis (PCA) for distant skin melanoma recognition is discussed. Processing of the measured clinical multi-spectral images (31 melanomas and 94 nonmalignant pigmented lesions) in the wavelength range of 450-950 nm by means of PCA resulted in 87 % sensitivity and 78 % specificity for separation between malignant melanomas and pigmented nevi.

Naltrexone/bupropion: Contrave(R); naltrexone SR/bupropion SR.

PubMed

2010-01-01

In March 2010, Orexigen(R) Therapeutics submitted a new drug application (NDA) for approval of naltrexone sustained release (SR)/bupropion SR (Contrave(R)) for the treatment of obesity in the US. The tablet contains naltrexone SR 32 mg and bupropion SR 360 mg. The drug has been tested in four randomized, double-blind, placebo-controlled, phase III trials and the co-primary endpoints were met in each case. This review discusses the key development milestones and clinical trial program to date.

Orthostatic hypotension

NASA Technical Reports Server (NTRS)

Ninet, J.

1981-01-01

Basic orientation of the article, by the leader of a group of medical researchers associated with hospitals in Lyon, France, is toward definition and classification. A table divides OH (orthostatic hypotension) according to physiopathological classification into sympathicotonic and asympathicotonic types and then each of these into primary and secondary with subdivisions. The figure sketches organization and functioning of the baroreflex arc. Applications to clinical study of circulatory reflexes, listing measurement tests and the biological study of hormonal regulation listing the appropriate kinds of studies. Data are not given.

Implementation issues relevant to outpatient neurology palliative care.

PubMed

Kluger, Benzi M; Persenaire, Michael J; Holden, Samantha K; Palmer, Laura T; Redwine, Hannah; Berk, Julie; Anderson, C Alan; Filley, Christopher M; Kutner, Jean; Miyasaki, Janis; Carter, Julie

2017-11-29

There is growing interest in the application of palliative care principles to improve care for patients and families affected by neurologic diseases. We developed an interdisciplinary outpatient clinic for patients and families affected by neurologic disorders to better address the problems faced by our highest need patients. We have developed and improved this program over the past three years and share several of our most important lessons as well as ongoing challenges and areas where we see our clinic evolving in the future. We provide a description of our clinic logistics, including key steps in the initiation of the clinic, and provide descriptions from similar clinics at other institutions to demonstrate some of the variability in this growing field. We also provide results from a formal one-year quality improvement project and a one-year retrospective study of patients attending this clinic. Our clinic has grown steadily since its inception and maintains high satisfaction ratings from patients, caregivers, and referring providers. To maintain standardized and efficient care we have developed materials for patients and referring physicians as well as checklists and other processes used by our interdisciplinary team. Feedback from our quality improvement project helped define optimal visit duration and refine communication among team members and with patients and families. Results from our chart review suggest our clinic influences advance care planning and place of death. Common referral reasons include psychosocial support, complex symptom management, and advance care planning. Current challenges for our clinic include developing a strategy for continued growth, creating a sustainable financial model for interdisciplinary care, integrating our services with disease-specific sections, improving primary palliative care knowledge and skills within our referral base, and building effective alliances with community neurologists, geriatrics, primary care, nursing homes, and hospices. Specialized outpatient palliative care for neurologic disorders fills several important gaps in care for this patient population, provides important educational opportunities for trainees, and creates opportunities for patient and caregiver-centered research. Educational initiatives are needed to train general neurologists in primary palliative care, to train neurologists in specialist palliative care, and to train palliative medicine specialists in neurology. Research is needed to build an evidence base to identify patient and caregiver needs, support specific interventions, and to build more efficient models of care in both academic and community settings.

Beyond the limits of clinical governance? The case of mental health in English primary care

PubMed Central

Gask, Linda; Rogers, Anne; Campbell, Stephen; Sheaff, Rod

2008-01-01

Background Little research attention has been given to attempts to implement organisational initiatives to improve quality of care for mental health care, where there is a high level of indeterminacy and clinical judgements are often contestable. This paper explores recent efforts made at an organisational level in England to improve the quality of primary care for people with mental health problems through the new institutional processes of 'clinical governance'. Methods Framework analysis, based on the Normalisation Process Model (NPM), of attempts over a five year period to develop clinical governance for primary mental health services in Primary Care Trusts (PCTs). The data come from a longitudinal qualitative multiple case-study approach in a purposive sample of 12 PCTs, chosen to reflect a maximum variety of organisational contexts for mental health care provision. Results The constant change within the English NHS provided a difficult context in which to attempt to implement 'clinical governance' or, indeed, to reconstruct primary mental health care. In the absence of clear evidence or direct guidance about what 'primary mental health care' should be, and a lack of actors with the power or skills to set about realising it, the actors in 'clinical governance' had little shared knowledge or understanding of their role in improving the quality of mental health care. There was a lack of ownership of 'mental health' as an integral, normalised part of primary care. Conclusion Despite some achievements in regard to monitoring and standardisation of prescribing practice, mental health care in primary care seems to have so far largely eluded the gaze of 'clinical governance'. Clinical governance in English primary mental health care has not yet become normalised. We make some policy recommendations which we consider would assist in the process normalisation and suggest other contexts to which our findings might apply. PMID:18366779

Patient costs in anticoagulation management: a comparison of primary and secondary care.

PubMed Central

Parry, D; Bryan, S; Gee, K; Murray, E; Fitzmaurice, D

2001-01-01

BACKGROUND: The demand for anticoagulation management is increasing. This has led to care being provided in non-hospital settings. While clinical studies have similarly demonstrated good clinical care in these settings, it is still unclear as to which alternative is the most efficient. AIM: To determine the costs borne by patients when attending an anticoagulation management clinic in either primary or secondary care and to use this information to consider the cost-effectiveness of anticoagulation management in primary and secondary care, both from the National Health Service and patient perspectives. DESIGN OF STUDY: Observational study comparing two cohorts of patients currently attending anticoagulation management clinics. SETTING: Four primary care clinics in Birmingham and one in Warwickshire, and the haematology clinics at the University of Birmingham Hospitals Trust and the City Hospital NHS Trust. METHOD: The survey of patients attending the clinics was used to ascertain patient costs. This information was then used in conjunction with the findings of a recent randomised controlled trial to establish cost-effectiveness. RESULTS: Patient costs were lower in primary care than in secondary care settings; the mean (standard deviation) costs per visit were Pound Sterling6.78 (Pound Sterling5.04) versus Pound Sterling14.58 (Pound Sterling9.08). While a previous cost-effectiveness analysis from a health sector perspective alone found a higher cost for primary care, the adoption of the societal perspective lead to a marked change in the result: a similar total cost per patient in both sectors. CONCLUSION: There are significantly higher costs borne by patients attending secondary care anticoagulation management clinics than similar patients attending primary care clinics. This study also demonstrates that the perspective adopted in an economic evaluation can influence the final result. PMID:11766869

Do Patients Who Access Clinical Information on Patient Internet Portals Have More Primary Care Visits?

PubMed

Leveille, Suzanne G; Mejilla, Roanne; Ngo, Long; Fossa, Alan; Elmore, Joann G; Darer, Jonathan; Ralston, James D; Delbanco, Tom; Walker, Jan

2016-01-01

As health care costs alarm the nation and the debate increases about the impact of health information technologies, patients are reviewing their medical records increasingly through secure Internet portals. Important questions remain about the impact of portal use on office visits. To evaluate whether use of patient Internet portals to access records is associated with increased primary care utilization. A prospective cohort study. Primary care patients registered on patient Internet portals, within an integrated health system serving rural Pennsylvania and an academic medical center in Boston. Frequency of "clinical portal use" (days/2 mo intervals over 2 y) included secure messaging about clinical issues and viewing laboratory and radiology findings. In year 2, a subset of patients also gained access to their primary care doctor's visit notes. The main outcome was number of primary care office visits. In the first 2 months of the 2-year period, 14% of 44,951 primary care patients engaged in clinical portal use 2 or more days per month, 31% did so 1 day per month, and the remainder had no clinical portal use. Overall, adjusted for age, sex, and chronic conditions, clinical portal use was not associated with subsequent office visits. Fewer than 0.1% of patients engaged in high levels of clinical portal use (31 or more login days in 2 mo) that were associated with 1 or more additional visits in the subsequent 2 months (months 3 and 4). However, the reverse was true: office visits led to subsequent clinical portal use. Similar trends were observed among patients with or without access to visit notes. Patients turn to their portals following visits, but clinical portal use does not contribute to an increase in primary care visits.

Retail clinic visits and receipt of primary care.

PubMed

Reid, Rachel O; Ashwood, J Scott; Friedberg, Mark W; Weber, Ellerie S; Setodji, Claude M; Mehrotra, Ateev

2013-04-01

An increasing number of patients are visiting retail clinics for simple acute conditions. Physicians worry that visits to retail clinics will interfere with primary care relationships. No prior study has evaluated the impact of retail clinics on receipt of primary care. To assess the association between retail clinic use and receipt of key primary care functions. We performed a retrospective cohort analysis using commercial insurance claims from 2007 to 2009. We identified patients who had a visit for a simple acute condition in 2008, the "index visit". We divided these 127,358 patients into two cohorts according to the location of that index visit: primary care provider (PCP) versus retail clinic. We evaluated three functions of primary care: (1) where patients first sought care for subsequent simple acute conditions; (2) continuity of care using the Bice-Boxerman index; and (3) preventive care and diabetes management. Using a difference-in-differences approach, we compared care received in the 365 days following the index visit to care received in the 365 days prior, using propensity score weights to account for selection bias. Visiting a retail clinic instead of a PCP for the index visit was associated with a 27.7 visits per 100 patients differential reduction (p < 0 .001) in subsequent PCP visits for new simple acute conditions. Visiting a retail clinic instead of a PCP was also associated with decreased subsequent continuity of care (10.9 percentage-point differential reduction in Bice-Boxerman index, p < 0 .001). There was no differential change between the cohorts in receipt of preventive care or diabetes management. Retail clinics may disrupt two aspects of primary care: whether patients go to a PCP first for new conditions and continuity of care. However, they do not negatively impact preventive care or diabetes management.

Development and integration of pharmacist clinical services into the patient-centered medical home.

PubMed

Berdine, Hildegarde J; Skomo, Monica L

2012-01-01

To describe the development of pharmacist clinical services within a primary care physician practice using a standardized business plan, the extent of clinical pharmacy service integration into the patient-centered medical home (PCMH), and the clinical changes in the pharmacist's patient cohort. A two-physician primary care/occupational care practice in Pittsburgh, PA, from May 2007 to December 2011. Pharmacist-led clinic receives physician referrals for medication management, adherence, and disease management services. Pharmacist practice in a primary care setting with emphasis on integration of clinical services into the medical home model designed by the American Academy of Family Physicians. Characterization of the patient's pharmacist and services provided by the pharmacist. Glycosylated hemoglobin (A1C), body mass index (BMI), low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total cholesterol, triglycerides, and blood pressure. The top five primary referral reasons were diabetes self-management, weight management, medication adherence, hypertension, and dyslipidemia management. Improvements in clinical parameters were demonstrated for lipids and A1C at 1 and 2 years after baseline. Statistically significant improvements in BMI also were observed. The pharmacist developed and integrated clinical services into a primary care practice, became an integral member of the clinical team in the two-physician PCMH, and improved patient outcomes.

Abnormal hepatic biochemistries and clinical liver disease in patients with primary Sjögren's syndrome.

PubMed

Montaño-Loza, Aldo J; Crispín-Acuña, José Carlos; Remes-Troche, José María; Uribe, Misael

2007-01-01

Patients with primary Sjögren's syndrome may present liver involvement. Our goals were to establish the prevalence of abnormal hepatic biochemistries and clinical liver disease in patients with primary Sjögren's syndrome and correlate their presence with other clinical and laboratory features. Ninety-five patients with diagnosis of primary Sjögren's syndrome were studied. Data on gender, age, clinical features, liver biochemistries, tests of inflammation and autoimmunity, and concomitant diseases were collected. Forty-two patients (44%) had abnormal hepatic biochemistries, and of these 19 patients (20%) had clinical liver disease. Patients with abnormal hepatic biochemistries had higher frequency of autoimmune hypotiroidism, arthritis, vasculitis, Raynaud's phenomenon, higher sedimentation rate,and higher frequency of antinuclear and antimitochondrial antibodies than patients with normal liver biochemistries (P < 0.05 for each). Patients with clinical liver disease had higher frequency of arthritis, vasculitis, and higher frequency of antimitochondrial antibodies than patients without clinical liver disease (P < 0.05 for each). Twenty-one patients had diagnosis of a specific liver disease, such as hepatitis C virus infection (n = 11), autoimmune hepatitis (n = 2), primary biliary cirrhosis (n =5),nonalcoholic fatty liver disease (n = 2), and hepatitis B virus infection (n = 1). In half of patients with liver involvement a definitive cause could not be identified. Liver involvement is frequently found in patients with primary Sjögren's syndrome, and its presence is associated with clinical features of systemic disease, and markers of autoimmunity and inflammation. There may be a subgroup of patients with liver involvement secondary to primary Sjögren's syndrome.

Rural Doctors’ Views on and Experiences with Evidence-Based Medicine: The FrEEDoM Qualitative Study

PubMed Central

Hisham, Ranita; Liew, Su May; Ng, Chirk Jenn; Mohd Nor, Kamaliah; Osman, Iskandar Firzada; Ho, Gah Juan; Hamzah, Nurazira; Glasziou, Paul

2016-01-01

Background Evidence-based medicine is the integration of individual clinical expertise, best external evidence and patient values which was introduced more than two decades ago. Yet, primary care physicians in Malaysia face unique barriers in accessing scientific literature and applying it to their clinical practice. Aim This study aimed to explore the views and experiences of rural doctors’ about evidence-based medicine in their daily clinical practice in a rural primary care setting. Methods Qualitative methodology was used. The interviews were conducted in June 2013 in two rural health clinics in Malaysia. The participants were recruited using purposive sampling. Four focus group discussions with 15 medical officers and three individual in-depth interviews with family medicine specialists were carried out. All interviews were conducted using a topic guide and were audio-recorded, transcribed verbatim, checked and analyzed using a thematic approach. Results Key themes identified were: (1) doctors viewed evidence-based medicine mainly as statistics, research and guidelines, (2) reactions to evidence-based medicine were largely negative, (3) doctors relied on specialists, peers, guidelines and non-evidence based internet sources for information, (4) information sources were accessed using novel methods such as mobile applications and (5) there are several barriers to evidence-based practice, including doctor-, evidence-based medicine-, patient- and system-related factors. These included inadequacies in knowledge, attitude, management support, time and access to evidence-based information sources. Participants recommended the use of online services to support evidence-based practice in the rural settings. Conclusion The level of evidence-based practice is low in the rural setting due to poor awareness, knowledge, attitude and resources. Doctors use non-evidence based sources and access them through new methods such as messaging applications. Further research is recommended to develop and evaluate interventions to overcome the identified barriers. PMID:27031700

Effectiveness of transcutaneous electrical nerve stimulation and interferential current in primary dysmenorrhea.

PubMed

Tugay, Nazan; Akbayrak, Türkan; Demirtürk, Funda; Karakaya, Ilkim Citak; Kocaacar, Ozge; Tugay, Umut; Karakaya, Mehmet Gürhan; Demirtürk, Fazli

2007-01-01

To compare the effectiveness of transcutaneous electrical nerve stimulation and interferential current in primary dysmenorrhea. A prospective, randomized, and controlled study. Hacettepe University School of Physical Therapy and Rehabilitation. Thirty-four volunteer subjects with primary dysmenorrhea (mean age: 21.35 +/- 1.70 years) were included. Statistical analyses were performed in 32 subjects who completed all measures. Fifteen subjects received interferential current application for 20 minutes and 17 subjects received transcutaneous electrical nerve stimulation for 20 minutes when they were experiencing dysmenorrhea. Physical characteristics, years since menarche, length of menstrual cycle (days), and duration of menstruation (days) were recorded. Visual analog scale ( VAS) intensities of menstrual pain, referred lower limb pain, and low back pain were recorded before treatment, and immediately, 8 hours, and 24 hours after treatment. Intensities of the evaluated parameters decreased beginning from just after the applications in both groups (P<0.05). Intensity of referring low back pain in first three measurement times was different between the groups (P<0.05), but this difference is thought to be due to the baseline values of the groups. So, it can be said that no superiority existed between the methods (P>0.05). Both transcutaneous electrical nerve stimulation and interferential current appear to be effective in primary dysmenorrhea. As they are free from the potentially adverse effects of analgesics, and no adverse effects are reported in the literature nor observed in this study, a clinical trial of their effectiveness in comparison with untreated and placebo-treated control groups is warranted.

Better health outcomes at lower costs: the benefits of primary care utilisation for chronic disease management in remote Indigenous communities in Australia's Northern Territory.

PubMed

Zhao, Yuejen; Thomas, Susan L; Guthridge, Steven L; Wakerman, John

2014-10-04

Indigenous residents living in remote communities in Australia's Northern Territory experience higher rates of preventable chronic disease and have poorer access to appropriate health services compared to other Australians. This study compared health outcomes and costs at different levels of primary care utilisation to determine if primary care represents an efficient use of resources for Indigenous patients with common chronic diseases namely hypertension, diabetes, ischaemic heart disease, chronic obstructive pulmonary disease and renal disease. This was an historical cohort study involving a total of 14,184 Indigenous residents, aged 15 years and over, who lived in remote communities and used a remote clinic or public hospital from 2002 to 2011. Individual level demographic and clinical data were drawn from primary care and hospital care information systems using a unique patient identifier. A propensity score was used to improve comparability between high, medium and low primary care utilisation groups. Incremental cost-effectiveness ratios and acceptability curves were used to analyse four health outcome measures: total and, avoidable hospital admissions, deaths and years of life lost. Compared to the low utilisation group, medium and high levels of primary care utilisation were associated with decreases in total and avoidable hospitalisations, deaths and years of life lost. Higher levels of primary care utilisation for renal disease reduced avoidable hospitalisations by 82-85%, deaths 72-75%, and years of life lost 78-81%. For patients with ischaemic heart disease, the reduction in avoidable hospitalisations was 63-78%, deaths 63-66% and years of life lost 69-73%. In terms of cost-effectiveness, primary care for renal disease and diabetes ranked as more cost-effective, followed by hypertension and ischaemic heart disease. Primary care for chronic obstructive pulmonary disease was the least cost-effective of the five conditions. Primary care in remote Indigenous communities was shown to be associated with cost-savings to public hospitals and health benefits to individual patients. Investing $1 in primary care in remote Indigenous communities could save $3.95-$11.75 in hospital costs, in addition to health benefits for individual patients. These findings may have wider applicability in strengthening primary care in the face of high chronic disease prevalence globally.

Implementation and evaluation of the 5As framework of obesity management in primary care: design of the 5As Team (5AsT) randomized control trial

PubMed Central

2014-01-01

Background Obesity is a pressing public health concern, which frequently presents in primary care. With the explosive obesity epidemic, there is an urgent need to maximize effective management in primary care. The 5As of Obesity Management™ (5As) are a collection of knowledge tools developed by the Canadian Obesity Network. Low rates of obesity management visits in primary care suggest provider behaviour may be an important variable. The goal of the present study is to increase frequency and quality of obesity management in primary care using the 5As Team (5AsT) intervention to change provider behaviour. Methods/design The 5AsT trial is a theoretically informed, pragmatic randomized controlled trial with mixed methods evaluation. Clinic-based multidisciplinary teams (RN/NP, mental health, dietitians) will be randomized to control or the 5AsT intervention group, to participate in biweekly learning collaborative sessions supported by internal and external practice facilitation. The learning collaborative content addresses provider-identified barriers to effective obesity management in primary care. Evidence-based shared decision making tools will be co-developed and iteratively tested by practitioners. Evaluation will be informed by the RE-AIM framework. The primary outcome measure, to which participants are blinded, is number of weight management visits/full-time equivalent (FTE) position. Patient-level outcomes will also be assessed, through a longitudinal cohort study of patients from randomized practices. Patient outcomes include clinical (e.g., body mass index [BMI], blood pressure), health-related quality of life (SF-12, EQ5D), and satisfaction with care. Qualitative data collected from providers and patients will be evaluated using thematic analysis to understand the context, implementation and effectiveness of the 5AsT program. Discussion The 5AsT trial will provide a wide range of insights into current practices, knowledge gaps and barriers that limit obesity management in primary practice. The use of existing resources, collaborative design, practice facilitation, and integrated feedback loops cultivate an applicable, adaptable and sustainable approach to increasing the quantity and quality of weight management visits in primary care. Trial registration NCT01967797. PMID:24947045

Implementation and evaluation of the 5As framework of obesity management in primary care: design of the 5As Team (5AsT) randomized control trial.

PubMed

Campbell-Scherer, Denise L; Asselin, Jodie; Osunlana, Adedayo M; Fielding, Sheri; Anderson, Robin; Rueda-Clausen, Christian F; Johnson, Jeffrey A; Ogunleye, Ayodele A; Cave, Andrew; Manca, Donna; Sharma, Arya M

2014-06-19

Obesity is a pressing public health concern, which frequently presents in primary care. With the explosive obesity epidemic, there is an urgent need to maximize effective management in primary care. The 5As of Obesity Management™ (5As) are a collection of knowledge tools developed by the Canadian Obesity Network. Low rates of obesity management visits in primary care suggest provider behaviour may be an important variable. The goal of the present study is to increase frequency and quality of obesity management in primary care using the 5As Team (5AsT) intervention to change provider behaviour. The 5AsT trial is a theoretically informed, pragmatic randomized controlled trial with mixed methods evaluation. Clinic-based multidisciplinary teams (RN/NP, mental health, dietitians) will be randomized to control or the 5AsT intervention group, to participate in biweekly learning collaborative sessions supported by internal and external practice facilitation. The learning collaborative content addresses provider-identified barriers to effective obesity management in primary care. Evidence-based shared decision making tools will be co-developed and iteratively tested by practitioners. Evaluation will be informed by the RE-AIM framework. The primary outcome measure, to which participants are blinded, is number of weight management visits/full-time equivalent (FTE) position. Patient-level outcomes will also be assessed, through a longitudinal cohort study of patients from randomized practices. Patient outcomes include clinical (e.g., body mass index [BMI], blood pressure), health-related quality of life (SF-12, EQ5D), and satisfaction with care. Qualitative data collected from providers and patients will be evaluated using thematic analysis to understand the context, implementation and effectiveness of the 5AsT program. The 5AsT trial will provide a wide range of insights into current practices, knowledge gaps and barriers that limit obesity management in primary practice. The use of existing resources, collaborative design, practice facilitation, and integrated feedback loops cultivate an applicable, adaptable and sustainable approach to increasing the quantity and quality of weight management visits in primary care. NCT01967797.

Nitrogen-Based Diazeniumdiolates: Versatile Nitric Oxide-Releasing Compounds for Biomedical Research and Potential Clinical Applications

NASA Astrophysics Data System (ADS)

Saavedra, Joseph E.; Keefer, Larry K.

2002-12-01

Nitric oxide-generating ions of the nitrogen-diazeniumdiolate class with the general structure R1R2N-[N(O)NO]1 have been prepared by exposing primary, secondary, and polyamines to nitric oxide (NO). The resulting complexes regenerate bioactive NO at physiological pH with half-lives ranging from 2 seconds to 20 hours. An important goal in our research is to deliver NO to a specific organ or cell type where it is needed without affecting other NO-sensitive parts of the anatomy. By taking advantage of the remarkable chemical versatility of diazeniumdiolates, we have developed general strategies to prepare either tissue-selective NO donor drugs or materials containing NO delivery agents that can be physically placed near the target sites. Inhibition of blood coagulation, induction of penile erection, relief of pulmonary hypertension, and reversal of cerebral vasospasm are a few examples of their potential clinical applications.

See Featured Molecules.

Disease-specific clinical pathways - are they feasible in primary care? A mixed-methods study.

PubMed

Grimsmo, Anders; Løhre, Audhild; Røsstad, Tove; Gjerde, Ingunn; Heiberg, Ina; Steinsbekk, Aslak

2018-06-01

To explore the feasibility of disease-specific clinical pathways when used in primary care. A mixed-method sequential exploratory design was used. First, merging and exploring quality interview data across two cases of collaboration between the specialist care and primary care on the introduction of clinical pathways for four selected chronic diseases. Secondly, using quantitative data covering a population of 214,700 to validate and test hypothesis derived from the qualitative findings. Primary care and specialist care collaborating to manage care coordination. Primary-care representatives expressed that their patients often have complex health and social needs that clinical pathways guidelines seldom consider. The representatives experienced that COPD, heart failure, stroke and hip fracture, frequently seen in hospitals, appear in low numbers in primary care. The quantitative study confirmed the extensive complexity among home healthcare nursing patients and demonstrated that, for each of the four selected diagnoses, a homecare nurse on average is responsible for preparing reception of the patient at home after discharge from hospital, less often than every other year. The feasibility of disease-specific pathways in primary care is limited, both from a clinical and organisational perspective, for patients with complex needs. The low prevalence in primary care of patients with important chronic conditions, needing coordinated care after hospital discharge, constricts transferring tasks from specialist care. Generic clinical pathways are likely to be more feasible and efficient for patients in this setting. Key points Clinical pathways in hospitals apply to single-disease guidelines, while more than 90% of the patients discharged to community health care for follow-up have multimorbidity. Primary care has to manage the health care of the patient holistically, with all his or her complex needs. Patients most frequently admitted to hospitals, i.e. patients with COPD, heart failure, stroke and hip fracture are infrequent in primary care and represent a minority among patients in need of coordinated community health care. In primary care, the low rate of receiving patients discharged from hospitals of major chronic diseases hampers maintenance of required specific skills, thus constricting the transfer of tasks to primary care. Generic clinical pathways are suggested to be more feasible than disease-specific pathways for most patients with complex needs.

Basic investigation of the laminated alginate impression technique: Setting time, permanent deformation, elastic deformation, consistency, and tensile bond strength tests.

PubMed

Kitamura, Aya; Kawai, Yasuhiko

2015-01-01

Laminated alginate impression for edentulous is simple and time efficient compared to border molding technique. The purpose of this study was to examine clinical applicability of the laminated alginate impression, by measuring the effects of different Water/Powder (W/P) and mixing methods, and different bonding methods in the secondary impression of alginate impression. Three W/P: manufacturer-designated mixing water amount (standard), 1.5-fold (1.5×) and 1.75-fold (1.75×) water amount were mixed by manual and automatic mixing methods. Initial and complete setting time, permanent and elastic deformation, and consistency of the secondary impression were investigated (n=10). Additionally, tensile bond strength between the primary and secondary impression were measured in the following surface treatment; air blow only (A), surface baking (B), and alginate impression material bonding agent (ALGI-BOND: AB) (n=12). Initial setting times significantly shortened with automatic mixing for all W/P (p<0.05). The permanent deformation decreased and elastic deformation increased as high W/P, regardless of the mixing method. Elastic deformation significantly reduced in 1.5× and 1.75× with automatic mixing (p<0.05). All of these properties resulted within JIS standards. For all W/P, AB showed a significantly high bonding strength as compared to A and B (p<0.01). The increase of mixing water, 1.5× and 1.75×, resulted within JIS standards in setting time, suggesting its applicability in clinical setting. The use of automatic mixing device decreased elastic strain and shortening of the curing time. For the secondary impression application of adhesives on the primary impression gives secure adhesion. Copyright © 2014 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

Application of hyperthermia induced by superparamagnetic iron oxide nanoparticles in glioma treatment

PubMed Central

Silva, André C; Oliveira, Tiago R; Mamani, Javier B; Malheiros, Suzana MF; Malavolta, Luciana; Pavon, Lorena F; Sibov, Tatiana T; Amaro, Edson; Tannús, Alberto; Vidoto, Edson LG; Martins, Mateus J; Santos, Ricardo S; Gamarra, Lionel F

2011-01-01

Gliomas are a group of heterogeneous primary central nervous system (CNS) tumors arising from the glial cells. Malignant gliomas account for a majority of malignant primary CNS tumors and are associated with high morbidity and mortality. Glioblastoma is the most frequent and malignant glioma, and despite the recent advances in diagnosis and new treatment options, its prognosis remains dismal. New opportunities for the development of effective therapies for malignant gliomas are urgently needed. Magnetic hyperthermia (MHT), which consists of heat generation in the region of the tumor through the application of magnetic nanoparticles subjected to an alternating magnetic field (AMF), has shown positive results in both preclinical and clinical assays. The aim of this review is to assess the relevance of hyperthermia induced by magnetic nanoparticles in the treatment of gliomas and to note the possible variations of the technique and its implication on the effectiveness of the treatment. We performed an electronic search in the literature from January 1990 to October 2010, in various databases, and after application of the inclusion criteria we obtained a total of 15 articles. In vitro studies and studies using animal models showed that MHT was effective in the promotion of tumor cell death and reduction of tumor mass or increase in survival. Two clinical studies showed that MHT could be applied safely and with few side effects. Some studies suggested that mechanisms of cell death, such as apoptosis, necrosis, and antitumor immune response were triggered by MHT. Based on these data, we could conclude that MHT proved to be efficient in most of the experiments, and that the improvement of the nanocomposites as well as the AMF equipment might contribute toward establishing MHT as a promising tool in the treatment of malignant gliomas. PMID:21674016

Mobile Technology in Undergraduate Nursing Education: A Systematic Review.

