'Televaluation' of clinical information systems: an integrative approach to assessing Web-based systems.

PubMed

Kushniruk, A W; Patel, C; Patel, V L; Cimino, J J

2001-04-01

The World Wide Web provides an unprecedented opportunity for widespread access to health-care applications by both patients and providers. The development of new methods for assessing the effectiveness and usability of these systems is becoming a critical issue. This paper describes the distance evaluation (i.e. 'televaluation') of emerging Web-based information technologies. In health informatics evaluation, there is a need for application of new ideas and methods from the fields of cognitive science and usability engineering. A framework is presented for conducting evaluations of health-care information technologies that integrates a number of methods, ranging from deployment of on-line questionnaires (and Web-based forms) to remote video-based usability testing of user interactions with clinical information systems. Examples illustrating application of these techniques are presented for the assessment of a patient clinical information system (PatCIS), as well as an evaluation of use of Web-based clinical guidelines. Issues in designing, prototyping and iteratively refining evaluation components are discussed, along with description of a 'virtual' usability laboratory.

Feasibility of automatic evaluation of clinical rules in general practice.

PubMed

Opondo, Dedan; Visscher, Stefan; Eslami, Saied; Medlock, Stephanie; Verheij, Robert; Korevaar, Joke C; Abu-Hanna, Ameen

2017-04-01

To assess the extent to which clinical rules (CRs) can be implemented for automatic evaluation of quality of care in general practice. We assessed 81 clinical rules (CRs) adapted from a subset of Assessing Care of Vulnerable Elders (ACOVE) clinical rules, against Dutch College of General Practitioners (NHG) data model. Each CR was analyzed using the Logical Elements Rule METHOD: (LERM). LERM is a stepwise method of assessing and formalizing clinical rules for decision support. Clinical rules that satisfied the criteria outlined in the LERM method were judged to be implementable in automatic evaluation in general practice. Thirty-three out of 81 (40.7%) Dutch-translated ACOVE clinical rules can be automatically evaluated in electronic medical record systems. Seven out of 7 CRs (100%) in the domain of diabetes can be automatically evaluated, 9/17 (52.9%) in medication use, 5/10 (50%) in depression care, 3/6 (50%) in nutrition care, 6/13 (46.1%) in dementia care, 1/6 (16.6%) in end of life care, 2/13 (15.3%) in continuity of care, and 0/9 (0%) in the fall-related care. Lack of documentation of care activities between primary and secondary health facilities and ambiguous formulation of clinical rules were the main reasons for the inability to automate the clinical rules. Approximately two-fifths of the primary care Dutch ACOVE-based clinical rules can be automatically evaluated. Clear definition of clinical rules, improved GP database design and electronic linkage of primary and secondary healthcare facilities can improve prospects of automatic assessment of quality of care. These findings are relevant especially because the Netherlands has very high automation of primary care. Copyright © 2017 Elsevier B.V. All rights reserved.

Clinical evaluation of patients with patellofemoral disorders.

PubMed

Post, W R

1999-01-01

Accurate clinical evaluation of patients with patellofemoral disorders is the cornerstone of effective treatment. This article defines how a careful history and physical examination can direct strategies for nonoperative and operative management. A critical analysis of traditional methods of evaluation and a streamlined rational approach to clinical evaluation is presented. Key questions and important physical findings that affect treatment decisions are emphasized.

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

PubMed

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

2011-10-01

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

[Modality of combined methods of quantitative and qualitative research in evaluation of therapeutic effects of Chinese medicine].

PubMed

Liu, Jian-ping

2011-05-01

The core of evidence-based medicine lies in implementing the current best available evidence of clinical research to direct the decision making in clinical practice, incorporation of individual experience and value and preference of patients. However, the current evaluation method for clinical therapeutic effect cannot reflect the humanity and wholesomeness as well as individualized tailored treatment of Chinese medicine (CM) by using randomized controlled trials. This assay addressed the complex intervention of highly individualized treatment of CM and its societal characteristics, and the author proposes a model for the evaluation of therapeutic effects of CM in which quantitative and qualitative methods are combined, embodying the characteristics of the social and natural sciences in CM. The model can show the dynamic process of CM diagnosis and treatment from a perspective of the whole system and can be used for the evaluation of complex intervention of CM. We hope to raise a different thinking and method from the new drug development in the therapeutic effect evaluation.

[Research advances in indices and methods for nutritional status evaluation in patients with liver cirrhosis].

PubMed

Li, H; Zhang, L

2017-03-20

In recent years, malnutrition in patients with liver cirrhosis has been taken more and more seriously in clinical physicians, and patients' nutritional status is closely associated with prognosis. At present, there are many methods for the evaluation of nutritional status in patients with liver cirrhosis, but there are still no unified standards. This article reviews the common evaluation indices and methods used in clinical practice in China and foreign countries, in order to provide a basis for accurately evaluating nutritional status and guiding nutritional therapy in patients with liver cirrhosis.

[Research Progress and Prospect of Applications of Finite Element Method in Lumbar Spine Biomechanics].

PubMed

Zhang, Zhenjun; Li, Yang; Liao, Zhenhua; Liu, Weiqiang

2016-12-01

Based on the application of finite element analysis in spine biomechanics,the research progress of finite element method applied in lumbar spine mechanics is reviewed and the prospect is forecasted.The related works,including lumbar ontology modeling,clinical application research,and occupational injury and protection,are summarized.The main research areas of finite element method are as follows:new accurate modeling process,the optimized simulation method,diversified clinical effect evaluation,and the clinical application of artificial lumbar disc.According to the recent research progress,the application prospects of finite element method,such as automation and individuation of modeling process,evaluation and analysis of new operation methods and simulation of mechanical damage and dynamic response,are discussed.The purpose of this paper is to provide the theoretical reference and practical guidance for the clinical lumbar problems by reviewing the application of finite element method in the field of the lumbar spine biomechanics.

Portfolio assessment and evaluation: implications and guidelines for clinical nursing education.

PubMed

Chabeli, M M

2002-08-01

With the advent of Outcomes-Based Education in South Africa, the quality of nursing education is debatable, especially with regard to the assessment and evaluation of clinical nursing education, which is complex and renders the validity and reliability of the methods used questionable. This paper seeks to explore and describe the use of portfolio assessment and evaluation, its implications and guidelines for its effective use in nursing education. Firstly, the concepts of assessment, evaluation, portfolio and alternative methods of evaluation are defined. Secondly, a comparison of the characteristics of the old (traditional) methods and the new alternative methods of evaluation is made. Thirdly, through deductive analysis, synthesis and inference, implications and guidelines for the effective use of portfolio assessment and evaluation are described. In view of the qualitative, descriptive and exploratory nature of the study, a focus group interview with twenty students following a post-basic degree at a university in Gauteng regarding their perceptions on the use of portfolio assessment and evaluation method in clinical nursing education was used. A descriptive method of qualitative data analysis of open coding in accordance with Tesch's protocol (in Creswell 1994:155) was used. Resultant implications and guidelines were conceptualised and described within the existing theoretical framework. Principles of trustworthiness were maintained as described by (Lincoln & Guba 1985:290-327). Ethical considerations were in accordance with DENOSA's standards of research (1998:7).

A Survey of Practice Patterns in Concussion Assessment and Management.

PubMed

Ferrara, Michael S.; McCrea, Michael; Peterson, Connie L.; Guskiewicz, Kevin M.

2001-06-01

OBJECTIVES: To identify methods used by athletic trainers to assess concussions and the use of that information to assist in return-to-play decisions and to determine athletic trainers' familiarity with new standardized methods of concussion assessment. DESIGN AND SETTING: A 21-item questionnaire was distributed to attendees of a minicourse at the 1999 National Athletic Trainers' Association Annual Meeting and Clinical Symposia entitled "Use of Standardized Assessment of Concussion (SAC) in the Immediate Sideline Evaluation of Injured Athletes." SUBJECTS: A total of 339 valid surveys were returned by the attendees of the minicourse. MEASUREMENTS: We used frequency analysis and descriptive statistics. RESULTS: Clinical examination (33%) and a symptom checklist (15.3%) were the most common evaluative tools used to assess concussions. The Colorado Guidelines (28%) were used more than other concussion management guidelines. Athletic trainers (34%) and team physicians (40%) were primarily responsible for making decisions regarding return to play. A large number of respondents (83.5%) believed that the use of a standardized method of concussion assessment provided more information than routine clinical and physical examination alone. CONCLUSIONS: Athletic trainers are using a variety of clinical tools to evaluate concussions in athletes. Clinical evaluation and collaboration with physicians still appear to be the primary methods used for return-to-play decisions. However, athletic trainers are beginning to use standardized methods of concussion to evaluate these injuries and to assist them in assessing the severity of injury and deciding when it is safe to return to play.

Evaluating current automatic de-identification methods with Veteran's health administration clinical documents.

PubMed

Ferrández, Oscar; South, Brett R; Shen, Shuying; Friedlin, F Jeffrey; Samore, Matthew H; Meystre, Stéphane M

2012-07-27

The increased use and adoption of Electronic Health Records (EHR) causes a tremendous growth in digital information useful for clinicians, researchers and many other operational purposes. However, this information is rich in Protected Health Information (PHI), which severely restricts its access and possible uses. A number of investigators have developed methods for automatically de-identifying EHR documents by removing PHI, as specified in the Health Insurance Portability and Accountability Act "Safe Harbor" method.This study focuses on the evaluation of existing automated text de-identification methods and tools, as applied to Veterans Health Administration (VHA) clinical documents, to assess which methods perform better with each category of PHI found in our clinical notes; and when new methods are needed to improve performance. We installed and evaluated five text de-identification systems "out-of-the-box" using a corpus of VHA clinical documents. The systems based on machine learning methods were trained with the 2006 i2b2 de-identification corpora and evaluated with our VHA corpus, and also evaluated with a ten-fold cross-validation experiment using our VHA corpus. We counted exact, partial, and fully contained matches with reference annotations, considering each PHI type separately, or only one unique 'PHI' category. Performance of the systems was assessed using recall (equivalent to sensitivity) and precision (equivalent to positive predictive value) metrics, as well as the F(2)-measure. Overall, systems based on rules and pattern matching achieved better recall, and precision was always better with systems based on machine learning approaches. The highest "out-of-the-box" F(2)-measure was 67% for partial matches; the best precision and recall were 95% and 78%, respectively. Finally, the ten-fold cross validation experiment allowed for an increase of the F(2)-measure to 79% with partial matches. The "out-of-the-box" evaluation of text de-identification systems provided us with compelling insight about the best methods for de-identification of VHA clinical documents. The errors analysis demonstrated an important need for customization to PHI formats specific to VHA documents. This study informed the planning and development of a "best-of-breed" automatic de-identification application for VHA clinical text.

Evaluation of the clinical process in a critical care information system using the Lean method: a case study.

PubMed

Yusof, Maryati Mohd; Khodambashi, Soudabeh; Mokhtar, Ariffin Marzuki

2012-12-21

There are numerous applications for Health Information Systems (HIS) that support specific tasks in the clinical workflow. The Lean method has been used increasingly to optimize clinical workflows, by removing waste and shortening the delivery cycle time. There are a limited number of studies on Lean applications related to HIS. Therefore, we applied the Lean method to evaluate the clinical processes related to HIS, in order to evaluate its efficiency in removing waste and optimizing the process flow. This paper presents the evaluation findings of these clinical processes, with regards to a critical care information system (CCIS), known as IntelliVue Clinical Information Portfolio (ICIP), and recommends solutions to the problems that were identified during the study. We conducted a case study under actual clinical settings, to investigate how the Lean method can be used to improve the clinical process. We used observations, interviews, and document analysis, to achieve our stated goal. We also applied two tools from the Lean methodology, namely the Value Stream Mapping and the A3 problem-solving tools. We used eVSM software to plot the Value Stream Map and A3 reports. We identified a number of problems related to inefficiency and waste in the clinical process, and proposed an improved process model. The case study findings show that the Value Stream Mapping and the A3 reports can be used as tools to identify waste and integrate the process steps more efficiently. We also proposed a standardized and improved clinical process model and suggested an integrated information system that combines database and software applications to reduce waste and data redundancy.

Digital transillumination in caries detection versus radiographic and clinical methods: an in-vivo study

PubMed Central

Lara-Capi, Cynthia; Lingström, Peter; Lai, Gianfranco; Cocco, Fabio; Simark-Mattsson, Charlotte; Campus, Guglielmo

2017-01-01

Objectives: This article aimed to evaluate: (a) the agreement between a near-infrared light transillumination device and clinical and radiographic examinations in caries lesion detection and (b) the reliability of images captured by the transillumination device. Methods: Two calibrated examiners evaluated the caries status in premolars and molars on 52 randomly selected subjects by comparing the transillumination device with a clinical examination for the occlusal surfaces and by comparing the transillumination device with a radiographic examination (bitewing radiographs) for the approximal surfaces. Forty-eight trained dental hygienists evaluated and reevaluated 30 randomly selected images 1-month later. Results: A high concordance between transillumination method and clinical examination (kappa = 0.99) was detected for occlusal caries lesions, while for approximal surfaces, the transillumination device identified a higher number of lesions with respect to bitewing (kappa = 0.91). At the dentinal level, the two methods identified the same number of caries lesions (kappa = 1), whereas more approximal lesions were recorded using the transillumination device in the enamel (kappa = 0.24). The intraexaminer reliability was substantial/almost perfect in 59.4% of the participants. Conclusions: The transillumination method showed a high concordance compared with traditional methods (clinical examination and bitewing radiographs). Caries detection reliability using the transillumination device images showed a high intraexaminer agreement. Transillumination showed to be a reliable method and as effective as traditional methods in caries detection. PMID:28191797

Improving Terminology Mapping in Clinical Text with Context-Sensitive Spelling Correction.

PubMed

Dziadek, Juliusz; Henriksson, Aron; Duneld, Martin

2017-01-01

The mapping of unstructured clinical text to an ontology facilitates meaningful secondary use of health records but is non-trivial due to lexical variation and the abundance of misspellings in hurriedly produced notes. Here, we apply several spelling correction methods to Swedish medical text and evaluate their impact on SNOMED CT mapping; first in a controlled evaluation using medical literature text with induced errors, followed by a partial evaluation on clinical notes. It is shown that the best-performing method is context-sensitive, taking into account trigram frequencies and utilizing a corpus-based dictionary.

Evaluation systems for clinical governance development: a comparative study.

PubMed

Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

2014-01-01

Lack of scientific and confirmed researches and expert knowledge about evaluation systems for clinical governance development in Iran have made studies on different evaluation systems for clinical governance development a necessity. These studies must provide applied strategies to design criteria of implementing clinical governance for hospital's accreditation. This is a descriptive and comparative study on development of clinical governance models all over the world. Data have been gathered by reviewing related articles. Models have been studied in comprehensive review method. The evaluated models of clinical governance development were Australian, NHS, SPOCK and OPTIGOV. The final aspects extracted from these models were Responsiveness, Policies and Strategies, Organizational Structure, Allocating Resources, Education and Occupational Development, Performance Evaluation, External Evaluation, Patient Oriented Approach, Risk Management, Personnel's Participation, Information Technology, Human Resources, Research and Development, Evidence Based Medicine, Clinical Audit, Health Technology Assessment and Quality. These results are applicable for completing the present criteria which evaluating clinical governance application and provide practical framework to evaluate country's hospital on the basis of clinical governance elements.

Evaluating Creative Thinking of Rn-Bsn Students in the Course of Clinical Case Study and Practicum

ERIC Educational Resources Information Center

Ku, Ya-Lie

2015-01-01

This case study evaluated creative thinking of RN-BSN students in the course of clinical case study and practicum. Study design used quantitative and qualitative evaluations of creative thinking of RN-BSN students by triangulation method in the course of clinical case study and practicum. Sixty RN-BSN students self-perceived the changing levels of…

Holistic rubric vs. analytic rubric for measuring clinical performance levels in medical students.

PubMed

Yune, So Jung; Lee, Sang Yeoup; Im, Sun Ju; Kam, Bee Sung; Baek, Sun Yong

2018-06-05

Task-specific checklists, holistic rubrics, and analytic rubrics are often used for performance assessments. We examined what factors evaluators consider important in holistic scoring of clinical performance assessment, and compared the usefulness of applying holistic and analytic rubrics respectively, and analytic rubrics in addition to task-specific checklists based on traditional standards. We compared the usefulness of a holistic rubric versus an analytic rubric in effectively measuring the clinical skill performances of 126 third-year medical students who participated in a clinical performance assessment conducted by Pusan National University School of Medicine. We conducted a questionnaire survey of 37 evaluators who used all three evaluation methods-holistic rubric, analytic rubric, and task-specific checklist-for each student. The relationship between the scores on the three evaluation methods was analyzed using Pearson's correlation. Inter-rater agreement was analyzed by Kappa index. The effect of holistic and analytic rubric scores on the task-specific checklist score was analyzed using multiple regression analysis. Evaluators perceived accuracy and proficiency to be major factors in objective structured clinical examinations evaluation, and history taking and physical examination to be major factors in clinical performance examinations evaluation. Holistic rubric scores were highly related to the scores of the task-specific checklist and analytic rubric. Relatively low agreement was found in clinical performance examinations compared to objective structured clinical examinations. Meanwhile, the holistic and analytic rubric scores explained 59.1% of the task-specific checklist score in objective structured clinical examinations and 51.6% in clinical performance examinations. The results show the usefulness of holistic and analytic rubrics in clinical performance assessment, which can be used in conjunction with task-specific checklists for more efficient evaluation.

Oxygen utilization of the human left ventricle - An indirect method for its evaluation and clinical considerations

NASA Technical Reports Server (NTRS)

Ghista, D. N.; Sandler, H.

1974-01-01

An analytical method is presented for determining the oxygen consumption rate of the intact heart working (as opposed to empty but beating) human left ventricle. Use is made of experimental recordings obtained for the chamber pressure and the associated dimensions of the LV. LV dimensions are determined by cineangiocardiography, and the chamber pressure is obtained by means of fluid-filled catheters during retrograde or transeptal catheterization. An analytical method incorporating these data is then employed for the evaluation of the LV coronary oxygen consumption in five subjects. Oxygen consumption for these subjects was also obtained by the conventional clinical method in order to evaluate the reliability of the proposed method.

Do Clinical Evaluations in a Psychiatry Clerkship Favor Students with Positive Personality Characteristics?

ERIC Educational Resources Information Center

Chibnall, John T.; Blaskiewicz, Robert J.

2008-01-01

Objective: The authors examine associations of personality characteristics, National Board of Medical Examiners subject examination performance, and Objective Structured Clinical Examination performance with clinical evaluations of third-year medical students in a psychiatry clerkship. Methods: Students completed the Revised NEO Personality…

Nursing students’ satisfaction about their field of study

PubMed Central

HAKIM, ASHRAFALSADAT

2014-01-01

Introduction: Nowadays students' opinion is considered as a necessary factor to evaluate quality in universities. This study was performed to evaluate the nursing students' satisfaction about their field of study. Methods: The research population in this study consists of all the students of nursing studying at the second to fourth year of university (72 students). The data were collected from all the studied population. Data collection instrument was a research questionnaire. In this cross-sectional research, nursing students' satisfaction (72 students) in 6 major topics (situation of educational environment, situation of clinical environment, trainers, social image, relation to colleagues and management) was studied. The data were analyzed in SPSS, version 14, using quantitative variables and descriptive statistics including frequency distribution tables and diagrams. Results: The findings indicated that 83.3% of the students had little satisfaction as to the situation of educational environment, 47.2% about situation of clinical environment, 41.7% concerning the theoretical educational method by professors, and 41.7% as to the method of clinical education by clinical trainers. Also 47.2% were not that satisfied with the method of evaluation by the school professors, 80.6% with the method of relationship with colleagues and also 62.5% with the nursing social image. Moreover, findings indicated that 33.3% of the participants in this research were dissatisfied with the method of evaluation by clinical trainers and 50% with the method of nursing management. Conclusion: In the present study, most students had little satisfaction concerning their field of study. So it is necessary to make an attempt for continuous development of quality services. PMID:25512925

Evaluation Apprehension and Impression Management in Clinical Medical Education.

PubMed

McGaghie, William C

2018-05-01

Historically, clinical medical education has relied on subjective evaluations of students and residents to judge their clinical competence. The uncertainty associated with these subjective clinical evaluations has produced evaluation apprehension among learners and attempts to manage one's professional persona (impression management) among peers and supervisors. Such behavior has been documented from antiquity through the Middle Ages to the present, including in two new qualitative studies in this issue of Academic Medicine on the social psychology of clinical medical education. New approaches to medical education, including competency-based education, mastery learning, and assessment methods that unite evaluation and education, are slowly changing the culture of clinical medical education. The author of this Invited Commentary argues that this shift will bring greater transparency and accountability to clinical medical education and gradually reduce evaluation apprehension and the impression management motives it produces.

Follow-up of solar lentigo depigmentation with a retinaldehyde-based cream by clinical evaluation and calibrated colour imaging.

PubMed

Questel, E; Durbise, E; Bardy, A-L; Schmitt, A-M; Josse, G

2015-05-01

To assess an objective method evaluating the effects of a retinaldehyde-based cream (RA-cream) on solar lentigines; 29 women randomly applied RA-cream on lentigines of one hand and a control cream on the other, once daily for 3 months. A specific method enabling a reliable visualisation of the lesions was proposed, using high-magnification colour-calibrated camera imaging. Assessment was performed using clinical evaluation by Physician Global Assessment score and image analysis. Luminance determination on the numeric images was performed either on the basis of 5 independent expert's consensus borders or probability map analysis via an algorithm automatically detecting the pigmented area. Both image analysis methods showed a similar lightening of ΔL* = 2 after a 3-month treatment by RA-cream, in agreement with single-blind clinical evaluation. High-magnification colour-calibrated camera imaging combined with probability map analysis is a fast and precise method to follow lentigo depigmentation. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Comparison between a clinical diagnosis method and the surveillance technique of the Center for Disease Control and Prevention for identification of mechanical ventilator-associated pneumonia.

PubMed

Waltrick, Renata; Possamai, Dimitri Sauter; de Aguiar, Fernanda Perito; Dadam, Micheli; de Souza Filho, Valmir João; Ramos, Lucas Rocker; Laurett, Renata da Silva; Fujiwara, Kênia; Caldeira Filho, Milton; Koenig, Álvaro; Westphal, Glauco Adrieno

2015-01-01

>To evaluate the agreement between a new epidemiological surveillance method of the Center for Disease Control and Prevention and the clinical pulmonary infection score for mechanical ventilator-associated pneumonia detection. This was a prospective cohort study that evaluated patients in the intensive care units of two hospitals who were intubated for more than 48 hours between August 2013 and June 2014. Patients were evaluated daily by physical therapist using the clinical pulmonary infection score. A nurse independently applied the new surveillance method proposed by the Center for Disease Control and Prevention. The diagnostic agreement between the methods was evaluated. A clinical pulmonary infection score of ≥ 7 indicated a clinical diagnosis of mechanical ventilator-associated pneumonia, and the association of a clinical pulmonary infection score ≥ 7 with an isolated semiquantitative culture consisting of ≥ 104 colony-forming units indicated a definitive diagnosis. Of the 801 patients admitted to the intensive care units, 198 required mechanical ventilation. Of these, 168 were intubated for more than 48 hours. A total of 18 (10.7%) cases of mechanical ventilation-associated infectious conditions were identified, 14 (8.3%) of which exhibited possible or probable mechanical ventilator-associated pneumonia, which represented 35% (14/38) of mechanical ventilator-associated pneumonia cases. The Center for Disease Control and Prevention method identified cases of mechanical ventilator-associated pneumonia with a sensitivity of 0.37, specificity of 1.0, positive predictive value of 1.0, and negative predictive value of 0.84. The differences resulted in discrepancies in the mechanical ventilator-associated pneumonia incidence density (CDC, 5.2/1000 days of mechanical ventilation; clinical pulmonary infection score ≥ 7, 13.1/1000 days of mechanical ventilation). The Center for Disease Control and Prevention method failed to detect mechanical ventilator-associated pneumonia cases and may not be satisfactory as a surveillance method.

A Methodology for Anatomic Ultrasound Image Diagnostic Quality Assessment.

PubMed

Hemmsen, Martin Christian; Lange, Theis; Brandt, Andreas Hjelm; Nielsen, Michael Bachmann; Jensen, Jorgen Arendt

2017-01-01

This paper discusses the methods for the assessment of ultrasound image quality based on our experiences with evaluating new methods for anatomic imaging. It presents a methodology to ensure a fair assessment between competing imaging methods using clinically relevant evaluations. The methodology is valuable in the continuing process of method optimization and guided development of new imaging methods. It includes a three phased study plan covering from initial prototype development to clinical assessment. Recommendations to the clinical assessment protocol, software, and statistical analysis are presented. Earlier uses of the methodology has shown that it ensures validity of the assessment, as it separates the influences between developer, investigator, and assessor once a research protocol has been established. This separation reduces confounding influences on the result from the developer to properly reveal the clinical value. This paper exemplifies the methodology using recent studies of synthetic aperture sequential beamforming tissue harmonic imaging.

[Development of non-invasive clinical examination methods for the anterior segment of the eye and their clinical significance].

PubMed

Sawa, Mitsuru

2011-03-01

1. Slit-lamp microscopy is a principal ophthalmic clinical method, because it provides microscopic findings of the anterior segment of the eye noninvasively. Its findings, however, are qualitative and there are large inter-observer variations in their evaluation. Furthermore, slit-lamp microscopy provides morphological findings, but a functional evaluation is difficult. We developed two novel methods that establish a qualitative methodology of the slit-lamp microscope and the pathophysiology of the anterior segment of the eye. One is the flare-cell photometer to evaluate flare and cells in the aqueous humor of the eye and the other is an immunohistochemical examination method using tear fluid to evaluate ocular surface disorders. The comprehensive evaluation of these studies is herein overviewed. 2. INNOVATION OF THE FLARE-CELL PHOTOMETER AND ITS CLINICAL SIGNIFICANCE: The breakdown of the blood-aqueous barrier (BAB) causes an increase in protein (flare) and leakage of blood cells (cell) into the aqueous humor of the eye and the severity of BAB breakdown has a positive correlation with the intensity of flare and cells. The flare and cells in the aqueous can be observed qualitatively by slit-lamp microscopy. These findings are primarily distinguished in optics by light scattering. Therefore, detection of the intensity of light scattering due to flare and cells can evaluate the BAB function. The flare-cell photometer comprises 3 novel components: a laser beam system as an incident light, a photomultiplier to detect scattered light intensity and a computer-assisted system to operate the whole system and analyze detected scattered light signals due to flare and cells. The instrument enables us to quantitatively analyze the flare and cells non-invasively and accurately with a wide dynamic measurement range, resulting in a repeated examination of each individual case. It also enables the evaluation of inflammation in the aqueous not only postoperatively but also in endogenous uveitis, evaluation of the effects of anti-inflammatory drugs on BAB and evaluation of aqueous humor dynamics. Furthermore, repeating the examination can minimize inter-individual variations and reduce the number of animals in animal experiments. 3. Sampling of tears can be performed noninvasively, but the obtainable volume is limited. Therefore, a determination of targeting biomarkers and a development of their micro-volume analysis methods play a crucial role in pathophysiological studies of the ocular surface. Targeting biomarkers should be determined according to the various specified bioactive substances such as eosinophil cationic protein (ECP), cytokines and others. A number of microvolume analysis methods, such as chemiluminescent enzyme immunoassay, immunochromatography, micro-array system and polymerase chain reaction method are used. Objective disorders in the studies include allergic conjunctivitis and infectious diseases such as herpetic keratitis. Quantitative evaluation methods for ECP concentration, antigen-specific secretory IgA in allergic diseases and herpetic keratitis, herpes simplex virus-DNA and cytokine and chemokine profile in tear fluid sampled by filter paper method were investigated. We developed a clinically applicable quantitative immunochemical method for ECP concentration in tear fluid. The results revealed that tear fluid analysis using the above mentioned methods is a clinically useful to investigate the pathophysiology of the ocular surface. 4. Laser flare-cell photometer and tear fluid analysis are potent clinical quantitative methods to investigate the pathophysiology of the anterior segment of the eye.

Connecting clinical and actuarial prediction with rule-based methods.

PubMed

Fokkema, Marjolein; Smits, Niels; Kelderman, Henk; Penninx, Brenda W J H

2015-06-01

Meta-analyses comparing the accuracy of clinical versus actuarial prediction have shown actuarial methods to outperform clinical methods, on average. However, actuarial methods are still not widely used in clinical practice, and there has been a call for the development of actuarial prediction methods for clinical practice. We argue that rule-based methods may be more useful than the linear main effect models usually employed in prediction studies, from a data and decision analytic as well as a practical perspective. In addition, decision rules derived with rule-based methods can be represented as fast and frugal trees, which, unlike main effects models, can be used in a sequential fashion, reducing the number of cues that have to be evaluated before making a prediction. We illustrate the usability of rule-based methods by applying RuleFit, an algorithm for deriving decision rules for classification and regression problems, to a dataset on prediction of the course of depressive and anxiety disorders from Penninx et al. (2011). The RuleFit algorithm provided a model consisting of 2 simple decision rules, requiring evaluation of only 2 to 4 cues. Predictive accuracy of the 2-rule model was very similar to that of a logistic regression model incorporating 20 predictor variables, originally applied to the dataset. In addition, the 2-rule model required, on average, evaluation of only 3 cues. Therefore, the RuleFit algorithm appears to be a promising method for creating decision tools that are less time consuming and easier to apply in psychological practice, and with accuracy comparable to traditional actuarial methods. (c) 2015 APA, all rights reserved).

Development, implementation and evaluation of a clinical research engagement and leadership capacity building program in a large Australian health care service.

PubMed

Misso, Marie L; Ilic, Dragan; Haines, Terry P; Hutchinson, Alison M; East, Christine E; Teede, Helena J

2016-01-14

Health professionals need to be integrated more effectively in clinical research to ensure that research addresses clinical needs and provides practical solutions at the coal face of care. In light of limited evidence on how best to achieve this, evaluation of strategies to introduce, adapt and sustain evidence-based practices across different populations and settings is required. This project aims to address this gap through the co-design, development, implementation, evaluation, refinement and ultimately scale-up of a clinical research engagement and leadership capacity building program in a clinical setting with little to no co-ordinated approach to clinical research engagement and education. The protocol is based on principles of research capacity building and on a six-step framework, which have previously led to successful implementation and long-term sustainability. A mixed methods study design will be used. Methods will include: (1) a review of the literature about strategies that engage health professionals in research through capacity building and/or education in research methods; (2) a review of existing local research education and support elements; (3) a needs assessment in the local clinical setting, including an online cross-sectional survey and semi-structured interviews; (4) co-design and development of an educational and support program; (5) implementation of the program in the clinical environment; and (6) pre- and post-implementation evaluation and ultimately program scale-up. The evaluation focuses on research activity and knowledge, attitudes and preferences about clinical research, evidence-based practice and leadership and post implementation, about their satisfaction with the program. The investigators will evaluate the feasibility and effect of the program according to capacity building measures and will revise where appropriate prior to scale-up. It is anticipated that this clinical research engagement and leadership capacity building program will enable and enhance clinically relevant research to be led and conducted by health professionals in the health setting. This approach will also encourage identification of areas of clinical uncertainty and need that can be addressed through clinical research within the health setting.

Nursing students' satisfaction about their field of study.

PubMed

Hakim, Ashrafalsadat

2014-04-01

Nowadays students' opinion is considered as a necessary factor to evaluate quality in universities. This study was performed to evaluate the nursing students' satisfaction about their field of study. The research population in this study consists of all the students of nursing studying at the second to fourth year of university (72 students). The data were collected from all the studied population. Data collection instrument was a research questionnaire. In this cross-sectional research, nursing students' satisfaction (72 students) in 6 major topics (situation of educational environment, situation of clinical environment, trainers, social image, relation to colleagues and management) was studied. The data were analyzed in SPSS, version 14, using quantitative variables and descriptive statistics including frequency distribution tables and diagrams. The findings indicated that 83.3% of the students had little satisfaction as to the situation of educational environment, 47.2% about situation of clinical environment, 41.7% concerning the theoretical educational method by professors, and 41.7% as to the method of clinical education by clinical trainers. Also 47.2% were not that satisfied with the method of evaluation by the school professors, 80.6% with the method of relationship with colleagues and also 62.5% with the nursing social image. Moreover, findings indicated that 33.3% of the participants in this research were dissatisfied with the method of evaluation by clinical trainers and 50% with the method of nursing management. In the present study, most students had little satisfaction concerning their field of study. So it is necessary to make an attempt for continuous development of quality services.

Iterative integral parameter identification of a respiratory mechanics model.

PubMed

Schranz, Christoph; Docherty, Paul D; Chiew, Yeong Shiong; Möller, Knut; Chase, J Geoffrey

2012-07-18

Patient-specific respiratory mechanics models can support the evaluation of optimal lung protective ventilator settings during ventilation therapy. Clinical application requires that the individual's model parameter values must be identified with information available at the bedside. Multiple linear regression or gradient-based parameter identification methods are highly sensitive to noise and initial parameter estimates. Thus, they are difficult to apply at the bedside to support therapeutic decisions. An iterative integral parameter identification method is applied to a second order respiratory mechanics model. The method is compared to the commonly used regression methods and error-mapping approaches using simulated and clinical data. The clinical potential of the method was evaluated on data from 13 Acute Respiratory Distress Syndrome (ARDS) patients. The iterative integral method converged to error minima 350 times faster than the Simplex Search Method using simulation data sets and 50 times faster using clinical data sets. Established regression methods reported erroneous results due to sensitivity to noise. In contrast, the iterative integral method was effective independent of initial parameter estimations, and converged successfully in each case tested. These investigations reveal that the iterative integral method is beneficial with respect to computing time, operator independence and robustness, and thus applicable at the bedside for this clinical application.

Quantitative methods in assessment of neurologic function.

PubMed

Potvin, A R; Tourtellotte, W W; Syndulko, K; Potvin, J

1981-01-01

Traditionally, neurologists have emphasized qualitative techniques for assessing results of clinical trials. However, in recent years qualitative evaluations have been increasingly augmented by quantitative tests for measuring neurologic functions pertaining to mental state, strength, steadiness, reactions, speed, coordination, sensation, fatigue, gait, station, and simulated activities of daily living. Quantitative tests have long been used by psychologists for evaluating asymptomatic function, assessing human information processing, and predicting proficiency in skilled tasks; however, their methodology has never been directly assessed for validity in a clinical environment. In this report, relevant contributions from the literature on asymptomatic human performance and that on clinical quantitative neurologic function are reviewed and assessed. While emphasis is focused on tests appropriate for evaluating clinical neurologic trials, evaluations of tests for reproducibility, reliability, validity, and examiner training procedures, and for effects of motivation, learning, handedness, age, and sex are also reported and interpreted. Examples of statistical strategies for data analysis, scoring systems, data reduction methods, and data display concepts are presented. Although investigative work still remains to be done, it appears that carefully selected and evaluated tests of sensory and motor function should be an essential factor for evaluating clinical trials in an objective manner.

Benchmarking routine psychological services: a discussion of challenges and methods.

PubMed

Delgadillo, Jaime; McMillan, Dean; Leach, Chris; Lucock, Mike; Gilbody, Simon; Wood, Nick

2014-01-01

Policy developments in recent years have led to important changes in the level of access to evidence-based psychological treatments. Several methods have been used to investigate the effectiveness of these treatments in routine care, with different approaches to outcome definition and data analysis. To present a review of challenges and methods for the evaluation of evidence-based treatments delivered in routine mental healthcare. This is followed by a case example of a benchmarking method applied in primary care. High, average and poor performance benchmarks were calculated through a meta-analysis of published data from services working under the Improving Access to Psychological Therapies (IAPT) Programme in England. Pre-post treatment effect sizes (ES) and confidence intervals were estimated to illustrate a benchmarking method enabling services to evaluate routine clinical outcomes. High, average and poor performance ES for routine IAPT services were estimated to be 0.91, 0.73 and 0.46 for depression (using PHQ-9) and 1.02, 0.78 and 0.52 for anxiety (using GAD-7). Data from one specific IAPT service exemplify how to evaluate and contextualize routine clinical performance against these benchmarks. The main contribution of this report is to summarize key recommendations for the selection of an adequate set of psychometric measures, the operational definition of outcomes, and the statistical evaluation of clinical performance. A benchmarking method is also presented, which may enable a robust evaluation of clinical performance against national benchmarks. Some limitations concerned significant heterogeneity among data sources, and wide variations in ES and data completeness.

Developing tools for the safety specification in risk management plans: lessons learned from a pilot project.

PubMed

Cooper, Andrew J P; Lettis, Sally; Chapman, Charlotte L; Evans, Stephen J W; Waller, Patrick C; Shakir, Saad; Payvandi, Nassrin; Murray, Alison B

2008-05-01

Following the adoption of the ICH E2E guideline, risk management plans (RMP) defining the cumulative safety experience and identifying limitations in safety information are now required for marketing authorisation applications (MAA). A collaborative research project was conducted to gain experience with tools for presenting and evaluating data in the safety specification. This paper presents those tools found to be useful and the lessons learned from their use. Archive data from a successful MAA were utilised. Methods were assessed for demonstrating the extent of clinical safety experience, evaluating the sensitivity of the clinical trial data to detect treatment differences and identifying safety signals from adverse event and laboratory data to define the extent of safety knowledge with the drug. The extent of clinical safety experience was demonstrated by plots of patient exposure over time. Adverse event data were presented using dot plots, which display the percentages of patients with the events of interest, the odds ratio, and 95% confidence interval. Power and confidence interval plots were utilised for evaluating the sensitivity of the clinical database to detect treatment differences. Box and whisker plots were used to display laboratory data. This project enabled us to identify new evidence-based methods for presenting and evaluating clinical safety data. These methods represent an advance in the way safety data from clinical trials can be analysed and presented. This project emphasises the importance of early and comprehensive planning of the safety package, including evaluation of the use of epidemiology data.

Periocular mexametric melanin and erythema indexes in adult glaucoma patients treated with topical prostaglandin analogs.

PubMed

Duman, Nilay; Duman, Reşat; Yavaş, Güliz Fatma; Doğruk Kaçar, Seval; Özuğuz, Pınar; Çetinkaya, Ersan

2017-03-01

Although topical prostaglandin analogs (PGAs) have been previously associated with periocular skin hyperpigmentation, studies using objective clinical methods are lacking. Furthermore changes in periocular skin erythema indexes associated with topical PGAs have not been reported previously. The purpose of the present study was to evaluate periocular melanin and erythema indexes in patients treated with topical PGA using an objective clinical method - Mexameter. About 45 glaucoma patients treated with topical PGA therapy, and 30 age-, and sex-matched controls were enrolled in the study. Demographic data, medical history including duration of therapy, PGA type, involved eye (unilateral, bilateral) were noted, and skin phototypes were evaluated. Melanin and erythema indexes on medial and lateral upper and lower eyelids, and normal skin from the upper cheeks were measured using Mexameter MX-18. The index of difference for lower/upper eyelid was calculated. Reading results of patients and controls were compared. Melanin and erythema indexes of upper/lower eyelids, and the index of differences for upper/lower eyelids were significantly higher in patients despite similar clinical findings (p < 0.05). Duration of therapy and type of PGA were not associated with skin changes (p > 0.05). Both periocular melanin and erythema indexes increased in both upper and lower eyelids due to PGA therapy compared to controls, despite similar clinical findings. Mexametric evaluation is more sensitive than clinical evaluation, and may be used as an objective, sensitive clinical method to evaluate periocular skin changes, even smallest changes, in such patients.

Relation between spiritual intelligence and clinical competency of nurses in Iran

PubMed Central

Karimi-Moonaghi, Hossein; Gazerani, Akram; Vaghee, Saeed; Gholami, Hassan; Salehmoghaddam, Amir Reza; Gharibnavaz, Raheleh

2015-01-01

Background: Clinical competency is one of the most important requirements in nursing profession, based on which nurses are assessed. To obtain an effective and improved form of clinical competency, several factors are observed and monitored by the health educational systems. Among these observed factors, spiritual intelligence is considered as one of the most significant factors in nurses’ success and efficacy. In this study, it is aimed to determine the spiritual intelligence status and its relationship with clinical competency. Materials and Methods: The descriptive–correlational research was carried out on 250 nurses in Mashhad educational hospitals, selected by multi-stage sampling. Demographic, clinical competency, and spiritual intelligence questionnaires were used for data collection and 212 questionnaires were analyzed. Results: About 53.3% of nurses obtained above average scores in spiritual intelligence. Clinical competency was evaluated by both self-evaluation and head nurse evaluation methods. Most nurses (53.8%) were having good level of clinical competency based on self-evaluation, 48.2% were at average level based on head nurse evaluation, and 53.3% were at average level based on overall score. A significant correlation was found between spiritual intelligence and clinical competency. Conclusions: In this study, the positive significant correlation between nurses’ spiritual intelligence and their clinical competency is investigated. Because of the positive effects of spiritual intelligence on nurses’ clinical competency and quality of care, it is recommended to develop nurses’ spiritual intelligence during their education and by way of continuous medical education. PMID:26793250

Validation of assessment of intraoral digital photography for evaluation of dental restorations in clinical research.

PubMed

Signori, Cácia; Collares, Kauê; Cumerlato, Catarina B F; Correa, Marcos B; Opdam, Niek J M; Cenci, Maximiliano S

2018-04-01

The aim of this study was to investigate the validity of assessment of intraoral digital photography in the evaluation of dental restorations. Intraoral photographs of anterior and posterior restorations were classified based on FDI criteria according to the need for intervention: no intervention, repair and replacement. Evaluations were performed by an experienced expert in restorative dentistry (gold standard evaluator) and 3 trained dentists (consensus). The clinical inspection was the reference standard method. The prevalence of failures was explored. Cohen's kappa statistic was used. Validity was accessed by sensitivity, specificity, likelihood ratio and predictives values. Higher prevalence of failed restorations intervention was identified by the intraoral photography (17.7%) in comparison to the clinical evaluation (14.1%). Moderate agreement in the diagnosis of total failures was shown between the methods for the gold standard evaluator (kappa = 0.51) and consensus of evaluators (kappa = 0.53). Gold standard evaluator and consensus showed substantial and moderate agreement for posterior restorations (kappa = 0.61; 0.59), and fair and moderate agreement for anterior restorations (kappa = 0.36; 0.43), respectively. The accuracy was 84.8% in the assessment by intraoral photographs. Sensitivity and specificity values of 87.5% and 89.3% were found. Under the limits of this study, the assessment of digital photography performed by intraoral camera is an indirect diagnostic method valid for the evaluation of dental restorations, mainly in posterior teeth. This method should be employed taking into account the higher detection of defects provided by the images, which are not always clinically relevant. Copyright © 2018 Elsevier Ltd. All rights reserved.

Evaluation of radiographic interpretation competence of veterinary students in Finland.

PubMed

Koskinen, Heli I; Snellman, Marjatta

2009-01-01

In the evaluation of the clinical competence of veterinary students, many different definitions and methods are approved. Due to the increasing discussion of the quality of outcomes produced by newly graduated veterinarians, methods for the evaluation of clinical competencies should also be evaluated. In this study, this was done by comparing two qualitative evaluation schemes: the well-known structure of observed learning outcome (SOLO) taxonomy and a modification of this taxonomy. A case-based final radiologic examination was selected and the investigation was performed by classifying students' outcomes. These classes were finally put next to original (quantitative) scores and the statistical calculations were initiated. Significant correlations between taxonomies (0.53) and the modified taxonomy and original scores (0.66) were found and some qualitative similarities between evaluation methods were observed. In addition, some supplements were recommended for the structure of evaluation schemes, especially for the structure of the modified SOLO taxonomy.

Cross-System Evaluation of Clinical Trial Search Engines

PubMed Central

Jiang, Silis Y.; Weng, Chunhua

2014-01-01

Clinical trials are fundamental to the advancement of medicine but constantly face recruitment difficulties. Various clinical trial search engines have been designed to help health consumers identify trials for which they may be eligible. Unfortunately, knowledge of the usefulness and usability of their designs remains scarce. In this study, we used mixed methods, including time-motion analysis, think-aloud protocol, and survey, to evaluate five popular clinical trial search engines with 11 users. Differences in user preferences and time spent on each system were observed and correlated with user characteristics. In general, searching for applicable trials using these systems is a cognitively demanding task. Our results show that user perceptions of these systems are multifactorial. The survey indicated eTACTS being the generally preferred system, but this finding did not persist among all mixed methods. This study confirms the value of mixed-methods for a comprehensive system evaluation. Future system designers must be aware that different users groups expect different functionalities. PMID:25954590

Cross-system evaluation of clinical trial search engines.

PubMed

Jiang, Silis Y; Weng, Chunhua

2014-01-01

Clinical trials are fundamental to the advancement of medicine but constantly face recruitment difficulties. Various clinical trial search engines have been designed to help health consumers identify trials for which they may be eligible. Unfortunately, knowledge of the usefulness and usability of their designs remains scarce. In this study, we used mixed methods, including time-motion analysis, think-aloud protocol, and survey, to evaluate five popular clinical trial search engines with 11 users. Differences in user preferences and time spent on each system were observed and correlated with user characteristics. In general, searching for applicable trials using these systems is a cognitively demanding task. Our results show that user perceptions of these systems are multifactorial. The survey indicated eTACTS being the generally preferred system, but this finding did not persist among all mixed methods. This study confirms the value of mixed-methods for a comprehensive system evaluation. Future system designers must be aware that different users groups expect different functionalities.

Evaluation of a Program by Assessing Students' Performance at the Beginning of the Next Course

ERIC Educational Resources Information Center

And Others; Petzel, Robert A.

1978-01-01

A method of evaluating a first-year introduction to clinical medicine (ICM) course is described in which assessment of student achievement of the course goals is made by subsequent clinical tutors. Tutors drawn from several clinical departments are urged to maximize students' opportunities to practice taking complete histories and physical…

Videotape Reliability: A Method of Evaluation of a Clinical Performance Examination.

ERIC Educational Resources Information Center

And Others; Liu, Philip

1980-01-01

A method of statistically analyzing clinical performance examinations for reliability and the application of this method in determining the reliability of two examinations of skill in administering anesthesia are described. Videotaped performances for the Spinal Anesthesia Skill Examination and the Anesthesia Setup and Machine Checkout Examination…

Comparison of methods for quantitative evaluation of endoscopic distortion

NASA Astrophysics Data System (ADS)

Wang, Quanzeng; Castro, Kurt; Desai, Viraj N.; Cheng, Wei-Chung; Pfefer, Joshua

2015-03-01

Endoscopy is a well-established paradigm in medical imaging, and emerging endoscopic technologies such as high resolution, capsule and disposable endoscopes promise significant improvements in effectiveness, as well as patient safety and acceptance of endoscopy. However, the field lacks practical standardized test methods to evaluate key optical performance characteristics (OPCs), in particular the geometric distortion caused by fisheye lens effects in clinical endoscopic systems. As a result, it has been difficult to evaluate an endoscope's image quality or assess its changes over time. The goal of this work was to identify optimal techniques for objective, quantitative characterization of distortion that are effective and not burdensome. Specifically, distortion measurements from a commercially available distortion evaluation/correction software package were compared with a custom algorithm based on a local magnification (ML) approach. Measurements were performed using a clinical gastroscope to image square grid targets. Recorded images were analyzed with the ML approach and the commercial software where the results were used to obtain corrected images. Corrected images based on the ML approach and the software were compared. The study showed that the ML method could assess distortion patterns more accurately than the commercial software. Overall, the development of standardized test methods for characterizing distortion and other OPCs will facilitate development, clinical translation, manufacturing quality and assurance of performance during clinical use of endoscopic technologies.

Surgery Clerkship Evaluations Are Insufficient for Clinical Skills Appraisal: The Value of a Medical Student Surgical Objective Structured Clinical Examination.

PubMed

Butler, Kathryn L; Hirsh, David A; Petrusa, Emil R; Yeh, D Dante; Stearns, Dana; Sloane, David E; Linder, Jeffrey A; Basu, Gaurab; Thompson, Lisa A; de Moya, Marc A

Optimal methods for medical student assessment in surgery remain elusive. Faculty- and housestaff-written evaluations constitute the chief means of student assessment in medical education. However, numerous studies show that this approach has poor specificity and a high degree of subjectivity. We hypothesized that an objective structured clinical examination (OSCE) in the surgery clerkship would provide additional data on student performance that would confirm or augment other measures of assessment. We retrospectively reviewed data from OSCEs, National Board of Medical Examiners shelf examinations, oral presentations, and written evaluations for 51 third-year Harvard Medical School students rotating in surgery at Massachusetts General Hospital from 2014 to 2015. We expressed correlations between numeric variables in Pearson coefficients, stratified differences between rater groups by one-way analysis of variance, and compared percentages with 2-sample t-tests. We examined commentary from both OSCE and clinical written evaluations through textual analysis and summarized these results in percentages. OSCE scores and clinical evaluation scores correlated poorly with each other, as well as with shelf examination scores and oral presentation grades. Textual analysis of clinical evaluation comments revealed a heavy emphasis on motivational factors and praise, whereas OSCE written comments focused on cognitive processes, patient management, and methods to improve performance. In this single-center study, an OSCE provided clinical skills data that were not captured elsewhere in the surgery clerkship. Textual analysis of faculty evaluations reflected an emphasis on interpersonal skills, rather than appraisal of clinical acumen. These findings suggest complementary roles of faculty evaluations and OSCEs in medical student assessment. Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Evaluation and comparison of predictive individual-level general surrogates.

PubMed

Gabriel, Erin E; Sachs, Michael C; Halloran, M Elizabeth

2018-07-01

An intermediate response measure that accurately predicts efficacy in a new setting at the individual level could be used both for prediction and personalized medical decisions. In this article, we define a predictive individual-level general surrogate (PIGS), which is an individual-level intermediate response that can be used to accurately predict individual efficacy in a new setting. While methods for evaluating trial-level general surrogates, which are predictors of trial-level efficacy, have been developed previously, few, if any, methods have been developed to evaluate individual-level general surrogates, and no methods have formalized the use of cross-validation to quantify the expected prediction error. Our proposed method uses existing methods of individual-level surrogate evaluation within a given clinical trial setting in combination with cross-validation over a set of clinical trials to evaluate surrogate quality and to estimate the absolute prediction error that is expected in a new trial setting when using a PIGS. Simulations show that our method performs well across a variety of scenarios. We use our method to evaluate and to compare candidate individual-level general surrogates over a set of multi-national trials of a pentavalent rotavirus vaccine.

Measuring Workload Demand of Informatics Systems with the Clinical Case Demand Index

PubMed Central

Iyengar, M. Sriram; Rogith, Deevakar; Florez-Arango, Jose F

2017-01-01

Introduction: The increasing use of Health Information Technology (HIT) can add substantially to workload on clinical providers. Current methods for assessing workload do not take into account the nature of clinical cases and the use of HIT tools while solving them. Methods: The Clinical Case Demand Index (CCDI), consisting of a summary score and visual representation, was developed to meet this need. Consistency with current perceived workload measures was evaluated in a Randomized Control Trial of a mobile health system. Results: CCDI is significantly correlated with existing workload measures and inversely related to provider performance. Discussion: CCDI combines subjective and objective characteristics of clinical cases along with cognitive and clinical dimensions. Applications include evaluation of HIT tools, clinician scheduling, medical education. Conclusion: CCDI supports comparative effectiveness research of HIT tools. In addition, CCDI could have numerous applications including training, clinical trials, design of clinical workflows, and others. PMID:29854166

Is This the Carbapenemase Test We've Been Waiting for? A Multicenter Evaluation of the Modified Carbapenem Inactivation Method.

PubMed

Butler-Wu, Susan M; Abbott, April N

2017-08-01

A plethora of phenotypic methods exist for the detection of carbapenemases; however, clinical laboratories have struggled for years with accurate, objective phenotypic detection of carbapenemase activity in Enterobacteriaceae In this issue of the Journal of Clinical Microbiology , V. M. Pierce et al. (J Clin Microbiol 55:2321-2333, 2017, https://doi.org/10.1128/JCM.00193-17) report on a multicenter evaluation of the modified carbapenem inactivation method (mCIM). The high sensitivity, specificity, reproducibility, and ease of interpretation associated with the mCIM for Enterobacteriaceae will likely lead to its adoption by clinical laboratories. Copyright © 2017 American Society for Microbiology.

[Evidence-based Chinese medicine：theory and practice].

PubMed

Zhang, Jun-Hua; Li, You-Ping; Zhang, Bo-Li

2018-01-01

The introduction and popularization of evidence-based medicine has opened up a new research field of clinical efficacy evaluation of traditional Chinese medicine(TCM), produced new research ideas and methods, and promoted the progress of clinical research of TCM. After about 20 years assiduous study and earnest practice, the evidence based evaluation method and technique, which conforms to the characteristics of TCM theory and practice, has been developing continuously. Evidence-based Chinese medicine (EBCM) has gradually formed and become an important branch of evidence-based medicine. The basic concept of evidence-based Chinese medicine: EBCM is an applied discipline, following the theory and methodology of evidence-based medicine, to collect, evaluate, produce, transform the evidence of effectiveness, safety and economy of TCM, to reveal the feature and regular pattern of TCM taking effect, and to guide the development of clinical guidelines, clinical pathways and health decisions. The effects and achievements of EBCM development: secondary studies mainly based on systematic review/Meta-analysis were extensively carried out; clinical efficacy studies mainly relying on randomized controlled trials grew rapidly; clinical safety evaluations based on real world study have been conducted; methodological researches mainly focused on study quality control deepened gradually; internationalization researches mainly on report specifications have got some breakthroughs; standardization researches based on treatment specification were strengthened gradually; the research team and talents with the characteristics of inter-disciplinary have been steadily increased. A number of high-quality research findings have been published at international well-known journals; the clinical efficacy and safety evidence of TCM has been increased; the level of clinical rational use of TCM has been improved; a large number of Chinese patent medicines with big market have been cultured. The future missions of EBCM mainly consist of four categories (scientific research, methodology and standard, platform construction and personnel training) with nine tasks. ①Carry out systematic reviews to systematically collect clinical trial reports of TCM and establish database of clinical evidence of TCM; ②Carry out evidence transformation research to lay the foundation for the development of clinical diagnosis and treatment guidelines, clinical pathways of TCM, and for the screening of basic drug list and medical insurance list, and for the policy-making relevant to TCM; ③Conduct researches to evaluate the advantages and effective regular patterns of TCM and form the evidence chain of TCM efficacy; ④Carry out researches for the safety evaluation of TCM, and provide evidence supporting the rational and safe use of TCM in clinical practice; ⑤Conduct researches on methodology of EBCM and provide method for developing high quality evidence; ⑥Carry out researches to develop standards and norms of TCM, and to form methods, standards, specifications and technical systems; ⑦Establish data management platform for evidence-based evaluation of TCM, and promote data sharing; ⑧Build international academic exchange platform to promote international cooperation and mutual recognition of EBCM research; ⑨Carry out education and popularization activities of evidence-based evaluation methods, and train undergraduate students, graduate students, clinical healthcare providers and practitioners of TCM. The development of EBCM, as it was, not only promoted the transformation of clinical research and decision-making mode of TCM, contributed to the modernization and internationalization of TCM, but also enriched the connotation of Evidence-based Medicine. Copyright© by the Chinese Pharmaceutical Association.

The contribution of clinical assessments to the diagnostic algorithm of pulmonary embolism.

PubMed

Turan, Onur; Turgut, Deniz; Gunay, Turkan; Yilmaz, Erkan; Turan, Ayse; Akkoclu, Atila

2017-01-01

Pulmonary thromboembolism (PE) is a major disease in respiratory emergencies. Thoracic CT angiography (CTA) is an important method of visualizing PE. Because of the high radiation and contrast exposure, the method should be performed selectively in patients in whom PE is suspected. The aim of the study was to identify the role of clinical scoring systems utilizing CTA results to diagnose PE. The study investigated 196 patients referred to the hospital emergency service in whom PE was suspected and CTA performed. They were evaluated by empirical, Wells, Geneva and Miniati assessments and classified as low, intermediate and high clinical probability. They were also classified according to serum D-dimer levels. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated and evaluated according to CTA findings. Empirical scoring was found to have the highest sensitivity, while the Wells system had the highest specificity. When low D-dimer levels and "low probabilty" were evaluated together for each scoring system, the sensitivity was found to be 100% for all methods. Wells scoring with a cut-off score of 4 had the highest specificity (56.1%). Clinical scoring systems may be guides for patients in whom PE is suspected in the emergency department. The empirical and Wells scoring systems are effective methods for patient selection. Adding evaluation of D-dimer serum levels to the clinical scores could identify patients in whom CTA should be performed. Since CTA can only be used conservatively, the use of clinical scoring systems in conjunction with D-dimer levels can be a useful guide for patient selection.

Measurement properties of existing clinical assessment methods evaluating scapular positioning and function. A systematic review.