PubMed

Lee, Hyejung; Min, Haeyoung; Oh, Su-Mi; Shim, Kaka

2018-04-01

This study aimed to identify and systematically review the literature on the use of mobile technology in nursing education. The research findings could evidence the effectiveness of mobile technology in undergraduate nursing students' learning outcomes. Computerized searches were conducted using the Ovid-MEDLINE, Ovid-EMBASE, Cochrane Library, and CINAHL databases for relevant primary studies and limited to those between 2000 and February 2018. Only randomized controlled trials (RCTs) and quasi-experimental studies published in either English or Korean were included and critically appraised using Joanna Briggs Institute tools. Seven RCTs and 7 quasi-experimental studies were identified. The mobile device and intervention applied varied throughout all the studies. Studies published earlier in the 2000s found that immediate access to clinical and pharmacological referencing information through the mobile device increased students' efficacy in clinical practice. Later studies, which were mostly conducted in Korea, reported that smartphone-based applications could promote nursing students' learning motivation and satisfaction but not their clinical skills and knowledge. We still seem to be in the beginning stage of implementing mobile technology in nursing education due to the limited implication of mobile technology and inconsistent research conclusions. In the future, rigorous primary empirical studies are needed to suggest the effective use of mobile devices in nursing education.

Mobile Technology in Undergraduate Nursing Education: A Systematic Review

PubMed Central

Lee, Hyejung; Oh, Su-mi; Shim, Kaka

2018-01-01

Objectives This study aimed to identify and systematically review the literature on the use of mobile technology in nursing education. The research findings could evidence the effectiveness of mobile technology in undergraduate nursing students' learning outcomes. Methods Computerized searches were conducted using the Ovid-MEDLINE, Ovid-EMBASE, Cochrane Library, and CINAHL databases for relevant primary studies and limited to those between 2000 and February 2018. Only randomized controlled trials (RCTs) and quasi-experimental studies published in either English or Korean were included and critically appraised using Joanna Briggs Institute tools. Results Seven RCTs and 7 quasi-experimental studies were identified. The mobile device and intervention applied varied throughout all the studies. Studies published earlier in the 2000s found that immediate access to clinical and pharmacological referencing information through the mobile device increased students' efficacy in clinical practice. Later studies, which were mostly conducted in Korea, reported that smartphone-based applications could promote nursing students' learning motivation and satisfaction but not their clinical skills and knowledge. Conclusions We still seem to be in the beginning stage of implementing mobile technology in nursing education due to the limited implication of mobile technology and inconsistent research conclusions. In the future, rigorous primary empirical studies are needed to suggest the effective use of mobile devices in nursing education. PMID:29770243

An embedded randomised controlled trial of a Teaser Campaign to optimise recruitment in primary care.

PubMed

Lee, Hopin; Hübscher, Markus; Moseley, G Lorimer; Kamper, Steven J; Traeger, Adrian C; Skinner, Ian W; Williams, Christopher M; McAuley, James H

2017-04-01

Marketing communication and brand identity is a fundamental principle of advertising and end-user engagement. Health researchers have begun to apply this principle to trial recruitment in primary care. The aim of this study was to evaluate whether a Teaser Campaign using a series of postcards in advance of a conventional mail-out increases the number of primary care clinics that engage with a clinical trial. Embedded randomised recruitment trial across primary care clinics (general practitioners and physiotherapists) in the Sydney metropolitan area. Clinics in the Teaser Campaign group received a series of branded promotional postcards in advance of a standard letter inviting them to participate in a clinical trial. Clinics in the Standard Mail group did not receive the postcards. From a total of 744 clinics that were sent an invitation letter, 46 clinics in the Teaser Campaign group and 40 clinics in the Standard Mail group responded (11.6% total response rate). There was no between-group difference in the odds of responding to the invitation letter (odds ratio = 1.18, 95% confidence interval = 0.75-1.85, p = 0.49). For physiotherapy clinics and general practice clinics, the odds ratios were 1.43 (confidence interval = 0.82-2.48, p = 0.21) and 0.77 (confidence interval = 0.34-1.75, p  = 0.54), respectively. A Teaser Campaign using a series of branded promotional postcards did not improve clinic engagement for a randomised controlled trial in primary care.

Antimicrobial resistance dashboard application for mapping environmental occurrence and resistant pathogens.

PubMed

Stedtfeld, Robert D; Williams, Maggie R; Fakher, Umama; Johnson, Timothy A; Stedtfeld, Tiffany M; Wang, Fang; Khalife, Walid T; Hughes, Mary; Etchebarne, Brett E; Tiedje, James M; Hashsham, Syed A

2016-03-01

An antibiotic resistance (AR) Dashboard application is being developed regarding the occurrence of antibiotic resistance genes (ARG) and bacteria (ARB) in environmental and clinical settings. The application gathers and geospatially maps AR studies, reported occurrence and antibiograms, which can be downloaded for offline analysis. With the integration of multiple data sets, the database can be used on a regional or global scale to identify hot spots for ARGs and ARB; track and link spread and transmission, quantify environmental or human factors influencing presence and persistence of ARG harboring organisms; differentiate natural ARGs from those distributed via human or animal activity; cluster and compare ARGs connections in different environments and hosts; and identify genes that can be used as proxies to routinely monitor anthropogenic pollution. To initially populate and develop the AR Dashboard, a qPCR ARG array was tested with 30 surface waters, primary influent from three waste water treatment facilities, ten clinical isolates from a regional hospital and data from previously published studies including river, park soil and swine farm samples. Interested users are invited to download a beta version (available on iOS or Android), submit AR information using the application, and provide feedback on current and prospective functionalities. © FEMS 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Effectiveness of a Psychoeducational Parenting Group on Child, Parent and Family Behavior: A Pilot Study in a Family Practice Clinic with an Underserved Population

PubMed Central

Berge, Jerica M.; Law, David D.; Johnson, Jennifer; Wells, M. Gawain

2013-01-01

Background Although integrated care for adults in primary care has steadily increased over the last several decades, there remains a paucity of research regarding integrated care for children in primary care. Purpose To report results of a pilot study testing initial feasibility of a parenting psychoeducational group targeting child behavioral problems within a primary care clinic. Method The participants (n = 35) were parents representing an underserved population from an inner-city primary care clinic. Participants attended a 12-week psychoeducational parenting group and reported pre- and post-measures of family functioning, child misbehavior and dyadic functioning. Paired t-tests and effects sizes are reported. Results Participants reported statistically significant improvement in family functioning, child misbehavior and couple functioning after participating in the parenting psychoeducational group. Conclusions Results suggest initial feasibility of a parenting psychoeducational group within a primary care clinic with an underserved population. This intervention may be useful for other primary care clinics seeking to offer more integrative care options for children and their families. PMID:20939627

Randomized trial for answers to clinical questions: evaluating a pre-appraised versus a MEDLINE search protocol.

PubMed

Patel, Manesh R; Schardt, Connie M; Sanders, Linda L; Keitz, Sheri A

2006-10-01

The paper compares the speed, validity, and applicability of two different protocols for searching the primary medical literature. A randomized trial involving medicine residents was performed. An inpatient general medicine rotation was used. Thirty-two internal medicine residents were block randomized into four groups of eight. Success rate of each search protocol was measured by perceived search time, number of questions answered, and proportion of articles that were applicable and valid. Residents randomized to the MEDLINE-first (protocol A) group searched 120 questions, and residents randomized to the MEDLINE-last (protocol B) searched 133 questions. In protocol A, 104 answers (86.7%) and, in protocol B, 117 answers (88%) were found to clinical questions. In protocol A, residents reported that 26 (25.2%) of the answers were obtained quickly or rated as "fast" (<5 minutes) as opposed to 55 (51.9%) in protocol B, (P = 0.0004). A subset of questions and articles (n = 79) were reviewed by faculty who found that both protocols identified similar numbers of answer articles that addressed the questions and were felt to be valid using critical appraisal criteria. For resident-generated clinical questions, both protocols produced a similarly high percentage of applicable and valid articles. The MEDLINE-last search protocol was perceived to be faster. However, in the MEDLINE-last protocol, a significant portion of questions (23%) still required searching MEDLINE to find an answer.

Using psychological theory to understand the clinical management of type 2 diabetes in Primary Care: a comparison across two European countries.

PubMed

Hrisos, Susan; Eccles, Martin P; Francis, Jill J; Bosch, Marije; Dijkstra, Rob; Johnston, Marie; Grol, Richard; Kaner, Eileen F S; Steen, Ian N

2009-08-05

Long term management of patients with Type 2 diabetes is well established within Primary Care. However, despite extensive efforts to implement high quality care both service provision and patient health outcomes remain sub-optimal. Several recent studies suggest that psychological theories about individuals' behaviour can provide a valuable framework for understanding generalisable factors underlying health professionals' clinical behaviour. In the context of the team management of chronic disease such as diabetes, however, the application of such models is less well established. The aim of this study was to identify motivational factors underlying health professional teams' clinical management of diabetes using a psychological model of human behaviour. A predictive questionnaire based on the Theory of Planned Behaviour (TPB) investigated health professionals' (HPs') cognitions (e.g., beliefs, attitudes and intentions) about the provision of two aspects of care for patients with diabetes: prescribing statins and inspecting feet.General practitioners and practice nurses in England and the Netherlands completed parallel questionnaires, cross-validated for equivalence in English and Dutch. Behavioural data were practice-level patient-reported rates of foot examination and use of statin medication. Relationships between the cognitive antecedents of behaviour proposed by the TPB and healthcare teams' clinical behaviour were explored using multiple regression. In both countries, attitude and subjective norm were important predictors of health professionals' intention to inspect feet (Attitude: beta = .40; Subjective Norm: beta = .28; Adjusted R2 = .34, p < 0.01), and their intention to prescribe statins (Attitude: beta = .44; Adjusted R2 = .40, p < 0.01). Individuals' self-reported intention did not predict practice-level performance of either clinical behaviour. Using the TPB, we identified modifiable factors underlying health professionals' intentions to perform two clinical behaviours, providing a rationale for the development of targeted interventions. However, we did not observe a relationship between health professionals' intentions and our proxy measure of team behaviour. Significant methodological issues were highlighted concerning the use of models of individual behaviour to explain behaviours performed by teams. In order to investigate clinical behaviours performed by teams it may be necessary to develop measures that reflect the collective cognitions of the members of the team to facilitate the application of these theoretical models to team behaviours.

Using psychological theory to understand the clinical management of type 2 diabetes in Primary Care: a comparison across two European countries

PubMed Central

Hrisos, Susan; Eccles, Martin P; Francis, Jill J; Bosch, Marije; Dijkstra, Rob; Johnston, Marie; Grol, Richard; Kaner, Eileen FS; Steen, Ian N

2009-01-01

Background Long term management of patients with Type 2 diabetes is well established within Primary Care. However, despite extensive efforts to implement high quality care both service provision and patient health outcomes remain sub-optimal. Several recent studies suggest that psychological theories about individuals' behaviour can provide a valuable framework for understanding generalisable factors underlying health professionals' clinical behaviour. In the context of the team management of chronic disease such as diabetes, however, the application of such models is less well established. The aim of this study was to identify motivational factors underlying health professional teams' clinical management of diabetes using a psychological model of human behaviour. Methods A predictive questionnaire based on the Theory of Planned Behaviour (TPB) investigated health professionals' (HPs') cognitions (e.g., beliefs, attitudes and intentions) about the provision of two aspects of care for patients with diabetes: prescribing statins and inspecting feet. General practitioners and practice nurses in England and the Netherlands completed parallel questionnaires, cross-validated for equivalence in English and Dutch. Behavioural data were practice-level patient-reported rates of foot examination and use of statin medication. Relationships between the cognitive antecedents of behaviour proposed by the TPB and healthcare teams' clinical behaviour were explored using multiple regression. Results In both countries, attitude and subjective norm were important predictors of health professionals' intention to inspect feet (Attitude: beta = .40; Subjective Norm: beta = .28; Adjusted R2 = .34, p < 0.01), and their intention to prescribe statins (Attitude: beta = .44; Adjusted R2 = .40, p < 0.01). Individuals' self-reported intention did not predict practice-level performance of either clinical behaviour. Conclusion Using the TPB, we identified modifiable factors underlying health professionals' intentions to perform two clinical behaviours, providing a rationale for the development of targeted interventions. However, we did not observe a relationship between health professionals' intentions and our proxy measure of team behaviour. Significant methodological issues were highlighted concerning the use of models of individual behaviour to explain behaviours performed by teams. In order to investigate clinical behaviours performed by teams it may be necessary to develop measures that reflect the collective cognitions of the members of the team to facilitate the application of these theoretical models to team behaviours. PMID:19656372

Describing the content of primary care: limitations of Canadian billing data.

PubMed

Katz, Alan; Halas, Gayle; Dillon, Michael; Sloshower, Jordan

2012-02-15

Primary health care systems are designed to provide comprehensive patient care. However, the ICD 9 coding system used for billing purposes in Canada neither characterizes nor captures the scope of clinical practice or complexity of physician-patient interactions. This study aims to describe the content of primary care clinical encounters and examine the limitations of using administrative data to capture the content of these visits. Although a number of U.S studies have described the content of primary care encounters, this is the first Canadian study to do so. Study-specific data collection forms were completed by 16 primary care physicians in community health and family practice clinics in Winnipeg, Manitoba, Canada. The data collection forms were completed immediately following the patient encounter and included patient and visit characteristics, such as primary reason for visit, topics discussed, actions taken, degree of complexity as well as diagnosis and ICD-9 codes. Data was collected for 760 patient encounters. The diagnostic codes often did not reflect the dominant topic of the visit or the topic requiring the most amount of time. Physicians often address multiple problems and provide numerous services thus increasing the complexity of care. This is one of the first Canadian studies to critically analyze the content of primary care clinical encounters. The data allowed a greater understanding of primary care clinical encounters and attests to the deficiencies of singular ICD-9 coding which fails to capture the comprehensiveness and complexity of the primary care encounter. As primary care reform initiatives in the U.S and Canada attempt to transform the way family physicians deliver care, it becomes increasingly important that other tools for structuring primary care data are considered in order to help physicians, researchers and policy makers understand the breadth and complexity of primary care.

Chasm in primary care provision in a universal health system: Findings from a nationally representative survey of health facilities in Malaysia

PubMed Central

Sivasampu, Sheamini; Khoo, Ee Ming; Mohamad Noh, Kamaliah

2017-01-01

Background Malaysia has achieved universal health coverage since 1980s through the expansion of direct public provision, particularly in rural areas. However, no systematic examination of the rural-urban distribution of primary care services and resources has been conducted to date for policy impact evaluation. Methods We conducted a national cross-sectional survey of 316 public and 597 private primary care clinics, selected through proportionate stratified random sampling, from June 2011 through February 2012. Using a questionnaire developed based on the World Health Organization toolkits on monitoring health systems strengthening, we examined the availability of primary care services/resources and the associations between service/resource availability and clinic ownership, locality, and patient load. Data were weighted for all analyses to account for the complex survey design and produce unbiased national estimates. Results Private primary care clinics and doctors outnumbered their public counterparts by factors of 5.6 and 3.9, respectively, but the private clinics were significantly less well-equipped with basic facilities and provided a more limited range of services. Per capita densities of primary care clinics and workforce were higher in urban areas (2.2 clinics and 15.1 providers per 10,000 population in urban areas versus 1.1 clinics and 11.7 providers per 10,000 population in rural areas). Within the public sector, the distribution of health services and resources was unequal and strongly favored the urban clinics. Regression analysis revealed that rural clinics had lower availability of services and resources after adjusting for ownership and patient load, but the associations were not significant except for workforce availability (adjusted odds ratio [OR]: 0.82; 95% confidence interval [CI]: 0.71–0.96). Conclusions Targeted primary care expansion in rural areas could be an effective first step towards achieving universal health coverage, especially in countries with limited healthcare resources. Nonetheless, geographic expansion alone is inadequate to achieve effective coverage in a dichotomous primary care system, and the role of the private sector in primary care delivery should not be overlooked. PMID:28196113

Chasm in primary care provision in a universal health system: Findings from a nationally representative survey of health facilities in Malaysia.

PubMed

Lim, Huy Ming; Sivasampu, Sheamini; Khoo, Ee Ming; Mohamad Noh, Kamaliah

2017-01-01

Malaysia has achieved universal health coverage since 1980s through the expansion of direct public provision, particularly in rural areas. However, no systematic examination of the rural-urban distribution of primary care services and resources has been conducted to date for policy impact evaluation. We conducted a national cross-sectional survey of 316 public and 597 private primary care clinics, selected through proportionate stratified random sampling, from June 2011 through February 2012. Using a questionnaire developed based on the World Health Organization toolkits on monitoring health systems strengthening, we examined the availability of primary care services/resources and the associations between service/resource availability and clinic ownership, locality, and patient load. Data were weighted for all analyses to account for the complex survey design and produce unbiased national estimates. Private primary care clinics and doctors outnumbered their public counterparts by factors of 5.6 and 3.9, respectively, but the private clinics were significantly less well-equipped with basic facilities and provided a more limited range of services. Per capita densities of primary care clinics and workforce were higher in urban areas (2.2 clinics and 15.1 providers per 10,000 population in urban areas versus 1.1 clinics and 11.7 providers per 10,000 population in rural areas). Within the public sector, the distribution of health services and resources was unequal and strongly favored the urban clinics. Regression analysis revealed that rural clinics had lower availability of services and resources after adjusting for ownership and patient load, but the associations were not significant except for workforce availability (adjusted odds ratio [OR]: 0.82; 95% confidence interval [CI]: 0.71-0.96). Targeted primary care expansion in rural areas could be an effective first step towards achieving universal health coverage, especially in countries with limited healthcare resources. Nonetheless, geographic expansion alone is inadequate to achieve effective coverage in a dichotomous primary care system, and the role of the private sector in primary care delivery should not be overlooked.

A randomized pilot comparative study of topical methyl aminolevulinate photodynamic therapy versus imiquimod 5% versus sequential application of both therapies in immunocompetent patients with actinic keratosis: clinical and histologic outcomes.

PubMed

Serra-Guillén, Carlos; Nagore, Eduardo; Hueso, Luis; Traves, Victor; Messeguer, Francesc; Sanmartín, Onofre; Llombart, Beatriz; Requena, Celia; Botella-Estrada, Rafael; Guillén, Carlos

2012-04-01

Photodynamic therapy (PDT) and imiquimod are the treatments of choice for actinic keratosis (AK). As they have different mechanisms of action, it seems reasonable to assume that applying both treatments sequentially would be efficacious. We sought to determine which of these therapeutic modalities provides a better clinical and histologic response in patients with AK and whether sequential use of both was more efficacious than each separately. Patients were randomly assigned to one treatment group: group 1, PDT only; group 2, imiquimod only; or group 3, sequential use of PDT and imiquimod. The primary outcome measure was complete clinical response. Partial clinical response was defined as a reduction of more than 75% in the initial number of lesions. A complete clinicopathologic response was defined as lack of evidence of AK in the biopsy specimen. In all, 105 patients completed the study (group 1, 40 patients; group 2, 33 patients; group 3, 32 patients). Sequential application of PDT and imiquimod was more efficacious in all the outcome measures. More patients were satisfied with PDT than with the other two modalities (P = .003). No significant differences were observed among the 3 modalities and tolerance to treatment. Only one cycle of imiquimod was administered. The follow-up period was brief. Sequential application of PDT and imiquimod provides a significantly better clinical and histologic response in the treatment of AK than PDT or imiquimod monotherapy. It also produces less intense local reactions and better tolerance and satisfaction than imiquimod monotherapy. Copyright © 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

Liver function testing with nuclear medicine techniques is coming of age.

PubMed

Bennink, Roelof J; Tulchinsky, Mark; de Graaf, Wilmar; Kadry, Zakiyah; van Gulik, Thomas M

2012-03-01

Liver function is a broad term, as the organ participates in a multitude of different physiological and biochemical processes, including metabolic, synthetic, and detoxifying functions. However, it is the function of the hepatocyte that is central to sustaining normal life and dealing with disease states. When the liver begins to fail in severely ill patients, it forecasts a terminal outcome. However, unlike the glomerular filtration rate which clearly quantifies the key renal function, at most practice sites, there is no clinically available quantitative test for liver function. Although it is commonplace to assess indirect evidence of that function (by measuring blood levels of its end products and by-products) and to detect an acute injury (by following rising transaminases), a widely available test that would directly measure hepatocellular function is lacking. This article reviews current knowledge on liver function studies and focuses on those nuclear medicine tests available to study the whole liver and regional liver function. The clinical application driving these tests, prediction of remnant liver function after partial hepatectomy for primary liver malignancy or metastatic disease, is addressed here in detail. The test was recently validated for this specific application and was shown to be better than the current standard of practice (computed tomography volumetry), particularly in patients with hepatic comorbidities like cirrhosis, steatosis, or cholestasis. Furthermore, early assessment of regional liver function increase after preoperative portal vein embolization becomes possible with this technology. The limiting factor to a wider acceptance of this test is based on the lack of clinical software that would allow calculation of liver function parameters. This article provides information that enables a clinical nuclear medicine facility to provide this test using readily available equipment. Furthermore, it addresses emerging clinical applications that are under investigation. Copyright © 2012 Elsevier Inc. All rights reserved.

Portable infrared pupillometry: a review.

PubMed

Larson, Merlin D; Behrends, Matthias

2015-06-01

Portable infrared pupillometers provide an objective measure of pupil size and pupillary reflexes, which for most clinicians was previously only a visual impression. But despite the fact that pupillometry can uncover aspects of how the human pupil reacts to drugs and noxious stimulation, the use of pupillometry has not gained widespread use among anesthesiologists and critical care physicians. The present review is an introduction to the physiology of pupillary reflexes and the currently established clinical applications of infrared pupillometry, which will hopefully encourage physicians to use this diagnostic tool in their clinical practice. Portable infrared pupillometry was introduced in 1989. The technology involves flooding the eye with infrared light and then measuring the reflected image on an infrared sensor. Pupil size, along with variables of the pupillary light reflex and pupillary reflex dilation, is calculated by the instrument and displayed on a screen immediately after each time-stamped measurement. Use of these instruments has uncovered aspects of how the human pupil reacts to drugs and noxious stimulation. The primary clinical applications for portable pupillometry have been in the assessment of brainstem function. Portable pupillometry is useful in the management of pain because it allows for assessments of the effect of opioids and in the titration of combined regional-general anesthetics.

Human embryonic stem cell therapies for neurodegenerative diseases.

PubMed

Tomaskovic-Crook, Eva; Crook, Jeremy M

2011-06-01

There is a renewed enthusiasm for the clinical translation of human embryonic stem (hES) cells. This is abetted by putative clinically-compliant strategies for hES cell maintenance and directed differentiation, greater understanding of and accessibility to cells through formal cell registries and centralized cell banking for distribution, the revised US government policy on funding hES cell research, and paradoxically the discovery of induced pluripotent stem (iPS) cells. Additionally, as we consider the constraints (practical and fiscal) of delivering cell therapies for global healthcare, the more efficient and economical application of allogeneic vs autologous treatments will bolster the clinical entry of hES cell derivatives. Neurodegenerative disorders such as Parkinson's disease are primary candidates for hES cell therapy, although there are significant hurdles to be overcome. The present review considers key advances and challenges to translating hES cells into novel therapies for neurodegenerative diseases, with special consideration given to Parkinson's disease and Alzheimer's disease. Importantly, despite the focus on degenerative brain disorders and hES cells, many of the issues canvassed by this review are relevant to systemic application of hES cells and other pluripotent stem cells such as iPS cells.

Rapid Detection of Dendritic Cell and Monocyte Disorders Using CD4 as a Lineage Marker of the Human Peripheral Blood Antigen-Presenting Cell Compartment

PubMed Central

Jardine, Laura; Barge, Dawn; Ames-Draycott, Ashley; Pagan, Sarah; Cookson, Sharon; Spickett, Gavin; Haniffa, Muzlifah; Collin, Matthew; Bigley, Venetia

2013-01-01

Dendritic cells (DCs) and monocytes are critical regulators and effectors of innate and adaptive immune responses. Monocyte expansion has been described in many pathological states while monocyte and DC deficiency syndromes are relatively recent additions to the catalog of human primary immunodeficiency disorders. Clinically applicable screening tests to diagnose and monitor these conditions are lacking. Conventional strategies for identifying human DCs and monocytes have been based on the use of a lineage gate to exclude lymphocytes, thus preventing simultaneous detection of DCs, monocytes, and lymphocyte subsets. Here we demonstrate that CD4 is a reliable lineage marker for the human peripheral blood antigen-presenting cell compartment that can be used to identify DCs and monocytes in parallel with lymphocytes. Based on this principle, simple modification of a standard lymphocyte phenotyping assay permits simultaneous enumeration of four lymphocyte and five DC/monocyte populations from a single sample. This approach is applicable to clinical samples and facilitates the diagnosis of DC and monocyte disorders in a wide range of clinical settings, including genetic deficiency, neoplasia, and inflammation. PMID:24416034

Review of Telemicrobiology

PubMed Central

Rhoads, Daniel D.; Mathison, Blaine A.; Bishop, Henry S.; da Silva, Alexandre J.; Pantanowitz, Liron

2016-01-01

Context Microbiology laboratories are continually pursuing means to improve quality, rapidity, and efficiency of specimen analysis in the face of limited resources. One means by which to achieve these improvements is through the remote analysis of digital images. Telemicrobiology enables the remote interpretation of images of microbiology specimens. To date, the practice of clinical telemicrobiology has not been thoroughly reviewed. Objective Identify the various methods that can be employed for telemicrobiology, including emerging technologies that may provide value to the clinical laboratory. Data Sources Peer-reviewed literature, conference proceedings, meeting presentations, and expert opinions pertaining to telemicrobiology have been evaluated. Results A number of modalities have been employed for telemicroscopy including static capture techniques, whole slide imaging, video telemicroscopy, mobile devices, and hybrid systems. Telemicrobiology has been successfully implemented for applications including routine primary diagnois, expert teleconsultation, and proficiency testing. Emerging areas include digital culture plate reading, mobile health applications and computer-augmented analysis of digital images. Conclusions Static image capture techniques to date have been the most widely used modality for telemicrobiology, despite the fact that other newer technologies are available and may produce better quality interpretations. Increased adoption of telemicrobiology offers added value, quality, and efficiency to the clinical microbiology laboratory. PMID:26317376

NASA/Drexel program. [research effort in large-scale technical programs management for application to urban problems

NASA Technical Reports Server (NTRS)

1973-01-01

The results are reported of the NASA/Drexel research effort which was conducted in two separate phases. The initial phase stressed exploration of the problem from the point of view of three primary research areas and the building of a multidisciplinary team. The final phase consisted of a clinical demonstration program in which the research associates consulted with the County Executive of New Castle County, Delaware, to aid in solving actual problems confronting the County Government. The three primary research areas of the initial phase are identified as technology, management science, and behavioral science. Five specific projects which made up the research effort are treated separately. A final section contains the conclusions drawn from total research effort as well as from the specific projects.

Use of skin stretchers for single-stage bilateral mastectomies in a dog and a cat.

PubMed

Miyazaki, Yuta; Aikawa, Takeshi; Shimatsu, Taichi; Nishimura, Masaaki; Sadahiro, Shigeo

2018-04-01

To describe the application of skin stretchers for closure of single-stage bilateral mastectomies in a dog and a cat. Clinical case report. A 12-year-old intact female Miniature Dachshund and a 13-year-old spayed female domestic short-hair cat. Skin stretchers were applied to the site of the skin adjacent to mammary glands for 2-4 days before surgery. Cable tension was adjusted every 6-8 hours to elongate the skin and to achieve primary closure of single-stage bilateral mastectomy without tension. Wound closure after single-stage bilateral mastectomy was achieved without tension or major complication in both animals. Use of skin stretchers allows primary closure of single-stage bilateral mastectomy in dogs and cats. © 2017 The American College of Veterinary Surgeons.

CER Hub: An informatics platform for conducting comparative effectiveness research using multi-institutional, heterogeneous, electronic clinical data.

PubMed

Hazlehurst, Brian L; Kurtz, Stephen E; Masica, Andrew; Stevens, Victor J; McBurnie, Mary Ann; Puro, Jon E; Vijayadeva, Vinutha; Au, David H; Brannon, Elissa D; Sittig, Dean F

2015-10-01

Comparative effectiveness research (CER) requires the capture and analysis of data from disparate sources, often from a variety of institutions with diverse electronic health record (EHR) implementations. In this paper we describe the CER Hub, a web-based informatics platform for developing and conducting research studies that combine comprehensive electronic clinical data from multiple health care organizations. The CER Hub platform implements a data processing pipeline that employs informatics standards for data representation and web-based tools for developing study-specific data processing applications, providing standardized access to the patient-centric electronic health record (EHR) across organizations. The CER Hub is being used to conduct two CER studies utilizing data from six geographically distributed and demographically diverse health systems. These foundational studies address the effectiveness of medications for controlling asthma and the effectiveness of smoking cessation services delivered in primary care. The CER Hub includes four key capabilities: the ability to process and analyze both free-text and coded clinical data in the EHR; a data processing environment supported by distributed data and study governance processes; a clinical data-interchange format for facilitating standardized extraction of clinical data from EHRs; and a library of shareable clinical data processing applications. CER requires coordinated and scalable methods for extracting, aggregating, and analyzing complex, multi-institutional clinical data. By offering a range of informatics tools integrated into a framework for conducting studies using EHR data, the CER Hub provides a solution to the challenges of multi-institutional research using electronic medical record data. Copyright © 2015. Published by Elsevier Ireland Ltd.

Clinical Practice Models for the Use of E-Mental Health Resources in Primary Health Care by Health Professionals and Peer Workers: A Conceptual Framework

PubMed Central

Griffiths, Kathleen M; Cunningham, John A; Bennett, Kylie; Bennett, Anthony

2015-01-01

Background Research into e-mental health technologies has developed rapidly in the last 15 years. Applications such as Internet-delivered cognitive behavioral therapy interventions have accumulated considerable evidence of efficacy and some evidence of effectiveness. These programs have achieved similar outcomes to face-to-face therapy, while requiring much less clinician time. There is now burgeoning interest in integrating e-mental health resources with the broader mental health delivery system, particularly in primary care. The Australian government has supported the development and deployment of e-mental health resources, including websites that provide information, peer-to-peer support, automated self-help, and guided interventions. An ambitious national project has been commissioned to promote key resources to clinicians, to provide training in their use, and to evaluate the impact of promotion and training upon clinical practice. Previous initiatives have trained clinicians to use a single e-mental health program or a suite of related programs. In contrast, the current initiative will support community-based service providers to access a diverse array of resources developed and provided by many different groups. Objective The objective of this paper was to develop a conceptual framework to support the use of e-mental health resources in routine primary health care. In particular, models of clinical practice are required to guide the use of the resources by diverse service providers and to inform professional training, promotional, and evaluation activities. Methods Information about service providers’ use of e-mental health resources was synthesized from a nonsystematic overview of published literature and the authors’ experience of training primary care service providers. Results Five emerging clinical practice models are proposed: (1) promotion; (2) case management; (3) coaching; (4) symptom-focused treatment; and (5) comprehensive therapy. We also consider the service provider skills required for each model and the ways that e-mental health resources might be used by general practice doctors and nurses, pharmacists, psychologists, social workers, occupational therapists, counselors, and peer workers Conclusions The models proposed in the current paper provide a conceptual framework for policy-makers, researchers and clinicians interested in integrating e-mental health resources into primary care. Research is needed to establish the safety and effectiveness of the models in routine care and the best ways to support their implementation. PMID:26543912

The effect of propolis fluoride on caries dentine activity

NASA Astrophysics Data System (ADS)

Darwita, Risqa Rina; Soekanto, Sri Angky; Finisha, Andanali Rhukul; Wahyuni, Hardiati Nur; Andiani, Salsabila Ghina

2018-02-01

This research was conducted to analyze the effect of propolis fluoride on the occurrence of arrested caries dentine surface. The design of the study was a clinical trial experimental. The respondent were primary school students aged 6-8 years, from primary school in Kukusan, Depok, West Java, Indonesia. They were screened of dental examination and the total number of 296 children with an age range of 6-8 year old were included in the study. All students who had dentin caries were get dental treatment with propolis fluoride topical application in dentin caries surface. After one month, two months and four months all students who were got propolis fluoride topical application in dentin caries surface were controlled. All data were analyzed by Wilcoxon test. The total number of dentinal decay of 296 student was 1740 surfaces indicated to Flolis topical application. After one, two and three months of Flolis application, all arrested of dentinal decay was evaluated, the result of evaluation from the second month to the third month evaluation was found that the arrested dentinal caries surfaces were decreased significantly at 29.36% (p<0.01), while the evaluation of arrested dentinal caries surface from the first month to the third month was decreased significantly at 38.62% (p<0.001). Flolis was proven significantly to be able to arrest the activity of dental caries, and their ability to arrest dental caries was significantly different. Flolis was found to be effective in arresting dentinal caries surface until three months application, and should be repeated after 3 months of Flolis application.

Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.

PubMed

Shepshelovich, D; Goldvaser, H; Wang, L; Abdul Razak, A R; Bedard, P L

2017-12-01

Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (p<0.001), multicenter trials (p<0.001) and publication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.

Using ClinicalTrials.gov to Supplement Information in Ophthalmology Conference Abstracts about Trial Outcomes: A Comparison Study

PubMed Central

Scherer, Roberta W.; Huynh, Lynn; Ervin, Ann-Margret; Dickersin, Kay

2015-01-01

Background Including results from unpublished randomized controlled trials (RCTs) in a systematic review may ameliorate the effect of publication bias in systematic review results. Unpublished RCTs are sometimes described in abstracts presented at conferences, included in trials registers, or both. Trial results may not be available in a trials register and abstracts describing RCT results often lack study design information. Complementary information from a trials register record may be sufficient to allow reliable inclusion of an unpublished RCT only available as an abstract in a systematic review. Methods We identified 496 abstracts describing RCTs presented at the 2007 to 2009 Association for Research in Vision and Ophthalmology (ARVO) meetings; 154 RCTs were registered in ClinicalTrials.gov. Two persons extracted verbatim primary and non-primary outcomes reported in the abstract and ClinicalTrials.gov record. We compared each abstract outcome with all ClinicalTrials.gov outcomes and coded matches as complete, partial, or no match. Results We identified 800 outcomes in 152 abstracts (95 primary [51 abstracts] and 705 [141 abstracts] non-primary outcomes). No outcomes were reported in 2 abstracts. Of 95 primary outcomes, 17 (18%) agreed completely, 53 (56%) partially, and 25 (26%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among 705 non-primary outcomes, 56 (8%) agreed completely, 205 (29%) agreed partially, and 444 (63%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among the 258 outcomes partially agreeing, we found additional information on the time when the outcome was measured more often in ClinicalTrials.gov than in the abstract (141/258 (55%) versus 55/258 (21%)). We found no association between the presence of non-matching “new” outcomes and year of registration, time to registry update, industry sponsorship, or multi-center status. Conclusion Conference abstracts may be a valuable source of information about results for outcomes of unpublished RCTs that have been registered in ClinicalTrials.gov. Complementary additional descriptive information may be present for outcomes reported in both sources. However, ARVO abstract authors also present outcomes not reported in ClinicalTrials.gov and these may represent analyses not originally planned. PMID:26107924

Optimization of antitumor treatment conditions for transcutaneous CO2 application: An in vivo study.

PubMed

Ueha, Takeshi; Kawamoto, Teruya; Onishi, Yasuo; Harada, Risa; Minoda, Masaya; Toda, Mitsunori; Hara, Hitomi; Fukase, Naomasa; Kurosaka, Masahiro; Kuroda, Ryosuke; Akisue, Toshihiro; Sakai, Yoshitada

2017-06-01

Carbon dioxide (CO2) therapy can be applied to treat a variety of disorders. We previously found that transcutaneous application of CO2 with a hydrogel decreased the tumor volume of several types of tumors and induced apoptosis via the mitochondrial pathway. However, only one condition of treatment intensity has been tested. For widespread application in clinical antitumor therapy, the conditions must be optimized. In the present study, we investigated the relationship between the duration, frequency, and treatment interval of transcutaneous CO2 application and antitumor effects in murine xenograft models. Murine xenograft models of three types of human tumors (breast cancer, osteosarcoma, and malignant fibrous histiocytoma/undifferentiated pleomorphic sarcoma) were used to assess the antitumor effects of transcutaneous CO2 application of varying durations, frequencies, and treatment intervals. In all human tumor xenografts, apoptosis was significantly induced by CO2 treatment for ≥10 min, and a significant decrease in tumor volume was observed with CO2 treatments of >5 min. The effect on tumor volume was not dependent on the frequency of CO2 application, i.e., twice or five times per week. However, treatment using 3- and 4-day intervals was more effective at decreasing tumor volume than treatment using 2- and 5-day intervals. The optimal conditions of transcutaneous CO2 application to obtain the best antitumor effect in various tumors were as follows: greater than 10 min per application, twice per week, with 3- and 4-day intervals, and application to the site of the tumor. The results suggest that this novel transcutaneous CO2 application might be useful to treat primary tumors, while mitigating some side effects, and therefore could be safe for clinical trials.

Application of lead-acrylic compensating filters in chiropractic full spine radiography: a technical report

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

Buehler, M.T.; Hrejsa, A.F.

X-raying the entire spinal column in the standing position in a single exposure (mainly the AP projection) is an often-used chiropractic radiography procedure which has also found some application in medical scoliosis screening program. Aside from any controversy of clinical objectives or medical necessity, the primary agreed-upon requisite for such procedure is twofold; achieving the best possible film image quality with the least amount of radiation exposure to the patient. A popular method of accomplishing this objective is by the use of collimator-attached devices designed to selectively filter the primary x-ray beam in accordance with regional variations of body thicknessmore » and/or density. This study was conducted to evaluate the use of a new lead-acrylic filter system under specialized chiropractic conditions. In comparison to other available systems, it was concluded that this new system; a) is generally equivalent in its radiation dose reduction capabilities; b) is capable of producing full spine radiographs with good to above average image quality; and c) is appreciably easier to use.« less

Therapeutic applications of curcumin for patients with pancreatic cancer

PubMed Central

Kanai, Masashi

2014-01-01

A number of preclinical studies have demonstrated anticancer effects for curcumin in various types of tumors, including pancreatic cancer. Curcumin has anticancer effects both alone and in combination with other anticancer drugs (e.g., gemcitabine, 5-fluorouracil, and oxaliplatin), and it has been shown to modulate a variety of molecular targets in preclinical models, with more than 30 molecular targets identified to date. Of these various molecules, NF-κB is thought to be one of the primary targets of curcumin activity. Based on these promising preclinical results, several research groups, including our own, have progressed to testing the anticancer effects of curcumin in clinical trials; however, the poor bioavailability of this agent has been the major challenge for its clinical application. Despite the ingestion of gram-level doses of curcumin, plasma curcumin levels remain at low (ng/mL) levels in patients, which is insufficient to yield the anticancer benefits of curcumin. This problem has been solved by the development of highly bioavailable forms of curcumin (THERACURMIN®), and higher plasma curcumin levels can now be achieved without increased toxicity in patients with pancreatic cancer. In this article, we review possible therapeutic applications of curcumin in patients with pancreatic cancer. PMID:25071333

Modeling paradigms for medical diagnostic decision support: a survey and future directions.

PubMed

Wagholikar, Kavishwar B; Sundararajan, Vijayraghavan; Deshpande, Ashok W

2012-10-01

Use of computer based decision tools to aid clinical decision making, has been a primary goal of research in biomedical informatics. Research in the last five decades has led to the development of Medical Decision Support (MDS) applications using a variety of modeling techniques, for a diverse range of medical decision problems. This paper surveys literature on modeling techniques for diagnostic decision support, with a focus on decision accuracy. Trends and shortcomings of research in this area are discussed and future directions are provided. The authors suggest that-(i) Improvement in the accuracy of MDS application may be possible by modeling of vague and temporal data, research on inference algorithms, integration of patient information from diverse sources and improvement in gene profiling algorithms; (ii) MDS research would be facilitated by public release of de-identified medical datasets, and development of opensource data-mining tool kits; (iii) Comparative evaluations of different modeling techniques are required to understand characteristics of the techniques, which can guide developers in choice of technique for a particular medical decision problem; and (iv) Evaluations of MDS applications in clinical setting are necessary to foster physicians' utilization of these decision aids.

Keys to success of a community of clinical practice in primary care: a qualitative evaluation of the ECOPIH project.

PubMed

Lacasta Tintorer, David; Manresa Domínguez, Josep Maria; Pujol-Rivera, Enriqueta; Flayeh Beneyto, Souhel; Mundet Tuduri, Xavier; Saigí-Rubió, Francesc

2018-05-09

The current reality of primary care (PC) makes it essential to have telemedicine systems available to facilitate communication between care levels. Communities of practice have great potential in terms of care and education, and that is why the Online Communication Tool between Primary and Hospital Care was created. This tool enables PC and non-GP specialist care (SC) professionals to raise clinical cases for consultation and to share information. The objective of this article is to explore healthcare professionals' views on communities of clinical practice (CoCPs) and the changes that need to be made in an uncontrolled real-life setting after more than two years of use. A descriptive-interpretative qualitative study was conducted on a total of 29 healthcare professionals who were users and non-users of a CoCP using 2 focus groups, 3 triangular groups and 5 individual interviews. There were 18 women, 21 physicians and 8 nurses. Of the interviewees, 21 were PC professionals, 24 were users of a CoCP and 7 held managerial positions. For a system of communication between PC and SC to become a tool that is habitually used and very useful, the interviewees considered that it would have to be able to find quick, effective solutions to the queries raised, based on up-to-date information that is directly applicable to daily clinical practice. Contact should be virtual - and probably collaborative - via a platform integrated into their habitual workstations and led by PC professionals. Organisational changes should be implemented to enable users to have more time in their working day to spend on the tool, and professionals should have a proactive attitude in order to make the most if its potential. It is also important to make certain technological changes, basically aimed at improving the tool's accessibility, by integrating it into habitual clinical workstations. The collaborative tool that provides reliable, up-to-date information that is highly transferrable to clinical practice is valued for its effectiveness, efficiency and educational capacity. In order to make the most of its potential in terms of care and education, organisational changes and techniques are required to foster greater use.

Clinical data, clinicopathologic findings and outcome in dogs with amegakaryocytic thrombocytopenia and primary immune-mediated thrombocytopenia.

PubMed

Cooper, S A; Huang, A A; Raskin, R E; Weng, H-Y; Scott-Moncrieff, J C

2016-03-01

The aim of this study was to identify distinguishing characteristics between dogs diagnosed with amegakaryocytic thrombocytopenia and those diagnosed with presumed primary peripheral immune-mediated thrombocytopenia. Presenting clinical and clinicopathologic data and outcomes were compared between the two groups. Retrospective study performed on seven client-owned dogs diagnosed with amegakaryocytic thrombocytopenia and 34 client-owned dogs with primary peripheral immune-mediated thrombocytopenia. All dogs in the amegakaryocytic thrombocytopenia group were anaemic on presentation with a median haematocrit of 23% (range 9·4 to 36), while the primary peripheral immune-mediated thrombocytopoenia group had a median presenting haematocrit of 35% (range 10 to 53). Dogs with amegakaryocytic thrombocytopenia had a median of five (range 4 to 7) clinical signs of bleeding compared to a median of three (range 0 to 6) in the primary peripheral immune-mediated thrombocytopenia group with 86% (6 of 7) of amegakaryocytic thrombocytopenia dogs requiring a blood transfusion compared to 41% (14 of 34) of primary peripheral immune-mediated thrombocytopenia dogs. Six of the seven amegakaryocytic thrombocytopenia dogs did not survive to discharge, while only five of the 34 primary peripheral immune-mediated thrombocytopenia dogs did not survive to discharge. The clinical presentation of dogs with amegakaryocytic thrombocytopenia and primary peripheral immune-mediated thrombocytopenia is similar, but dogs with amegakaryocytic thrombocytopenia had a more severe clinical course compared to primary peripheral immune-mediated thrombocytopenia dogs. The prognosis for dogs with amegakaryocytic thrombocytopenia is poor. © 2016 British Small Animal Veterinary Association.

How do primary care physicians seek answers to clinical questions? A literature review.

PubMed

Coumou, Herma C H; Meijman, Frans J

2006-01-01

The authors investigated the extent to which changes occurred between 1992 and 2005 in the ways that primary care physicians seek answers to clinical problems. What search strategies are used? How much time is spent on them? How do primary care physicians evaluate various search activities and information sources? Can a clinical librarian be useful to a primary care physician? Twenty-one original research papers and three literature reviews were examined. No systematic reviews were identified. Primary care physicians seek answers to only a limited number of questions about which they first consult colleagues and paper sources. This practice has basically not changed over the years despite the enormous increase in and better accessibility to electronic information sources. One of the major obstacles is the time it takes to search for information. Other difficulties primary care physicians experience are related to formulating an appropriate search question, finding an optimal search strategy, and interpreting the evidence found. Some studies have been done on the supporting role of a clinical librarian in general practice. However, the effects on professional behavior of the primary care physician and on patient outcome have not been studied. A small group of primary care physicians prefer this support to developing their own search skills. Primary care physicians have several options for finding quick answers: building a question-and-answer database, consulting filtered information sources, or using an intermediary such as a clinical librarian.

How do primary care physicians seek answers to clinical questions? A literature review

PubMed Central

Coumou, Herma C. H.; Meijman, Frans J.

2006-01-01

Objectives: The authors investigated the extent to which changes occurred between 1992 and 2005 in the ways that primary care physicians seek answers to clinical problems. What search strategies are used? How much time is spent on them? How do primary care physicians evaluate various search activities and information sources? Can a clinical librarian be useful to a primary care physician? Methods: Twenty-one original research papers and three literature reviews were examined. No systematic reviews were identified. Results: Primary care physicians seek answers to only a limited number of questions about which they first consult colleagues and paper sources. This practice has basically not changed over the years despite the enormous increase in and better accessibility to electronic information sources. One of the major obstacles is the time it takes to search for information. Other difficulties primary care physicians experience are related to formulating an appropriate search question, finding an optimal search strategy, and interpreting the evidence found. Some studies have been done on the supporting role of a clinical librarian in general practice. However, the effects on professional behavior of the primary care physician and on patient outcome have not been studied. A small group of primary care physicians prefer this support to developing their own search skills. Discussion: Primary care physicians have several options for finding quick answers: building a question-and-answer database, consulting filtered information sources, or using an intermediary such as a clinical librarian. PMID:16404470

Evolving models of the immunopathogenesis of T-cell mediated drug allergy: the role of host, pathogens, and drug response

PubMed Central

White, Katie D.; Chung, Wen-Hung; Hung, Shuen-Iu; Mallal, Simon; Phillips, Elizabeth J.

2015-01-01

Immune-mediated adverse drug reactions (IM-ADRs) are an underrecognized source of preventable morbidity, mortality, and cost. Increasingly, genetic variation in the HLA loci is associated with risk of severe reactions, highlighting the importance of T-cell immune responses in the mechanisms of both B-cell mediated and primary T-cell mediated IM-ADRs. In this review, we summarize the role of host genetics, microbes and drugs in the development of IM-ADRs, expand upon the existing models of IM-ADR pathogenesis to address multiple unexplained observations, discuss the implications of this work in clinical practice today, and describe future applications for pre-clinical drug toxicity screening, drug design, and development. PMID:26254049

Progress in atherosclerotic plaque imaging

PubMed Central

Soloperto, Giulia; Casciaro, Sergio

2012-01-01

Cardiovascular diseases are the primary cause of mortality in the industrialized world, and arterial obstruction, triggered by rupture-prone atherosclerotic plaques, lead to myocardial infarction and cerebral stroke. Vulnerable plaques do not necessarily occur with flow-limiting stenosis, thus conventional luminographic assessment of the pathology fails to identify unstable lesions. In this review we discuss the currently available imaging modalities used to investigate morphological features and biological characteristics of the atherosclerotic plaque. The different imaging modalities such as ultrasound, magnetic resonance imaging, computed tomography, nuclear imaging and their intravascular applications are illustrated, highlighting their specific diagnostic potential. Clinically available and upcoming methodologies are also reviewed along with the related challenges in their clinical translation, concerning the specific invasiveness, accuracy and cost-effectiveness of these methods. PMID:22937215

The use of medical grade honey in clinical practice.

PubMed

Dunwoody, Gillian; Acton, Claire

In the current healthcare environment, clinicians are increasingly under pressure to use wound care products that are cost-effective. This includes products that can be used in a variety of wounds to achieve different outcomes, depending on the wound-bed requirements. Medical grade honey has emerged as a product that can achieve a variety of outcomes within the wound and is safe and easy to use. This article reviews the use of a medical grade honey (Medihoney) in various clinical applications, with a view to placement on the wound care formulary in both primary and secondary care. It provides an in-depth account of case studies featured in a poster presentation at the 2008 European Wound Management Association meeting in Lisbon, Portugal.

Attachment-Based Family Therapy with a 13-Year-Old Girl Presenting with High Risk for Suicide

PubMed Central

Krauthamer Ewing, E. Stephanie; Levy, Suzanne A.; Boamah-Wiafe, Linda; Kobak, Roger; Diamond, Guy

2014-01-01

This paper describes the application of Attachment-Based Family Therapy (ABFT) to the treatment of a 13-year old female adolescent presenting with high risk of suicide, complicated by a history of depression and sexual trauma. The paper begins with an overview of ABFT, including 1) how attachment theory guides treatment; 2) the structure of the clinical model; and 3) the data that provide empirical support. A case example is then presented that exemplifies the primary clinical procedures used to reach therapeutic goals in ABFT, including attachment repair and autonomy/competence promotion. Weekly changes in suicide ideation and depression scores are presented. The paper concludes with a discussion about implications for family-based treatment of suicidal youth. PMID:25329356

Rural access to clinical pharmacy services.

PubMed

Patterson, Brandon J; Kaboli, Peter J; Tubbs, Traviss; Alexander, Bruce; Lund, Brian C

2014-01-01

To examine the impact of rural residence and primary care site on use of clinical pharmacy services (CPS) and to describe the use of clinical telepharmacy within the Veterans Health Administration (VHA) health care system. Using 2011 national VHA data, the frequency of patients with CPS encounters was compared across patient residence (urban or rural) and principal site of primary care (medical center, urban clinic, or rural clinic). The likelihood of CPS utilization was estimated with random effects logistic regression. Individual service types (e.g., anticoagulation clinics) and delivery modes (e.g., telehealth) were also examined. Of 3,040,635 patients, 711,348 (23.4%) received CPS. Service use varied by patient residence (urban: 24.9%; rural: 19.7%) and principal site of primary care (medical center: 25.9%; urban clinic: 22.5%; rural clinic: 17.6%). However, in adjusted analyses, urban-rural differences were explained primarily by primary care site and less so by patient residence. Similar findings were observed for individual CPS types. Telehealth encounters were common, accounting for nearly one-half of patients receiving CPS. Video telehealth was infrequent (<0.2%), but more common among patients of rural clinics than those receiving CPS at medical centers (odds ratio [OR] = 9.7; 95% CI 9.0-10.5). We identified a potential disparity between rural and urban patients' access to CPS, which was largely explained by greater reliance on community clinics for primary care than on medical centers. Future research is needed to determine if this disparity will be alleviated by emerging organizational changes, including expanding telehealth capacity and integrating pharmacists into primary care teams, and whether lessons learned at VHA translate to other settings.

Depression care management for adults older than 60 years in primary care clinics in urban China: a cluster-randomised trial.

PubMed

Chen, Shulin; Conwell, Yeates; He, Jin; Lu, Naiji; Wu, Jiayan

2015-04-01

China's national health policy classifies depression as a chronic disease that should be managed in primary care settings. In some high-income countries use of chronic disease management principles and primary care-based collaborative-care models have improved outcomes for late-life depression; however, this approach has not yet been tested in China. We aimed to assess whether use of a collaborative-care depression care management (DCM) intervention could improve outcomes for Chinese adults with depression aged 60 years and older. Between Jan 17, 2011, [corrected] and Nov 30, 2013, we did a cluster-randomised trial in patients from primary care centre clinics in Shangcheng district of Hangzhou city in eastern China. We randomly assigned (1:1) clinics to either DCM (involving training for physicians in use of treatment guidelines, training for primary care nurses to function as care managers, and consultation with psychiatrists as support) or to give enhanced care as usual to all eligible patients aged 60 years and older with major depressive disorder. Clinics were chosen randomly for inclusion from all primary care clinics in the district by computer algorithm and then randomly allocated depression care interventions remotely by computer algorithm. Physicians, study personnel, and patients were not masked to clinic assignment. Our primary outcome was difference in Hamilton Depression Rating Scale (HAMD) score using data for clusters at baseline and 3, 6, and 12 month follow-up in a mixed-effects model of the intention-to-treat population. We originally aimed to analyse outcomes at 24 months, however the difference between groups at 12 months was large and funding was insufficient to continue to 24 months, therefore we decided to end the trial at 12 months. This trial is registered with ClinicalTrials.gov, number NCT01287494. Of 34 primary care clinics in Shangcheng district, 16 were randomly chosen. We randomly assigned eight clinics to the DCM intervention (164 patients enrolled) and eight primary care clinics to enhanced care as usual (162 patients). There were no major differences in baseline demographic and clinical variables between the groups of patients for each intervention. Over the 12 months, patients in clinics assigned to DCM had a significantly greater reduction in HAMD score than did those in practices assigned to enhanced care as usual (estimated between group difference -6·5 [95% CI -7·1 to -5·9]; Cohen's d 0·8 [95% CI 0·8-0·9]; p<0·0001). The intercluster correlation for change in HAMD total score was 0·07 (95% CI 0·06-0·08). There were no study-related adverse events in either group. Clinical outcomes of Chinese adults older than 60 years who had major depression were improved when their primary care clinic used DCM. Primary care-based collaborative management of depression is promising to address this pressing public health need in China. National Institutes of Health, Program for New Century Excellent Talents in Universities of China, Ministry of Education, China. Copyright © 2015 Elsevier Ltd. All rights reserved.

Meta-Review of CSF Core Biomarkers in Alzheimer’s Disease: The State-of-the-Art after the New Revised Diagnostic Criteria

PubMed Central

Ferreira, Daniel; Perestelo-Pérez, Lilisbeth; Westman, Eric; Wahlund, Lars-Olof; Sarría, Antonio; Serrano-Aguilar, Pedro

2014-01-01

Background: Current research criteria for Alzheimer’s disease (AD) include cerebrospinal fluid (CSF) biomarkers into the diagnostic algorithm. However, spreading their use to the clinical routine is still questionable. Objective: To provide an updated, systematic and critical review on the diagnostic utility of the CSF core biomarkers for AD. Data sources: MEDLINE, PreMedline, EMBASE, PsycInfo, CINAHL, Cochrane Library, and CRD. Eligibility criteria: (1a) Systematic reviews with meta-analysis; (1b) Primary studies published after the new revised diagnostic criteria; (2) Evaluation of the diagnostic performance of at least one CSF core biomarker. Results: The diagnostic performance of CSF biomarkers is generally satisfactory. They are optimal for discriminating AD patients from healthy controls. Their combination may also be suitable for mild cognitive impairment (MCI) prognosis. However, CSF biomarkers fail to distinguish AD from other forms of dementia. Limitations: (1) Use of clinical diagnosis as standard instead of pathological postmortem confirmation; (2) variability of methodological aspects; (3) insufficiently long follow-up periods in MCI studies; and (4) lower diagnostic accuracy in primary care compared with memory clinics. Conclusion: Additional work needs to be done to validate the application of CSF core biomarkers as they are proposed in the new revised diagnostic criteria. The use of CSF core biomarkers in clinical routine is more likely if these limitations are overcome. Early diagnosis is going to be of utmost importance when effective pharmacological treatment will be available and the CSF core biomarkers can also be implemented in clinical trials for drug development. PMID:24715863

Complex adaptive systems (CAS): an overview of key elements, characteristics and application to management theory.

PubMed

Ellis, Beverley; Herbert, Stuart Ian

2011-01-01

To identify key elements and characteristics of complex adaptive systems (CAS) relevant to implementing clinical governance, drawing on lessons from quality improvement programmes and the use of informatics in primary care. The research strategy includes a literature review to develop theoretical models of clinical governance of quality improvement in primary care organisations (PCOs) and a survey of PCOs. Complex adaptive system theories are a valuable tool to help make sense of natural phenomena, which include human responses to problem solving within the sampled PCOs. The research commenced with a survey; 76% (n16) of respondents preferred to support the implementation of clinical governance initiatives guided by outputs from general practice electronic health records. There was considerable variation in the way in which consultation data was captured, recorded and organised. Incentivised information sharing led to consensus on coding policies and models of data recording ahead of national contractual requirements. Informatics was acknowledged as a mechanism to link electronic health record outputs, quality improvement and resources. Investment in informatics was identified as a development priority in order to embed clinical governance principles in practice. Complex adaptive system theory usefully describes evolutionary change processes, providing insight into how the origins of quality assurance were predicated on rational reductionism and linearity. New forms of governance do not neutralise previous models, but add further dimensions to them. Clinical governance models have moved from deterministic and 'objective' factors to incorporate cultural aspects with feedback about quality enabled by informatics. The socio-technical lessons highlighted should inform healthcare management.

The role of clinical governance as a strategy for quality improvement in primary care.

PubMed Central

Campbell, Stephen M; Sweeney, Grace M

2002-01-01

This power considers the process of implementing clinical governance in primary care and its impact on quality improvement. It discuss how clinical governance is being implemented both at the level of Primary Care Organisations and general practices, and the challenges to implementing clinical governance. It also suggests a model for promoting the factors that will help clinical governance improve quality of care. The experience of implementing clinical governance is broadly positive to date. However, the government needs to match its commitment to a ten-year programme of change with realistic timetables to secure the cultural and organisational changes needed to improve quality of care. PMID:12389764

Does Lean healthcare improve patient satisfaction? A mixed-method investigation into primary care.

PubMed

Poksinska, Bozena Bonnie; Fialkowska-Filipek, Malgorzata; Engström, Jon

2017-02-01

Lean healthcare is claimed to contribute to improved patient satisfaction, but there is limited evidence to support this notion. This study investigates how primary-care centres working with Lean define and improve value from the patient's perspective, and how the application of Lean healthcare influences patient satisfaction. This paper contains two qualitative case studies and a quantitative study based on results from the Swedish National Patient Survey. Through the case studies, we investigated how primary-care organisations realised the principle of defining and improving value from the patient's perspective. In the quantitative study, we compared results from the patient satisfaction survey for 23 primary-care centres working with Lean with a control group of 23 care centres not working with Lean. We also analysed changes in patient satisfaction over time. Our case studies reveal that Lean healthcare implementations primarily target efficiency and little attention is paid to the patient's perspective. The quantitative study shows no significantly better results in patient satisfaction for primary-care centres working with Lean healthcare compared with those not working with Lean. Further, care centres working with Lean show no significant improvements in patient satisfaction over time. Lean healthcare implementations seem to have a limited impact on improving patient satisfaction. Care providers need to pay more attention to integrating the patient's perspective in the application of Lean healthcare. Value needs to be defined and value streams need to be improved based on both the knowledge and clinical expertise of care providers, and the preferences and needs of patients. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Non-surgical treatment of dentin caries in preschool children--systematic review.