PubMed

Larsen, Camilla Marie; Juul-Kristensen, Birgit; Lund, Hans; Søgaard, Karen

2014-10-01

The aims were to compile a schematic overview of clinical scapular assessment methods and critically appraise the methodological quality of the involved studies. A systematic, computer-assisted literature search using Medline, CINAHL, SportDiscus and EMBASE was performed from inception to October 2013. Reference lists in articles were also screened for publications. From 50 articles, 54 method names were identified and categorized into three groups: (1) Static positioning assessment (n = 19); (2) Semi-dynamic (n = 13); and (3) Dynamic functional assessment (n = 22). Fifteen studies were excluded for evaluation due to no/few clinimetric results, leaving 35 studies for evaluation. Graded according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN checklist), the methodological quality in the reliability and validity domains was "fair" (57%) to "poor" (43%), with only one study rated as "good". The reliability domain was most often investigated. Few of the assessment methods in the included studies that had "fair" or "good" measurement property ratings demonstrated acceptable results for both reliability and validity. We found a substantially larger number of clinical scapular assessment methods than previously reported. Using the COSMIN checklist the methodological quality of the included measurement properties in the reliability and validity domains were in general "fair" to "poor". None were examined for all three domains: (1) reliability; (2) validity; and (3) responsiveness. Observational evaluation systems and assessment of scapular upward rotation seem suitably evidence-based for clinical use. Future studies should test and improve the clinimetric properties, and especially diagnostic accuracy and responsiveness, to increase utility for clinical practice.

Attitudes of affiliate faculty members toward medical student summative evaluation for clinical clerkships: a qualitative analysis.

PubMed

Wang, Karen E; Fitzpatrick, Caroline; George, David; Lane, Lindsey

2012-01-01

Summative evaluation of medical students is a critical component of the educational process. Despite extensive literature on evaluation, few studies have centered on affiliate faculty members' attitudes toward summative evaluation of students, though it has been suggested that these attitudes influence their effectiveness as evaluators. The objective is to examine affiliate faculty members' attitudes toward clinical clerkship evaluation using primarily qualitative research methods. The study used a nonexperimental research design and employed mixed methods. Data were collected through interviews, focus groups, and a questionnaire from 11 affiliate faculty members. Themes emerging from the data fell into three broad categories: (a) factors that influence grading, (b) consequences of negative evaluations, and (c) disconnections in the grading process. The quantitative portion of the study revealed important discrepancies supporting the use of qualitative methods. The study highlights faculty members' struggles with the evaluative process and emphasizes the need for improvements in evaluation tools and faculty development.

Comparative evaluation of neonatal bilirubin using Radiometer whole blood co-oximetry and plasma bilirubin methods from Roche Diagnostics and Ortho Clinical Diagnostics.

PubMed

Lano, Ian Marie; Lyon, Andrew W; Wang, Li; Ruskin, Rob; Lyon, Martha E

2018-03-01

Clinically significant variation has been reported within and between plasma and whole blood total bilirubin methods used to identify neonates for whom clinical intervention for hyperbilirubinemia may be required. To evaluate total bilirubin measurements between the Radiometer whole blood co-oximeter and plasma bilirubin methods from Roche Diagnostics and Ortho Clinical Diagnostics using neonatal specimens. Total bilirubin levels were analyzed by whole blood co-oximetry (Radiometer® ABL90). Specimens were centrifuged and plasma analyzed for total bilirubin with a diazo method (Roche Cobas® C-601) and a reflectance spectrophotometric BuBc dry film method (Ortho Clinical Diagnostics VITROS® 350). Results were evaluated by regression, Bland-Altman comparisons and t-tests. The patient correlation study yielded the following regression equations in μmol/L: a) Radiometer=1.03 Roche - 3.5μmol/L b) Radiometer=0.98 Ortho - 5.7μmol/L c) Roche=0.97 Ortho - 2.4μmol/L. The mean bias over the range of total bilirubin levels examined was -1.0μmol/L for the Radiometer versus the Roche (p≤0.305); -4.4μmol/L for the Radiometer versus Ortho (p≤0.005) and -4.4μmol/L for the Roche versus Ortho (p≤0.002). Whole blood total bilirubin measurement using the Radiometer ABL90 blood gas analyzer provides accurate and precise results compared to the Roche plasma diazo method. Compared to the reflectance spectrophotometric method, results are precise and had a small but statistically significant bias of -4.4μmol/L. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Natural air leak test without submergence for spontaneous pneumothorax.

PubMed

Uramoto, Hidetaka; Tanaka, Fumihiro

2011-12-24

Postoperative air leaks are frequent complications after surgery for a spontaneous pneumothorax (SP). We herein describe a new method to test for air leaks by using a transparent film and thoracic tube in a closed system. Between 2005 and 2010, 35 patients underwent a novel method for evaluating air leaks without submergence, and their clinical records were retrospectively reviewed. The data on patient characteristics, surgical details, and perioperative outcomes were analyzed. The differences in the clinical background and intraoperative factors did not reach a statistically significant level between the new and classical methods. The incidence of recurrence was also equivalent to the standard method. However, the length of the operation and drainage periods were significantly shorter in patients evaluated using the new method than the conventional method. Further, no postoperative complications were observed in patients evaluated using the new method. This simple technique is satisfactorily effective and does not result in any complications.

The influence of an elective introductory clinical research course on pharmacy student interest in pursuing research-based careers.

PubMed

Overholser, Brian R; Foster, David R; Henry, Joshua R; Plake, Kimberly S; Sowinski, Kevin M

2010-11-10

To assess the impact of an elective clinical research course on second- and third-year pharmacy students' knowledge of clinical research methods, training programs, career options, and interest in pursuing postgraduate training. A 2-credit hour elective course in clinical research was designed that included lectures, discussions, workshops, and in-class presentations related to study design and implementation, protocol synthesis, research evaluation, ethical and legal considerations, data analysis, and professional opportunities involving clinical research. Learner knowledge of these topics was assessed using several methods, including 3 assignments related to research protocol, ethical documentation, and presentation. A survey instrument designed to evaluate the effect the course had on pharmacy students' knowledge of clinical research methods and interest in pursuing postgraduate training in clinical research was administered. Students who completed the elective had a greater level of familiarity with research-related topics, training options, and career opportunities (p < 0.05) and a greater interest in pursuing a career in clinical research (p < 0.05) than did students in a matched control group. Taking a 2-credit hour elective course in clinical research increased pharmacy students' interest in pursuing a career in clinical research.

[Sample size calculation in clinical post-marketing evaluation of traditional Chinese medicine].

PubMed

Fu, Yingkun; Xie, Yanming

2011-10-01

In recent years, as the Chinese government and people pay more attention on the post-marketing research of Chinese Medicine, part of traditional Chinese medicine breed has or is about to begin after the listing of post-marketing evaluation study. In the post-marketing evaluation design, sample size calculation plays a decisive role. It not only ensures the accuracy and reliability of post-marketing evaluation. but also assures that the intended trials will have a desired power for correctly detecting a clinically meaningful difference of different medicine under study if such a difference truly exists. Up to now, there is no systemic method of sample size calculation in view of the traditional Chinese medicine. In this paper, according to the basic method of sample size calculation and the characteristic of the traditional Chinese medicine clinical evaluation, the sample size calculation methods of the Chinese medicine efficacy and safety are discussed respectively. We hope the paper would be beneficial to medical researchers, and pharmaceutical scientists who are engaged in the areas of Chinese medicine research.

The effectiveness of clinical teaching of mental health courses in nursing using clinical supervision and Kirkpatrick's model.

PubMed

Maddineshat, Maryam; Hashemi, Mitra; Besharati, Reza; Gholami, Sepideh; Ghavidel, Fatemeh

2018-01-01

Clinical experience associated with the fear and anxiety of nursing students in the psychiatric unit. Mental health nursing instructors find it challenging to teach nursing students to deal with patients with mental disorders in an environment where they need to provide patient teaching and clinical decision-making based on evidence and new technology. To measure the effectiveness of clinical teaching of mental health courses in nursing using clinical supervision and Kirkpatrick's model evaluation in the psychiatry unit of Imam Reza Hospital, Bojnurd, Iran. This cross-sectional study was carried out from 2011 to 2016 on 76 nursing students from a university as part of a clinical mental health course in two semesters. The students were selected by a non-probable convenient sampling method. After completing their clinical education, each student responded to checklist questions based on the four-level Kirkpatrick's model evaluation and open questions relating to clinical supervision. Finally, all data was analyzed using the SPSS version 16. The students have evaluated clinical supervision as a useful approach, and appreciated the instructor's supportive behavior during teaching and imparting clinical skills. This has made them feel relaxed at the end of the clinical teaching course. In addition, in the evaluation through Kirkpatrick's model, more than 70% of the students have been satisfied with the method of conducting the teaching and average score of nursing students' attitude toward mental health students: Their mean self-confidence score was 18.33±1.69, and the mean score of their performance in the study was evaluated to be 93.74±5.3 from 100 points. The results of clinical mental health teaching through clinical supervision and Kirkpatrick's model evaluation show that the satisfaction, self-esteem, attitude, and skill of nursing students are excellent, thereby portraying the effectiveness of clinical teaching. But this program still needs to be reformed. To establish long-term goals and obtain knowledge and clinical skills of nursing, it is recommended to develop a curriculum and evaluate it appropriately.

[Methods of investigation in clinical cardiology. VIII. Socioeconomic evaluation of clinical cardiology practice].

PubMed

Lázaro de Mercado, P

1997-06-01

Health services are systems whose mission is to improve the health status of both individuals and society in general. In recent decades, these systems have faced challenges such as their increasing complexity, limited resources, rapid innovation and diffusion of medical technologies, pressures on demand from society and professionals, and the lack of knowledge of the effects of these factors on costs and society's health. In addition, health care expenditures have grown twice as fast as wealth in industrialized countries during the last 25 years. These problems have prompted cost containment as a key issue in health policy and, at the same time, have promoted the development of socioeconomic evaluation as a scientific activity in the frame of health services research. Socioeconomic evaluation tries to determine if the sacrifice made by society, which devotes part of its limited resources to health care, maximizes the outcomes for population. This article describes basic concepts and methods of economic appraisal in health services which are illustrated with examples of clinical practice in cardiology. Common methods of evaluation are described; the relation between the clinical outcome of a procedure and its associated costs is emphasized in explaining the types of efficiency analysis (cost-efficacy, cost-effectiveness, cost-utility, and cost-benefit); and finally a guide for socioeconomic evaluation is provided.

Evaluation of evidence-based literature and formulation of recommendations for the clinical preventive guidelines for immigrants and refugees in Canada

PubMed Central

Tugwell, Peter; Pottie, Kevin; Welch, Vivian; Ueffing, Erin; Chambers, Andrea; Feightner, John

2011-01-01

Background: This article describes the evidence review and guideline development method developed for the Clinical Preventive Guidelines for Immigrants and Refugees in Canada by the Canadian Collaboration for Immigrant and Refugee Health Guideline Committee. Methods: The Appraisal of Guidelines for Research and Evaluation (AGREE) best-practice framework was combined with the recently developed Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to produce evidence-based clinical guidelines for immigrants and refugees in Canada. Results: A systematic approach was designed to produce the evidence reviews and apply the GRADE approach, including building on evidence from previous systematic reviews, searching for and comparing evidence between general and specific immigrant populations, and applying the GRADE criteria for making recommendations. This method was used for priority health conditions that had been selected by practitioners caring for immigrants and refugees in Canada. Interpretation: This article outlines the 14-step method that was defined to standardize the guideline development process for each priority health condition. PMID:20573711

Clinical role of non-invasive assessment of portal hypertension.

PubMed

Bolognesi, Massimo; Di Pascoli, Marco; Sacerdoti, David

2017-01-07

Measurement of portal pressure is pivotal in the evaluation of patients with liver cirrhosis. The measurement of the hepatic venous pressure gradient represents the reference method by which portal pressure is estimated. However, it is an invasive procedure that requires significant hospital resources, including experienced staff, and is associated with considerable cost. Non-invasive methods that can be reliably used to estimate the presence and the degree of portal hypertension are urgently needed in clinical practice. Biochemical and morphological parameters have been proposed for this purpose, but have shown disappointing results overall. Splanchnic Doppler ultrasonography and the analysis of microbubble contrast agent kinetics with contrast-enhanced ultrasonography have shown better accuracy for the evaluation of patients with portal hypertension. A key advancement in the non-invasive evaluation of portal hypertension has been the introduction in clinical practice of methods able to measure stiffness in the liver, as well as stiffness/congestion in the spleen. According to the data published to date, it appears to be possible to rule out clinically significant portal hypertension in patients with cirrhosis ( i.e ., hepatic venous pressure gradient ≥ 10 mmHg) with a level of clinically-acceptable accuracy by combining measurements of liver stiffness and spleen stiffness along with Doppler ultrasound evaluation. It is probable that the combination of these methods may also allow for the identification of patients with the most serious degree of portal hypertension, and ongoing research is helping to ensure progress in this field.

Clinical role of non-invasive assessment of portal hypertension

PubMed Central

Bolognesi, Massimo; Di Pascoli, Marco; Sacerdoti, David

2017-01-01

Measurement of portal pressure is pivotal in the evaluation of patients with liver cirrhosis. The measurement of the hepatic venous pressure gradient represents the reference method by which portal pressure is estimated. However, it is an invasive procedure that requires significant hospital resources, including experienced staff, and is associated with considerable cost. Non-invasive methods that can be reliably used to estimate the presence and the degree of portal hypertension are urgently needed in clinical practice. Biochemical and morphological parameters have been proposed for this purpose, but have shown disappointing results overall. Splanchnic Doppler ultrasonography and the analysis of microbubble contrast agent kinetics with contrast-enhanced ultrasonography have shown better accuracy for the evaluation of patients with portal hypertension. A key advancement in the non-invasive evaluation of portal hypertension has been the introduction in clinical practice of methods able to measure stiffness in the liver, as well as stiffness/congestion in the spleen. According to the data published to date, it appears to be possible to rule out clinically significant portal hypertension in patients with cirrhosis (i.e., hepatic venous pressure gradient ≥ 10 mmHg) with a level of clinically-acceptable accuracy by combining measurements of liver stiffness and spleen stiffness along with Doppler ultrasound evaluation. It is probable that the combination of these methods may also allow for the identification of patients with the most serious degree of portal hypertension, and ongoing research is helping to ensure progress in this field. PMID:28104976

A Preliminary Study of Clinical Abbreviation Disambiguation in Real Time.

PubMed

Wu, Y; Denny, J C; Rosenbloom, S T; Miller, R A; Giuse, D A; Song, M; Xu, H

2015-01-01

To save time, healthcare providers frequently use abbreviations while authoring clinical documents. Nevertheless, abbreviations that authors deem unambiguous often confuse other readers, including clinicians, patients, and natural language processing (NLP) systems. Most current clinical NLP systems "post-process" notes long after clinicians enter them into electronic health record systems (EHRs). Such post-processing cannot guarantee 100% accuracy in abbreviation identification and disambiguation, since multiple alternative interpretations exist. Authors describe a prototype system for real-time Clinical Abbreviation Recognition and Disambiguation (rCARD) - i.e., a system that interacts with authors during note generation to verify correct abbreviation senses. The rCARD system design anticipates future integration with web-based clinical documentation systems to improve quality of healthcare records. When clinicians enter documents, rCARD will automatically recognize each abbreviation. For abbreviations with multiple possible senses, rCARD will show a ranked list of possible meanings with the best predicted sense at the top. The prototype application embodies three word sense disambiguation (WSD) methods to predict the correct senses of abbreviations. We then conducted three experments to evaluate rCARD, including 1) a performance evaluation of different WSD methods; 2) a time evaluation of real-time WSD methods; and 3) a user study of typing clinical sentences with abbreviations using rCARD. Using 4,721 sentences containing 25 commonly observed, highly ambiguous clinical abbreviations, our evaluation showed that the best profile-based method implemented in rCARD achieved a reasonable WSD accuracy of 88.8% (comparable to SVM - 89.5%) and the cost of time for the different WSD methods are also acceptable (ranging from 0.630 to 1.649 milliseconds within the same network). The preliminary user study also showed that the extra time costs by rCARD were about 5% of total document entry time and users did not feel a significant delay when using rCARD for clinical document entry. The study indicates that it is feasible to integrate a real-time, NLP-enabled abbreviation recognition and disambiguation module with clinical documentation systems.

Evaluating clinical librarian services: a systematic review.

PubMed

Brettle, Alison; Maden-Jenkins, Michelle; Anderson, Lucy; McNally, Rosalind; Pratchett, Tracey; Tancock, Jenny; Thornton, Debra; Webb, Anne

2011-03-01

  Previous systematic reviews have indicated limited evidence and poor quality evaluations of clinical librarian (CL) services. Rigorous evaluations should demonstrate the value of CL services, but guidance is needed before this can be achieved.   To undertake a systematic review which examines models of CL services, quality, methods and perspectives of clinical librarian service evaluations.   Systematic review methodology and synthesis of evidence, undertaken collaboratively by a group of 8 librarians to develop research and critical appraisal skills.   There are four clear models of clinical library service provision. Clinical librarians are effective in saving health professionals time, providing relevant, useful information and high quality services. Clinical librarians have a positive effect on clinical decision making by contributing to better informed decisions, diagnosis and choice of drug or therapy. The quality of CL studies is improving, but more work is needed on reducing bias and providing evidence of specific impacts on patient care. The Critical Incident Technique as part of a mixed method approach appears to offer a useful approach to demonstrating impact.   This systematic review provides practical guidance regarding the evaluation of CL services. It also provides updated evidence regarding the effectiveness and impact of CL services. The approach used was successful in developing research and critical appraisal skills in a group of librarians. © 2010 The authors. Health Information and Libraries Journal © 2010 Health Libraries Group.

Challenges in evaluating clinical governance systems in iran: a qualitative study.

PubMed

Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

2014-04-01

In spite of the pivotal role of clinical governance in enhancing quality of services provided by hospitals across the country, a scientific framework with specific criteria for evaluating hospitals has not been developed so far. This study was conducted with the aim to identify the challenges involved in evaluating systems of clinical governance in Iran. For the purposes of this qualitative study, 15 semi-structured interviews with experts in the field were conducted in 2011 and the data were analyzed using framework analysis method. Five major challenges in evaluating clinical governance include managing human resources, improving clinical quality, managing development, organizing clinical governance, and providing patient-oriented healthcare system. Healthcare system in Iran requires a clinical governance program which has a patient-oriented approach in philosophy, operation, and effectiveness in order to meet the challenges ahead.

[Abdomen specific bioelectrical impedance analysis (BIA) methods for evaluation of abdominal fat distribution].

PubMed

Ida, Midori; Hirata, Masakazu; Hosoda, Kiminori; Nakao, Kazuwa

2013-02-01

Two novel bioelectrical impedance analysis (BIA) methods have been developed recently for evaluation of intra-abdominal fat accumulation. Both methods use electrodes that are placed on abdominal wall and allow evaluation of intra-abdominal fat area (IAFA) easily without radiation exposure. Of these, "abdominal BIA" method measures impedance distribution along abdominal anterior-posterior axis, and IAFA by BIA method(BIA-IAFA) is calculated from waist circumference and the voltage occurring at the flank. Dual BIA method measures impedance of trunk and body surface at the abdominal level and calculates BIA-IAFA from transverse and antero-posterior diameters of the abdomen and the impedance of trunk and abdominal surface. BIA-IAFA by these two BIA methods correlated well with IAFA measured by abdominal CT (CT-IAFA) with correlatipn coefficient of 0.88 (n = 91, p < 0.0001) for the former, and 0.861 (n = 469, p < 0.01) for the latter. These new BIA methods are useful for evaluating abdominal adiposity in clinical study and routine clinical practice of metabolic syndrome and obesity.

[Critical revision of the available methods for evaluate the body composition in population-based and clinical studies].

PubMed

Rezende, Fabiane; Rosado, Lina; Franceschinni, Sylvia; Rosado, Gilberto; Ribeiro, Rita; Marins, João Carlos Bouzas

2007-12-01

The corporal composition evaluation is extremely important for the individual and population nutritional state diagnosis and for the establishment of appropriate clinical-nutritional conducts. An excess of body fat is frequently associated with important metabolic alterations and chronic diseases, such as diabetes, hypertension and dyslipidemia The availability of methods to assess body composition is essential to evaluate health status of individuals. There are several methods for the corporal composition analysis, and it is important to know the limitation of each one and his/her validity so that the obtained estimates are reliable and correctly interpreted. The purpose of this study was to revise the applicability of some nutritional state indicators and corporal composition evaluation methods, such as corporal mass index, waist circumference and waist-hip relation, skinfold measurements, bioelectrical impedance analysis and near-infrared interactance.

ACORN's Accelerated Income Redistribution Project: A Program Evaluation

ERIC Educational Resources Information Center

Brooks, Fred; Russell, Daniel; Fisher, Robert

2006-01-01

Objective: This study evaluated the Association of Community Organizations for Reform Now's (ACORN) efforts to increase the uptake of families claiming the earned income tax credit through door-to-door canvassing and managing free tax preparation clinics in three pilot cities. Method: The mixed-method program evaluation included administrative…

Tremor Detection Using Parametric and Non-Parametric Spectral Estimation Methods: A Comparison with Clinical Assessment

PubMed Central

Martinez Manzanera, Octavio; Elting, Jan Willem; van der Hoeven, Johannes H.; Maurits, Natasha M.

2016-01-01

In the clinic, tremor is diagnosed during a time-limited process in which patients are observed and the characteristics of tremor are visually assessed. For some tremor disorders, a more detailed analysis of these characteristics is needed. Accelerometry and electromyography can be used to obtain a better insight into tremor. Typically, routine clinical assessment of accelerometry and electromyography data involves visual inspection by clinicians and occasionally computational analysis to obtain objective characteristics of tremor. However, for some tremor disorders these characteristics may be different during daily activity. This variability in presentation between the clinic and daily life makes a differential diagnosis more difficult. A long-term recording of tremor by accelerometry and/or electromyography in the home environment could help to give a better insight into the tremor disorder. However, an evaluation of such recordings using routine clinical standards would take too much time. We evaluated a range of techniques that automatically detect tremor segments in accelerometer data, as accelerometer data is more easily obtained in the home environment than electromyography data. Time can be saved if clinicians only have to evaluate the tremor characteristics of segments that have been automatically detected in longer daily activity recordings. We tested four non-parametric methods and five parametric methods on clinical accelerometer data from 14 patients with different tremor disorders. The consensus between two clinicians regarding the presence or absence of tremor on 3943 segments of accelerometer data was employed as reference. The nine methods were tested against this reference to identify their optimal parameters. Non-parametric methods generally performed better than parametric methods on our dataset when optimal parameters were used. However, one parametric method, employing the high frequency content of the tremor bandwidth under consideration (High Freq) performed similarly to non-parametric methods, but had the highest recall values, suggesting that this method could be employed for automatic tremor detection. PMID:27258018

The use of digital PCR to improve the application of quantitative molecular diagnostic methods for tuberculosis.

PubMed

Devonshire, Alison S; O'Sullivan, Denise M; Honeyborne, Isobella; Jones, Gerwyn; Karczmarczyk, Maria; Pavšič, Jernej; Gutteridge, Alice; Milavec, Mojca; Mendoza, Pablo; Schimmel, Heinz; Van Heuverswyn, Fran; Gorton, Rebecca; Cirillo, Daniela Maria; Borroni, Emanuele; Harris, Kathryn; Barnard, Marinus; Heydenrych, Anthenette; Ndusilo, Norah; Wallis, Carole L; Pillay, Keshree; Barry, Thomas; Reddington, Kate; Richter, Elvira; Mozioğlu, Erkan; Akyürek, Sema; Yalçınkaya, Burhanettin; Akgoz, Muslum; Žel, Jana; Foy, Carole A; McHugh, Timothy D; Huggett, Jim F

2016-08-03

Real-time PCR (qPCR) based methods, such as the Xpert MTB/RIF, are increasingly being used to diagnose tuberculosis (TB). While qualitative methods are adequate for diagnosis, the therapeutic monitoring of TB patients requires quantitative methods currently performed using smear microscopy. The potential use of quantitative molecular measurements for therapeutic monitoring has been investigated but findings have been variable and inconclusive. The lack of an adequate reference method and reference materials is a barrier to understanding the source of such disagreement. Digital PCR (dPCR) offers the potential for an accurate method for quantification of specific DNA sequences in reference materials which can be used to evaluate quantitative molecular methods for TB treatment monitoring. To assess a novel approach for the development of quality assurance materials we used dPCR to quantify specific DNA sequences in a range of prototype reference materials and evaluated accuracy between different laboratories and instruments. The materials were then also used to evaluate the quantitative performance of qPCR and Xpert MTB/RIF in eight clinical testing laboratories. dPCR was found to provide results in good agreement with the other methods tested and to be highly reproducible between laboratories without calibration even when using different instruments. When the reference materials were analysed with qPCR and Xpert MTB/RIF by clinical laboratories, all laboratories were able to correctly rank the reference materials according to concentration, however there was a marked difference in the measured magnitude. TB is a disease where the quantification of the pathogen could lead to better patient management and qPCR methods offer the potential to rapidly perform such analysis. However, our findings suggest that when precisely characterised materials are used to evaluate qPCR methods, the measurement result variation is too high to determine whether molecular quantification of Mycobacterium tuberculosis would provide a clinically useful readout. The methods described in this study provide a means by which the technical performance of quantitative molecular methods can be evaluated independently of clinical variability to improve accuracy of measurement results. These will assist in ultimately increasing the likelihood that such approaches could be used to improve patient management of TB.

Detecting clinically relevant new information in clinical notes across specialties and settings.

PubMed

Zhang, Rui; Pakhomov, Serguei V S; Arsoniadis, Elliot G; Lee, Janet T; Wang, Yan; Melton, Genevieve B

2017-07-05

Automated methods for identifying clinically relevant new versus redundant information in electronic health record (EHR) clinical notes is useful for clinicians and researchers involved in patient care and clinical research, respectively. We evaluated methods to automatically identify clinically relevant new information in clinical notes, and compared the quantity of redundant information across specialties and clinical settings. Statistical language models augmented with semantic similarity measures were evaluated as a means to detect and quantify clinically relevant new and redundant information over longitudinal clinical notes for a given patient. A corpus of 591 progress notes over 40 inpatient admissions was annotated for new information longitudinally by physicians to generate a reference standard. Note redundancy between various specialties was evaluated on 71,021 outpatient notes and 64,695 inpatient notes from 500 solid organ transplant patients (April 2015 through August 2015). Our best method achieved at best performance of 0.87 recall, 0.62 precision, and 0.72 F-measure. Addition of semantic similarity metrics compared to baseline improved recall but otherwise resulted in similar performance. While outpatient and inpatient notes had relatively similar levels of high redundancy (61% and 68%, respectively), redundancy differed by author specialty with mean redundancy of 75%, 66%, 57%, and 55% observed in pediatric, internal medicine, psychiatry and surgical notes, respectively. Automated techniques with statistical language models for detecting redundant versus clinically relevant new information in clinical notes do not improve with the addition of semantic similarity measures. While levels of redundancy seem relatively similar in the inpatient and ambulatory settings in the Fairview Health Services, clinical note redundancy appears to vary significantly with different medical specialties.

Clinical use of acid steatocrit.

PubMed

Van den Neucker, A; Pestel, N; Tran, T M; Forget, P P; Veeze, H J; Bouquet, J; Sinaasappel, M

1997-05-01

Malabsorption of fat is an important gastrointestinal cause of malnutrition and growth retardation in childhood. The gold standard for the evaluation of fat malabsorption is the faecal fat balance method. The acid steatocrit method has recently been introduced as a simple method to evaluate faecal fat. The present study was aimed at evaluating the acid steatocrit in clinical practice. Faecal fat excretion and acid steatocrit results were determined in 42 children, half with and half without fat malabsorption. Acid steatocrit results correlated significantly with both faecal fat excretion (p < 0.01) and faecal fat concentration (p < 0.001). Sensitivity and specificity of the acid steatocrit for the diagnosis of malabsorption were 90% and 100%, respectively. We consider the acid steatocrit method useful for the screening and monitoring of patients with steatorrhoea.

Method of evaluation of process of red blood cell sedimentation based on photometry of droplet samples.

PubMed

Aristov, Alexander; Nosova, Ekaterina

2017-04-01

The paper focuses on research aimed at creating and testing a new approach to evaluate the processes of aggregation and sedimentation of red blood cells for purpose of its use in clinical laboratory diagnostics. The proposed method is based on photometric analysis of blood sample formed as a sessile drop. The results of clinical approbation of this method are given in the paper. Analysis of the processes occurring in the sample in the form of sessile drop during the process of blood cells sedimentation is described. The results of experimental studies to evaluate the effect of the droplet sample focusing properties on light radiation transmittance are presented. It is shown that this method significantly reduces the sample volume and provides sufficiently high sensitivity to the studied processes.

Decision curve analysis: a novel method for evaluating prediction models.

PubMed

Vickers, Andrew J; Elkin, Elena B

2006-01-01

Diagnostic and prognostic models are typically evaluated with measures of accuracy that do not address clinical consequences. Decision-analytic techniques allow assessment of clinical outcomes but often require collection of additional information and may be cumbersome to apply to models that yield a continuous result. The authors sought a method for evaluating and comparing prediction models that incorporates clinical consequences,requires only the data set on which the models are tested,and can be applied to models that have either continuous or dichotomous results. The authors describe decision curve analysis, a simple, novel method of evaluating predictive models. They start by assuming that the threshold probability of a disease or event at which a patient would opt for treatment is informative of how the patient weighs the relative harms of a false-positive and a false-negative prediction. This theoretical relationship is then used to derive the net benefit of the model across different threshold probabilities. Plotting net benefit against threshold probability yields the "decision curve." The authors apply the method to models for the prediction of seminal vesicle invasion in prostate cancer patients. Decision curve analysis identified the range of threshold probabilities in which a model was of value, the magnitude of benefit, and which of several models was optimal. Decision curve analysis is a suitable method for evaluating alternative diagnostic and prognostic strategies that has advantages over other commonly used measures and techniques.

Developing and using a rubric for evaluating evidence-based medicine point-of-care tools

PubMed Central

Foster, Margaret J

2011-01-01

Objective: The research sought to establish a rubric for evaluating evidence-based medicine (EBM) point-of-care tools in a health sciences library. Methods: The authors searched the literature for EBM tool evaluations and found that most previous reviews were designed to evaluate the ability of an EBM tool to answer a clinical question. The researchers' goal was to develop and complete rubrics for assessing these tools based on criteria for a general evaluation of tools (reviewing content, search options, quality control, and grading) and criteria for an evaluation of clinical summaries (searching tools for treatments of common diagnoses and evaluating summaries for quality control). Results: Differences between EBM tools' options, content coverage, and usability were minimal. However, the products' methods for locating and grading evidence varied widely in transparency and process. Conclusions: As EBM tools are constantly updating and evolving, evaluation of these tools needs to be conducted frequently. Standards for evaluating EBM tools need to be established, with one method being the use of objective rubrics. In addition, EBM tools need to provide more information about authorship, reviewers, methods for evidence collection, and grading system employed. PMID:21753917

Competence evaluation processes for nursing students abroad: Findings from an international case study.

PubMed

Tommasini, Cristina; Dobrowolska, Beata; Zarzycka, Danuta; Bacatum, Claudia; Bruun, Anne Marie Gran; Korsath, Dag; Roel, Siv; Jansen, Mette Bro; Milling, Tine; Deschamps, Anne; Mantzoukas, Stefanos; Mantzouka, Christine; Palese, Alvisa

2017-04-01

Assessing clinical competence in nursing students abroad is a challenge, and requires both methods and instruments capable of capturing the multidimensional nature of the clinical competences acquired. The aim of the study was to compare the clinical competence assessment processes and instruments adopted for nursing students during their clinical placement abroad. A case study design was adopted in 2015. A purposeful sample of eight nursing programmes located in seven countries (Belgium, Denmark, Greece, Norway, Poland, Portugal and Italy) were approached. Tools as instruments for evaluating competences developed in clinical training by international nursing students, and written procedures aimed at guiding the evaluation process, were scrutinised through a content analysis method. All clinical competence evaluation procedures and instruments used in the nursing programmes involved were provided in English. A final evaluation of the competences was expected by all nursing programmes at the end of the clinical placement, while only four provided an intermediate evaluation. Great variability emerged in the tools, with between five and 88 items included. Through content analysis, 196 items emerged, classified into 12 different core competence categories, the majority were categorised as 'Technical skills' (=60), 'Self-learning and critical thinking' (=27) and 'Nursing care process' (=25) competences. Little emphasis was given in the tools to competences involving 'Self-adaptation', 'Inter-professional skills', 'Clinical documentation', 'Managing nursing care', 'Patient communication', and 'Theory and practice integration'. Institutions signing Bilateral Agreements should agree upon the competences expected from students during their clinical education abroad. The tools used in the process, as well as the role expected by the student, should also be agreed upon. Intercultural competences should be further addressed in the process of evaluation, in addition to adaptation to different settings. There is also a need to establish those competences achievable or not in the host country, aiming at increasing transparency in learning expectations and evaluation. Copyright © 2017 Elsevier Ltd. All rights reserved.

Word sense disambiguation in the clinical domain: a comparison of knowledge-rich and knowledge-poor unsupervised methods

PubMed Central

Chasin, Rachel; Rumshisky, Anna; Uzuner, Ozlem; Szolovits, Peter

2014-01-01

Objective To evaluate state-of-the-art unsupervised methods on the word sense disambiguation (WSD) task in the clinical domain. In particular, to compare graph-based approaches relying on a clinical knowledge base with bottom-up topic-modeling-based approaches. We investigate several enhancements to the topic-modeling techniques that use domain-specific knowledge sources. Materials and methods The graph-based methods use variations of PageRank and distance-based similarity metrics, operating over the Unified Medical Language System (UMLS). Topic-modeling methods use unlabeled data from the Multiparameter Intelligent Monitoring in Intensive Care (MIMIC II) database to derive models for each ambiguous word. We investigate the impact of using different linguistic features for topic models, including UMLS-based and syntactic features. We use a sense-tagged clinical dataset from the Mayo Clinic for evaluation. Results The topic-modeling methods achieve 66.9% accuracy on a subset of the Mayo Clinic's data, while the graph-based methods only reach the 40–50% range, with a most-frequent-sense baseline of 56.5%. Features derived from the UMLS semantic type and concept hierarchies do not produce a gain over bag-of-words features in the topic models, but identifying phrases from UMLS and using syntax does help. Discussion Although topic models outperform graph-based methods, semantic features derived from the UMLS prove too noisy to improve performance beyond bag-of-words. Conclusions Topic modeling for WSD provides superior results in the clinical domain; however, integration of knowledge remains to be effectively exploited. PMID:24441986

Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.

PubMed

Lansky, Alexandra J; Messé, Steven R; Brickman, Adam M; Dwyer, Michael; Bart van der Worp, H; Lazar, Ronald M; Pietras, Cody G; Abrams, Kevin J; McFadden, Eugene; Petersen, Nils H; Browndyke, Jeffrey; Prendergast, Bernard; Ng, Vivian G; Cutlip, Donald E; Kapadia, Samir; Krucoff, Mitchell W; Linke, Axel; Scala Moy, Claudia; Schofer, Joachim; van Es, Gerrit-Anne; Virmani, Renu; Popma, Jeffrey; Parides, Michael K; Kodali, Susheel; Bilello, Michel; Zivadinov, Robert; Akar, Joseph; Furie, Karen L; Gress, Daryl; Voros, Szilard; Moses, Jeffrey; Greer, David; Forrest, John K; Holmes, David; Kappetein, Arie P; Mack, Michael; Baumbach, Andreas

2018-05-14

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.

Improving the clinical assessment of consciousness with advances in electrophysiological and neuroimaging techniques

PubMed Central

2010-01-01

In clinical neurology, a comprehensive understanding of consciousness has been regarded as an abstract concept - best left to philosophers. However, times are changing and the need to clinically assess consciousness is increasingly becoming a real-world, practical challenge. Current methods for evaluating altered levels of consciousness are highly reliant on either behavioural measures or anatomical imaging. While these methods have some utility, estimates of misdiagnosis are worrisome (as high as 43%) - clearly this is a major clinical problem. The solution must involve objective, physiologically based measures that do not rely on behaviour. This paper reviews recent advances in physiologically based measures that enable better evaluation of consciousness states (coma, vegetative state, minimally conscious state, and locked in syndrome). Based on the evidence to-date, electroencephalographic and neuroimaging based assessments of consciousness provide valuable information for evaluation of residual function, formation of differential diagnoses, and estimation of prognosis. PMID:20113490

Towards standardized assessment of endoscope optical performance: geometric distortion

NASA Astrophysics Data System (ADS)

Wang, Quanzeng; Desai, Viraj N.; Ngo, Ying Z.; Cheng, Wei-Chung; Pfefer, Joshua

2013-12-01

Technological advances in endoscopes, such as capsule, ultrathin and disposable devices, promise significant improvements in safety, clinical effectiveness and patient acceptance. Unfortunately, the industry lacks test methods for preclinical evaluation of key optical performance characteristics (OPCs) of endoscopic devices that are quantitative, objective and well-validated. As a result, it is difficult for researchers and developers to compare image quality and evaluate equivalence to, or improvement upon, prior technologies. While endoscope OPCs include resolution, field of view, and depth of field, among others, our focus in this paper is geometric image distortion. We reviewed specific test methods for distortion and then developed an objective, quantitative test method based on well-defined experimental and data processing steps to evaluate radial distortion in the full field of view of an endoscopic imaging system. Our measurements and analyses showed that a second-degree polynomial equation could well describe the radial distortion curve of a traditional endoscope. The distortion evaluation method was effective for correcting the image and can be used to explain other widely accepted evaluation methods such as picture height distortion. Development of consensus standards based on promising test methods for image quality assessment, such as the method studied here, will facilitate clinical implementation of innovative endoscopic devices.

[Detection of KRAS mutation in colorectal cancer patients' cfDNA with droplet digital PCR].

PubMed

Luo, Yuwen; Li, Yao

2018-03-25

This study aims to develop a new method for the detection of KRAS mutations related to colorectal cancer in cfDNA, and to evaluate the sensitivity and accuracy of the detection. We designed a method of cfDNA based KRAS detection by droplets digital PCR (ddPCR). The theoretical performance of the method is evaluated by reference standard and compared to the ARMS PCR method. Two methods, ddPCR and qPCR, were successfully established to detect KRAS wild type and 7 mutants. Both methods were validated using plasmid standards and actual samples. The results were evaluated by false positive rate, linearity, and limit of detection. Finally, 52 plasma cfDNA samples from patients and 20 samples from healthy people were tested, the clinical sensitivity is 97.64%, clinical specificity is 81.43%. ddPCR method shows higher performance than qPCR. The LOD of ddPCR method reached single digits of cfDNA copies, it can detect as low as 0.01% to 0.04% mutation abundance.

Feasibility, acceptability and clinical utility of the Cultural Formulation Interview: mixed-methods results from the DSM-5 international field trial.

PubMed

Lewis-Fernández, Roberto; Aggarwal, Neil Krishan; Lam, Peter C; Galfalvy, Hanga; Weiss, Mitchell G; Kirmayer, Laurence J; Paralikar, Vasudeo; Deshpande, Smita N; Díaz, Esperanza; Nicasio, Andel V; Boiler, Marit; Alarcón, Renato D; Rohlof, Hans; Groen, Simon; van Dijk, Rob C J; Jadhav, Sushrut; Sarmukaddam, Sanjeev; Ndetei, David; Scalco, Monica Z; Bassiri, Kavoos; Aguilar-Gaxiola, Sergio; Ton, Hendry; Westermeyer, Joseph; Vega-Dienstmaier, Johann M

2017-04-01

Background There is a need for clinical tools to identify cultural issues in diagnostic assessment. Aims To assess the feasibility, acceptability and clinical utility of the DSM-5 Cultural Formulation Interview (CFI) in routine clinical practice. Method Mixed-methods evaluation of field trial data from six countries. The CFI was administered to diagnostically diverse psychiatric out-patients during a diagnostic interview. In post-evaluation sessions, patients and clinicians completed debriefing qualitative interviews and Likert-scale questionnaires. The duration of CFI administration and the full diagnostic session were monitored. Results Mixed-methods data from 318 patients and 75 clinicians found the CFI feasible, acceptable and useful. Clinician feasibility ratings were significantly lower than patient ratings and other clinician-assessed outcomes. After administering one CFI, however, clinician feasibility ratings improved significantly and subsequent interviews required less time. Conclusions The CFI was included in DSM-5 as a feasible, acceptable and useful cultural assessment tool. © The Royal College of Psychiatrists 2017.

Implementing novel imaging methods for improved diagnosis of disorder of consciousness patients.

PubMed

Bick, Atira S; Leker, Ronen R; Ben-Hur, Tamir; Levin, Netta

2013-11-15

The clinical evaluation of consciousness in disorder of consciousness (DOC) patients based on their exhibited behavior is difficult and remains erroneous in many cases. Recent studies demonstrated different levels of stimulus processing as well as evidence of some level of awareness in sub-groups of these patients. The aim of the current study was to examine the plausibility and challenges of implementing a clinical service for evaluation of consciousness level in DOC patients. Eleven Patients (ages 11-67) diagnosed as being in vegetative or minimal conscious states were included. Functional MRI evaluations included auditory, language, voice familiarity, imagery, and visual tests. In 9 patients auditory-related activation was found, however only in 5 of the subjects was differential activation found for language. Six patients exhibited differential response to their own name. In three patients a response to visual stimuli was identified. In one patient the auditory and linguistic systems were clearly activated in a hierarchical pattern, and moreover willful modulation of brain activity was identified in the imagery test. We discuss the importance of using a wide battery of tests, the difference between our clinical cohort and previous publications, as well as the challenges of clinically implementing this method. Translating novel imaging methods into the clinical evaluation of DOC patients is essential for better diagnosis and may encourage treatment development. © 2013 Elsevier B.V. All rights reserved.

Suicide in Children Younger than Age Fourteen: Clinical Judgment and Assessment Issues.

ERIC Educational Resources Information Center

Wise, Amy J.; Spengler, Paul M.

1997-01-01

Discusses the importance of accurate information about childhood suicide to prevent clinical judgment errors. Describes available methods for evaluating suicide risk in children. Looks at myths and misconceptions surrounding childhood suicide; risk factors, such as family dysfunction and distress; and evaluation techniques, such as interviews and…

[Clinical data that are essential for the primary care clinical records: an experience of evaluation and improvement].

PubMed

López-Picazo Ferrer, J J; Agulló Roca, F; Villaescusa Pedemonte, M; Cerezo Corbalán, J M

2002-06-30

To evaluate and improve the presence of essential clinical data in the clinical records of a primary care management area (PCMA) by means of an intervention programme. Intervention study without a control, using evaluation and improvement-of-quality methods. We chose 4 criteria from the minimum technical standards: personal history (PH), family background (FB), allergies to medicines (AM) and list of problems (LP). We evaluated overall compliance and compliance per primary care team (PCT) through batch quality acceptance of samples (LQAS), designed an intervention to improve the situation, and then re-evaluated. PCMA of Murcia (45 PCTs). Participants. 42 PCTs (3 were excluded because they had poor coverage in their records). These lasted 12 months (October 1999-October 2000) and involved the following: graphic report per PCT; session with the PCT; discussion on results and strategies in the Area Management Council; and inclusion of an explicit objective, with incentives, in the management contracts. Significant improvement of the four criteria of the PCMA (improvements: FB, 48.1%; PH, 51.1%; AM, 55.4%; LP, 50.9%). LQAS analysis: we rejected 24 batches (14.3%) at the 1st evaluation and 15 (9.0%) at the second, with FB being the criterion most rejected in both instances. Defects appeared in 14 PCT (33.3%; 3 PCT accounted for 41.7%) at the 1st evaluation, and 7 PCT at the re-evaluation (16.7%; 2 reaching 46.7%). The presence of essential clinical data in clinical records has improved. LQAS proved to be a rapid and simple method for evaluating, improving and monitoring quality in primary care.

TH-EF-BRA-03: Assessment of Data-Driven Respiratory Motion-Compensation Methods for 4D-CBCT Image Registration and Reconstruction Using Clinical Datasets

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

Riblett, MJ; Weiss, E; Hugo, GD

Purpose: To evaluate the performance of a 4D-CBCT registration and reconstruction method that corrects for respiratory motion and enhances image quality under clinically relevant conditions. Methods: Building on previous work, which tested feasibility of a motion-compensation workflow using image datasets superior to clinical acquisitions, this study assesses workflow performance under clinical conditions in terms of image quality improvement. Evaluated workflows utilized a combination of groupwise deformable image registration (DIR) and image reconstruction. Four-dimensional cone beam CT (4D-CBCT) FDK reconstructions were registered to either mean or respiratory phase reference frame images to model respiratory motion. The resulting 4D transformation was usedmore » to deform projection data during the FDK backprojection operation to create a motion-compensated reconstruction. To simulate clinically realistic conditions, superior quality projection datasets were sampled using a phase-binned striding method. Tissue interface sharpness (TIS) was defined as the slope of a sigmoid curve fit to the lung-diaphragm boundary or to the carina tissue-airway boundary when no diaphragm was discernable. Image quality improvement was assessed in 19 clinical cases by evaluating mitigation of view-aliasing artifacts, tissue interface sharpness recovery, and noise reduction. Results: For clinical datasets, evaluated average TIS recovery relative to base 4D-CBCT reconstructions was observed to be 87% using fixed-frame registration alone; 87% using fixed-frame with motion-compensated reconstruction; 92% using mean-frame registration alone; and 90% using mean-frame with motion-compensated reconstruction. Soft tissue noise was reduced on average by 43% and 44% for the fixed-frame registration and registration with motion-compensation methods, respectively, and by 40% and 42% for the corresponding mean-frame methods. Considerable reductions in view aliasing artifacts were observed for each method. Conclusion: Data-driven groupwise registration and motion-compensated reconstruction have the potential to improve the quality of 4D-CBCT images acquired under clinical conditions. For clinical image datasets, the addition of motion compensation after groupwise registration visibly reduced artifact impact. This work was supported by the National Cancer Institute of the National Institutes of Health under Award Number R01CA166119. Hugo and Weiss hold a research agreement with Philips Healthcare and license agreement with Varian Medical Systems. Weiss receives royalties from UpToDate. Christensen receives funds from Roger Koch to support research.« less

The PBL-Evaluator: A Web-Based Tool for Assessment in Tutorials.

ERIC Educational Resources Information Center

Chaves, John F.; Chaves, John A.; Lantz, Marilyn S.

1998-01-01

Describes design and use of the PBL Evaluator, a computer-based method of evaluating dental students' clinical problem-solving skills. Analysis of Indiana University students' self-, peer, and tutor ratings for one iteration of a course in critical thinking and professional behavior shows differences in these ratings. The method is found useful…

Magnetic resonance imaging in the evaluation of clinical treatment of otospongiosis: a pilot study.

PubMed

de Oliveira Vicente, Andy; Chandrasekhar, Sujana S; Yamashita, Helio K; Cruz, Oswaldo Laercio M; Barros, Flavia A; Penido, Norma O

2015-06-01

To evaluate the applicability of magnetic resonance imaging (MRI) as a method for monitoring the activity of otospongiotic lesions before and after clinical treatment. Prospective, randomized, controlled, double-blind study. One single tertiary care institution in a large, cosmopolitan city. Twenty-six patients (n = 42 ears) with clinical, audiometric, and tomographic diagnosis of otosclerosis were enrolled. If computed tomography (CT) demonstrated active lesions, these patients underwent MRI to detect otospongiotic foci, seen as areas of gadolinium enhancement. Patients were divided into 3 groups and received treatment with placebo, sodium alendronate, or sodium fluoride for 6 months. After this period, clinical and audiometric evaluations and a second MRI were performed. Each MRI was evaluated by both a neuroradiologist and an otolaryngologist in a subjective (visual) and objective (using specific eFilm Workstation software) manner. Otospongiosis was most predominantly identified in the region anterior to the oval window, and this site was reliable for comparing pre- and posttreatment scans. The patients in the alendronate and sodium fluoride groups had MRI findings that suggested a decrease in activity of otospongiotic lesions, more relevant in the alendronate group. These findings were statistically significant for both subjective and objective MRI evaluations. MRI shows higher sensitivity than clinical or audiometric assessment for detecting reduction in activity of otospongiosis. The objective MRI evaluation based on software analysis was the most accurate method of monitoring clinical treatment response in otospongiosis. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015.

A framework for evaluating the appropriateness of clinical decision support alerts and responses

PubMed Central

Waitman, Lemuel R; Lewis, Julia B; Wright, Julie A; Choma, David P; Miller, Randolph A; Peterson, Josh F

2011-01-01

Objective Alerting systems, a type of clinical decision support, are increasingly prevalent in healthcare, yet few studies have concurrently measured the appropriateness of alerts with provider responses to alerts. Recent reports of suboptimal alert system design and implementation highlight the need for better evaluation to inform future designs. The authors present a comprehensive framework for evaluating the clinical appropriateness of synchronous, interruptive medication safety alerts. Methods Through literature review and iterative testing, metrics were developed that describe successes, justifiable overrides, provider non-adherence, and unintended adverse consequences of clinical decision support alerts. The framework was validated by applying it to a medication alerting system for patients with acute kidney injury (AKI). Results Through expert review, the framework assesses each alert episode for appropriateness of the alert display and the necessity and urgency of a clinical response. Primary outcomes of the framework include the false positive alert rate, alert override rate, provider non-adherence rate, and rate of provider response appropriateness. Application of the framework to evaluate an existing AKI medication alerting system provided a more complete understanding of the process outcomes measured in the AKI medication alerting system. The authors confirmed that previous alerts and provider responses were most often appropriate. Conclusion The new evaluation model offers a potentially effective method for assessing the clinical appropriateness of synchronous interruptive medication alerts prior to evaluating patient outcomes in a comparative trial. More work can determine the generalizability of the framework for use in other settings and other alert types. PMID:21849334

Developing and using a rubric for evaluating evidence-based medicine point-of-care tools.

PubMed

Shurtz, Suzanne; Foster, Margaret J

2011-07-01

The research sought to establish a rubric for evaluating evidence-based medicine (EBM) point-of-care tools in a health sciences library. The authors searched the literature for EBM tool evaluations and found that most previous reviews were designed to evaluate the ability of an EBM tool to answer a clinical question. The researchers' goal was to develop and complete rubrics for assessing these tools based on criteria for a general evaluation of tools (reviewing content, search options, quality control, and grading) and criteria for an evaluation of clinical summaries (searching tools for treatments of common diagnoses and evaluating summaries for quality control). Differences between EBM tools' options, content coverage, and usability were minimal. However, the products' methods for locating and grading evidence varied widely in transparency and process. As EBM tools are constantly updating and evolving, evaluation of these tools needs to be conducted frequently. Standards for evaluating EBM tools need to be established, with one method being the use of objective rubrics. In addition, EBM tools need to provide more information about authorship, reviewers, methods for evidence collection, and grading system employed.

Consensus Recommendations for Systematic Evaluation of Drug-Drug Interaction Evidence for Clinical Decision Support

PubMed Central

Scheife, Richard T.; Hines, Lisa E.; Boyce, Richard D.; Chung, Sophie P.; Momper, Jeremiah; Sommer, Christine D.; Abernethy, Darrell R.; Horn, John; Sklar, Stephen J.; Wong, Samantha K.; Jones, Gretchen; Brown, Mary; Grizzle, Amy J.; Comes, Susan; Wilkins, Tricia Lee; Borst, Clarissa; Wittie, Michael A.; Rich, Alissa; Malone, Daniel C.

2015-01-01

Background Healthcare organizations, compendia, and drug knowledgebase vendors use varying methods to evaluate and synthesize evidence on drug-drug interactions (DDIs). This situation has a negative effect on electronic prescribing and medication information systems that warn clinicians of potentially harmful medication combinations. Objective To provide recommendations for systematic evaluation of evidence from the scientific literature, drug product labeling, and regulatory documents with respect to DDIs for clinical decision support. Methods A conference series was conducted to develop a structured process to improve the quality of DDI alerting systems. Three expert workgroups were assembled to address the goals of the conference. The Evidence Workgroup consisted of 15 individuals with expertise in pharmacology, drug information, biomedical informatics, and clinical decision support. Workgroup members met via webinar from January 2013 to February 2014. Two in-person meetings were conducted in May and September 2013 to reach consensus on recommendations. Results We developed expert-consensus answers to three key questions: 1) What is the best approach to evaluate DDI evidence?; 2) What evidence is required for a DDI to be applicable to an entire class of drugs?; and 3) How should a structured evaluation process be vetted and validated? Conclusion Evidence-based decision support for DDIs requires consistent application of transparent and systematic methods to evaluate the evidence. Drug information systems that implement these recommendations should be able to provide higher quality information about DDIs in drug compendia and clinical decision support tools. PMID:25556085

Evaluation of fatty proportion in fatty liver using least squares method with constraints.

PubMed

Li, Xingsong; Deng, Yinhui; Yu, Jinhua; Wang, Yuanyuan; Shamdasani, Vijay

2014-01-01

Backscatter and attenuation parameters are not easily measured in clinical applications due to tissue inhomogeneity in the region of interest (ROI). A least squares method(LSM) that fits the echo signal power spectra from a ROI to a 3-parameter tissue model was used to get attenuation coefficient imaging in fatty liver. Since fat's attenuation value is higher than normal liver parenchyma, a reasonable threshold was chosen to evaluate the fatty proportion in fatty liver. Experimental results using clinical data of fatty liver illustrate that the least squares method can get accurate attenuation estimates. It is proved that the attenuation values have a positive correlation with the fatty proportion, which can be used to evaluate the syndrome of fatty liver.

Standardized Methods to Generate Mock (Spiked) Clinical Specimens by Spiking Blood or Plasma with Cultured Pathogens

PubMed Central

Dong, Ming; Fisher, Carolyn; Añez, Germán; Rios, Maria; Nakhasi, Hira L.; Hobson, J. Peyton; Beanan, Maureen; Hockman, Donna; Grigorenko, Elena; Duncan, Robert

2016-01-01

Aims To demonstrate standardized methods for spiking pathogens into human matrices for evaluation and comparison among diagnostic platforms. Methods and Results This study presents detailed methods for spiking bacteria or protozoan parasites into whole blood and virus into plasma. Proper methods must start with a documented, reproducible pathogen source followed by steps that include standardized culture, preparation of cryopreserved aliquots, quantification of the aliquots by molecular methods, production of sufficient numbers of individual specimens and testing of the platform with multiple mock specimens. Results are presented following the described procedures that showed acceptable reproducibility comparing in-house real-time PCR assays to a commercially available multiplex molecular assay. Conclusions A step by step procedure has been described that can be followed by assay developers who are targeting low prevalence pathogens. Significance and Impact of Study The development of diagnostic platforms for detection of low prevalence pathogens such as biothreat or emerging agents is challenged by the lack of clinical specimens for performance evaluation. This deficit can be overcome using mock clinical specimens made by spiking cultured pathogens into human matrices. To facilitate evaluation and comparison among platforms, standardized methods must be followed in the preparation and application of spiked specimens. PMID:26835651

Development and implementation of clinical algorithms in occupational health practice.

PubMed

Ghafur, Imran; Lalloo, Drushca; Macdonald, Ewan B; Menon, Manju

2013-12-01

Occupational health (OH) practice is framed by legal, ethical, and regulatory requirements. Integrating this information into daily practice can be a difficult task. We devised evidence-based framework standards of good practice that would aid clinical management, and assessed their impact. The clinical algorithm was the method deemed most appropriate to our needs. Using "the first OH consultation" as an example, the development, implementation, and evaluation of an algorithm is described. The first OH consultation algorithm was developed. Evaluation demonstrated an overall improvement in recording of information, specifically consent, recreational drug history, function, and review arrangements. Clinical algorithms can be a method for assimilating and succinctly presenting the various facets of OH practice, for use by all OH clinicians as a practical guide and as a way of improving quality in clinical record-keeping.

BoB, a best-of-breed automated text de-identification system for VHA clinical documents.

PubMed

Ferrández, Oscar; South, Brett R; Shen, Shuying; Friedlin, F Jeffrey; Samore, Matthew H; Meystre, Stéphane M

2013-01-01

De-identification allows faster and more collaborative clinical research while protecting patient confidentiality. Clinical narrative de-identification is a tedious process that can be alleviated by automated natural language processing methods. The goal of this research is the development of an automated text de-identification system for Veterans Health Administration (VHA) clinical documents. We devised a novel stepwise hybrid approach designed to improve the current strategies used for text de-identification. The proposed system is based on a previous study on the best de-identification methods for VHA documents. This best-of-breed automated clinical text de-identification system (aka BoB) tackles the problem as two separate tasks: (1) maximize patient confidentiality by redacting as much protected health information (PHI) as possible; and (2) leave de-identified documents in a usable state preserving as much clinical information as possible. We evaluated BoB with a manually annotated corpus of a variety of VHA clinical notes, as well as with the 2006 i2b2 de-identification challenge corpus. We present evaluations at the instance- and token-level, with detailed results for BoB's main components. Moreover, an existing text de-identification system was also included in our evaluation. BoB's design efficiently takes advantage of the methods implemented in its pipeline, resulting in high sensitivity values (especially for sensitive PHI categories) and a limited number of false positives. Our system successfully addressed VHA clinical document de-identification, and its hybrid stepwise design demonstrates robustness and efficiency, prioritizing patient confidentiality while leaving most clinical information intact.

The Biomarker-Surrogacy Evaluation Schema: a review of the biomarker-surrogate literature and a proposal for a criterion-based, quantitative, multidimensional hierarchical levels of evidence schema for evaluating the status of biomarkers as surrogate endpoints.