PubMed

Duangthip, Duangporn; Jiang, Ming; Chu, Chun Hung; Lo, Edward C M

2015-04-03

Untreated dentin caries in primary teeth is commonly found in preschool children worldwide. Recently, the use of simple non-surgical approaches to manage the situation has been advocated. The aim of the study was to systematically review and evaluate the literature on effectiveness of non-surgical methods in arresting or slowing down the progression of active dentin caries in primary teeth in preschool children. A systematic search of the main electronic databases (Pubmed, Cochrane Collaboration, EMBASE) was conducted to identify peer reviewed papers published in English in the years 1947-2014. Keywords and MeSH terms used in the search were "dental caries", "primary dentition" and various non-surgical treatments (fluoride, sealant, resin infiltration, xylitol, chlorhexidine, CPP-ACP, ozone, etc.). The inclusion criteria were clinical studies conducted in children under 6 years old, and reported findings on caries arrest or caries progression in primary teeth. Retrieved papers were read by two reviewers independently to assess suitability for inclusion, and the final decision was made by consensus. Quality of the included studies was assessed and data were extracted for analysis. The search identified 323 papers for screening. Among these, 290 papers did not satisfy the study inclusion criteria. Consequently, 33 full papers were retrieved and reviewed. Finally, 4 studies were included. Three studies reported that topical applications of silver diammine fluoride (SDF) solution could arrest dentin caries in preschool children. One study supported that having a daily toothbrushing exercise in kindergarten using toothpaste with 1000 ppm fluoride could stabilize the caries situation in young children. There is limited evidence to support the effectiveness of SDF applications or daily toothbrushing with fluoride toothpaste in arresting or slowing down the progression of active dentin caries in primary teeth in preschool children. More well-designed randomized controlled trials are required to confirm these findings.

A Little Effort Can Withstand the Hardship: Fielding an Internet-Based Intervention to Prevent Depression among Urban Racial/Ethnic Minority Adolescents in a Primary Care Setting.

PubMed

Bansa, Melishia; Brown, Darryl; DeFrino, Daniela; Mahoney, Nicholas; Saulsberry, Alexandria; Marko-Holguin, Monika; Fogel, Joshua; Gladstone, Tracy R G; Van Voorhees, Benjamin W

2018-04-01

This study explored the implementation of Chicago Urban Resiliency Building (CURB), a randomized clinical trial designed as an Internet-based primary care depression prevention intervention for urban African American and Latino adolescents. We utilized a mixed methods analysis to explore four aims. First, we estimated the percent of at-risk adolescents that were successfully screened. Second, we examined clinic site factors and performance. Third, primary care providers (n = 10) and clinic staff (n = 18) were surveyed to assess their knowledge and attitudes about the intervention. Fourth, clinic staff (nursing and medical assistant) interviews were analyzed using thematic analysis to gather perspectives of the implementation process. We found that the estimated percent of at-risk adolescents who were successfully screened in each clinic varied widely between clinics with a mean of 14.48%. Daily clinic communication was suggestive of greater successful screening. Feasibility of screening was high for both primary care providers and clinic staff. Clinic staff exit interviews indicated the presence of community barriers that inhibited successful implementation of the intervention. This study shares the challenges and successes for depression screening and implementing Internet-based mental health interventions for urban racial/ethnic minority adolescents in primary care settings. Published by Elsevier Inc.

Family medicine patients who use retail clinics have lower continuity of care.

PubMed

Rohrer, James E; Angstman, Kurt B; Garrison, Gregory M; Maxson, Julie A; Furst, Joseph W

2013-04-01

The purpose of this study was to compare continuity of care for family medicine patients using retail medicine clinics to continuity for patients not using retail clinics. Retail medicine clinics have become popular in some markets. However, their impact on continuity of care has not been studied. Electronic medical records of adult primary care patients seen in a large group practice in Minnesota in 2011 were analyzed for this study. Two randomly chosen groups of patients were selected (N = 400): those using 1 of 3 retail walk-in clinics staffed by nurse practitioners in addition to standard office care and a comparison group that only used standard office care. Continuity was measured as the percentage of visits that involved the primary care provider. We also compared patients who made zero visits to their primary care providers with those who made some visits to their primary care providers. Continuity of care was lower for patients who used retail clinics than for patients who did not use retail clinics (0.17 vs 0.44, mean difference 0.27). The percentage of patients who made zero visits to their primary care providers was 54.5 for users of retail clinics versus 31.0 for those who did not use retail clinics. Continuity of care should be monitored as retail medicine continues to expand.

Children's Mental Health as a Primary Care and Concern

PubMed Central

Tolan, Patrick H.; Dodge, Kenneth A.

2009-01-01

In response to the serious crisis in mental health care for children in the United States, this article proposes as a priority for psychology a comprehensive approach that treats mental health as a primary issue in child health and welfare. Consistent with the principles of a system of care and applying epidemiological, risk-development, and intervention-research findings, this approach emphasizes 4 components: easy access to effective professional clinical services for children exhibiting disorders; further development and application of sound prevention principles for high-risk youths; support for and access to short-term intervention in primary care settings; and greater recognition and promotion of mental health issues in common developmental settings and other influential systems. Integral to this approach is the need to implement these components simultaneously and to incorporate family-focused, culturally competent, evidence-based, and developmentally appropriate services. This comprehensive, simultaneous, and integrated approach is needed to achieve real progress in children's mental health in this country. PMID:16173893

Evaluation of protective shielding thickness for diagnostic radiology rooms: theory and computer simulation.

PubMed

Costa, Paulo R; Caldas, Linda V E

2002-01-01

This work presents the development and evaluation using modern techniques to calculate radiation protection barriers in clinical radiographic facilities. Our methodology uses realistic primary and scattered spectra. The primary spectra were computer simulated using a waveform generalization and a semiempirical model (the Tucker-Barnes-Chakraborty model). The scattered spectra were obtained from published data. An analytical function was used to produce attenuation curves from polychromatic radiation for specified kVp, waveform, and filtration. The results of this analytical function are given in ambient dose equivalent units. The attenuation curves were obtained by application of Archer's model to computer simulation data. The parameters for the best fit to the model using primary and secondary radiation data from different radiographic procedures were determined. They resulted in an optimized model for shielding calculation for any radiographic room. The shielding costs were about 50% lower than those calculated using the traditional method based on Report No. 49 of the National Council on Radiation Protection and Measurements.

Hypothermia and targeted temperature management in cats and dogs.

PubMed

Brodeur, Andrea; Wright, Annie; Cortes, Yonaira

2017-03-01

To review current knowledge surrounding the effects, treatment, and prognosis of hypothermia in people, dogs, and cats, as well as the application of therapeutic hypothermia in clinical medicine. Hypothermia may be a primary or secondary condition, and may be due to environmental exposure, illness, medications, anesthesia, or trauma. Hypothermia has been applied therapeutically in human medicine for a variety of conditions, including postcardiac arrest. In veterinary medicine, the technique has been applied in cardiac surgeries requiring bypass and in a patient with intractable seizures. Hypothermia can be diagnosed based on presenting temperature or clinical signs, and appropriate diagnosis may require nontraditional thermometers. Rewarming is the primary treatment for accidental hypothermia, with intensity ranging from passive surface rewarming to extracorporeal rewarming. The goal is to return the core temperature to a level that restores normal physiologic function of all body processes. Other supportive therapies such as intravenous fluids are typically indicated, and if cardiopulmonary arrest is present, prolonged resuscitation may be required. In cases of secondary hypothermia, reversal of the underlying cause is important. There are few prognostic indicators in human and veterinary patients with hypothermia. Even the most severely affected individuals, including those presenting in cardiopulmonary arrest, have potential for complete recovery with appropriate therapy. Therapeutic hypothermia has been shown to improve outcome in people following cardiac arrest. Further studies are needed to examine this application in veterinary medicine, as well as appropriate therapy and prognosis for cases of spontaneous hypothermia. © Veterinary Emergency and Critical Care Society 2017.

Evaluation of clinical and financial outcomes of a new no-sting barrier film and barrier cream in a large UK primary care organisation.

PubMed

Stephen-Haynes, Jackie; Stephens, Claire

2013-12-01

The study involves 95 subjects within a UK Primary Care Organisation and was undertaken in two arms. The objective was to determine the clinical outcomes and clinical acceptability of a newly available range of no-sting barrier film and no-sting barrier cream products offering significant financial benefits. The importance of undertaking this study is underpinned by evidence in the literature relating to the use of no-sting barrier preparations within clinical practice. The first part of the study (arm 1) involved extensive evaluation of either the film or cream barrier in 36 patients and was compared to existing standardised barrier protection care within the organisation. The results indicated that the new product range met all the criteria for formulary inclusion and following this the barrier range was further evaluated in arm 2, 33 patients with barrier cream and 26 patients with barrier film. The entire study was conducted over a 3-month period with patient treatment lasting a minimum of 2 days to a maximum 4-week period adhering to the agreed evaluation protocol as approved by clinical governance. In arm 1 (n = 36), the clinical expectation of the product was met in 32 cases relating to ease of use, conformability, no-sting, quick drying, ease of absorption, compatibility with devices, frequency of application, prevention and management including visual skin improvement resulting in a recommendation for formulary listing in 31 of 36 cases. In arm 2 (n = 59), barrier film and barrier cream performance was consistently rated same as, better than or much better than the existing barrier used. A formulary listing recommendation was made in 51 of 59 cases. © 2012 The Authors. International Wound Journal © 2012 John Wiley & Sons Ltd and Medicalhelplines.com Inc.

Clinical productivity of primary care nurse practitioners in ambulatory settings.

PubMed

Xue, Ying; Tuttle, Jane

Nurse practitioners are increasingly being integrated into primary care delivery to help meet the growing demand for primary care. It is therefore important to understand nurse practitioners' productivity in primary care practice. We examined nurse practitioners' clinical productivity in regard to number of patients seen per week, whether they had a patient panel, and patient panel size. We further investigated practice characteristics associated with their clinical productivity. We conducted cross-sectional analysis of the 2012 National Sample Survey of Nurse Practitioners. The sample included full-time primary care nurse practitioners in ambulatory settings. Multivariable survey regression analyses were performed to examine the relationship between practice characteristics and nurse practitioners' clinical productivity. Primary care nurse practitioners in ambulatory settings saw an average of 80 patients per week (95% confidence interval [CI]: 79-82), and 64% of them had their own patient panel. The average patient panel size was 567 (95% CI: 522-612). Nurse practitioners who had their own patient panel spent a similar percent of time on patient care and documentation as those who did not. However, those with a patient panel were more likely to provide a range of clinical services to most patients. Nurse practitioners' clinical productivity was associated with several modifiable practice characteristics such as practice autonomy and billing and payment policies. The estimated number of patients seen in a typical week by nurse practitioners is comparable to that by primary care physicians reported in the literature. However, they had a significantly smaller patient panel. Nurse practitioners' clinical productivity can be further improved. Copyright © 2016 Elsevier Inc. All rights reserved.

Modeling the value for money of changing clinical practice change: a stochastic application in diabetes care.

PubMed

Hoomans, Ties; Abrams, Keith R; Ament, Andre J H A; Evers, Silvia M A A; Severens, Johan L

2009-10-01

Decision making about resource allocation for guideline implementation to change clinical practice is inevitably undertaken in a context of uncertainty surrounding the cost-effectiveness of both clinical guidelines and implementation strategies. Adopting a total net benefit approach, a model was recently developed to overcome problems with the use of combined ratio statistics when analyzing decision uncertainty. To demonstrate the stochastic application of the model for informing decision making about the adoption of an audit and feedback strategy for implementing a guideline recommending intensive blood glucose control in type 2 diabetes in primary care in the Netherlands. An integrated Bayesian approach to decision modeling and evidence synthesis is adopted, using Markov Chain Monte Carlo simulation in WinBUGs. Data on model parameters is gathered from various sources, with effectiveness of implementation being estimated using pooled, random-effects meta-analysis. Decision uncertainty is illustrated using cost-effectiveness acceptability curves and frontier. Decisions about whether to adopt intensified glycemic control and whether to adopt audit and feedback alter for the maximum values that decision makers are willing to pay for health gain. Through simultaneously incorporating uncertain economic evidence on both guidance and implementation strategy, the cost-effectiveness acceptability curves and cost-effectiveness acceptability frontier show an increase in decision uncertainty concerning guideline implementation. The stochastic application in diabetes care demonstrates that the model provides a simple and useful tool for quantifying and exploring the (combined) uncertainty associated with decision making about adopting guidelines and implementation strategies and, therefore, for informing decisions about efficient resource allocation to change clinical practice.

Whole-exome/genome sequencing and genomics.

PubMed

Grody, Wayne W; Thompson, Barry H; Hudgins, Louanne

2013-12-01

As medical genetics has progressed from a descriptive entity to one focused on the functional relationship between genes and clinical disorders, emphasis has been placed on genomics. Genomics, a subelement of genetics, is the study of the genome, the sum total of all the genes of an organism. The human genome, which is contained in the 23 pairs of nuclear chromosomes and in the mitochondrial DNA of each cell, comprises >6 billion nucleotides of genetic code. There are some 23,000 protein-coding genes, a surprisingly small fraction of the total genetic material, with the remainder composed of noncoding DNA, regulatory sequences, and introns. The Human Genome Project, launched in 1990, produced a draft of the genome in 2001 and then a finished sequence in 2003, on the 50th anniversary of the initial publication of Watson and Crick's paper on the double-helical structure of DNA. Since then, this mass of genetic information has been translated at an ever-increasing pace into useable knowledge applicable to clinical medicine. The recent advent of massively parallel DNA sequencing (also known as shotgun, high-throughput, and next-generation sequencing) has brought whole-genome analysis into the clinic for the first time, and most of the current applications are directed at children with congenital conditions that are undiagnosable by using standard genetic tests for single-gene disorders. Thus, pediatricians must become familiar with this technology, what it can and cannot offer, and its technical and ethical challenges. Here, we address the concepts of human genomic analysis and its clinical applicability for primary care providers.

The application of telemedicine in orthopedic surgery in singapore: a pilot study on a secure, mobile telehealth application and messaging platform.

PubMed

Daruwalla, Zubin Jimmy; Wong, Keng Lin; Thambiah, Joseph

2014-06-05

The application of telemedicine has been described for its use in medical training and education, management of stroke patients, urologic surgeries, pediatric laparoscopic surgeries, clinical outreach, and the field of orthopedics. However, the usefulness of a secure, mobile telehealth application, and messaging platform has not been well described. A pilot study was conducted to implement a health insurance portability and accountability act (HIPAA) compliant form of communication between doctors in an orthopedic clinical setting and determine their reactions to MyDoc, a secure, mobile telehealth application, and messaging platform. By replacing current methods of communication through various mobile applications and text messaging services with MyDoc over a six week period, we gained feedback and determined user satisfaction with this innovative system from questionnaires handed to the program director, program coordinator, one trauma consultant, all orthopedic residents, and six non-orthopedic residents at the National University Hospital in Singapore. Almost everyone who completed the questionnaire strongly agreed that MyDoc should replace current systems of peer to peer communication in the hospital. The majority also felt that the quality of images, videos, and sound were excellent. Almost everyone agreed that they could communicate easily with each other and would feel comfortable doing so routinely. The majority felt that virtual consults through MyDoc should be made available to inpatients as well as outpatients to potentially lessen clinic loads and provide a secure manner in which patients can communicate with their primary teams any time convenient to both. It was also agreed by most that the potential of telerounding had advantages, especially on weekends as a supplement to normal rounds. Potential uses of MyDoc in an orthopedic clinical setting include HIPAA-compliant peer to peer communication, clinical outreach in the setting of trauma, supervision in the operating room or watching procedures being performed remotely, providing both patient and parent reassurance in pediatric orthopedic patients, and finally in the setting of outpatient clinics. With our pilot study having excellent results in terms of acceptance and satisfaction, the integration of a secure, mobile telehealth application, and messaging platform, not only in the orthopedic department but also the hospital in general, has an exciting and limitless potential. More so in this era where downsizing hospital costs is beneficial, doing so may also be mandatory in order to comply with the soon to be introduced personal data protection act.

40 CFR 421.20 - Applicability: description of the primary aluminum smelting subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... primary aluminum smelting subcategory. 421.20 Section 421.20 Protection of Environment ENVIRONMENTAL... CATEGORY Primary Aluminum Smelting Subcategory § 421.20 Applicability: description of the primary aluminum... production of aluminum from alumina in the Hall-Heroult process. ...

International developments in openEHR archetypes and templates.

PubMed

Leslie, Heather

Electronic Health Records (EHRs) are a complex knowledge domain. The ability to design EHRs to cope with the changing nature of health knowledge, and to be shareable, has been elusive. A recent pilot study1 tested the applicability of the CEN 13606 as an electronic health record standard. Using openEHR archetypes and tools2, 650 clinical content specifi cations (archetypes) were created (e.g. for blood pressure) and re-used across all clinical specialties and contexts. Groups of archetypes were aggregated in templates to support clinical information gathering or viewing (e.g. 80 separate archetypes make up the routine antenatal visit record). Over 60 templates were created for use in the emergency department, antenatal care and delivery of an infant, and paediatric hearing loss assessment. The primary goal is to define a logical clinical record architecture for the NHS but potentially, with archetypes as the keystone, shareable EHRs will also be attainable. Archetype and template development work is ongoing, with associated evaluation occurring in parallel.

Cost-efficiency of knowledge creation: randomized controlled trials vs. observational studies.

PubMed

Struck, Rafael; Baumgarten, Georg; Wittmann, Maria

2014-04-01

This article reviews traditional and current perspectives on randomized, controlled trials (RCTs) and observational studies relative to the economic implications for public healthcare stakeholders. It takes an average of 17 years to bring 14% of original research into clinical practice. Results from high-quality observational studies may complement limited RCTs in primary and secondary literature bases, and enhance the incorporation of sound evidence-based guidelines. Observational findings from comprehensive medical databases may offer valuable clues on the effectiveness and relevance of public healthcare interventions. Major expenditures associated with RCTs relate to recruitment, inappropriate site selection, conduct and reporting. Application of business strategies and economic evaluation tools, in addition to the planning and conduct of RCTs, may enhance clinical trial site performances. Considering the strengths and limitations of each study type, clinical researchers should explore the contextual worthiness of either design in promulgating knowledge. They should focus on quality of conduct and reporting that may allow for the liberation of limited public and private clinical research funding.

Articulating nurse practitioner practice using King's theory of goal attainment.

PubMed

de Leon-Demare, Kathleen; MacDonald, Jane; Gregory, David M; Katz, Alan; Halas, Gayle

2015-11-01

To further understand the interactions between nurse practitioners (NPs) and patients, King's nursing theory of goal attainment was applied as the conceptual framework to describe the interactions between NPs and patients in the primary care setting. Six dyads of NPs and their patients were video- and audio-taped over three consecutive clinic visits. For the purposes of this arm of the study, the audio-taped interactions were transcribed and then coded using King's concepts in her theory of goal attainment. King's theory was applicable to describe NP practice. King's concepts and processes of nurse-patient interactions, such as disturbances, mutual goal setting, and transactions, were observed in NP-patient interactions. Disturbances during clinical encounters were essential in the progression toward goal attainment. Elements, such as social exchange, symptom reporting, role explanation, and information around clinical processes facilitated relationship building. NPs as practitioners need to be reflective of their own practice, embrace disturbances in the clinical encounter, and attend to these as opportunities for mutual goal setting. ©2015 American Association of Nurse Practitioners.

Recognition of central sensitization in patients with musculoskeletal pain: Application of pain neurophysiology in manual therapy practice.

PubMed

Nijs, Jo; Van Houdenhove, Boudewijn; Oostendorp, Rob A B

2010-04-01

Central sensitization plays an important role in the pathophysiology of numerous musculoskeletal pain disorders, yet it remains unclear how manual therapists can recognize this condition. Therefore, mechanism based clinical guidelines for the recognition of central sensitization in patients with musculoskeletal pain are provided. By using our current understanding of central sensitization during the clinical assessment of patients with musculoskeletal pain, manual therapists can apply the science of nociceptive and pain processing neurophysiology to the practice of manual therapy. The diagnosis/assessment of central sensitization in individual patients with musculoskeletal pain is not straightforward, however manual therapists can use information obtained from the medical diagnosis, combined with the medical history of the patient, as well as the clinical examination and the analysis of the treatment response in order to recognize central sensitization. The clinical examination used to recognize central sensitization entails the distinction between primary and secondary hyperalgesia. Copyright 2009 Elsevier Ltd. All rights reserved.

[Development of an Excel spreadsheet for meta-analysis of indirect and mixed treatment comparisons].

PubMed

Tobías, Aurelio; Catalá-López, Ferrán; Roqué, Marta

2014-01-01

Meta-analyses in clinical research usually aimed to evaluate treatment efficacy and safety in direct comparison with a unique comparator. Indirect comparisons, using the Bucher's method, can summarize primary data when information from direct comparisons is limited or nonexistent. Mixed comparisons allow combining estimates from direct and indirect comparisons, increasing statistical power. There is a need for simple applications for meta-analysis of indirect and mixed comparisons. These can easily be conducted using a Microsoft Office Excel spreadsheet. We developed a spreadsheet for indirect and mixed effects comparisons of friendly use for clinical researchers interested in systematic reviews, but non-familiarized with the use of more advanced statistical packages. The use of the proposed Excel spreadsheet for indirect and mixed comparisons can be of great use in clinical epidemiology to extend the knowledge provided by traditional meta-analysis when evidence from direct comparisons is limited or nonexistent.

The self-regulating brain and neurofeedback: Experimental science and clinical promise.

PubMed

Thibault, Robert T; Lifshitz, Michael; Raz, Amir

2016-01-01

Neurofeedback, one of the primary examples of self-regulation, designates a collection of techniques that train the brain and help to improve its function. Since coming on the scene in the 1960s, electroencephalography-neurofeedback has become a treatment vehicle for a host of mental disorders; however, its clinical effectiveness remains controversial. Modern imaging technologies of the living human brain (e.g., real-time functional magnetic resonance imaging) and increasingly rigorous research protocols that utilize such methodologies begin to shed light on the underlying mechanisms that may facilitate more effective clinical applications. In this paper we focus on recent technological advances in the field of human brain imaging and discuss how these modern methods may influence the field of neurofeedback. Toward this end, we outline the state of the evidence and sketch out future directions to further explore the potential merits of this contentious therapeutic prospect. Copyright © 2015 Elsevier Ltd. All rights reserved.

Transforming primary care in the New Orleans safety-net: the patient experience.

PubMed

Schmidt, Laura A; Rittenhouse, Diane R; Wu, Kevin J; Wiley, James A

2013-02-01

The patient-centered medical home (PCMH) is a key service delivery innovation in health reform. However, there are growing questions about whether the changes in clinics promoted by the PCMH model lead to improvements in the patient experience. To test the hypothesis that PCMH improvements in safety-net primary care clinics are associated with a more positive patient experience. Multilevel cross-sectional analysis of patients nested within the primary care clinics that serve them. Primary care clinic leaders and patients throughout the City of New Orleans health care safety-net. Dependent variables included patient ratings of accessibility, coordination, and confidence in the quality/safety of care. The key independent variable was a score measuring PCMH structural and process improvements at the clinic level. Approximately two thirds of patients in New Orleans gave positive ratings to their clinics on access and quality/safety, but only one third did for care coordination. In all but the largest clinics, patient experiences of care coordination were positively associated with the clinic's use of PCMH structural and process changes. Results for patient ratings of access and quality/safety were mixed. Among primary care clinics in the New Orleans safety-net, use of more PCMH improvements at the clinic level led to more positive patient rating of care coordination, but not of accessibility or confidence in quality/safety. Ongoing efforts to pilot, demonstrate, implement, and evaluate the PCMH should consider how the impact of medical practice transformation could vary across different aspects of the patient experience.

MR-monitored LITT as a palliative concept in patients with high grade gliomas: preliminary clinical experience.

PubMed

Reimer, P; Bremer, C; Horch, C; Morgenroth, C; Allkemper, T; Schuierer, G

1998-01-01

The purpose of this study was to evaluate the clinical utility of laser-induced thermotherapy (LITT) as a palliative treatment for patients with high-grade gliomas. Four consenting patients with recurrent high grade III/IV gliomas near the primary language or motor areas were palliatively treated with LITT (2-5 W, 3-13 minutes; Neodym YAG Laser, Dornier, Friedrichshafen, Germany). Temperature monitoring was performed by T1-weighted turbo-fast low-angle shot (FLASH) imaging at 1.5 T (Siemens Magnetom SP 4000, Siemens, Erlangen, Germany). MRI studies before LITT included contrast-enhanced conventional scans and functional activation studies to localize the primary motor cortex or language areas using an echo-planar imaging (EPI) spin-echo (SE) sequence. Follow-up studies consisted of contrast-enhanced conventional scans as well as diffusion studies (contrast-enhanced Fourier-acquired steady-state technique and EPI-SE) and perfusion studies (EPI-SE with .2 mmol of gadolinium (Gd)/kg body weight) to differentiate post-therapeutic effects from residual or recurrent tumor growth. Local tumor control was achieved in areas with laser energy deposition with clinically stable conditions > or = 6 months. Conventional contrast-enhanced scans demonstrated strong enhancement surrounding ablated tumor components, which showed a reduction in CBV/CBF. Perfusion studies were useful to discriminate granulomatous tissue enhancement from residual or recurrent tumor growth. Careful application of LITT may evolve as an alternative palliative concept for patients with end-stage high-grade cerebral gliomas reducing clinical symptoms from circumscribed areas of pathology.

Use Of Clinical Decision Analysis In Predicting The Efficacy Of Newer Radiological Imaging Modalities: Radioscintigraphy Versus Single Photon Transverse Section Emission Computed Tomography

NASA Astrophysics Data System (ADS)

Prince, John R.

1982-12-01

Sensitivity, specificity, and predictive accuracy have been shown to be useful measures of the clinical efficacy of diagnostic tests and can be used to predict the potential improvement in diagnostic certitude resulting from the introduction of a competing technology. This communication demonstrates how the informal use of clinical decision analysis may guide health planners in the allocation of resources, purchasing decisions, and implementation of high technology. For didactic purposes the focus is on a comparison between conventional planar radioscintigraphy (RS) and single photon transverse section emission conputed tomography (SPECT). For example, positive predictive accuracy (PPA) for brain RS in a specialist hospital with a 50% disease prevalance is about 95%. SPECT should increase this predicted accuracy to 96%. In a primary care hospital with only a 15% disease prevalance the PPA is only 77% and SPECT may increase this accuracy to about 79%. Similar calculations based on published data show that marginal improvements are expected with SPECT in the liver. It is concluded that: a) The decision to purchase a high technology imaging modality such as SPECT for clinical purposes should be analyzed on an individual organ system and institutional basis. High technology may be justified in specialist hospitals but not necessarily in primary care hospitals. This is more dependent on disease prevalance than procedure volume; b) It is questionable whether SPECT imaging will be competitive with standard RS procedures. Research should concentrate on the development of different medical applications.

Definitions, Criteria and Global Classification of Mast Cell Disorders with Special Reference to Mast Cell Activation Syndromes: A Consensus Proposal

PubMed Central

Valent, Peter; Akin, Cem; Arock, Michel; Brockow, Knut; Butterfield, Joseph H.; Carter, Melody C.; Castells, Mariana; Escribano, Luis; Hartmann, Karin; Lieberman, Philip; Nedoszytko, Boguslaw; Orfao, Alberto; Schwartz, Lawrence B.; Sotlar, Karl; Sperr, Wolfgang R.; Triggiani, Massimo; Valenta, Rudolf; Horny, Hans-Peter; Metcalfe, Dean D.

2012-01-01

Activation of tissue mast cells (MCs) and their abnormal growth and accumulation in various organs are typically found in primary MC disorders also referred to as mastocytosis. However, increasing numbers of patients are now being informed that their clinical findings are due to MC activation (MCA) that is neither associated with mastocytosis nor with a defined allergic or inflammatory reaction. In other patients with MCA, MCs appear to be clonal cells, but criteria for diagnosing mastocytosis are not met. A working conference was organized in 2010 with the aim to define criteria for diagnosing MCA and related disorders, and to propose a global unifying classification of all MC disorders and pathologic MC reactions. This classification includes three types of ‘MCA syndromes’ (MCASs), namely primary MCAS, secondary MCAS and idiopathic MCAS. MCA is now defined by robust and generally applicable criteria, including (1) typical clinical symptoms, (2) a substantial transient increase in serum total tryptase level or an increase in other MC-derived mediators, such as histamine or prostaglandin D2, or their urinary metabolites, and (3) a response of clinical symptoms to agents that attenuate the production or activities of MC mediators. These criteria should assist in the identification and diagnosis of patients with MCAS, and in avoiding misdiagnoses or overinterpretation of clinical symptoms in daily practice. Moreover, the MCAS concept should stimulate research in order to identify and exploit new molecular mechanisms and therapeutic targets. PMID:22041891

Health economic evaluation of a serum-based blood test for brain tumour diagnosis: exploration of two clinical scenarios.

PubMed

Gray, Ewan; Butler, Holly J; Board, Ruth; Brennan, Paul M; Chalmers, Anthony J; Dawson, Timothy; Goodden, John; Hamilton, Willie; Hegarty, Mark G; James, Allan; Jenkinson, Michael D; Kernick, David; Lekka, Elvira; Livermore, Laurent J; Mills, Samantha J; O'Neill, Kevin; Palmer, David S; Vaqas, Babar; Baker, Matthew J

2018-05-24

To determine the potential costs and health benefits of a serum-based spectroscopic triage tool for brain tumours, which could be developed to reduce diagnostic delays in the current clinical pathway. A model-based health pre-trial economic assessment. Decision tree models were constructed based on simplified diagnostic pathways. Models were populated with parameters identified from rapid reviews of the literature and clinical expert opinion. Explored as a test in both primary and secondary care (neuroimaging) in the UK health service, as well as application to the USA. Calculations based on an initial cohort of 10 000 patients. In primary care, it is estimated that the volume of tests would approach 75 000 per annum. The volume of tests in secondary care is estimated at 53 000 per annum. The primary outcome measure was quality-adjusted life-years (QALY), which were employed to derive incremental cost-effectiveness ratios (ICER) in a cost-effectiveness analysis. Results indicate that using a blood-based spectroscopic test in both scenarios has the potential to be highly cost-effective in a health technology assessment agency decision-making process, as ICERs were well below standard threshold values of £20 000-£30 000 per QALY. This test may be cost-effective in both scenarios with test sensitivities and specificities as low as 80%; however, the price of the test would need to be lower (less than approximately £40). Use of this test as triage tool in primary care has the potential to be both more effective and cost saving for the health service. In secondary care, this test would also be deemed more effective than the current diagnostic pathway. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Planning oral health and clinical discharge in primary care: the comprehensive dental care protocol outcome.

PubMed

Cavalcanti, Yuri Wanderley; Dantas de Almeida, Leopoldina de Fátima; Barbosa, Ailma de Souza; Nascimento Padilha, Wilton Wilney

2015-03-01

The dental care must be driven by preventive and curative measures that can contribute to the population's oral health promotion. To evaluate the impact of the actions proposed by a comprehensive dental care protocol (CDCP) on the oral health condition of primary care users. The sample consisted of 32 volunteers, assisted throughout the six phases proposed by the CDCP: diagnosis of dental needs; resolution of urgencies; restorative interventions; application of promotional measures; evaluation of the achieved health level; and periodic controls. Data were collected through clinical exams, which measured the simplified oral hygiene index (OHI-S), gingival bleeding index (GBI) and the decayed, missing and filled teeth (DMFT) Index, before and after the CDCP was implemented. Statistical analysis consisted of the Wilcoxon test, at 5% significance level (α = 0.05). The OHI-S and GBI indices showed a significant reduction (p < 0.05) from the initial (1.4 ± 0.6 and 46.3 ± 19.9) to final condition (0.9 ± 0.3 and 21.5 ± 7.5). The decayed, missing and filled teeth and the missing teeth component were not significantly altered (p > 0.05), showing final values equal to 12.7 ± 9.6 and 5.6 ± 7.8, respectively. Decayed elements were fully converted into filled elements, and the final values of the decayed and filled elements were, respectively, 0.0 ± 0.0 and 7.3 ± 5.7 (p < 0.05). The enactment of the CDCP had a beneficial effect on the oral health of the population assisted by the dental services offered in primary care and this protocol seems to ft the public dental service demands. The CDCP can be useful to public dental service planning since it showed an efficient clinical outcome to the patients. We consider that this protocol should be employed in primary care oral health services in order to achieve overall upgrade, access enlargement and public oral health promotion.

40 CFR 421.80 - Applicability: Description of the primary zinc subcategory.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 30 2012-07-01 2012-07-01 false Applicability: Description of the primary zinc subcategory. 421.80 Section 421.80 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS NONFERROUS METALS MANUFACTURING POINT SOURCE CATEGORY Primary Zinc Subcategory § 421.80 Applicability...

40 CFR 421.80 - Applicability: Description of the primary zinc subcategory.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 30 2013-07-01 2012-07-01 true Applicability: Description of the primary zinc subcategory. 421.80 Section 421.80 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS NONFERROUS METALS MANUFACTURING POINT SOURCE CATEGORY Primary Zinc Subcategory § 421.80 Applicability:...

40 CFR 421.80 - Applicability: Description of the primary zinc subcategory.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 29 2014-07-01 2012-07-01 true Applicability: Description of the primary zinc subcategory. 421.80 Section 421.80 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS NONFERROUS METALS MANUFACTURING POINT SOURCE CATEGORY Primary Zinc Subcategory § 421.80 Applicability:...

Evaluation of clinical pharmacy interventions in a Veterans Affairs medical center primary care clinic.

PubMed

Hough, Augustus; Vartan, Christine M; Groppi, Julie A; Reyes, Sonia; Beckey, Nick P

2013-07-01

The development of an electronic tool to quantify and characterize the interventions made by clinical pharmacy specialists (CPSs) in a primary care setting is described. An electronic clinical tool was developed to document the clinical pharmacy interventions made by CPSs at the Veterans Affairs Medical Center in West Palm Beach, Florida. The tool, embedded into the electronic medical record, utilizes a novel reminder dialogue to complete pharmacotherapy visit encounters and allows CPSs to document interventions made during patient care visits. Interventions are documented using specific electronic health factors so that the type and number of interventions made for both disease-specific and other pharmacotherapy interventions can be tracked. These interventions were assessed and analyzed to evaluate the impact of CPSs in the primary care setting. From February 2011 through January 2012, a total of 16,494 pharmacotherapy interventions (therapeutic changes and goals attained) were recorded. The average numbers of interventions documented per patient encounter were 0.96 for the management of diabetes mellitus, hypertension, dyslipidemia, and heart failure and 1.36 for non-disease-specific interventions, independent of those interventions being made by the primary physician or other members of the primary care team. A clinical reminder tool developed to quantify and characterize the interventions provided by CPSs found that for every visit with a CPS, approximately one disease-specific intervention and one additional pharmacotherapy intervention were made, independent of those interventions being made by the primary physician or other members of the primary care team.

From cottage industry to a dominant mode of primary care: stages in the diffusion of a health care innovation (retail clinics).

PubMed

McKinlay, John B; Marceau, Lisa D

2012-09-01

Primary health care is essential to population health and there is increasing need for it, especially with an aging population with multiple comorbidities. Primary health care in the U.S. is widely considered in an ever-deepening crisis. This paper presents a detailed case study of the recent rise of a "disruptive innovation" - retail clinics - which have the potential to transform the face of primary health care in the US. We describe six stages in the diffusion of retail clinics, from cottage industry to a dominant mode for the delivery of primary health care, and consider sociopolitical influences that facilitate and impede their emerging potential. Retail clinics may provide a strategic opportunity to re-engineer the primary health care system, although they may also produce worrisome unanticipated consequences. Discussion concerning the potential threats and opportunities posed by retail clinics occurs in the absence of sound evidence concerning their comparative effectiveness and quality-of-care. This case study identifies the sociopolitical influences and processes that determine whether health care innovations rise or fall, and highlights critically important points along the pathway to health system change. Copyright © 2012 Elsevier Ltd. All rights reserved.

Antibiotics for URTI and UTI -- prescribing in Malaysian primary care settings.

PubMed

Teng, Cheong Lieng; Tong, Seng Fah; Khoo, Ee Ming; Lee, Verna; Zailinawati, Abu Hassan; Mimi, Omar; Chen, Wei Seng; Nordin, Salleh

2011-05-01

Overprescription of antibiotics is a continuing problem in primary care. This study aims to assess the antibiotic prescribing rates and antibiotic choices for upper respiratory tract infections (URTI) and urinary tract infections (UTI) in Malaysian primary care. Antibiotic prescribing data for URTI and UTI was extracted from a morbidity survey of randomly selected primary care clinics in Malaysia. Analysis was performed of 1,163 URTI and 105 UTI encounters. Antibiotic prescribing rates for URTI and UTI were 33.8% and 57.1% respectively. Antibiotic prescribing rates were higher in private clinics compared to public clinics for URTI, but not for UTI. In URTI encounters, the majority of antibiotics prescribed were penicillins and macrolides, but penicillin V was notably underused. In UTI encounters, the antibiotics prescribed were predominantly penicillins or cotrimoxazole. Greater effort is needed to bring about evidence based antibiotic prescribing in Malaysian primary care, especially for URTIs in private clinics.

Pilot Study for Managing Complex Chronic Care Medicaid Patients With Diabetes Using a Mobile Health Application Achieves "Triple Aim" Improvement in a Primary Care Setting.

PubMed

Bovbjerg, Marit L; Lee, Jenney; Wolff, Rosa; Bangs, Bobby; May, Michael A

2017-10-01

IN BRIEF Cost-effective innovations to improve health and health care in patients with complex chronic diseases are urgently needed. Mobile health (mHealth) remote monitoring applications (apps) are a promising technology to meet this need. This article reports on a study evaluating patients' use of a tablet device with an mHealth app and a cellular-enabled glucose meter that automatically uploaded blood glucose values to the app. Improvements were observed across all three components of the Patient Protection and Affordable Care Act's "triple aim." Self-rated wellness and numerous quality-of-care metrics improved, billed charges and paid claims decreased, but no changes in clinical endpoints were observed.

An ethnography of clinic "noise" in a community-based, promotora-centered mental health intervention.

PubMed

Getrich, Christina; Heying, Shirley; Willging, Cathleen; Waitzkin, Howard

2007-07-01

Community-based health interventions have emerged as a growing focus for anthropological research. The application of ethnographic approaches in clinical practice settings reveals that community-based interventions must grapple with "noise," or unanticipated factors such as patients' own perceptions of illness and treatment, primary care providers' non-adherence to guidelines-based treatment, the social dynamics of the clinic site itself, and incomplete understanding and acceptance of an intervention by a clinic's staff members. Such noise can influence the implementation and quality of treatment. Thus, identifying clinic-based noise is critical in assessments of fidelity to intervention protocols as well as outcomes of community-based interventions. This paper highlights findings from an evaluation of a mental health intervention focusing on the role of promotoras (briefly trained, non-professional community health workers) as mental health practitioners in two urban New Mexico, USA, community health centers. Our research identified three areas of clinic-based noise: the clinics' physical ability to "absorb" the intervention, the challenges of co-worker instability and interpersonal relationships, and balancing extra workplace demands. The findings demonstrate the value of ethnographic approaches in community-based intervention research.

Electronic health records to facilitate clinical research.

PubMed

Cowie, Martin R; Blomster, Juuso I; Curtis, Lesley H; Duclaux, Sylvie; Ford, Ian; Fritz, Fleur; Goldman, Samantha; Janmohamed, Salim; Kreuzer, Jörg; Leenay, Mark; Michel, Alexander; Ong, Seleen; Pell, Jill P; Southworth, Mary Ross; Stough, Wendy Gattis; Thoenes, Martin; Zannad, Faiez; Zalewski, Andrew

2017-01-01

Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the primary data source is envisioned for observational studies, embedded pragmatic or post-marketing registry-based randomized studies, or comparative effectiveness studies. Advancing this approach to randomized clinical trials, electronic health records may potentially be used to assess study feasibility, to facilitate patient recruitment, and streamline data collection at baseline and follow-up. Ensuring data security and privacy, overcoming the challenges associated with linking diverse systems and maintaining infrastructure for repeat use of high quality data, are some of the challenges associated with using electronic health records in clinical research. Collaboration between academia, industry, regulatory bodies, policy makers, patients, and electronic health record vendors is critical for the greater use of electronic health records in clinical research. This manuscript identifies the key steps required to advance the role of electronic health records in cardiovascular clinical research.

40 CFR 421.50 - Applicability: Description of the primary electrolytic copper refining subcategory.

Code of Federal Regulations, 2011 CFR

2011-07-01

... primary electrolytic copper refining subcategory. 421.50 Section 421.50 Protection of Environment... POINT SOURCE CATEGORY Primary Electrolytic Copper Refining Subcategory § 421.50 Applicability: Description of the primary electrolytic copper refining subcategory. The provisions of this subpart apply to...

40 CFR 421.50 - Applicability: Description of the primary electrolytic copper refining subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... primary electrolytic copper refining subcategory. 421.50 Section 421.50 Protection of Environment... POINT SOURCE CATEGORY Primary Electrolytic Copper Refining Subcategory § 421.50 Applicability: Description of the primary electrolytic copper refining subcategory. The provisions of this subpart apply to...

Incurable suffering from the "hiatus theoreticus"? Some epistemological problems in modern medicine and the clinical relevance of philosophy of medicine.

PubMed

Paul, N

1998-06-01

Up to now neither the question, whether all theoretical medical knowledge can at least be described as scientific, nor the one how exactly access to the existing scientific and theoretical medical knowledge during clinical problem-solving is made, has been sufficiently answered. Scientific theories play an important role in controlling clinical practice and improving the quality of clinical care in modern medicine on the one hand, and making it vindicable on the other. Therefore, the vagueness of unexplicit interrelations between medicine's stock of knowledge and medical practice appears as a gap in the theoretical concept of modern medicine which can be described as "Hiatus theoreticus" in the anatomy of medicine. A central intention of the paper is to analyze the role of philosophy of medicine for the clarification of the theoretical basis of medical practice. Clinical relevance and normativity in the sense of modern theory of science are suggested as criteria to establish a differentiation between philosophy of medicine as a primary medical discipline and the application of general philosophy in medicine.

Integrating Musculoskeletal Education and Patient Care at Medical Student-Run Free Clinics.

PubMed

McQuillan, Thomas; Wilcox-Fogel, Nate; Kraus, Emily; Ladd, Amy; Fredericson, Michael

2017-11-01

Student-run free clinics (SRFCs) have emerged as an important educational component of United States (U.S.) medical schools. Despite the prevalence of musculoskeletal (MSK) problems presenting to SRFCs, students and clinics are often unprepared to diagnose and to treat common MSK complaints. We sought to determine the scope of diagnosis and treatment at a medical student-run free clinic specializing in musculoskeletal care using physical medicine and rehabilitation (PM&R) residents. Secondary goals included reviewing student satisfaction and determining the appropriateness of the clinic in medical education. Retrospective chart review, anonymous online survey. Primary care, free student clinic affiliated with tertiary academic medical center. A total of 20 medical student volunteers, 6 PM&R residents, and 91 community patients. We established a musculoskeletal clinic as a specialty referral clinic for the 2 primary care SRFCs with institutional support from a partner medical school. We then reviewed clinical operations retrospectively using electronic medical records and student satisfaction based on an online survey. We analyzed patient demographics and chief complaints, referrals provided, and medical services rendered. We also used a 5-point Likert scale to assess student satisfaction. A monthly musculoskeletal referral clinic was established with the oversight of PM&R attendings and residents. The clinic received 91 referrals and managed 61 unique patients over a 2.5-year study period. The most common presentations to the clinic involved knee pain (n = 17, 27.9%) and back pain (n = 16, 26.2%). Pro bono relationships with community and institutional partners enabled all patients to receive medical examinations, physical therapy visits, plain film radiographs, and insurance consultations free of charge. Student satisfaction with teaching and patient care was high, with 19 of 20 students reporting their experience as "good" or "excellent." SRFCs represent an underused opportunity to enhance MSK education among medical students by treating a variety of common MSK complaints in an underserved population. Not applicable. Copyright © 2017 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Clinical Decisions Made in Primary Care Clinics Before and After Choosing Wisely.

PubMed

Kost, Amanda; Genao, Inginia; Lee, Jay W; Smith, Stephen R

2015-01-01

The Choosing Wisely campaign encourages physicians to avoid low-value care. Although widely lauded, no study has examined its impact on clinical decisions made in primary care settings. We compared clinical decisions made for 5 Choosing Wisely recommendations over two 6-month time periods before and after the campaign launch and an educational intervention to promote it at 3 primary care residency clinics. The rate of recommendations adherence was high (93.2%) at baseline but did significantly increase to 96.5% after the launch. These findings suggest primary care physicians respond to training and publicity in low-value care, though further research is needed. Given that even small decreases of physician test ordering can produce large cost savings, the Choosing Wisely project may help achieve the health care triple aim. © Copyright 2015 by the American Board of Family Medicine.

Amelogenesis imperfecta associated with dental follicular-like hamartomas and generalised gingival enlargement.

PubMed

O'Connell, S; Davies, J; Smallridge, J; Vaidyanathan, M

2014-10-01

Amelogenesis imperfecta (AI) is an inherited disorder characterised by generalised defects of dental enamel, but has been associated with other dental and medical conditions. It affects the appearance and structure of teeth, both in the primary and secondary dentition. AI in the presence of dental follicular hamartomas and gingival hyperplasia is rare and the management presents several challenges to the clinician. This article describes a case of a girl who presented to the paediatric department at the age of 7 years complaining of discomfort when eating and that she was unhappy with the appearance of her anterior teeth. The patient was born in the UK but she and her family were African and of Kenyan origin. She was otherwise fit and well. Investigations included clinical, radiographic and pathological examination as well as cone beam computed tomography imaging and X-ray Microtomography of extracted primary teeth. A diagnosis of AI in the presence of dental follicular hamartomas and generalised gingival hyperplasia was made, which had resulted in the delayed eruption of permanent teeth and an associated anterior open bite. There was no family history of dental defects. Initial treatment included preventative advice and the application of preformed metal crowns on all primary molars. Extraction of all remaining primary incisors was carried out followed by gingivectomy around the maxillary permanent incisors, mandibular central incisors and maxillary left second primary molar. Composite resin reconstruction of all permanent incisors and mandibular primary canines was complicated by the poor quality of enamel. Orthodontic extrusion of the anterior incisors was carried out to improve surface area for bonding with some success. A multidisciplinary team managed this case and decided that no surgical intervention of the dental follicular hamartomas was warranted. The patient coped well with treatment and attended for regular review over an 8-year period. She was reviewed at 6 monthly intervals clinically by a paediatric dentist and radiographs were taken as required to monitor the hamartomas, maintain the restorations and monitor her dental development. She was also seen on the multidisciplinary clinic once a year. This is the first case of its kind to be reported in the UK and the 8th worldwide. While this condition is rare, it is important that paediatric dentists are made aware of it.

Concussion Care Practices and Utilization of Evidence-Based Guidelines in the Evaluation and Management of Concussion: A Survey of New England Emergency Departments.

PubMed

Stern, Robert A; Seichepine, Daniel; Tschoe, Christine; Fritts, Nathan G; Alosco, Michael L; Berkowitz, Oren; Burke, Peter; Howland, Jonathan; Olshaker, Jonathan; Cantu, Robert C; Baugh, Christine M; Holsapple, James W

2017-02-15

Evidence-based clinical practice guidelines can facilitate proper evaluation and management of concussions in the emergency department (ED), often the initial and primary point of contact for concussion care. There is no universally adopted set of guidelines for concussion management, and extant evidence suggests that there may be variability in concussion care practices and limited application of clinical practice guidelines in the ED. This study surveyed EDs throughout New England to examine current practices of concussion care and utilization of evidence-based clinical practice guidelines in the evaluation and management of concussions. In 2013, a 32-item online survey was e-mailed to 149/168 EDs throughout New England (Connecticut, Rhode Island, Massachusetts, Vermont, New Hampshire, Maine). Respondents included senior administrators asked to report on their EDs use of clinical practice guidelines, neuroimaging decision-making, and discharge instructions for concussion management. Of the 72/78 respondents included, 35% reported absence of clinical practice guidelines, and 57% reported inconsistency in the type of guidelines used. Practitioner preference guided neuroimaging decision-making for 57%. Although 94% provided written discharge instructions, there was inconsistency in the recommended time frame for follow-up care (13% provided no specific time frame), the referral specialist to be seen (25% did not recommend any specialist), and return to activity instructions were inconsistent. There is much variability in concussion care practices and application of evidence-based clinical practice guidelines in the evaluation and management of concussions in New England EDs. Knowledge translational efforts will be critical to improve concussion management in the ED setting.

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

Evidence-based medicine in HBP surgery: Is there any?

PubMed Central

Thorlacius, Henrik

2005-01-01

Background. Evidence-based medicine (EBM) has become widely accepted as a basis for clinical decision in many fields of medicine. This review examines the specific role of EBM in hepato-biliary and pancreatic (HBP) surgery. EBM relies on four main sources, including clinical guidelines, meta-analyses, primary information and clinical experience. Randomized controlled trials (RCTs) constitute the cornerstone of EBM and a recent study reported that there are relatively few RCTs evaluating the effectiveness of surgical therapies and procedures (1,530 out of 45,342 or 3.4% in five leading surgical journals) and only a few in HBP surgery. Although the effort must be to implement EBM as far as possible in HBP surgery, there are several obstacles to conducting RCTs in HBP surgery, including problems associated with standardization of surgical skills, sham-operations often impossible to perform, and the general applicability of specific findings may be uncertain. Discussion. This paper will provide two relevant examples of EBM in HBP surgery in patients with hepatic metastases and pancreatic adenocarcinoma, illustrating some problems but also the potential of introducing EBM in HBP surgery. In the future, our effort must be devoted to implementing EBM in applicable areas of HBP surgery but also remembering that in certain areas accumulated knowledge from observational studies, including drainage of abscesses and surgical treatment of intestinal obstruction, may have similar or even higher clinical value than RCTs. PMID:18333189

Improving the quality of nurse clinical documentation for chronic patients at primary care clinics: A multifaceted intervention.

PubMed

Mahomed, Ozayr H; Naidoo, Salsohni; Asmall, Shaidah; Taylor, Myra

2015-09-25

Deficiencies in record keeping practices have been reported at primary care level in the public health sector in South Africa. These deficiencies have the potential to negatively impact patient health outcomes as the break in information may hinder continuity of care. This disruption in information management has particular relevance for patients with chronic diseases. The aim of this study was to establish if the implementation of a structured clinical record (SCR) as an adjunct tool to the algorithmic guidelines for chronic disease management improved the quality of clinical records at primary care level. A quasi-experimental study (before and after study with a comparison group) was conducted across 30 primary health care clinics (PHCs) located in three districts in South Africa. Twenty PHCs that received the intervention were selected as intervention clinics and 10 facilities were selected as comparison facilities. The lot quality assurance sampling (LQAS) method was used to determine the number of records required to be reviewed per diagnostic condition per facility. There was a a statistically significant increase in the percentage of clinical records achieving compliance to the minimum criteria from the baseline to six months post-intervention for both HIV patients on antiretroviral treatment and patients with non-communicable diseases (hypertension and diabetes). A multifaceted intervention using a SCR to supplement the educational outreach component (PC 101 training) has demonstrated the potential for improving the quality of clinical records for patients with chronic diseases at primary care clinics in South Africa.

Novel Application of a Reverse Triage Protocol Providing Increased Access to Care in an Outpatient, Primary Care Clinic Setting.

PubMed

Sacino, Amanda N; Shuster, Jonathan J; Nowicki, Kamil; Carek, Peter J; Wegman, Martin P; Listhaus, Alyson; Gibney, Joseph M; Chang, Ku-Lang

2016-02-01

As the number of patients with access to care increases, outpatient clinics will need to implement innovative strategies to maintain or enhance clinic efficiency. One viable alternative involves reverse triage. A reverse triage protocol was implemented during a student-run free clinic. Each patient's chief complaint(s) were obtained at the beginning of the clinic session and ranked by increasing complexity. "Complexity" was defined as the subjective amount of time required to provide a full, thorough evaluation of a patient. Less complex cases were prioritized first since they could be expedited through clinic processing and allow for more time and resources to be dedicated to complex cases. Descriptive statistics were used to characterize and summarize the data obtained. Categorical variables were analyzed using chi-square. A time series analysis of the outcome versus centered time in weeks was also conducted. The average number of patients seen per clinic session increased by 35% (9.5 versus 12.8) from pre-implementation of the reverse triage protocol to 6 months after the implementation of the protocol. The implementation of a reverse triage in an outpatient setting significantly increased clinic efficiency as noted by a significant increase in the number of patients seen during a clinic session.

Design and methodology of the COACH-2 (Comparative study on guideline adherence and patient compliance in heart failure patients) study: HF clinics versus primary care in stable patients on optimal therapy.

PubMed

Luttik, M L A; Brons, M; Jaarsma, T; Hillege, H L; Hoes, A; de Jong, R; Linssen, G; Lok, D J; Berger, M; van Veldhuisen, D J

2012-08-01

Since the number of heart failure (HF) patients is still growing and long-term treatment of HF patients is necessary, it is important to initiate effective ways for structural involvement of primary care services in HF management programs. However, evidence on whether and when patients can be referred back to be managed in primary care is lacking. To determine whether long-term patient management in primary care, after initial optimisation of pharmacological and non-pharmacological treatment in a specialised HF clinic, is equally effective as long-term management in a specialised HF clinic in terms of guideline adherence and patient compliance. The study is designed as a randomised, controlled, non-inferiority trial. Two-hundred patients will be randomly assigned to be managed and followed in primary care or in a HFclinic. Patients are eligible to participate if they are (1) clinically stable, (2) optimally up-titrated on medication (according to ESC guidelines) and, (3) have received optimal education and counselling on pre-specified issues regarding HF and its treatment. Furthermore, close cooperation between secondary and primary care in terms of back referral to or consultation of the HF clinic will be provided.The primary outcome will be prescriber adherence and patient compliance with medication after 12 months. Secondary outcomes measures will be readmission rate, mortality, quality of life and patient compliance with other lifestyle changes. The results of the study will add to the understanding of the role of primary care and HF clinics in the long-term follow-up of HF patients.

Racism: A Symptom of the Narcissistic Personality

PubMed Central

Bell, Carl C.

1980-01-01

Despite the criticism that psychoanalytic models are not applicable to social phenomena, knowledge of the dynamics of narcissistic development aids in understanding a particular kind of racist individual. Specifically, racist attitudes may be indicative of a narcissistic personality disorder or of a regression to primitive narcissistic functioning secondary to environmental forces. The differentiation between the narcissistic racist, the stress-induced racist, and the socially misinformed racist is discussed utilizing clinical paradigms discovered in psychotherapy. Life experiences and religion are discussed as possible aids in the transformation of primary narcissism into secondary narcissism. PMID:7392083

Getting Funded

PubMed Central

Gill, Thomas M; McDermott, Mary M; Ibrahim, Said A; Petersen, Laura A; Doebbeling, Bradley N

2004-01-01

For aspiring clinical investigators, career development awards provide a primary mechanism for “getting funded.” The objective of this article is to provide information that will facilitate a successful application for a research career development award. Specifically, we discuss important issues that cut across the diverse array of awards, and we highlight the most common sources of funding, including the unique opportunities that are available for underrepresented minorities. The target audience includes junior faculty and fellows who are pursuing or considering a research career in academic medicine, as well as their mentors and program directors. PMID:15109347

Diagnosis of retinal detachments by a tele-ophthalmology screening program.

PubMed

McCord, Sarah A; Lynch, Mary G; Maa, April Y

2018-01-01

In 2015, a tele-ophthalmology program was undertaken at the Atlanta Veterans Affairs Medical Center to provide screening eye care for veterans in their primary care clinics. Though this program was developed as a screening tool, the availability of these services in primary care clinics has enabled triage of certain acute eye complaints. These case reports describe two patients who were diagnosed with retinal detachments through this program, although their primary care providers had triaged them as requiring non-urgent referrals to the eye clinic. Although many patients are seen for acute ocular complaints in primary care clinics and emergency departments, providers in such settings may lack the ability to adequately examine eyes and thus triage ocular complaints. These cases demonstrate the ability of tele-ophthalmology to assist in diagnosing urgent ocular conditions in primary care clinics. Though tele-ophthalmology has been accepted in some parts of the world, in the United States of America it remains widely underutilized. These cases highlight the ability of tele-ophthalmology to close the gap in acute eye care coverage that exists in the USA, most prominently in rural regions.

Primary Versus Secondary Diagnosis of Generalized Anxiety Disorder in Youth: Is the Distinction an Important One?

PubMed

Ollendick, Thomas H; Jarrett, Matthew A; White, Bradley A; White, Susan W; Grills, Amie E

2016-08-01

Examine whether children with a primary diagnosis of generalized anxiety disorder (GAD) differ from children with a secondary diagnosis of GAD on clinician, parent, teacher, and youth-report measures. Based on consensus diagnoses, 64 youth referred to a general outpatient assessment clinic were categorized as having either a primary or secondary diagnosis of GAD. A semi-structured diagnostic interview was used to guide diagnostic decisions and assign primary versus secondary diagnostic status. We predicted that youth with a primary GAD diagnosis would present with greater anxiety symptomatology and symptom impairment on a variety of anxiety-related measures than youth with a secondary GAD diagnosis. Contrary to our hypotheses, no differences were found between those with primary versus secondary GAD diagnoses on measures of symptom severity and clinical impairment, comorbid diagnoses, or youth and teacher-report measures. Our findings have potential implications for the current practice of requiring primary anxiety diagnostic status as an inclusion criterion in clinical research and treatment outcome studies. Assuming our findings are confirmed in larger samples and with other anxiety disorders, future clinical trials and basic psychopathology research might not exclude youth based on absence of a particular anxiety disorder as the primary disorder but rather include individuals for whom that anxiety disorder is secondary as well.

High-energy proton imaging for biomedical applications

DOE PAGES

Prall, Matthias; Durante, Marco; Berger, Thomas; ...

2016-06-10

The charged particle community is looking for techniques exploiting proton interactions instead of X-ray absorption for creating images of human tissue. Due to multiple Coulomb scattering inside the measured object it has shown to be highly non-trivial to achieve sufficient spatial resolution. We present imaging of biological tissue with a proton microscope. This device relies on magnetic optics, distinguishing it from most published proton imaging methods. For these methods reducing the data acquisition time to a clinically acceptable level has turned out to be challenging. In a proton microscope, data acquisition and processing are much simpler. This device even allowsmore » imaging in real time. The primary medical application will be image guidance in proton radiosurgery. Proton images demonstrating the potential for this application are presented. As a result, tomographic reconstructions are included to raise awareness of the possibility of high-resolution proton tomography using magneto-optics.« less

High-energy proton imaging for biomedical applications

NASA Astrophysics Data System (ADS)

Prall, M.; Durante, M.; Berger, T.; Przybyla, B.; Graeff, C.; Lang, P. M.; Latessa, C.; Shestov, L.; Simoniello, P.; Danly, C.; Mariam, F.; Merrill, F.; Nedrow, P.; Wilde, C.; Varentsov, D.

2016-06-01

The charged particle community is looking for techniques exploiting proton interactions instead of X-ray absorption for creating images of human tissue. Due to multiple Coulomb scattering inside the measured object it has shown to be highly non-trivial to achieve sufficient spatial resolution. We present imaging of biological tissue with a proton microscope. This device relies on magnetic optics, distinguishing it from most published proton imaging methods. For these methods reducing the data acquisition time to a clinically acceptable level has turned out to be challenging. In a proton microscope, data acquisition and processing are much simpler. This device even allows imaging in real time. The primary medical application will be image guidance in proton radiosurgery. Proton images demonstrating the potential for this application are presented. Tomographic reconstructions are included to raise awareness of the possibility of high-resolution proton tomography using magneto-optics.

Activity of terbinafine in experimental fungal infections of laboratory animals.