PubMed

Lassere, Marissa N

2008-06-01

There are clear advantages to using biomarkers and surrogate endpoints, but concerns about clinical and statistical validity and systematic methods to evaluate these aspects hinder their efficient application. Section 2 is a systematic, historical review of the biomarker-surrogate endpoint literature with special reference to the nomenclature, the systems of classification and statistical methods developed for their evaluation. In Section 3 an explicit, criterion-based, quantitative, multidimensional hierarchical levels of evidence schema - Biomarker-Surrogacy Evaluation Schema - is proposed to evaluate and co-ordinate the multiple dimensions (biological, epidemiological, statistical, clinical trial and risk-benefit evidence) of the biomarker clinical endpoint relationships. The schema systematically evaluates and ranks the surrogacy status of biomarkers and surrogate endpoints using defined levels of evidence. The schema incorporates the three independent domains: Study Design, Target Outcome and Statistical Evaluation. Each domain has items ranked from zero to five. An additional category called Penalties incorporates additional considerations of biological plausibility, risk-benefit and generalizability. The total score (0-15) determines the level of evidence, with Level 1 the strongest and Level 5 the weakest. The term ;surrogate' is restricted to markers attaining Levels 1 or 2 only. Surrogacy status of markers can then be directly compared within and across different areas of medicine to guide individual, trial-based or drug-development decisions. This schema would facilitate communication between clinical, researcher, regulatory, industry and consumer participants necessary for evaluation of the biomarker-surrogate-clinical endpoint relationship in their different settings.

Mining a clinical data warehouse to discover disease-finding associations using co-occurrence statistics.

PubMed

Cao, Hui; Markatou, Marianthi; Melton, Genevieve B; Chiang, Michael F; Hripcsak, George

2005-01-01

This paper applies co-occurrence statistics to discover disease-finding associations in a clinical data warehouse. We used two methods, chi2 statistics and the proportion confidence interval (PCI) method, to measure the dependence of pairs of diseases and findings, and then used heuristic cutoff values for association selection. An intrinsic evaluation showed that 94 percent of disease-finding associations obtained by chi2 statistics and 76.8 percent obtained by the PCI method were true associations. The selected associations were used to construct knowledge bases of disease-finding relations (KB-chi2, KB-PCI). An extrinsic evaluation showed that both KB-chi2 and KB-PCI could assist in eliminating clinically non-informative and redundant findings from problem lists generated by our automated problem list summarization system.

Development and validation of a nursing professionalism evaluation model in a career ladder system.

PubMed

Kim, Yeon Hee; Jung, Young Sun; Min, Ja; Song, Eun Young; Ok, Jung Hui; Lim, Changwon; Kim, Kyunghee; Kim, Ji-Su

2017-01-01

The clinical ladder system categorizes the degree of nursing professionalism and rewards and is an important human resource tool for managing nursing. We developed a model to evaluate nursing professionalism, which determines the clinical ladder system levels, and verified its validity. Data were collected using a clinical competence tool developed in this study, and existing methods such as the nursing professionalism evaluation tool, peer reviews, and face-to-face interviews to evaluate promotions and verify the presented content in a medical institution. Reliability and convergent and discriminant validity of the clinical competence evaluation tool were verified using SmartPLS software. The validity of the model for evaluating overall nursing professionalism was also analyzed. Clinical competence was determined by five dimensions of nursing practice: scientific, technical, ethical, aesthetic, and existential. The structural model explained 66% of the variance. Clinical competence scales, peer reviews, and face-to-face interviews directly determined nursing professionalism levels. The evaluation system can be used for evaluating nurses' professionalism in actual medical institutions from a nursing practice perspective. A conceptual framework for establishing a human resources management system for nurses and a tool for evaluating nursing professionalism at medical institutions is provided.

Assessing Clinical Significance: Does it Matter which Method we Use?

ERIC Educational Resources Information Center

Atkins, David C.; Bedics, Jamie D.; Mcglinchey, Joseph B.; Beauchaine, Theodore P.

2005-01-01

Measures of clinical significance are frequently used to evaluate client change during therapy. Several alternatives to the original method devised by N. S. Jacobson, W. C. Follette, & D. Revenstorf (1984) have been proposed, each purporting to increase accuracy. However, researchers have had little systematic guidance in choosing among…

Evaluation Using Sequential Trials Methods.

ERIC Educational Resources Information Center

Cohen, Mark E.; Ralls, Stephen A.

1986-01-01

Although dental school faculty as well as practitioners are interested in evaluating products and procedures used in clinical practice, research design and statistical analysis can sometimes pose problems. Sequential trials methods provide an analytical structure that is both easy to use and statistically valid. (Author/MLW)

Machine learning-based dual-energy CT parametric mapping

NASA Astrophysics Data System (ADS)

Su, Kuan-Hao; Kuo, Jung-Wen; Jordan, David W.; Van Hedent, Steven; Klahr, Paul; Wei, Zhouping; Helo, Rose Al; Liang, Fan; Qian, Pengjiang; Pereira, Gisele C.; Rassouli, Negin; Gilkeson, Robert C.; Traughber, Bryan J.; Cheng, Chee-Wai; Muzic, Raymond F., Jr.

2018-06-01

The aim is to develop and evaluate machine learning methods for generating quantitative parametric maps of effective atomic number (Zeff), relative electron density (ρ e), mean excitation energy (I x ), and relative stopping power (RSP) from clinical dual-energy CT data. The maps could be used for material identification and radiation dose calculation. Machine learning methods of historical centroid (HC), random forest (RF), and artificial neural networks (ANN) were used to learn the relationship between dual-energy CT input data and ideal output parametric maps calculated for phantoms from the known compositions of 13 tissue substitutes. After training and model selection steps, the machine learning predictors were used to generate parametric maps from independent phantom and patient input data. Precision and accuracy were evaluated using the ideal maps. This process was repeated for a range of exposure doses, and performance was compared to that of the clinically-used dual-energy, physics-based method which served as the reference. The machine learning methods generated more accurate and precise parametric maps than those obtained using the reference method. Their performance advantage was particularly evident when using data from the lowest exposure, one-fifth of a typical clinical abdomen CT acquisition. The RF method achieved the greatest accuracy. In comparison, the ANN method was only 1% less accurate but had much better computational efficiency than RF, being able to produce parametric maps in 15 s. Machine learning methods outperformed the reference method in terms of accuracy and noise tolerance when generating parametric maps, encouraging further exploration of the techniques. Among the methods we evaluated, ANN is the most suitable for clinical use due to its combination of accuracy, excellent low-noise performance, and computational efficiency.

Machine learning-based dual-energy CT parametric mapping.

PubMed

Su, Kuan-Hao; Kuo, Jung-Wen; Jordan, David W; Van Hedent, Steven; Klahr, Paul; Wei, Zhouping; Al Helo, Rose; Liang, Fan; Qian, Pengjiang; Pereira, Gisele C; Rassouli, Negin; Gilkeson, Robert C; Traughber, Bryan J; Cheng, Chee-Wai; Muzic, Raymond F

2018-06-08

The aim is to develop and evaluate machine learning methods for generating quantitative parametric maps of effective atomic number (Z eff ), relative electron density (ρ e ), mean excitation energy (I x ), and relative stopping power (RSP) from clinical dual-energy CT data. The maps could be used for material identification and radiation dose calculation. Machine learning methods of historical centroid (HC), random forest (RF), and artificial neural networks (ANN) were used to learn the relationship between dual-energy CT input data and ideal output parametric maps calculated for phantoms from the known compositions of 13 tissue substitutes. After training and model selection steps, the machine learning predictors were used to generate parametric maps from independent phantom and patient input data. Precision and accuracy were evaluated using the ideal maps. This process was repeated for a range of exposure doses, and performance was compared to that of the clinically-used dual-energy, physics-based method which served as the reference. The machine learning methods generated more accurate and precise parametric maps than those obtained using the reference method. Their performance advantage was particularly evident when using data from the lowest exposure, one-fifth of a typical clinical abdomen CT acquisition. The RF method achieved the greatest accuracy. In comparison, the ANN method was only 1% less accurate but had much better computational efficiency than RF, being able to produce parametric maps in 15 s. Machine learning methods outperformed the reference method in terms of accuracy and noise tolerance when generating parametric maps, encouraging further exploration of the techniques. Among the methods we evaluated, ANN is the most suitable for clinical use due to its combination of accuracy, excellent low-noise performance, and computational efficiency.

Clinical evaluation of a chemomechanical method for caries removal in children and adolescents.

PubMed

Peric, Tamara; Markovic, Dejan; Petrovic, Bojan

2009-01-01

The purpose of this study was to make a clinical comparison of the chemomechanical method for caries removal and the conventional rotary instruments technique when used in children and adolescents. The study comprised 120 patients aged 3-17 years randomized into two groups: caries were removed chemomechanically in 60 patients and 60 patients received conventional treatment with rotary instruments. The outcome variables were: clinically complete caries removal, pain during caries removal, need for local anesthesia, treatment time, preferences of patients, and clinical success of the restorations during the 12-month evaluation period. Complete caries removal was achieved in 92% of chemomechanically treated teeth and in all teeth treated with rotary instruments (p>0.05). The chemomechanical method significantly reduced the need for local anesthesia (p<0.001). Eighty-five percent of patients treated with Carisolv and 47% treated with rotary instruments were satisfied with the treatment (p<0.05). The mean time for chemomechanical caries removal was 11.2 ± 3.3 min and 5.2 ± 2.8 min for caries removal with rotary instruments (p<0.001). At the end of the 12-month evaluation period, there was no observed influence of the caries removal method on the survival of the restorations. The chemomechanical caries removal technique is an adequate alternative to the conventional rotary instruments method and is advantageous in pediatric dentistry.

A study of active learning methods for named entity recognition in clinical text.

PubMed

Chen, Yukun; Lasko, Thomas A; Mei, Qiaozhu; Denny, Joshua C; Xu, Hua

2015-12-01

Named entity recognition (NER), a sequential labeling task, is one of the fundamental tasks for building clinical natural language processing (NLP) systems. Machine learning (ML) based approaches can achieve good performance, but they often require large amounts of annotated samples, which are expensive to build due to the requirement of domain experts in annotation. Active learning (AL), a sample selection approach integrated with supervised ML, aims to minimize the annotation cost while maximizing the performance of ML-based models. In this study, our goal was to develop and evaluate both existing and new AL methods for a clinical NER task to identify concepts of medical problems, treatments, and lab tests from the clinical notes. Using the annotated NER corpus from the 2010 i2b2/VA NLP challenge that contained 349 clinical documents with 20,423 unique sentences, we simulated AL experiments using a number of existing and novel algorithms in three different categories including uncertainty-based, diversity-based, and baseline sampling strategies. They were compared with the passive learning that uses random sampling. Learning curves that plot performance of the NER model against the estimated annotation cost (based on number of sentences or words in the training set) were generated to evaluate different active learning and the passive learning methods and the area under the learning curve (ALC) score was computed. Based on the learning curves of F-measure vs. number of sentences, uncertainty sampling algorithms outperformed all other methods in ALC. Most diversity-based methods also performed better than random sampling in ALC. To achieve an F-measure of 0.80, the best method based on uncertainty sampling could save 66% annotations in sentences, as compared to random sampling. For the learning curves of F-measure vs. number of words, uncertainty sampling methods again outperformed all other methods in ALC. To achieve 0.80 in F-measure, in comparison to random sampling, the best uncertainty based method saved 42% annotations in words. But the best diversity based method reduced only 7% annotation effort. In the simulated setting, AL methods, particularly uncertainty-sampling based approaches, seemed to significantly save annotation cost for the clinical NER task. The actual benefit of active learning in clinical NER should be further evaluated in a real-time setting. Copyright © 2015 Elsevier Inc. All rights reserved.

Improving Clinical Feedback to Anesthesia Residents by Using an Optical Scanner and a Microcomputer.

ERIC Educational Resources Information Center

Albanese, Mark A.; And Others

1989-01-01

At the University of Iowa problems associated with managing evaluations of anesthesia residents led to a major backlog of unanalyzed evaluation forms. A system developed at the University that enables ongoing feedback to residents and provides a method to assess the clinical competence of residents is described. (Author/MLW)

Using Multiple Assessments to Evaluate Medical Students' Clinical Ability in Psychiatric Clerkships

ERIC Educational Resources Information Center

Wang, Peng-Wei; Cheng, Cheng-Chung; Chou, Frank Huang-Chih; Tsang, Hin-Yeung; Chang, Yu-San; Huang, Mei-Feng; Yen, Cheng-Fang

2011-01-01

Background: No single assessment method can successfully evaluate the clinical ability of medical students in psychiatric clerkships; however, few studies have examined the efficacy of multiple assessments, especially in psychiatry. The aim of this study was to examine the relationship among different types of assessments of medical students'…

Evaluating an Objective Structured Clinical Examination (OSCE) Adapted for Social Work

ERIC Educational Resources Information Center

Bogo, Marion; Regehr, Cheryl; Katz, Ellen; Logie, Carmen; Tufford, Lea; Litvack, Andrea

2012-01-01

Objectives: To evaluate an objective structured clinical examination (OSCE) adapted for social work in a lab course and examine the degree to which it predicts competence in the practicum. Method: 125 Masters students participated in a one-scenario OSCE and wrote responses to standardized reflection questions. OSCE performance and reflections were…

Preliminary investigation of Brain Network Activation (BNA) and its clinical utility in sport-related concussion

PubMed Central

Reches, A.; Kutcher, J.; Elbin, R. J.; Or-Ly, H.; Sadeh, B.; Greer, J.; McAllister, D. J.; Geva, A.; Kontos, A. P.

2017-01-01

ABSTRACT Background: The clinical diagnosis and management of patients with sport-related concussion is largely dependent on subjectively reported symptoms, clinical examinations, cognitive, balance, vestibular and oculomotor testing. Consequently, there is an unmet need for objective assessment tools that can identify the injury from a physiological perspective and add an important layer of information to the clinician’s decision-making process. Objective: The goal of the study was to evaluate the clinical utility of the EEG-based tool named Brain Network Activation (BNA) as a longitudinal assessment method of brain function in the management of young athletes with concussion. Methods: Athletes with concussion (n = 86) and age-matched controls (n = 81) were evaluated at four time points with symptom questionnaires and BNA. BNA scores were calculated by comparing functional networks to a previously defined normative reference brain network model to the same cognitive task. Results: Subjects above 16 years of age exhibited a significant decrease in BNA scores immediately following injury, as well as notable changes in functional network activity, relative to the controls. Three representative case studies of the tested population are discussed in detail, to demonstrate the clinical utility of BNA. Conclusion: The data support the utility of BNA to augment clinical examinations, symptoms and additional tests by providing an effective method for evaluating objective electrophysiological changes associated with sport-related concussions. PMID:28055228

eTACTS: A Method for Dynamically Filtering Clinical Trial Search Results

PubMed Central

Miotto, Riccardo; Jiang, Silis; Weng, Chunhua

2013-01-01

Objective Information overload is a significant problem facing online clinical trial searchers. We present eTACTS, a novel interactive retrieval framework using common eligibility tags to dynamically filter clinical trial search results. Materials and Methods eTACTS mines frequent eligibility tags from free-text clinical trial eligibility criteria and uses these tags for trial indexing. After an initial search, eTACTS presents to the user a tag cloud representing the current results. When the user selects a tag, eTACTS retains only those trials containing that tag in their eligibility criteria and generates a new cloud based on tag frequency and co-occurrences in the remaining trials. The user can then select a new tag or unselect a previous tag. The process iterates until a manageable number of trials is returned. We evaluated eTACTS in terms of filtering efficiency, diversity of the search results, and user eligibility to the filtered trials using both qualitative and quantitative methods. Results eTACTS (1) rapidly reduced search results from over a thousand trials to ten; (2) highlighted trials that are generally not top-ranked by conventional search engines; and (3) retrieved a greater number of suitable trials than existing search engines. Discussion eTACTS enables intuitive clinical trial searches by indexing eligibility criteria with effective tags. User evaluation was limited to one case study and a small group of evaluators due to the long duration of the experiment. Although a larger-scale evaluation could be conducted, this feasibility study demonstrated significant advantages of eTACTS over existing clinical trial search engines. Conclusion A dynamic eligibility tag cloud can potentially enhance state-of-the-art clinical trial search engines by allowing intuitive and efficient filtering of the search result space. PMID:23916863

A unified procedure for meta-analytic evaluation of surrogate end points in randomized clinical trials

PubMed Central

Dai, James Y.; Hughes, James P.

2012-01-01

The meta-analytic approach to evaluating surrogate end points assesses the predictiveness of treatment effect on the surrogate toward treatment effect on the clinical end point based on multiple clinical trials. Definition and estimation of the correlation of treatment effects were developed in linear mixed models and later extended to binary or failure time outcomes on a case-by-case basis. In a general regression setting that covers nonnormal outcomes, we discuss in this paper several metrics that are useful in the meta-analytic evaluation of surrogacy. We propose a unified 3-step procedure to assess these metrics in settings with binary end points, time-to-event outcomes, or repeated measures. First, the joint distribution of estimated treatment effects is ascertained by an estimating equation approach; second, the restricted maximum likelihood method is used to estimate the means and the variance components of the random treatment effects; finally, confidence intervals are constructed by a parametric bootstrap procedure. The proposed method is evaluated by simulations and applications to 2 clinical trials. PMID:22394448

Use of the false discovery rate for evaluating clinical safety data.

PubMed

Mehrotra, Devan V; Heyse, Joseph F

2004-06-01

Clinical adverse experience (AE) data are routinely evaluated using between group P values for every AE encountered within each of several body systems. If the P values are reported and interpreted without multiplicity considerations, there is a potential for an excess of false positive findings. Procedures based on confidence interval estimates of treatment effects have the same potential for false positive findings as P value methods. Excess false positive findings can needlessly complicate the safety profile of a safe drug or vaccine. Accordingly, we propose a novel method for addressing multiplicity in the evaluation of adverse experience data arising in clinical trial settings. The method involves a two-step application of adjusted P values based on the Benjamini and Hochberg false discovery rate (FDR). Data from three moderate to large vaccine trials are used to illustrate our proposed 'Double FDR' approach, and to reinforce the potential impact of failing to account for multiplicity. This work was in collaboration with the late Professor John W. Tukey who coined the term 'Double FDR'.

Using normalization 3D model for automatic clinical brain quantative analysis and evaluation

NASA Astrophysics Data System (ADS)

Lin, Hong-Dun; Yao, Wei-Jen; Hwang, Wen-Ju; Chung, Being-Tau; Lin, Kang-Ping

2003-05-01

Functional medical imaging, such as PET or SPECT, is capable of revealing physiological functions of the brain, and has been broadly used in diagnosing brain disorders by clinically quantitative analysis for many years. In routine procedures, physicians manually select desired ROIs from structural MR images and then obtain physiological information from correspondent functional PET or SPECT images. The accuracy of quantitative analysis thus relies on that of the subjectively selected ROIs. Therefore, standardizing the analysis procedure is fundamental and important in improving the analysis outcome. In this paper, we propose and evaluate a normalization procedure with a standard 3D-brain model to achieve precise quantitative analysis. In the normalization process, the mutual information registration technique was applied for realigning functional medical images to standard structural medical images. Then, the standard 3D-brain model that shows well-defined brain regions was used, replacing the manual ROIs in the objective clinical analysis. To validate the performance, twenty cases of I-123 IBZM SPECT images were used in practical clinical evaluation. The results show that the quantitative analysis outcomes obtained from this automated method are in agreement with the clinical diagnosis evaluation score with less than 3% error in average. To sum up, the method takes advantage of obtaining precise VOIs, information automatically by well-defined standard 3-D brain model, sparing manually drawn ROIs slice by slice from structural medical images in traditional procedure. That is, the method not only can provide precise analysis results, but also improve the process rate for mass medical images in clinical.

Information technology model for evaluating emergency medicine teaching

NASA Astrophysics Data System (ADS)

Vorbach, James; Ryan, James

1996-02-01

This paper describes work in progress to develop an Information Technology (IT) model and supporting information system for the evaluation of clinical teaching in the Emergency Medicine (EM) Department of North Shore University Hospital. In the academic hospital setting student physicians, i.e. residents, and faculty function daily in their dual roles as teachers and students respectively, and as health care providers. Databases exist that are used to evaluate both groups in either academic or clinical performance, but rarely has this information been integrated to analyze the relationship between academic performance and the ability to care for patients. The goal of the IT model is to improve the quality of teaching of EM physicians by enabling the development of integrable metrics for faculty and resident evaluation. The IT model will include (1) methods for tracking residents in order to develop experimental databases; (2) methods to integrate lecture evaluation, clinical performance, resident evaluation, and quality assurance databases; and (3) a patient flow system to monitor patient rooms and the waiting area in the Emergency Medicine Department, to record and display status of medical orders, and to collect data for analyses.

[Research on evolution and transition of quality evaluation of Shihu].

PubMed

Zhao, Yu-Jiao; Han, Bang-Xing; Peng, Hua-Sheng; Peng, Dai-Yin

2016-04-01

Shihu is one of the most valuable Chinese medicines in China. The sources of Shihu are complex and the quality evaluation of it mainly depends on morphologic characteristics distinction. In order to understand the Shihu's quality evaluation concept of Chinese herbalists in the past dynasties. This paper summarizes the methods of quality evaluation in ancient bencao systematically. The ancient bencao records that the quality of Shihu is closely related to its germplasm, habitat, processing and character. The concept of germplasm about shihu includes generalized and narrow sense, besides, the clinical applications of Dendrobium huoshanenese, D. officinale and D. nobile are focused on different diseases. D. huoshanenese has been regarded as Dao-di herbs since Qing Dynasty. The main products of Shihu contain fresh goods and dry goods, their clinical applications are also treated differently. Fengdou is one of the commodity specifications in Shihu. Its processing method probably dated from the Qing Dynasty, but now, it has become the mainstream commodityform. There was a common sense that different kinds of Shihu owed different characters and curative effects in ancient bencao, and the quality would enhance with the increasing viscidity. Therefore, the "Germplasm", "Geoherbs", "processing", "characters" were integrated into traditional quality evaluation methods of Shihu. Meanwhile, we should pay attention to the clinical efficacy of shihu with different species and processing methods. Copyright© by the Chinese Pharmaceutical Association.

Electrical bioimpedance and other techniques for gastric emptying and motility evaluation

PubMed Central

Huerta-Franco, María Raquel; Vargas-Luna, Miguel; Montes-Frausto, Juana Berenice; Flores-Hernández, Corina; Morales-Mata, Ismael

2012-01-01

The aim of this article is to identify non-invasive, inexpensive, highly sensitive and accurate techniques for evaluating and diagnosing gastric diseases. In the case of the stomach, there are highly sensitive and specific methods for assessing gastric motility and emptying (GME). However, these methods are invasive, expensive and/or not technically feasible for all clinicians and patients. We present a summary of the most relevant international information on non-invasive methods and techniques for clinically evaluating GME. We particularly emphasize the potential of gastric electrical bioimpedance (EBI). EBI was initially used mainly in gastric emptying studies and was essentially abandoned in favor of techniques such as electrogastrography and the gold standard, scintigraphy. The current research evaluating the utility of gastric EBI either combines this technique with other frequently used techniques or uses new methods for gastric EBI signal analysis. In this context, we discuss our results and those of other researchers who have worked with gastric EBI. In this review article, we present the following topics: (1) a description of the oldest methods and procedures for evaluating GME; (2) an explanation of the methods currently used to evaluate gastric activity; and (3) a perspective on the newest trends and techniques in clinical and research GME methods. We conclude that gastric EBI is a highly effective non-invasive, easy to use and inexpensive technique for assessing GME. PMID:22368782

Characterization of Change and Significance for Clinical Findings in Radiology Reports Through Natural Language Processing.

PubMed

Hassanpour, Saeed; Bay, Graham; Langlotz, Curtis P

2017-06-01

We built a natural language processing (NLP) method to automatically extract clinical findings in radiology reports and characterize their level of change and significance according to a radiology-specific information model. We utilized a combination of machine learning and rule-based approaches for this purpose. Our method is unique in capturing different features and levels of abstractions at surface, entity, and discourse levels in text analysis. This combination has enabled us to recognize the underlying semantics of radiology report narratives for this task. We evaluated our method on radiology reports from four major healthcare organizations. Our evaluation showed the efficacy of our method in highlighting important changes (accuracy 99.2%, precision 96.3%, recall 93.5%, and F1 score 94.7%) and identifying significant observations (accuracy 75.8%, precision 75.2%, recall 75.7%, and F1 score 75.3%) to characterize radiology reports. This method can help clinicians quickly understand the key observations in radiology reports and facilitate clinical decision support, review prioritization, and disease surveillance.

[Enhanced Recovery after Surgery from Theory to Practice
What do We Need to Do?

PubMed

Che, Guowei; Liu, Lunxu; Zhou, Qinghua

2017-04-20

Enhanced recovery after surgery (ERAS) is a paradigm shift in perioperative care, resulting in substantial improvements in clinical outcomes, shorter length of hospital stay and cost savings. But the current ERAS either by application of breadth or depth is not enough, why? The main reason is the lack of "operability, evaluation, repetition" ERAS protocol and suitable for clinical extensive application protocol. How to form the clinical available protocol? Operational mainly refers to the clinical scheme is simple and feasible, and protocol compliance is good; Evaluate refers to the methods used before, during and after are the objective evaluation criteria and plan; Repeatable is clinical scheme repeatability in the process of single or multiple center.

Clinical outcomes of arthroscopic single and double row repair in full thickness rotator cuff tears

PubMed Central

Ji, Jong-Hun; Shafi, Mohamed; Kim, Weon-Yoo; Kim, Young-Yul

2010-01-01

Background: There has been a recent interest in the double row repair method for arthroscopic rotator cuff repair following favourable biomechanical results reported by some studies. The purpose of this study was to compare the clinical results of arthroscopic single row and double row repair methods in the full-thickness rotator cuff tears. Materials and Methods: 22 patients of arthroscopic single row repair (group I) and 25 patients who underwent double row repair (group II) from March 2003 to March 2005 were retrospectively evaluated and compared for the clinical outcomes. The mean age was 58 years and 56 years respectively for group I and II. The average follow-up in the two groups was 24 months. The evaluation was done by using the University of California Los Angeles (UCLA) rating scale and the shoulder index of the American Shoulder and Elbow Surgeons (ASES). Results: In Group I, the mean ASES score increased from 30.48 to 87.40 and the mean ASES score increased from 32.00 to 91.45 in the Group II. The mean UCLA score increased from the preoperative 12.23 to 30.82 in Group I and from 12.20 to 32.40 in Group II. Each method has shown no statistical clinical differences between two methods, but based on the sub scores of UCLA score, the double row repair method yields better results for the strength, and it gives more satisfaction to the patients than the single row repair method. Conclusions: Comparing the two methods, double row repair group showed better clinical results in recovering strength and gave more satisfaction to the patients but no statistical clinical difference was found between 2 methods. PMID:20697485

Construction of a Clinical Decision Support System for Undergoing Surgery Based on Domain Ontology and Rules Reasoning

PubMed Central

Bau, Cho-Tsan; Huang, Chung-Yi

2014-01-01

Abstract Objective: To construct a clinical decision support system (CDSS) for undergoing surgery based on domain ontology and rules reasoning in the setting of hospitalized diabetic patients. Materials and Methods: The ontology was created with a modified ontology development method, including specification and conceptualization, formalization, implementation, and evaluation and maintenance. The Protégé–Web Ontology Language editor was used to implement the ontology. Embedded clinical knowledge was elicited to complement the domain ontology with formal concept analysis. The decision rules were translated into JENA format, which JENA can use to infer recommendations based on patient clinical situations. Results: The ontology includes 31 classes and 13 properties, plus 38 JENA rules that were built to generate recommendations. The evaluation studies confirmed the correctness of the ontology, acceptance of recommendations, satisfaction with the system, and usefulness of the ontology for glycemic management of diabetic patients undergoing surgery, especially for domain experts. Conclusions: The contribution of this research is to set up an evidence-based hybrid ontology and an evaluation method for CDSS. The system can help clinicians to achieve inpatient glycemic control in diabetic patients undergoing surgery while avoiding hypoglycemia. PMID:24730353

Model for teaching population health and community-based care across diverse clinical experiences.

PubMed

Van Dyk, Elizabeth J; Valentine-Maher, Sarah K; Tracy, Janet P

2015-02-01

The pillars constructivist model is designed to offer a unifying clinical paradigm to support consistent learning opportunities across diverse configurations of community and public health clinical sites. Thirty-six students and six faculty members participated in a mixed methods evaluation to assess the model after its inaugural semester of implementation. The evaluation methods included a rating scale that measures the model's ability to provide consistent learning opportunities at both population health and direct care sites, a case study to measure student growth within the five conceptual pillars, and a faculty focus group. Results revealed that the model served as an effective means of clinical education to support the use of multiple, small-scale public health sites. Although measurements of student growth within the pillars are inconclusive, the findings suggest efficacy. The authors recommend the continued use of the pillars constructivist model in baccalaureate programs, with further study of the author-designed evaluation tools. Copyright 2015, SLACK Incorporated.

Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.

PubMed

Lansky, Alexandra J; Messé, Steven R; Brickman, Adam M; Dwyer, Michael; van der Worp, H Bart; Lazar, Ronald M; Pietras, Cody G; Abrams, Kevin J; McFadden, Eugene; Petersen, Nils H; Browndyke, Jeffrey; Prendergast, Bernard; Ng, Vivian G; Cutlip, Donald E; Kapadia, Samir; Krucoff, Mitchell W; Linke, Axel; Moy, Claudia Scala; Schofer, Joachim; van Es, Gerrit-Anne; Virmani, Renu; Popma, Jeffrey; Parides, Michael K; Kodali, Susheel; Bilello, Michel; Zivadinov, Robert; Akar, Joseph; Furie, Karen L; Gress, Daryl; Voros, Szilard; Moses, Jeffrey; Greer, David; Forrest, John K; Holmes, David; Kappetein, Arie P; Mack, Michael; Baumbach, Andreas

2017-02-14

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Evaluation of the 95% limits of agreement of the volumes of 5-year clinically stable solid nodules for the development of a follow-up system for indeterminate solid nodules in CT lung cancer screening

PubMed Central

Muramatsu, Yukio; Yamamichi, Junta; Gomi, Shiho; Oubel, Estanislao; Moriyama, Noriyuki

2018-01-01

Background This study sought to evaluate the 95% limits of agreement of the volumes of 5-year clinically stable solid nodules for the development of a follow-up system for indeterminate solid nodules. Methods The volumes of 226 solid nodules that had been clinically stable for 5 years were measured in 186 patients (53 female never-smokers, 36 male never-smokers, 51 males with <30 pack-years, and 46 males with ≥30 pack-years) using a three-dimensional semiautomated method. Volume changes were evaluated using three methods: percent change, proportional change and growth rate. The 95% limits of agreement were evaluated using the Bland-Altman method. Results The 95% limits of agreement were as follows: range of percent change, from ±34.5% to ±37.8%; range of proportional change, from ±34.1% to ±36.8%; and range of growth rate, from ±39.2% to ±47.4%. Percent change-based, proportional change-based, and growth rate-based diagnoses of an increase or decrease in ten solid nodules were made at a mean of 302±402, 367±455, and 329±496 days, respectively, compared with a clinical diagnosis made at 809±616 days (P<0.05). Conclusions The 95% limits of agreement for volume change in 5-year stable solid nodules may enable the detection of an increase or decrease in the solid nodule at an earlier stage than that enabled by a clinical diagnosis, possibly contributing to the development of a follow-up system for reducing the number of additional Computed tomography (CT) scans performed during the follow-up period. PMID:29600047

Comparative analysis of perceptual evaluation, acoustic analysis and indirect laryngoscopy for vocal assessment of a population with vocal complaint.

PubMed

Nemr, Kátia; Amar, Ali; Abrahão, Marcio; Leite, Grazielle Capatto de Almeida; Köhle, Juliana; Santos, Alexandra de O; Correa, Luiz Artur Costa

2005-01-01

As a result of technology evolution and development, methods of voice evaluation have changed both in medical and speech and language pathology practice. To relate the results of perceptual evaluation, acoustic analysis and medical evaluation in the diagnosis of vocal and/or laryngeal affections of the population with vocal complaint. Clinical prospective. 29 people that attended vocal health protection campaign were evaluated. They were submitted to perceptual evaluation (AFPA), acoustic analysis (AA), indirect laryngoscopy (LI) and telelaryngoscopy (TL). Correlations between medical and speech language pathology evaluation methods were established, verifying possible statistical signification with the application of Fischer Exact Test. There were statistically significant results in the correlation between AFPA and LI, AFPA and TL, LI and TL. This research study conducted in a vocal health protection campaign presented correlations between speech language pathology evaluation and perceptual evaluation and clinical evaluation, as well as between vocal affection and/or laryngeal medical exams.

[Discussion on efficacy evaluation thought and method for innovation medicine of Chinese herbal compound formula based on clinical application characteristics].

PubMed

Sun, Jian-Ning; Sun, Wen-Yan; Dong, Shi-Fen

2017-03-01

The Chinese herbal compound formula preparation was made based on theory of Chinese medicine, which was confirmed by long period clinical application, and with multi-compound and multi-target characteristics. During the exploitation process of innovation medicine of Chinese herbal compound formula, selecting and speeding up the research development of drugs with clinical value shall be paid more attention, and as request of rules involved in new drug research and development, the whole process management should be carried out, including project evaluation, manufacturing process determination, establishment of quality control standards, evaluation for pharmacological and toxic effect, as well as new drug application process. This reviews was aimed to give some proposals for pharmacodynamics research methods involved in exploration of Chinese herbal compound formula preparation, including： ①the endpoint criteria should meet the clinical attribution of new drugs; ②the pre-clinical pharmacodynamics evaluation should be carried on appropriate animal models according to the characteristics of diagnosis and therapy of Chinese medicine and observation indexes; ③during the innovation of drug for infants and children, information on drug action conforming to physiological characteristics of infants and children should be supplied, and the pharmacodynamics and toxicology research shall be conducted in immature rats according to the body weight of children. In a summary, the clinical application characteristics are the important criteria for evaluation of pharmacological effect of innovation medicine of Chinese herbal compound formula. Copyright© by the Chinese Pharmaceutical Association.

Design and implementation of a controlled clinical trial to evaluate the effectiveness and efficiency of routine opt-out rapid human immunodeficiency virus screening in the emergency department.

PubMed

Haukoos, Jason S; Hopkins, Emily; Byyny, Richard L; Conroy, Amy A; Silverman, Morgan; Eisert, Sheri; Thrun, Mark; Wilson, Michael; Boyett, Brian; Heffelfinger, James D

2009-08-01

In 2006, the Centers for Disease Control and Prevention (CDC) released revised recommendations for performing human immunodeficiency virus (HIV) testing in health care settings, including implementing routine rapid HIV screening, the use of an integrated opt-out consent, and limited prevention counseling. Emergency departments (EDs) have been a primary focus of these efforts. These revised CDC recommendations were primarily based on feasibility studies and have not been evaluated through the application of rigorous research methods. This article describes the design and implementation of a large prospective controlled clinical trial to evaluate the CDC's recommendations in an ED setting. From April 15, 2007, through April 15, 2009, a prospective quasi-experimental equivalent time-samples clinical trial was performed to compare the clinical effectiveness and efficiency of routine (nontargeted) opt-out rapid HIV screening (intervention) to physician-directed diagnostic rapid HIV testing (control) in a high-volume urban ED. In addition, three nested observational studies were performed to evaluate the cost-effectiveness and patient and staff acceptance of the two rapid HIV testing methods. This article describes the rationale, methodologies, and study design features of this program evaluation clinical trial. It also provides details regarding the integration of the principal clinical trial and its nested observational studies. Such ED-based trials are rare, but serve to provide valid comparisons between testing approaches. Investigators should consider similar methodology when performing future ED-based health services research.

Audit method suited for DSS in clinical environment.

PubMed

Vicente, Javier

2015-01-01

This chapter presents a novel online method to audit predictive models using a Bayesian perspective. The auditing model has been specifically designed for Decision Support Systems (DSSs) suited for clinical or research environments. Taking as starting point the working diagnosis supplied by the clinician, this method compares and evaluates the predictive skills of those models able to answer to that diagnosis. The approach consists in calculating the posterior odds of a model through the composition of a prior odds, a static odds, and a dynamic odds. To do so, this method estimates the posterior odds from the cases that the comparing models had in common during the design stage and from the cases already viewed by the DSS after deployment in the clinical site. In addition, if an ontology of the classes is available, this method can audit models answering related questions, which offers a reinforcement to the decisions the user already took and gives orientation on further diagnostic steps.The main technical novelty of this approach lies in the design of an audit model adapted to suit the decision workflow of a clinical environment. The audit model allows deciding what is the classifier that best suits each particular case under evaluation and allows the detection of possible misbehaviours due to population differences or data shifts in the clinical site. We show the efficacy of our method for the problem of brain tumor diagnosis with Magnetic Resonance Spectroscopy (MRS).

Systematic evaluation of a targeted gene capture sequencing panel for molecular diagnosis of retinitis pigmentosa

PubMed Central

Ma, Yuanyuan; Chiang, Pei-Wen; Zhong, Jing; Liu, Xuyang; Asan; Wu, Jing; Su, Yan; Li, Xin; Deng, Jianlian; Huang, Yingping; Zhang, Xinxin; Li, Yang; Fan, Ning; Wang, Ying; Tang, Lihui; Shen, Jinting; Chen, Meiyan; Zhang, Xiuqing; Te, Deng; Banerjee, Santasree; Liu, Hui; Qi, Ming; Yi, Xin

2018-01-01

Background Inherited eye diseases are major causes of vision loss in both children and adults. Inherited eye diseases are characterized by clinical variability and pronounced genetic heterogeneity. Genetic testing may provide an accurate diagnosis for ophthalmic genetic disorders and allow gene therapy for specific diseases. Methods A targeted gene capture panel was designed to capture exons of 283 inherited eye disease genes including 58 known causative retinitis pigmentosa (RP) genes. 180 samples were tested with this panel, 68 were previously tested by Sanger sequencing. Systematic evaluation of our method and comprehensive molecular diagnosis were carried on 99 RP patients. Results 96.85% targeted regions were covered by at least 20 folds, the accuracy of variants detection was 99.994%. In 4 of the 68 samples previously tested by Sanger sequencing, mutations of other diseases not consisting with the clinical diagnosis were detected by next-generation sequencing (NGS) not Sanger. Among the 99 RP patients, 64 (64.6%) were detected with pathogenic mutations, while in 3 patients, it was inconsistent between molecular diagnosis and their initial clinical diagnosis. After revisiting, one patient’s clinical diagnosis was reclassified. In addition, 3 patients were found carrying large deletions. Conclusions We have systematically evaluated our method and compared it with Sanger sequencing, and have identified a large number of novel mutations in a cohort of 99 RP patients. The results showed a sufficient accuracy of our method and suggested the importance of molecular diagnosis in clinical diagnosis. PMID:29641573

Mining a clinical data warehouse to discover disease-finding associations using co-occurrence statistics

PubMed Central

Cao, Hui; Markatou, Marianthi; Melton, Genevieve B.; Chiang, Michael F.; Hripcsak, George

2005-01-01

This paper applies co-occurrence statistics to discover disease-finding associations in a clinical data warehouse. We used two methods, χ2 statistics and the proportion confidence interval (PCI) method, to measure the dependence of pairs of diseases and findings, and then used heuristic cutoff values for association selection. An intrinsic evaluation showed that 94 percent of disease-finding associations obtained by χ2 statistics and 76.8 percent obtained by the PCI method were true associations. The selected associations were used to construct knowledge bases of disease-finding relations (KB-χ2, KB-PCI). An extrinsic evaluation showed that both KB-χ2 and KB-PCI could assist in eliminating clinically non-informative and redundant findings from problem lists generated by our automated problem list summarization system. PMID:16779011

Beginning level nursing students' experiences with cancer patients in their first clinical placement: a qualitative appraisal in Turkey.

PubMed

Yildiz, Hicran; Akansel, Neriman

2011-01-01

This study was conducted to evaluate beginning nursing students' point of view related to caring cancer patients in their first clinical placement. Data were collected by evaluating the diaries kept by four beginning level nursing students who were assigned to do their fundamentals of nursing clinical practice in hematology clinic from February to May 2011. A qualitative research method was used and data were analyzed using inductive method. Nursing students experienced anxiety, had difficulties while communicating with cancer patients and observed some negative practices related to patient care and treatment. During their clinical placement nursing students were able to differentiate right and wrong practices in clinical environment, they tried to tailor their theoretical knowledge to the clinical practice and reported decrease in their anxiety by the end of clinical rotation. Being assigned to care for cancer patients was a stressful experience for the first year students. According to these results, it can be said that clinics such as hematology can be used as a clinical placement only in mandatory conditions for beginning level nursing students because of their limited clinical experience and the knowledge requirement related to these patients.

Randomized Controlled Trial in Clinical Settings to Evaluate Effectiveness of Coping Skills Education Used with Progressive Tinnitus Management

ERIC Educational Resources Information Center

Henry, James A.; Thielman, Emily J.; Zaugg, Tara L.; Kaelin, Christine; Schmidt, Caroline J.; Griest, Susan; McMillan, Garnett P.; Myers, Paula; Rivera, Izel; Baldwin, Robert; Carlson, Kathleen

2017-01-01

Purpose: This randomized controlled trial evaluated, within clinical settings, the effectiveness of coping skills education that is provided with progressive tinnitus management (PTM). Method: At 2 Veterans Affairs medical centers, N = 300 veterans were randomized to either PTM intervention or 6-month wait-list control. The PTM intervention…

Considered Evaluation of Clinical Placements in a New Medical School

ERIC Educational Resources Information Center

Booth, Jerry; Collins, Sarah; Hammond, Anna

2009-01-01

This article suggests that quality assessment in the UK has been largely set apart from learning and teaching and reports on a pilot project at the Hull York Medical School which attempted to integrate students' evaluation of their clinical placements into the curriculum. It outlines the operational demands of this integrated method and compares…

Blood Pressure Measurement: Clinic, Home, Ambulatory, and Beyond

PubMed Central

Drawz, Paul E.; Abdalla, Mohamed; Rahman, Mahboob

2014-01-01

Blood pressure has traditionally been measured in the clinic setting using the auscultory method and a mercury sphygmomanometer. Technological advances have led to improvements in measuring clinic blood pressure and allowed for measuring blood pressures outside the clinic. This review outlines various methods for evaluating blood pressure and the clinical utility of each type of measurement. Home blood pressures and 24 hour ambulatory blood pressures have improved our ability to evaluate risk for target organ damage and hypertension related morbidity and mortality. Measuring home blood pressures may lead to more active participation in health care by patients and has the potential to improve blood pressure control. Ambulatory blood pressure monitoring enables the measuring nighttime blood pressures and diurnal changes, which may be the most accurate predictors of risk associated with elevated blood pressure. Additionally, reducing nighttime blood pressure is feasible and may be an important component of effective antihypertensive therapy. Finally, estimating central aortic pressures and pulse wave velocity are two of the newer methods for assessing blood pressure and hypertension related target organ damage. PMID:22521624

Integration of an EEG biomarker with a clinician's ADHD evaluation

PubMed Central

Snyder, Steven M; Rugino, Thomas A; Hornig, Mady; Stein, Mark A

2015-01-01

Background This study is the first to evaluate an assessment aid for attention-deficit/hyperactivity disorder (ADHD) according to both Class-I evidence standards of American Academy of Neurology and De Novo requirements of US Food and Drug Administration. The assessment aid involves a method to integrate an electroencephalographic (EEG) biomarker, theta/beta ratio (TBR), with a clinician's ADHD evaluation. The integration method is intended as a step to help improve certainty with criterion E (i.e., whether symptoms are better explained by another condition). Methods To evaluate the assessment aid, investigators conducted a prospective, triple-blinded, 13-site, clinical cohort study. Comprehensive clinical evaluation data were obtained from 275 children and adolescents presenting with attentional and behavioral concerns. A qualified clinician at each site performed differential diagnosis. EEG was collected by separate teams. The reference standard was consensus diagnosis by an independent, multidisciplinary team (psychiatrist, psychologist, and neurodevelopmental pediatrician), which is well-suited to evaluate criterion E in a complex clinical population. Results Of 209 patients meeting ADHD criteria per a site clinician's judgment, 93 were separately found by the multidisciplinary team to be less likely to meet criterion E, implying possible overdiagnosis by clinicians in 34% of the total clinical sample (93/275). Of those 93, 91% were also identified by EEG, showing a relatively lower TBR (85/93). Further, the integration method was in 97% agreement with the multidisciplinary team in the resolution of a clinician's uncertain cases (35/36). TBR showed statistical power specific to supporting certainty of criterion E per the multidisciplinary team (Cohen's d, 1.53). Patients with relatively lower TBR were more likely to have other conditions that could affect criterion E certainty (10 significant results; P ≤ 0.05). Integration of this information with a clinician's ADHD evaluation could help improve diagnostic accuracy from 61% to 88%. Conclusions The EEG-based assessment aid may help improve accuracy of ADHD diagnosis by supporting greater criterion E certainty. PMID:25798338

Outcome methods used in clinical studies of Chiari malformation Type I: a systematic review.

PubMed

Greenberg, Jacob K; Milner, Eric; Yarbrough, Chester K; Lipsey, Kim; Piccirillo, Jay F; Smyth, Matthew D; Park, Tae Sung; Limbrick, David D

2015-02-01

Chiari malformation Type I (CM-I) is a common and often debilitating neurological disease. Efforts to improve treatment of CM-I are impeded by inconsistent and limited methods of evaluating clinical outcomes. To understand current approaches and lay a foundation for future research, the authors conducted a systematic review of the methods used in original published research articles to evaluate clinical outcomes in patients treated for CM-I. The authors searched PubMed, Embase, the Cumulative Index to Nursing and Allied Health Literature, ClinicalTrials.gov , and Cochrane databases to identify publications between January 2003 and August 2013 that met the following criteria: 1) reported clinical outcomes in patients treated for CM-I; 2) were original research articles; 3) included at least 10 patients or, if a comparative study, at least 5 patients per group; and 4) were restricted to patients with CM-I. Among the 74 papers meeting inclusion criteria, there was wide variation in the outcome methods used. However, all approaches were broadly grouped into 3 categories: 1) "gestalt" impression of overall symptomatic improvement (n=45 papers); 2) postoperative change in specific signs or symptoms (n=20); or 3) results of various standardized assessment scales (n=22). Among standardized scales, 11 general function measures were used, compared with 6 disease-specific tools. Only 3 papers used scales validated in patients with CM-I. To facilitate a uniform comparison of these heterogeneous approaches, the authors appraised articles in multiple domains defined a priori as integral to reporting clinical outcomes in CM-I. Notably, only 7 articles incorporated patient-response instruments when reporting outcome, and only 22 articles explicitly assessed quality of life. The methods used to evaluate clinical outcomes in CM-I are inconsistent and frequently not comparable, complicating efforts to analyze results across studies. Development, validation, and incorporation of a small number of disease-specific patient-based instruments will improve the quality of research and care of CM-I patients.

Impact of a dedicated cancer-associated thrombosis service on clinical outcomes: a mixed-methods evaluation of a clinical improvement exercise

PubMed Central

Noble, Simon; Pease, Nikki; Sui, Jessica; Davies, James; Lewis, Sarah; Malik, Usman; Alikhan, Raza; Prout, Hayley; Nelson, Annmarie

2016-01-01

Objectives Cancer-associated thrombosis (CAT) complex condition, which may present to any healthcare professional and at any point during the cancer journey. As such, patients may be managed by a number of specialties, resulting in inconsistent practice and suboptimal care. We describe the development of a dedicated CAT service and its evaluation. Setting Specialist cancer centre, district general hospital and primary care. Participants Patients with CAT and their referring clinicians. Intervention A cross specialty team developed a dedicated CAT service , including clear referral pathways, consistent access to medicines, patient's information and a specialist clinic. Primary and secondary outcome measures The service was evaluated using a mixed-methods evaluation , including audits of clinical practice, clinical outcomes, staff surveys and qualitative interviewing of patients and healthcare professionals. Results Data from 457 consecutive referrals over an 18-month period were evaluated. The CAT service has led to an 88% increase in safe and consistent community prescribing of low-molecular-weight heparin, with improved access to specialist advice and information. Patients reported improved understanding of their condition, enabling better self-management as well as better access to support and information. Referring clinicians reported better care standards for their patients with improved access to expertise and appropriate management. Conclusions A dedicated CAT service improves overall standards of care and is viewed positively by patients and clinicians alike. Further health economic evaluation would enhance the case for establishing this as the standard model of care. PMID:27895068

The Identification and Assessment of Late-Life ADHD in Memory Clinics

ERIC Educational Resources Information Center

Fischer, Barbara L.; Gunter-Hunt, Gail; Steinhafel, Courtney Holm; Howell, Timothy

2012-01-01

Objective: Little data exist about ADHD in late life. While evaluating patients' memory problems, the memory clinic staff has periodically identified ADHD in previously undiagnosed older adults. The authors conducted a survey to assess the extent to which other memory clinics view ADHD as a relevant clinical issue. Method: The authors developed…

An Integrated Evaluation of Nonspeech Oral Motor Treatments

ERIC Educational Resources Information Center

Powell, Thomas W.

2008-01-01

Purpose: This article functions as an epilogue to the clinical forum examining the use of nonspeech oral motor treatments (NSOMTs) to remediate speech sound disorders in children. Method: Conclusions to eight clinical questions are formed based on the findings that were reported in the clinical forum. Theoretical and clinical challenges are also…

Ethnographic process evaluation in primary care: explaining the complexity of implementation.

PubMed

Bunce, Arwen E; Gold, Rachel; Davis, James V; McMullen, Carmit K; Jaworski, Victoria; Mercer, MaryBeth; Nelson, Christine

2014-12-05

The recent growth of implementation research in care delivery systems has led to a renewed interest in methodological approaches that deliver not only intervention outcome data but also deep understanding of the complex dynamics underlying the implementation process. We suggest that an ethnographic approach to process evaluation, when informed by and integrated with quantitative data, can provide this nuanced insight into intervention outcomes. The specific methods used in such ethnographic process evaluations are rarely presented in detail; our objective is to stimulate a conversation around the successes and challenges of specific data collection methods in health care settings. We use the example of a translational clinical trial among 11 community clinics in Portland, OR that are implementing an evidence-based, health-information technology (HIT)-based intervention focused on patients with diabetes. Our ethnographic process evaluation employed weekly diaries by clinic-based study employees, observation, informal and formal interviews, document review, surveys, and group discussions to identify barriers and facilitators to implementation success, provide insight into the quantitative study outcomes, and uncover lessons potentially transferable to other implementation projects. These methods captured the depth and breadth of factors contributing to intervention uptake, while minimizing disruption to clinic work and supporting mid-stream shifts in implementation strategies. A major challenge is the amount of dedicated researcher time required. The deep understanding of the 'how' and 'why' behind intervention outcomes that can be gained through an ethnographic approach improves the credibility and transferability of study findings. We encourage others to share their own experiences with ethnography in implementation evaluation and health services research, and to consider adapting the methods and tools described here for their own research.

Evaluation of clinical methods for peroneal muscle testing.

PubMed

Sarig-Bahat, Hilla; Krasovsky, Andrei; Sprecher, Elliot

2013-03-01

Manual muscle testing of the peroneal muscles is well accepted as a testing method in musculoskeletal physiotherapy for the assessment of the foot and ankle. The peroneus longus and brevis are primary evertors and secondary plantar flexors of the ankle joint. However, some international textbooks describe them as dorsi flexors, when instructing peroneal muscle testing. The identified variability raised a question whether these educational texts are reflected in the clinical field. The purposes of this study were to investigate what are the methods commonly used in the clinical field for peroneal muscle testing and to evaluate their compatibility with functional anatomy. A cross-sectional study was conducted, using an electronic questionnaire sent to 143 Israeli physiotherapists in the musculoskeletal field. The survey questioned on the anatomical location of manual resistance and the combination of motions resisted. Ninety-seven responses were received. The majority (69%) of respondents related correctly to the peronei as evertors, but asserted that resistance should be located over the dorsal aspect of the fifth metatarsus, thereby disregarding the peroneus longus. Moreover, 38% of the respondents described the peronei as dorsi flexors, rather than plantar flexors. Only 2% selected the correct method of resisting plantarflexion and eversion at the base of the first metatarsus. We consider this technique to be the most compatible with the anatomy of the peroneus longus and brevis. The Fisher-Freeman-Halton test indicated that there was a significant relationship between responses on the questions (P = 0.0253, 95% CI 0.0249-0.0257), thus justifying further correspondence analysis. The correspondence analysis found no clustering of the answers that were compatible with anatomical evidence and were applied in the correct technique, but did demonstrate a common error, resisting dorsiflexion rather than plantarflexion, which was in agreement with the described frequencies. Inconsistencies were identified between the instruction method commonly provided for peroneal muscle testing in textbook and the functional anatomy of these muscles. Results reflect the lack of accuracy in applying functional anatomy to peroneal testing. This may be due to limited use of peroneal muscle testing or to inadequate investigation of the existing evaluation methods and their validity. Accordingly, teaching materials and clinical methods used for this test should be re-evaluated. Further research should investigate the value of peroneal muscle testing in clinical ankle evaluation. Copyright © 2012 John Wiley & Sons, Ltd.

Clinical outcomes of arthroscopic single and double row repair in full thickness rotator cuff tears.

PubMed

Ji, Jong-Hun; Shafi, Mohamed; Kim, Weon-Yoo; Kim, Young-Yul

2010-07-01

There has been a recent interest in the double row repair method for arthroscopic rotator cuff repair following favourable biomechanical results reported by some studies. The purpose of this study was to compare the clinical results of arthroscopic single row and double row repair methods in the full-thickness rotator cuff tears. 22 patients of arthroscopic single row repair (group I) and 25 patients who underwent double row repair (group II) from March 2003 to March 2005 were retrospectively evaluated and compared for the clinical outcomes. The mean age was 58 years and 56 years respectively for group I and II. The average follow-up in the two groups was 24 months. The evaluation was done by using the University of California Los Angeles (UCLA) rating scale and the shoulder index of the American Shoulder and Elbow Surgeons (ASES). In Group I, the mean ASES score increased from 30.48 to 87.40 and the mean ASES score increased from 32.00 to 91.45 in the Group II. The mean UCLA score increased from the preoperative 12.23 to 30.82 in Group I and from 12.20 to 32.40 in Group II. Each method has shown no statistical clinical differences between two methods, but based on the sub scores of UCLA score, the double row repair method yields better results for the strength, and it gives more satisfaction to the patients than the single row repair method. Comparing the two methods, double row repair group showed better clinical results in recovering strength and gave more satisfaction to the patients but no statistical clinical difference was found between 2 methods.

App Chronic Disease Checklist: Protocol to Evaluate Mobile Apps for Chronic Disease Self-Management

PubMed Central

Anderson, Kevin; Burford, Oksana

2016-01-01

Background The availability of mobile health apps for self-care continues to increase. While little evidence of their clinical impact has been published, there is general agreement among health authorities and authors that consumers’ use of health apps assist in self-management and potentially clinical decision making. A consumer’s sustained engagement with a health app is dependent on the usability and functionality of the app. While numerous studies have attempted to evaluate health apps, there is a paucity of published methods that adequately recognize client experiences in the academic evaluation of apps for chronic conditions. Objective This paper reports (1) a protocol to shortlist health apps for academic evaluation, (2) synthesis of a checklist to screen health apps for quality and reliability, and (3) a proposed method to theoretically evaluate usability of health apps, with a view towards identifying one or more apps suitable for clinical assessment. Methods A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram was developed to guide the selection of the apps to be assessed. The screening checklist was thematically synthesized with reference to recurring constructs in published checklists and related materials for the assessment of health apps. The checklist was evaluated by the authors for face and construct validity. The proposed method for evaluation of health apps required the design of procedures for raters of apps, dummy data entry to test the apps, and analysis of raters’ scores. Results The PRISMA flow diagram comprises 5 steps: filtering of duplicate apps; eliminating non-English apps; removing apps requiring purchase, filtering apps not updated within the past year; and separation of apps into their core functionality. The screening checklist to evaluate the selected apps was named the App Chronic Disease Checklist, and comprises 4 sections with 6 questions in each section. The validity check verified classification of, and ambiguity in, wording of questions within constructs. The proposed method to evaluate shortlisted and downloaded apps comprises instructions to attempt set-up of a dummy user profile, and dummy data entry to represent in-range and out-of-range clinical measures simulating a range of user behaviors. A minimum score of 80% by consensus (using the Intraclass Correlation Coefficient) between raters is proposed to identify apps suitable for clinical trials. Conclusions The flow diagram allows researchers to shortlist health apps that are potentially suitable for formal evaluation. The evaluation checklist enables quantitative comparison of shortlisted apps based on constructs reported in the literature. The use of multiple raters, and comparison of their scores, is proposed to manage inherent subjectivity in assessing user experiences. Initial trial of the combined protocol is planned for apps pertaining to the self-monitoring of asthma; these results will be reported elsewhere. PMID:27815233

Management of Gene Variants of Unknown Significance: Analysis Method and Risk Assessment of the VHL Mutation p.P81S (c.241C>T).