PubMed Central

Petranyi, G; Meingassner, J G; Mieth, H

1987-01-01

The allylamine derivative terbinafine is the first antifungal agent with primary fungicidal properties against dermatophytes which acts systemically after oral application as well as locally after topical application. Comparative oral studies carried out with griseofulvin and ketoconazole in model infections such as guinea pig trichophytosis and microsporosis revealed terbinafine to be superior to the reference compounds both clinically and mycologically. An excellent antimycotic activity of terbinafine was also demonstrable after topical treatment of guinea pig dermatophytoses caused by Trichophyton mentagrophytes or Microsporum canis. Results of comparative chemotherapeutic studies carried out with econazole and tolnaftate demonstrated superior efficacy of terbinafine in the treatment of both trichophytosis and microsporosis. Skin infections of guinea pigs caused by Candida albicans and vaginal candidiasis in rats proved to be responsive to a topical application of terbinafine also. However, the reference compounds, clotrimazole and miconazole, exhibited activity superior to that of terbinafine in both models. PMID:3435103

High-energy proton imaging for biomedical applications

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

Prall, Matthias; Durante, Marco; Berger, Thomas

The charged particle community is looking for techniques exploiting proton interactions instead of X-ray absorption for creating images of human tissue. Due to multiple Coulomb scattering inside the measured object it has shown to be highly non-trivial to achieve sufficient spatial resolution. We present imaging of biological tissue with a proton microscope. This device relies on magnetic optics, distinguishing it from most published proton imaging methods. For these methods reducing the data acquisition time to a clinically acceptable level has turned out to be challenging. In a proton microscope, data acquisition and processing are much simpler. This device even allowsmore » imaging in real time. The primary medical application will be image guidance in proton radiosurgery. Proton images demonstrating the potential for this application are presented. As a result, tomographic reconstructions are included to raise awareness of the possibility of high-resolution proton tomography using magneto-optics.« less

Embodied Conversational Agents in Clinical Psychology: A Scoping Review

PubMed Central

Lau, Ho Ming; Ruwaard, Jeroen; Riper, Heleen

2017-01-01

Background Embodied conversational agents (ECAs) are computer-generated characters that simulate key properties of human face-to-face conversation, such as verbal and nonverbal behavior. In Internet-based eHealth interventions, ECAs may be used for the delivery of automated human support factors. Objective We aim to provide an overview of the technological and clinical possibilities, as well as the evidence base for ECA applications in clinical psychology, to inform health professionals about the activity in this field of research. Methods Given the large variety of applied methodologies, types of applications, and scientific disciplines involved in ECA research, we conducted a systematic scoping review. Scoping reviews aim to map key concepts and types of evidence underlying an area of research, and answer less-specific questions than traditional systematic reviews. Systematic searches for ECA applications in the treatment of mood, anxiety, psychotic, autism spectrum, and substance use disorders were conducted in databases in the fields of psychology and computer science, as well as in interdisciplinary databases. Studies were included if they conveyed primary research findings on an ECA application that targeted one of the disorders. We mapped each study’s background information, how the different disorders were addressed, how ECAs and users could interact with one another, methodological aspects, and the study’s aims and outcomes. Results This study included N=54 publications (N=49 studies). More than half of the studies (n=26) focused on autism treatment, and ECAs were used most often for social skills training (n=23). Applications ranged from simple reinforcement of social behaviors through emotional expressions to sophisticated multimodal conversational systems. Most applications (n=43) were still in the development and piloting phase, that is, not yet ready for routine practice evaluation or application. Few studies conducted controlled research into clinical effects of ECAs, such as a reduction in symptom severity. Conclusions ECAs for mental disorders are emerging. State-of-the-art techniques, involving, for example, communication through natural language or nonverbal behavior, are increasingly being considered and adopted for psychotherapeutic interventions in ECA research with promising results. However, evidence on their clinical application remains scarce. At present, their value to clinical practice lies mostly in the experimental determination of critical human support factors. In the context of using ECAs as an adjunct to existing interventions with the aim of supporting users, important questions remain with regard to the personalization of ECAs’ interaction with users, and the optimal timing and manner of providing support. To increase the evidence base with regard to Internet interventions, we propose an additional focus on low-tech ECA solutions that can be rapidly developed, tested, and applied in routine practice. PMID:28487267

Embodied Conversational Agents in Clinical Psychology: A Scoping Review.

PubMed

Provoost, Simon; Lau, Ho Ming; Ruwaard, Jeroen; Riper, Heleen

2017-05-09

Embodied conversational agents (ECAs) are computer-generated characters that simulate key properties of human face-to-face conversation, such as verbal and nonverbal behavior. In Internet-based eHealth interventions, ECAs may be used for the delivery of automated human support factors. We aim to provide an overview of the technological and clinical possibilities, as well as the evidence base for ECA applications in clinical psychology, to inform health professionals about the activity in this field of research. Given the large variety of applied methodologies, types of applications, and scientific disciplines involved in ECA research, we conducted a systematic scoping review. Scoping reviews aim to map key concepts and types of evidence underlying an area of research, and answer less-specific questions than traditional systematic reviews. Systematic searches for ECA applications in the treatment of mood, anxiety, psychotic, autism spectrum, and substance use disorders were conducted in databases in the fields of psychology and computer science, as well as in interdisciplinary databases. Studies were included if they conveyed primary research findings on an ECA application that targeted one of the disorders. We mapped each study's background information, how the different disorders were addressed, how ECAs and users could interact with one another, methodological aspects, and the study's aims and outcomes. This study included N=54 publications (N=49 studies). More than half of the studies (n=26) focused on autism treatment, and ECAs were used most often for social skills training (n=23). Applications ranged from simple reinforcement of social behaviors through emotional expressions to sophisticated multimodal conversational systems. Most applications (n=43) were still in the development and piloting phase, that is, not yet ready for routine practice evaluation or application. Few studies conducted controlled research into clinical effects of ECAs, such as a reduction in symptom severity. ECAs for mental disorders are emerging. State-of-the-art techniques, involving, for example, communication through natural language or nonverbal behavior, are increasingly being considered and adopted for psychotherapeutic interventions in ECA research with promising results. However, evidence on their clinical application remains scarce. At present, their value to clinical practice lies mostly in the experimental determination of critical human support factors. In the context of using ECAs as an adjunct to existing interventions with the aim of supporting users, important questions remain with regard to the personalization of ECAs' interaction with users, and the optimal timing and manner of providing support. To increase the evidence base with regard to Internet interventions, we propose an additional focus on low-tech ECA solutions that can be rapidly developed, tested, and applied in routine practice. ©Simon Provoost, Ho Ming Lau, Jeroen Ruwaard, Heleen Riper. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 09.05.2017.

Lidocaine/monoethylglycinexylidide test, galactose elimination test, and sorbitol elimination test for metabolic assessment of liver cell bioreactors.

PubMed

Gerlach, Jörg C; Brayfield, Candace; Puhl, Gero; Borneman, Reiner; Müller, Christian; Schmelzer, Eva; Zeilinger, Katrin

2010-06-01

Various metabolic tests were compared for the performance characterization of a liver cell bioreactor as a routine function assessment of cultures in a standby for patient application in clinical studies. Everyday quality assessment (QA) is essential to ensure a continuous level of cellular functional capacity in the development of hepatic progenitor cell expansion systems providing cells for regenerative medicine research; it is also of interest to meet safety requirements in bioartificial extracorporeal liver support systems under clinical evaluation. Quality criteria for the description of bioreactor cultures were developed using primary porcine liver cells as a model. Porcine liver cells isolated by collagenase perfusion with an average of 3 x 10(9) primary cells were used in 39 bioreactors for culture periods up to 33 days. Measurements of monoethylglycinexylidide synthesis and elimination of lidocaine, galactose elimination, and sorbitol elimination proved to be useful for routine QA of primary liver cell cultures. We demonstrate two methods for dispensing test substances, bolus administration and continuous, steady-state administration. Bolus test data were grouped in Standard, Therapy, Infection/Contamination, and Cell-free control groups. Statistical analyses show significant differences among all groups for every test substance. Post hoc comparisons indicated significant differences between Standard and Cell-free groups for all elimination parameters. For continuous tests, results were categorized according to number of culture days and time-dependent changes were analyzed. Continuous administration enables a better view of culture health and the time dependency of cellular function, whereas bolus administration is more flexible. Both procedures can be used to define cell function. Assessment of cellular function and bioreactor quality can contribute significantly to the quality of experimental or clinical studies in the field of hepatic bioreactor development.

A clinical study of the LiVac laparoscopic liver retractor system.

PubMed

Gan, Philip; Bingham, Judy

2016-02-01

All retractors for laparoscopic operations on the gallbladder or stomach apply an upward force to the under-surface of the liver or gallbladder, most requiring an additional skin incision. The LiVac laparoscopic liver retractor system (LiVac retractor) comprises a soft silicone ring attached to suction tubing and connected to a regulated source of suction. The suction tubing extends alongside existing ports. When placed between the liver and diaphragm, and suction applied, a vacuum is created within the ring, keeping these in apposition. Following successful proof-of-concept animal testing, a clinical study was conducted to evaluate the performance and safety of the retractor in patients. The study was a dual-centre, single-surgeon, open-label study and recruited ten patients scheduled to undergo routine upper abdominal laparoscopic surgery including cholecystectomy, primary gastric banding surgery or fundoplication. The study was conducted at two sites and was approved by the institutions' ethics committees. The primary objective of the study was to evaluate the performance of the LiVac retractor in patients undergoing upper abdominal single- or multi-port laparoscopic surgery. Performance was measured by the attainment of milestones for the retractor and accessory bevel, where used, and safety outcomes through the recording of adverse events, physical parameters, pain scales, blood tests and a post-operative liver ultrasound. The LiVac retractor achieved both primary and secondary performance and safety objectives in all patients. No serious adverse events and no device-related adverse events or device deficiencies were reported. The LiVac retractor achieved effective liver retraction without clinically significant trauma and has potential application in multi- or single-port laparoscopic upper abdominal surgery. As a separate incision is not required, the use of the LiVac retractor in multi-port surgery therefore reduces the number of incisions.

L-MTP-PE and zoledronic acid combination in osteosarcoma: preclinical evidence of positive therapeutic combination for clinical transfer

PubMed Central

Biteau, Kevin; Guiho, Romain; Chatelais, Mathias; Taurelle, Julien; Chesneau, Julie; Corradini, Nadège; Heymann, Dominique; Redini, Françoise

2016-01-01

Osteosarcoma, the most frequent malignant primary bone tumor in pediatric patients is characterized by osteolysis promoting tumor growth. Lung metastasis is the major bad prognosis factor of this disease. Zoledronic Acid (ZA), a potent inhibitor of bone resorption is currently evaluated in phase III randomized studies in Europe for the treatment of osteosarcoma and Ewing sarcoma. The beneficial effect of the liposomal form of Muramyl-TriPeptide-Phosphatidyl Ethanolamine (L-mifamurtide, MEPACT®), an activator of macrophage populations has been demonstrated to eradicate lung metastatic foci in osteosarcoma. The objective of this study was to evaluate the potential therapeutic benefit and the safety of the ZA and L-mifamurtide combination in preclinical models of osteosarcoma, as a prerequisite before translation to patients. The effects of ZA (100 μg/kg) and L-mifamurtide (1 mg/kg) were investigated in vivo in xenogeneic and syngeneic mice models of osteosarcoma, at clinical (tumor proliferation, spontaneous lung metastases development), radiological (bone microarchitecture by microCT analysis), biological and histological levels. No interference between the two drugs could be observed on ZA-induced bone protection and on L-mifamurtide-induced inhibition of lung metastasis development. Unexpectedly, ZA and L-mifamurtide association induced an additional and in some cases synergistic inhibition of primary tumor progression. L-mifamurtide has no effect on tumor proliferation in vitro or in vivo, and macrophage population was not affected at the tumor site whatever the treatment. This study evidenced for the first time a significant inhibition of primary osteosarcoma progression when both drugs are combined. This result constitutes a first proof-of-principle for clinical application in osteosarcoma patients. PMID:27152244

Patient and professional user experiences of simple telehealth for hypertension, medication reminders and smoking cessation: a service evaluation

PubMed Central

Cottrell, Elizabeth; Cox, Tracey; O'Connell, Phil; Chambers, Ruth

2015-01-01

Objectives To establish patient and professional user satisfaction with the Advice & Interactive Messaging (AIM) for Health programme delivered using a mobile phone-based, simple telehealth intervention, ‘Florence’. Design A service evaluation using data extracted from Florence and from a professional user electronic survey. Setting 425 primary care practices across 31 Clinical Commissioning Groups in England. Participants 3381 patients registered on 1 of 10 AIM protocols between March 2013 and January 2014 and 77 professional users. Intervention The AIM programme offered 10 clinical protocols, in three broad groups: (1) hypertension diagnosis/monitoring, (2) medication reminders and (3) smoking cessation. Florence sent patients prompts to submit clinical information, educational messages and user satisfaction questions. Patient responses were reviewed by their primary healthcare providers. Primary outcome measures Patients and professional user experiences of using AIM, and within this, Florence. Results Patient activity using Florence was generally good at month 1 for the hypertension protocols (71–80%), but reduced over 2–3 months (31–60%). For the other protocols, patient activity was 0–39% at 3 months. Minimum target days of texting were met for half the hypertension protocols. 1707/2304 (74%) patients sent evaluative texts responded at least once. Among responders, agreement with the adapted friends and family statement generally exceeded preproject aspirations. Professional responders were generally positive or equivocal about the programme. Conclusions Satisfaction with AIM appeared optimal when patients were carefully selected for the protocol; professional users were familiar with the system, the programme addressed a problem with the previous service delivery that was identified by users and users took an active approach to achieve clinical goals. However, there was a significant decrease in patients’ use of Florence over time. Future applications may be optimised by identifying and addressing reasons for the waning use of the service and enhancing support during implementation of the service. PMID:25795698

Primary Care Clinic Re-Design for Prescription Opioid Management.

PubMed

Parchman, Michael L; Von Korff, Michael; Baldwin, Laura-Mae; Stephens, Mark; Ike, Brooke; Cromp, DeAnn; Hsu, Clarissa; Wagner, Ed H

The challenge of responding to prescription opioid overuse within the United States has fallen disproportionately on the primary care clinic setting. Here we describe a framework comprised of 6 Building Blocks to guide efforts within this setting to address the use of opioids for chronic pain. Investigators conducted site visits to thirty primary care clinics across the United States selected for their use of team-based workforce innovations. Site visits included interviews with leadership, clinic tours, observations of clinic processes and team meetings, and interviews with staff and clinicians. Data were reviewed to identify common attributes of clinic system changes around chronic opioid therapy (COT) management. These concepts were reviewed to develop narrative descriptions of key components of changes made to improve COT use. Twenty of the thirty sites had addressed improvements in COT prescribing. Across these sites a common set of 6 Building Blocks were identified: 1) providing leadership support; 2) revising and aligning clinic policies, patient agreements (contracts) and workflows; 3) implementing a registry tracking system; 4) conducting planned, patient-centered visits; 5) identifying resources for complex patients; and 6) measuring progress toward achieving clinic objectives. Common components of clinic policies, patient agreements and data tracked in registries to assess progress are described. In response to prescription opioid overuse and the resulting epidemic of overdose and addiction, primary care clinics are making improvements driven by a common set of best practices that address complex challenges of managing COT patients in primary care settings. © Copyright 2017 by the American Board of Family Medicine.

Developing a Decision Support System for Tobacco Use Counseling Using Primary Care Physicians

PubMed Central

Marcy, Theodore W.; Kaplan, Bonnie; Connolly, Scott W.; Michel, George; Shiffman, Richard N.; Flynn, Brian S.

2009-01-01

Background Clinical decision support systems (CDSS) have the potential to improve adherence to guidelines, but only if they are designed to work in the complex environment of ambulatory clinics as otherwise physicians may not use them. Objective To gain input from primary care physicians in designing a CDSS for smoking cessation to ensure that the design is appropriate to a clinical environment before attempts to test this CDSS in a clinical trial. This approach is of general interest to those designing similar systems. Design and Approach We employed an iterative ethnographic process that used multiple evaluation methods to understand physician preferences and workflow integration. Using results from our prior survey of physicians and clinic managers, we developed a prototype CDSS, validated content and design with an expert panel, and then subjected it to usability testing by physicians, followed by iterative design changes based on their feedback. We then performed clinical testing with individual patients, and conducted field tests of the CDSS in two primary care clinics during which four physicians used it for routine patient visits. Results The CDSS prototype was substantially modified through these cycles of usability and clinical testing, including removing a potentially fatal design flaw. During field tests in primary care clinics, physicians incorporated the final CDSS prototype into their workflow, and used it to assist in smoking cessation interventions up to eight times daily. Conclusions A multi-method evaluation process utilizing primary care physicians proved useful for developing a CDSS that was acceptable to physicians and patients, and feasible to use in their clinical environment. PMID:18713526

The role of advanced echocardiography and cardiovascular magnetic resonance in the assessment of myocardial function in Marfan syndrome-An update.

PubMed

Kiotsekoglou, Anatoli; Moggridge, James C; Child, Anne H; Rask, Peter

2017-05-01

Cardiovascular assessment of patients with Marfan syndrome has normally focused on the aortic root and vascular manifestations of the disease due to the high risk of aortic dissection. Although primary myocardial impairment has long been suspected in these patients, the evidence has been controversial. Advanced echocardiography and cardiovascular magnetic resonance imaging have proven to be effective, accurate, and more sensitive in the detection of subtle cardiac dysfunction. The application of these techniques to Marfan syndrome over the last 10 years has made significant progress in demonstrating the presence of primary myocardial impairment in these patients, but further work is still required to obtain confirmatory molecular, pathophysiological, and prognostic clinical data. Phenotypic expression of the disease has prognostic value, also suggesting potential effective medical therapy. © 2017, Wiley Periodicals, Inc.

Patient-derived Models of Human Breast Cancer: Protocols for In vitro and In vivo Applications in Tumor Biology and Translational Medicine

PubMed Central

DeRose, Yoko S.; Gligorich, Keith M.; Wang, Guoying; Georgelas, Ann; Bowman, Paulette; Courdy, Samir J.; Welm, Alana L.; Welm, Bryan E.

2013-01-01

Research models that replicate the diverse genetic and molecular landscape of breast cancer are critical for developing the next generation therapeutic entities that can target specific cancer subtypes. Patient-derived tumorgrafts, generated by transplanting primary human tumor samples into immune-compromised mice, are a valuable method to model the clinical diversity of breast cancer in mice, and are a potential resource in personalized medicine. Primary tumorgrafts also enable in vivo testing of therapeutics and make possible the use of patient cancer tissue for in vitro screens. Described in this unit are a variety of protocols including tissue collection, biospecimen tracking, tissue processing, transplantation, and 3-dimensional culturing of xenografted tissue, that enable use of bona fide uncultured human tissue in designing and validating cancer therapies. PMID:23456611

The current evidence for a biomarker-based approach in cancer of unknown primary.

PubMed

El Rassy, Elie; Pavlidis, Nicholas

2018-05-02

Cancer of unknown primary (CUP) accounts for the seventh to eighth most frequently diagnosed cancer yet its prognosis remains poor with conventional chemotherapy. The spectrum of therapeutic management includes both locoregional and systemic therapy and should intend to offer optimal benefit to favorable CUP patients and palliative care to unfavorable cases. The recent molecular advances have revolutionized the armamentarium of cancer treatments though a biomarker-based approach. Unfortunately, solid data in CUP is lacking in the absence of a CUP-specific driver molecular signature. This prompted us to screen the medical literature for clinical data that evaluates the efficacy and safety of the biomarker-based approach in CUP patients. In this review, we will summarize the available evidence for the applicability of targeted therapies in CUP. Copyright © 2018 Elsevier Ltd. All rights reserved.

40 CFR 421.250 - Applicability: Description of the primary precious metals and mercury subcategory.

Code of Federal Regulations, 2014 CFR

2014-07-01

... primary precious metals and mercury subcategory. 421.250 Section 421.250 Protection of Environment... POINT SOURCE CATEGORY Primary Precious Metals and Mercury Subcategory § 421.250 Applicability: Description of the primary precious metals and mercury subcategory. The provisions of this subpart are...

40 CFR 421.250 - Applicability: Description of the primary precious metals and mercury subcategory.

Code of Federal Regulations, 2011 CFR

2011-07-01

... primary precious metals and mercury subcategory. 421.250 Section 421.250 Protection of Environment... POINT SOURCE CATEGORY Primary Precious Metals and Mercury Subcategory § 421.250 Applicability: Description of the primary precious metals and mercury subcategory. The provisions of this subpart are...

40 CFR 421.250 - Applicability: Description of the primary precious metals and mercury subcategory.

Code of Federal Regulations, 2012 CFR

2012-07-01

... primary precious metals and mercury subcategory. 421.250 Section 421.250 Protection of Environment... POINT SOURCE CATEGORY Primary Precious Metals and Mercury Subcategory § 421.250 Applicability: Description of the primary precious metals and mercury subcategory. The provisions of this subpart are...

40 CFR 421.250 - Applicability: Description of the primary precious metals and mercury subcategory.

Code of Federal Regulations, 2013 CFR

2013-07-01

... primary precious metals and mercury subcategory. 421.250 Section 421.250 Protection of Environment... POINT SOURCE CATEGORY Primary Precious Metals and Mercury Subcategory § 421.250 Applicability: Description of the primary precious metals and mercury subcategory. The provisions of this subpart are...

Reducing barriers to mental health and social services for Iraq and Afghanistan veterans: outcomes of an integrated primary care clinic.

PubMed

Seal, Karen H; Cohen, Greg; Bertenthal, Daniel; Cohen, Beth E; Maguen, Shira; Daley, Aaron

2011-10-01

Despite high rates of post-deployment psychosocial problems in Iraq and Afghanistan veterans, mental health and social services are under-utilized. To evaluate whether a Department of Veterans Affairs (VA) integrated care (IC) clinic (established in April 2007), offering an initial three-part primary care, mental health and social services visit, improved psychosocial services utilization in Iraq and Afghanistan veterans compared to usual care (UC), a standard primary care visit with referral for psychosocial services as needed. Retrospective cohort study using VA administrative data. Five hundred and twenty-six Iraq and Afghanistan veterans initiating primary care at a VA medical center between April 1, 2005 and April 31, 2009. Multivariable models compared the independent effects of primary care clinic type (IC versus UC) on mental health and social services utilization outcomes. After 2007, compared to UC, veterans presenting to the IC primary care clinic were significantly more likely to have had a within-30-day mental health evaluation (92% versus 59%, p < 0.001) and social services evaluation [77% (IC) versus 56% (UC), p < 0.001]. This exceeded background system-wide increases in mental health services utilization that occurred in the UC Clinic after 2007 compared to before 2007. In particular, female veterans, younger veterans, and those with positive mental health screens were independently more likely to have had mental health and social service evaluations if seen in the IC versus UC clinic. Among veterans who screened positive for  ≥ 1 mental health disorder(s), there was a median of 1 follow-up specialty mental health visit within the first year in both clinics. Among Iraq and Afghanistan veterans new to primary care, an integrated primary care visit further improved the likelihood of an initial mental health and social services evaluation over background increases, but did not improve retention in specialty mental health services.

Who attends Dunedin's free clinic? A study of patients facing cost barriers to primary health care access.

PubMed

Loh, Lik; Dovey, Susan

2015-03-01

Several methods of reducing the cost barrier to primary health care have been implemented in New Zealand, but research about free primary health care and the patients who use such services is scarce. To compare the characteristics of patients at Dunedin's free clinic with those at a traditional general practice clinic. A written survey was distributed to waiting room patients at the Free Clinic and a fee-charging clinic in close proximity. Patient records were accessed to determine health services utilisation rates at both clinics and the discounting rate at the traditional clinic. There were 126 patient surveys returned at the Traditional Clinic and 65 at the Free Clinic. There was a significantly greater proportion of Maori respondents at the Free Clinic than at the Traditional Clinic (24.1% versus 9.2%, p=0.011). The difference in deprivation profiles of Free Clinic and Traditional Clinic respondents was more marked for the individual deprivation measure (five or more NZiDep deprivation characteristics: 65.5% versus 13.3%, p<0.001) than for residential area deprivation (NZDep2006 quintile 5: 41.4% versus 15.8%, p<0.001). Emergency department presentation rates were high for Free Clinic patients, despite free primary care access and high general practitioner consultation rates. Among Traditional Clinic respondents, 31.7% reported deferring health care because of cost in the previous 12 months. The equivalent figure for Free Clinic respondents was 63.8%. This survey suggests that Dunedin's Free Clinic serves a vulnerable population, in whom levels of unmet health need and health service usage are high.

Quick screening tool for patients with severe negative emotional reactions to chronic illness: psychometric study of the negative emotions due to chronic illness screening test (NECIS).

PubMed

Huang, Yun-Hsin; Wu, Chih-Hsun; Chen, Hsiu-Jung; Cheng, Yih-Ru; Hung, Fu-Chien; Leung, Kai-Kuan; Lue, Bee-Horng; Chen, Ching-Yu; Chiu, Tai-Yuan; Wu, Yin-Chang

2018-01-16

Severe negative emotional reactions to chronic illness are maladaptive to patients and they need to be addressed in a primary care setting. The psychometric properties of a quick screening tool-the Negative Emotions due to Chronic Illness Screening Test (NECIS)-for general emotional problems among patients with chronic illness being treated in a primary care setting was investigated. Three studies including 375 of patients with chronic illness were used to assess and analyze internal consistency, test-retest reliability, criterion-related validity, a cut-off point for distinguishing maladaptive emotions and clinical application validity of NECIS. Self-report questionnaires were used. Internal consistency (Cronbach's α) ranged from 0.78 to 0.82, and the test-retest reliability was 0.71 (P < 0.001). Criterion-related validity was 0.51 (P < 0.001). Based on the 'severe maladaptation' and 'moderate maladaptation' groups defined by using the 'Worsening due to Chronic Illness' index as the analysis reference, the receiver-operating characteristic curve analysis revealed an area under the curve of 0.81 and 0.82 (ps < 0.001), and a cut-off point of 19/20 was the most satisfactory for distinguishing those with overly negative emotions, with a sensitivity and specificity of 83.3 and 69.0%, and 68.5 and 83.0%, respectively. The clinical application validity analysis revealed that low NECIS group showed significantly better adaptation to chronic illness on the scales of subjective health, general satisfaction with life, self-efficacy of self-care for disease, illness perception and stressors in everyday life. The NECIS has satisfactory psychometric properties for use in the primary care setting. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Effectiveness of a multifactorial intervention based on an application for smartphones, heart-healthy walks and a nutritional workshop in patients with type 2 diabetes mellitus in primary care (EMID): study protocol for a randomised controlled trial.

PubMed

Alonso-Domínguez, Rosario; Gómez-Marcos, Manuel A; Patino-Alonso, Maria C; Sánchez-Aguadero, Natalia; Agudo-Conde, Cristina; Castaño-Sánchez, Carmen; García-Ortiz, Luis; Recio-Rodríguez, José I

2017-09-14

New information and communication technologies (ICTs) may promote lifestyle changes, but no adequate evidence is available on their combined effect of ICTs with multifactorial interventions aimed at improving diet and increasing physical activity in patients with type 2 diabetes mellitus (DM2). The primary objective of this study is to assess the effect of a multifactorial intervention to increase physical activity and adherence to Mediterranean diet in DM2. METHODS AND ANALYSIS: Study scope and population: The study will be conducted at 'La Alamedilla' primary care research unit in Salamanca (Spain). 200 patients with DM2 of both sexes, aged 25-70 years and who meet the inclusion criteria and sign the informed consent will be recruited. Each participant will attend the clinic at baseline and 3 and 12 months after intervention. Both groups will be given short advice on diet and physical activity. The intervention group will also take five heart-healthy walks and attend a group session on diet education and will be trained on use of an application for smartphone (EVIDENT II) for 3 months. The main study endpoints will be changes in physical activity, as assessed by a pedometer and the International Physical Activity Questionnaire, and adherence to the Mediterranean diet, as evaluated by an adherence questionnaire and the Diet Quality Index. Anthropometric parameters and laboratory values, lifestyles and quality of life will also be assessed. It was approved by the Clinical Research Ethics Committee of Salamanca on 28/11/2016. NCT02991079; Pre-results. © 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.

Translating Atopic Dermatitis Management Guidelines Into Practice for Primary Care Providers.

PubMed

Eichenfield, Lawrence F; Boguniewicz, Mark; Simpson, Eric L; Russell, John J; Block, Julie K; Feldman, Steven R; Clark, Adele R; Tofte, Susan; Dunn, Jeffrey D; Paller, Amy S

2015-09-01

Atopic dermatitis affects a substantial number of children, many of whom seek initial treatment from their pediatrician or other primary care provider. Approximately two-thirds of these patients have mild disease and can be adequately managed at the primary care level. However, recent treatment guidelines are written primarily for use by specialists and lack certain elements that would make them more useful to primary care providers. This article evaluates these recent treatment guidelines in terms of evaluation criteria, treatment recommendations, usability, accessibility, and applicability to nonspecialists and integrates them with clinical evidence to present a streamlined severity-based treatment model for the management of a majority of atopic dermatitis cases. Because each patient's situation is unique, individualization of treatment plans is critical as is efficient communication and implementation of the plan with patients and caregivers. Specifically, practical suggestions for individualizing, optimizing, implementing, and communicating treatment plans such as choosing a moisturizer formulation, avoiding common triggers, educating patients/caregivers, providing written treatment plans, and scheduling physician follow-up are provided along with a discussion of available resources for patients/caregivers and providers. Copyright © 2015 by the American Academy of Pediatrics.

Preclinical Antileukemia Activity of Tramesan: A Newly Identified Bioactive Fungal Metabolite.

PubMed

Ricciardi, M R; Licchetta, R; Mirabilii, S; Scarpari, M; Parroni, A; Fabbri, A A; Cescutti, P; Reverberi, M; Fanelli, C; Tafuri, A

2017-01-01

Despite improvements that occurred in the last decades in the acute myeloid leukemia (AML) treatment, clinical results are still unsatisfactory. More effective therapies are required, and innovative approaches are ongoing, including the discovery of novel antileukemia natural compounds. Several studies have described the activity of extracts from mushrooms which produce compounds that exhibited immunological and antitumor activities. The latter has been demonstrated to be promoted in vitro by mushroom polysaccharides via induction of apoptosis. However, the antileukemia activity of these compounds on primary cells is still not reported. In the present study, we examined the in vitro effects of Tramesan (TR), a bioactive compound extracted from Trametes versicolor , on leukemic cell lines and primary cells. Our results demonstrated that TR induced a marked growth inhibition of leukemic cell lines and primary cells from AML patients. The antiproliferative effects of TR were associated in primary AML cells with a significant increase of apoptosis. No significant cytotoxic effects were observed in normal peripheral blood mononuclear cells (MNC) from healthy donors. Our data demonstrated a cytotoxic activity of TR on leukemia cells prompting further translational applications. Ongoing studies are elucidating the molecular mechanisms underlying its antileukemic activity.

Preclinical Antileukemia Activity of Tramesan: A Newly Identified Bioactive Fungal Metabolite

PubMed Central

Scarpari, M.; Parroni, A.; Fabbri, A. A.; Cescutti, P.; Reverberi, M.; Fanelli, C.

2017-01-01

Despite improvements that occurred in the last decades in the acute myeloid leukemia (AML) treatment, clinical results are still unsatisfactory. More effective therapies are required, and innovative approaches are ongoing, including the discovery of novel antileukemia natural compounds. Several studies have described the activity of extracts from mushrooms which produce compounds that exhibited immunological and antitumor activities. The latter has been demonstrated to be promoted in vitro by mushroom polysaccharides via induction of apoptosis. However, the antileukemia activity of these compounds on primary cells is still not reported. In the present study, we examined the in vitro effects of Tramesan (TR), a bioactive compound extracted from Trametes versicolor, on leukemic cell lines and primary cells. Our results demonstrated that TR induced a marked growth inhibition of leukemic cell lines and primary cells from AML patients. The antiproliferative effects of TR were associated in primary AML cells with a significant increase of apoptosis. No significant cytotoxic effects were observed in normal peripheral blood mononuclear cells (MNC) from healthy donors. Our data demonstrated a cytotoxic activity of TR on leukemia cells prompting further translational applications. Ongoing studies are elucidating the molecular mechanisms underlying its antileukemic activity. PMID:29270245

The clinical application of genome-wide sequencing for monogenic diseases in Canada: Position Statement of the Canadian College of Medical Geneticists

PubMed Central

Boycott, Kym; Hartley, Taila; Adam, Shelin; Bernier, Francois; Chong, Karen; Fernandez, Bridget A; Friedman, Jan M; Geraghty, Michael T; Hume, Stacey; Knoppers, Bartha M; Laberge, Anne-Marie; Majewski, Jacek; Mendoza-Londono, Roberto; Meyn, M Stephen; Michaud, Jacques L; Nelson, Tanya N; Richer, Julie; Sadikovic, Bekim; Skidmore, David L; Stockley, Tracy; Taylor, Sherry; van Karnebeek, Clara; Zawati, Ma'n H; Lauzon, Julie; Armour, Christine M

2015-01-01

Purpose and scope The aim of this Position Statement is to provide recommendations for Canadian medical geneticists, clinical laboratory geneticists, genetic counsellors and other physicians regarding the use of genome-wide sequencing of germline DNA in the context of clinical genetic diagnosis. This statement has been developed to facilitate the clinical translation and development of best practices for clinical genome-wide sequencing for genetic diagnosis of monogenic diseases in Canada; it does not address the clinical application of this technology in other fields such as molecular investigation of cancer or for population screening of healthy individuals. Methods of statement development Two multidisciplinary groups consisting of medical geneticists, clinical laboratory geneticists, genetic counsellors, ethicists, lawyers and genetic researchers were assembled to review existing literature and guidelines on genome-wide sequencing for clinical genetic diagnosis in the context of monogenic diseases, and to make recommendations relevant to the Canadian context. The statement was circulated for comment to the Canadian College of Medical Geneticists (CCMG) membership-at-large and, following incorporation of feedback, approved by the CCMG Board of Directors. The CCMG is a Canadian organisation responsible for certifying medical geneticists and clinical laboratory geneticists, and for establishing professional and ethical standards for clinical genetics services in Canada. Results and conclusions Recommendations include (1) clinical genome-wide sequencing is an appropriate approach in the diagnostic assessment of a patient for whom there is suspicion of a significant monogenic disease that is associated with a high degree of genetic heterogeneity, or where specific genetic tests have failed to provide a diagnosis; (2) until the benefits of reporting incidental findings are established, we do not endorse the intentional clinical analysis of disease-associated genes other than those linked to the primary indication; and (3) clinicians should provide genetic counselling and obtain informed consent prior to undertaking clinical genome-wide sequencing. Counselling should include discussion of the limitations of testing, likelihood and implications of diagnosis and incidental findings, and the potential need for further analysis to facilitate clinical interpretation, including studies performed in a research setting. These recommendations will be routinely re-evaluated as knowledge of diagnostic and clinical utility of clinical genome-wide sequencing improves. While the document was developed to direct practice in Canada, the applicability of the statement is broader and will be of interest to clinicians and health jurisdictions internationally. PMID:25951830

The clinical application of genome-wide sequencing for monogenic diseases in Canada: Position Statement of the Canadian College of Medical Geneticists.

PubMed

Boycott, Kym; Hartley, Taila; Adam, Shelin; Bernier, Francois; Chong, Karen; Fernandez, Bridget A; Friedman, Jan M; Geraghty, Michael T; Hume, Stacey; Knoppers, Bartha M; Laberge, Anne-Marie; Majewski, Jacek; Mendoza-Londono, Roberto; Meyn, M Stephen; Michaud, Jacques L; Nelson, Tanya N; Richer, Julie; Sadikovic, Bekim; Skidmore, David L; Stockley, Tracy; Taylor, Sherry; van Karnebeek, Clara; Zawati, Ma'n H; Lauzon, Julie; Armour, Christine M

2015-07-01

The aim of this Position Statement is to provide recommendations for Canadian medical geneticists, clinical laboratory geneticists, genetic counsellors and other physicians regarding the use of genome-wide sequencing of germline DNA in the context of clinical genetic diagnosis. This statement has been developed to facilitate the clinical translation and development of best practices for clinical genome-wide sequencing for genetic diagnosis of monogenic diseases in Canada; it does not address the clinical application of this technology in other fields such as molecular investigation of cancer or for population screening of healthy individuals. Two multidisciplinary groups consisting of medical geneticists, clinical laboratory geneticists, genetic counsellors, ethicists, lawyers and genetic researchers were assembled to review existing literature and guidelines on genome-wide sequencing for clinical genetic diagnosis in the context of monogenic diseases, and to make recommendations relevant to the Canadian context. The statement was circulated for comment to the Canadian College of Medical Geneticists (CCMG) membership-at-large and, following incorporation of feedback, approved by the CCMG Board of Directors. The CCMG is a Canadian organisation responsible for certifying medical geneticists and clinical laboratory geneticists, and for establishing professional and ethical standards for clinical genetics services in Canada. Recommendations include (1) clinical genome-wide sequencing is an appropriate approach in the diagnostic assessment of a patient for whom there is suspicion of a significant monogenic disease that is associated with a high degree of genetic heterogeneity, or where specific genetic tests have failed to provide a diagnosis; (2) until the benefits of reporting incidental findings are established, we do not endorse the intentional clinical analysis of disease-associated genes other than those linked to the primary indication; and (3) clinicians should provide genetic counselling and obtain informed consent prior to undertaking clinical genome-wide sequencing. Counselling should include discussion of the limitations of testing, likelihood and implications of diagnosis and incidental findings, and the potential need for further analysis to facilitate clinical interpretation, including studies performed in a research setting. These recommendations will be routinely re-evaluated as knowledge of diagnostic and clinical utility of clinical genome-wide sequencing improves. While the document was developed to direct practice in Canada, the applicability of the statement is broader and will be of interest to clinicians and health jurisdictions internationally. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Clinical assessment and patient-reported outcome measures in low-back pain - a survey among primary health care physiotherapists.

PubMed

Östhols, Sara; Boström, Carina; Rasmussen-Barr, Eva

2018-05-09

We aimed to map the physiotherapy practice in Sweden of clinical tests and patient-reported outcome measures in low-back pain (LBP), and to study advantages and barriers in using patient-reported outcome measures. An online survey was mailed to 4934 physiotherapists in primary health care in Sweden. Multiple choice questions investigated the use of clinical tests and patient-reported outcome measures in assessing patients with LBP. Open questions investigating the advantages and barriers to the use of patient-reported outcome measures were analyzed with content analysis. The response rate was 25% (n = 1217). Clinical tests were used "always/often" by >60% of the participants, while most patient-reported outcome measures were used by <15%. Advantages in using patient-reported outcome measures were: the clinical reasoning process, to increase the quality of assessment, to get the patient's voice, education and motivation of patients, and communication with health professionals. Barriers were lack of time and knowledge, administrative aspects, the interaction between physiotherapist and patient and, the applicability and validity of the patient-reported outcome measures. Our findings show that physiotherapists working in primary health care use clinical testing in LBP to a great extent, while various patient-reported outcome measures are used to a low-to-very-low extent. Several barriers to the use of patient-reported outcome measures were reported such as time, knowledge, and administrative issues, while important findings on advantages were to enhance the clinical reasoning process and to educate and motivate the patient. Barriers might be changed through education or organizational change-work. To enhance the use of patient-reported outcome measures and thus person-centered care in low-back pain, recommendation, and education on various patient-reported outcome measures need to be advocated. Implications for rehabilitation To increase the effects of rehabilitation in low-back pain, yellow flags, and other factors need to be taken into the consideration in the assessment which means the use of patient-reported outcome measures in addition to clinical testing. The use of patient-reported outcome measures is an advantage in the clinical reasoning process to enhance the quality of assessment and to educate and motivate the patient. Barriers to use patient-reported outcome measures are mainly lack of time and knowledge, and administrative aspects. Through education or organizational change-work, barriers to the use of patient-reported outcome measures might be changed.

Comparison of mechanical and biological properties of zirconia and titanium alloy orthodontic micro-implants.

PubMed

Choi, Hae Won; Park, Young Seok; Chung, Shin Hye; Jung, Min Ho; Moon, Won; Rhee, Sang Hoon

2017-07-01

The aim of this study was to compare the initial stability as insertion and removal torque and the clinical applicability of novel orthodontic zirconia micro-implants made using a powder injection molding (PIM) technique with those parameters in conventional titanium micro-implants. Sixty zirconia and 60 titanium micro-implants of similar design (diameter, 1.6 mm; length, 8.0 mm) were inserted perpendicularly in solid polyurethane foam with varying densities of 20 pounds per cubic foot (pcf), 30 pcf, and 40 pcf. Primary stability was measured as maximum insertion torque (MIT) and maximum removal torque (MRT). To investigate clinical applicability, compressive and tensile forces were recorded at 0.01, 0.02, and 0.03 mm displacement of the implants at angles of 0°, 10°, 20°, 30°, and 40°. The biocompatibility of zirconia micro-implants was assessed via an experimental animal study. There were no statistically significant differences between zirconia micro-implants and titanium alloy implants with regard to MIT, MRT, or the amount of movement in the angulated lateral displacement test. As angulation increased, the mean compressive and tensile forces required to displace both types of micro-implants increased substantially at all distances. The average bone-to-implant contact ratio of prototype zirconia micro-implants was 56.88 ± 6.72%. Zirconia micro-implants showed initial stability and clinical applicability for diverse orthodontic treatments comparable to that of titanium micro-implants under compressive and tensile forces.

Magnetic resonance imaging of cervical carcinoma using an endorectal surface coil.

PubMed

Brocker, Kerstin A; Alt, Céline D; Gebauer, Gerhard; Sohn, Christof; Hallscheidt, Peter

2014-07-01

The objective of this trial is to investigate the diagnostic value of magnetic resonance imaging (MRI) with an endorectal surface coil for precise local staging of patients with histologically proven cervical cancer by comparing the radiological, clinical, and histological results. Women with cervical cancer were recruited for this trial between February 2007, and September 2010. All the patients were clinically staged according to the FIGO classification and underwent radiological staging by MRI that employed an endorectal surface coil. The staging results after surgery were compared to histopathology in all the operable patients. A total of 74 consecutive patients were included in the trial. Forty-four (59.5%) patients underwent primary surgery, whereas 30 (40.5%) patients were inoperable according to FIGO and underwent primary radiochemotherapy. The mean age of the patients was 50.6 years. In 11 out of the 44 patients concordant staging results were obtained by all three staging modalities. Thirty-two of the 44 patients were concordantly staged by FIGO and histopathological examination, while only 16 were concordantly staged by eMRI and histopathological examination. eMRI overstaged tumors in 14 cases and understaged them in 7 cases. eMRI is applicable in patients with cervical cancer, yet of no benefit than staging with FIGO or standard pelvic MRI. The most precise preoperative staging procedure still appears to be the clinical examination. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Long-term follow-up in optimally treated and stable heart failure patients: primary care vs. heart failure clinic. Results of the COACH-2 study.

PubMed

Luttik, Marie Louise A; Jaarsma, Tiny; van Geel, Peter Paul; Brons, Maaike; Hillege, Hans L; Hoes, Arno W; de Jong, Richard; Linssen, Gerard; Lok, Dirk J A; Berge, Marjolein; van Veldhuisen, Dirk J

2014-11-01

It has been suggested that home-based heart failure (HF) management in primary care may be an alternative to clinic-based management in HF patients. However, little is known about adherence to HF guidelines and adherence to the medication regimen in these home-based programmes. The aim of the current study was to determine whether long-term follow-up and treatment in primary care is equally effective as follow-up at a specialized HF clinic in terms of guideline adherence and patient adherence, in HF patients initially managed and up-titrated to optimal treatment at a specialized HF clinic. We conducted a multicentre, randomized, controlled study in 189 HF patients (62% male, age 72 ± 11 years), who were assigned to follow-up either in primary care (n = 97) or in a HF clinic (n = 92). After 12 months, no differences between guideline adherence, as estimated by the Guideline Adherence Indicator (GAI-3), and patient adherence, in terms of the medication possession ratio (MPR), were found between treatment groups. There was no difference in the number of deaths (n = 12 in primary care and n = 8 in the HF clinic; P = 0.48), and hospital readmissions for cardiovascular (CV) reasons were also similar. The total number of unplanned non-CV hospital readmissions, however, tended to be higher in the primary care group (n = 22) than in the HF clinic group (n = 10; P = 0.05). Patients discharged after initial management in a specialized HF clinic can be discharged to primary care for long-term follow-up with regard to maintaining guideline adherence and patient adherence. However, the complexity of the HF syndrome and its associated co-morbidities requires continuous monitoring. Close collaboration between healthcare providers will be crucial in order to provide HF patients with optimal, integrated care. © 2014 The Authors. European Journal of Heart Failure © 2014 European Society of Cardiology.

Health benefits of primary care social work for adults with complex health and social needs: a systematic review.

PubMed

McGregor, Jules; Mercer, Stewart W; Harris, Fiona M

2018-01-01

The prevalence of complex health and social needs in primary care patients is growing. Furthermore, recent research suggests that the impact of psychosocial distress on the significantly poorer health outcomes in this population may have been underestimated. The potential of social work in primary care settings has been extensively discussed in both health and social work literature and there is evidence that social work interventions in other settings are particularly effective in addressing psychosocial needs. However, the evidence base for specific improved health outcomes related to primary care social work is minimal. This review aimed to identify and synthesise the available evidence on the health benefits of social work interventions in primary care settings. Nine electronic databases were searched from 1990 to 2015 and seven primary research studies were retrieved. Due to the heterogeneity of studies, a narrative synthesis was conducted. Although there is no definitive evidence for effectiveness, results suggest a promising role for primary care social work interventions in improving health outcomes. These include subjective health measures and self-management of long-term conditions, reducing psychosocial morbidity and barriers to treatment and health maintenance. Although few rigorous study designs were found, the contextual detail and clinical settings of studies provide evidence of the practice applicability of social work intervention. Emerging policy on the integration of health and social care may provide an opportunity to develop this model of care. © 2016 John Wiley & Sons Ltd.

Spatial distribution of clinical computer systems in primary care in England in 2016 and implications for primary care electronic medical record databases: a cross-sectional population study.

PubMed

Kontopantelis, Evangelos; Stevens, Richard John; Helms, Peter J; Edwards, Duncan; Doran, Tim; Ashcroft, Darren M

2018-02-28

UK primary care databases (PCDs) are used by researchers worldwide to inform clinical practice. These databases have been primarily tied to single clinical computer systems, but little is known about the adoption of these systems by primary care practices or their geographical representativeness. We explore the spatial distribution of clinical computing systems and discuss the implications for the longevity and regional representativeness of these resources. Cross-sectional study. English primary care clinical computer systems. 7526 general practices in August 2016. Spatial mapping of family practices in England in 2016 by clinical computer system at two geographical levels, the lower Clinical Commissioning Group (CCG, 209 units) and the higher National Health Service regions (14 units). Data for practices included numbers of doctors, nurses and patients, and area deprivation. Of 7526 practices, Egton Medical Information Systems (EMIS) was used in 4199 (56%), SystmOne in 2552 (34%) and Vision in 636 (9%). Great regional variability was observed for all systems, with EMIS having a stronger presence in the West of England, London and the South; SystmOne in the East and some regions in the South; and Vision in London, the South, Greater Manchester and Birmingham. PCDs based on single clinical computer systems are geographically clustered in England. For example, Clinical Practice Research Datalink and The Health Improvement Network, the most popular primary care databases in terms of research outputs, are based on the Vision clinical computer system, used by <10% of practices and heavily concentrated in three major conurbations and the South. Researchers need to be aware of the analytical challenges posed by clustering, and barriers to accessing alternative PCDs need to be removed. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Understanding Clinic Practices for Human Papilloma Virus Vaccination Series Completion in Clinics That Provide Primary Care: Survey of Clinic Managers in Iowa.

PubMed

Askelson, Natoshia M; Edmonds, Stephanie W; Momany, Elizabeth T; Tegegne, Mesay A

2016-07-01

Rates for human papilloma virus (HPV) vaccination are low across the United States. Evidence-based-practices to increase immunization coverage have been recommended by public health organizations, yet many primary care clinics do not follow these practices. The purpose of this study was to examine if primary care clinics use these best practices to promote completion of the HPV vaccine series for their adolescent patients. Understanding the prevalence of evidence-based immunization strategies is key to increasing vaccination coverage. We mailed 914 surveys to clinic managers of clinics that provide primary care in Iowa. The survey content was based on immunization strategies related to clinic practice and policies that have been proven effective to promote the completion of the HPV vaccination series. Survey responses from 127 clinics were used in the final analysis. Most clinics always used the state's immunization information system to record HPV vaccinations (89.4%). Over a quarter of clinics (27.6%) did not use any type of reminder or recall system to alert parents or providers that an HPV vaccine was due, and 35.0% did not give the vaccine at sick visits. Clinics need to focus more on the recommended logistics and processes to ensure that patients receive the entire HPV vaccination series. Survey results indicate that clinics are not consistently implementing the recommended best practices to ensure that vaccination series are completed.

Midwifery education roundtable discussion: transitions to the workplace.

PubMed

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

2002-01-01

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

The Limits of Informed Consent for an Overwhelmed Patient: Clinicians' Role in Protecting Patients and Preventing Overwhelm.

PubMed

Bester, Johan; Cole, Cristie M; Kodish, Eric

2016-09-01

In this paper, we examine the limits of informed consent with particular focus on ways in which various factors can overwhelm decision-making capacity. We introduce overwhelm as a phenomenon commonly experienced by patients in clinical settings and distinguish between emotional overwhelm and informational overload. We argue that in these situations, a clinician's primary duty is prevention of harm and suggest ways in which clinicians can discharge this obligation. To illustrate our argument, we consider the clinical application of genetic sequencing testing, which involves scientific and technical information that can compromise the understanding and decisional capacity of most patients. Finally, we consider and rebut objections that this could lead to paternalism. © 2016 American Medical Association. All Rights Reserved.

[Advantages and disadvantages of composite tissue allotransplantation].

PubMed

Yang, Yang; Lu, Binglun; Zhang, Hui; Xia, Wei; Yi, Chenggang; Guo, Shuzhong

2009-12-01

To review the research progress of composite tissue allotransplantation (CTA), analyze the superiority and the inferiority, and inform the possible direction of further research. Literature concerning CTA was reviewed and analyzed in terms of the limits of conventional reparative and reconstructive surgery, the definition of CTA, potential advantages, and treatment risks. The clinical research of CTA both at home and abroad proved that the therapeutic effect of CTA was better than that of conventional reparative and reconstructive surgery. However, the risks resulting from immunosuppressive therapy were still the primary factors restraining the wide clinical application of CTA. The development of immunosuppressive therapy explores a great development potential for the CTA, and how to decrease the treatment risk of immunosuppressive therapy will be the main research direction in the field of CTA.

Interactive web-based learning modules prior to general medicine advanced pharmacy practice experiences.

PubMed

Isaacs, Alex N; Walton, Alison M; Nisly, Sarah A

2015-04-25

To implement and evaluate interactive web-based learning modules prior to advanced pharmacy practice experiences (APPEs) on inpatient general medicine. Three clinical web-based learning modules were developed for use prior to APPEs in 4 health care systems. The aim of the interactive modules was to strengthen baseline clinical knowledge before the APPE to enable the application of learned material through the delivery of patient care. For the primary endpoint, postassessment scores increased overall and for each individual module compared to preassessment scores. Postassessment scores were similar among the health care systems. The survey demonstrated positive student perceptions of this learning experience. Prior to inpatient general medicine APPEs, web-based learning enabled the standardization and assessment of baseline student knowledge across 4 health care systems.

Biomechanical and bioactivity concepts of polyetheretherketone composites for use in orthopedic implants-a review.

PubMed

Abdullah, Mohamed Ruslan; Goharian, Amirhossein; Abdul Kadir, Mohammed Rafiq; Wahit, Mat Uzir

2015-11-01

The use of polyetheretherketone (PEEK) composites in the trauma plating system, total replacement implants, and tissue scaffolds has found great interest among researchers. In recent years (2008 afterward), this type of composites has been examined for suitability as substitute material over stainless steel, titanium alloys, ultra high molecular weight polyethylene, or even biodegradable materials in orthopedic implant applications. Biomechanical and bioactivity concepts were contemplated for the development of PEEK orthopedic implants and a few primary clinical studies reported the clinical outcomes of PEEK-based orthopedic implants. This study aims to review and discuss the recent concepts and contribute further concepts in terms of biomechanical and bioactivity challenges for the development of PEEK and PEEK composites in orthopedic implants. © 2015 Wiley Periodicals, Inc.

Attachment-Based Family Therapy With a 13-Year-Old Girl Presenting With High Risk for Suicide.

PubMed

Krauthamer Ewing, E Stephanie; Levy, Suzanne A; Boamah-Wiafe, Linda; Kobak, Roger; Diamond, Guy

2016-01-01

This article describes the application of Attachment-Based Family Therapy (ABFT) to the treatment of a 13-year-old female adolescent presenting with high risk of suicide, complicated by a history of depression and sexual trauma. The article begins with an overview of ABFT, including (a) how attachment theory guides treatment; (b) the structure of the clinical model; and (c) the data that provide empirical support. A case example is then presented that exemplifies the primary clinical procedures used to reach therapeutic goals in ABFT, including attachment repair and autonomy/competence promotion. Weekly changes in suicide ideation and depression scores are presented. The article concludes with a discussion about implications for family-based treatment of suicidal youth. © 2015 American Association for Marriage and Family Therapy.

Adoptive cell therapy: genetic modification to redirect effector cell specificity.

PubMed

Morgan, Richard A; Dudley, Mark E; Rosenberg, Steven A

2010-01-01

Building on the principals that the adoptive transfer of T cells can lead to the regression of established tumors in humans, investigators are now further manipulating these cells using genetic engineering. Two decades of human gene transfer experiments have resulted in the translation of laboratory technology into robust clinical applications. The purpose of this review is to give the reader an introduction to the 2 major approaches being developed to redirect effector T-cell specificity. Primary human T cells can be engineered to express exogenous T-cell receptors or chimeric antigen receptors directed against multiple human tumor antigens. Initial clinical trial results have demonstrated that both T-cell receptor- and chimeric antigen receptor-engineered T cells can be administered to cancer patients and mediate tumor regression.

Advanced Practice Pharmacists: a retrospective evaluation of the efficacy and cost of ClinicaL Pharmacist PractitionErs managing ambulatory Medicare patients in North Carolina (APPLE-NC).

PubMed

Kislan, Michèle M; Bernstein, Adam T; Fearrington, Loretta R; Ives, Timothy J

2016-10-21

Clinical Pharmacist Practitioners are advanced practicing pharmacists in North Carolina that provide disease-specific management. The purpose of this retrospective cohort study was to compare the efficacy and charges from referrals to a Clinical Pharmacist Practitioner by the primary care provider, to those managed by a primary care provider alone. Patients were separated into cohorts depending if they had at least two appointments with a Clinical Pharmacist Practitioner from November 2008 to November 2011. A primary care provider saw all patients at least twice during the study period. Cohorts were then matched by age, gender, and disease states. Medicare billed data was evaluated from outpatient visits related to hypertension, diabetes mellitus, and peripheral neuropathy, as well as emergency department visits and inpatient admissions. Cost of medications was estimated using 2009 AWP data corresponding to medication histories within the electronic medical record. Efficacy was defined as ability to reach disease state goal determined using national guidelines and reduction in pain score. Efficacy was analyzed by difference-in-differences test and all other numerical data tested by paired t-tests. The Clinical Pharmacist Practitioners cohort experienced more outpatient visits (1338 vs. 858, p < 0.001), fewer emergency department visits (115 vs. 190, p < 0.05), and similar inpatient admissions (88 vs. 117, p > 0.05) than the primary care providers cohort, respectively. The Clinical Pharmacist Practitioners cohort showed changes in charges of +22.6 % for outpatient visits, -45.5 % emergency department visits, and -13.2 % inpatient admissions relative to the primary care provider cohort. There was no difference in average daily medication cost (Clinical Pharmacist Practitioners $38.52 vs. primary care providers $38.23, p = 0.97) or achievement of disease state goals. APPLE-NC demonstrated that through referrals, Clinical Pharmacist Practitioners provide services comparable in charges and efficacy to primary care providers. Consequently, the current increased need for primary care practitioners can be met in part by increasing the utilization of advanced practice pharmacists for chronic disease management. This does not apply for this retrospective cohort study.

Comparison of depression symptoms between primary depression and secondary-to-schizophrenia depression.

PubMed

Rahim, Twana; Rashid, Roshe

2017-11-01

This study exclusively aimed to clinically assess which symptom pattern discriminates primary depression from depression-secondary to-schizophrenia. A total of 98 patients with primary depression and 71 patients with secondary-to-schizophrenia depression were assessed for identifying the clinical phenomena of depression. Diagnosis of schizophrenia was confirmed by Mini International Neuropsychiatric Interview. Each participant was, however, assessed by Patient Health Questionnaire-9 as well as Calgary Depression Scale for Schizophrenia (CDSS) for possible concurrent depressive symptoms. Depressed mood, loss of interest, reduced energy and pathological guilt were more common in primary depression, whereas sleep disturbance and guilty ideas of reference were more amounting towards the diagnosis of depression secondary-to-schizophrenia. It is clinically hard to differentiate primary from secondary-to-schizophrenia depression, especially in the absence of obvious psychotic symptoms. However, the classical symptoms of depression like subjective depressed mood, anhedonia, reduced energy and pathological guilt are more prominent in the primary depression.

Pilot Study of Implementation of an Internet-Based Depression Prevention Intervention (CATCH-IT) for Adolescents in 12 US Primary Care Practices: Clinical and Management/Organizational Behavioral Perspectives

PubMed Central

Eisen, Jeffrey C.; Marko-Holguin, Monika; Fogel, Joshua; Cardenas, Alonso; Bahn, My; Bradford, Nathan; Fagan, Blake; Wiedmann, Peggy

2013-01-01

Objective: To explore the implementation of CATCH-IT (Competent Adulthood Transition with Cognitive-behavioral Humanistic and Interpersonal Training), an Internet-based depression intervention program in 12 primary care sites, occurring as part of a randomized clinical trial comparing 2 versions of the intervention (motivational interview + Internet program versus brief advice + Internet program) in 83 adolescents aged 14 to 21 years recruited from February 1, 2007, to November 31, 2007. Method: The CATCH-IT intervention model consists of primary care screening to assess risk, a primary care physician interview to encourage participation, and 14 online modules of Internet training to teach adolescents how to reduce behaviors that increase vulnerability to depressive disorders. Specifically, we evaluated this program from both a management/organizational behavioral perspective (provider attitudes and demonstrated competence) and a clinical outcomes perspective (depressed mood scores) using the RE-AIM model (Reach, Efficacy, Adoption, Implementation, and Maintenance of the intervention). Results: While results varied by clinic, overall, clinics demonstrated satisfactory reach, efficacy, adoption, implementation, and maintenance of the CATCH-IT depression prevention program. Measures of program implementation and management predicted clinical outcomes at practices in exploratory analyses. Conclusion: Multidisciplinary approaches may be essential to evaluating the impact of complex interventions to prevent depression in community settings. Primary care physicians and nurses can use Internet-based programs to create a feasible and cost-effective model for the prevention of mental disorders in adolescents in primary care settings. Trial Registration: ClinicalTrials.gov identifiers: NCT00152529 and NCT00145912 PMID:24800110

Pilot Study of Implementation of an Internet-Based Depression Prevention Intervention (CATCH-IT) for Adolescents in 12 US Primary Care Practices: Clinical and Management/Organizational Behavioral Perspectives.