PubMed

Alosi, Daniela; Bisgaard, Marie Luise; Hemmingsen, Sophie Nowak; Krogh, Lotte Nylandsted; Mikkelsen, Hanne Birte; Binderup, Marie Louise Mølgaard

2017-02-01

Evaluation of the pathogenicity of a gene variant of unknown significance (VUS) is crucial for molecular diagnosis and genetic counseling, but can be challenging. This is especially so in phenotypically variable diseases, such as von Hippel-Lindau disease (vHL). vHL is caused by germline mutations in the VHL gene, which predispose to the development of multiple tumors such as central nervous system hemangioblastomas and renal cell carcinoma (RCC). We propose a method for the evaluation of VUS pathogenicity through our experience with the VHL missense mutation c.241C>T (p.P81S). 1) Clinical evaluation of known variant carriers: We evaluated a family of five VHL p.P81S carriers, as well as the clinical characteristics of all the p.P81S carriers reported in the literature; 2) Evaluation of tumor tissue via genetic analysis, histology, and immunohistochemistry (IHC); 3) Assessment of the variant's impact on protein structure and function, using multiple databases, in silico algorithms, and reports of functional studies. Only one family member had clinical signs of vHL with early-onset RCC. IHC analysis showed no VHL protein expressed in the tumor, consistent with biallelic VHL inactivation. The majority of in silico algorithms reported p.P81S as possibly pathogenic in relation to vHL or RCC, but there were discrepancies. Functional studies suggest that p.P81S impairs the VHL protein's function. The VHL p.P81S mutation is most likely a low-penetrant pathogenic variant predisposing to RCC development. We suggest the above-mentioned method for VUS evaluation with use of different methods, especially a variety of in silico methods and tumor tissue analysis.

Methodological Reflections on the Contribution of Qualitative Research to the Evaluation of Clinical Ethics Support Services.

PubMed

Wäscher, Sebastian; Salloch, Sabine; Ritter, Peter; Vollmann, Jochen; Schildmann, Jan

2017-05-01

This article describes a process of developing, implementing and evaluating a clinical ethics support service intervention with the goal of building up a context-sensitive structure of minimal clinical-ethics in an oncology department without prior clinical ethics structure. Scholars from different disciplines have called for an improvement in the evaluation of clinical ethics support services (CESS) for different reasons over several decades. However, while a lot has been said about the concepts and methodological challenges of evaluating CESS up to the present time, relatively few empirical studies have been carried out. The aim of this article is twofold. On the one hand, it describes a process of development, modifying and evaluating a CESS intervention as part of the ETHICO research project, using the approach of qualitative-formative evaluation. On the other hand, it provides a methodological analysis which specifies the contribution of qualitative empirical methods to the (formative) evaluation of CESS. We conclude with a consideration of the strengths and limitations of qualitative evaluation research with regards to the evaluation and development of context sensitive CESS. We further discuss our own approach in contrast to rather traditional consult or committee models. © 2017 John Wiley & Sons Ltd.

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

PubMed

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

2011-12-01

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

A strategy for evaluating pathway analysis methods.

PubMed

Yu, Chenggang; Woo, Hyung Jun; Yu, Xueping; Oyama, Tatsuya; Wallqvist, Anders; Reifman, Jaques

2017-10-13

Researchers have previously developed a multitude of methods designed to identify biological pathways associated with specific clinical or experimental conditions of interest, with the aim of facilitating biological interpretation of high-throughput data. Before practically applying such pathway analysis (PA) methods, we must first evaluate their performance and reliability, using datasets where the pathways perturbed by the conditions of interest have been well characterized in advance. However, such 'ground truths' (or gold standards) are often unavailable. Furthermore, previous evaluation strategies that have focused on defining 'true answers' are unable to systematically and objectively assess PA methods under a wide range of conditions. In this work, we propose a novel strategy for evaluating PA methods independently of any gold standard, either established or assumed. The strategy involves the use of two mutually complementary metrics, recall and discrimination. Recall measures the consistency of the perturbed pathways identified by applying a particular analysis method to an original large dataset and those identified by the same method to a sub-dataset of the original dataset. In contrast, discrimination measures specificity-the degree to which the perturbed pathways identified by a particular method to a dataset from one experiment differ from those identifying by the same method to a dataset from a different experiment. We used these metrics and 24 datasets to evaluate six widely used PA methods. The results highlighted the common challenge in reliably identifying significant pathways from small datasets. Importantly, we confirmed the effectiveness of our proposed dual-metric strategy by showing that previous comparative studies corroborate the performance evaluations of the six methods obtained by our strategy. Unlike any previously proposed strategy for evaluating the performance of PA methods, our dual-metric strategy does not rely on any ground truth, either established or assumed, of the pathways perturbed by a specific clinical or experimental condition. As such, our strategy allows researchers to systematically and objectively evaluate pathway analysis methods by employing any number of datasets for a variety of conditions.

An Overview and Evaluation of Recent Machine Learning Imputation Methods Using Cardiac Imaging Data.

PubMed

Liu, Yuzhe; Gopalakrishnan, Vanathi

2017-03-01

Many clinical research datasets have a large percentage of missing values that directly impacts their usefulness in yielding high accuracy classifiers when used for training in supervised machine learning. While missing value imputation methods have been shown to work well with smaller percentages of missing values, their ability to impute sparse clinical research data can be problem specific. We previously attempted to learn quantitative guidelines for ordering cardiac magnetic resonance imaging during the evaluation for pediatric cardiomyopathy, but missing data significantly reduced our usable sample size. In this work, we sought to determine if increasing the usable sample size through imputation would allow us to learn better guidelines. We first review several machine learning methods for estimating missing data. Then, we apply four popular methods (mean imputation, decision tree, k-nearest neighbors, and self-organizing maps) to a clinical research dataset of pediatric patients undergoing evaluation for cardiomyopathy. Using Bayesian Rule Learning (BRL) to learn ruleset models, we compared the performance of imputation-augmented models versus unaugmented models. We found that all four imputation-augmented models performed similarly to unaugmented models. While imputation did not improve performance, it did provide evidence for the robustness of our learned models.

A novel approach to generating CER hypotheses based on mining clinical data.

PubMed

Zhang, Shuo; Li, Lin; Yu, Yiqin; Sun, Xingzhi; Xu, Linhao; Zhao, Wei; Teng, Xiaofei; Pan, Yue

2013-01-01

Comparative effectiveness research (CER) is a scientific method of investigating the effectiveness of alternative intervention methods. In a CER study, clinical researchers typically start with a CER hypothesis, and aim to evaluate it by applying a series of medical statistical methods. Traditionally, the CER hypotheses are defined manually by clinical researchers. This makes the task of hypothesis generation very time-consuming and the quality of hypothesis heavily dependent on the researchers' skills. Recently, with more electronic medical data being collected, it is highly promising to apply the computerized method for discovering CER hypotheses from clinical data sets. In this poster, we proposes a novel approach to automatically generating CER hypotheses based on mining clinical data, and presents a case study showing that the approach can facilitate clinical researchers to identify potentially valuable hypotheses and eventually define high quality CER studies.

Deriving the expected utility of a predictive model when the utilities are uncertain.

PubMed

Cooper, Gregory F; Visweswaran, Shyam

2005-01-01

Predictive models are often constructed from clinical databases with the goal of eventually helping make better clinical decisions. Evaluating models using decision theory is therefore natural. When constructing a model using statistical and machine learning methods, however, we are often uncertain about precisely how the model will be used. Thus, decision-independent measures of classification performance, such as the area under an ROC curve, are popular. As a complementary method of evaluation, we investigate techniques for deriving the expected utility of a model under uncertainty about the model's utilities. We demonstrate an example of the application of this approach to the evaluation of two models that diagnose coronary artery disease.

Enhancing predictive accuracy and reproducibility in clinical evaluation research: Commentary on the special section of the Journal of Evaluation in Clinical Practice.

PubMed

Bryant, Fred B

2016-12-01

This paper introduces a special section of the current issue of the Journal of Evaluation in Clinical Practice that includes a set of 6 empirical articles showcasing a versatile, new machine-learning statistical method, known as optimal data (or discriminant) analysis (ODA), specifically designed to produce statistical models that maximize predictive accuracy. As this set of papers clearly illustrates, ODA offers numerous important advantages over traditional statistical methods-advantages that enhance the validity and reproducibility of statistical conclusions in empirical research. This issue of the journal also includes a review of a recently published book that provides a comprehensive introduction to the logic, theory, and application of ODA in empirical research. It is argued that researchers have much to gain by using ODA to analyze their data. © 2016 John Wiley & Sons, Ltd.

Building a comprehensive syntactic and semantic corpus of Chinese clinical texts.

PubMed

He, Bin; Dong, Bin; Guan, Yi; Yang, Jinfeng; Jiang, Zhipeng; Yu, Qiubin; Cheng, Jianyi; Qu, Chunyan

2017-05-01

To build a comprehensive corpus covering syntactic and semantic annotations of Chinese clinical texts with corresponding annotation guidelines and methods as well as to develop tools trained on the annotated corpus, which supplies baselines for research on Chinese texts in the clinical domain. An iterative annotation method was proposed to train annotators and to develop annotation guidelines. Then, by using annotation quality assurance measures, a comprehensive corpus was built, containing annotations of part-of-speech (POS) tags, syntactic tags, entities, assertions, and relations. Inter-annotator agreement (IAA) was calculated to evaluate the annotation quality and a Chinese clinical text processing and information extraction system (CCTPIES) was developed based on our annotated corpus. The syntactic corpus consists of 138 Chinese clinical documents with 47,426 tokens and 2612 full parsing trees, while the semantic corpus includes 992 documents that annotated 39,511 entities with their assertions and 7693 relations. IAA evaluation shows that this comprehensive corpus is of good quality, and the system modules are effective. The annotated corpus makes a considerable contribution to natural language processing (NLP) research into Chinese texts in the clinical domain. However, this corpus has a number of limitations. Some additional types of clinical text should be introduced to improve corpus coverage and active learning methods should be utilized to promote annotation efficiency. In this study, several annotation guidelines and an annotation method for Chinese clinical texts were proposed, and a comprehensive corpus with its NLP modules were constructed, providing a foundation for further study of applying NLP techniques to Chinese texts in the clinical domain. Copyright © 2017. Published by Elsevier Inc.

Novel diagnostic procedure for determining metastasis to sentinel lymph nodes in breast cancer using a semi-dry dot-blot method.

PubMed

Otsubo, Ryota; Oikawa, Masahiro; Hirakawa, Hiroshi; Shibata, Kenichiro; Abe, Kuniko; Hayashi, Tomayoshi; Kinoshita, Naoe; Shigematsu, Kazuto; Hatachi, Toshiko; Yano, Hiroshi; Matsumoto, Megumi; Takagi, Katsunori; Tsuchiya, Tomoshi; Tomoshige, Koichi; Nakashima, Masahiro; Taniguchi, Hideki; Omagari, Takeyuki; Itoyanagi, Noriaki; Nagayasu, Takeshi

2014-02-15

We developed an easy, quick and cost-effective detection method for lymph node metastasis called the semi-dry dot-blot (SDB) method, which visualizes the presence of cancer cells with washing of sectioned lymph nodes by anti-pancytokeratin antibody, modifying dot-blot technology. We evaluated the validity and efficacy of the SDB method for the diagnosis of lymph node metastasis in a clinical setting (Trial 1). To evaluate the validity of the SDB method in clinical specimens, 180 dissected lymph nodes from 29 cases, including breast, gastric and colorectal cancer, were examined. Each lymph node was sliced at the maximum diameter and the sensitivity, specificity and accuracy of the SDB method were determined and compared with the final pathology report. Metastasis was detected in 32 lymph nodes (17.8%), and the sensitivity, specificity and accuracy of the SDB method were 100, 98.0 and 98.3%, respectively (Trial 2). To evaluate the efficacy of the SDB method in sentinel lymph node (SLN) biopsy, 174 SLNs from 100 cases of clinically node-negative breast cancer were analyzed. Each SLN was longitudinally sliced at 2-mm intervals and the sensitivity, specificity, accuracy and time required for the SDB method were determined and compared with the intraoperative pathology report. Metastasis was detected in 15 SLNs (8.6%), and the sensitivity, specificity, accuracy and mean required time of the SDB method were 93.3, 96.9, 96.6 and 43.3 min, respectively. The SDB method is a novel and reliable modality for the intraoperative diagnosis of SLN metastasis. © 2013 UICC.

Investigating Invariant Item Ordering in Personality and Clinical Scales: Some Empirical Findings and a Discussion

ERIC Educational Resources Information Center

Meijer, Rob R.; Egberink, Iris J. L.

2012-01-01

In recent studies, different methods were proposed to investigate invariant item ordering (IIO), but practical IIO research is an unexploited field in questionnaire construction and evaluation. In the present study, the authors explored the usefulness of different IIO methods to analyze personality scales and clinical scales. From the authors'…

Dynamic Chest Image Analysis: Evaluation of Model-Based Pulmonary Perfusion Analysis With Pyramid Images

DTIC Science & Technology

2001-10-25

Image Analysis aims to develop model-based computer analysis and visualization methods for showing focal and general abnormalities of lung ventilation and perfusion based on a sequence of digital chest fluoroscopy frames collected with the Dynamic Pulmonary Imaging technique 18,5,17,6. We have proposed and evaluated a multiresolutional method with an explicit ventilation model based on pyramid images for ventilation analysis. We have further extended the method for ventilation analysis to pulmonary perfusion. This paper focuses on the clinical evaluation of our method for

The Effects of Aging on Clinical Vestibular Evaluations

PubMed Central

Maheu, Maxime; Houde, Marie-Soleil; Landry, Simon P.; Champoux, François

2015-01-01

Balance disorders are common issues for aging populations due to the effects of normal aging on peripheral vestibular structures. These changes affect the results of vestibular function evaluations and make the interpretation of these results more difficult. The objective of this article is to review the current state of knowledge of clinically relevant vestibular measures. We will first focus on otolith function assessment methods cervical-VEMP (cVEMP) and ocular-VEMP (oVEMP), then the caloric and video-head impulse test (vHIT) methods for semicircular canals assessment. cVEMP and oVEMP are useful methods, though research on the effects of age for some parameters are still inconclusive. vHIT results are largely independent of age as compared to caloric stimulation and should therefore be preferred for the evaluation of the semicircular canals function. PMID:26441824

Clinical results of resection arthrodesis by triangular external fixation for posttraumatic arthrosis of the ankle joint in 89 cases

PubMed Central

2009-01-01

The methods for ankle arthrodesis differ significantly, probably a sign that no method is clearly superior to others. In the last ten years there is a clear favour toward internal fixation. We retrospectively evaluate the technique and evaluate the clinical long term results of external fixation in a triangular frame. Patients and Methods From 1994 to 2001 a consecutive series of 95 patients with end stage arthritis of the ankle joint were treated. Retrospectively the case notes were evaluated regarding trauma history, medical complaints, further injuries and illnesses, walking and pain status and occupational issues and the clinical examination before arthrodesis. Mean age at the index procedure was 45.4 years (18-82), 67 patients were male (70.5%). Via a bilateral approach the malleoli and the joint surfaces were resected. An AO fixator was applied with two Steinmann-nails inserted with approximately 8 cm distance in the distal tibia, one in the neck of the talus and one in the dorsal calcaneus. The fixator was removed after approximately 12 weeks. Follow up examination at mean 4.4 years included a standardised questionnaire and a clinical examination including the criteria of the AOFAS-Score and radiographs. Results: Due to different complications, 8 (8.9%) further surgical procedures were necessary including 1 below knee amputation. In 4 patients a non-union of the ankle arthrodesis developed (4.5%). The mean AOFAS score improved from 20.8 to 69.3 points. Conclusion Non-union rates and clinical results of arthrodesis by triangular external fixation of the ankle joint do not differ to internal fixation methods. The complication rate and the reduced patient comfort reserve this method mainly for infected arthritis and complicated soft tissue situations. PMID:19258207

Agreement between clinical estimation and a new quantitative analysis by Photoshop software in fundus and angiographic image variables.

PubMed

Ramezani, Alireza; Ahmadieh, Hamid; Azarmina, Mohsen; Soheilian, Masoud; Dehghan, Mohammad H; Mohebbi, Mohammad R

2009-12-01

To evaluate the validity of a new method for the quantitative analysis of fundus or angiographic images using Photoshop 7.0 (Adobe, USA) software by comparing with clinical evaluation. Four hundred and eighteen fundus and angiographic images of diabetic patients were evaluated by three retina specialists and then by computing using Photoshop 7.0 software. Four variables were selected for comparison: amount of hard exudates (HE) on color pictures, amount of HE on red-free pictures, severity of leakage, and the size of the foveal avascular zone (FAZ). The coefficient of agreement (Kappa) between the two methods in the amount of HE on color and red-free photographs were 85% (0.69) and 79% (0.59), respectively. The agreement for severity of leakage was 72% (0.46). In the two methods for the evaluation of the FAZ size using the magic and lasso software tools, the agreement was 54% (0.09) and 89% (0.77), respectively. Agreement in the estimation of the FAZ size by the lasso magnetic tool was excellent and was almost as good in the quantification of HE on color and on red-free images. Considering the agreement of this new technique for the measurement of variables in fundus images using Photoshop software with the clinical evaluation, this method seems to have sufficient validity to be used for the quantitative analysis of HE, leakage, and FAZ size on the angiograms of diabetic patients.

Psychometric Evaluation of Children with Auditory Processing Disorder (APD): Comparison with Normal-Hearing and Clinical Non-APD Groups

ERIC Educational Resources Information Center

Iliadou, Vasiliki; Bamiou, Doris Eva

2012-01-01

Purpose: To investigate the clinical utility of the Children's Auditory Processing Performance Scale (CHAPPS; Smoski, Brunt, & Tannahill, 1992) to evaluate listening ability in 12-year-old children referred for auditory processing assessment. Method: This was a prospective case control study of 97 children (age range = 11;4 [years;months] to…

Assessment of metal artifact reduction methods in pelvic CT

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

Abdoli, Mehrsima; Mehranian, Abolfazl; Ailianou, Angeliki

2016-04-15

Purpose: Metal artifact reduction (MAR) produces images with improved quality potentially leading to confident and reliable clinical diagnosis and therapy planning. In this work, the authors evaluate the performance of five MAR techniques for the assessment of computed tomography images of patients with hip prostheses. Methods: Five MAR algorithms were evaluated using simulation and clinical studies. The algorithms included one-dimensional linear interpolation (LI) of the corrupted projection bins in the sinogram, two-dimensional interpolation (2D), a normalized metal artifact reduction (NMAR) technique, a metal deletion technique, and a maximum a posteriori completion (MAPC) approach. The algorithms were applied to ten simulatedmore » datasets as well as 30 clinical studies of patients with metallic hip implants. Qualitative evaluations were performed by two blinded experienced radiologists who ranked overall artifact severity and pelvic organ recognition for each algorithm by assigning scores from zero to five (zero indicating totally obscured organs with no structures identifiable and five indicating recognition with high confidence). Results: Simulation studies revealed that 2D, NMAR, and MAPC techniques performed almost equally well in all regions. LI falls behind the other approaches in terms of reducing dark streaking artifacts as well as preserving unaffected regions (p < 0.05). Visual assessment of clinical datasets revealed the superiority of NMAR and MAPC in the evaluated pelvic organs and in terms of overall image quality. Conclusions: Overall, all methods, except LI, performed equally well in artifact-free regions. Considering both clinical and simulation studies, 2D, NMAR, and MAPC seem to outperform the other techniques.« less

Extracting important information from Chinese Operation Notes with natural language processing methods.

PubMed

Wang, Hui; Zhang, Weide; Zeng, Qiang; Li, Zuofeng; Feng, Kaiyan; Liu, Lei

2014-04-01

Extracting information from unstructured clinical narratives is valuable for many clinical applications. Although natural Language Processing (NLP) methods have been profoundly studied in electronic medical records (EMR), few studies have explored NLP in extracting information from Chinese clinical narratives. In this study, we report the development and evaluation of extracting tumor-related information from operation notes of hepatic carcinomas which were written in Chinese. Using 86 operation notes manually annotated by physicians as the training set, we explored both rule-based and supervised machine-learning approaches. Evaluating on unseen 29 operation notes, our best approach yielded 69.6% in precision, 58.3% in recall and 63.5% F-score. Copyright © 2014 Elsevier Inc. All rights reserved.

Clinical assessment of nutritional status and feeding programs in horses.

PubMed

Becvarova, Iveta; Pleasant, R Scott; Thatcher, Craig D

2009-04-01

Veterinarians are a primary source of nutritional information and advice for horse owners. This article reviews methods for clinical assessment of nutritional status and feeding programs that can be applied to an individual horse or group of horses. Physical examination, including measurement of body weight and evaluation of body condition score, estimation of nutrient requirements and the nutrient content of the horse's diet, and evaluation of the feeding method are important components of the assessment. Ongoing clinical assessment of health and body condition will gauge the need for reassessment of the feeding plan. Obvious indications for prompt reevaluation of diet and feeding include changes in health status (eg, body condition), life stage or physiologic state (eg, pregnancy), or performance status.

Video-recorded simulated patient interactions: can they help develop clinical and communication skills in today's learning environment?

PubMed

Seif, Gretchen A; Brown, Debora

2013-01-01

It is difficult to provide real-world learning experiences for students to master clinical and communication skills. The purpose of this paper is to describe a novel instructional method using self- and peer-assessment, reflection, and technology to help students develop effective interpersonal and clinical skills. The teaching method is described by the constructivist learning theory and incorporates the use of educational technology. The learning activities were incorporated into the pre-clinical didactic curriculum. The students participated in two video-recording assignments and performed self-assessments on each and had a peer-assessment on the second video-recording. The learning activity was evaluated through the self- and peer-assessments and an instructor-designed survey. This evaluation identified several themes related to the assignment, student performance, clinical behaviors and establishing rapport. Overall the students perceived that the learning activities assisted in the development of clinical and communication skills prior to direct patient care. The use of video recordings of a simulated history and examination is a unique learning activity for preclinical PT students in the development of clinical and communication skills.

[Clinical practice guidelines (II): searching and critical evaluation].

PubMed

Alonso, P; Bonfill, X

2007-01-01

Clinical practice guidelines have unique characteristics of the Internet era in which they are starting to be increasingly popular. The fact that they are often elaborated by governmental agencies and are not published in conventional journals means that they may not be accessible using the usual search methods employed for other types of scientific studies and documents (clinical trials, reviews, etc.). The Internet has become an essential tool for locating clinical practice guidelines, and meta-search engines, specific databases, directories, and elaborating institutions are of special importance. The relative lack of indexing of clinical practice guides means that Medline and Embase are not as useful in this context as in searching for original studies. With the aim of evaluating the validity, reproducibility, and reliability of clinical practice guidelines, a series of European institutions designed a tool to evaluate clinical practice guidelines at the end of the 1990s. This instrument, named AGREE, aims to offer a framework for the evaluation of the quality of clinical practice guidelines. It can also be useful in the design of new clinical practice guidelines as well as in the evaluation of the validity of guidelines to be updated or adapted. The AGREE instrument has become the reference for those that use guidelines, those that elaborate them, and for healthcare providers.

External evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical settings

PubMed Central

Zhao, Wei; Kaguelidou, Florentia; Biran, Valérie; Zhang, Daolun; Allegaert, Karel; Capparelli, Edmund V; Holford, Nick; Kimura, Toshimi; Lo, Yoke-Lin; Peris, José-Esteban; Thomson, Alison; Anker, John N; Fakhoury, May; Jacqz-Aigrain, Evelyne

2013-01-01

Aims Vancomycin is one of the most evaluated antibiotics in neonates using modeling and simulation approaches. However no clear consensus on optimal dosing has been achieved. The objective of the present study was to perform an external evaluation of published models, in order to test their predictive performances in an independent dataset and to identify the possible study-related factors influencing the transferability of pharmacokinetic models to different clinical settings. Method Published neonatal vancomycin pharmacokinetic models were screened from the literature. The predictive performance of six models was evaluated using an independent dataset (112 concentrations from 78 neonates). The evaluation procedures used simulation-based diagnostics [visual predictive check (VPC) and normalized prediction distribution errors (NPDE)]. Results Differences in predictive performances of models for vancomycin pharmacokinetics in neonates were found. The mean of NPDE for six evaluated models were 1.35, −0.22, −0.36, 0.24, 0.66 and 0.48, respectively. These differences were explained, at least partly, by taking into account the method used to measure serum creatinine concentrations. The adult conversion factor of 1.3 (enzymatic to Jaffé) was tested with an improvement in the VPC and NPDE, but it still needs to be evaluated and validated in neonates. Differences were also identified between analytical methods for vancomycin. Conclusion The importance of analytical techniques for serum creatinine concentrations and vancomycin as predictors of vancomycin concentrations in neonates have been confirmed. Dosage individualization of vancomycin in neonates should consider not only patients' characteristics and clinical conditions, but also the methods used to measure serum creatinine and vancomycin. PMID:23148919

Evaluating Integrative Cancer Clinics With the Claim Assessment Profile: An Example With the InspireHealth Clinic

PubMed Central

Hilton, Lara; Elfenbaum, Pamela; Jain, Shamini; Sprengel, Meredith; Jonas, Wayne B.

2016-01-01

Background: The evaluation of freestanding integrative cancer clinical programs is challenging and is rarely done. We have developed an approach called the Claim Assessment Profile (CAP) to identify whether evaluation of a practice is justified, feasible, and likely to provide useful information. Objectives: A CAP was performed in order to (1) clarify the healing claims at InspireHealth, an integrative oncology treatment program, by defining the most important impacts on its clients; (2) gather information about current research capacity at the clinic; and (3) create a program theory and path model for use in prospective research. Study Design/Methods: This case study design incorporates methods from a variety of rapid assessment approaches. Procedures included site visits to observe the program, structured qualitative interviews with 26 providers and staff, surveys to capture descriptive data about the program, and observational data on program implementation. Results: The InspireHealth program is a well-established, multi-site, thriving integrative oncology clinical practice that focuses on patient support, motivation, and health behavior engagement. It delivers patient-centered care via a standardized treatment protocol. There arehigh levels of research interest from staff and resources by which to conduct research. Conclusions: This analysis provides the primary descriptive and claims clarification of an integrative oncology treatment program, an evaluation readiness report, a detailed logic model explicating program theory, and a clinical outcomes path model for conducting prospective research. Prospective evaluation of this program would be feasible and valuable, adding to our knowledge base of integrative cancer therapies. PMID:29444602

Evaluating new HbA1c methods for adoption by the IFCC and NGSP reference networks using international quality targets.

PubMed

Lenters-Westra, Erna; English, Emma

2017-08-28

As a reference laboratory for HbA1c, it is essential to have accurate and precise HbA1c methods covering a range of measurement principles. We report an evaluation of the Abbott Enzymatic (Architect c4000), Roche Gen.3 HbA1c (Cobas c513) and Tosoh G11 using different quality targets. The effect of hemoglobin variants, other potential interferences and the performance in comparison to both the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the National Glycohemoglobin Standardization Program (NGSP) reference systems was assessed using certified evaluation protocols. Each of the evaluated HbA1c methods had CVs <3% in SI units and <2% in NGSP units at 46 mmol/mol (6.4%) and 72 mmol/mol (8.7%) and passed the NGSP criteria when compared with six secondary reference measurement procedures (SRMPs). Sigma was 8.6 for Abbott Enzymatic, 3.3 for Roche Cobas c513 and 6.9 for Tosoh G11. No clinically significant interference was detected for the common Hb variants for the three methods. All three methods performed well and are suitable for clinical application in the analysis of HbA1c. Partly based on the result of this study, the Abbott Enzymatic method on the Architect c4000 and the Roche Gen.3 HbA1c on the Cobas c513 are now official, certified IFCC and NGSP SRMPs in the IFCC and NGSP networks. Sigma metrics quality criteria presented in a graph distinguish between good and excellent performance.

Comparative Evaluation of American Cancer Society and American Lung Association Smoking Cessation Clinics.

ERIC Educational Resources Information Center

Lando, Harry A.; And Others

1990-01-01

Compared the effectiveness of the American Cancer Society's "FreshStart," the American Lung Association's "Freedom from Smoking," and a laboratory smoking cessation clinic. A one-year followup favored the more intensive laboratory and "Freedom from Smoking" clinics over the "FreshStart" method. (FMW)

Reducing Diagnostic Error with Computer-Based Clinical Decision Support

ERIC Educational Resources Information Center

Greenes, Robert A.

2009-01-01

Information technology approaches to delivering diagnostic clinical decision support (CDS) are the subject of the papers to follow in the proceedings. These will address the history of CDS and present day approaches (Miller), evaluation of diagnostic CDS methods (Friedman), and the role of clinical documentation in supporting diagnostic decision…

Directions for new developments on statistical design and analysis of small population group trials.

PubMed

Hilgers, Ralf-Dieter; Roes, Kit; Stallard, Nigel

2016-06-14

Most statistical design and analysis methods for clinical trials have been developed and evaluated where at least several hundreds of patients could be recruited. These methods may not be suitable to evaluate therapies if the sample size is unavoidably small, which is usually termed by small populations. The specific sample size cut off, where the standard methods fail, needs to be investigated. In this paper, the authors present their view on new developments for design and analysis of clinical trials in small population groups, where conventional statistical methods may be inappropriate, e.g., because of lack of power or poor adherence to asymptotic approximations due to sample size restrictions. Following the EMA/CHMP guideline on clinical trials in small populations, we consider directions for new developments in the area of statistical methodology for design and analysis of small population clinical trials. We relate the findings to the research activities of three projects, Asterix, IDeAl, and InSPiRe, which have received funding since 2013 within the FP7-HEALTH-2013-INNOVATION-1 framework of the EU. As not all aspects of the wide research area of small population clinical trials can be addressed, we focus on areas where we feel advances are needed and feasible. The general framework of the EMA/CHMP guideline on small population clinical trials stimulates a number of research areas. These serve as the basis for the three projects, Asterix, IDeAl, and InSPiRe, which use various approaches to develop new statistical methodology for design and analysis of small population clinical trials. Small population clinical trials refer to trials with a limited number of patients. Small populations may result form rare diseases or specific subtypes of more common diseases. New statistical methodology needs to be tailored to these specific situations. The main results from the three projects will constitute a useful toolbox for improved design and analysis of small population clinical trials. They address various challenges presented by the EMA/CHMP guideline as well as recent discussions about extrapolation. There is a need for involvement of the patients' perspective in the planning and conduct of small population clinical trials for a successful therapy evaluation.

Kidney volume measurement methods for clinical studies on autosomal dominant polycystic kidney disease

PubMed Central

Sharma, Kanishka; Caroli, Anna; Quach, Le Van; Petzold, Katja; Bozzetto, Michela; Serra, Andreas L.; Remuzzi, Giuseppe; Remuzzi, Andrea

2017-01-01

Background In autosomal dominant polycystic kidney disease (ADPKD), total kidney volume (TKV) is regarded as an important biomarker of disease progression and different methods are available to assess kidney volume. The purpose of this study was to identify the most efficient kidney volume computation method to be used in clinical studies evaluating the effectiveness of treatments on ADPKD progression. Methods and findings We measured single kidney volume (SKV) on two series of MR and CT images from clinical studies on ADPKD (experimental dataset) by two independent operators (expert and beginner), twice, using all of the available methods: polyline manual tracing (reference method), free-hand manual tracing, semi-automatic tracing, Stereology, Mid-slice and Ellipsoid method. Additionally, the expert operator also measured the kidney length. We compared different methods for reproducibility, accuracy, precision, and time required. In addition, we performed a validation study to evaluate the sensitivity of these methods to detect the between-treatment group difference in TKV change over one year, using MR images from a previous clinical study. Reproducibility was higher on CT than MR for all methods, being highest for manual and semiautomatic contouring methods (planimetry). On MR, planimetry showed highest accuracy and precision, while on CT accuracy and precision of both planimetry and Stereology methods were comparable. Mid-slice and Ellipsoid method, as well as kidney length were fast but provided only a rough estimate of kidney volume. The results of the validation study indicated that planimetry and Stereology allow using an importantly lower number of patients to detect changes in kidney volume induced by drug treatment as compared to other methods. Conclusions Planimetry should be preferred over fast and simplified methods for accurately monitoring ADPKD progression and assessing drug treatment effects. Expert operators, especially on MR images, are required for performing reliable estimation of kidney volume. The use of efficient TKV quantification methods considerably reduces the number of patients to enrol in clinical investigations, making them more feasible and significant. PMID:28558028

Clinical evaluation of GEM 21S® and a collagen membrane with a coronally advanced flap as a root coverage procedure in the treatment of gingival recession defects: A comparative study

PubMed Central

Singh, Preetinder; Suresh, D. K.

2012-01-01

Aim: Clinical evaluation of efficacy of rhPDGF-BB plus beta tricalcium phosphate (GEM 21S®) along with a collagen membrane in root coverage using a coronally advanced flap. Materials and Methods: This human case series evaluated the clinical outcome of rhPDGF-BB with beta-tricalcium phosphate (GEM 21S®) and a collagen membrane in the treatment of recession defects using a coronally advanced flap. Patients were followed postoperatively, and healing was evaluated at 1, 3, and 6 months, with recession depth as the primary outcome measure. Results: This pioneer case series revealed a favorable tissue response to GEM 21S® and collagen membrane from both clinical and esthetic point of view in regenerative periodontal surgery. PMID:23493720

A method for evaluating competency in assessment and management of suicide risk.

PubMed

Hung, Erick K; Binder, Renée L; Fordwood, Samantha R; Hall, Stephen E; Cramer, Robert J; McNiel, Dale E

2012-01-01

Although health professionals increasingly are expected to be able to assess and manage patients' risk for suicide, few methods are available to evaluate this competency. This report describes development of a competency-assessment instrument for suicide risk-assessment (CAI-S), and evaluates its use in an objective structured clinical examination (OSCE). The authors developed the CAI-S on the basis of the literature on suicide risk-assessment and management, and consultation with faculty focus groups from three sites in a large academic psychiatry department. The CAI-S structures faculty ratings regarding interviewing and data collection, case formulation and presentation, treatment-planning, and documentation. To evaluate the CAI-S, 31 faculty members used it to rate the performance of 31 learners (26 psychiatric residents and 5 clinical psychology interns) who participated in an OSCE. After interviewing a standardized patient, learners presented their risk-assessment findings and treatment plans. Faculty used the CAI-S to structure feedback to the learners. In a subsidiary study of interrater reliability, six faculty members rated video-recorded suicide risk-assessments. The CAI-S showed good internal consistency, reliability, and interrater reliability. Concurrent validity was supported by the finding that CAI-S ratings were higher for senior learners than junior learners, and were higher for learners with more clinical experience with suicidal patients than learners with less clinical experience. Faculty and learners rated the method as helpful for structuring feedback and supervision. The findings support the usefulness of the CAI-S for evaluating competency in suicide risk-assessment and management.

Decision tool for clients with medical issues: a framework for identifying driving risk and potential to return to driving.

PubMed

Dickerson, Anne E; Bédard, Michel

2014-04-01

This paper offers occupational therapy generalists and specialists a new framework by which to consider clinical evaluation data and an older adult's driving risk and potential to resume this previously learned skill. Based on Michon's model describing the hierarchy of driving levels, clinical questions identify the factors that may affect a client's fitness to drive. The first part is intended to support clinical judgment of whether a client needs a driving evaluation by a driver rehabilitation specialist. The second part offers a framework to organize clinical data that are already known and determine what other evaluation information is justified and necessary to make a driving recommendation. Methods and rational for use are discussed.

Evaluation of image features and classification methods for Barrett's cancer detection using VLE imaging

NASA Astrophysics Data System (ADS)

Klomp, Sander; van der Sommen, Fons; Swager, Anne-Fré; Zinger, Svitlana; Schoon, Erik J.; Curvers, Wouter L.; Bergman, Jacques J.; de With, Peter H. N.

2017-03-01

Volumetric Laser Endomicroscopy (VLE) is a promising technique for the detection of early neoplasia in Barrett's Esophagus (BE). VLE generates hundreds of high resolution, grayscale, cross-sectional images of the esophagus. However, at present, classifying these images is a time consuming and cumbersome effort performed by an expert using a clinical prediction model. This paper explores the feasibility of using computer vision techniques to accurately predict the presence of dysplastic tissue in VLE BE images. Our contribution is threefold. First, a benchmarking is performed for widely applied machine learning techniques and feature extraction methods. Second, three new features based on the clinical detection model are proposed, having superior classification accuracy and speed, compared to earlier work. Third, we evaluate automated parameter tuning by applying simple grid search and feature selection methods. The results are evaluated on a clinically validated dataset of 30 dysplastic and 30 non-dysplastic VLE images. Optimal classification accuracy is obtained by applying a support vector machine and using our modified Haralick features and optimal image cropping, obtaining an area under the receiver operating characteristic of 0.95 compared to the clinical prediction model at 0.81. Optimal execution time is achieved using a proposed mean and median feature, which is extracted at least factor 2.5 faster than alternative features with comparable performance.

Assessing Risk/Benefit for Trials Using Preclinical Evidence: A Proposal

PubMed Central

Kimmelman, Jonathan; Henderson, Valerie C.

2015-01-01

Abstract Moral evaluation of risk/benefit in early phase studies requires assessing the clinical promise of a candidate intervention using preclinical evidence. Yet there is little to guide ethics committees, investigators, sponsors or other stakeholders morally charged with making these assessments (“evaluators”). In what follows, we draw on published guidelines for preclinical study design to develop a structured process for assessing the clinical promise of new interventions. In the first step, evaluators gather all relevant preclinical studies, assess the magnitude of treatment effects, and determine clinical promise in light of various threats to valid clinical inference. In the second step, evaluators adjust assessments of clinical promise from preclinical studies by examining how other agents in the same reference class-and supported by similar evidence- have fared in clinical development. Assessments of clinical promise can then be fed into moral evaluation of risk and benefit in early phase trials. Though our approach has limitations, it offers a systematic and transparent method for assessing risk/benefit in early phase trials of novel interventions. PMID:26463620

Clinical Trials Methods for Evaluation of Potential Reduced Exposure Products

PubMed Central

Hatsukami, Dorothy K.; Hanson, Karen; Briggs, Anna; Parascandola, Mark; Genkinger, Jeanine M.; O'Connor, Richard; Shields, Peter

2009-01-01

Potential reduced exposure tobacco products (PREPs) may have promise in reducing tobacco-related morbidity or mortality or may promote greater harm to individuals or the population. Critical to determining the risks or benefits from these products are valid human clinical trial PREP assessment methods. Assessment involves determining the effects of these products on biomarkers of exposure and of effect, which serve as proxies for harm, and assessing the potential for consumer uptake and abuse of the product. This article raises the critical methodological issues associated with PREP assessment, reviews the methods that have been used to assess PREPs, and describes the strengths and limitations of these methods. Additionally, recommendations for clinical trials PREP assessment methods and future research directions in this area based on this review and on the deliberations from a National Cancer Institute sponsored Clinical Trials PREP Methods Workshop are provided. PMID:19959672

Impact of a dedicated cancer-associated thrombosis service on clinical outcomes: a mixed-methods evaluation of a clinical improvement exercise.

PubMed

Noble, Simon; Pease, Nikki; Sui, Jessica; Davies, James; Lewis, Sarah; Malik, Usman; Alikhan, Raza; Prout, Hayley; Nelson, Annmarie

2016-11-28

Cancer-associated thrombosis (CAT) complex condition, which may present to any healthcare professional and at any point during the cancer journey. As such, patients may be managed by a number of specialties, resulting in inconsistent practice and suboptimal care. We describe the development of a dedicated CAT service and its evaluation. Specialist cancer centre, district general hospital and primary care. Patients with CAT and their referring clinicians. A cross specialty team developed a dedicated CAT service , including clear referral pathways, consistent access to medicines, patient's information and a specialist clinic. The service was evaluated using a mixed-methods evaluation , including audits of clinical practice, clinical outcomes, staff surveys and qualitative interviewing of patients and healthcare professionals. Data from 457 consecutive referrals over an 18-month period were evaluated. The CAT service has led to an 88% increase in safe and consistent community prescribing of low-molecular-weight heparin, with improved access to specialist advice and information. Patients reported improved understanding of their condition, enabling better self-management as well as better access to support and information. Referring clinicians reported better care standards for their patients with improved access to expertise and appropriate management. A dedicated CAT service improves overall standards of care and is viewed positively by patients and clinicians alike. Further health economic evaluation would enhance the case for establishing this as the standard model of care. 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/.

Evaluation Criteria for Nursing Student Application of Evidence-Based Practice: A Delphi Study.

PubMed

Bostwick, Lina; Linden, Lois

2016-06-01

Core clinical evaluation criteria do not exist for measuring prelicensure baccalaureate nursing students' application of evidence-based practice (EBP) during direct care assignments. The study objective was to achieve consensus among EBP nursing experts to create clinical criteria for faculty to use in evaluating students' application of EBP principles. A three-round Delphi method was used. Experts were invited to participate in Web-based surveys. Data were analyzed using qualitative coding and categorizing. Quantitative analyses were descriptive calculations for rating and ranking. Expert consensus occurred in the Delphi rounds. The study provides a set of 10 core clinical evaluation criteria for faculty evaluating students' progression toward competency in their application of EBP. A baccalaureate program curriculum requiring the use of Bostwick's EBP Core Clinical Evaluation Criteria will provide a clear definition for understanding basic core EBP competence as expected for the assessment of student learning. [J Nurs Educ. 2016;55(5):336-341.]. Copyright 2016, SLACK Incorporated.

Liver Cirrhosis: Evaluation, Nutritional Status, and Prognosis

PubMed Central

Nishikawa, Hiroki; Osaki, Yukio

2015-01-01

The liver is the major organ for the metabolism of three major nutrients: protein, fat, and carbohydrate. Chronic hepatitis C virus infection is the major cause of chronic liver disease. Liver cirrhosis (LC) results from different mechanisms of liver injury that lead to necroinflammation and fibrosis. LC has been seen to be not a single disease entity but one that can be graded into distinct clinical stages related to clinical outcome. Several noninvasive methods have been developed for assessing liver fibrosis and these methods have been used for predicting prognosis in patients with LC. On the other hand, subjects with LC often have protein-energy malnutrition (PEM) and poor physical activity. These conditions often result in sarcopenia, which is the loss of skeletal muscle volume and increased muscle weakness. Recent studies have demonstrated that PEM and sarcopenia are predictive factors for poorer survival in patients with LC. Based on these backgrounds, several methods for evaluating nutritional status in patients with chronic liver disease have been developed and they have been preferably used in the clinical field practice. In this review, we will summarize the current knowledge in the field of LC from the viewpoints of diagnostic method, nutritional status, and clinical outcomes. PMID:26494949

The structured menstrual history: developing a tool to facilitate diagnosis and aid in symptom management.

PubMed

Matteson, Kristen A; Munro, Malcolm G; Fraser, Ian S

2011-09-01

Abnormal uterine bleeding (AUB) is a prevalent symptom that encompasses abnormalities in menstrual regularity, duration, frequency and/or volume, and it is encountered frequently by both primary care physicians and obstetrician-gynecologists. Research on AUB has used numerous methods to measure bleeding and assess symptoms, but the lack of universally accepted outcome measures hinder the quality of research and the ability of clinical investigators to collaborate in multicenter trials. Similarly, clinical care for women reporting heavy, prolonged, or irregular menstrual bleeding is not optimized because standard ways of evaluating symptoms and change in symptoms over time do not exist. This article describes (1) the current methods of evaluating women with AUB, both in research and clinical care; and (2) offers suggestions for the development of a standardized structured menstrual history for use in both research and clinical care. © Thieme Medical Publishers.

Standardization of Clinical Assessment and Sample Collection Across All PERCH Study Sites

PubMed Central

Prosperi, Christine; Baggett, Henry C.; Brooks, W. Abdullah; Deloria Knoll, Maria; Hammitt, Laura L.; Howie, Stephen R. C.; Kotloff, Karen L.; Levine, Orin S.; Madhi, Shabir A.; Murdoch, David R.; O’Brien, Katherine L.; Thea, Donald M.; Awori, Juliet O.; Bunthi, Charatdao; DeLuca, Andrea N.; Driscoll, Amanda J.; Ebruke, Bernard E.; Goswami, Doli; Hidgon, Melissa M.; Karron, Ruth A.; Kazungu, Sidi; Kourouma, Nana; Mackenzie, Grant; Moore, David P.; Mudau, Azwifari; Mwale, Magdalene; Nahar, Kamrun; Park, Daniel E.; Piralam, Barameht; Seidenberg, Phil; Sylla, Mamadou; Feikin, Daniel R.; Scott, J. Anthony G.; O’Brien, Katherine L.; Levine, Orin S.; Knoll, Maria Deloria; Feikin, Daniel R.; DeLuca, Andrea N.; Driscoll, Amanda J.; Fancourt, Nicholas; Fu, Wei; Hammitt, Laura L.; Higdon, Melissa M.; Kagucia, E. Wangeci; Karron, Ruth A.; Li, Mengying; Park, Daniel E.; Prosperi, Christine; Wu, Zhenke; Zeger, Scott L.; Watson, Nora L.; Crawley, Jane; Murdoch, David R.; Brooks, W. Abdullah; Endtz, Hubert P.; Zaman, Khalequ; Goswami, Doli; Hossain, Lokman; Jahan, Yasmin; Ashraf, Hasan; Howie, Stephen R. C.; Ebruke, Bernard E.; Antonio, Martin; McLellan, Jessica; Machuka, Eunice; Shamsul, Arifin; Zaman, Syed M.A.; Mackenzie, Grant; Scott, J. Anthony G.; Awori, Juliet O.; Morpeth, Susan C.; Kamau, Alice; Kazungu, Sidi; Kotloff, Karen L.; Tapia, Milagritos D.; Sow, Samba O.; Sylla, Mamadou; Tamboura, Boubou; Onwuchekwa, Uma; Kourouma, Nana; Toure, Aliou; Madhi, Shabir A.; Moore, David P.; Adrian, Peter V.; Baillie, Vicky L.; Kuwanda, Locadiah; Mudau, Azwifarwi; Groome, Michelle J.; Baggett, Henry C.; Thamthitiwat, Somsak; Maloney, Susan A.; Bunthi, Charatdao; Rhodes, Julia; Sawatwong, Pongpun; Akarasewi, Pasakorn; Thea, Donald M.; Mwananyanda, Lawrence; Chipeta, James; Seidenberg, Phil; Mwansa, James; wa Somwe, Somwe; Kwenda, Geoffrey

2017-01-01

Abstract Background. Variable adherence to standardized case definitions, clinical procedures, specimen collection techniques, and laboratory methods has complicated the interpretation of previous multicenter pneumonia etiology studies. To circumvent these problems, a program of clinical standardization was embedded in the Pneumonia Etiology Research for Child Health (PERCH) study. Methods. Between March 2011 and August 2013, standardized training on the PERCH case definition, clinical procedures, and collection of laboratory specimens was delivered to 331 clinical staff at 9 study sites in 7 countries (The Gambia, Kenya, Mali, South Africa, Zambia, Thailand, and Bangladesh), through 32 on-site courses and a training website. Staff competency was assessed throughout 24 months of enrollment with multiple-choice question (MCQ) examinations, a video quiz, and checklist evaluations of practical skills. Results. MCQ evaluation was confined to 158 clinical staff members who enrolled PERCH cases and controls, with scores obtained for >86% of eligible staff at each time-point. Median scores after baseline training were ≥80%, and improved by 10 percentage points with refresher training, with no significant intersite differences. Percentage agreement with the clinical trainer on the presence or absence of clinical signs on video clips was high (≥89%), with interobserver concordance being substantial to high (AC1 statistic, 0.62–0.82) for 5 of 6 signs assessed. Staff attained median scores of >90% in checklist evaluations of practical skills. Conclusions. Satisfactory clinical standardization was achieved within and across all PERCH sites, providing reassurance that any etiological or clinical differences observed across the study sites are true differences, and not attributable to differences in application of the clinical case definition, interpretation of clinical signs, or in techniques used for clinical measurements or specimen collection. PMID:28575355

Validity of three clinical performance assessments of internal medicine clerks.

PubMed

Hull, A L; Hodder, S; Berger, B; Ginsberg, D; Lindheim, N; Quan, J; Kleinhenz, M E

1995-06-01

To analyze the construct validity of three methods to assess the clinical performances of internal medicine clerks. A multitrait-multimethod (MTMM) study was conducted at the Case Western Reserve University School of Medicine to determine the convergent and divergent validity of a clinical evaluation form (CEF) completed by faculty and residents, an objective structured clinical examination (OSCE), and the medicine subject test of the National Board of Medical Examiners. Three traits were involved in the analysis: clinical skills, knowledge, and personal characteristics. A correlation matrix was computed for 410 third-year students who completed the clerkship between August 1988 and July 1991. There was a significant (p < .01) convergence of the four correlations that assessed the same traits by using different methods. However, the four convergent correlations were of moderate magnitude (ranging from .29 to .47). Divergent validity was assessed by comparing the magnitudes of the convergence correlations with the magnitudes of correlations among unrelated assessments (i.e., different traits by different methods). Seven of nine possible coefficients were smaller than the convergent coefficients, suggesting evidence of divergent validity. A significant CEF method effect was identified. There was convergent validity and some evidence of divergent validity with a significant method effect. The findings were similar for correlations corrected for attenuation. Four conclusions were reached: (1) the reliability of the OSCE must be improved, (2) the CEF ratings must be redesigned to further discriminate among the specific traits assessed, (3) additional methods to assess personal characteristics must be instituted, and (4) several assessment methods should be used to evaluate individual student performances.

Summer 1967 Clinics for Speech Handicapped Children. Evaluation of New York City Title I Educational Projects 1966-67.

ERIC Educational Resources Information Center

Fox, David J.; And Others

Individualized and intensive daily therapy was provided to 870 New York City pupils with severe speech handicaps in this summer program funded by the Elementary and Secondary Education Act, Title I. The evaluation focuses on pupil's progress in correction of speech problems, the effectiveness of the clinical methods, the reactions of the staff and…

Towards an operational definition of pharmacy clinical competency

NASA Astrophysics Data System (ADS)

Douglas, Charles Allen

The scope of pharmacy practice and the training of future pharmacists have undergone a strategic shift over the last few decades. The pharmacy profession recognizes greater pharmacist involvement in patient care activities. Towards this strategic objective, pharmacy schools are training future pharmacists to meet these new clinical demands. Pharmacy students have clerkships called Advanced Pharmacy Practice Experiences (APPEs), and these clerkships account for 30% of the professional curriculum. APPEs provide the only opportunity for students to refine clinical skills under the guidance of an experienced pharmacist. Nationwide, schools of pharmacy need to evaluate whether students have successfully completed APPEs and are ready treat patients. Schools are left to their own devices to develop assessment programs that demonstrate to the public and regulatory agencies, students are clinically competent prior to graduation. There is no widely accepted method to evaluate whether these assessment programs actually discriminate between the competent and non-competent students. The central purpose of this study is to demonstrate a rigorous method to evaluate the validity and reliability of APPE assessment programs. The method introduced in this study is applicable to a wide variety of assessment programs. To illustrate this method, the study evaluated new performance criteria with a novel rating scale. The study had two main phases. In the first phase, a Delphi panel was created to bring together expert opinions. Pharmacy schools nominated exceptional preceptors to join a Delphi panel. Delphi is a method to achieve agreement of complex issues among experts. The principal researcher recruited preceptors representing a variety of practice settings and geographical regions. The Delphi panel evaluated and refined the new performance criteria. In the second phase, the study produced a novel set of video vignettes that portrayed student performances based on recommendations of an expert panel. Pharmacy preceptors assessed the performances with the new performance criteria. Estimates of reliability and accuracy from preceptors' assessments can be used to establish benchmarks for future comparisons. Findings from the first phase suggested preceptors held a unique perspective, where APPE assessments are based in relevance to clinical activities. The second phase analyzed assessment results from pharmacy preceptors who watched the video simulations. Reliability results were higher for non-randomized compared to randomized video simulations. Accuracy results showed preceptors more readily identified high and low student performances compared to average students. These results indicated the need for pharmacy preceptor training in performance assessment. The study illustrated a rigorous method to evaluate the validity and reliability of APPE assessment instruments.

Recruiting U.S. Chinese Elders into Clinical Research for Dementia

PubMed Central

Li, Clara; Neugroschl, Judith; Umpierre, Mari; Martin, Jane; Huang, QiYing; Zeng, Xiaoyi; Cai, Dongming; Sano, Mary

2016-01-01

Purpose This study described and evaluated the rapid recruitment of elderly Chinese into clinical research at the Mount Sinai Alzheimer’s Disease Research Center (MSADRC). Design and Methods Methods of publicizing the study included lectures to local senior centers/churches and publications in local Chinese newspapers. The amount of time and success of these methods were evaluated. A “go to them” model of evaluation was employed to enable participants to complete the study visit at locations where they were comfortable. Results From January to December 2015, we recruited 98 participants aged ≥ 65 who primarily speak Mandarin/Cantonese and reside in New York. The mean age and years of education was 73.93±6.34 and 12.79±4.58, respectively. The majority of participants were female (65.3%) and primarily Mandarin speaking (53.1%). Of all enrollees, 54.1% were recruited from community lectures, 29.6% through newspapers, 10.2% through word of mouth, and 6.1% from our clinical services. 40.8% of participants underwent evaluations at the MSADRC, 44.9% at local senior centers/churches, and 14.3% at home. Implications Given that the majority of our participants had low English proficiency, the use of bilingual recruiters probably allowed us to overcome the language barrier, facilitating recruitment. Our “go to them” model of evaluation is another important factor contributing to our successful recruitment. PMID:27819841

The feasibility, perceived satisfaction, and value of using synchronous webinars to educate clinical research professionals on reporting adverse events in clinical trials: a report from the Children's Oncology Group.

PubMed

Borgerson, Dawn; Dino, Jennifer

2012-01-01

Clinical research professionals are faced with decreased funding and increased workloads; innovative methods of professional development programs are necessary to accommodate these factors. This study evaluated the feasibility, perceived satisfaction, and value of using webinars to educate clinical research professionals on reporting adverse events commonly experienced in pediatric oncology clinical trials. The setting incorporated synchronous web-based educational technology. Constructivist learning provides the theoretical framework for this study. Participants evaluated the professional development program at 2 time points: (a) at the conclusion and (b) 4 to 6 weeks afterward, using survey method. Synchronous webinars were both economical and effective in educating clinical research professionals across institutional sites. Participants reported exceptionally high levels of satisfaction with the accessibility, scope, quality, and interactivity of the professional development program. The vast majority of participants reported that the education would assist with reporting adverse events in pediatric oncology clinical trials and this perception persisted into clinical practice. Although the results of this study were intended to guide future educational efforts of the Children's Oncology Group, they may also apply to other cooperative groups.

Comparing the Effects of Objective Structured Assessment of Technical Skills (OSATS) and Traditional Method on Learning of Students.

PubMed

Mansoorian, Mohammad Reza; Hosseiny, Marzeih Sadat; Khosravan, Shahla; Alami, Ali; Alaviani, Mehri

2015-06-01

Despite the benefits of the objective structured assessment of technical skills (OSATS) and it appropriateness for evaluating clinical abilities of nursing students , few studies are available on the application of this method in nursing education. The purpose of this study was to compare the effect of using OSATS and traditional methods on the students' learning. We also aimed to signify students' views about these two methods and their views about the scores they received in these methods in a medical emergency course. A quasi-experimental study was performed on 45 first semester students in nursing and medical emergencies passing a course on fundamentals of practice. The students were selected by a census method and evaluated by both the OSATS and traditional methods. Data collection was performed using checklists prepared based on the 'text book of nursing procedures checklists' published by Iranian nursing organization and a questionnaire containing learning rate and students' estimation of their received scores. Descriptive statistics as well as paired t-test and independent samples t-test were used in data analysis. The mean of students' score in OSATS was significantly higher than their mean score in traditional method (P = 0.01). Moreover, the mean of self-evaluation score after the traditional method was relatively the same as the score the students received in the exam. However, the mean of self-evaluation score after the OSATS was relatively lower than the scores the students received in the OSATS exam. Most students believed that OSATS can evaluate a wide range of students' knowledge and skills compared to traditional method. Results of this study indicated the better effect of OSATS on learning and its relative superiority in precise assessment of clinical skills compared with the traditional evaluation method. Therefore, we recommend using this method in evaluation of students in practical courses.

Clinical and translational scientist career success: metrics for evaluation.

PubMed

Lee, Linda S; Pusek, Susan N; McCormack, Wayne T; Helitzer, Deborah L; Martina, Camille A; Dozier, Ann M; Ahluwalia, Jasjit S; Schwartz, Lisa S; McManus, Linda M; Reynolds, Brian D; Haynes, Erin N; Rubio, Doris M

2012-10-01

Despite the increased emphasis on formal training in clinical and translational research and the growth in the number and scope of training programs over the past decade, the impact of training on research productivity and career success has yet to be fully evaluated at the institutional level. In this article, the Education Evaluation Working Group of the Clinical and Translational Science Award Consortium introduces selected metrics and methods associated with the assessment of key factors that affect research career success. The goals in providing this information are to encourage more consistent data collection across training sites, to foster more rigorous and systematic exploration of factors associated with career success, and to help address previously identified difficulties in program evaluation. © 2012 Wiley Periodicals, Inc.

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine].