PubMed

Eisen, Jeffrey C; Marko-Holguin, Monika; Fogel, Joshua; Cardenas, Alonso; Bahn, My; Bradford, Nathan; Fagan, Blake; Wiedmann, Peggy; Van Voorhees, Benjamin W

2013-01-01

To explore the implementation of CATCH-IT (Competent Adulthood Transition with Cognitive-behavioral Humanistic and Interpersonal Training), an Internet-based depression intervention program in 12 primary care sites, occurring as part of a randomized clinical trial comparing 2 versions of the intervention (motivational interview + Internet program versus brief advice + Internet program) in 83 adolescents aged 14 to 21 years recruited from February 1, 2007, to November 31, 2007. The CATCH-IT intervention model consists of primary care screening to assess risk, a primary care physician interview to encourage participation, and 14 online modules of Internet training to teach adolescents how to reduce behaviors that increase vulnerability to depressive disorders. Specifically, we evaluated this program from both a management/organizational behavioral perspective (provider attitudes and demonstrated competence) and a clinical outcomes perspective (depressed mood scores) using the RE-AIM model (Reach, Efficacy, Adoption, Implementation, and Maintenance of the intervention). While results varied by clinic, overall, clinics demonstrated satisfactory reach, efficacy, adoption, implementation, and maintenance of the CATCH-IT depression prevention program. Measures of program implementation and management predicted clinical outcomes at practices in exploratory analyses. Multidisciplinary approaches may be essential to evaluating the impact of complex interventions to prevent depression in community settings. Primary care physicians and nurses can use Internet-based programs to create a feasible and cost-effective model for the prevention of mental disorders in adolescents in primary care settings. ClinicalTrials.gov identifiers: NCT00152529 and NCT00145912.

A scoping review of adult chronic kidney disease clinical pathways for primary care.

PubMed

Elliott, Meghan J; Gil, Sarah; Hemmelgarn, Brenda R; Manns, Braden J; Tonelli, Marcello; Jun, Min; Donald, Maoliosa

2017-05-01

Chronic kidney disease (CKD) affects ∼10% of the adult population. The majority of patients with CKD are managed by primary care physicians, and despite the availability of effective treatment options, the use of evidence-based interventions for CKD in this setting remains suboptimal. Clinical pathways have been identified as effective tools to guide primary care physicians in providing evidence-based care. We aimed to describe the availability, characteristics and credibility of clinical pathways for adult CKD using a scoping review methodology. We searched Medline, Embase, CINAHL and targeted Internet sites from inception to 31 October 2014 to identify studies and resources that identified adult CKD clinical pathways for primary care settings. Study selection and data extraction were independently performed by two reviewers. From 487 citations, 41 items were eligible for review: 7 published articles and 34 grey literature resources published between 2001 and 2014. Of the 41 clinical pathways, 32, 24 and 22% were from the UK, USA and Canada, respectively. The majority (66%, n = 31) of clinical pathways were static in nature (did not have an online interactive feature). The majority (76%) of articles/resources reported using one or more clinical practice guidelines as a resource to guide the clinical pathway content. Few articles described a dissemination and evaluation plan for the clinical pathway, but most reported the targeted end-users. Our scoping review synthesized available literature on CKD clinical pathways in the primary care setting. We found that existing clinical pathways are diverse in their design, content and implementation. These results can be used by researchers developing or testing new or existing clinical pathways and by practitioners and health system stakeholders who aim to implement CKD clinical pathways in clinical practice. © The Author 2016. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

RECODE: design and baseline results of a cluster randomized trial on cost-effectiveness of integrated COPD management in primary care.

PubMed

Kruis, Annemarije L; Boland, Melinde R S; Schoonvelde, Catharina H; Assendelft, Willem J J; Rutten-van Mölken, Maureen P M H; Gussekloo, Jacobijn; Tsiachristas, Apostolos; Chavannes, Niels H

2013-03-23

Favorable effects of formal pulmonary rehabilitation in selected moderate to severe COPD patients are well established. Few data are available on the effects and costs of integrated disease management (IDM) programs on quality of care and health status of COPD patients in primary care, representing a much larger group of COPD patients. Therefore, the RECODE trial assesses the long-term clinical and cost-effectiveness of IDM in primary care. RECODE is a cluster randomized trial with two years of follow-up, during which 40 clusters of primary care teams (including 1086 COPD patients) are randomized to IDM or usual care. The intervention started with a 2-day multidisciplinary course in which healthcare providers are trained as a team in essential components of effective COPD IDM in primary care. During the course, the team redesigns the care process and defines responsibilities of different caregivers. They are trained in how to use feedback on process and outcome data to guide implement guideline-driven integrated healthcare. Practice-tailored feedback reports are provided at baseline, and at 6 and 12 months. The team learns the details of an ICT program that supports recording of process and outcome measures. Afterwards, the team designs a time-contingent individual practice plan, agreeing on steps to be taken in order to integrate a COPD IDM program into daily practice. After 6 and 12 months, there is a refresher course for all teams simultaneously to enable them to learn from each other's experience. Health status of patients at 12 months is the primary outcome, measured by the Clinical COPD Questionnaire (CCQ). Secondary outcomes include effects on quality of care, disease-specific and generic health-related quality of life, COPD exacerbations, dyspnea, costs of healthcare utilization, and productivity loss. This article presents the protocol and baseline results of the RECODE trial. This study will allow to evaluate whether IDM implemented in primary care can positively influence quality of life and quality of care in mild to moderate COPD patients, thereby making the benefits of multidisciplinary rehabilitation applicable to a substantial part of the COPD population. Netherlands Trial Register (NTR): NTR2268.

Evaluation of a multicomponent programme for the management of musculoskeletal pain and depression in primary care: a cluster-randomised clinical trial (the DROP study).

PubMed

Aragonès, Enric; López-Cortacans, Germán; Caballero, Antonia; Piñol, Josep Ll; Sánchez-Rodríguez, Elisabet; Rambla, Concepció; Tomé-Pires, Catarina; Miró, Jordi

2016-03-16

Chronic musculoskeletal pain and depression are very common in primary care patients. Furthermore, they often appear as comorbid conditions, resulting in additive effect on adverse health outcomes. On the basis of previous studies, we hypothesise that depression and chronic musculoskeletal pain may benefit from an integrated management programme at primary care level. We expect positive effects on both physical and psychological distress of patients. To determine whether a new programme for an integrated approach to chronic musculoskeletal pain and depression leads to better outcomes than usual care. Cluster-randomised controlled trial involving two arms: a) control arm (usual care); and b) intervention arm, where patients participate in a programme for an integrated approach to the pain-depression dyad. Primary care centres in the province of Tarragona, Catalonia, Spain, Participants: We will recruit 330 patients aged 18-80 with moderate or severe musculoskeletal pain (Brief Pain Inventory, average pain subscale ≥5) for at least 3 months, and with criteria for major depression (DSM-IV). A multicomponent programme according to the chronic care model. The main components are care management, optimised antidepressant treatment, and a psychoeducational group action. Blind measurements: The patients will be monitored through blind telephone interviews held at 0, 3, 6 and 12 months. Severity of pain and depressive symptoms, pain and depression treatment response rates, and depression remission rates. The outcomes will be analysed on an intent-to-treat basis and the analysis units will be the individual patients. This analysis will consider the effect of the study design on any potential lack of independence between observations made within the same cluster. The protocol was approved by the Research Ethics Committee of the Jordi Gol Primary Care Research Institute (IDIAP), Barcelona, (P14/142). This project strengthens and improves treatment approaches for a major comorbidity in primary care. The design of the intervention takes into account its applicability under typical primary care conditions, so that if the programme is found to be effective it will be feasible to apply it in a generalised manner. ClinicalTrials.gov: NCT02605278 ; Registered 28 September, 2015.

40 CFR 421.180 - Applicability: Description of the primary and secondary germanium and gallium subcategory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... primary and secondary germanium and gallium subcategory. 421.180 Section 421.180 Protection of Environment... POINT SOURCE CATEGORY Primary and Secondary Germanium and Gallium Subcategory § 421.180 Applicability: Description of the primary and secondary germanium and gallium subcategory. The provisions of this subpart are...

40 CFR 421.180 - Applicability: Description of the primary and secondary germanium and gallium subcategory.

Code of Federal Regulations, 2011 CFR

2011-07-01

... primary and secondary germanium and gallium subcategory. 421.180 Section 421.180 Protection of Environment... POINT SOURCE CATEGORY Primary and Secondary Germanium and Gallium Subcategory § 421.180 Applicability: Description of the primary and secondary germanium and gallium subcategory. The provisions of this subpart are...

40 CFR 421.180 - Applicability: Description of the primary and secondary germanium and gallium subcategory.

Code of Federal Regulations, 2014 CFR

2014-07-01

... primary and secondary germanium and gallium subcategory. 421.180 Section 421.180 Protection of Environment... POINT SOURCE CATEGORY Primary and Secondary Germanium and Gallium Subcategory § 421.180 Applicability: Description of the primary and secondary germanium and gallium subcategory. The provisions of this subpart are...

40 CFR 421.180 - Applicability: Description of the primary and secondary germanium and gallium subcategory.

Code of Federal Regulations, 2012 CFR

2012-07-01

... primary and secondary germanium and gallium subcategory. 421.180 Section 421.180 Protection of Environment... POINT SOURCE CATEGORY Primary and Secondary Germanium and Gallium Subcategory § 421.180 Applicability: Description of the primary and secondary germanium and gallium subcategory. The provisions of this subpart are...

40 CFR 421.180 - Applicability: Description of the primary and secondary germanium and gallium subcategory.

Code of Federal Regulations, 2013 CFR

2013-07-01

... primary and secondary germanium and gallium subcategory. 421.180 Section 421.180 Protection of Environment... POINT SOURCE CATEGORY Primary and Secondary Germanium and Gallium Subcategory § 421.180 Applicability: Description of the primary and secondary germanium and gallium subcategory. The provisions of this subpart are...

The current status and clinical value of circulating tumor cells and circulating cell-free tumor DNA in bladder cancer

PubMed Central

Soave, Armin; Rink, Michael

2017-01-01

Urothelial carcinoma of the bladder (UCB) is a complex disease, which is associated with highly aggressive tumor biologic behavior, especially in patients with muscle-invasive and advanced tumors. Despite multimodal therapy options including surgery, radiotherapy and chemotherapy, UCB patients frequently suffer from poor clinical outcome. Indeed, the potential of diverse opportunities for modern targeted therapies is not sufficiently elucidated in UCB yet. To improve the suboptimal treatment situation in UCB, biomarkers are urgently needed that help detecting minimal residual disease (MRD), predicting therapy response and subsequently prognosis as well as enabling patient stratification for further therapies and therapy monitoring, respectively. To date, decision making regarding treatment planning is mainly based on histopathologic evaluation of biopsies predominantly derived from the primary tumors and on clinical staging. However, both methods are imperfect for sufficient outcome prediction. During disease progression, individual disseminated tumor cells and consecutively metastases can acquire characteristics that do not match those of the corresponding primary tumors, and often are only hardly assessable for further evaluation. Therefore, during recent years, strong efforts were directed to establish non-invasive biomarkers from liquid biopsies. Urine cytology and serum tumor markers have been established for diagnostic purposes, but are still insufficient as universal biomarkers for decision-making and treatment of UCB patients. To date, the clinical relevance of various newly established blood-based biomarkers comprising circulating tumor cells (CTCs), circulating cell-free nucleic acids or tumor-educated platelets is being tested in cancer patients. In this review we summarize the current state and clinical application of CTCs and circulating cell-free tumor DNA originating from blood as biomarkers in patients with different UCB stages. PMID:29354496

[Determination of irreversibility of clinical brain death. Electroencephalography and evoked potentials].

PubMed

Buchner, H; Ferbert, A

2016-02-01

Principally, in the fourth update of the rules for the procedure to finally determine the irreversible cessation of function of the cerebrum, the cerebellum and the brainstem, the importance of an electroencephalogram (EEG), somatosensory evoked potentials (SEP) and brainstem auditory evoked potentials (BAEP) are confirmed. This paper presents the reliability and validity of the electrophysiological diagnosis, discusses the amendments in the fourth version of the guidelines and introduces the practical application, problems and sources of error.An EEG is the best established supplementary diagnostic method for determining the irreversibility of clinical brain death syndrome. It should be noted that residual brain activity can often persist for many hours after the onset of brain death syndrome, particularly in patients with primary brainstem lesions. The derivation and analysis of an EEG requires a high level of expertise to be able to safely distinguish artefacts from primary brain activity. The registration of EEGs to demonstrate the irreversibility of clinical brain death syndrome is extremely time consuming.The BAEPs can only be used to confirm the irreversibility of brain death syndrome in serial examinations or in the rare cases of a sustained wave I or sustained waves I and II. Very often, an investigation cannot be reliably performed because of existing sound conduction disturbances or failure of all potentials even before the onset of clinical brain death syndrome. This explains why BAEPs are only used in exceptional cases.The SEPs of the median nerve can be very reliably derived, are technically simple and with few sources of error. A serial investigation is not required and the time needed for examination is short. For these reasons SEPs are given preference over EEGs and BAEPs for establishing the irreversibility of clinical brain death syndrome.

Evolution of a Multidisciplinary Clinical Pathway for the Management of Unstable Patients With Pelvic Fractures

PubMed Central

Biffl, Walter L.; Smith, Wade R.; Moore, Ernest E.; Gonzalez, Ricardo J.; Morgan, Steven J.; Hennessey, Theresa; Offner, Patrick J.; Ray, Charles E.; Franciose, Reginald J.; Burch, Jon M.

2001-01-01

Objective To determine whether the evolution of the authors’ clinical pathway for the treatment of hemodynamically compromised patients with pelvic fractures was associated with improved patient outcome. Summary Background Data Hemodynamically compromised patients with pelvic fractures present a complex challenge. The multidisciplinary trauma team must control hemorrhage, restore hemodynamics, and rapidly identify and treat associated life-threatening injuries. The authors developed a clinical pathway consisting of five primary elements: immediate trauma attending surgeon’s presence in the emergency department, early simultaneous transfusion of blood and coagulation factors, prompt diagnosis and management of associated life-threatening injuries, stabilization of the pelvic girdle, and timely insinuation of pelvic angiography and embolization. The addition of two orthopedic pelvic fracture specialists led to a revision of the pathway, emphasizing immediate emergency department presence of the orthopedic trauma attending to provide joint decision making with the trauma surgeon, closing the pelvic volume in the emergency department, and using alternatives to traditional external fixation devices. Methods Using trauma registry and blood bank records, the authors identified pelvic fracture patients receiving blood transfusions in the emergency department. They analyzed patients treated before versus after the May 1998 revision of the clinical pathway. Results A higher proportion of patients in the late period had blood pressure less than 90 mmHg (52% vs. 35%). In the late period, diagnostic peritoneal lavage was phased out in favor of torso ultrasound as a primary triage tool, and pelvic binding and C-clamp application largely replaced traditional external fixation devices. The overall death rate decreased from 31% in the early period to 15% in the later period, as did the rate of deaths from exsanguination (9% to 1%), multiple organ failure (12% to 1%), and death within 24 hours (16% to 5%). Conclusions The evolution of a multidisciplinary clinical pathway, coordinating the resources of a level 1 trauma center and directed by joint decision making between trauma surgeons and orthopedic traumatologists, has resulted in improved patient survival. The primary benefits appear to be in reducing early deaths from exsanguination and late deaths from multiple organ failure. PMID:11407336

Toward a Unified Integration Approach: Uniting Diverse Primary Care Strategies Under the Primary Care Behavioral Health (PCBH) Model.

PubMed

Sandoval, Brian E; Bell, Jennifer; Khatri, Parinda; Robinson, Patricia J

2018-06-01

Primary care continues to be at the center of health care transformation. The Primary Care Behavioral Health (PCBH) model of service delivery includes patient-centered care delivery strategies that can improve clinical outcomes, cost, and patient and primary care provider satisfaction with services. This article reviews the link between the PCBH model of service delivery and health care services quality improvement, and provides guidance for initiating PCBH model clinical pathways for patients facing depression, chronic pain, alcohol misuse, obesity, insomnia, and social barriers to health.

Utility of the Roche Cobas 4800 for detection of high-risk human papillomavirus in formalin-fixed paraffin-embedded oropharyngeal squamous cell carcinoma.

PubMed

Pettus, Jason R; Wilson, Terri L; Steinmetz, Heather B; Lefferts, Joel A; Tafe, Laura J

2017-02-01

Clinical laboratories are expected to reliably identify human papilloma virus (HPV) associated oropharyngeal squamous cell carcinoma (OPSCC) for prognostic and potential therapeutic applications. In addition to surrogate p16 immunohistochemistry (IHC) testing, DNA-based HPV-specific testing strategies are widely utilized. Recognizing the efficiency of the Roche Cobas 4800 platform for testing gynecological cytology specimens for high-risk HPV, we elected to evaluate the potential utility of this platform for testing formalin-fixed paraffin-embedded (FFPE) OPSCC tissue. Using the Roche Linear Array assay for comparison, we tested twenty-eight samples (16 primary OPSCC, 2 lymph node metastases from primary OPSCC, 1 oral tongue carcinoma, 3 benign squamous papillomas, and 3 non-oropharyngeal carcinoma tissues). Excluding two invalid results, the Roche Cobas 4800 testing resulted in excellent inter-assay concordance (25/26, 96.2%) and 100% concordance for HPV-16/HPV-18 positive samples. This data suggests that the Roche Cobas 4800 platform may be a cost-effective method for testing OPSCC FFPE tissues in a clinical molecular pathology laboratory setting. Copyright © 2016 Elsevier Inc. All rights reserved.

Risk stratification in autoimmune cholestatic liver diseases: Opportunities for clinicians and trialists

PubMed Central

Trivedi, Palak J.; Corpechot, Christophe; Pares, Albert

2015-01-01

Primary biliary cirrhosis (PBC) and primary sclerosing cholangitis (PSC) are infrequent autoimmune cholestatic liver diseases, that disproportionate to their incidence and prevalence, remain very important causes of morbidity and mortality for patients with liver disease. Mechanistic insights spanning genetic risks and biological pathways to liver injury and fibrosis have led to a renewed interest in developing therapies beyond ursodeoxycholic acid that are aimed at both slowing disease course and improving quality of life. International cohort studies have facilitated a much greater understanding of disease heterogeneity, and in so doing highlight the opportunity to provide patients with a more individualized assessment of their risk of progressive liver disease, based on clinical, laboratory, or imaging findings. This has led to a new approach to patient care that focuses on risk stratification (both high and low risk); and furthermore allows such stratification tools to help identify patient subgroups at greatest potential benefit from inclusion in clinical trials. In this article, we review the applicability and validity of risk stratification in autoimmune cholestatic liver disease, highlighting strengths and weaknesses of current and emergent approaches. (Hepatology 2016;63:644–659) PMID:26290473

Indications for laboratory tests in primary care: assessment of the most frequent indications and requests with blank clinical information

PubMed Central

Salinas, Maria; López-Garrigós, Maite; Flores, Emilio; Leiva-Salinas, Maria; Esteban, Patricia; Ahumada, Miguel; Leiva-Salinas, Carlos

2016-01-01

Introduction The aim of this work is twofold. Firstly, to study the temporal evolution in the number of laboratory requests from primary care without clinical indication, and to analyse the number of such requests before and after the implementation of an automated requesting procedure. Secondly, to investigate what are the most frequent clinical indications that prompted laboratory testing. Materials and methods This is a retrospective observational study conducted from January 2009 to December 2015. We counted the requests without clinical question, calculated the number of such requests per total number of requests and listed the most frequent indications. Results The number of tests requests with a blank clinical indication was significantly higher in 2009 when compared to 2015 (80% vs. 20%; P < 0.001). For every year in this 7-year period, dyslipidemia, essential hypertension and diabetes were the most prevalent diagnoses that prompted a laboratory test in primary care, accounting for more than 20% of all indications. Conclusions The number of primary care requests without patient clinical question has decreased after the implementation of an automated requesting procedure. Disorders of lipid metabolism, essential hypertension and diabetes mellitus were the most prevalent diagnoses that prompted a laboratory test in primary care. PMID:27812310

Improving scar quality: a prospective clinical study.

PubMed

Atiyeh, Bishara S; Ioannovich, John; Al-Amm, Christian A; El-Musa, Kusai A; Dham, Ruwayda

2002-01-01

Following traumatic or surgical injury to the skin, wounds do not heal by tissue regeneration but rather by scar formation. Though healing is definitely a welcomed event, the resultant scar, very often, is not aesthetically pleasing, and not infrequently, may be pathologic causing serious deformities and contractures. Management of problematic scars continues to be a frustrating endeavor with less than optimal results. Prophylactic methods of wound management to minimize serious scarring are being developed. In a previously published study, we have demonstrated improved healing of split thickness skin graft donor sites following treatment with Moist Exposed Burn Ointment (MEBO, Julphar Gulf Pharmaceutical Industries, Ras Al-Khaimah, UAE). At present, we are reporting the results of a comparative clinical prospective study evaluating scar quality following primary healing of elective surgical and traumatic facial wounds with prophylactic MEBO application, topical antibiotic ointment application, and no topical therapy at all. Scars were evaluated according to the Visual Analogue Scale for scar assessment. Statistical analysis of scar assessment scores demonstrated marked prevention of unfavorable scars with improved cosmetic results following MEBO prophylactic therapy.

Enrollment success in state children's health insurance program after free clinic referral.

PubMed

Brown, Ann-Marie; Glazer, Greer

2004-01-01

More than 11 million children remain uninsured and receive no primary health care despite the advent of the State Children's Health Insurance Program (S-CHIP). The purpose of this pilot study was to evaluate whether each child in a northeast Ohio county free pediatric clinic is referred to S-CHIP and whether the enrollment process is successful. A record review was done to evaluate documentation indicating that such a referral was made. A phone call was made to each family for whom there was no evidence of application to S-CHIP. Twenty-eight referrals to Ohio's S-CHIP were documented (60%). Only 12% of families submitted an application to S-CHIP. Ten parents agreed to share their reasons for nonsubmission, the most common reason being that they thought their household income too high, followed by they did not think the program was needed. The mere existence of or referral to such a program is not adequate to ensure utilization of health care resources. Recommendations are made to increase enrollment and access to health care for low-income children.

High-Resolution Microscopy-Coil MR Imaging of Skin Tumors: Techniques and Novel Clinical Applications.

PubMed

Budak, Matthew J; Weir-McCall, Jonathan R; Yeap, Phey M; White, Richard D; Waugh, Shelley A; Sudarshan, Thiru A P; Zealley, Ian A

2015-01-01

High-resolution magnetic resonance (MR) imaging performed with a microscopy coil is a robust radiologic tool for the evaluation of skin lesions. Microscopy-coil MR imaging uses a small surface coil and a 1.5-T or higher MR imaging system. Simple T1- and T2-weighted imaging protocols can be implemented to yield high-quality, high-spatial-resolution images that provide an excellent depiction of dermal anatomy. The primary application of microscopy-coil MR imaging is to delineate the deep margins of skin tumors, thereby providing a preoperative road map for dermatologic surgeons. This information is particularly useful for surgeons who perform Mohs micrographic surgery and in cases of nasofacial neoplasms, where the underlying anatomy is complex. Basal cell carcinoma is the most common nonmelanocytic skin tumor and has a predilection to manifest on the face, where it can be challenging to achieve complete surgical excision while preserving the cosmetic dignity of the patient. Microscopy-coil MR imaging provides dermatologic surgeons with valuable preoperative anatomic information that is not available at conventional clinical examination. ©RSNA, 2015.

Photonic crystals: emerging biosensors and their promise for point-of-care applications.

PubMed

Inan, Hakan; Poyraz, Muhammet; Inci, Fatih; Lifson, Mark A; Baday, Murat; Cunningham, Brian T; Demirci, Utkan

2017-01-23

Biosensors are extensively employed for diagnosing a broad array of diseases and disorders in clinical settings worldwide. The implementation of biosensors at the point-of-care (POC), such as at primary clinics or the bedside, faces impediments because they may require highly trained personnel, have long assay times, large sizes, and high instrumental cost. Thus, there exists a need to develop inexpensive, reliable, user-friendly, and compact biosensing systems at the POC. Biosensors incorporated with photonic crystal (PC) structures hold promise to address many of the aforementioned challenges facing the development of new POC diagnostics. Currently, PC-based biosensors have been employed for detecting a variety of biotargets, such as cells, pathogens, proteins, antibodies, and nucleic acids, with high efficiency and selectivity. In this review, we provide a broad overview of PCs by explaining their structures, fabrication techniques, and sensing principles. Furthermore, we discuss recent applications of PC-based biosensors incorporated with emerging technologies, including telemedicine, flexible and wearable sensing, smart materials and metamaterials. Finally, we discuss current challenges associated with existing biosensors, and provide an outlook for PC-based biosensors and their promise at the POC.

Diagnostic and interventional musculoskeletal ultrasound: part 1. Fundamentals.

PubMed

Smith, Jay; Finnoff, Jonathan T

2009-01-01

Musculoskeletal ultrasound involves the use of high-frequency sound waves to image soft tissues and bony structures in the body for the purposes of diagnosing pathology or guiding real-time interventional procedures. Recently, an increasing number of physicians have integrated musculoskeletal ultrasound into their practices to facilitate patient care. Technological advancements, improved portability, and reduced costs continue to drive the proliferation of ultrasound in clinical medicine. This increased interest creates a need for education pertaining to all aspects of musculoskeletal ultrasound. The primary purpose of this article is to review diagnostic ultrasound technology and its potential clinical applications in the evaluation and treatment of patients with neurologic and musculoskeletal disorders. After reviewing this article, physicians should be able to (1) list the advantages and disadvantages of ultrasound compared with other available imaging modalities, (2) describe how ultrasound machines produce images using sound waves, (3) discuss the steps necessary to acquire and optimize an ultrasound image, (4) understand the different ultrasound appearances of tendons, nerves, muscles, ligaments, blood vessels, and bones, and (5) identify multiple applications for diagnostic and interventional musculoskeletal ultrasound in musculoskeletal practice. Part 1 of this 2-part article reviews the fundamentals of clinical ultrasonographic imaging, including relevant physics, equipment, training, image optimization, and scanning principles for diagnostic and interventional purposes.

Pressure application measurement (PAM): a novel behavioural technique for measuring hypersensitivity in a rat model of joint pain.

PubMed

Barton, Nicola J; Strickland, Iain T; Bond, Susan M; Brash, Harry M; Bate, Simon T; Wilson, Alex W; Chessell, Iain P; Reeve, Alison J; McQueen, Daniel S

2007-06-15

Chronic joint pain affects physical well being and can lead to severe psychological and social problems, therefore successful long-term management is highly sought-after. No current behavioural measures of pain used in pre-clinical models mimic the clinical dolorimeter, which provides an objective measure of joint hypersensitivity. In this study we aim to use a novel behavioural readout alongside an established measure to mimic the multifactorial measurements taken in the clinic. Using the pressure application measurement (PAM) device a gradually increasing squeeze was applied across the knee joint of rats until the animal gave an indication of pain or discomfort. PAM and the incapacitance tester were used to detect joint hypersensitivity in a well-established rodent model of adjuvant-induced arthritis. Subsequently, the analgesic effects of prednisolone (1, 3 or 10 mg kg(-1)), morphine (3 mg kg(-1)) and celecoxib (15 mg kg(-1)) were assessed. Both PAM and the incapacitance tester detected a reversal of hypersensitivity 1h post-drug administration. Furthermore, the two readouts were highly correlated, and power analysis indicated that PAM was highly reproducible. In conclusion, PAM provides a novel, accurate behavioural tool for detecting a primary mechanical hypersensitivity in a rat model of chronic inflammatory joint pain.

Mesenchymal Stromal Cells for Antineoplastic Drug Loading and Delivery.

PubMed

Petrella, Francesco; Rimoldi, Isabella; Rizzo, Stefania; Spaggiari, Lorenzo

2017-11-23

Mesenchymal stromal cells are a population of undifferentiated multipotent adult cells possessing extensive self-renewal properties and the potential to differentiate into a variety of mesenchymal lineage cells. They express broad anti-inflammatory and immunomodulatory activity on the immune system and after transplantation can interact with the surrounding microenvironment, promoting tissue healing and regeneration. For this reason, mesenchymal stromal cells have been widely used in regenerative medicine, both in preclinical and clinical settings. Another clinical application of mesenchymal stromal cells is the targeted delivery of chemotherapeutic agents to neoplastic cells, maximizing the cytotoxic activity against cancer cells and minimizing collateral damage to non-neoplastic tissues. Mesenchymal stem cells are home to the stroma of several primary and metastatic neoplasms and hence can be used as vectors for targeted delivery of antineoplastic drugs to the tumour microenvironment, thereby reducing systemic toxicity and maximizing antitumour effects. Paclitaxel and gemcitabine are the chemotherapeutic drugs best loaded by mesenchymal stromal cells and delivered to neoplastic cells, whereas other agents, like pemetrexed, are not internalized by mesenchymal stromal cells and therefore are not suitable for advanced antineoplastic therapy. This review focuses on the state of the art of advanced antineoplastic cell therapy and its future perspectives, emphasizing in vitro and in vivo preclinical results and future clinical applications.

System requirements for a computerised patient record information system at a busy primary health care clinic.

PubMed

Blignaut, P J; McDonald, T; Tolmie, C J

2001-05-01

A prototyping approach was used to determine the essential system requirements of a computerised patient record information system for a typical township primary health care clinic. A pilot clinic was identified and the existing manual system and business processes in this clinic was studied intensively before the first prototype was implemented. Interviews with users, incidental observations and analysis of actual data entered were used as primary techniques to refine the prototype system iteratively until a system with an acceptable data set and adequate functionalities were in place. Several non-functional and user-related requirements were also discovered during the prototyping period.

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.