PubMed

Han, Xue-Jie; Liu, Meng-Yu; Lian, Zhi-Hua; Wang, Li-Ying; Shi, Nan-Nan; Zhao, Jun

2017-09-01

To evaluate the applicability and clinical applications of Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine, so as to provide the basis for the revision of the guidelines. This study was completed by the research and promotion base for traditional Chinese medicine(TCM) standard. The methods of applicability evaluation and application evaluation were used in the study. The questionnaires were filled out to evaluate applicability of the guideline, including doctor's familiarity with the guideline,the quality of the guideline, applicable conditions and clinical applications. The prospective case study analysis method was used to evaluate application of the guideline, including evaluation of clinical application compliance and application results(such as clinical effects, safety and economy). There were two parts in the guideline, which were TCM guideline and Western medicine guideline. The results of applicability evaluation showed that there were no obvious differences between TCM guideline and Western medicine guideline in doctor's familiarity with guideline(85.43%, 84.57%) and the use of the guideline(52.10%, 54.47%); the guidelines with good quality, and higher scores in the scope of application and the use of the term rationality(91.94%, 93.35%); the rationality scores of relevant contents in syndrome differentiation and treatment were more than 75%; the applicable conditions were better, and the safety score was the the highest. The comprehensive applicability evaluation showed that the proportion of the application of TCM guideline and Western medicine guideline were 77.73%, 75.46%, respectively. The results of application evaluation showed that there was high degree coincidence between the guideline with its clinical application; except for "other treatment" and "recuperation and prevention" in TCM, other items got high scores which were more than 90%; in the evaluation of application effects, safety of the guideline was best, economy of the guideline was better, and clincal effect was good. The comprehensive application evaluation showed that 75%~80% doctors were satisfied with the guideline. The Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine has been widely used in clinical practice, which is of high quality, high degree of clinical application,good safety and economy. But there were some disadvantages of the guideline such as lack of evidence-based medicine and innovation, which is need to be improved constantly in the guideline revision. Copyright© by the Chinese Pharmaceutical Association.

Gram stain method shows better sensitivity than clinical criteria for detection of bacterial vaginosis in surveillance of pregnant, low-income women in a clinical setting.

PubMed Central

Tam, M T; Yungbluth, M; Myles, T

1998-01-01

OBJECTIVE: The purpose of the study is to determine whether the Gram stain method is superior to the clinical criteria for the diagnosis of bacterial vaginosis in low-income pregnant women seen in a resident clinic setting. The clinical criteria is the current diagnostic method employed to diagnose bacterial vaginosis. STUDY DESIGN: In this study, 51 pregnant women with vaginal discharge were prospectively evaluated. All were screened using the clinical criteria, Gram stain method, and culture of the discharge. The modified scoring system instituted by Nugent et al. (J Clin Microbiol 29:297-301, 1991) was employed in reading the Gram stain smears. The clinical criteria were then compared with the Gram stain method. Isolation of moderate to many Gardnerella vaginalis growth by culture was used as the confirmatory finding. RESULTS: Sensitivity of the Gram stain method (91%) was significantly higher than that of the clinical criteria (46%), (sign test P = 0.0023, < 0.01). The Gram stain method also has both a low false-negative (4%) and high negative predictive value (96%), making it an ideal diagnostic test. CONCLUSION: The Gram stain method is a rapid and cost-effective test that is also highly reproducible and readily available in many laboratories. These features make the Gram stain method a more desirable screening procedure for bacterial vaginosis in a clinic population. PMID:9894174

Method using in vivo quantitative spectroscopy to guide design and optimization of low-cost, compact clinical imaging devices: emulation and evaluation of multispectral imaging systems

NASA Astrophysics Data System (ADS)

Saager, Rolf B.; Baldado, Melissa L.; Rowland, Rebecca A.; Kelly, Kristen M.; Durkin, Anthony J.

2018-04-01

With recent proliferation in compact and/or low-cost clinical multispectral imaging approaches and commercially available components, questions remain whether they adequately capture the requisite spectral content of their applications. We present a method to emulate the spectral range and resolution of a variety of multispectral imagers, based on in-vivo data acquired from spatial frequency domain spectroscopy (SFDS). This approach simulates spectral responses over 400 to 1100 nm. Comparing emulated data with full SFDS spectra of in-vivo tissue affords the opportunity to evaluate whether the sparse spectral content of these imagers can (1) account for all sources of optical contrast present (completeness) and (2) robustly separate and quantify sources of optical contrast (crosstalk). We validate the approach over a range of tissue-simulating phantoms, comparing the SFDS-based emulated spectra against measurements from an independently characterized multispectral imager. Emulated results match the imager across all phantoms (<3 % absorption, <1 % reduced scattering). In-vivo test cases (burn wounds and photoaging) illustrate how SFDS can be used to evaluate different multispectral imagers. This approach provides an in-vivo measurement method to evaluate the performance of multispectral imagers specific to their targeted clinical applications and can assist in the design and optimization of new spectral imaging devices.

Comparative evaluation of fluorescent in situ hybridization and Giemsa microscopy with quantitative real-time PCR technique in detecting malaria parasites in a holoendemic region of Kenya.

PubMed

Osoga, Joseph; Waitumbi, John; Guyah, Bernard; Sande, James; Arima, Cornel; Ayaya, Michael; Moseti, Caroline; Morang'a, Collins; Wahome, Martin; Achilla, Rachel; Awinda, George; Nyakoe, Nancy; Wanja, Elizabeth

2017-07-24

Early and accurate diagnosis of malaria is important in treatment as well as in the clinical evaluation of drugs and vaccines. Evaluation of Giemsa-stained smears remains the gold standard for malaria diagnosis, although diagnostic errors and potential bias estimates of protective efficacy have been reported in practice. Plasmodium genus fluorescent in situ hybridization (P-Genus FISH) is a microscopy-based method that uses fluorescent labelled oligonucleotide probes targeted to pathogen specific ribosomal RNA fragments to detect malaria parasites in whole blood. This study sought to evaluate the diagnostic performance of P-Genus FISH alongside Giemsa microscopy compared to quantitative reverse transcription polymerase chain reaction (qRT-PCR) in a clinical setting. Five hundred study participants were recruited prospectively and screened for Plasmodium parasites by P-Genus FISH assay, and Giemsa microscopy. The microscopic methods were performed by two trained personnel and were blinded, and if the results were discordant a third reading was performed as a tie breaker. The diagnostic performance of both methods was evaluated against qRT-PCR as a more sensitive method. The number of Plasmodium positive cases was 26.8% by P-Genus FISH, 33.2% by Giemsa microscopy, and 51.2% by qRT-PCR. The three methods had 46.8% concordant results with 61 positive cases and 173 negative cases. Compared to qRT-PCR the sensitivity and specificity of P-Genus FISH assay was 29.3 and 75.8%, respectively, while microscopy had 58.2 and 93.0% respectively. Microscopy had a higher positive and negative predictive values (89.8 and 68.0% respectively) compared to P-Genus FISH (56.0 and 50.5%). In overall, microscopy had a good measure of agreement (76%, k = 0.51) compared to P-Genus FISH (52%, k = 0.05). The diagnostic performance of P-Genus FISH was shown to be inferior to Giemsa microscopy in the clinical samples. This hinders the possible application of the method in the field despite the many advantages of the method especially diagnosis of low parasite density infections. The P-Genus assay has great potential but application of the method in clinical setting would rely on extensive training of microscopist and continuous proficiency testing.

Clinical image quality evaluation for panoramic radiography in Korean dental clinics

PubMed Central

Choi, Bo-Ram; Choi, Da-Hye; Huh, Kyung-Hoe; Yi, Won-Jin; Heo, Min-Suk; Choi, Soon-Chul; Bae, Kwang-Hak

2012-01-01

Purpose The purpose of this study was to investigate the level of clinical image quality of panoramic radiographs and to analyze the parameters that influence the overall image quality. Materials and Methods Korean dental clinics were asked to provide three randomly selected panoramic radiographs. An oral and maxillofacial radiology specialist evaluated those images using our self-developed Clinical Image Quality Evaluation Chart. Three evaluators classified the overall image quality of the panoramic radiographs and evaluated the causes of imaging errors. Results A total of 297 panoramic radiographs were collected from 99 dental hospitals and clinics. The mean of the scores according to the Clinical Image Quality Evaluation Chart was 79.9. In the classification of the overall image quality, 17 images were deemed 'optimal for obtaining diagnostic information,' 153 were 'adequate for diagnosis,' 109 were 'poor but diagnosable,' and nine were 'unrecognizable and too poor for diagnosis'. The results of the analysis of the causes of the errors in all the images are as follows: 139 errors in the positioning, 135 in the processing, 50 from the radiographic unit, and 13 due to anatomic abnormality. Conclusion Panoramic radiographs taken at local dental clinics generally have a normal or higher-level image quality. Principal factors affecting image quality were positioning of the patient and image density, sharpness, and contrast. Therefore, when images are taken, the patient position should be adjusted with great care. Also, standardizing objective criteria of image density, sharpness, and contrast is required to evaluate image quality effectively. PMID:23071969

Recruitment methods in a clinical trial of provoked vulvodynia: Predictors of enrollment.

PubMed

Bachour, Candi C; Bachmann, Gloria A; Foster, David C; Wan, Jim Y; Rawlinson, Leslie A; Brown, Candace S

2017-02-01

Successful recruitment in clinical trials for chronic pain conditions is challenging, especially in women with provoked vulvodynia due to reluctance in discussing pain associated with sexual intercourse. The most successful recruitment methods and the characteristics of women reached with these methods are unknown. To compare the effectiveness and efficiency of four recruitment methods and to determine socioeconomic predictors for successful enrollment in a National Institutes of Health-sponsored multicenter clinical trial evaluating a gabapentin intervention in women with provoked vulvodynia. Recruitment methods utilized mass mailing, media, clinician referrals and community outreach. Effectiveness (number of participants enrolled) and efficiency (proportion screened who enrolled) were determined. Socioeconomic variables including race, educational level, annual household income, relationship status, age, menopausal status and employment status were also evaluated regarding which recruitment strategies were best at targeting specific cohorts. Of 868 potential study participants, 219 were enrolled. The most effective recruitment method in enrolling participants was mass mailing ( p < 0.001). There were no statistically significant differences in efficiency between recruitment methods ( p = 0.11). Relative to clinician referral, black women were 13 times as likely to be enrolled through mass mailing (adjusted odds ratio 12.5, 95% confidence interval, 3.6-43.1) as white women. There were no differences in enrollment according to educational level, annual income, relationship status, age, menopausal status, or employment status and recruitment method. In this clinical trial, mass mailing was the most effective recruitment method. Race of participants enrolled in a provoked vulvodynia trial was related to the recruitment method.

Millon Clinical Multiaxial Inventory-III Subtypes of Opioid Dependence: Validity and Matching to Behavioral Therapies

ERIC Educational Resources Information Center

Ball, Samuel A.; Nich, Charla; Rounsaville, Bruce J.; Eagan, Dorothy; Carroll, Kathleen M.

2004-01-01

The concurrent and predictive validity of 2 different methods of Millon Clinical Multiaxial Inventory-III subtyping (protocol sorting, cluster analysis) was evaluated in 125 recently detoxified opioid-dependent outpatients in a 12-week randomized clinical trial. Participants received naltrexone and relapse prevention group counseling and were…

The Varied Circumstances Prompting Requests for Emergency Contraception at School-Based Clinics

ERIC Educational Resources Information Center

Sidebottom, Abbey; Harrison, Patricia A.; Amidon, Donna; Finnegan, Katie

2008-01-01

Background: Little is known about the circumstances that prompt teenagers to request emergency contraception (EC). This evaluation was designed to refine the EC clinical protocol and improve pregnancy prevention efforts in high school-based clinics by analyzing information on EC use and subsequent contraception use of EC patients. Methods: Sites…

A Survey on Clinical Research Training Status and Needs in Public Hospitals from Shenzhen

ERIC Educational Resources Information Center

Ji, Ping; Wang, Haibo; Zhang, Chao; Liu, Min; Zhou, Liping; Xiao, Ping; Wang, Yanfang; Wu, Yangfeng

2017-01-01

Objective: To obtain information on the current clinical research training status and evaluate the training needs comprehensively for medical staff in hospitals. Methods: This survey was initiated and conducted by the Health and Family Planning Commission of Shenzhen in conjunction with the Peking University Clinical Research Institute (Shenzhen)…

Job analysis and student assessment tool: perfusion education clinical preceptor.

PubMed

Riley, Jeffrey B

2007-09-01

The perfusion education system centers on the cardiac surgery operating room and the perfusionist teacher who serves as a preceptor for the perfusion student. One method to improve the quality of perfusion education is to create a valid method for perfusion students to give feedback to clinical teachers. The preceptor job analysis consisted of a literature review and interviews with preceptors to list their critical tasks, critical incidents, and cognitive and behavioral competencies. Behaviorally anchored rating traits associated with the preceptors' tasks were identified. Students voted to validate the instrument items. The perfusion instructor rating instrument with a 0-4, "very weak" to "very strong" Likert rating scale was used. The five preceptor traits for student evaluation of clinical instruction (SECI) are as follows: The clinical instructor (1) encourages self-learning, (2) encourages clinical reasoning, (3) meets student's learning needs, (4) gives continuous feedback, and (5) represents a good role model. Scores from 430 student-preceptor relationships for 28 students rotating at 24 affiliate institutions with 134 clinical instructors were evaluated. The mean overall good preceptor average (GPA) was 3.45 +/- 0.76 and was skewed to the left, ranging from 0.0 to 4.0 (median = 3.8). Only 21 of the SECI relationships earned a GPA < 2.0. Analyzing the role of the clinical instructor and performing SECI are methods to provide valid information to improve the quality of a perfusion education program.

A Conceptual and Empirical Review of the Meaning, Measurement, Development, and Teaching of Intervention Competence in Clinical Psychology

PubMed Central

Barber, Jacques P.

2009-01-01

Through the course of this paper we discuss several fundamental issues related to the intervention competence of psychologists. Following definitional clarification and proposals for more strictly distinguishing competence from adherence, we interpret Dreyfus and Dreyfus’s (1986) five stage theory of competence development (from novice to expert) within a strictly clinical framework. Existing methods of competence assessment are then evaluated, and we argue for the use of new and multiple assessment modalities. Next, we utilize the previous sections as a foundation to propose methods for training and evaluating competent psychologists. Lastly, we discuss several potential impediments to large scale competence assessment and education, such as the heterogeneity of therapeutic orientations and what could be termed a lack of transparency in clinical training. PMID:18952334

Safety Evaluation of an Automated Remote Monitoring System for Heart Failure in an Urban, Indigent Population.

PubMed

Gross-Schulman, Sandra; Sklaroff, Laura Myerchin; Hertz, Crystal Coyazo; Guterman, Jeffrey J

2017-12-01

Heart Failure (HF) is the most expensive preventable condition, regardless of patient ethnicity, race, socioeconomic status, sex, and insurance status. Remote telemonitoring with timely outpatient care can significantly reduce avoidable HF hospitalizations. Human outreach, the traditional method used for remote monitoring, is effective but costly. Automated systems can potentially provide positive clinical, fiscal, and satisfaction outcomes in chronic disease monitoring. The authors implemented a telephonic HF automated remote monitoring system that utilizes deterministic decision tree logic to identify patients who are at risk of clinical decompensation. This safety study evaluated the degree of clinical concordance between the automated system and traditional human monitoring. This study focused on a broad underserved population and demonstrated a safe, reliable, and inexpensive method of monitoring patients with HF.

Melanoma detection. A prospective study comparing diagnosis with the naked eye, dermatoscopy and telespectrophotometry.

PubMed

Bono, Aldo; Bartoli, Cesare; Cascinelli, Natale; Lualdi, Manuela; Maurichi, Andrea; Moglia, Daniele; Tragni, Gabrina; Tomatis, Stefano; Marchesini, Renato

2002-01-01

Successful treatment of melanoma depends directly on early diagnosis. Such a diagnosis is based on clinical examination and dermatoscopy. Recently, automated instruments for melanoma detection are under development. To prospectively evaluate the diagnostic possibilities provided by clinical and dermatoscopic examinations and by a computerized telespectrophotometric system (TS). The study involves a consecutive series of 298 patients with 313 cutaneous pigmented lesions (66 melanomas and 247 non-melanoma lesions). Each lesion was subjected to the triple diagnostic evaluation, before surgery. Results were expressed in terms of sensitivity and specificity of each kind of evaluation. Clinical evaluation had sensitivity and specificity values of 86 and 77%, respectively, whereas dermatoscopy gave corresponding values of 91 and 74%. TS assessment resulted in a sensitivity of 80% and a specificity of 49%. Differences between clinical and dermatoscopic diagnoses lacked statistical significance (p = 0.22), whereas there was a significant difference comparing both clinical and TS evaluations (p < 0.01) and dermatoscopic and TS evaluations (p < 0.01). Combining clinical and dermatoscopic evaluations, a sensitivity of 97% was achieved. Addition of TS has not changed this figure. Results of this study confirm and stress the importance of dermatoscopy in the diagnosis of melanoma. Clinical evaluation coupled with dermatoscopy can be considered the cornerstone of such a diagnosis. Although TS is able to achieve interesting results, at present it cannot significantly compete with any of the other tested methods. Copyright 2002 S. Karger AG, Basel

[Basic assessment of the CNR measurement method of MRI system in phantom-suggestion for improvement in the CNR evaluation method].

PubMed

Wada, Yoichi; Hara, Takanori; Miyati, Tosiaki

2008-02-20

Many methods of measuring contrast-to-noise ratio (CNR) in magnetic resonance imaging (MRI) have been proposed. However, it is not clear which method is best for evaluating clinical or phantom images. In this study we examined the characteristics of the methods of evaluation proposed in the past, and we proposed new CNR evaluation method that improved noise evaluation. We examined the relationship of theoretical CNR value and measurement value when measurement sensitivity was changed. We measured the relationship between number of signal averaged (NSA) and value of CNR. The CNR value changed greatly according to where noise was measured. The measuring method that we proposed in this study was superior for the following reasons: the measurement point of noise and signal are the same; the influence of the low frequency element is slight; and the correlation of measurements and theoretical value is high. The method that we proposed in this study is useful for evaluating phantom images.

[In vitro antifungal activity of azoles and amphotericin B against Malassezia furfur by the CLSI M27-A3 microdilution and Etest® methods].

PubMed

Galvis-Marín, Juan Camilo; Rodríguez-Bocanegra, María Ximena; Pulido-Villamarín, Adriana Del Pilar; Castañeda-Salazar, Rubiela; Celis-Ramírez, Adriana Marcela; Linares-Linares, Melva Yomary

Malassezia furfur is a human skin commensal yeast that can cause skin and opportunistic systemic infections. Given its lipid dependant status, the reference methods established by the Clinical and Laboratory Standards Institute (CLSI) to evaluate antifungal susceptibility in yeasts are not applicable. To evaluate the in vitro susceptibility of M. furfur isolates from infections in humans to antifungals of clinical use. The susceptibility profile to amphotericin B, itraconazole, ketoconazole and voriconazole of 20 isolates of M. furfur, using the broth microdilution method (CLSI M27-A3) and Etest ® , was evaluated. Itraconazole and voriconazole had the highest antifungal activity against the isolates tested. The essential agreement between the two methods for azoles antifungal activity was in the region of 60-85% and the categorical agreement was around 70-80%, while the essential and categorical agreement for amphotericin B was 10%. The azoles were the compounds that showed the highest antifungal activity against M. furfur, as determined by the two techniques used; however more studies need to be performed to support that Etest ® is a reliable method before its implementation as a routine clinical laboratory test. Copyright © 2016 Asociación Española de Micología. Publicado por Elsevier España, S.L.U. All rights reserved.

Distributed capillary adiabatic tissue homogeneity model in parametric multi-channel blind AIF estimation using DCE-MRI.

PubMed

Kratochvíla, Jiří; Jiřík, Radovan; Bartoš, Michal; Standara, Michal; Starčuk, Zenon; Taxt, Torfinn

2016-03-01

One of the main challenges in quantitative dynamic contrast-enhanced (DCE) MRI is estimation of the arterial input function (AIF). Usually, the signal from a single artery (ignoring contrast dispersion, partial volume effects and flow artifacts) or a population average of such signals (also ignoring variability between patients) is used. Multi-channel blind deconvolution is an alternative approach avoiding most of these problems. The AIF is estimated directly from the measured tracer concentration curves in several tissues. This contribution extends the published methods of multi-channel blind deconvolution by applying a more realistic model of the impulse residue function, the distributed capillary adiabatic tissue homogeneity model (DCATH). In addition, an alternative AIF model is used and several AIF-scaling methods are tested. The proposed method is evaluated on synthetic data with respect to the number of tissue regions and to the signal-to-noise ratio. Evaluation on clinical data (renal cell carcinoma patients before and after the beginning of the treatment) gave consistent results. An initial evaluation on clinical data indicates more reliable and less noise sensitive perfusion parameter estimates. Blind multi-channel deconvolution using the DCATH model might be a method of choice for AIF estimation in a clinical setup. © 2015 Wiley Periodicals, Inc.

The Power of Neuroimaging Biomarkers for Screening Frontotemporal Dementia

PubMed Central

McMillan, Corey T.; Avants, Brian B.; Cook, Philip; Ungar, Lyle; Trojanowski, John Q.; Grossman, Murray

2014-01-01

Frontotemporal dementia (FTD) is a clinically and pathologically heterogeneous neurodegenerative disease that can result from either frontotemporal lobar degeneration (FTLD) or Alzheimer’s disease (AD) pathology. It is critical to establish statistically powerful biomarkers that can achieve substantial cost-savings and increase feasibility of clinical trials. We assessed three broad categories of neuroimaging methods to screen underlying FTLD and AD pathology in a clinical FTD series: global measures (e.g., ventricular volume), anatomical volumes of interest (VOIs) (e.g., hippocampus) using a standard atlas, and data-driven VOIs using Eigenanatomy. We evaluated clinical FTD patients (N=93) with cerebrospinal fluid, gray matter (GM) MRI, and diffusion tensor imaging (DTI) to assess whether they had underlying FTLD or AD pathology. Linear regression was performed to identify the optimal VOIs for each method in a training dataset and then we evaluated classification sensitivity and specificity in an independent test cohort. Power was evaluated by calculating minimum sample sizes (mSS) required in the test classification analyses for each model. The data-driven VOI analysis using a multimodal combination of GM MRI and DTI achieved the greatest classification accuracy (89% SENSITIVE; 89% SPECIFIC) and required a lower minimum sample size (N=26) relative to anatomical VOI and global measures. We conclude that a data-driven VOI approach employing Eigenanatomy provides more accurate classification, benefits from increased statistical power in unseen datasets, and therefore provides a robust method for screening underlying pathology in FTD patients for entry into clinical trials. PMID:24687814

Reporting standards for Bland-Altman agreement analysis in laboratory research: a cross-sectional survey of current practice.

PubMed

Chhapola, Viswas; Kanwal, Sandeep Kumar; Brar, Rekha

2015-05-01

To carry out a cross-sectional survey of the medical literature on laboratory research papers published later than 2012 and available in the common search engines (PubMed, Google Scholar) on the quality of statistical reporting of method comparison studies using Bland-Altman (B-A) analysis. Fifty clinical studies were identified which had undertaken method comparison of laboratory analytes using B-A. The reporting of B-A was evaluated using a predesigned checklist with following six items: (1) correct representation of x-axis on B-A plot, (2) representation and correct definition of limits of agreement (LOA), (3) reporting of confidence interval (CI) of LOA, (4) comparison of LOA with a priori defined clinical criteria, (5) evaluation of the pattern of the relationship between difference (y-axis) and average (x-axis) and (6) measures of repeatability. The x-axis and LOA were presented correctly in 94%, comparison with a priori clinical criteria in 74%, CI reporting in 6%, evaluation of pattern in 28% and repeatability assessment in 38% of studies. There is incomplete reporting of B-A in published clinical studies. Despite its simplicity, B-A appears not to be completely understood by researchers, reviewers and editors of journals. There appear to be differences in the reporting of B-A between laboratory medicine journals and other clinical journals. A uniform reporting of B-A method will enhance the generalizability of results. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Systematic evaluation of a targeted gene capture sequencing panel for molecular diagnosis of retinitis pigmentosa.

PubMed

Huang, Hui; Chen, Yanhua; Chen, Huishuang; Ma, Yuanyuan; Chiang, Pei-Wen; Zhong, Jing; Liu, Xuyang; Asan; Wu, Jing; Su, Yan; Li, Xin; Deng, Jianlian; Huang, Yingping; Zhang, Xinxin; Li, Yang; Fan, Ning; Wang, Ying; Tang, Lihui; Shen, Jinting; Chen, Meiyan; Zhang, Xiuqing; Te, Deng; Banerjee, Santasree; Liu, Hui; Qi, Ming; Yi, Xin

2018-01-01

Inherited eye diseases are major causes of vision loss in both children and adults. Inherited eye diseases are characterized by clinical variability and pronounced genetic heterogeneity. Genetic testing may provide an accurate diagnosis for ophthalmic genetic disorders and allow gene therapy for specific diseases. A targeted gene capture panel was designed to capture exons of 283 inherited eye disease genes including 58 known causative retinitis pigmentosa (RP) genes. 180 samples were tested with this panel, 68 were previously tested by Sanger sequencing. Systematic evaluation of our method and comprehensive molecular diagnosis were carried on 99 RP patients. 96.85% targeted regions were covered by at least 20 folds, the accuracy of variants detection was 99.994%. In 4 of the 68 samples previously tested by Sanger sequencing, mutations of other diseases not consisting with the clinical diagnosis were detected by next-generation sequencing (NGS) not Sanger. Among the 99 RP patients, 64 (64.6%) were detected with pathogenic mutations, while in 3 patients, it was inconsistent between molecular diagnosis and their initial clinical diagnosis. After revisiting, one patient's clinical diagnosis was reclassified. In addition, 3 patients were found carrying large deletions. We have systematically evaluated our method and compared it with Sanger sequencing, and have identified a large number of novel mutations in a cohort of 99 RP patients. The results showed a sufficient accuracy of our method and suggested the importance of molecular diagnosis in clinical diagnosis.

Assessment of periodontal bone level revisited: a controlled study on the diagnostic accuracy of clinical evaluation methods and intra-oral radiography.

PubMed

Christiaens, Véronique; De Bruyn, Hugo; Thevissen, Eric; Koole, Sebastiaan; Dierens, Melissa; Cosyn, Jan

2018-01-01

The accuracy of analogue and especially digital intra-oral radiography in assessing interdental bone level needs further documentation. The aim of this study was to compare clinical and radiographic bone level assessment to intra-surgical bone level registration (1) and to identify the clinical variables rendering interdental bone level assessment inaccurate (2). The study sample included 49 interdental sites in 17 periodontitis patients. Evaluation methods included vertical relative probing attachment level (RAL-V), analogue and digital intra-oral radiography and bone sounding without and with flap elevation. The latter was considered the true bone level. Five examiners evaluated all radiographs. Significant underestimation of the true bone level was observed for all evaluation methods pointing to 2.7 mm on average for analogue radiography, 2.5 mm for digital radiography, 1.8 mm for RAL-V and 0.6 mm for bone sounding without flap elevation (p < 0.001). Radiographic underestimation of the true bone level was higher in the (pre)molar region (p ≤ 0.047) and increased with defect depth (p < 0.001). Variation between clinicians was huge (range analogue radiography 2.2-3.2 mm; range digital radiography 2.1-3.0 mm). All evaluation methods significantly underestimated the true bone level. Bone sounding was most accurate, whereas intra-oral radiographs were least accurate. Deep periodontal defects in the (pre)molar region were most underrated by intra-oral radiography. Bone sounding had the highest accuracy in assessing interdental bone level.

Alarm characterization for continuous glucose monitors used as adjuncts to self-monitoring of blood glucose.

PubMed

McGarraugh, Geoffrey

2010-01-01

Continuous glucose monitoring (CGM) devices available in the United States are approved for use as adjuncts to self-monitoring of blood glucose (SMBG). Alarm evaluation in the Clinical and Laboratory Standards Institute (CLSI) guideline for CGM does not specifically address devices that employ both CGM and SMBG. In this report, an alarm evaluation method is proposed for these devices. The proposed method builds on the CLSI method using data from an in-clinic study of subjects with type 1 diabetes. CGM was used to detect glycemic events, and SMBG was used to determine treatment. To optimize detection of a single glucose level, such as 70 mg/dl, a range of alarm threshold settings was evaluated. The alarm characterization provides a choice of alarm settings that trade off detection and false alarms. Detection of a range of high glucose levels was similarly evaluated. Using low glucose alarms, detection of 70 mg/dl within 30 minutes increased from 64 to 97% as alarm settings increased from 70 to 100 mg/dl, and alarms that did not require treatment (SMBG >85 mg/dl) increased from 18 to 52%. Using high glucose alarms, detection of 180 mg/dl within 30 minutes increased from 87 to 96% as alarm settings decreased from 180 to 165 mg/dl, and alarms that did not require treatment (SMBG <180 mg/dl) increased from 24 to 42%. The proposed alarm evaluation method provides information for choosing appropriate alarm thresholds and reflects the clinical utility of CGM alarms. 2010 Diabetes Technology Society.

Evaluation of the 95% limits of agreement of the volumes of 5-year clinically stable solid nodules for the development of a follow-up system for indeterminate solid nodules in CT lung cancer screening.

PubMed

Kakinuma, Ryutaro; Muramatsu, Yukio; Yamamichi, Junta; Gomi, Shiho; Oubel, Estanislao; Moriyama, Noriyuki

2018-01-01

This study sought to evaluate the 95% limits of agreement of the volumes of 5-year clinically stable solid nodules for the development of a follow-up system for indeterminate solid nodules. The volumes of 226 solid nodules that had been clinically stable for 5 years were measured in 186 patients (53 female never-smokers, 36 male never-smokers, 51 males with <30 pack-years, and 46 males with ≥30 pack-years) using a three-dimensional semiautomated method. Volume changes were evaluated using three methods: percent change, proportional change and growth rate. The 95% limits of agreement were evaluated using the Bland-Altman method. The 95% limits of agreement were as follows: range of percent change, from ±34.5% to ±37.8%; range of proportional change, from ±34.1% to ±36.8%; and range of growth rate, from ±39.2% to ±47.4%. Percent change-based, proportional change-based, and growth rate-based diagnoses of an increase or decrease in ten solid nodules were made at a mean of 302±402, 367±455, and 329±496 days, respectively, compared with a clinical diagnosis made at 809±616 days (P<0.05). The 95% limits of agreement for volume change in 5-year stable solid nodules may enable the detection of an increase or decrease in the solid nodule at an earlier stage than that enabled by a clinical diagnosis, possibly contributing to the development of a follow-up system for reducing the number of additional Computed tomography (CT) scans performed during the follow-up period.

Incorporating Topic Assignment Constraint and Topic Correlation Limitation into Clinical Goal Discovering for Clinical Pathway Mining.

PubMed

Xu, Xiao; Jin, Tao; Wei, Zhijie; Wang, Jianmin

2017-01-01

Clinical pathways are widely used around the world for providing quality medical treatment and controlling healthcare cost. However, the expert-designed clinical pathways can hardly deal with the variances among hospitals and patients. It calls for more dynamic and adaptive process, which is derived from various clinical data. Topic-based clinical pathway mining is an effective approach to discover a concise process model. Through this approach, the latent topics found by latent Dirichlet allocation (LDA) represent the clinical goals. And process mining methods are used to extract the temporal relations between these topics. However, the topic quality is usually not desirable due to the low performance of the LDA in clinical data. In this paper, we incorporate topic assignment constraint and topic correlation limitation into the LDA to enhance the ability of discovering high-quality topics. Two real-world datasets are used to evaluate the proposed method. The results show that the topics discovered by our method are with higher coherence, informativeness, and coverage than the original LDA. These quality topics are suitable to represent the clinical goals. Also, we illustrate that our method is effective in generating a comprehensive topic-based clinical pathway model.

Incorporating Topic Assignment Constraint and Topic Correlation Limitation into Clinical Goal Discovering for Clinical Pathway Mining

PubMed Central

Xu, Xiao; Wei, Zhijie

2017-01-01

Clinical pathways are widely used around the world for providing quality medical treatment and controlling healthcare cost. However, the expert-designed clinical pathways can hardly deal with the variances among hospitals and patients. It calls for more dynamic and adaptive process, which is derived from various clinical data. Topic-based clinical pathway mining is an effective approach to discover a concise process model. Through this approach, the latent topics found by latent Dirichlet allocation (LDA) represent the clinical goals. And process mining methods are used to extract the temporal relations between these topics. However, the topic quality is usually not desirable due to the low performance of the LDA in clinical data. In this paper, we incorporate topic assignment constraint and topic correlation limitation into the LDA to enhance the ability of discovering high-quality topics. Two real-world datasets are used to evaluate the proposed method. The results show that the topics discovered by our method are with higher coherence, informativeness, and coverage than the original LDA. These quality topics are suitable to represent the clinical goals. Also, we illustrate that our method is effective in generating a comprehensive topic-based clinical pathway model. PMID:29065617

Evaluation and validation of social and psychological markers in randomised trials of complex interventions in mental health: a methodological research programme.

PubMed

Dunn, Graham; Emsley, Richard; Liu, Hanhua; Landau, Sabine; Green, Jonathan; White, Ian; Pickles, Andrew

2015-11-01

The development of the capability and capacity to evaluate the outcomes of trials of complex interventions is a key priority of the National Institute for Health Research (NIHR) and the Medical Research Council (MRC). The evaluation of complex treatment programmes for mental illness (e.g. cognitive-behavioural therapy for depression or psychosis) not only is a vital component of this research in its own right but also provides a well-established model for the evaluation of complex interventions in other clinical areas. In the context of efficacy and mechanism evaluation (EME) there is a particular need for robust methods for making valid causal inference in explanatory analyses of the mechanisms of treatment-induced change in clinical outcomes in randomised clinical trials. The key objective was to produce statistical methods to enable trial investigators to make valid causal inferences about the mechanisms of treatment-induced change in these clinical outcomes. The primary objective of this report is to disseminate this methodology, aiming specifically at trial practitioners. The three components of the research were (1) the extension of instrumental variable (IV) methods to latent growth curve models and growth mixture models for repeated-measures data; (2) the development of designs and regression methods for parallel trials; and (3) the evaluation of the sensitivity/robustness of findings to the assumptions necessary for model identifiability. We illustrate our methods with applications from psychological and psychosocial intervention trials, keeping the technical details to a minimum, leaving the reporting of the more theoretical and mathematically demanding results for publication in appropriate specialist journals. We show how to estimate treatment effects and introduce methods for EME. We explain the use of IV methods and principal stratification to evaluate the role of putative treatment effect mediators and therapeutic process measures. These results are extended to the analysis of longitudinal data structures. We consider the design of EME trials. We focus on designs to create convincing IVs, bearing in mind assumptions needed to attain model identifiability. A key area of application that has become apparent during this work is the potential role of treatment moderators (predictive markers) in the evaluation of treatment effect mechanisms for personalised therapies (stratified medicine). We consider the role of targeted therapies and multiarm trials and the use of parallel trials to help elucidate the evaluation of mediators working in parallel. In order to demonstrate both efficacy and mechanism, it is necessary to (1) demonstrate a treatment effect on the primary (clinical) outcome, (2) demonstrate a treatment effect on the putative mediator (mechanism) and (3) demonstrate a causal effect from the mediator to the outcome. Appropriate regression models should be applied for (3) or alternative IV procedures, which account for unmeasured confounding, provided that a valid instrument can be identified. Stratified medicine may provide a setting where such instruments can be designed into the trial. This work could be extended by considering improved trial designs, sample size considerations and measurement properties. The project presents independent research funded under the MRC-NIHR Methodology Research Programme (grant reference G0900678).

From Usability Testing to Clinical Simulations: Bringing Context into the Design and Evaluation of Usable and Safe Health Information Technologies. Contribution of the IMIA Human Factors Engineering for Healthcare Informatics Working Group.

PubMed

Kushniruk, A; Nohr, C; Jensen, S; Borycki, E M

2013-01-01

The objective of this paper is to explore human factors approaches to understanding the use of health information technology (HIT) by extending usability engineering approaches to include analysis of the impact of clinical context through use of clinical simulations. Methods discussed are considered on a continuum from traditional laboratory-based usability testing to clinical simulations. Clinical simulations can be conducted in a simulation laboratory and they can also be conducted in real-world settings. The clinical simulation approach attempts to bring the dimension of clinical context into stronger focus. This involves testing of systems with representative users doing representative tasks, in representative settings/environments. Application of methods where realistic clinical scenarios are used to drive the study of users interacting with systems under realistic conditions and settings can lead to identification of problems and issues with systems that may not be detected using traditional usability engineering methods. In conducting such studies, careful consideration is needed in creating ecologically valid test scenarios. The evidence obtained from such evaluation can be used to improve both the usability and safety of HIT. In addition, recent work has shown that clinical simulations, in particular those conducted in-situ, can lead to considerable benefits when compared to the costs of running such studies. In order to bring context of use into the testing of HIT, clinical simulation, involving observing representative users carrying out tasks in representative settings, holds considerable promise.

Task-oriented evaluation of electronic medical records systems: development and validation of a questionnaire for physicians

PubMed Central

2004-01-01

Background Evaluation is a challenging but necessary part of the development cycle of clinical information systems like the electronic medical records (EMR) system. It is believed that such evaluations should include multiple perspectives, be comparative and employ both qualitative and quantitative methods. Self-administered questionnaires are frequently used as a quantitative evaluation method in medical informatics, but very few validated questionnaires address clinical use of EMR systems. Methods We have developed a task-oriented questionnaire for evaluating EMR systems from the clinician's perspective. The key feature of the questionnaire is a list of 24 general clinical tasks. It is applicable to physicians of most specialties and covers essential parts of their information-oriented work. The task list appears in two separate sections, about EMR use and task performance using the EMR, respectively. By combining these sections, the evaluator may estimate the potential impact of the EMR system on health care delivery. The results may also be compared across time, site or vendor. This paper describes the development, performance and validation of the questionnaire. Its performance is shown in two demonstration studies (n = 219 and 80). Its content is validated in an interview study (n = 10), and its reliability is investigated in a test-retest study (n = 37) and a scaling study (n = 31). Results In the interviews, the physicians found the general clinical tasks in the questionnaire relevant and comprehensible. The tasks were interpreted concordant to their definitions. However, the physicians found questions about tasks not explicitly or only partially supported by the EMR systems difficult to answer. The two demonstration studies provided unambiguous results and low percentages of missing responses. In addition, criterion validity was demonstrated for a majority of task-oriented questions. Their test-retest reliability was generally high, and the non-standard scale was found symmetric and ordinal. Conclusion This questionnaire is relevant for clinical work and EMR systems, provides reliable and interpretable results, and may be used as part of any evaluation effort involving the clinician's perspective of an EMR system. PMID:15018620

Studying the Therapeutic Process by Observing Clinicians' In-Session Behaviour.

PubMed

Montaño-Fidalgo, Montserrat; Ruiz, Elena M; Calero-Elvira, Ana; Froján-Parga, María Xesús

2015-01-01

This paper presents a further step in the use and validation of a systematic, functional-analytic method of describing psychologists' verbal behaviour during therapy. We observed recordings from 92 clinical sessions of 19 adults (14 women and 5 men of Caucasian origin, with ages ranging from 19 to 51 years) treated by nine cognitive-behavioural therapists (eight women and one man, Caucasian as well, with ages ranging from 25 to 48 years). The therapists' verbal behaviour was codified and then classified according to its possible functionality. A cluster analysis of the data, followed by a discriminant analysis, showed that the therapists' verbal behaviour tended to aggregate around four types of session differentiated by their clinical objective (assessment, explanation, treatment and consolidation). These results confirm the validity of our method and enable us to further describe clinical phenomena by distinguishing psychologists' classes of clinically relevant activities. Specific learning mechanisms may be responsible for clinical change within each class. These issues should be analysed more closely when explaining therapeutic phenomena and when developing more effective forms of clinical intervention. We described therapists' verbal behaviour in a focused fashion so as to develop new research methods that evaluate psychological work moment by moment. We performed a cluster analysis in order to evaluate how the therapists' verbal behaviour was distributed throughout the intervention. A discriminant analysis gave us further information about the statistical significance and possible nature of the clusters we observed. The therapists' verbal behaviour depended on current clinical objectives and could be classified into four classes of clinically relevant activities: evaluation, explanation, treatment and consolidation. Some of the therapist's verbalizations were more important than others when carrying out these clinically relevant activities. The distribution of the therapists' verbal behaviour across classes may provide us with clues regarding the functionality of their in-session verbal behaviour. Copyright © 2014 John Wiley & Sons, Ltd.

Development of a Learning-Oriented Computer Assisted Instruction Designed to Improve Skills in the Clinical Assessment of the Nutritional Status: A Pilot Evaluation

PubMed Central

García de Diego, Laura; Cuervo, Marta; Martínez, J. Alfredo

2015-01-01

Computer assisted instruction (CAI) is an effective tool for evaluating and training students and professionals. In this article we will present a learning-oriented CAI, which has been developed for students and health professionals to acquire and retain new knowledge through the practice. A two-phase pilot evaluation was conducted, involving 8 nutrition experts and 30 postgraduate students, respectively. In each training session, the software developed guides users in the integral evaluation of a patient’s nutritional status and helps them to implement actions. The program includes into the format clinical tools, which can be used to recognize possible patient’s needs, to improve the clinical reasoning and to develop professional skills. Among them are assessment questionnaires and evaluation criteria, cardiovascular risk charts, clinical guidelines and photographs of various diseases. This CAI is a complete software package easy to use and versatile, aimed at clinical specialists, medical staff, scientists, educators and clinical students, which can be used as a learning tool. This application constitutes an advanced method for students and health professionals to accomplish nutritional assessments combining theoretical and empirical issues, which can be implemented in their academic curriculum. PMID:25978456

Unruly grandmothers, ghosts and ancestors: Chinese elders and the importance of culture in dementia evaluations.

PubMed

Elliott, Kathryn S; Di Minno, Mariann

2006-01-01

This article explores the cultural clashes that occurred when Chinese patients at an Alzheimer's center in California were evaluated for dementia. Lack of familiarity with Chinese culture made the culturally mainstream American clinicians at this center more likely to misinterpret the behavior of elderly Chinese-speaking patients and their families and, thereby, more likely to misdiagnose such patients and suggest culturally inappropriate recommendations. This tendency was reduced when relevant cultural knowledge was incorporated into the clinical evaluation. The evaluation process at this clinic and two patient examples are discussed to illustrate that familiarity with a patient's cultural background is essential for accurate diagnosis and referral. This ethnographic case study places the evaluation process in one particular clinic in cultural context and is suggestive in the way that exploratory qualitative research is meant to be, rather than broadly representative of dementia clinics or clinicians as a whole. However, problems created by cultural clashes at this clinic do suggest that what may be happening at other dementia clinics as they encounter increasingly more patients from diverse cultural backgrounds is an important empirical question worthy of further research, using both qualitative and quantitative methods.

Development of a learning-oriented computer assisted instruction designed to improve skills in the clinical assessment of the nutritional status: a pilot evaluation.

PubMed

García de Diego, Laura; Cuervo, Marta; Martínez, J Alfredo

2015-01-01

Computer assisted instruction (CAI) is an effective tool for evaluating and training students and professionals. In this article we will present a learning-oriented CAI, which has been developed for students and health professionals to acquire and retain new knowledge through the practice. A two-phase pilot evaluation was conducted, involving 8 nutrition experts and 30 postgraduate students, respectively. In each training session, the software developed guides users in the integral evaluation of a patient's nutritional status and helps them to implement actions. The program includes into the format clinical tools, which can be used to recognize possible patient's needs, to improve the clinical reasoning and to develop professional skills. Among them are assessment questionnaires and evaluation criteria, cardiovascular risk charts, clinical guidelines and photographs of various diseases. This CAI is a complete software package easy to use and versatile, aimed at clinical specialists, medical staff, scientists, educators and clinical students, which can be used as a learning tool. This application constitutes an advanced method for students and health professionals to accomplish nutritional assessments combining theoretical and empirical issues, which can be implemented in their academic curriculum.

The need to approximate the use-case in clinical machine learning

PubMed Central

Saeb, Sohrab; Jayaraman, Arun; Mohr, David C.; Kording, Konrad P.

2017-01-01

Abstract The availability of smartphone and wearable sensor technology is leading to a rapid accumulation of human subject data, and machine learning is emerging as a technique to map those data into clinical predictions. As machine learning algorithms are increasingly used to support clinical decision making, it is vital to reliably quantify their prediction accuracy. Cross-validation (CV) is the standard approach where the accuracy of such algorithms is evaluated on part of the data the algorithm has not seen during training. However, for this procedure to be meaningful, the relationship between the training and the validation set should mimic the relationship between the training set and the dataset expected for the clinical use. Here we compared two popular CV methods: record-wise and subject-wise. While the subject-wise method mirrors the clinically relevant use-case scenario of diagnosis in newly recruited subjects, the record-wise strategy has no such interpretation. Using both a publicly available dataset and a simulation, we found that record-wise CV often massively overestimates the prediction accuracy of the algorithms. We also conducted a systematic review of the relevant literature, and found that this overly optimistic method was used by almost half of the retrieved studies that used accelerometers, wearable sensors, or smartphones to predict clinical outcomes. As we move towards an era of machine learning-based diagnosis and treatment, using proper methods to evaluate their accuracy is crucial, as inaccurate results can mislead both clinicians and data scientists. PMID:28327985

A novel resident-as-teacher training program to improve and evaluate obstetrics and gynecology resident teaching skills.

PubMed

Ricciotti, Hope A; Dodge, Laura E; Head, Julia; Atkins, K Meredith; Hacker, Michele R

2012-01-01

Residents play a significant role in teaching, but formal training, feedback, and evaluation are needed. Our aims were to assess resident teaching skills in the resident-as-teacher program, quantify correlations of faculty evaluations with resident self-evaluations, compare resident-as-teacher evaluations with clinical evaluations, and evaluate the resident-as-teacher program. The resident-as-teacher training program is a simulated, videotaped teaching encounter with a trained medical student and standardized teaching evaluation tool. Evaluations from the resident-as-teacher training program were compared to evaluations of resident teaching done by faculty, residents, and medical students from the clinical setting. Faculty evaluation of resident teaching skills in the resident-as-teacher program showed a mean total score of 4.5 ± 0.5 with statistically significant correlations between faculty assessment and resident self-evaluations (r = 0.47; p < 0.001). However, resident self-evaluation of teaching skill was lower than faculty evaluation (mean difference: 0.4; 95% CI 0.3-0.6). When compared to the clinical setting, resident-as-teacher evaluations were significantly correlated with faculty and resident evaluations, but not medical student evaluations. Evaluations from both the resident-as-teacher program and the clinical setting improved with duration of residency. The resident-as-teacher program provides a method to train, give feedback, and evaluate resident teaching.

Development and psychometric evaluation of the Undergraduate Clinical Education Environment Measure (UCEEM).

PubMed

Strand, Pia; Sjöborg, Karolina; Stalmeijer, Renée; Wichmann-Hansen, Gitte; Jakobsson, Ulf; Edgren, Gudrun

2013-12-01

There is a paucity of instruments designed to evaluate the multiple dimensions of the workplace as an educational environment for undergraduate medical students. The aim was to develop and psychometrically evaluate an instrument to measure how undergraduate medical students perceive the clinical workplace environment, based on workplace learning theories and empirical findings. Development of the instrument relied on established standards including theoretical and empirical grounding, systematic item development and expert review at various stages to ensure content validity. Qualitative and quantitative methods were employed using a series of steps from conceptualization through psychometric analysis of scores in a Swedish medical student population. The final result was a 25-item instrument with two overarching dimensions, experiential learning and social participation, and four subscales that coincided well with theory and empirical findings: Opportunities to learn in and through work & quality of supervision; Preparedness for student entry; Workplace interaction patterns & student inclusion; and Equal treatment. Evidence from various sources supported content validity, construct validity and reliability of the instrument. The Undergraduate Clinical Education Environment Measure represents a valid, reliable and feasible multidimensional instrument for evaluation of the clinical workplace as a learning environment for undergraduate medical students. Further validation in different populations using various psychometric methods is needed.

Sternal instability measured with radiostereometric analysis. A study of method feasibility, accuracy and precision.

PubMed

Vestergaard, Rikke Falsig; Søballe, Kjeld; Hasenkam, John Michael; Stilling, Maiken

2018-05-18

A small, but unstable, saw-gap may hinder bone-bridging and induce development of painful sternal dehiscence. We propose the use of Radiostereometric Analysis (RSA) for evaluation of sternal instability and present a method validation. Four bone analogs (phantoms) were sternotomized and tantalum beads were inserted in each half. The models were reunited with wire cerclage and placed in a radiolucent separation device. Stereoradiographs (n = 48) of the phantoms in 3 positions were recorded at 4 imposed separation points. The accuracy and precision was compared statistically and presented as translations along the 3 orthogonal axes. 7 sternotomized patients were evaluated for clinical RSA precision by double-examination stereoradiographs (n = 28). In the phantom study, we found no systematic error (p > 0.3) between the three phantom positions, and precision for evaluation of sternal separation was 0.02 mm. Phantom accuracy was mean 0.13 mm (SD 0.25). In the clinical study, we found a detection limit of 0.42 mm for sternal separation and of 2 mm for anterior-posterior dislocation of the sternal halves for the individual patient. RSA is a precise and low-dose image modality feasible for clinical evaluation of sternal stability in research. ClinicalTrials.gov Identifier: NCT02738437 , retrospectively registered.

Idiopathic club foot treated with the Ponseti method. Clinical and sonographic evaluation of Achilles tendon tenotomy. A review of 221 club feet.

PubMed

Marleix, S; Chapuis, M; Fraisse, B; Tréguier, C; Darnault, P; Rozel, C; Rayar, M; Violas, P

2012-06-01

The Ponseti method applied to treating idiopathic club foot consists in placing successive corrective casts, possibly an Achilles tendon tenotomy, then derotation braces, a method that has proven its efficacy. This study compared 221 cases of club foot treated with this method between 2002 and 2007 divided into two groups, based on whether or not Achilles tendon tenotomy was performed. Assessment was both clinical and sonographic. We observed clear improvement of the results in the group that underwent Achilles tendon tenotomy and a significant difference in the rate of secondary surgery. The sonographic evaluation also showed improvement of the morphological results. We now systematically propose Achilles tendon tenotomy however severe club foot may be. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

Link between immunoexpression of hMLH1 and hMSH2 proteins and clinical-epidemiological aspects of actinic cheilitis*

PubMed Central

Sarmento, Dmitry José de Santana; Godoy, Gustavo Pina; Miguel, Márcia Cristina da Costa; da Silveira, Éricka Janine Dantas

2016-01-01

Background The studies found in the literature associate the immunoexpression of hMLH1 and hMSH2 proteins with histologic aspects, but do not correlate it with clinical and epidemiological data. Objective To evaluate the immunoexpression of hMLH1 and hMSH2 in actinic cheilitis, correlating it with clinical characteristics. Methods We analyzed 40 cases. Histological and immunohistochemical analyses were performed. The following clinical variables were evaluated: gender, age range, ethnicity, clinical aspect and occupational sunlight exposure. Statistical evaluation included the Student t-test, while the significance level was set at 5%. Results Greater immunoexpression of hMLH1 and hMSH2 was observed in females, individuals aged over 40, and mixed-race/black patients. Furthermore, the immunoexpression of these proteins was greater in actinic cheilitis with a white-colored appearance and in patients without occupational sunlight exposure. No statistical differences were observed for the variables studied. Conclusion This study uncovered variations of hMLH1 and hMSH2 protein expression upon evaluation of clinical aspects in actinic cheilitis. PMID:27579741

Performance Measurement for Substance Abuse Treatment Services. Integrated Evaluation Methods. Revised.

ERIC Educational Resources Information Center

Harwood, Henrick; Bazron, Barbara; Fountain, Douglas

This paper presents state-of-the-art models addressing issues related to coordination of treatment and evaluation activities, and integration of clinical, performance, and evaluation information. Specifically, this concept paper contains a discussion of the need for and types of cost analyses for CSAT treatment evaluation and knowledge-generating…

Evaluation of the marginal and internal gaps of three different dental prostheses: comparison of the silicone replica technique and three-dimensional superimposition analysis

PubMed Central

2017-01-01

PURPOSE The purposes of this study were to evaluate the marginal and internal gaps, and the potential clinical applications of three different methods of dental prostheses fabrication, and to compare the prostheses prepared using the silicone replica technique (SRT) and those prepared using the three-dimensional superimposition analysis (3DSA). MATERIALS AND METHODS Five Pekkton, lithium disilicate, and zirconia crowns were each manufactured and tested using both the SRT and the two-dimensional section of the 3DSA. The data were analyzed with the nonparametric version of a two-way analysis of variance using rank-transformed values and the Tukey's post-hoc test (α = .05). RESULTS Significant differences were observed between the fabrication methods in the marginal gap (P < .010), deep chamfer (P < .001), axial wall (P < .001), and occlusal area (P < .001). A significant difference in the occlusal area was found between the two measurement methods (P < .030), whereas no significant differences were found in the marginal gap (P > .350), deep chamfer (P > .719), and axial wall (P > .150). As the 3DSA method is three-dimensional, it allows for the measurement of arbitrary points. CONCLUSION All of the three fabrication methods are valid for measuring clinical objectives because they produced prostheses within the clinically acceptable range. Furthermore, a three-dimensional superimposition analysis verification method such as the silicone replica technique is also applicable in clinical settings. PMID:28680546

Systematic data ingratiation of clinical trial recruitment locations for geographic-based query and visualization

PubMed Central

Luo, Jake; Chen, Weiheng; Wu, Min; Weng, Chunhua

2018-01-01

Background Prior studies of clinical trial planning indicate that it is crucial to search and screen recruitment sites before starting to enroll participants. However, currently there is no systematic method developed to support clinical investigators to search candidate recruitment sites according to their interested clinical trial factors. Objective In this study, we aim at developing a new approach to integrating the location data of over one million heterogeneous recruitment sites that are stored in clinical trial documents. The integrated recruitment location data can be searched and visualized using a map-based information retrieval method. The method enables systematic search and analysis of recruitment sites across a large amount of clinical trials. Methods The location data of more than 1.4 million recruitment sites of over 183,000 clinical trials was normalized and integrated using a geocoding method. The integrated data can be used to support geographic information retrieval of recruitment sites. Additionally, the information of over 6000 clinical trial target disease conditions and close to 4000 interventions was also integrated into the system and linked to the recruitment locations. Such data integration enabled the construction of a novel map-based query system. The system will allow clinical investigators to search and visualize candidate recruitment sites for clinical trials based on target conditions and interventions. Results The evaluation results showed that the coverage of the geographic location mapping for the 1.4 million recruitment sites was 99.8%. The evaluation of 200 randomly retrieved recruitment sites showed that the correctness of geographic information mapping was 96.5%. The recruitment intensities of the top 30 countries were also retrieved and analyzed. The data analysis results indicated that the recruitment intensity varied significantly across different countries and geographic areas. Conclusion This study contributed a new data processing framework to extract and integrate the location data of heterogeneous recruitment sites from clinical trial documents. The developed system can support effective retrieval and analysis of potential recruitment sites using target clinical trial factors. PMID:29132636

Clinical results of resection arthrodesis by triangular external fixation for posttraumatic arthrosis of the ankle joint in 89 cases.

PubMed

Kiene, J; Schulz, Arndt P; Hillbricht, S; Jürgens, Ch; Paech, A

2009-01-28

The methods for ankle arthrodesis differ significantly, probably a sign that no method is clearly superior to others. In the last ten years there is a clear favour toward internal fixation. We retrospectively evaluate the technique and evaluate the clinical long term results of external fixation in a triangular frame. From 1994 to 2001 a consecutive series of 95 patients with end stage arthritis of the ankle joint were treated. Retrospectively the case notes were evaluated regarding trauma history, medical complaints, further injuries and illnesses, walking and pain status and occupational issues and the clinical examination before arthrodesis. Mean age at the index procedure was 45.4 years (18-82), 67 patients were male (70.5%). Via a bilateral approach the malleoli and the joint surfaces were resected. An AO fixator was applied with two Steinmann-nails inserted with approximately 8 cm distance in the distal tibia, one in the neck of the talus and one in the dorsal calcaneus. The fixator was removed after approximately 12 weeks. Follow up examination at mean 4.4 years included a standardised questionnaire and a clinical examination including the criteria of the AOFAS-Score and radiographs. Due to different complications, 8 (8.9%) further surgical procedures were necessary including 1 below knee amputation. In 4 patients a non-union of the ankle arthrodesis developed (4.5%). The mean AOFAS score improved from 20.8 to 69.3 points. Non-union rates and clinical results of arthrodesis by triangular external fixation of the ankle joint do not differ to internal fixation methods. The complication rate and the reduced patient comfort reserve this method mainly for infected arthritis and complicated soft tissue situations.

How to translate therapeutic recommendations in clinical practice guidelines into rules for critiquing physician prescriptions? Methods and application to five guidelines

PubMed Central

2010-01-01

Background Clinical practice guidelines give recommendations about what to do in various medical situations, including therapeutical recommendations for drug prescription. An effective way to computerize these recommendations is to design critiquing decision support systems, i.e. systems that criticize the physician's prescription when it does not conform to the guidelines. These systems are commonly based on a list of "if conditions then criticism" rules. However, writing these rules from the guidelines is not a trivial task. The objective of this article is to propose methods that (1) simplify the implementation of guidelines' therapeutical recommendations in critiquing systems by automatically translating structured therapeutical recommendations into a list of "if conditions then criticize" rules, and (2) can generate an appropriate textual label to explain to the physician why his/her prescription is not recommended. Methods We worked on the therapeutic recommendations in five clinical practice guidelines concerning chronic diseases related to the management of cardiovascular risk. We evaluated the system using a test base of more than 2000 cases. Results Algorithms for automatically translating therapeutical recommendations into "if conditions then criticize" rules are presented. Eight generic recommendations are also proposed; they are guideline-independent, and can be used as default behaviour for handling various situations that are usually implicit in the guidelines, such as decreasing the dose of a poorly tolerated drug. Finally, we provide models and methods for generating a human-readable textual critique. The system was successfully evaluated on the test base. Conclusion We show that it is possible to criticize physicians' prescriptions starting from a structured clinical guideline, and to provide clear explanations. We are now planning a randomized clinical trial to evaluate the impact of the system on practices. PMID:20509903

Swab Protocol for Rapid Laboratory Diagnosis of Cutaneous Anthrax

PubMed Central

Marston, Chung K.; Bhullar, Vinod; Baker, Daniel; Rahman, Mahmudur; Hossain, M. Jahangir; Chakraborty, Apurba; Khan, Salah Uddin; Hoffmaster, Alex R.

2012-01-01

The clinical laboratory diagnosis of cutaneous anthrax is generally established by conventional microbiological methods, such as culture and directly straining smears of clinical specimens. However, these methods rely on recovery of viable Bacillus anthracis cells from swabs of cutaneous lesions and often yield negative results. This study developed a rapid protocol for detection of B. anthracis on clinical swabs. Three types of swabs, flocked-nylon, rayon, and polyester, were evaluated by 3 extraction methods, the swab extraction tube system (SETS), sonication, and vortex. Swabs were spiked with virulent B. anthracis cells, and the methods were compared for their efficiency over time by culture and real-time PCR. Viability testing indicated that the SETS yielded greater recovery of B. anthracis from 1-day-old swabs; however, reduced viability was consistent for the 3 extraction methods after 7 days and nonviability was consistent by 28 days. Real-time PCR analysis showed that the PCR amplification was not impacted by time for any swab extraction method and that the SETS method provided the lowest limit of detection. When evaluated using lesion swabs from cutaneous anthrax outbreaks, the SETS yielded culture-negative, PCR-positive results. This study demonstrated that swab extraction methods differ in their efficiency of recovery of viable B. anthracis cells. Furthermore, the results indicated that culture is not reliable for isolation of B. anthracis from swabs at ≥7 days. Thus, we recommend the use of the SETS method with subsequent testing by culture and real-time PCR for diagnosis of cutaneous anthrax from clinical swabs of cutaneous lesions. PMID:23035192

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Common Diseases of Dermatology in Traditional Chinese Medicine].

PubMed

Wang, Yue-Xi; Liu, Meng-Yu; Wang, Li-Ying; Shi, Nan-Nan; Zhao, Xue-Yao; Liu, Yu-Qi; Wang, Yan-Ping; Han, Xue-Jie

2017-09-01

To assess the quality and application effect of Guidelines for Diagnosis and Treatment of Common Diseases of Dermatology in Traditional Chinese Medicine(Guidelines) through the applicability and applicability evaluation respectively. The questionnaire survey was adopted to evaluate the applicability of the Guidelines, including the utilization, quality, and clinical application conditions. The results showed that the familiarity rate and utilization rate of the Guidelines were 85.37%, 48.78%, respectively. The data showed that the familiarity and the utilization rates were different in the working staff with different professional titles. The evaluation level was the lowest given by the staff with junior professional title (70.97%, 29.03%) in comparison. The assessment showed the overall quality of the Guideline was good and slightly low level for the rationality scores of the other therapeutic methods as well as for the recuperation and prevention (80.49%, 85.37%), which was in line with the clinical compliance of the Guideline. The perspective observation of clinical cases was used for the applicability evaluation, including clinical compliance of the Guideline, effect evaluation, and comprehensive assessment, et al. The results showed that the safety score was the highest, followed by the economic issue and efficacy. For the comprehensive evaluation of the applicability, complete applicability accounted for 29.27%, and the general applicability accounted for 87.80%. It was showed in the three index scores of the applicability evaluation that the accumulative score 7-9 scores were 75.65%, 73.89%, 71.12%. Through the applicability and applicability evaluation, the Guideline was satisfactory in the overall quality, high in the safety of clinical application and good in efficacy and economic issues. There are some limits on the development method and technical issues in the Guideline, which is required to be supplemented in the revision. Additionally, the strategy study on the promotion of the Guideline should be enhanced so as to expedite the recognition and utilization of the Guideline. Copyright© by the Chinese Pharmaceutical Association.

[Feasibility of implementing a learning based problem solving and peer evaluation approach among medical students in Mexico].

PubMed

Amato, Dante; de Jesús Novales-Castro, Xavier

2009-01-01

Assess the degree to which medical students accept and consider useful the techniques of problem based learning (PBL) and evaluation among peers. Analyze the association between the number of PBL clinical cases reviewed and the students' perception about their own learning in a basic course. A questionnaire was administered to 334 students enrolled in the third semester of medical school (Facultad de Estudios Superiores Iztacala, Universidad Nacional Autónoma de México). Questions included acceptability of PBL, peer evaluation, and their perception about the usefulness of these techniques after having used them during the school year. We used a Likert scale to measure opinions on the degree of usefulness of the PBL, perception of their own learning, and the acceptance of the notion that evaluation activities evaluation among peers promote justice and favor the student's character formation. We measured the association of these variables with the number of clinical cases studied using Spearman's rank correlation coefficient. Most of the students considered that PBL method is useful (82%) and that evaluation activities among peers promote justice and character formation (70%). Students who reviewed more PBL cases considered the PBL activities more useful (rho = 0.489, p < 0.0001), and perceived that they achieved a better learning experience (rho = 0.200, p < 0.0001). Results show a fair acceptance by the students of the PBL method and activities of peer evaluation. The number of clinical cases reviewed during the course correlated with considering the PBL to be a useful method and perceiving a better learning experience. Our results support the inclusion of PBL and peer evaluation in the medical school curricula.

Association between quantitative measures obtained using fluorescence-based methods and activity status of occlusal caries lesions in primary molars.

PubMed

Novaes, Tatiane Fernandes; Reyes, Alessandra; Matos, Ronilza; Antunes-Pontes, Laura Regina; Marques, Renata Pereira de Samuel; Braga, Mariana Minatel; Diniz, Michele Baffi; Mendes, Fausto Medeiros

2017-05-01

Fluorescence-based methods (FBM) can add objectiveness to diagnosis strategy for caries. Few studies, however, have focused on the evaluation of caries activity. To evaluate the association between quantitative measures obtained with FBM, clinical parameters acquired from the patients, caries detection, and assessment of activity status in occlusal surfaces of primary molars. Six hundred and six teeth from 113 children (4-14 years) were evaluated. The presence of a biofilm, caries experience, and the number of active lesions were recorded. The teeth were assessed using FBM: DIAGNOdent pen (Lfpen) and Quantitative light-induced fluorescence (QLF). As reference standard, all teeth were evaluated using the ICDAS (International Caries Detection and Assessment System) associated with clinical activity assessments. Multilevel regressions compared the FBM values and evaluated the association between the FBM measures and clinical variables related to the caries activity. The measures from the FBM were higher in cavitated lesions. Only, ∆F values distinguished active and inactive lesions. The LFpen measures were higher in active lesions, at the cavitated threshold (56.95 ± 29.60). Following regression analyses, only the presence of visible biofilm on occlusal surfaces (adjusted prevalence ratio = 1.43) and ∆R values of the teeth (adjusted prevalence ratio = 1.02) were associated with caries activity. Some quantitative measures from FBM parameters are associated with caries activity evaluation, which is similar to the clinical evaluation of the presence of visible biofilm. © 2016 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[Comparison of microdilution and disk diffusion methods for the detection of fluconazole and voriconazole susceptibility against clinical Candida glabrata isolates and determination of changing susceptibility with new CLSI breakpoints].

PubMed

Hazırolan, Gülşen; Sarıbaş, Zeynep; Arıkan Akdağlı, Sevtap

2016-07-01

Candida albicans is the most frequently isolated species as the causative agent of Candida infections. However, in recent years, the isolation rate of non-albicans Candida species have increased. In many centers, Candida glabrata is one of the commonly isolated non-albicans species of C.glabrata infections which are difficult-to-treat due to decreased susceptibility to fluconazole and cross-resistance to other azoles. The aims of this study were to determine the in vitro susceptibility profiles of clinical C.glabrata isolates against fluconazole and voriconazole by microdilution and disk diffusion methods and to evaluate the results with both the previous (CLSI) and current species-specific CLSI (Clinical and Laboratory Standards Institute) clinical breakpoints. A total of 70 C.glabrata strains isolated from clinical samples were included in the study. The identification of the isolates was performed by morphologic examination on cornmeal Tween 80 agar and assimilation profiles obtained by using ID32C (BioMérieux, France). Broth microdilution and disk diffusion methods were performed according to CLSI M27-A3 and CLSI M44-A2 documents, respectively. The results were evaluated according to CLSI M27-A3 and M44-A2 documents and new vs. species-specific CLSI breakpoints. By using both previous and new CLSI breakpoints, broth microdilution test results showed that voriconazole has greater in vitro activity than fluconazole against C.glabrata isolates. For the two drugs tested, very major error was not observed with disk diffusion method when microdilution method was considered as the reference method. Since "susceptible" category no more exists for fluconazole vs. C.glabrata, the isolates that were interpreted as susceptible by previous breakpoints were evaluated as susceptible-dose dependent by current CLSI breakpoints. Since species-specific breakpoints remain yet undetermined for voriconazole, comparative analysis was not possible for this agent. The results obtained at 24 hours by disk diffusion method were evaluated by using both previous and current CLSI breakpoints and the agreement rates for fluconazole and voriconazole were 80% and 92.8% with previous CLSI breakpoint, 87.1% and 94.2% with new breakpoints, respectively. The high agreement rates between the two methods obtained by the new breakpoints in particular suggest that disk diffusion appears as a reliable alternative method in general for in vitro susceptibility testing of fluconazole and voriconazole against C.glabrata isolates.

Validating and determining the weight of items used for evaluating clinical governance implementation based on analytic hierarchy process model.

PubMed

Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Vafaee Najar, Ali; Meraji, Marziye; Ebrahimipour, Hossein

2015-04-08

The purpose of implementing a system such as Clinical Governance (CG) is to integrate, establish and globalize distinct policies in order to improve quality through increasing professional knowledge and the accountability of healthcare professional toward providing clinical excellence. Since CG is related to change, and change requires money and time, CG implementation has to be focused on priority areas that are in more dire need of change. The purpose of the present study was to validate and determine the significance of items used for evaluating CG implementation. The present study was descriptive-quantitative in method and design. Items used for evaluating CG implementation were first validated by the Delphi method and then compared with one another and ranked based on the Analytical Hierarchy Process (AHP) model. The items that were validated for evaluating CG implementation in Iran include performance evaluation, training and development, personnel motivation, clinical audit, clinical effectiveness, risk management, resource allocation, policies and strategies, external audit, information system management, research and development, CG structure, implementation prerequisites, the management of patients' non-medical needs, complaints and patients' participation in the treatment process. The most important items based on their degree of significance were training and development, performance evaluation, and risk management. The least important items included the management of patients' non-medical needs, patients' participation in the treatment process and research and development. The fundamental requirements of CG implementation included having an effective policy at national level, avoiding perfectionism, using the expertise and potentials of the entire country and the coordination of this model with other models of quality improvement such as accreditation and patient safety. © 2015 by Kerman University of Medical Sciences.

Development and Evaluation of Assessments for Counseling Professionals

ERIC Educational Resources Information Center

Lenz, A. Stephen; Wester, Kelly L.

2017-01-01

It is imperative that counselors understand how to critically evaluate assessments before using them to make clinical decisions. This evaluation can be conducted through integrating the 5 sources of validity. Each source of validity is discussed, along with methods to appraise psychometric quality, throughout this special issue.

A Systems Approach to Designing Effective Clinical Trials Using Simulations

PubMed Central

Fusaro, Vincent A.; Patil, Prasad; Chi, Chih-Lin; Contant, Charles F.; Tonellato, Peter J.

2013-01-01

Background Pharmacogenetics in warfarin clinical trials have failed to show a significant benefit compared to standard clinical therapy. This study demonstrates a computational framework to systematically evaluate pre-clinical trial design of target population, pharmacogenetic algorithms, and dosing protocols to optimize primary outcomes. Methods and Results We programmatically created an end-to-end framework that systematically evaluates warfarin clinical trial designs. The framework includes options to create a patient population, multiple dosing strategies including genetic-based and non-genetic clinical-based, multiple dose adjustment protocols, pharmacokinetic/pharmacodynamics (PK/PD) modeling and international normalization ratio (INR) prediction, as well as various types of outcome measures. We validated the framework by conducting 1,000 simulations of the CoumaGen clinical trial primary endpoints. The simulation predicted a mean time in therapeutic range (TTR) of 70.6% and 72.2% (P = 0.47) in the standard and pharmacogenetic arms, respectively. Then, we evaluated another dosing protocol under the same original conditions and found a significant difference in TTR between the pharmacogenetic and standard arm (78.8% vs. 73.8%; P = 0.0065), respectively. Conclusions We demonstrate that this simulation framework is useful in the pre-clinical assessment phase to study and evaluate design options and provide evidence to optimize the clinical trial for patient efficacy and reduced risk. PMID:23261867

[Immunological surrogate endpoints to evaluate vaccine efficacy].

PubMed

Jin, Pengfei; Li, Jingxin; Zhou, Yang; Zhu, Fengcai

2015-12-01

An immunological surrogate endpoints is a vaccine-induced immune response (either humoral or cellular immune) that predicts protection against clinical endpoints (infection or disease), and can be used to evaluate vaccine efficacy in clinical vaccine trials. Compared with field efficacy trials observing clinical endpoints, immunological vaccine trials could reduce the sample size or shorten the duration of a trial, which promote the license and development of new candidate vaccines. For these reasons, establishing immunological surrogate endpoints is one of 14 Grand Challenges of Global Health of the National Institutes of Health (NIH) and the Bill and Melinda Gates Foundation. From two parts of definition and statistical methods for evaluation of surrogate endpoints, this review provides a more comprehensive description.

Fully automated treatment planning for head and neck radiotherapy using a voxel-based dose prediction and dose mimicking method

NASA Astrophysics Data System (ADS)

McIntosh, Chris; Welch, Mattea; McNiven, Andrea; Jaffray, David A.; Purdie, Thomas G.

2017-08-01

Recent works in automated radiotherapy treatment planning have used machine learning based on historical treatment plans to infer the spatial dose distribution for a novel patient directly from the planning image. We present a probabilistic, atlas-based approach which predicts the dose for novel patients using a set of automatically selected most similar patients (atlases). The output is a spatial dose objective, which specifies the desired dose-per-voxel, and therefore replaces the need to specify and tune dose-volume objectives. Voxel-based dose mimicking optimization then converts the predicted dose distribution to a complete treatment plan with dose calculation using a collapsed cone convolution dose engine. In this study, we investigated automated planning for right-sided oropharaynx head and neck patients treated with IMRT and VMAT. We compare four versions of our dose prediction pipeline using a database of 54 training and 12 independent testing patients by evaluating 14 clinical dose evaluation criteria. Our preliminary results are promising and demonstrate that automated methods can generate comparable dose distributions to clinical. Overall, automated plans achieved an average of 0.6% higher dose for target coverage evaluation criteria, and 2.4% lower dose at the organs at risk criteria levels evaluated compared with clinical. There was no statistically significant difference detected in high-dose conformity between automated and clinical plans as measured by the conformation number. Automated plans achieved nine more unique criteria than clinical across the 12 patients tested and automated plans scored a significantly higher dose at the evaluation limit for two high-risk target coverage criteria and a significantly lower dose in one critical organ maximum dose. The novel dose prediction method with dose mimicking can generate complete treatment plans in 12-13 min without user interaction. It is a promising approach for fully automated treatment planning and can be readily applied to different treatment sites and modalities.

Fully automated treatment planning for head and neck radiotherapy using a voxel-based dose prediction and dose mimicking method.

PubMed

McIntosh, Chris; Welch, Mattea; McNiven, Andrea; Jaffray, David A; Purdie, Thomas G

2017-07-06

Recent works in automated radiotherapy treatment planning have used machine learning based on historical treatment plans to infer the spatial dose distribution for a novel patient directly from the planning image. We present a probabilistic, atlas-based approach which predicts the dose for novel patients using a set of automatically selected most similar patients (atlases). The output is a spatial dose objective, which specifies the desired dose-per-voxel, and therefore replaces the need to specify and tune dose-volume objectives. Voxel-based dose mimicking optimization then converts the predicted dose distribution to a complete treatment plan with dose calculation using a collapsed cone convolution dose engine. In this study, we investigated automated planning for right-sided oropharaynx head and neck patients treated with IMRT and VMAT. We compare four versions of our dose prediction pipeline using a database of 54 training and 12 independent testing patients by evaluating 14 clinical dose evaluation criteria. Our preliminary results are promising and demonstrate that automated methods can generate comparable dose distributions to clinical. Overall, automated plans achieved an average of 0.6% higher dose for target coverage evaluation criteria, and 2.4% lower dose at the organs at risk criteria levels evaluated compared with clinical. There was no statistically significant difference detected in high-dose conformity between automated and clinical plans as measured by the conformation number. Automated plans achieved nine more unique criteria than clinical across the 12 patients tested and automated plans scored a significantly higher dose at the evaluation limit for two high-risk target coverage criteria and a significantly lower dose in one critical organ maximum dose. The novel dose prediction method with dose mimicking can generate complete treatment plans in 12-13 min without user interaction. It is a promising approach for fully automated treatment planning and can be readily applied to different treatment sites and modalities.

An Official American Thoracic Society Clinical Practice Guideline: Classification, Evaluation, and Management of Childhood Interstitial Lung Disease in Infancy

PubMed Central

Kurland, Geoffrey; Deterding, Robin R.; Hagood, James S.; Young, Lisa R.; Brody, Alan S.; Castile, Robert G.; Dell, Sharon; Fan, Leland L.; Hamvas, Aaron; Hilman, Bettina C.; Langston, Claire; Nogee, Lawrence M.; Redding, Gregory J.

2013-01-01

Background: There is growing recognition and understanding of the entities that cause interstitial lung disease (ILD) in infants. These entities are distinct from those that cause ILD in older children and adults. Methods: A multidisciplinary panel was convened to develop evidence-based guidelines on the classification, diagnosis, and management of ILD in children, focusing on neonates and infants under 2 years of age. Recommendations were formulated using a systematic approach. Outcomes considered important included the accuracy of the diagnostic evaluation, complications of delayed or incorrect diagnosis, psychosocial complications affecting the patient’s or family’s quality of life, and death. Results: No controlled clinical trials were identified. Therefore, observational evidence and clinical experience informed judgments. These guidelines: (1) describe the clinical characteristics of neonates and infants (<2 yr of age) with diffuse lung disease (DLD); (2) list the common causes of DLD that should be eliminated during the evaluation of neonates and infants with DLD; (3) recommend methods for further clinical investigation of the remaining infants, who are regarded as having “childhood ILD syndrome”; (4) describe a new pathologic classification scheme of DLD in infants; (5) outline supportive and continuing care; and (6) suggest areas for future research. Conclusions: After common causes of DLD are excluded, neonates and infants with childhood ILD syndrome should be evaluated by a knowledgeable subspecialist. The evaluation may include echocardiography, controlled ventilation high-resolution computed tomography, infant pulmonary function testing, bronchoscopy with bronchoalveolar lavage, genetic testing, and/or lung biopsy. Preventive care, family education, and support are essential. PMID:23905526

An Automatic Assessment System of Diabetic Foot Ulcers Based on Wound Area Determination, Color Segmentation, and Healing Score Evaluation.

PubMed

Wang, Lei; Pedersen, Peder C; Strong, Diane M; Tulu, Bengisu; Agu, Emmanuel; Ignotz, Ron; He, Qian

2015-08-07

For individuals with type 2 diabetes, foot ulcers represent a significant health issue. The aim of this study is to design and evaluate a wound assessment system to help wound clinics assess patients with foot ulcers in a way that complements their current visual examination and manual measurements of their foot ulcers. The physical components of the system consist of an image capture box, a smartphone for wound image capture and a laptop for analyzing the wound image. The wound image assessment algorithms calculate the overall wound area, color segmented wound areas, and a healing score, to provide a quantitative assessment of the wound healing status both for a single wound image and comparisons of subsequent images to an initial wound image. The system was evaluated by assessing foot ulcers for 12 patients in the Wound Clinic at University of Massachusetts Medical School. As performance measures, the Matthews correlation coefficient (MCC) value for the wound area determination algorithm tested on 32 foot ulcer images was .68. The clinical validity of our healing score algorithm relative to the experienced clinicians was measured by Krippendorff's alpha coefficient (KAC) and ranged from .42 to .81. Our system provides a promising real-time method for wound assessment based on image analysis. Clinical comparisons indicate that the optimized mean-shift-based algorithm is well suited for wound area determination. Clinical evaluation of our healing score algorithm shows its potential to provide clinicians with a quantitative method for evaluating wound healing status. © 2015 Diabetes Technology Society.

Preliminary investigation of Brain Network Activation (BNA) and its clinical utility in sport-related concussion.

PubMed

Reches, A; Kutcher, J; Elbin, R J; Or-Ly, H; Sadeh, B; Greer, J; McAllister, D J; Geva, A; Kontos, A P

2017-01-01

The clinical diagnosis and management of patients with sport-related concussion is largely dependent on subjectively reported symptoms, clinical examinations, cognitive, balance, vestibular and oculomotor testing. Consequently, there is an unmet need for objective assessment tools that can identify the injury from a physiological perspective and add an important layer of information to the clinician's decision-making process. The goal of the study was to evaluate the clinical utility of the EEG-based tool named Brain Network Activation (BNA) as a longitudinal assessment method of brain function in the management of young athletes with concussion. Athletes with concussion (n = 86) and age-matched controls (n = 81) were evaluated at four time points with symptom questionnaires and BNA. BNA scores were calculated by comparing functional networks to a previously defined normative reference brain network model to the same cognitive task. Subjects above 16 years of age exhibited a significant decrease in BNA scores immediately following injury, as well as notable changes in functional network activity, relative to the controls. Three representative case studies of the tested population are discussed in detail, to demonstrate the clinical utility of BNA. The data support the utility of BNA to augment clinical examinations, symptoms and additional tests by providing an effective method for evaluating objective electrophysiological changes associated with sport-related concussions.

How does feedback from patients impact upon healthcare student clinical skill development and learning? A systematic review.

PubMed

Finch, Emma; Lethlean, Jennifer; Rose, Tanya; Fleming, Jennifer; Theodoros, Deborah; Cameron, Ashley; Coleman, Adele; Copland, David; McPhail, Steven M

2018-03-01

A key feature of health professionals' training, irrespective of discipline, is the acquisition and application of clinical and communication skills. Despite this, little is known about the potential role of patient feedback on this process. This systematic review aimed to answer the question: How does feedback from patients impact upon healthcare student clinical skill development and learning? Systematic review of published literature. Electronic databases were searched for studies that explored the effects of patient feedback on student learning and were published before March 2016. Eligible articles underwent methodological evaluation using the McMaster University Critical Evaluation Forms and data extraction. A total of 237 articles were retrieved following searches of electronic databases and hand searches of reference lists. Twelve (7 quantitative, 2 qualitative, 3 mixed methods) studies met the inclusion criteria. Eleven studies reported that patient feedback improved students' clinical skills. Minimal research has explored the impact of patient feedback on student learning. The research to date suggests that direct feedback from patients may be beneficial for the development of students' communication and clinical skills; however, the wide variety of evaluation methods and the lack of validated tools for patients to provide feedback suggest that further exploration is warranted.

Clinical and Translational Scientist Career Success: Metrics for Evaluation

PubMed Central

Lee, Linda S.; Pusek, Susan N.; McCormack, Wayne T.; Helitzer, Deborah L.; Martina, Camille A.; Dozier, Ann M.; Ahluwalia, Jasjit S.; Schwartz, Lisa S.; McManus, Linda M.; Reynolds, Brian D.; Haynes, Erin N.; Rubio, Doris M.

2012-01-01

Abstract Despite the increased emphasis on formal training in clinical and translational research and the growth in the number and scope of training programs over the past decade, the impact of training on research productivity and career success has yet to be fully evaluated at the institutional level. In this article, the Education Evaluation Working Group of the Clinical and Translational Science Award Consortium introduces selected metrics and methods associated with the assessment of key factors that affect research career success. The goals in providing this information are to encourage more consistent data collection across training sites, to foster more rigorous and systematic exploration of factors associated with career success, and to help address previously identified difficulties in program evaluation. Clin Trans Sci 2012; Volume 5: 400–407 PMID:23067352

Maintenance of a smoking cessation program in public health clinics beyond the experimental evaluation period.

PubMed Central

Manfredi, C.; Crittenden, K.; Cho, Y. I.; Engler, J.; Warnecke, R.

2001-01-01

OBJECTIVES: As phase 3 of a study to evaluate a smoking cessation program in public health practice, the authors assess the maintenance and impact of the It's Time smoking cessation program in seven public maternal and child health clinics in Chicago. METHODS: The authors interviewed 404 clinic patients in the study's baseline phase (prior to introduction of the It's Time intervention program), and 610 in the program maintenance phase (in the year after experimental evaluation had ended) to assess exposure to smoking cessation interventions offered at the clinic, and smoking cessation outcomes (quit, actions toward quitting, scores on action, motivation, readiness, and confidence scales). The authors controlled for clustering of smokers within clinics, smokers' characteristics prior to clinic visit, and type of clinic service. They compared outcomes by study group (control or intervention) to which each clinic had been assigned in the earlier experimental phase. RESULTS: Compared to baseline, smokers in the maintenance phase had greater exposure to posters, provider advice and booklet, and better outcomes on seven of eight smoking cessation measures, including quitting. These improvements were larger for clinics with prior experience implementing It's Time. CONCLUSION: Participation in the experimental evaluation of the It's Time program prepared and possibly motivated the clinics to continue the program. Continuing the program resulted in greater delivery of interventions and improved smoking cessation outcomes for smokers in the clinics. PMID:11889280

A Nurse-Led Smoking Cessation Clinic--Quit Rate Results and Views of Participants

ERIC Educational Resources Information Center

Thompson, K. A.; Parahoo, A. K.; Blair, N.

2007-01-01

This study evaluated the success of a community nurse-led smoking cessation clinic, based in one trust in Northern Ireland. The clinic operated a group therapy approach. The study employed quantitative and qualitative methods of data collection to measure smoking behaviour and to gain the views of participants. Smoking behaviour was measured by…

Clinical assessment of external rotation for the diagnosis of anterior shoulder hyperlaxity.

PubMed

Ropars, M; Fournier, A; Campillo, B; Bonan, I; Delamarche, P; Crétual, A; Thomazeau, H

2010-12-01

The aim of this study was to evaluate two methods of clinical assessment for external rotation of the shoulder to optimise the diagnosis of hyperlaxity in patients being selected for surgery for stabilisation of chronic anterior instability. External rotation was evaluated in 70 healthy student volunteers by two examiners (intertester study) using two methods of assessment at 15-day intervals (intratester study). The first method used was the protocol described for the Instability Severity Index Score (ISIS). In this case, the subject was evaluated in the sitting position, bilaterally with passive range of motion movements. The shoulder was considered hyperlax if ER1 was greater than 85°. With the second, so-called "elbow on the table" (EOT) method, the subject was evaluated in the decubitus dorsal position, unilaterally with passive range of motion. The subject was considered to be hyperlax if ER1 was greater than 90°. Kappa values for intra- and intertester agreement with the ISIS method were average, while they were satisfactory with the intraclass coefficient (ICC). Kappa values for inter- and intratester agreement with the EOT method were average and good, respectively. This tendency was confirmed by the ICC which went from good to excellent for the two examiners in both series of measurements using the EOT method, showing better reproducibility with this method. Our study confirms that the most reproducible method for assessing external rotation is obtained by unilateral assessment of the patient in the decubitus dorsal position, with passive range of motion. An ER1 of 90° is the necessary threshold for hyperlaxity because of elbow retropulsion with this method, which provides immediate and visual evaluation and eliminates the necessity of goniometry. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by Cetuximab plus chemotherapy

PubMed Central

Di Fiore, F; Blanchard, F; Charbonnier, F; Le Pessot, F; Lamy, A; Galais, M P; Bastit, L; Killian, A; Sesboüé, R; Tuech, J J; Queuniet, A M; Paillot, B; Sabourin, J C; Michot, F; Michel, P; Frebourg, T

2007-01-01

The predictive value of KRAS mutation in metastatic colorectal cancer (MCRC) patients treated with cetuximab plus chemotherapy has recently been suggested. In our study, 59 patients with a chemotherapy-refractory MCRC treated with cetuximab plus chemotherapy were included and clinical response was evaluated according to response evaluation criteria in solid tumours (RECIST). Tumours were screened for KRAS mutations using first direct sequencing, then two sensitive methods based on SNaPshot and PCR-ligase chain reaction (LCR) assays. Clinical response was evaluated according to gene mutations using the Fisher exact test. Times to progression (TTP) were calculated using the Kaplan–Meier method and compared with log-rank test. A KRAS mutation was detected in 22 out of 59 tumours and, in six cases, was missed by sequencing analysis but detected using the SNaPshot and PCR-LCR assays. Remarkably, no KRAS mutation was found in the 12 patients with clinical response. KRAS mutation was associated with disease progression (P=0.0005) and TTP was significantly decreased in mutated KRAS patients (3 vs 5.5 months, P=0.015). Our study confirms that KRAS mutation is highly predictive of a non-response to cetuximab plus chemotherapy in MCRC and highlights the need to use sensitive molecular methods, such as SNaPshot or PCR-LCR assays, to ensure an efficient mutation detection. PMID:17375050

eTACTS: a method for dynamically filtering clinical trial search results.

PubMed

Miotto, Riccardo; Jiang, Silis; Weng, Chunhua

2013-12-01

Information overload is a significant problem facing online clinical trial searchers. We present eTACTS, a novel interactive retrieval framework using common eligibility tags to dynamically filter clinical trial search results. eTACTS mines frequent eligibility tags from free-text clinical trial eligibility criteria and uses these tags for trial indexing. After an initial search, eTACTS presents to the user a tag cloud representing the current results. When the user selects a tag, eTACTS retains only those trials containing that tag in their eligibility criteria and generates a new cloud based on tag frequency and co-occurrences in the remaining trials. The user can then select a new tag or unselect a previous tag. The process iterates until a manageable number of trials is returned. We evaluated eTACTS in terms of filtering efficiency, diversity of the search results, and user eligibility to the filtered trials using both qualitative and quantitative methods. eTACTS (1) rapidly reduced search results from over a thousand trials to ten; (2) highlighted trials that are generally not top-ranked by conventional search engines; and (3) retrieved a greater number of suitable trials than existing search engines. eTACTS enables intuitive clinical trial searches by indexing eligibility criteria with effective tags. User evaluation was limited to one case study and a small group of evaluators due to the long duration of the experiment. Although a larger-scale evaluation could be conducted, this feasibility study demonstrated significant advantages of eTACTS over existing clinical trial search engines. A dynamic eligibility tag cloud can potentially enhance state-of-the-art clinical trial search engines by allowing intuitive and efficient filtering of the search result space. Copyright © 2013 The Authors. Published by Elsevier Inc. All rights reserved.

Recommendations for conducting controlled clinical studies of dental restorative materials. Science Committee Project 2/98--FDI World Dental Federation study design (Part I) and criteria for evaluation (Part II) of direct and indirect restorations including onlays and partial crowns.

PubMed

Hickel, Reinhard; Roulet, Jean-François; Bayne, Stephen; Heintze, Siegward D; Mjör, Ivar A; Peters, Mathilde; Rousson, Valentin; Randall, Ros; Schmalz, Gottfried; Tyas, Martin; Vanherle, Guido

2007-01-01

About 35 years ago, Ryge provided a practical approach to the evaluation of the clinical performance of restorative materials. This systematic approach was soon universally accepted. While that methodology has served us well, a large number of scientific methodologies and more detailed questions have arisen that require more rigor. Current restorative materials have vastly improved clinical performance, and any changes over time are not easily detected by the limited sensitivity of the Ryge criteria in short-term clinical investigations. However, the clinical evaluation of restorations not only involves the restorative material per se but also different operative techniques. For instance, a composite resin may show good longevity data when applied in conventional cavities but not in modified operative approaches. Insensitivity, combined with the continually evolving and nonstandard investigator modifications of the categories, scales, and reporting methods, has created a body of literature that is extremely difficult to interpret meaningfully. In many cases, the insensitivity of the original Ryge methods leads to misinterpretation as good clinical performance. While there are many good features of the original system, it is now time to move on to a more contemporary one. The current review approaches this challenge in two ways: (1) a proposal for a modern clinical testing protocol for controlled clinical trials, and (2) an in-depth discussion of relevant clinical evaluation parameters, providing 84 references that are primarily related to issues or problems for clinical research trials. Together, these two parts offer a standard for the clinical testing of restorative materials/procedures and provide significant guidance for research teams in the design and conduct of contemporary clinical trials. Part 1 of the review considers the recruitment of subjects, restorations per subject, clinical events, validity versus bias, legal and regulatory aspects, rationales for clinical trial designs, guidelines for design, randomization, number of subjects, characteristics of participants, clinical assessment, standards and calibration, categories for assessment, criteria for evaluation, and supplemental documentation. Part 2 of the review considers categories of assessment for esthetic evaluation, functional assessment, biological responses to restorative materials, and statistical analysis of results. The overall review represents a considerable effort to include a range of clinical research interests over the past years. As part of the recognition of the importance of these suggestions, the review is being published simultaneously in identical form in both the Journal of Adhesive Dentistry and Clinical Oral Investigations. Additionally, an extended abstract will be published in the International Dental Journal, giving a link to the web full version. This should help to introduce these considerations more quickly to the scientific community.

Clinical Trials in Benign Prostatic Hyperplasia: A Moving Target of Success.

PubMed

Thomas, Dominique; Chung, Caroline; Zhang, Yiye; Te, Alexis; Gratzke, Christian; Woo, Henry; Chughtai, Bilal

2018-05-24

Benign prostatic hyperplasia (BPH) affects over 50% of men above the age of 50 yr. With half of these men having bothersome lower urinary tract symptoms, this area represents a hot bed of novel treatments. Many BPH therapies have favorable short-term outcomes but lack durability or well-defined adverse events (AEs). Clinical trials are a gold standard for comparing treatments. We characterized all BPH clinical trials registered worldwide from inception to 2017. A total of 251 clinical trials were included. Of the studies, 30.1% used patient-reported outcomes such as the American Urological Association Symptom Score. Approximately 70% of clinical trials studied medical interventions, while the remaining trials investigated surgical approaches. Seventy-nine percent of trials were industry sponsored, while a minority were funded without commercial interest. Only 42% of trials had 12-mo follow-up, with the majority with <3 mo of follow-up. No trials evaluated prevention, diet, behavior, or alternative methods Overall, only 23% of trials reported results. Management options for BPH need unified benchmarks of success, AEs, durability, and standard reporting for all clinical trials, regardless of outcomes. We found that the majority of clinical trials were medical intervention, with very few trials evaluating prevention, diet, behavior, or alternative methods Furthermore, a few trials reported results in peer-reviewed journals. All clinical trials need to report results regardless of outcome, and in conclusion, standardized methods are needed in order to document the successes, adverse events, and durability for all clinical trials. Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.

System and algorithm for evaluation of human auditory analyzer state

NASA Astrophysics Data System (ADS)

Bachynskiy, Mykhaylo V.; Azarkhov, Oleksandr Yu.; Shtofel, Dmytro Kh.; Horbatiuk, Svitlana M.; Ławicki, Tomasz; Kalizhanova, Aliya; Smailova, Saule; Askarova, Nursanat

2017-08-01

The paper discusses questions of human auditory state evaluation with technical means. It considers the disadvantages of existing clinical audiometry methods and systems. It is proposed to use method for evaluating of auditory analyzer state by means of pulsometry to get the medical study more objective and efficient. It provides for use of two optoelectronic sensors located on the carotid artery and ear lobe, Using this method the biotechnical system for evaluation and stimulation of human auditory analyzer stare wad developed. Its hardware and software were substantiated. Different modes of simulation in the designed system were tested and the influence of the procedure on a patient was studied.

A semi-automated tool for treatment plan-quality evaluation and clinical trial quality assurance

NASA Astrophysics Data System (ADS)

Wang, Jiazhou; Chen, Wenzhou; Studenski, Matthew; Cui, Yunfeng; Lee, Andrew J.; Xiao, Ying

2013-07-01

The goal of this work is to develop a plan-quality evaluation program for clinical routine and multi-institutional clinical trials so that the overall evaluation efficiency is improved. In multi-institutional clinical trials evaluating the plan quality is a time-consuming and labor-intensive process. In this note, we present a semi-automated plan-quality evaluation program which combines MIMVista, Java/MATLAB, and extensible markup language (XML). More specifically, MIMVista is used for data visualization; Java and its powerful function library are implemented for calculating dosimetry parameters; and to improve the clarity of the index definitions, XML is applied. The accuracy and the efficiency of the program were evaluated by comparing the results of the program with the manually recorded results in two RTOG trials. A slight difference of about 0.2% in volume or 0.6 Gy in dose between the semi-automated program and manual recording was observed. According to the criteria of indices, there are minimal differences between the two methods. The evaluation time is reduced from 10-20 min to 2 min by applying the semi-automated plan-quality evaluation program.

A quantitative and qualitative evaluation of trainee opinions of four methods of personality disorder diagnosis.

PubMed

Nelson, Sharon M; Huprich, Steven K; Shankar, Sneha; Sohnleitner, Aimee; Paggeot, Amy V

2017-07-01

Four methods of how to assess and diagnose personality disorders have received much attention within the literature: the Shedler-Westen Assessment Procedure (Shedler & Westen, 1998), the DSM-5 Section III Personality Disorders section (APA, 2011), the DSM-5 Section III trait model (APA, 2013), and the Psychodynamic Diagnostic Manual (PDM; PDM Task Force, 2006) descriptions of 15 personality disorders. Given that much of the debate has been driven by clinician concerns, it is important to consider clinical utility when evaluating the usefulness of each method. The present study compares the 4 models on ratings of several dimensions of clinical utility provided by 329 graduate student clinicians and psychology interns from across the United States. Findings suggest that participants rated the DSM-5 trait model significantly higher in most clinical utility domains. Additionally, qualitative analyses of the open-ended responses provided by participants indicated that each method had strengths and weaknesses. Most notably, participants commented positively on the PDM's level of comprehensiveness and appreciated the SWAP-II's inclusion of a health category, despite the ease of use not being as highly rated for these methods. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Recommendations for conducting controlled clinical studies of dental restorative materials.

PubMed

Hickel, R; Roulet, J-F; Bayne, S; Heintze, S D; Mjör, I A; Peters, M; Rousson, V; Randall, R; Schmalz, G; Tyas, M; Vanherle, G

2007-03-01

About 35 years ago, Ryge provided a practical approach to evaluation of clinical performance of restorative materials. This systematic approach was soon universally accepted. While that methodology has served us well, a large number of scientific methodologies and more detailed questions have arisen that require more rigor. Current restorative materials have vastly improved clinical performance and any changes over time are not easily detected by the limited sensitivity of the Ryge criteria in short term clinical investigations. However, the clinical evaluation of restorations not only involves the restorative material per se but also different operative techniques. For instance, a composite resin may show good longevity data when applied in conventional cavities but not in modified operative approaches. Insensitivity, combined with the continually evolving and non-standard investigator modifications of the categories, scales, and reporting methods, has created a body of literature that is extremely difficult to meaningfully interpret. In many cases, the insensitivity of the original Ryge methods is misinterpreted as good clinical performance. While there are many good features of the original system, it is now time to move to a more contemporary one. The current review approaches this challenge in two ways: (1) a proposal for a modern clinical testing protocol for controlled clinical trials, and (2) an in-depth discussion of relevant clinical evaluation parameters, providing 84 references that are primarily related to issues or problems for clinical research trials. Together, these two parts offer a standard for the clinical testing of restorative materials/procedures and provide significant guidance for research teams in the design and conduct of contemporary clinical trials. Part 1 of the review considers the recruitment of subjects, restorations per subject, clinical events, validity versus bias, legal and regulatory aspects, rationales for clinical trial designs, guidelines for design, randomization, number of subjects, characteristics of participants, clinical assessment, standards and calibration, categories for assessment, criteria for evaluation, and supplemental documentation. Part 2 of the review considers categories of assessment for esthetic evaluation, functional assessment, biological responses to restorative materials, and statistical analysis of results. The overall review represents a considerable effort to include a range of clinical research interests over the past years. As part of the recognition of the importance of these suggestions, the review is being published simultaneously in identical form in both the "Journal of Adhesive Dentistry" and the "Clinical Oral Investigations." Additionally an extended abstract will be published in the "International Dental Journal" giving a link to the web full version. This should help to introduce these considerations more quickly to the scientific community.

Evaluation of stratification factors and score-scales in clinical trials of treatment of clinical mastitis in dairy cows.

PubMed

Hektoen, L; Ødegaard, S A; Løken, T; Larsen, S

2004-05-01

There is often a need to reduce sample size in clinical trials due to practical limitations and ethical considerations. Better comparability between treatment groups by use of stratification in the design, and use of continuous outcome variables in the evaluation of treatment results, are two methods that can be used in order to achieve this. In this paper the choice of stratification factors in trials of clinical mastitis in dairy cows is investigated, and two score-scales for evaluation of clinical mastitis are introduced. The outcome in 57 dairy cows suffering from clinical mastitis and included in a clinical trial comparing homeopathic treatment, placebo and a standard antibiotic treatment is investigated. The strata of various stratification factors are compared across treatments to determine which other factors influence outcome. The two score scales, measuring acute and chronic mastitis symptoms, respectively, are evaluated on their ability to differentiate between patients classified from clinical criteria as responders or non-responders to treatment. Differences were found between the strata of the factors severity of mastitis, lactation number, previous mastitis this lactation and bacteriological findings. These factors influence outcome of treatment and appear relevant as stratification factors in mastitis trials. Both score scales differentiated between responders and non-responders to treatment and were found useful for evaluation of mastitis and mastitis treatment.

Clinical leadership and pre-registration nursing programmes: A model for clinical leadership and a prospective curriculum implementation and evaluation research strategy.

PubMed

Brown, Angela; Dewing, Jan; Crookes, Patrick

2016-07-01

To present for wider debate a conceptual model for clinical leadership development in pre-registration nursing programmes and a proposed implementation plan. Globally, leadership in nursing has become a significant issue. Whilst there is continued support for leadership preparation in pre-registration nursing programmes, there have been very few published accounts of curriculum content and/or pedagogical approaches that foster clinical leadership development in pre-registration nursing. A doctoral research study has resulted in the creation of an overarching model for clinical leadership. A multi-method research study using theoretical and empirical literature 1974-2015, a focus group, expert opinion and a national on-line survey. A conceptual model of clinical leadership development in pre-registration nursing programme is presented, including the infinity loop of clinical leadership, an integral curriculum thread and a conceptual model: a curriculum-pedagogy nexus for clinical leadership. In order to test out usability and evaluate effectiveness, a multi method programme of research in one school of nursing in Australia is outlined. Implementation of the proposed conceptual model for clinical leadership development in pre-registration nursing programmes and a programme of (post-doctoral) research will contribute to what is known about curriculum content and pedagogy for nurse academics. Importantly, for nursing students and the profession as a whole, there is a clearer expectation of what clinical leadership might look like in the novice registered nurse. For nurse academics a model is offered for consideration in curriculum design and implementation with an evaluation strategy that could be replicated. Copyright © 2016 Elsevier Ltd. All rights reserved.

Reporter-Interpreter-Manager-Educator (RIME) descriptive ratings as an evaluation tool in an emergency medicine clerkship.

PubMed

Ander, Douglas S; Wallenstein, Joshua; Abramson, Jerome L; Click, Lorie; Shayne, Philip

2012-10-01

Emergency Medicine (EM) clerkships traditionally assess students using numerical ratings of clinical performance. The descriptive ratings of the Reporter, Interpreter, Manager, and Educator (RIME) method have been shown to be valuable in other specialties. We hypothesized that the RIME descriptive ratings would correlate with clinical performance and examination scores in an EM clerkship, indicating that the RIME ratings are a valid measure of performance. This was a prospective cohort study of an evaluation instrument for 4(th)-year medical students completing an EM rotation. This study received exempt Institutional Review Board status. EM faculty and residents completed shift evaluation forms including both numerical and RIME ratings. Students completed a final examination. Mean scores for RIME and clinical evaluations were calculated. Linear regression models were used to determine whether RIME ratings predicted clinical evaluation scores or final examination scores. Four hundred thirty-nine students who completed the EM clerkship were enrolled in the study. After excluding items with missing data, there were 2086 evaluation forms (based on 289 students) available for analysis. There was a clear positive relationship between RIME category and clinical evaluation score (r(2)=0.40, p<0.01). RIME ratings correlated most strongly with patient management skills and least strongly with humanistic qualities. A very weak correlation was seen with RIME and final examination. We found a positive association between RIME and clinical evaluation scores, suggesting that RIME is a valid clinical evaluation instrument. RIME descriptive ratings can be incorporated into EM evaluation instruments and provides useful data related to patient management skills. Copyright © 2012 Elsevier Inc. All rights reserved.

Clinical performance evaluation of total protein measurement by digital refractometry and characterization of non-protein solute interferences.

PubMed

Hunsaker, Joshua J H; Wyness, Sara P; Snow, Taylor M; Genzen, Jonathan R

2016-12-01

Refractometric methods to measure total protein (TP) in serum and plasma specimens have been replaced by automated biuret methods in virtually all routine clinical testing. A subset of laboratories, however, still report using refractometry to measure TP in conjunction with serum protein electrophoresis. The objective of this study was therefore to conduct a modern performance evaluation of a digital refractometer for TP measurement. Performance evaluation of a MISCO Palm Abbe™ digital refractometer was conducted through device familiarization, carryover, precision, accuracy, linearity, analytical sensitivity, analytical specificity, and reference interval verification. Comparison assays included a manual refractometer and an automated biuret assay. Carryover risk was eliminated using a demineralized distilled water (ddH 2 O) wash step. Precision studies demonstrated overall imprecision of 2.2% CV (low TP pool) and 0.5% CV (high TP pool). Accuracy studies demonstrated correlation to both manual refractometry and the biuret method. An overall positive bias (+5.0%) was observed versus the biuret method. On average, outlier specimens had an increased triglyceride concentration. Linearity was verified using mixed dilutions of: a) low and high concentration patient pools, or b) albumin-spiked ddH 2 O and high concentration patient pool. Decreased recovery was observed using ddH 2 O dilutions at low TP concentrations. Significant interference was detected at high concentrations of glucose (>267 mg/dL) and triglycerides (>580 mg/dL). Current laboratory reference intervals for TP were verified. Performance characteristics of this digital refractometer were validated in a clinical laboratory setting. Biuret method remains the preferred assay for TP measurement in routine clinical analyses.

Disseminated histoplasmosis and AIDS: clinical aspects and diagnostic methods for early detection.

PubMed

Corti, M E; Cendoya, C A; Soto, I; Esquivel, P; Trione, N; Villafañe, M F; Corbera, K M; Helou, S; Negroni, R

2000-03-01

Disseminated histoplasmosis in AIDS patients is the focus of this paper. Cutaneous lesions are reported as a frequent clinical sign. Bone marrow aspiration and biopsy, blood cultures (lysis-centrifugation technique), bronchoalveolar lavage, and skin lesion scrapings are the most effective diagnostic methods. The identification of a specific antigen in blood and urine may be a rapid means of evaluation and follow-up of patients with this disease.

Experimental Evaluation of the Training Structure of the Picture Exchange Communication System (PECS)

ERIC Educational Resources Information Center

Cummings, Anne R.; Carr, James E.; LeBlanc, Linda A.

2012-01-01

The Picture Exchange Communication System (PECS) is a picture-based alternative communication method that is widely accepted and utilized with individuals with disabilities. Although prior studies have examined the clinical efficacy of PECS, none have experimentally evaluated its manualized training structure. We experimentally evaluated the…

Teledynamic Evaluation of Oropharyngeal Swallowing

ERIC Educational Resources Information Center

Malandraki, Georgia A.; McCullough, Gary; He, Xuming; McWeeny, Elizabeth; Perlman, Adrienne L.

2011-01-01

Purpose: The objective of the present investigation was to test the feasibility and clinical utility of a real-time Internet-based protocol for remote, telefluoroscopic evaluation of oropharyngeal swallowing. Method: In this prospective cohort study, the authors evaluated 32 patients with a primary diagnosis of stroke or head/neck cancer. All…

Management of intrathecal baclofen therapy for severe acquired brain injury: consensus and recommendations for good clinical practice.

PubMed

De Tanti, Antonio; Scarponi, Federico; Bertoni, Michele; Gasperini, Giulio; Lanzillo, Bernardo; Molteni, Franco; Posteraro, Federico; Vitale, Dino Francesco; Zanpolini, Mauro

2017-08-01

Although widespread in the treatment of generalised spasticity due to severe acquired brain injury, clinical use of intrathecal baclofen administered through an implanted catheter is not yet supported by full scientific evidence. The aim of the study is to provide recommendations for good clinical practice regarding intrathecal baclofen therapy. We used a modified RAND Delphi method to develop consensus-based medical guidelines, involving clinicians who use intrathecal baclofen therapy throughout Italy. The clinicians were asked 38 questions grouped in six areas (patient selection, contraindications for implant, tests prior to implant, method of implant and management of therapy, efficacy evaluation and goal setting, and management of complications). To establish consensus, 75% agreement was required in answers to every question. Consensus was reached on the second round of the Delphi process on 27/38 questions (71%), specifically those regarding identification of objectives, efficacy evaluation, and method of implant and management of therapy, whereas management of complications and contraindications for implant remained critical areas. Despite the limits of our method, a set of recommendations was drawn up for clinical practice in this sector. The study also revealed residual critical areas and indicated future lines of research necessary to reach evidence-based consensus.

[Literature review and hospital information system data real world clinical outcome analysis of role of parenterally administered shenmai in treatment of shock].

PubMed

Wang, Lian-Xin; Tang, Hao; Xie, Yan-Ming

2013-09-01

Parenterally administered Shenmai has the functions of benefiting vital energy, nourishing Yin, generating body fluids, and activating the pulse. Modern pharmacological studies have shown that constituents of parenterally administered Shenmai such as ginsenosides and ophiopogonin can improve hypoxia tolerance, immunity, function, and microcirculation of the heart, and free radical scavenging. Therefore, parenterally administered Shenmai is a suitable treatment for shock. Literature review and analysis of HIS data outcomes, are the two methods used to study the type of shock treated, dose and combinations of other medications used with parenterally administered Shenmai. The results of the two methods are consistent in understanding the clinical features of shock therapy with parenterally administered Shenmai which thereby provides information for the design of prospective studies. However, the results of the two methods are limited by the poor quality of the literature and the low level of evidence for clinical evaluation after the registration of Shenmai. Nevertheless, HIS data provides retrospective data although some information is missing. Thus, although the results of the two methods can be used as the foundation to support the clinical evaluation of post-marketing parenterally administered Shenmai, final conclusions can only be drawn based on prospective studies.

A low-complexity 2-point step size gradient projection method with selective function evaluations for smoothed total variation based CBCT reconstructions.

PubMed

Song, Bongyong; Park, Justin C; Song, William Y

2014-11-07

The Barzilai-Borwein (BB) 2-point step size gradient method is receiving attention for accelerating Total Variation (TV) based CBCT reconstructions. In order to become truly viable for clinical applications, however, its convergence property needs to be properly addressed. We propose a novel fast converging gradient projection BB method that requires 'at most one function evaluation' in each iterative step. This Selective Function Evaluation method, referred to as GPBB-SFE in this paper, exhibits the desired convergence property when it is combined with a 'smoothed TV' or any other differentiable prior. This way, the proposed GPBB-SFE algorithm offers fast and guaranteed convergence to the desired 3DCBCT image with minimal computational complexity. We first applied this algorithm to a Shepp-Logan numerical phantom. We then applied to a CatPhan 600 physical phantom (The Phantom Laboratory, Salem, NY) and a clinically-treated head-and-neck patient, both acquired from the TrueBeam™ system (Varian Medical Systems, Palo Alto, CA). Furthermore, we accelerated the reconstruction by implementing the algorithm on NVIDIA GTX 480 GPU card. We first compared GPBB-SFE with three recently proposed BB-based CBCT reconstruction methods available in the literature using Shepp-Logan numerical phantom with 40 projections. It is found that GPBB-SFE shows either faster convergence speed/time or superior convergence property compared to existing BB-based algorithms. With the CatPhan 600 physical phantom, the GPBB-SFE algorithm requires only 3 function evaluations in 30 iterations and reconstructs the standard, 364-projection FDK reconstruction quality image using only 60 projections. We then applied the algorithm to a clinically-treated head-and-neck patient. It was observed that the GPBB-SFE algorithm requires only 18 function evaluations in 30 iterations. Compared with the FDK algorithm with 364 projections, the GPBB-SFE algorithm produces visibly equivalent quality CBCT image for the head-and-neck patient with only 180 projections, in 131.7 s, further supporting its clinical applicability.

Quantification of myocardium at risk in ST- elevation myocardial infarction: a comparison of contrast-enhanced steady-state free precession cine cardiovascular magnetic resonance with coronary angiographic jeopardy scores.

PubMed

De Palma, Rodney; Sörensson, Peder; Verouhis, Dinos; Pernow, John; Saleh, Nawzad

2017-07-27

Clinical outcome following acute myocardial infarction is predicted by final infarct size evaluated in relation to left ventricular myocardium at risk (MaR). Contrast-enhanced steady-state free precession (CE-SSFP) cardiovascular magnetic resonance imaging (CMR) is not widely used for assessing MaR. Evidence of its utility compared to traditional assessment methods and as a surrogate for clinical outcome is needed. Retrospective analysis within a study evaluating post-conditioning during ST elevation myocardial infarction (STEMI) treated with coronary intervention (n = 78). CE-SSFP post-infarction was compared with angiographic jeopardy methods. Differences and variability between CMR and angiographic methods using Bland-Altman analyses were evaluated. Clinical outcomes were compared to MaR and extent of infarction. MaR showed correlation between CE-SSFP, and both BARI and APPROACH scores of 0.83 (p < 0.0001) and 0.84 (p < 0.0001) respectively. Bias between CE-SSFP and BARI was 1.1% (agreement limits -11.4 to +9.1). Bias between CE-SSFP and APPROACH was 1.2% (agreement limits -13 to +10.5). Inter-observer variability for the BARI score was 0.56 ± 2.9; 0.42 ± 2.1 for the APPROACH score; -1.4 ± 3.1% for CE-SSFP. Intra-observer variability was 0.15 ± 1.85 for the BARI score; for the APPROACH score 0.19 ± 1.6; and for CE-SSFP -0.58 ± 2.9%. Quantification of MaR with CE-SSFP imaging following STEMI shows high correlation and low bias compared with angiographic scoring and supports its use as a reliable and practical method to determine myocardial salvage in this patient population. Clinical trial registration information for the parent clinical trial: Karolinska Clinical Trial Registration (2008) Unique identifier: CT20080014. Registered 04 th January 2008.

Medical student appraisal: searching on smartphones.

PubMed

Khalifian, S; Markman, T; Sampognaro, P; Mitchell, S; Weeks, S; Dattilo, J

2013-01-01

The rapidly growing industry for mobile medical applications provides numerous smartphone resources designed for healthcare professionals. However, not all applications are equally useful in addressing the questions of early medical trainees. Three popular, free, mobile healthcare applications were evaluated along with a Google(TM) web search on both Apple(TM) and Android(TM) devices. Six medical students at a large academic hospital evaluated each application for a one-week period while on various clinical rotations. Google(TM) was the most frequently used search method and presented multimedia resources but was inefficient for obtaining clinical management information. Epocrates(TM) Pill ID feature was praised for its clinical utility. Medscape(TM) had the highest satisfaction of search and excelled through interactive educational features. Micromedex(TM) offered both FDA and off-label dosing for drugs. Google(TM) was the preferred search method for questions related to basic disease processes and multimedia resources, but was inadequate for clinical management. Caution should also be exercised when using Google(TM) in front of patients. Medscape(TM) was the most appealing application due to a broad scope of content and educational features relevant to medical trainees. Students should also be cognizant of how mobile technology may be perceived by their evaluators to avoid false impressions.

Construction of a clinical decision support system for undergoing surgery based on domain ontology and rules reasoning.

PubMed

Bau, Cho-Tsan; Chen, Rung-Ching; Huang, Chung-Yi

2014-05-01

To construct a clinical decision support system (CDSS) for undergoing surgery based on domain ontology and rules reasoning in the setting of hospitalized diabetic patients. The ontology was created with a modified ontology development method, including specification and conceptualization, formalization, implementation, and evaluation and maintenance. The Protégé-Web Ontology Language editor was used to implement the ontology. Embedded clinical knowledge was elicited to complement the domain ontology with formal concept analysis. The decision rules were translated into JENA format, which JENA can use to infer recommendations based on patient clinical situations. The ontology includes 31 classes and 13 properties, plus 38 JENA rules that were built to generate recommendations. The evaluation studies confirmed the correctness of the ontology, acceptance of recommendations, satisfaction with the system, and usefulness of the ontology for glycemic management of diabetic patients undergoing surgery, especially for domain experts. The contribution of this research is to set up an evidence-based hybrid ontology and an evaluation method for CDSS. The system can help clinicians to achieve inpatient glycemic control in diabetic patients undergoing surgery while avoiding hypoglycemia.

Identification of design features to enhance utilization and acceptance of systems for Internet-based decision support at the point of care.

PubMed

Gadd, C S; Baskaran, P; Lobach, D F

1998-01-01

Extensive utilization of point-of-care decision support systems will be largely dependent on the development of user interaction capabilities that make them effective clinical tools in patient care settings. This research identified critical design features of point-of-care decision support systems that are preferred by physicians, through a multi-method formative evaluation of an evolving prototype of an Internet-based clinical decision support system. Clinicians used four versions of the system--each highlighting a different functionality. Surveys and qualitative evaluation methodologies assessed clinicians' perceptions regarding system usability and usefulness. Our analyses identified features that improve perceived usability, such as telegraphic representations of guideline-related information, facile navigation, and a forgiving, flexible interface. Users also preferred features that enhance usefulness and motivate use, such as an encounter documentation tool and the availability of physician instruction and patient education materials. In addition to identifying design features that are relevant to efforts to develop clinical systems for point-of-care decision support, this study demonstrates the value of combining quantitative and qualitative methods of formative evaluation with an iterative system development strategy to implement new information technology in complex clinical settings.

Actigraphy in Human African Trypanosomiasis as a Tool for Objective Clinical Evaluation and Monitoring: A Pilot Study

PubMed Central

Njamnshi, Alfred K.; Seke Etet, Paul F.; Perrig, Stephen; Acho, Alphonse; Funsah, Julius Y.; Mumba, Dieudonné; Muyembe, Jean-Jacques; Kristensson, Krister; Bentivoglio, Marina

2012-01-01

Background Human African trypanosomiasis (HAT) or sleeping sickness leads to a complex neuropsychiatric syndrome with characteristic sleep alterations. Current division into a first, hemolymphatic stage and second, meningoencephalitic stage is primarily based on the detection of white blood cells and/or trypanosomes in the cerebrospinal fluid. The validity of this criterion is, however, debated, and novel laboratory biomarkers are under study. Objective clinical HAT evaluation and monitoring is therefore needed. Polysomnography has effectively documented sleep-wake disturbances during HAT, but could be difficult to apply as routine technology in field work. The non-invasive, cost-effective technique of actigraphy has been widely validated as a tool for the ambulatory evaluation of sleep disturbances. In this pilot study, actigraphy was applied to the clinical assessment of HAT patients. Methods/Principal Findings Actigraphy was recorded in patients infected by Trypanosoma brucei gambiense, and age- and sex-matched control subjects. Simultaneous nocturnal polysomnography was also performed in the patients. Nine patients, including one child, were analyzed at admission and two of them also during specific treatment. Parameters, analyzed with user-friendly software, included sleep time evaluated from rest-activity signals, rest-activity rhythm waveform and characteristics. The findings showed sleep-wake alterations of various degrees of severity, which in some patients did not parallel white blood cell counts in the cerebrospinal fluid. Actigraphic recording also showed improvement of the analyzed parameters after treatment initiation. Nocturnal polysomnography showed alterations of sleep time closely corresponding to those derived from actigraphy. Conclusions/Significance The data indicate that actigraphy can be an interesting tool for HAT evaluation, providing valuable clinical information through simple technology, well suited also for long-term follow-up. Actigraphy could therefore objectively contribute to the clinical assessment of HAT patients. This method could be incorporated into a clinical scoring system adapted to HAT to be used in the evaluation of novel treatments and laboratory biomarkers. PMID:22348168

The Development and Implementation of a Model for Evaluating Clinical Specialty Education Programs.

ERIC Educational Resources Information Center

McLean, James E.; And Others

A new method for evaluating cancer education programs, using an external/internal evaluation team is outlined. The internal program staff are required to collect the data, arrange for a site visit, provide access to personnel, and make available other information requested by the evaluators. The external team consists of a dentist with oncological…

Evaluation of a Noise Reduction Procedure for Chest Radiography

PubMed Central

Fukui, Ryohei; Ishii, Rie; Kodani, Kazuhiko; Kanasaki, Yoshiko; Suyama, Hisashi; Watanabe, Masanari; Nakamoto, Masaki; Fukuoka, Yasushi

2013-01-01

Background The aim of this study was to evaluate the usefulness of noise reduction procedure (NRP), a function in the new image processing for chest radiography. Methods A CXDI-50G Portable Digital Radiography System (Canon) was used for X-ray detection. Image noise was analyzed with a noise power spectrum (NPS) and a burger phantom was used for evaluation of density resolution. The usefulness of NRP was evaluated by chest phantom images and clinical chest radiography. We employed the Bureau of Radiological Health Method for scoring chest images while carrying out our observations. Results NPS through the use of NRP was improved compared with conventional image processing (CIP). The results in image quality showed high-density resolution through the use of NRP, so that chest radiography examination can be performed with a low dose of radiation. Scores were significantly higher than for CIP. Conclusion In this study, use of NRP led to a high evaluation in these so we are able to confirm the usefulness of NRP for clinical chest radiography. PMID:24574577

Development of an iterative reconstruction method to overcome 2D detector low resolution limitations in MLC leaf position error detection for 3D dose verification in IMRT.

PubMed

Visser, R; Godart, J; Wauben, D J L; Langendijk, J A; Van't Veld, A A; Korevaar, E W

2016-05-21

The objective of this study was to introduce a new iterative method to reconstruct multi leaf collimator (MLC) positions based on low resolution ionization detector array measurements and to evaluate its error detection performance. The iterative reconstruction method consists of a fluence model, a detector model and an optimizer. Expected detector response was calculated using a radiotherapy treatment plan in combination with the fluence model and detector model. MLC leaf positions were reconstructed by minimizing differences between expected and measured detector response. The iterative reconstruction method was evaluated for an Elekta SLi with 10.0 mm MLC leafs in combination with the COMPASS system and the MatriXX Evolution (IBA Dosimetry) detector with a spacing of 7.62 mm. The detector was positioned in such a way that each leaf pair of the MLC was aligned with one row of ionization chambers. Known leaf displacements were introduced in various field geometries ranging from  -10.0 mm to 10.0 mm. Error detection performance was tested for MLC leaf position dependency relative to the detector position, gantry angle dependency, monitor unit dependency, and for ten clinical intensity modulated radiotherapy (IMRT) treatment beams. For one clinical head and neck IMRT treatment beam, influence of the iterative reconstruction method on existing 3D dose reconstruction artifacts was evaluated. The described iterative reconstruction method was capable of individual MLC leaf position reconstruction with millimeter accuracy, independent of the relative detector position within the range of clinically applied MU's for IMRT. Dose reconstruction artifacts in a clinical IMRT treatment beam were considerably reduced as compared to the current dose verification procedure. The iterative reconstruction method allows high accuracy 3D dose verification by including actual MLC leaf positions reconstructed from low resolution 2D measurements.

Clinical evaluation of a loop-mediated isothermal amplification (LAMP) assay for rapid detection of Neisseria meningitidis in cerebrospinal fluid.

PubMed

Lee, DoKyung; Kim, Eun Jin; Kilgore, Paul E; Kim, Soon Ae; Takahashi, Hideyuki; Ohnishi, Makoto; Anh, Dang Duc; Dong, Bai Qing; Kim, Jung Soo; Tomono, Jun; Miyamoto, Shigehiko; Notomi, Tsugunori; Kim, Dong Wook; Seki, Mitsuko

2015-01-01

Neisseria meningitidis (Nm) is a leading causative agent of bacterial meningitis in humans. Traditionally, meningococcal meningitis has been diagnosed by bacterial culture. However, isolation of bacteria from patients' cerebrospinal fluid (CSF) is time consuming and sometimes yields negative results. Recently, polymerase chain reaction (PCR)-based diagnostic methods of detecting Nm have been considered the gold standard because of their superior sensitivity and specificity compared with culture. In this study, we developed a loop-mediated isothermal amplification (LAMP) method and evaluated its ability to detect Nm in cerebrospinal fluid (CSF). We developed a meningococcal LAMP assay (Nm LAMP) that targets the ctrA gene. The primer specificity was validated using 16 strains of N. meningitidis (serogroup A, B, C, D, 29-E, W-135, X, Y, and Z) and 19 non-N. meningitidis species. Within 60 min, the Nm LAMP detected down to ten copies per reaction with sensitivity 1000-fold more than that of conventional PCR. The LAMP assays were evaluated using a set of 1574 randomly selected CSF specimens from children with suspected meningitis collected between 1998 and 2002 in Vietnam, China, and Korea. The LAMP method was shown to be more sensitive than PCR methods for CSF samples (31 CSF samples were positive by LAMP vs. 25 by PCR). The detection rate of the LAMP method was substantially higher than that of the PCR method. In a comparative analysis of the PCR and LAMP assays, the clinical sensitivity, specificity, positive predictive value, and negative predictive value of the LAMP assay were 100%, 99.6%, 80.6%, and 100%, respectively. Compared to PCR, LAMP detected Nm with higher analytical and clinical sensitivity. This sensitive and specific LAMP method offers significant advantages for screening patients on a population basis and for diagnosis in clinical settings.

Axial computed tomography evaluation of the internal nasal valve correlates with clinical valve narrowing and patient complaint.

PubMed

Moche, Jason A; Cohen, Justin C; Pearlman, Steven J

2013-07-01

The objective of this work was to explore the utility of axial computed tomography (CT) imaging to objectively define a narrow internal nasal valve, and compare those findings with clinical examination and patient complaint. Retrospective review from a single facial plastic surgery center. We reviewed 40 consecutive patients evaluated for either sinusitis or nasal airway obstruction for which a CT scan was obtained at a single radiology institution. Thirty-six complete office records were examined for the presence of clinical internal valve narrowing and complaints of nasal obstruction. In total, 72 internal nasal valves were analyzed using axial plane CT and measurements were compared to clinical findings and presence of airway obstruction. Measured valve areas for clinically normal internal nasal valves averaged 0.47 cm(2) vs 0.28 cm(2) for clinically narrow valves, a decrease of 40.4%. In unobstructed nasal airways the valve area averaged 0.51 cm(2) vs 0.38 cm(2) in obstructed airways, a difference of 25.5%. A radiographically measured valve area of <0.30 cm(2) suggests clinical narrowing with a sensitivity of 71.4%, specificity of 88.9%, positive predictive value of 62.5%, and negative predictive value of 92.3%. Using standard axial CT imaging we describe an objective method of radiographically evaluating the nasal valve, demonstrating strong correlation with physical examination and patient complaint. Additionally, radiographic valve areas can be used to screen for clinically narrow nasal valves with good sensitivity and specificity, providing a novel straightforward method for nasal valve assessment. © 2012 ARS-AAOA, LLC.

Methodologic Guide for Evaluating Clinical Performance and Effect of Artificial Intelligence Technology for Medical Diagnosis and Prediction.

PubMed

Park, Seong Ho; Han, Kyunghwa

2018-03-01

The use of artificial intelligence in medicine is currently an issue of great interest, especially with regard to the diagnostic or predictive analysis of medical images. Adoption of an artificial intelligence tool in clinical practice requires careful confirmation of its clinical utility. Herein, the authors explain key methodology points involved in a clinical evaluation of artificial intelligence technology for use in medicine, especially high-dimensional or overparameterized diagnostic or predictive models in which artificial deep neural networks are used, mainly from the standpoints of clinical epidemiology and biostatistics. First, statistical methods for assessing the discrimination and calibration performances of a diagnostic or predictive model are summarized. Next, the effects of disease manifestation spectrum and disease prevalence on the performance results are explained, followed by a discussion of the difference between evaluating the performance with use of internal and external datasets, the importance of using an adequate external dataset obtained from a well-defined clinical cohort to avoid overestimating the clinical performance as a result of overfitting in high-dimensional or overparameterized classification model and spectrum bias, and the essentials for achieving a more robust clinical evaluation. Finally, the authors review the role of clinical trials and observational outcome studies for ultimate clinical verification of diagnostic or predictive artificial intelligence tools through patient outcomes, beyond performance metrics, and how to design such studies. © RSNA, 2018.

Pre-clinical characterization of tissue engineering constructs for bone and cartilage regeneration

PubMed Central

Trachtenberg, Jordan E.; Vo, Tiffany N.; Mikos, Antonios G.

2014-01-01

Pre-clinical animal models play a crucial role in the translation of biomedical technologies from the bench top to the bedside. However, there is a need for improved techniques to evaluate implanted biomaterials within the host, including consideration of the care and ethics associated with animal studies, as well as the evaluation of host tissue repair in a clinically relevant manner. This review discusses non-invasive, quantitative, and real-time techniques for evaluating host-materials interactions, quality and rate of neotissue formation, and functional outcomes of implanted biomaterials for bone and cartilage tissue engineering. Specifically, a comparison will be presented for pre-clinical animal models, histological scoring systems, and non-invasive imaging modalities. Additionally, novel technologies to track delivered cells and growth factors will be discussed, including methods to directly correlate their release with tissue growth. PMID:25319726

Pre-clinical characterization of tissue engineering constructs for bone and cartilage regeneration.

PubMed

Trachtenberg, Jordan E; Vo, Tiffany N; Mikos, Antonios G

2015-03-01

Pre-clinical animal models play a crucial role in the translation of biomedical technologies from the bench top to the bedside. However, there is a need for improved techniques to evaluate implanted biomaterials within the host, including consideration of the care and ethics associated with animal studies, as well as the evaluation of host tissue repair in a clinically relevant manner. This review discusses non-invasive, quantitative, and real-time techniques for evaluating host-materials interactions, quality and rate of neotissue formation, and functional outcomes of implanted biomaterials for bone and cartilage tissue engineering. Specifically, a comparison will be presented for pre-clinical animal models, histological scoring systems, and non-invasive imaging modalities. Additionally, novel technologies to track delivered cells and growth factors will be discussed, including methods to directly correlate their release with tissue growth.

The use of functional neuroimaging to evaluate psychological and other non-pharmacological treatments for clinical pain

PubMed Central

Jensen, Karin B.; Berna, Chantal; Loggia, Marco L.; Wasan, Ajay; Edwards, Robert R.; Gollub, Randy L.

2013-01-01

A large number of studies have provided evidence for the efficacy of psychological and other non-pharmacological interventions in the treatment of chronic pain. While these methods are increasingly used to treat pain, remarkably few studies focused on the exploration of their neural correlates. The aim of this article was to review the findings from neuroimaging studies that evaluated the neural response to distraction-based techniques, cognitive behavioral therapy (CBT), clinical hypnosis, mental imagery, physical therapy/exercise, biofeedback, and mirror therapy. To date, the results from studies that used neuroimaging to evaluate these methods have not been conclusive and the experimental methods have been suboptimal for assessing clinical pain. Still, several different psychological and non-pharmacological treatment modalities were associated with increased painrelated activations of executive cognitive brain regions, such as the ventral- and dorsolateral prefrontal cortex. There was also evidence for decreased pain-related activations in afferent pain regions and limbic structures. If future studies will address the technical and methodological challenges of today’s experiments, neuroimaging might have the potential of segregating the neural mechanisms of different treatment interventions and elucidate predictive and mediating factors for successful treatment outcomes. Evaluations of treatment-related brain changes (functional and structural) might also allow for sub-grouping of patients and help to develop individualized treatments. PMID:22445888

Clinical application of a rapid method using agarose gel electrophoresis and Western blotting to evaluate von Willebrand factor protease activity.

PubMed

Kirzek, D M; Rick, M E

2001-03-01

A method for evaluating the activity of the von Willebrand factor (vWF) protease is described, and a clinical application is illustrated. The procedure utilizes gel electrophoresis, Western blotting, and luminographic detection methods to evaluate the distribution of vWF multimers before and after incubation of clinical samples under conditions that favor proteolysis by this enzyme. Physiologically, the high-molecular-weight multimers of vWF are cleaved by the vWF protease under conditions of high shear stress in parts of the arterial circulation; cleavage of vWF multimers is also observed after exposure of vWF to denaturing agents in vitro and thus can serve as a laboratory test for the activity of the protease. vWF protease activity is decreased or absent in patients with thrombotic thrombocytopenic purpura due to an inhibiting autoantibody, and this leads to high levels of noncleaved vWF and to life-threatening thrombosis, thrombocytopenia and anemia. The assay evaluates the activity of the protease by assessing the cleavage of vWF multimers after patient plasmas are incubated in vitro under denaturing conditions. With the use of these electrophoresis and Western blotting techniques, patient plasmas can be rapidly assessed for the activity of the vWF protease which may aid in the treatment strategy for these patients.

Job Analysis and Student Assessment Tool: Perfusion Education Clinical Preceptor

PubMed Central

Riley, Jeffrey B.

2007-01-01

Abstract: The perfusion education system centers on the cardiac surgery operating room and the perfusionist teacher who serves as a preceptor for the perfusion student. One method to improve the quality of perfusion education is to create a valid method for perfusion students to give feedback to clinical teachers. The preceptor job analysis consisted of a literature review and interviews with preceptors to list their critical tasks, critical incidents, and cognitive and behavioral competencies. Behaviorally anchored rating traits associated with the preceptors’ tasks were identified. Students voted to validate the instrument items. The perfusion instructor rating instrument with a 0–4, “very weak” to “very strong” Likert rating scale was used. The five preceptor traits for student evaluation of clinical instruction (SECI) are as follows: The clinical instructor (1) encourages self-learning, (2) encourages clinical reasoning, (3) meets student’s learning needs, (4) gives continuous feedback, and (5) represents a good role model. Scores from 430 student–preceptor relationships for 28 students rotating at 24 affiliate institutions with 134 clinical instructors were evaluated. The mean overall good preceptor average (GPA) was 3.45 ± 0.76 and was skewed to the left, ranging from 0.0 to 4.0 (median = 3.8). Only 21 of the SECI relationships earned a GPA <2.0. Analyzing the role of the clinical instructor and performing SECI are methods to provide valid information to improve the quality of a perfusion education program. PMID:17972453

Effect of portfolio assessment on student learning in prenatal training for midwives.

PubMed

Kariman, Nourossadat; Moafi, Farnoosh

2011-01-01

The tendency to use portfolios for evaluation has been developed with the aim of optimizing the culture of assessment. The present study was carried out to determine the effect of using portfolios as an evaluation method on midwifery students' learning and satisfaction in prenatal practical training. In this prospective cohort study, all midwifery students in semester four (n=40), were randomly allocated to portfolio and routine evaluation groups. Based on their educational goals, the portfolio groups prepared packages which consisted of a complete report of the history, physical examinations, and methods of patient management (as evaluated by a checklist) for women who visited a prenatal clinic. During the last day of their course, a posttest, clinical exam, and student satisfaction form were completed. The two groups' mean age, mean pretest scores, and their prerequisite course that they should have taken in the previous semester were similar. The mean difference in the pre and post test scores for the two groups' knowledge and comprehension levels did not differ significantly (P>0.05). The average scores on questions in Bloom's taxonomy 2 and 3 of the portfolio group were significantly greater than those of the routine evaluation group (P=0.002, P=0.03, respectively). The mean of the two groups' clinical exam scores was significantly different. The portfolio group's mean scores on generating diagnostic and therapeutic solutions and the ability to apply theory in practice were higher than those of the routine group. Overall, students' satisfaction scores in the two evaluation methods were relatively similar. Portfolio evaluation provides the opportunity for more learning by increasing the student's participation in the learning process and helping them to apply theory in practice.

77 FR 36550 - Advisory Committee on Training in Primary Care Medicine and Dentistry; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-19

...-supported program is to train clinical educators on methods to teach and assess trainee competencies for...'s development of performance measures and methods of longitudinal evaluation for Public Health...

Evaluation and comparison of current fetal ultrasound image segmentation methods for biometric measurements: a grand challenge.

PubMed

Rueda, Sylvia; Fathima, Sana; Knight, Caroline L; Yaqub, Mohammad; Papageorghiou, Aris T; Rahmatullah, Bahbibi; Foi, Alessandro; Maggioni, Matteo; Pepe, Antonietta; Tohka, Jussi; Stebbing, Richard V; McManigle, John E; Ciurte, Anca; Bresson, Xavier; Cuadra, Meritxell Bach; Sun, Changming; Ponomarev, Gennady V; Gelfand, Mikhail S; Kazanov, Marat D; Wang, Ching-Wei; Chen, Hsiang-Chou; Peng, Chun-Wei; Hung, Chu-Mei; Noble, J Alison

2014-04-01

This paper presents the evaluation results of the methods submitted to Challenge US: Biometric Measurements from Fetal Ultrasound Images, a segmentation challenge held at the IEEE International Symposium on Biomedical Imaging 2012. The challenge was set to compare and evaluate current fetal ultrasound image segmentation methods. It consisted of automatically segmenting fetal anatomical structures to measure standard obstetric biometric parameters, from 2D fetal ultrasound images taken on fetuses at different gestational ages (21 weeks, 28 weeks, and 33 weeks) and with varying image quality to reflect data encountered in real clinical environments. Four independent sub-challenges were proposed, according to the objects of interest measured in clinical practice: abdomen, head, femur, and whole fetus. Five teams participated in the head sub-challenge and two teams in the femur sub-challenge, including one team who tackled both. Nobody attempted the abdomen and whole fetus sub-challenges. The challenge goals were two-fold and the participants were asked to submit the segmentation results as well as the measurements derived from the segmented objects. Extensive quantitative (region-based, distance-based, and Bland-Altman measurements) and qualitative evaluation was performed to compare the results from a representative selection of current methods submitted to the challenge. Several experts (three for the head sub-challenge and two for the femur sub-challenge), with different degrees of expertise, manually delineated the objects of interest to define the ground truth used within the evaluation framework. For the head sub-challenge, several groups produced results that could be potentially used in clinical settings, with comparable performance to manual delineations. The femur sub-challenge had inferior performance to the head sub-challenge due to the fact that it is a harder segmentation problem and that the techniques presented relied more on the femur's appearance.

Instructional Development for Clinical Settings.

ERIC Educational Resources Information Center

Cranton, P. A.

Clinical teaching involves instruction in a natural health-related environment which allows students to observe and participate in the actual practice of the profession. The use of objectives, the sequence of instruction, the instructional methods and materials, and the evaluation of student performance constitute the components studied in…

Objective and subjective treatment evaluation of scars using optical coherence tomography, sonography, photography, and standardised questionnaires.

PubMed

Reinholz, Markus; Schwaiger, Hannah; Poetschke, Julian; Epple, Andreas; Ruzicka, Thomas; Von Braunmühl, Tanja; Gauglitz, Gerd G

2016-12-01

Currently, different types of treatments for pathological scars are available, however, to date, there is no established method of measurement to objectively assess therapeutic outcome. Treatment success is usually evaluated clinically by the physician and patient. Non-invasive imaging techniques, such as HD-OCT (high-definition optical coherence tomography), may represent a valuable diagnostic tool to objectively measure therapeutic outcome. To compare HD-OCT with ultrasound and subjective evaluation tools, such as questionnaires. In total, eight patients with pathological scars were treated in this pilot study with cryotherapy and intralesional steroid injections, and evaluated pre- and post-treatment using clinical examination, photography, sonography, and HD-OCT. The analysis of objective and subjective measuring methods was used to draw direct comparisons. HD-OCT revealed reduced epidermal and dermal thickness of the scar after four treatments with triamcinolone acetonide and cryotherapy. Based on sonography, a total reduction in scar height and reduction in scar depth was demonstrated. Both methods correlated well with the injected amount of triamcinolone acetonide. In addition, a positive correlation between well-established subjective and objective evaluation methods was found. We demonstrate that HD-OCT may be used as an objective diagnostic instrument to evaluate skin thickness under therapy for pathological scars, and serves as a valuable adjunctive device in combination with ultrasound and subjective evaluation tools. This provides additional information for the therapist concerning the quality and success of the applied treatment.

Impact of a mHealth intervention for peer health workers on AIDS care in rural Uganda: a mixed methods evaluation of a cluster-randomized trial.

PubMed

Chang, Larry W; Kagaayi, Joseph; Arem, Hannah; Nakigozi, Gertrude; Ssempijja, Victor; Serwadda, David; Quinn, Thomas C; Gray, Ronald H; Bollinger, Robert C; Reynolds, Steven J

2011-11-01

Mobile phone access in low and middle-income countries is rapidly expanding and offers an opportunity to leverage limited human resources for health. We conducted a mixed methods evaluation of a cluster-randomized trial exploratory substudy on the impact of a mHealth (mobile phone) support intervention used by community-based peer health workers (PHW) on AIDS care in rural Uganda. 29 PHWs at 10 clinics were randomized by clinic to receive the intervention or not. PHWs used phones to call and text higher level providers with patient-specific clinical information. 970 patients cared for by the PHWs were followed over a 26 month period. No significant differences were found in patients' risk of virologic failure. Qualitative analyses found improvements in patient care and logistics and broad support for the mHealth intervention among patients, clinic staff, and PHWs. Key challenges identified included variable patient phone access, privacy concerns, and phone maintenance.

Minimal residual disease in acute lymphoblastic leukemia: optimal methods and clinical relevance, pitfalls and recent approaches.

PubMed

Salari, Fatemeh; Shahjahani, Mohammad; Shahrabi, Saeid; Saki, Najmaldin

2014-11-01

After advances in experimental and clinical testing, minimal residual disease (MRD) assay results are considered a determining factor in treatment of acute lymphoblastic leukemia patients. According to MRD assay results, bone marrow (BM) leukemic burden and the rate of its decline after treatment can be directly evaluated. Detailed knowledge of the leukemic burden in BM can minimize toxicity and treatment complications in patients by tailoring the therapeutic dose based on patients' conditions. In addition, reduction of MRD before allo-HSCT is an important prerequisite for reception of transplant by the patient. In direct examination of MRD by morphological methods (even by a professional hematologist), leukemic cells can be under- or over-estimated due to similarity with hematopoietic precursor cells. As a result, considering the importance of MRD, it is necessary to use other methods including flow cytometry, polymerase chain reaction (PCR) amplification and RQ-PCR to detect MRD. Each of these methods has its own advantages and disadvantages in terms of accuracy and sensitivity. In this review article, different MRD assay methods and their sensitivity, correlation of MRD assay results with clinical symptoms of the patient as well as pitfalls in results of these methods are evaluated. In the final section, recent advances in MRD have been addressed.

Quantifying Data Quality for Clinical Trials Using Electronic Data Capture

PubMed Central

Nahm, Meredith L.; Pieper, Carl F.; Cunningham, Maureen M.

2008-01-01

Background Historically, only partial assessments of data quality have been performed in clinical trials, for which the most common method of measuring database error rates has been to compare the case report form (CRF) to database entries and count discrepancies. Importantly, errors arising from medical record abstraction and transcription are rarely evaluated as part of such quality assessments. Electronic Data Capture (EDC) technology has had a further impact, as paper CRFs typically leveraged for quality measurement are not used in EDC processes. Methods and Principal Findings The National Institute on Drug Abuse Treatment Clinical Trials Network has developed, implemented, and evaluated methodology for holistically assessing data quality on EDC trials. We characterize the average source-to-database error rate (14.3 errors per 10,000 fields) for the first year of use of the new evaluation method. This error rate was significantly lower than the average of published error rates for source-to-database audits, and was similar to CRF-to-database error rates reported in the published literature. We attribute this largely to an absence of medical record abstraction on the trials we examined, and to an outpatient setting characterized by less acute patient conditions. Conclusions Historically, medical record abstraction is the most significant source of error by an order of magnitude, and should be measured and managed during the course of clinical trials. Source-to-database error rates are highly dependent on the amount of structured data collection in the clinical setting and on the complexity of the medical record, dependencies that should be considered when developing data quality benchmarks. PMID:18725958

Evaluating statistical and clinical significance of intervention effects in single-case experimental designs: an SPSS method to analyze univariate data.

PubMed

Maric, Marija; de Haan, Else; Hogendoorn, Sanne M; Wolters, Lidewij H; Huizenga, Hilde M

2015-03-01

Single-case experimental designs are useful methods in clinical research practice to investigate individual client progress. Their proliferation might have been hampered by methodological challenges such as the difficulty applying existing statistical procedures. In this article, we describe a data-analytic method to analyze univariate (i.e., one symptom) single-case data using the common package SPSS. This method can help the clinical researcher to investigate whether an intervention works as compared with a baseline period or another intervention type, and to determine whether symptom improvement is clinically significant. First, we describe the statistical method in a conceptual way and show how it can be implemented in SPSS. Simulation studies were performed to determine the number of observation points required per intervention phase. Second, to illustrate this method and its implications, we present a case study of an adolescent with anxiety disorders treated with cognitive-behavioral therapy techniques in an outpatient psychotherapy clinic, whose symptoms were regularly assessed before each session. We provide a description of the data analyses and results of this case study. Finally, we discuss the advantages and shortcomings of the proposed method. Copyright © 2014. Published by Elsevier Ltd.

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

PubMed

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

2015-12-01

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

Designing Real-time Decision Support for Trauma Resuscitations

PubMed Central

Yadav, Kabir; Chamberlain, James M.; Lewis, Vicki R.; Abts, Natalie; Chawla, Shawn; Hernandez, Angie; Johnson, Justin; Tuveson, Genevieve; Burd, Randall S.

2016-01-01

Background Use of electronic clinical decision support (eCDS) has been recommended to improve implementation of clinical decision rules. Many eCDS tools, however, are designed and implemented without taking into account the context in which clinical work is performed. Implementation of the pediatric traumatic brain injury (TBI) clinical decision rule at one Level I pediatric emergency department includes an electronic questionnaire triggered when ordering a head computed tomography using computerized physician order entry (CPOE). Providers use this CPOE tool in less than 20% of trauma resuscitation cases. A human factors engineering approach could identify the implementation barriers that are limiting the use of this tool. Objectives The objective was to design a pediatric TBI eCDS tool for trauma resuscitation using a human factors approach. The hypothesis was that clinical experts will rate a usability-enhanced eCDS tool better than the existing CPOE tool for user interface design and suitability for clinical use. Methods This mixed-methods study followed usability evaluation principles. Pediatric emergency physicians were surveyed to identify barriers to using the existing eCDS tool. Using standard trauma resuscitation protocols, a hierarchical task analysis of pediatric TBI evaluation was developed. Five clinical experts, all board-certified pediatric emergency medicine faculty members, then iteratively modified the hierarchical task analysis until reaching consensus. The software team developed a prototype eCDS display using the hierarchical task analysis. Three human factors engineers provided feedback on the prototype through a heuristic evaluation, and the software team refined the eCDS tool using a rapid prototyping process. The eCDS tool then underwent iterative usability evaluations by the five clinical experts using video review of 50 trauma resuscitation cases. A final eCDS tool was created based on their feedback, with content analysis of the evaluations performed to ensure all concerns were identified and addressed. Results Among 26 EPs (76% response rate), the main barriers to using the existing tool were that the information displayed is redundant and does not fit clinical workflow. After the prototype eCDS tool was developed based on the trauma resuscitation hierarchical task analysis, the human factors engineers rated it to be better than the CPOE tool for nine of 10 standard user interface design heuristics on a three-point scale. The eCDS tool was also rated better for clinical use on the same scale, in 84% of 50 expert–video pairs, and was rated equivalent in the remainder. Clinical experts also rated barriers to use of the eCDS tool as being low. Conclusions An eCDS tool for diagnostic imaging designed using human factors engineering methods has improved perceived usability among pediatric emergency physicians. PMID:26300010

Multidisciplinary ALS Telemedicine Care: The Store and Forward Method.

PubMed

Pulley, Michael T; Brittain, Rebecca; Hodges, Wayne; Frazier, Christine; Miller, Leslie; Matyjasik-Liggett, Maria; Maurer, Susan; Peters, Melissa; Solomon, Kimberly; Berger, Alan R

2018-05-26

ALS patients benefit from multidisciplinary care in an ALS clinic. We studied whether multidisciplinary care of ALS patients using the store and forward method of telemedicine was feasible and acceptable to patients and providers. ALS patients seen in the UF Jacksonville ALS clinic were eligible. A trained telemedicine nurse performed and recorded a multidisciplinary assessment of the patient in their home. Clinic team members reviewed the assessments, provided recommendations and the clinic director discussed the plan with the patient via videoconference. Patient and provider satisfaction was evaluated using surveys. 18 patients completed a total of 27 telemedicine visits. Patient satisfaction was excellent and provider satisfaction was very good. The store and forward method of telemedicine is an acceptable alternative to live telemedicine for the multidisciplinary care of ALS patients. This method of care may improve access to multidisciplinary care for this patient population. This article is protected by copyright. All rights reserved. © 2018 Wiley Periodicals, Inc.

Evaluation Considerations for Secondary Uses of Clinical Data: Principles for an Evidence-based Approach to Policy and Implementation of Secondary Analysis.

PubMed

Scott, P J; Rigby, M; Ammenwerth, E; McNair, J Brender; Georgiou, A; Hyppönen, H; de Keizer, N; Magrabi, F; Nykänen, P; Gude, W T; Hackl, W

2017-08-01

Objectives: To set the scientific context and then suggest principles for an evidence-based approach to secondary uses of clinical data, covering both evaluation of the secondary uses of data and evaluation of health systems and services based upon secondary uses of data. Method: Working Group review of selected literature and policy approaches. Results: We present important considerations in the evaluation of secondary uses of clinical data from the angles of governance and trust, theory, semantics, and policy. We make the case for a multi-level and multi-factorial approach to the evaluation of secondary uses of clinical data and describe a methodological framework for best practice. We emphasise the importance of evaluating the governance of secondary uses of health data in maintaining trust, which is essential for such uses. We also offer examples of the re-use of routine health data to demonstrate how it can support evaluation of clinical performance and optimize health IT system design. Conclusions: Great expectations are resting upon "Big Data" and innovative analytics. However, to build and maintain public trust, improve data reliability, and assure the validity of analytic inferences, there must be independent and transparent evaluation. A mature and evidence-based approach needs not merely data science, but must be guided by the broader concerns of applied health informatics. Georg Thieme Verlag KG Stuttgart.

A Quality Assurance Method that Utilizes 3D Dosimetry and Facilitates Clinical Interpretation

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

Oldham, Mark, E-mail: mark.oldham@duke.edu; Thomas, Andrew; O'Daniel, Jennifer

2012-10-01

Purpose: To demonstrate a new three-dimensional (3D) quality assurance (QA) method that provides comprehensive dosimetry verification and facilitates evaluation of the clinical significance of QA data acquired in a phantom. Also to apply the method to investigate the dosimetric efficacy of base-of-skull (BOS) intensity-modulated radiotherapy (IMRT) treatment. Methods and Materials: Two types of IMRT QA verification plans were created for 6 patients who received BOS IMRT. The first plan enabled conventional 2D planar IMRT QA using the Varian portal dosimetry system. The second plan enabled 3D verification using an anthropomorphic head phantom. In the latter, the 3D dose distribution wasmore » measured using the DLOS/Presage dosimetry system (DLOS = Duke Large-field-of-view Optical-CT System, Presage Heuris Pharma, Skillman, NJ), which yielded isotropic 2-mm data throughout the treated volume. In a novel step, measured 3D dose distributions were transformed back to the patient's CT to enable calculation of dose-volume histograms (DVH) and dose overlays. Measured and planned patient DVHs were compared to investigate clinical significance. Results: Close agreement between measured and calculated dose distributions was observed for all 6 cases. For gamma criteria of 3%, 2 mm, the mean passing rate for portal dosimetry was 96.8% (range, 92.0%-98.9%), compared to 94.9% (range, 90.1%-98.9%) for 3D. There was no clear correlation between 2D and 3D passing rates. Planned and measured dose distributions were evaluated on the patient's anatomy, using DVH and dose overlays. Minor deviations were detected, and the clinical significance of these are presented and discussed. Conclusions: Two advantages accrue to the methods presented here. First, treatment accuracy is evaluated throughout the whole treated volume, yielding comprehensive verification. Second, the clinical significance of any deviations can be assessed through the generation of DVH curves and dose overlays on the patient's anatomy. The latter step represents an important development that advances the clinical relevance of complex treatment QA.« less

The need to approximate the use-case in clinical machine learning.

PubMed

Saeb, Sohrab; Lonini, Luca; Jayaraman, Arun; Mohr, David C; Kording, Konrad P

2017-05-01

The availability of smartphone and wearable sensor technology is leading to a rapid accumulation of human subject data, and machine learning is emerging as a technique to map those data into clinical predictions. As machine learning algorithms are increasingly used to support clinical decision making, it is vital to reliably quantify their prediction accuracy. Cross-validation (CV) is the standard approach where the accuracy of such algorithms is evaluated on part of the data the algorithm has not seen during training. However, for this procedure to be meaningful, the relationship between the training and the validation set should mimic the relationship between the training set and the dataset expected for the clinical use. Here we compared two popular CV methods: record-wise and subject-wise. While the subject-wise method mirrors the clinically relevant use-case scenario of diagnosis in newly recruited subjects, the record-wise strategy has no such interpretation. Using both a publicly available dataset and a simulation, we found that record-wise CV often massively overestimates the prediction accuracy of the algorithms. We also conducted a systematic review of the relevant literature, and found that this overly optimistic method was used by almost half of the retrieved studies that used accelerometers, wearable sensors, or smartphones to predict clinical outcomes. As we move towards an era of machine learning-based diagnosis and treatment, using proper methods to evaluate their accuracy is crucial, as inaccurate results can mislead both clinicians and data scientists. © The Author 2017. Published by Oxford University Press.

Clinical Experience Using the Mann Assessment of Swallowing Ability for Identification of Patients at Risk for Aspiration in a Mixed-Disease Population

ERIC Educational Resources Information Center

Gonzalez-Fernandez, Marlis; Sein, Michael T.; Palmer, Jeffrey B.

2011-01-01

Purpose: To determine the clinical performance characteristics of the Mann Assessment of Swallowing Ability (MASA) for predicting aspiration (determined by videofluoroscopic swallowing study [VFSS]) in a mixed population. Method: We selected 133 cases clinically evaluated using MASA and VFSS from January through June 2007. Ordinal risk rating…

Evaluation of a new ultrasensitive assay for cardiac troponin I.

PubMed

Casals, Gregori; Filella, Xavier; Bedini, Josep Lluis

2007-12-01

We evaluated the analytical and clinical performance of a new ultrasensitive cardiac troponin I assay (cTnI) on the ADVIA Centaur system (TnI-Ultra). The evaluation included the determination of detection limit, within-assay and between-assay variation and comparison with two other non-ultrasensitive methods. Moreover, cTnI was determined in 120 patients with acute chest pain with three methods. To evaluate the ability of the new method to detect MI earlier, it was assayed in 8 MI patients who first tested negative then positive by the other methods. The detection limit was 0.009 microg/L and imprecision was <10% at all concentrations evaluated. In comparison with two other methods, 10% of the anginas diagnosed were recategorized to MI. The ADVIA Centaur TnI-Ultra assay presented high reproducibility and high sensitivity. The use of the recommended lower cutpoint (0.044 microg/L) implied an increased and earlier identification of MI.

Decision tools in health care: focus on the problem, not the solution.

PubMed

Liu, Joseph; Wyatt, Jeremy C; Altman, Douglas G

2006-01-20

Systematic reviews or randomised-controlled trials usually help to establish the effectiveness of drugs and other health technologies, but are rarely sufficient by themselves to ensure actual clinical use of the technology. The process from innovation to routine clinical use is complex. Numerous computerised decision support systems (DSS) have been developed, but many fail to be taken up into actual use. Some developers construct technologically advanced systems with little relevance to the real world. Others did not determine whether a clinical need exists. With NHS investing 5 billion pounds sterling in computer systems, also occurring in other countries, there is an urgent need to shift from a technology-driven approach to one that identifies and employs the most cost-effective method to manage knowledge, regardless of the technology. The generic term, 'decision tool' (DT), is therefore suggested to demonstrate that these aids, which seem different technically, are conceptually the same from a clinical viewpoint. Many computerised DSSs failed for various reasons, for example, they were not based on best available knowledge; there was insufficient emphasis on their need for high quality clinical data; their development was technology-led; or evaluation methods were misapplied. We argue that DSSs and other computer-based, paper-based and even mechanical decision aids are members of a wider family of decision tools. A DT is an active knowledge resource that uses patient data to generate case specific advice, which supports decision making about individual patients by health professionals, the patients themselves or others concerned about them. The identification of DTs as a consistent and important category of health technology should encourage the sharing of lessons between DT developers and users and reduce the frequency of decision tool projects focusing only on technology. The focus of evaluation should become more clinical, with the impact of computer-based DTs being evaluated against other computer, paper- or mechanical tools, to identify the most cost effective tool for each clinical problem. We suggested the generic term 'decision tool' to demonstrate that decision-making aids, such as computerised DSSs, paper algorithms, and reminders are conceptually the same, so the methods to evaluate them should be the same.

The potential impact of recruitment method on sample characteristics and treatment outcomes in a psychosocial trial for women with co-occurring substance use disorder and PTSD.

PubMed

Winhusen, Theresa; Winstanley, Erin L; Somoza, Eugene; Brigham, Gregory

2012-01-01

Recruitment method can impact the sample composition of a clinical trial and, thus, the generalizability of the results, but the importance of recruitment method in substance use disorder trials has received little attention. The present paper sought to address this research gap by evaluating the association between recruitment method and sample characteristics and treatment outcomes in a substance use disorder trial. In a multi-site trial evaluating Seeking Safety (SS), relative to Women's Health Education (WHE), for women with co-occurring PTSD (either sub-threshold or full PTSD) and substance use disorders, one site assessed the method by which each participant was recruited. Data from this site (n=106), which recruited participants from newspaper advertising and clinic intakes, were analyzed. Participants recruited through advertising, relative to those from the clinic, had significantly higher levels of baseline drug use and higher rates of meeting DSM-IV-TR criteria for full PTSD. Results suggest that the effectiveness of SS in decreasing PTSD symptoms was greater for participants recruited through advertising relative to those recruited from the clinic. Conversely, the results revealed a significant treatment effect in the clinic-recruited participants, not seen in the advertising-recruited participants, with SS, relative to WHE, participants being more likely to report past week drug use during the follow-up phase. Recruitment method may impact sample composition and treatment effects. Replication of this finding would have important implications for substance use disorder efficacy trials which often utilize advertising to recruit participants. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Multicenter evaluation of an enzymatic method for glycated albumin.

PubMed

Paleari, Renata; Bonetti, Graziella; Callà, Cinzia; Carta, Mariarosa; Ceriotti, Ferruccio; Di Gaetano, Nicola; Ferri, Marilisa; Guerra, Elena; Lavalle, Gabriella; Cascio, Claudia Lo; Martino, Francesca Gabriela; Montagnana, Martina; Moretti, Marco; Santini, Gabriele; Scribano, Donata; Testa, Roberto; Vero, Anna; Mosca, Andrea

2017-06-01

The use of glycated albumin (GA) has been proposed as an additional glycemic control marker particularly useful in intermediate-term monitoring and in situation when HbA 1c test is not reliable. We have performed the first multicenter evaluation of the analytical performance of the enzymatic method quantILab Glycated Albumin assay implemented on the most widely used clinical chemistry analyzers (i.e. Abbott Architect C8000, Beckman Coulter AU 480 and 680, Roche Cobas C6000, Siemens ADVIA 2400 and 2400 XPT). The repeatability of the GA measurement (expressed as CV, %) implemented in the participating centers ranged between 0.9% and 1.2%. The within-laboratory CVs ranged between 1.2% and 1.6%. A good alignment between laboratories was found, with correlation coefficients from 0.996 to 0.998. Linearity was confirmed in the range from 7.6 to 84.7%. The new enzymatic method for glycated albumin evaluated by our investigation is suitable for clinical use. Copyright © 2017 Elsevier B.V. All rights reserved.

Using virtual worlds for role play simulation in child and adolescent psychiatry: an evaluation study

PubMed Central

Vallance, Aaron K.; Hemani, Ashish; Fernandez, Victoria; Livingstone, Daniel; McCusker, Kerri; Toro-Troconis, Maria

2014-01-01

Aims and method To develop and evaluate a novel teaching session on clinical assessment using role play simulation. Teaching and research sessions occurred sequentially in computer laboratories. Ten medical students were divided into two online small-group teaching sessions. Students role-played as clinician avatars and the teacher played a suicidal adolescent avatar. Questionnaire and focus-group methodology evaluated participants’ attitudes to the learning experience. Quantitative data were analysed using SPSS, qualitative data through nominal-group and thematic analyses. Results Participants reported improvements in psychiatric skills/knowledge, expressing less anxiety and more enjoyment than role-playing face to face. Data demonstrated a positive relationship between simulator fidelity and perceived utility. Some participants expressed concern about added value over other learning methods and non-verbal communication. Clinical implications The study shows that virtual worlds can successfully host role play simulation, valued by students as a useful learning method. The potential for distance learning would allow delivery irrespective of geographical distance and boundaries. PMID:25285217

Qualitative radiology assessment of tumor response: does it measure up?

PubMed

Gottlieb, Ronald H; Litwin, Alan; Gupta, Bhavna; Taylor, John; Raczyk, Cheryl; Mashtare, Terry; Wilding, Gregory; Fakih, Marwan

2008-01-01

Our purpose was to assess whether a simpler qualitative evaluation of tumor response by computed tomography is as reproducible and predictive of clinical outcome as the Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization (WHO) methods. This study was a two-reader retrospective evaluation in which qualitative assessment resulted in agreement in 21 of 23 patients with metastatic colorectal carcinoma (91.3%, kappa=0.78; 95% CI, 0.51-1.00). Hepatic metastases were classified as increased, decreased, or unchanged, compared with agreement in 20 of 23 patients (87.0%) for RECIST (kappa=0.62; 95% CI, 0.23-1.00) and WHO (kappa=0.67; 95% CI, 0.34-1.00) methods. Patients were placed into partial response, stable disease, and disease progression categories. Time to progression of disease was better predicted qualitatively than by RECIST or WHO. Our pilot data suggest that our qualitative scoring system is more reproducible and predictive of patient clinical outcome than the RECIST and WHO methods.

The Correction of Myopia Evaluation Trial: lessons from the study design.

PubMed

Hyman, L; Gwiazda, J

2004-01-01

The Correction of Myopia Evaluation Trial (COMET), a multicentre clinical trial based in 4 schools of optometry in the United States, evaluated the effect of progressive addition lenses versus single vision lenses on myopia progression in an ethnically diverse group of 469 myopic children aged 6 to 11 years. Completion of the clinical trial phase of the study provides an opportunity to evaluate aspects of the study design that contribute to its success. This article describes aspects of the study design that were influential in ensuring the smooth conduct of COMET. These include a dedicated team of investigators, an organisational structure with strong leadership and an independent Co-ordinating Centre, regular communication among investigators, flexible and creative approaches to recruitment and retention, sensitivity to concerns for child safety and child participation, and methods for enhancing and monitoring data reliability. The experience with COMET has provided a number of valuable lessons for all aspects of the study design that should benefit the development and implementation of future clinical trials, particularly those done in similar populations of children. The use of a carefully designed protocol using standard methods by dedicated members of the study team is essential in ensuring achievement of the study aims.

Usefulness of BFB/EMG in facial palsy rehabilitation.

PubMed

Dalla Toffola, Elena; Bossi, Daniela; Buonocore, Michelangelo; Montomoli, Cristina; Petrucci, Lucia; Alfonsi, Enrico

2005-07-22

To analyze and to compare the recovery and the development of synkinesis in patients with idiopathic facial palsy (Bell's palsy) following treatment with two methods of rehabilitation, kinesitherapy (KT) and biofeedback/EMG (BFB/EMG). Retrospective cases--series review. Seventy-four patients with Bell' palsy were clinically evaluated within 1 month from onset of palsy and at 12 months after palsy (House scale and synkinesis evaluation). Electromyography (EMG) and Electroneurography (ENG) were performed about 4 weeks after palsy to better evaluate functional abnormalities due to facial nerve lesion. The patients followed two different protocols for rehabilitation: the first 32 patients were treated with therapeutic exercises performed by therapists (KT group), the latter 42 patients were treated using BFB/EMG methods (BFB group) with inhibition of synkinetic movement as the primary goal. KT and BFB patients were evaluated for clinical and neurophysiological characteristics before rehabilitative treatment. BFB patients showed better clinical recovery and minor synkinesis than KT patients. BFB/EMG seems to be more useful than KT in Bell's palsy treatment. This could be due to the fact that BFB/EMG gives more accurate information than KT on muscle activation with better modulation in voluntary recruitment of motor unit.

[Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

PubMed

Zheng, Wen-ke; Liu, Zhi; Lei, Xiang; Tian, Ran; Zheng, Rui; Li, Nan; Ren, Jing-tian; Du, Xiao-xi; Shang, Hong-cai

2015-09-01

The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.

Evaluation of DNA extraction methods and their clinical application for direct detection of causative bacteria in continuous ambulatory peritoneal dialysis culture fluids from patients with peritonitis by using broad-range PCR.

PubMed

Kim, Si Hyun; Jeong, Haeng Soon; Kim, Yeong Hoon; Song, Sae Am; Lee, Ja Young; Oh, Seung Hwan; Kim, Hye Ran; Lee, Jeong Nyeo; Kho, Weon-Gyu; Shin, Jeong Hwan

2012-03-01

The aims of this study were to compare several DNA extraction methods and 16S rDNA primers and to evaluate the clinical utility of broad-range PCR in continuous ambulatory peritoneal dialysis (CAPD) culture fluids. Six type strains were used as model organisms in dilutions from 10(8) to 10(0) colony-forming units (CFU)/mL for the evaluation of 5 DNA extraction methods and 5 PCR primer pairs. Broad-range PCR was applied to 100 CAPD culture fluids, and the results were compared with conventional culture results. There were some differences between the various DNA extraction methods and primer sets with regard to the detection limits. The InstaGene Matrix (Bio-Rad Laboratories, USA) and Exgene Clinic SV kits (GeneAll Biotechnology Co. Ltd, Korea) seem to have higher sensitivities than the others. The results of broad-range PCR were concordant with the results from culture in 97% of all cases (97/100). Two culture-positive cases that were broad-range PCR-negative were identified as Candida albicans, and 1 PCR-positive but culture-negative sample was identified as Bacillus circulans by sequencing. Two samples among 54 broad-range PCR-positive products could not be sequenced. There were differences in the analytical sensitivity of various DNA extraction methods and primers for broad-range PCR. The broad-range PCR assay can be used to detect bacterial pathogens in CAPD culture fluid as a supplement to culture methods.

Accuracy of clinical swallowing evaluation for diagnosis of dysphagia in children with laryngomalacia or glossoptosis.

PubMed

Gasparin, Marisa; Schweiger, Cláudia; Manica, Denise; Maciel, Antônio Carlos; Kuhl, Gabriel; Levy, Deborah Salle; Marostica, Paulo José Cauduro

2017-01-01

To investigate the accuracy of clinical evaluation of swallowing in a sample of children with laryngomalacia or glossoptosis and describe the prevalence of dysphagia in each of these diseases, as well as characterize the swallow response to speech and language therapy interventions. Children aged 1 month to 11 years receiving care at the Department of Otolaryngology, Hospital de Clínicas de Porto Alegre, Brazil, were evaluated in a cross-sectional design. Evaluation of swallowing was performed at two time points by two blinded speech-language pathologists, one responsible for clinical evaluation and the other for videofluoroscopic study. The protocols employed were based on the instruments proposed by DeMatteo et al. (DeMatteo C, Matovich D, Hjartarson A. Comparison of clinical and videofluoroscopic evaluation of children with feeding and swallowing difficulties. Dev Med Child Neurol 2005;47:149-157.). The study sample consisted of 29 patients: 10 patients with laryngomalacia and 19 patients with glossoptosis. The sensitivity of clinical evaluation did not exceed 50% in any of the evaluations, but specificity reached 100% in some cases, using thickened liquids. The prevalence of dysphagia was 100%, and the use of thickened liquids significantly reduced tracheal aspiration. Dysphagia was highly prevalent in this sample. The sensitivity of clinical evaluation to detect laryngeal penetration and tracheal aspiration was low, as the majority of aspiration events were silent. The videofluoroscopic study is important in order to determine a safest method to feed the patient. Pediatr Pulmonol. 2017;52:41-47. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Normative Data for an Instrumental Assessment of the Upper-Limb Functionality.

PubMed

Caimmi, Marco; Guanziroli, Eleonora; Malosio, Matteo; Pedrocchi, Nicola; Vicentini, Federico; Molinari Tosatti, Lorenzo; Molteni, Franco

2015-01-01

Upper-limb movement analysis is important to monitor objectively rehabilitation interventions, contributing to improving the overall treatments outcomes. Simple, fast, easy-to-use, and applicable methods are required to allow routinely functional evaluation of patients with different pathologies and clinical conditions. This paper describes the Reaching and Hand-to-Mouth Evaluation Method, a fast procedure to assess the upper-limb motor control and functional ability, providing a set of normative data from 42 healthy subjects of different ages, evaluated for both the dominant and the nondominant limb motor performance. Sixteen of them were reevaluated after two weeks to perform test-retest reliability analysis. Data were clustered into three subgroups of different ages to test the method sensitivity to motor control differences. Experimental data show notable test-retest reliability in all tasks. Data from older and younger subjects show significant differences in the measures related to the ability for coordination thus showing the high sensitivity of the method to motor control differences. The presented method, provided with control data from healthy subjects, appears to be a suitable and reliable tool for the upper-limb functional assessment in the clinical environment.

Normative Data for an Instrumental Assessment of the Upper-Limb Functionality

PubMed Central

Caimmi, Marco; Guanziroli, Eleonora; Malosio, Matteo; Pedrocchi, Nicola; Vicentini, Federico; Molinari Tosatti, Lorenzo; Molteni, Franco

2015-01-01

Upper-limb movement analysis is important to monitor objectively rehabilitation interventions, contributing to improving the overall treatments outcomes. Simple, fast, easy-to-use, and applicable methods are required to allow routinely functional evaluation of patients with different pathologies and clinical conditions. This paper describes the Reaching and Hand-to-Mouth Evaluation Method, a fast procedure to assess the upper-limb motor control and functional ability, providing a set of normative data from 42 healthy subjects of different ages, evaluated for both the dominant and the nondominant limb motor performance. Sixteen of them were reevaluated after two weeks to perform test-retest reliability analysis. Data were clustered into three subgroups of different ages to test the method sensitivity to motor control differences. Experimental data show notable test-retest reliability in all tasks. Data from older and younger subjects show significant differences in the measures related to the ability for coordination thus showing the high sensitivity of the method to motor control differences. The presented method, provided with control data from healthy subjects, appears to be a suitable and reliable tool for the upper-limb functional assessment in the clinical environment. PMID:26539500

Cryopreservation of Human Mesenchymal Stem Cells for Clinical Applications: Current Methods and Challenges.

PubMed

Yong, Kar Wey; Wan Safwani, Wan Kamarul Zaman; Xu, Feng; Wan Abas, Wan Abu Bakar; Choi, Jane Ru; Pingguan-Murphy, Belinda

2015-08-01

Mesenchymal stem cells (MSCs) hold many advantages over embryonic stem cells (ESCs) and other somatic cells in clinical applications. MSCs are multipotent cells with strong immunosuppressive properties. They can be harvested from various locations in the human body (e.g., bone marrow and adipose tissues). Cryopreservation represents an efficient method for the preservation and pooling of MSCs, to obtain the cell counts required for clinical applications, such as cell-based therapies and regenerative medicine. Upon cryopreservation, it is important to preserve MSCs functional properties including immunomodulatory properties and multilineage differentiation ability. Further, a biosafety evaluation of cryopreserved MSCs is essential prior to their clinical applications. However, the existing cryopreservation methods for MSCs are associated with notable limitations, leading to a need for new or improved methods to be established for a more efficient application of cryopreserved MSCs in stem cell-based therapies. We review the important parameters for cryopreservation of MSCs and the existing cryopreservation methods for MSCs. Further, we also discuss the challenges to be addressed in order to preserve MSCs effectively for clinical applications.

High-throughput ocular artifact reduction in multichannel electroencephalography (EEG) using component subspace projection.

PubMed

Ma, Junshui; Bayram, Sevinç; Tao, Peining; Svetnik, Vladimir

2011-03-15

After a review of the ocular artifact reduction literature, a high-throughput method designed to reduce the ocular artifacts in multichannel continuous EEG recordings acquired at clinical EEG laboratories worldwide is proposed. The proposed method belongs to the category of component-based methods, and does not rely on any electrooculography (EOG) signals. Based on a concept that all ocular artifact components exist in a signal component subspace, the method can uniformly handle all types of ocular artifacts, including eye-blinks, saccades, and other eye movements, by automatically identifying ocular components from decomposed signal components. This study also proposes an improved strategy to objectively and quantitatively evaluate artifact reduction methods. The evaluation strategy uses real EEG signals to synthesize realistic simulated datasets with different amounts of ocular artifacts. The simulated datasets enable us to objectively demonstrate that the proposed method outperforms some existing methods when no high-quality EOG signals are available. Moreover, the results of the simulated datasets improve our understanding of the involved signal decomposition algorithms, and provide us with insights into the inconsistency regarding the performance of different methods in the literature. The proposed method was also applied to two independent clinical EEG datasets involving 28 volunteers and over 1000 EEG recordings. This effort further confirms that the proposed method can effectively reduce ocular artifacts in large clinical EEG datasets in a high-throughput fashion. Copyright © 2011 Elsevier B.V. All rights reserved.

App Chronic Disease Checklist: Protocol to Evaluate Mobile Apps for Chronic Disease Self-Management.

PubMed

Anderson, Kevin; Burford, Oksana; Emmerton, Lynne

2016-11-04

The availability of mobile health apps for self-care continues to increase. While little evidence of their clinical impact has been published, there is general agreement among health authorities and authors that consumers' use of health apps assist in self-management and potentially clinical decision making. A consumer's sustained engagement with a health app is dependent on the usability and functionality of the app. While numerous studies have attempted to evaluate health apps, there is a paucity of published methods that adequately recognize client experiences in the academic evaluation of apps for chronic conditions. This paper reports (1) a protocol to shortlist health apps for academic evaluation, (2) synthesis of a checklist to screen health apps for quality and reliability, and (3) a proposed method to theoretically evaluate usability of health apps, with a view towards identifying one or more apps suitable for clinical assessment. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram was developed to guide the selection of the apps to be assessed. The screening checklist was thematically synthesized with reference to recurring constructs in published checklists and related materials for the assessment of health apps. The checklist was evaluated by the authors for face and construct validity. The proposed method for evaluation of health apps required the design of procedures for raters of apps, dummy data entry to test the apps, and analysis of raters' scores. The PRISMA flow diagram comprises 5 steps: filtering of duplicate apps; eliminating non-English apps; removing apps requiring purchase, filtering apps not updated within the past year; and separation of apps into their core functionality. The screening checklist to evaluate the selected apps was named the App Chronic Disease Checklist, and comprises 4 sections with 6 questions in each section. The validity check verified classification of, and ambiguity in, wording of questions within constructs. The proposed method to evaluate shortlisted and downloaded apps comprises instructions to attempt set-up of a dummy user profile, and dummy data entry to represent in-range and out-of-range clinical measures simulating a range of user behaviors. A minimum score of 80% by consensus (using the Intraclass Correlation Coefficient) between raters is proposed to identify apps suitable for clinical trials. The flow diagram allows researchers to shortlist health apps that are potentially suitable for formal evaluation. The evaluation checklist enables quantitative comparison of shortlisted apps based on constructs reported in the literature. The use of multiple raters, and comparison of their scores, is proposed to manage inherent subjectivity in assessing user experiences. Initial trial of the combined protocol is planned for apps pertaining to the self-monitoring of asthma; these results will be reported elsewhere. ©Kevin Anderson, Oksana Burford, Lynne Emmerton. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 04.11.2016.

Evaluation of a Family-Centred Children's Weight Management Intervention

ERIC Educational Resources Information Center

Jinks, Annette; English, Sue; Coufopoulos, Anne

2013-01-01

Purpose: The purpose of this paper is to conduct an in-depth quantitative and qualitative evaluation of a family-based weight loss and healthy life style programme for clinically obese children in England. Design/methodology/approach: The mixed method case study evaluation used included obtaining pre and post measurements of anthropometry and a…

Design of a Competency Evaluation Model for Clinical Nursing Practicum, Based on Standardized Language Systems: Psychometric Validation Study.

PubMed

Iglesias-Parra, Maria Rosa; García-Guerrero, Alfonso; García-Mayor, Silvia; Kaknani-Uttumchandani, Shakira; León-Campos, Álvaro; Morales-Asencio, José Miguel

2015-07-01

To develop an evaluation system of clinical competencies for the practicum of nursing students based on the Nursing Interventions Classification (NIC). Psychometric validation study: the first two phases addressed definition and content validation, and the third phase consisted of a cross-sectional study for analyzing reliability. The study population was undergraduate nursing students and clinical tutors. Through the Delphi technique, 26 competencies and 91 interventions were isolated. Cronbach's α was 0.96. Factor analysis yielded 18 factors that explained 68.82% of the variance. Overall inter-item correlation was 0.26, and total-item correlation ranged between 0.66 and 0.19. A competency system for the nursing practicum, structured on the NIC, is a reliable method for assessing and evaluating clinical competencies. Further evaluations in other contexts are needed. The availability of standardized language systems in the nursing discipline supposes an ideal framework to develop the nursing curricula. © 2015 Sigma Theta Tau International.

Impact of cataract surgery on vision-related life performances: the usefulness of Real-Life Vision Test for cataract surgery outcomes evaluation

PubMed Central

Ni, W; Li, X; Hou, Z; Zhang, H; Qiu, W; Wang, W

2015-01-01

Purpose Real-Life Vision Test (RLVT) is a newly developed performance-based measures of functional vision. This present study is designed to determine whether it could be a meaningful assessment for cataract surgery outcomes evaluation. Patients and methods Age-related cataract patients (56) who scheduled for bilateral cataract surgery and 44 age-matched controls were evaluated by four types of measurements: (1) demographic, medical, cognitive and depressive evaluation, and the reaction time testing; (2) clinical measures (visual acuity, contrast sensitivity, stereopsis, and color perception); (3) the 25-item National Eye Institute's Visual Functioning Questionnaire (NEI-VFQ); (4) the RLVT. Spearman's coefficients and multiple regression analysis were conducted to investigate the relationship among RLVT, clinical measures, and self-report assessment of visual function. Results The results of RLVT, clinical measures, and NEI-VFQ total scores were improved significantly after cataract surgery. There were no differences between control subjects and post-surgery patients with respect to NEI-VFQ-25 total scores, self-rating depression scale scores and three tasks of RLVT. Change of RLVT was significantly associated with the change of clinical measures in the cataract group. Multiple regression analysis demonstrated that change of distance, intermediate, and near visual acuity, and binocular contrast sensitivity were significant predictors of improvements of RLVT. Conclusions Cataract surgery could improve real-world visual ability effectively for cataract patients. Our study highlights the potential usefulness of RLVT as an adjunct to the current outcomes evaluation system for cataract surgery. The use of RLVT combined with clinical and self-survey methods may be the comprehensive strategy to manifest the impact of cataract surgery on patients' overall vision-related quality of life. PMID:26272444

The applicability of real-time PCR in the diagnostic of cutaneous leishmaniasis and parasite quantification for clinical management: Current status and perspectives.

PubMed

Moreira, Otacilio C; Yadon, Zaida E; Cupolillo, Elisa

2017-09-29

Cutaneous leishmaniasis (CL) is spread worldwide and is the most common manifestation of leishmaniasis. Diagnosis is performed by combining clinical and epidemiological features, and through the detection of Leishmania parasites (or DNA) in tissue specimens or trough parasite isolation in culture medium. Diagnosis of CL is challenging, reflecting the pleomorphic clinical manifestations of this disease. Skin lesions vary in severity, clinical appearance, and duration, and in some cases, they can be indistinguishable from lesions related to other diseases. Over the past few decades, PCR-based methods, including real-time PCR assays, have been developed for Leishmania detection, quantification and species identification, improving the molecular diagnosis of CL. This review provides an overview of many real-time PCR methods reported for the diagnostic evaluation of CL and some recommendations for the application of these methods for quantification purposes for clinical management and epidemiological studies. Furthermore, the use of real-time PCR for Leishmania species identification is also presented. The advantages of real-time PCR protocols are numerous, including increased sensitivity and specificity and simpler standardization of diagnostic procedures. However, despite the numerous assays described, there is still no consensus regarding the methods employed. Furthermore, the analytical and clinical validation of CL molecular diagnosis has not followed international guidelines so far. A consensus methodology comprising a DNA extraction protocol with an exogenous quality control and an internal reference to normalize parasite load is still needed. In addition, the analytical and clinical performance of any consensus methodology must be accurately assessed. This review shows that a standardization initiative is essential to guide researchers and clinical laboratories towards the achievement of a robust and reproducible methodology, which will permit further evaluation of parasite load as a surrogate marker of prognosis and monitoring of aetiological treatment, particularly in multi-centric observational studies and clinical trials. Copyright © 2017 Elsevier B.V. All rights reserved.

[Thinking about vertigo effectiveness evaluation methods in clinical research of Chinese medicine].

PubMed

Liu, Hong-mei; Li, Tao

2014-10-01

Vertigo is a kind of patients' subjective feelings. The severity of vertigo is closely related to many factors. But we are short of a well accepted quantitative evaluation method capable of accurately and comprehensively evaluating vertigo in clinics. Reducing the onset of vertigo, enhancing the re- covery of equilibrium function, and improving the quality of life of vertigo patients should be taken as the focus of evaluating therapeutic effects. As for establishing a Chinese medical effectiveness evaluation system for vertigo, we believe we should distinguish different "diseases". We could roughly identify it as systemic vertigo and non-systemic vertigo. For systemic vertigo, the efficacy of vertigo could be comprehensively evaluated by UCLA vertigo questionnaire or dizziness handicap inventory combined with equilibrium function testing indices. But for non-systemic vertigo, the efficacy of vertigo could be comprehensively evaluated by taking UCLA vertigo questionnaire or dizziness handicap inventory as main efficacy indices. Secondly, we should analyze different reasons for vertigo, choose symptoms and signs in line with vertigo features as well as with Chinese medical theories, and formulate corresponding syndrome effectiveness standards according to different diseases. We should not simply take syndrome diagnosis standards as efficacy evaluation standards.

[Evaluation of four methods for detecting methicillin-resistant Staphylococcus aureus isolates from clinical specimens at a regional hospital in Mexico].

PubMed

Acosta-Pérez, Gabriel; Rodríguez-Ábrego, Gabriela; Longoria-Revilla, Ernesto; Castro-Mussot, María Eugenia

2012-01-01

To estimate the prevalence of methicillin-resistant Staphylococcus aureus (MRSA) in clinical isolates and to compare different methods for detection of MRSA in a lab with limited available personnel and resources. 140 Staphylococcus aureus strains isolated from patients in several departments were assayed for β-lactamase production, MIC-Vitek 2 oxacillin, ChromID MRSA, disk diffusion in agar for cefoxitin 30 μg and PBP2a detection. The results of conventional tests were compared with the "gold standard" PCR test for mecA gene. Cohen´s kappa index was also calculated in order to evaluate the intra assay agreement between the used methods. The found prevalence was 90.7%. Sensitivity and specificity were: disk diffusion for cefoxitin 97 and 92% respectively, MIC Vitek 2-XL 97 and 69%, ChromoID MRSA 97 and 85%, and PBP2a detection 98 and 100%. All methods are very good for detecting MRSA, choosing a method to use will depend on each laboratory infrastructure.

Evidence-Based Indicators of Neuropsychological Change in the Individual Patient: Relevant Concepts and Methods

PubMed Central

Duff, Kevin

2012-01-01

Repeated assessments are a relatively common occurrence in clinical neuropsychology. The current paper will review some of the relevant concepts (e.g., reliability, practice effects, alternate forms) and methods (e.g., reliable change index, standardized based regression) that are used in repeated neuropsychological evaluations. The focus will be on the understanding and application of these concepts and methods in the evaluation of the individual patient through examples. Finally, some future directions for assessing change will be described. PMID:22382384

Evaluation of the end user (dentist) experience of undertaking clinical audit in the post April 2001 general dental services (GDS) scheme.

PubMed

Cannell, P J

2012-09-01

A mandatory scheme for clinical audit in the general dental services (GDS) was launched in April 2001. No evaluation of this mandatory scheme exists in the literature. This study provides an evaluation of this scheme. More recently a new dental contract was introduced in the general dental services (GDS) in April 2006. Responsibility for clinical audit activities was devolved to primary care trusts (PCTs) as part of their clinical governance remit. All GDPs within Essex were contacted by letter and invited to participate in the research. A qualitative research method was selected for this evaluation, utilising audio-taped semi-structured research interviews with eight general dental practitioners (GDPs) who had taken part in the GDS clinical audit scheme and who fitted the sampling criteria and strategy. The evaluation focused on dentists' experiences of the scheme. The main findings from the analysis of the GDS scheme data suggest that there is clear evidence of change following audit activities occurring within practices and for the benefit of patients. However, often it is the dentist only that undertakes a clinical audit project rather than the dental team, there is a lack of dissemination of project findings beyond the individual participating practices, very little useful feedback provided to participants who have completed a project and very limited use of formal re-auditing of a particular topic. This study provides evaluation of the GDS clinical audit scheme. Organisations who propose to undertake clinical audit activities in conjunction with dentistry in the future may benefit from incorporating and/or developing some findings from this evaluation into their project design and avoiding others.

[Clinical application evaluation of Guidelines for the Diagnosis and Treatment of Common Diseases of Pediatrics in Traditional Chinese Medicine].

PubMed

Liu, Meng-Yu; Yang, Wei; Wang, Li-Ying; Zhao, Xue-Yao; Wang, Yue-Xi; Liu, Yu-Qi; Han, Xue-Jie; Lv, Ai-Ping

2017-09-01

Clinical application evaluation research of Guidelines for the Diagnosis and Treatment of Common Diseases of Pediatrics in Traditional Chinese Medicine intends to evaluate the quality level and clinical application of the guideline. A questionnaire and prospective case survey methods were used to evaluate the applicability evaluation based on the clinician questionnaire and the application evaluation based on clinical case observation. The applicability evaluation, familiarity and utilization rate of doctors' guidelines were 85.06%, 62.76%; Sort by technical grade, intermediate grade doctors have a higher familiarity rate and utilization rate, while the junior grade doctor's is lower; Guide quality level of applicability evaluation, other items' rational percentage are better than 96% except the items of health preserving and prevention and other treatment is relatively low; Items' applicable percentage of applicability evaluation are more than 91% except the item of guide simplicity. Comprehensive applicability evaluation, The percentage of the guideline applicable to clinical practice accounted for 94.94%. The consistency rate of syndrome differentiation and clinical application is more than 96% in addition to prescription medication, other treatments and health preserving and prevention of the guidelines apply consistency of application evaluation. The percentage of good treatment effect accounted for 92.96% of application effect evaluation. The safety percentage is 99.89% and economy is 97.45%. The research shows that of Guidelines for the Diagnosis and Treatment of Common Diseases of Pediatrics in Traditional Chinese Medicine quality level is good and is basically applicable to pediatric clinical practice which can be used as a standardized recommendation of pediatric common diseases' treatment specification. A small part of the guidelines are not applicable and need to be further consummated. Health preserving and prevention and other treatment of the guideline need to be revised. Copyright© by the Chinese Pharmaceutical Association.

Changing physician behavior: what works?

PubMed

Mostofian, Fargoi; Ruban, Cynthiya; Simunovic, Nicole; Bhandari, Mohit

2015-01-01

There are various interventions for guideline implementation in clinical practice, but the effects of these interventions are generally unclear. We conducted a systematic review to identify effective methods of implementing clinical research findings and clinical guidelines to change physician practice patterns, in surgical and general practice. Systematic review of reviews. We searched electronic databases (MEDLINE, EMBASE, and PubMed) for systematic reviews published in English that evaluated the effectiveness of different implementation methods. Two reviewers independently assessed eligibility for inclusion and methodological quality, and extracted relevant data. Fourteen reviews covering a wide range of interventions were identified. The intervention methods used include: audit and feedback, computerized decision support systems, continuing medical education, financial incentives, local opinion leaders, marketing, passive dissemination of information, patient-mediated interventions, reminders, and multifaceted interventions. Active approaches, such as academic detailing, led to greater effects than traditional passive approaches. According to the findings of 3 reviews, 71% of studies included in these reviews showed positive change in physician behavior when exposed to active educational methods and multifaceted interventions. Active forms of continuing medical education and multifaceted interventions were found to be the most effective methods for implementing guidelines into general practice. Additionally, active approaches to changing physician performance were shown to improve practice to a greater extent than traditional passive methods. Further primary research is necessary to evaluate the effectiveness of these methods in a surgical setting.

How to quantify microparticles in RBCs? A validated flow cytometry method allows the detection of an increase in microparticles during storage.

PubMed

Gamonet, Clémentine; Mourey, Guillaume; Aupet, Sophie; Biichle, Sabéha; Petitjean, Régis; Vidal, Chrystelle; Pugin, Aurore; Naegelen, Christian; Tiberghien, Pierre; Morel, Pascal; Angelot-Delettre, Fanny; Seilles, Estelle; Saas, Philippe; Bardiaux, Laurent; Garnache-Ottou, Francine

2017-03-01

The procoagulant and proinflammatory microparticles (MPs) released during storage of packed red blood cells (pRBCs) can potentially modify transfusion benefits. A robust method to quantify MPs in pRBCs is needed to evaluate their impact in clinical trials. The objective was to validate the preanalytic conditions required to prepare pRBC supernatant as well as a method to quantify and evaluate MP variations over 42 days of pRBC storage.A flow cytometry method with size-calibrated beads was developed and fully validated. Quantification of MPs in pRBCs (n = 109) was assessed during short-term (7 days) and long-term (42 days) storage at 4°C, during short-term storage (8 hours) at room temperature, and after 2 years frozen. Repeatability, reproducibility, and linearity of the quantification method were validated, and variations during conservation are presented. There was high variability in RBC (erythrocyte) MP (ERMP) and platelet MP (PMP) levels between RBC units, depending on the filter used for leukocyte reduction. During the 42 days of storage at 4°C, significant increases in ERMPs and PMPs occurred (from 58 to 138 ERMPs/µL from Day 2 to Day 42; p = 0.0002; and from 326 to 771 PMPs/µL from Day 2 to Day 42; p = 0.00026). We use a robust method to confirm that ERMPs and PMPs are present to various degrees in pRBCs and that storage for 42 days significantly increases their generation. This method is robust enough to allow MP quantification in pRBCs and is adapted to evaluate the clinical impact of transfused MPs in prospective clinical trials. © 2017 AABB.

Methods for Evaluating the Content, Usability, and Efficacy of Commercial Mobile Health Apps

PubMed Central

Silfee, Valerie J; Waring, Molly E; Boudreaux, Edwin D; Sadasivam, Rajani S; Mullen, Sean P; Carey, Jennifer L; Hayes, Rashelle B; Ding, Eric Y; Bennett, Gary G; Pagoto, Sherry L

2017-01-01

Commercial mobile apps for health behavior change are flourishing in the marketplace, but little evidence exists to support their use. This paper summarizes methods for evaluating the content, usability, and efficacy of commercially available health apps. Content analyses can be used to compare app features with clinical guidelines, evidence-based protocols, and behavior change techniques. Usability testing can establish how well an app functions and serves its intended purpose for a target population. Observational studies can explore the association between use and clinical and behavioral outcomes. Finally, efficacy testing can establish whether a commercial app impacts an outcome of interest via a variety of study designs, including randomized trials, multiphase optimization studies, and N-of-1 studies. Evidence in all these forms would increase adoption of commercial apps in clinical practice, inform the development of the next generation of apps, and ultimately increase the impact of commercial apps. PMID:29254914

Estimating Return on Investment in Translational Research: Methods and Protocols

PubMed Central

Trochim, William; Dilts, David M.; Kirk, Rosalind

2014-01-01

Assessing the value of clinical and translational research funding on accelerating the translation of scientific knowledge is a fundamental issue faced by the National Institutes of Health and its Clinical and Translational Awards (CTSA). To address this issue, the authors propose a model for measuring the return on investment (ROI) of one key CTSA program, the clinical research unit (CRU). By estimating the economic and social inputs and outputs of this program, this model produces multiple levels of ROI: investigator, program and institutional estimates. A methodology, or evaluation protocol, is proposed to assess the value of this CTSA function, with specific objectives, methods, descriptions of the data to be collected, and how data are to be filtered, analyzed, and evaluated. This paper provides an approach CTSAs could use to assess the economic and social returns on NIH and institutional investments in these critical activities. PMID:23925706

Estimating return on investment in translational research: methods and protocols.

PubMed

Grazier, Kyle L; Trochim, William M; Dilts, David M; Kirk, Rosalind

2013-12-01

Assessing the value of clinical and translational research funding on accelerating the translation of scientific knowledge is a fundamental issue faced by the National Institutes of Health (NIH) and its Clinical and Translational Awards (CTSAs). To address this issue, the authors propose a model for measuring the return on investment (ROI) of one key CTSA program, the clinical research unit (CRU). By estimating the economic and social inputs and outputs of this program, this model produces multiple levels of ROI: investigator, program, and institutional estimates. A methodology, or evaluation protocol, is proposed to assess the value of this CTSA function, with specific objectives, methods, descriptions of the data to be collected, and how data are to be filtered, analyzed, and evaluated. This article provides an approach CTSAs could use to assess the economic and social returns on NIH and institutional investments in these critical activities.

Two-year clinical trial of a universal adhesive in total-etch and self-etch mode in non-carious cervical lesions☆

PubMed Central

Lawson, Nathaniel C.; Robles, Augusto; Fu, Chin-Chuan; Lin, Chee Paul; Sawlani, Kanchan; Burgess, John O.

2016-01-01

Objectives To compare the clinical performance of Scotchbond™ Universal Adhesive used in self- and total-etch modes and two-bottle Scotchbond™ Multi-purpose Adhesive in total-etch mode for Class 5 non-carious cervical lesions (NCCLs). Methods 37 adults were recruited with 3 or 6 NCCLs (>1.5 mm deep). Teeth were isolated, and a short cervical bevel was prepared. Teeth were restored randomly with Scotchbond Universal total-etch, Scotchbond Universal self-etch or Scotchbond Multi-purpose followed with a composite resin. Restorations were evaluated at baseline, 6, 12 and 24 months for marginal adaptation, marginal discoloration, secondary caries, and sensitivity to cold using modified USPHS Criteria. Patients and evaluators were blinded. Logistic and linear regression models using a generalized estimating equation were applied to evaluate the effects of time and adhesive material on clinical assessment outcomes over the 24 month follow-up period. Kaplan–Meier method was used to compare the retention between adhesive materials. Results Clinical performance of all adhesive materials deteriorated over time for marginal adaptation, and discoloration (p <0.0001). Both Scotchbond Universal self-etch and Scotchbond Multi-purpose materials were more than three times as likely to contribute to less satisfying performance in marginal discoloration over time than Scotchbond Universal total-etch. The retention rates up to 24 months were 87.6%, 94.9% and 100% for Scotchbond Multi-purpose and Scotchbond Universal self-etch and total-etch, respectively. Conclusions Scotchbond Universal in self- and total- etch modes performed similar to or better than Scotchbond Multipurpose, respectively. Clinical significance 24 month evaluation of a universal adhesive indicates acceptable clinical performance, particularly in a total-etch mode. PMID:26231300

Clinical evaluation of an innovative operative procedure in the treatment of the tethered cord syndrome.

PubMed

Hou, Yang; Sun, Jingchuan; Shi, Jiangang; Guo, Yongfei; Wang, Yuan; Shi, Guodong; Xu, Guohua

2018-06-01

The tethered cord syndrome (TCS) characterized by urination dysfunction has long been a worldwide clinical problem, of which clinical effects remains controversial. The objective of this study was to evaluate the clinical effects of an innovative surgical method for the treatment of TCS. This is a retrospective clinical study. There were 15 patients included in this study. The visual analog scale (VAS) and the Japanese Orthopaedic Association (JOA) scores were evaluated. The incidence of complications after surgery was also analyzed. A total of 15 patients including 9 men and 6 women with TCS underwent homogeneous spinal-shortening axial decompression (HSAD) from September 2011 to February 2015. The average age at the time of surgery was 38.1±17.7 years. The average postoperative follow-up period was 21.5±7.5 months. The VAS and JOA scores were used to evaluate the clinical effects of the new operational procedure. In addition, the incidence of complications was also recorded and analyzed. The VAS scores decreased from 3.93±2.52 to 1.80±1.21 at the final follow-up after surgery with a significant statistical difference (p=.006). The JOA scores also significantly increased from 9.93±3.43 to 21.20±4.18 at the final follow-up (p<.001). Fourteen cases (93.3%) with bladder dysfunction and 7 cases with sensory dysfunction of the lower limbs (87.5%) had a significant improvement postoperatively. Complications such as infection, pulmonary embolism, nerve injury, and broken rod were not observed during the follow-up period. The operation of HSAD was an effective and safe surgical method for TCS, which can achieve direct decompression of the tethered spinal cord. Copyright © 2017. Published by Elsevier Inc.

Evaluation of an automatic brain segmentation method developed for neonates on adult MR brain images

NASA Astrophysics Data System (ADS)

Moeskops, Pim; Viergever, Max A.; Benders, Manon J. N. L.; Išgum, Ivana

2015-03-01

Automatic brain tissue segmentation is of clinical relevance in images acquired at all ages. The literature presents a clear distinction between methods developed for MR images of infants, and methods developed for images of adults. The aim of this work is to evaluate a method developed for neonatal images in the segmentation of adult images. The evaluated method employs supervised voxel classification in subsequent stages, exploiting spatial and intensity information. Evaluation was performed using images available within the MRBrainS13 challenge. The obtained average Dice coefficients were 85.77% for grey matter, 88.66% for white matter, 81.08% for cerebrospinal fluid, 95.65% for cerebrum, and 96.92% for intracranial cavity, currently resulting in the best overall ranking. The possibility of applying the same method to neonatal as well as adult images can be of great value in cross-sectional studies that include a wide age range.

Systematic data ingratiation of clinical trial recruitment locations for geographic-based query and visualization.

PubMed

Luo, Jake; Chen, Weiheng; Wu, Min; Weng, Chunhua

2017-12-01

Prior studies of clinical trial planning indicate that it is crucial to search and screen recruitment sites before starting to enroll participants. However, currently there is no systematic method developed to support clinical investigators to search candidate recruitment sites according to their interested clinical trial factors. In this study, we aim at developing a new approach to integrating the location data of over one million heterogeneous recruitment sites that are stored in clinical trial documents. The integrated recruitment location data can be searched and visualized using a map-based information retrieval method. The method enables systematic search and analysis of recruitment sites across a large amount of clinical trials. The location data of more than 1.4 million recruitment sites of over 183,000 clinical trials was normalized and integrated using a geocoding method. The integrated data can be used to support geographic information retrieval of recruitment sites. Additionally, the information of over 6000 clinical trial target disease conditions and close to 4000 interventions was also integrated into the system and linked to the recruitment locations. Such data integration enabled the construction of a novel map-based query system. The system will allow clinical investigators to search and visualize candidate recruitment sites for clinical trials based on target conditions and interventions. The evaluation results showed that the coverage of the geographic location mapping for the 1.4 million recruitment sites was 99.8%. The evaluation of 200 randomly retrieved recruitment sites showed that the correctness of geographic information mapping was 96.5%. The recruitment intensities of the top 30 countries were also retrieved and analyzed. The data analysis results indicated that the recruitment intensity varied significantly across different countries and geographic areas. This study contributed a new data processing framework to extract and integrate the location data of heterogeneous recruitment sites from clinical trial documents. The developed system can support effective retrieval and analysis of potential recruitment sites using target clinical trial factors. Copyright © 2017 Elsevier B.V. All rights reserved.

Association of clinical signs with endoscopic findings in horses with nasopharyngeal cicatrix syndrome: 118 cases (2003-2008).

PubMed

Norman, Tracy E; Chaffin, M Keith; Bisset, Wesley T; Thompson, James A

2012-03-15

To characterize the associations between clinical signs of nasopharyngeal cicatrix syndrome (NCS) and endoscopic findings in horses. Retrospective, case-control study. 239 horses (118 case horses and 121 control horses). Medical records of horses that had an endoscopic evaluation of the upper airway performed between January 2003 and December 2008 were reviewed. Clinical signs and the appearance and anatomic locations of lesions identified during endoscopic evaluation were reviewed and recorded for each horse. The associations between clinical signs and endoscopic findings were evaluated by the use of a prospective logistic model that used a Bayesian method for inference and was implemented by a Markov chain Monte Carlo method. Nasal discharge was associated with acute inflammation of the pharynx and larynx. Exercise intolerance was associated with circumferential pharyngeal lesions. Respiratory noise was associated with chronic scarring of the pharynx, a combination of pharyngeal and laryngeal scarring, and circumferential scarring of the pharynx. Respiratory distress was associated with acute inflammation of all portions of the airway, especially when there was preexisting scarring and narrowing of the airway by ≥ 50%. Cough did not have any significant association with NCS, compared with results in control horses. Associations between the endoscopic appearance of NCS lesions and relevant clinical signs will help practitioners identify horses with NCS and allow them to select appropriate treatment.

Evaluation of the Microbial Identification System for identification of clinically isolated yeasts.

PubMed Central

Crist, A E; Johnson, L M; Burke, P J

1996-01-01

The Microbial Identification System (MIS; Microbial ID, Inc., Newark, Del.) was evaluated for the identification of 550 clinically isolated yeasts. The organisms evaluated were fresh clinical isolates identified by methods routinely used in our laboratory (API 20C and conventional methods) and included Candida albicans (n = 294), C. glabrata (n = 145), C. tropicalis (n = 58), C. parapsilosis (n = 33), and other yeasts (n = 20). In preparation for fatty acid analysis, yeasts were inoculated onto Sabouraud dextrose agar and incubated at 28 degrees C for 24 h. Yeasts were harvested, saponified, derivatized, and extracted, and fatty acid analysis was performed according to the manufacturer's instructions. Fatty acid profiles were analyzed, and computer identifications were made with the Yeast Clinical Library (database version 3.8). Of the 550 isolates tested, 374 (68.0%) were correctly identified to the species level, with 87 (15.8%) being incorrectly identified and 89 (16.2%) giving no identification. Repeat testing of isolates giving no identification resulted in an additional 18 isolates being correctly identified. This gave the MIS an overall identification rate of 71.3%. The most frequently misidentified yeast was C. glabrata, which was identified as Saccharomyces cerevisiae 32.4% of the time. On the basis of these results, the MIS, with its current database, does not appear suitable for the routine identification of clinically important yeasts. PMID:8880489

A Sociotechnical Approach to Evaluating the Impact of ICT on Clinical Care Environments

PubMed Central

Li, Julie

2010-01-01

Introduction: Process-supporting information technology holds the potential to increase efficiency, reduce errors, and alter professional roles and responsibilities in a manner which allows improvement in the delivery of patient care. However, clashes between the model of health care work inscribed in these tools with the actual nature of work has resulted in staff resistance and decreased organisational uptake of ICT, as well as the facilitation of unexpected and negative effects in efficiency and patient safety. Sociotechnical theory provides a paradigm against which workflow and transfusion of ICT in healthcare could be better explored and understood. Design: This paper will conceptualise a formative, multi-method longitudinal evaluation process to explore the impact of ICT with an appreciation of the relationship between the social and technical systems within a clinical department. Method: Departmental culture, including clinical work processes and communication patterns will be thoroughly explored before system implementation using both quantitative and qualitative research methods. Findings will be compared with post implementation data, which will incorporate measurement of safety and workflow efficiency indicators. Discussion: Sociotechnical theory provides a paradigm against which workflow and transfusion of ICT in healthcare could be better explored and understood. However, sociotechnical and multimethod approaches to evaluation do not exist without criticism. Inherent in the protocol are limitations of sociotechnical theory and criticism of the multimethod approach; testing of the methodology in real clinical settings will serve to verify efficacy and refine the process. PMID:21594005

Anxiety and performance of nursing students in regard to assessment via clinical simulations in the classroom versus filmed assessments.

PubMed

de Souza Teixeira, Carla Regina; Kusumota, Luciana; Alves Pereira, Marta Cristiane; Merizio Martins Braga, Fernanda Titareli; Pirani Gaioso, Vanessa; Mara Zamarioli, Cristina; Campos de Carvalho, Emilia

2014-01-01

To compare the level of anxiety and performance of nursing students when performing a clinical simulation through the traditional method of assessment with the presence of an evaluator and through a filmed assessment without the presence of an evaluator. Controlled trial with the participation of Brazilian public university 20 students who were randomly assigned to one of two groups: a) assessment through the traditional method with the presence of an evaluator; or b) filmed assessment. The level of anxiety was assessed using the Zung test and performance was measured based on the number of correct answers. Averages of 32 and 27 were obtained on the anxiety scale by the group assessed through the traditional method before and after the simulation, respectively, while the filmed group obtained averages of 33 and 26; the final scores correspond to mild anxiety. Even though there was a statistically significant reduction in the intra-groups scores before and after the simulation, there was no difference between the groups. As for the performance assessments in the clinical simulation, the groups obtained similar percentages of correct answers (83% in the traditional assessment and 84% in the filmed assessment) without statistically significant differences. Filming can be used and encouraged as a strategy to assess nursing undergraduate students.

Clinical applicability of nursing outcomes in the evolution of orthopedic patients with Impaired Physical Mobility 1

PubMed Central

da Silva, Marcos Barragan; Almeida, Miriam de Abreu; Panato, Bruna Paulsen; Siqueira, Ana Paula de Oliveira; da Silva, Mariana Palma; Reisderfer, Letícia

2015-01-01

AIM: to evaluate the clinical applicability of outcomes, according to the Nursing Outcomes Classification (NOC) in the evolution of orthopedic patients with Impaired Physical Mobility METHOD: longitudinal study conducted in 2012 in a university hospital, with 21 patients undergoing Total Hip Arthroplasty, evaluated daily by pairs of trained data collectors. Data were collected using an instrument containing five Nursing Outcomes, 16 clinical indicators and a five point Likert scale, and statistically analyzed. RESULTS: The outcomes Body Positioning: self-initiated, Mobility, Knowledge: prescribed activity, and Fall Prevention Behavior presented significant increases in mean scores when comparing the first and final evaluations (p<0.001) and (p=0.035). CONCLUSION: the use of the NOC outcomes makes it possible to demonstrate the clinical progression of orthopedic patients with Impaired Physical Mobility, as well as its applicability in this context. PMID:25806631

Cheyletiella infestation in the dog: observations on diagnostic methods and clinical signs.

PubMed

Saevik, B K; Bredal, W; Ulstein, T L

2004-10-01

The aims of this study were to evaluate the ability of diagnostic methods to detect naturally occurring Cheyletiella infestation in dogs, and to quantify and relate the number of mites and eggs present to clinical signs. Privately owned dogs with skin problems were eligible for inclusion in the study. Four diagnostic tests were performed on each dog in the following order: tape impression, hair plucking, skin scraping and vacuum cleaning. Dogs with positive test results for Cheyletiella infestation in at least one of the tests under evaluation were included in the study (n=27). The severity of pruritus and scaling was graded on a four-point fixed scale. The diagnostic findings in vacuum cleaning samples provided a semiquantitative measure of the grade of infestation. The vacuum cleaning test gave a positive test result in all dogs and was significantly more efficient than the other tests evaluated (P<0.01). The number of diagnostic findings varied considerably among the different vacuum samples. No significant relationship between the number of diagnostic findings and severity of clinical signs was detected.

Should Athletic Training Educators Utilize Grades When Evaluating Student Clinical Performance?

ERIC Educational Resources Information Center

Scriber, Kent; Gray, Courtney; Millspaugh, Rose

2010-01-01

Objective: To explore and address some of the challenges for assessing, interpreting, and grading athletic training students' clinical performance and to suggest athletic training educators consider using a more universal assessment method for professional consistency. Background: In years past students learned from teachers or mentors on an…

Clinical Biophysics; A New Concept in Undergraduate Medical Education.

ERIC Educational Resources Information Center

Anbar, Michael

1981-01-01

The abilities to understand medical technology, to evaluate new devices and procedures, and to assess their effectiveness, reliability, costs, and risks in comparison with existing methods are discussed. A course in clinical biophysics offered at the State University of New York at Buffalo is described. (Author/MLW)

Workplace-Based Assessments in Psychiatry: Evaluation of a Whole Assessment System

ERIC Educational Resources Information Center

Brittlebank, Andrew; Archer, Julian; Longson, Damien; Malik, Amit; Bhugra, Dinesh K.

2013-01-01

Objective: Work Place-Based Assessments (WPBAs) were introduced into psychiatry along with the new curriculum in 2005. The Royal College of Psychiatrists decided to pilot several WPBAs to ascertain their suitability. Method: Eight types of assessments (Case-Based Discussion, Assessment of Clinical Expertise, Mini-Assessed Clinical Encounter,…

Application of gray level mapping in computed tomographic colonography: a pilot study to compare with traditional surface rendering method for identification and differentiation of endoluminal lesions

PubMed Central

Chen, Lih-Shyang; Hsu, Ta-Wen; Chang, Shu-Han; Lin, Chih-Wen; Chen, Yu-Ruei; Hsieh, Chin-Chiang; Han, Shu-Chen; Chang, Ku-Yaw; Hou, Chun-Ju

2017-01-01

Objective: In traditional surface rendering (SR) computed tomographic endoscopy, only the shape of endoluminal lesion is depicted without gray-level information unless the volume rendering technique is used. However, volume rendering technique is relatively slow and complex in terms of computation time and parameter setting. We use computed tomographic colonography (CTC) images as examples and report a new visualization technique by three-dimensional gray level mapping (GM) to better identify and differentiate endoluminal lesions. Methods: There are 33 various endoluminal cases from 30 patients evaluated in this clinical study. These cases were segmented using gray-level threshold. The marching cube algorithm was used to detect isosurfaces in volumetric data sets. GM is applied using the surface gray level of CTC. Radiologists conducted the clinical evaluation of the SR and GM images. The Wilcoxon signed-rank test was used for data analysis. Results: Clinical evaluation confirms GM is significantly superior to SR in terms of gray-level pattern and spatial shape presentation of endoluminal cases (p < 0.01) and improves the confidence of identification and clinical classification of endoluminal lesions significantly (p < 0.01). The specificity and diagnostic accuracy of GM is significantly better than those of SR in diagnostic performance evaluation (p < 0.01). Conclusion: GM can reduce confusion in three-dimensional CTC and well correlate CTC with sectional images by the location as well as gray-level value. Hence, GM increases identification and differentiation of endoluminal lesions, and facilitates diagnostic process. Advances in knowledge: GM significantly improves the traditional SR method by providing reliable gray-level information for the surface points and is helpful in identification and differentiation of endoluminal lesions according to their shape and density. PMID:27925483

A Clinical Evaluation of Cone Beam Computed Tomography

DTIC Science & Technology

2013-07-31

body of literature lacks in vivo studies comparing CBCT images with clinical findings. The purpose of this descriptive case series was to...All (18/18) bone measurements were underrepresented on CBCT images in this study . This case series also identified limitations in accuracy when... study was to compare pre-surgical CBCT images against the actual clinical presentation of the hard tissues. METHOD: Eleven patients requiring

Evaluating clinical ethics support in mental healthcare: a systematic literature review.

PubMed

Hem, Marit Helene; Pedersen, Reidar; Norvoll, Reidun; Molewijk, Bert

2015-06-01

A systematic literature review on evaluation of clinical ethics support services in mental healthcare is presented and discussed. The focus was on (a) forms of clinical ethics support services, (b) evaluation of clinical ethics support services, (c) contexts and participants and (d) results. Five studies were included. The ethics support activities described were moral case deliberations and ethics rounds. Different qualitative and quantitative research methods were utilized. The results show that (a) participants felt that they gained an increased insight into moral issues through systematic reflection; (b) there was improved cooperation among multidisciplinary team members; (c) it was uncertain whether clinical ethics support services led to better patient care; (d) the issue of patient and client participation is complex; and (e) the implementation process is challenging. Clinical ethics support services have mainly been studied through the experiences of the participating facilitators and healthcare professionals. Hence, there is limited knowledge of whether and how various types of clinical ethics support services influence the quality of care and how patients and relatives may evaluate clinical ethics support services. Based on the six excluded 'grey zone articles', in which there was an implicit focus on ethics reflection, other ways of working with ethical reflection in practice are discussed. Implementing and evaluating clinical ethics support services as approaches to clinical ethics support that are more integrated into the development of good practice are in focus. In order to meet some of the shortcomings of the field of clinical ethics support services, a research project that aims to strengthen ethics support in the mental health services, including patients' and caregivers' views on ethical challenges, is presented. © The Author(s) 2014.

Epidemiologic methods in mastitis treatment and control.

PubMed

Thurmond, M C

1993-11-01

Methods and concepts of epidemiology offer means whereby udder health can be monitored and evaluated. Prerequisite to a sound epidemiologic approach is development of measures of mastitis that minimize biases and that account for sensitivity and specificity of diagnostic tests. Mastitis surveillance offers an ongoing and passive system for evaluation of udder health, whereas clinical and observational trials offer a more proactive and developmental approach to improving udder health.

Candida bloodstream infection: a clinical microbiology laboratory perspective.

PubMed

Pongrácz, Júlia; Kristóf, Katalin

2014-09-01

The incidence of Candida bloodstream infection (BSI) has been on the rise in several countries worldwide. Species distribution is changing; an increase in the percentage of non-albicans species, mainly fluconazole non-susceptible C. glabrata was reported. Existing microbiology diagnostic methods lack sensitivity, and new methods need to be developed or further evaluation for routine application is necessary. Although reliable, standardized methods for antifungal susceptibility testing are available, the determination of clinical breakpoints remains challenging. Correct species identification is important and provides information on the intrinsic susceptibility profile of the isolate. Currently, acquired resistance in clinical Candida isolates is rare, but reports indicate that it could be an issue in the future. The role of the clinical microbiology laboratory is to isolate and correctly identify the infective agent and provide relevant and reliable susceptibility data as soon as possible to guide antifungal therapy.

Forensic Luminol Blood Test for Preventing Cross-contamination in Dentistry: An Evaluation of a Dental School Clinic

PubMed Central

Bortoluzzi, Marcelo Carlos; Cadore, Peterson; Gallon, Andrea; Imanishi, Soraia Almeida Watanabe

2014-01-01

Background: More than 200 different diseases may be transmitted from exposure to blood in the dental setting. The aim of this study is to identify possible faults in the crosscontamination chain control in a dental school clinic searching for traces of blood in the clinical contact surfaces (CCS) through forensic luminol blood test. Methods: Traces of invisible blood where randomly searched in CCS of one dental school clinic. Results: Forty eight surfaces areas in the CCS were tested and the presence of invisible and remnant blood was identified in 28 (58.3%) items. Conclusions: We suggest that the luminol method is suitable for identifying contamination with invisible blood traces and this method may be a useful tool to prevent cross-contamination in the dental care setting. PMID:25400895

Influence of the isolation method on the 10-year clinical behaviour of posterior resin composite restorations.

PubMed

Raskin, A; Setcos, J C; Vreven, J; Wilson, N H

2000-09-01

The aims of this prospective randomised clinical study were to clinically evaluate a radiopaque, highly filled, hybrid, light-activated resin-based composite for posterior teeth (Occlusin, ICI Dental, Macclesfield, UK and GC Dental, Tokyo, Japan) and compare the performance of restorations placed using rubber dam or cotton roll isolation. One clinician placed 100 (42 Class I and 58 Class II) restorations of the material under investigation. The isolation mode for each restoration was determined randomly: 52 preparations were protected from contamination with cotton rolls and aspiration, and 48 preparations were isolated under rubber dam. At baseline and periodically thereafter (0.5, 1, 2, 3, 4, 5, 6, and 10 years), each composite was evaluated by two practitioners using a modified (USPHS) rating system. After 10 years, 37 restorations were reviewed. The results showed satisfactory clinical performance with and without rubber dam after 10 years. A concern was the number of failures at 10 years due to unsatisfactory proximal contact. The evaluations for the surviving restorations were acceptable but with a large reduction in the percentage with ideal occlusal and proximal anatomy. The 10-year comparison of isolation modes showed no statistically significant differences (Kruskal-Wallis test) for each of the evaluation criteria. Furthermore, survival analysis showed no significant difference between the groups (Mantel-Haenszel method). It was concluded that the 10-year clinical behaviour of the restorations of a posterior composite placed under well-controlled, effective isolation with cotton rolls and aspiration, was not significantly different from the behaviour of restorations placed using rubber dam isolation.

Investigation on physiological and clinical effects of different light sources in TMJ photobiomodulation therapy

NASA Astrophysics Data System (ADS)

Kamenoff, J.

2017-02-01

Introduction Laser light Electromagnetic energy has some typical properties for discussions on laser irradiation abilities to control the acute and chronic disorders in TMJ. Material and Methods During the last six years we have been completed well controlled clinical trials based on the criteria of the American Academy of orofacial pain. The study over the 600 patients (300 women and 300 men), mean age of 47 years have been developed. Patients have been selected on the main clinical sign of TMJ pain and have been divided into four main groups according to the type of PDT method. Based on the action spectra, various wavelengths have been used for TMJ Photodynamic Therapy. Constant dose and time of exposition, as well as various range of frequencies have been applied. In this way the Laser biostimulation response has been directly proportional to the total energy dose, depending of light intensity. Physiological and clinical effects of the followed "active regions"- 660 - 680, 760 - 780, 810 - 830 and 904 - 987 nm have been valued by method of comparative analysis. Methods applied: LLLT - TENS - red surface laser acupuncture (LA), PIPBM - LA, Laser bioenergetics approach, Complex therapeutic program (CTP). Results evaluation will be demonstrated by comparative digital ortopantomograph analysis, EEG brain maps, VAS, a metric analysis of the level of the maximum active Mandible opening and EPST through electrophysiological signal evaluation of the patient's body.

Enhanced skills in periodontology: evaluation of a pilot scheme for general dental practitioners and dental care professionals in London.

PubMed

Ghotane, S G; Harrison, V; Radcliffe, E; Jones, E; Gallagher, J E

2017-05-12

Background The need for periodontal management is great and increasing; thus, the oral and dental workforce should be suitably equipped to deliver contemporary care. Health Education London developed a training scheme to extend the skills of dentists and dental care professionals (DCPs).Aim To examine the feasibility of assessing a skill-mix initiative established to enhance skills in clinical periodontology involving the views of patients, clinicians and key stakeholders, together with clinical and patient outcomes in London.Methods This mixed methods feasibility and pilot study involved four parallel elements: a postal questionnaire survey of patients; analysis of clinical logbooks; self-completion questionnaire survey of clinicians; and semi-structured interviews of key stakeholders, including clinicians.Results Twelve of the 19 clinicians participated in the evaluation, returning completed questionnaires (63%) and providing access to log diaries and patients. Periodontal data from 42 log-diary cases (1,103 teeth) revealed significant improvement in clinical outcomes (P = 0.001 for all). Eighty-four percent (N = 99) of the 142 patients returning a questionnaire reported improved dental health; however, responses from hospital patients greatly exceeded those from dental practice. Interviews (N = 22) provided evidence that the programme contributed to professional healthcare across four key domains: 'service', 'quality care', 'professional' and 'educational'. Clinicians, while supportive of the concept, raised concerns regarding the mismatch of their expectations and its educational and service outcomes.Discussion The findings suggest that it is feasible to deliver and evaluate inter-professional extended skills training for dentists and dental care professionals, and this may be evaluated using mixed methods to examine outcomes including clinical log diaries, patient questionnaires and stakeholder interviews. This inter-professional course represents a positive development for patient care using the expertise of different members of the dental team; however, its formal integration to the health and educational sectors require further consideration.

Accelerated Training of Skilled Birth Attendants in a Marginalized Population on the Thai-Myanmar Border: A Multiple Methods Program Evaluation

PubMed Central

White, Adrienne Lynne; Min, Thaw Htwe; Gross, Mechthild M.; Kajeechiwa, Ladda; Thwin, May Myo; Hanboonkunupakarn, Borimas; Than, Hla Hla; Zin, Thet Wai; Rijken, Marcus J.; Hoogenboom, Gabie; McGready, Rose

2016-01-01

Background To evaluate a skilled birth attendant (SBA) training program in a neglected population on the Thai-Myanmar border, we used multiple methods to show that refugee and migrant health workers can be given effective training in their own environment to become SBAs and teachers of SBAs. The loss of SBAs through resettlement to third countries necessitated urgent training of available workers to meet local needs. Methods and Findings All results were obtained from student records of theory grades and clinical log books. Qualitative evaluation of both the SBA and teacher programs was obtained using semi-structured interviews with supervisors and teachers. We also reviewed perinatal indicators over an eight-year period, starting prior to the first training program until after the graduation of the fourth cohort of SBAs. Results Four SBA training programs scheduled between 2009 and 2015 resulted in 79/88 (90%) of students successfully completing a training program of 250 theory hours and 625 supervised clinical hours. All 79 students were able to: achieve pass grades on theory examination (median 80%, range [70–89]); obtain the required clinical experience within twelve months; achieve clinical competence to provide safe care during childbirth. In 2010–2011, five experienced SBAs completed a train-the-trainer (TOT) program and went on to facilitate further training programs. Perinatal indicators within Shoklo Malaria Research Unit (SMRU), such as place of birth, maternal and newborn outcomes, showed no significant differences before and after introduction of training or following graduate deployment in the local maternity units. Confidence, competence and teamwork emerged from qualitative evaluation by senior SBAs working with and supervising students in the clinics. Conclusions We demonstrate that in resource-limited settings or in marginalized populations, it is possible to accelerate training of skilled birth attendants to provide safe maternity care. Education needs to be tailored to local needs to ensure evidence-based care of women and their families. PMID:27711144

A Comparative Analysis of Health-Related Quality of Life and Family Impact between Children with ADHD Treated in a General Pediatric Clinic and a Psychiatric Clinic Utilizing the PedsQL

ERIC Educational Resources Information Center

Limbers, Christine A.; Ripperger-Suhler, Jane; Boutton, Kelly; Ransom, Daniel; Varni, James W.

2011-01-01

Objective: To evaluate health-related quality of life (HRQOL) from the perspective of children with ADHD and their parents being seen in a Pediatric Clinic in comparison to healthy children and children with ADHD being seen in a Psychiatric Clinic. Method: Participants were children with a physician diagnosis of ADHD ages 5-18 years and their…

An application of actuarial methods in psychiatric diagnosis.

PubMed

Overall, J E; Higgins, C W

1977-10-01

An actuarial program for psychiatric diagnosis is evaluated for agreement with final clinical diagnosis in a series of 288 patients. The acturial program provides a probability differential diagnosis based on an analysis of history and background data, symptom rating profiles, and MMPI clinical scale profiles. The observed agreement with final clinical diagnosis is approximately 50% higher than previously reported for psychological testing in this same setting. The results emphasize the importance for psychologists of clinical interview and observation skills.

An evaluation of automatic coronary artery calcium scoring methods with cardiac CT using the orCaScore framework.

PubMed

Wolterink, Jelmer M; Leiner, Tim; de Vos, Bob D; Coatrieux, Jean-Louis; Kelm, B Michael; Kondo, Satoshi; Salgado, Rodrigo A; Shahzad, Rahil; Shu, Huazhong; Snoeren, Miranda; Takx, Richard A P; van Vliet, Lucas J; van Walsum, Theo; Willems, Tineke P; Yang, Guanyu; Zheng, Yefeng; Viergever, Max A; Išgum, Ivana

2016-05-01

The amount of coronary artery calcification (CAC) is a strong and independent predictor of cardiovascular disease (CVD) events. In clinical practice, CAC is manually identified and automatically quantified in cardiac CT using commercially available software. This is a tedious and time-consuming process in large-scale studies. Therefore, a number of automatic methods that require no interaction and semiautomatic methods that require very limited interaction for the identification of CAC in cardiac CT have been proposed. Thus far, a comparison of their performance has been lacking. The objective of this study was to perform an independent evaluation of (semi)automatic methods for CAC scoring in cardiac CT using a publicly available standardized framework. Cardiac CT exams of 72 patients distributed over four CVD risk categories were provided for (semi)automatic CAC scoring. Each exam consisted of a noncontrast-enhanced calcium scoring CT (CSCT) and a corresponding coronary CT angiography (CCTA) scan. The exams were acquired in four different hospitals using state-of-the-art equipment from four major CT scanner vendors. The data were divided into 32 training exams and 40 test exams. A reference standard for CAC in CSCT was defined by consensus of two experts following a clinical protocol. The framework organizers evaluated the performance of (semi)automatic methods on test CSCT scans, per lesion, artery, and patient. Five (semi)automatic methods were evaluated. Four methods used both CSCT and CCTA to identify CAC, and one method used only CSCT. The evaluated methods correctly detected between 52% and 94% of CAC lesions with positive predictive values between 65% and 96%. Lesions in distal coronary arteries were most commonly missed and aortic calcifications close to the coronary ostia were the most common false positive errors. The majority (between 88% and 98%) of correctly identified CAC lesions were assigned to the correct artery. Linearly weighted Cohen's kappa for patient CVD risk categorization by the evaluated methods ranged from 0.80 to 1.00. A publicly available standardized framework for the evaluation of (semi)automatic methods for CAC identification in cardiac CT is described. An evaluation of five (semi)automatic methods within this framework shows that automatic per patient CVD risk categorization is feasible. CAC lesions at ambiguous locations such as the coronary ostia remain challenging, but their detection had limited impact on CVD risk determination.

[Evaluation of mass spectrometry for the identification of clinically interesting yeasts].

PubMed

Galán, Fátima; García-Agudo, Lidia; Guerrero, Inmaculada; Marín, Pilar; García-Tapia, Ana; García-Martos, Pedro; Rodríguez-Iglesias, Manuel

2015-01-01

Identification of yeasts is based on morphological, biochemical and nutritional characteristics, and using molecular methods. Matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry, a new method for the identification of microorganisms, has demonstrated to be very useful. The aim of this study is to evaluate this new method in the identification of yeasts. A total of 600 strains of yeasts isolated from clinical specimens belonging to 9 genera and 43 species were tested. Identification was made by sequencing of the ITS regions of ribosomal DNA, assimilation of carbon compounds (ID 32C), and mass spectrometry on a Microflex spectrometer (Bruker Daltonics GmbH, Germany). A total of 569 strains (94.8%) were identified to species level by ID 32C, and 580 (96.7%) by MALDI-TOF. Concordance between both methods was observed for 553 strains (92.2%), with 100% in clinically relevant species: C. albicans, C. glabrata, C. parapsilosis, C. tropicalis, and almost 100% in C. krusei. MALDI-TOF identified species requiring molecular methods: Candida dubliniensis, C. nivariensis, C. metapsilosis and C. orthopsilosis. Some irregularities were observed in the identification of arthroconidia yeast and basidiomycetes. MALDI-TOF is a rapid, effective and economic method, which enables the identification of most clinically important yeasts and the differentiation of closely related species. It would be desirable to include more species in its database to expand its performance. Copyright © 2014 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

A non-linear regression method for CT brain perfusion analysis

NASA Astrophysics Data System (ADS)

Bennink, E.; Oosterbroek, J.; Viergever, M. A.; Velthuis, B. K.; de Jong, H. W. A. M.

2015-03-01

CT perfusion (CTP) imaging allows for rapid diagnosis of ischemic stroke. Generation of perfusion maps from CTP data usually involves deconvolution algorithms providing estimates for the impulse response function in the tissue. We propose the use of a fast non-linear regression (NLR) method that we postulate has similar performance to the current academic state-of-art method (bSVD), but that has some important advantages, including the estimation of vascular permeability, improved robustness to tracer-delay, and very few tuning parameters, that are all important in stroke assessment. The aim of this study is to evaluate the fast NLR method against bSVD and a commercial clinical state-of-art method. The three methods were tested against a published digital perfusion phantom earlier used to illustrate the superiority of bSVD. In addition, the NLR and clinical methods were also tested against bSVD on 20 clinical scans. Pearson correlation coefficients were calculated for each of the tested methods. All three methods showed high correlation coefficients (>0.9) with the ground truth in the phantom. With respect to the clinical scans, the NLR perfusion maps showed higher correlation with bSVD than the perfusion maps from the clinical method. Furthermore, the perfusion maps showed that the fast NLR estimates are robust to tracer-delay. In conclusion, the proposed fast NLR method provides a simple and flexible way of estimating perfusion parameters from CT perfusion scans, with high correlation coefficients. This suggests that it could be a better alternative to the current clinical and academic state-of-art methods.

4D co-registration of X-ray and MR-mammograms: initial clinical results and potential incremental diagnostic value.

PubMed

Dietzel, Matthias; Hopp, Torsten; Ruiter, Nicole V; Kaiser, Clemens G; Kaiser, Werner A; Baltzer, Pascal A

2015-01-01

4D co-registration of X-ray- and MR-mammograms (XM and MM) is a new method of image fusion. The present study aims to evaluate its clinical feasibility, radiological accuracy, and potential clinical value. XM and MM of 25 patients were co-registered. Results were evaluated by a blinded reader. Precision of the 4D co-registration was "very good" (mean-score [ms]=7), and lesions were "easier to delineate" (ms=5). In 88.8%, "relevant additional diagnostic information" was present, accounting for a more "confident diagnosis" in 76% (ms=5). 4D co-registration is feasible, accurate, and of potential clinical value. Copyright © 2015 Elsevier Inc. All rights reserved.

Preliminary evaluation of a gel tube agglutination major cross-match method in dogs.

PubMed

Villarnovo, Dania; Burton, Shelley A; Horney, Barbara S; MacKenzie, Allan L; Vanderstichel, Raphaël

2016-09-01

A major cross-match gel tube test is available for use in dogs yet has not been clinically evaluated. This study compared cross-match results obtained using the gel tube and the standard tube methods for canine samples. Study 1 included 107 canine sample donor-recipient pairings cross-match tested with the RapidVet-H method gel tube test and compared results with the standard tube method. Additionally, 120 pairings using pooled sera containing anti-canine erythrocyte antibody at various concentrations were tested with leftover blood from a hospital population to assess sensitivity and specificity of the gel tube method in comparison with the standard method. The gel tube method had a good relative specificity of 96.1% in detecting lack of agglutination (compatibility) compared to the standard tube method. Agreement between the 2 methods was moderate. Nine of 107 pairings showed agglutination/incompatibility on either test, too few to allow reliable calculation of relative sensitivity. Fifty percent of the gel tube method results were difficult to interpret due to sample spreading in the reaction and/or negative control tubes. The RapidVet-H method agreed with the standard cross-match method on compatible samples, but detected incompatibility in some sample pairs that were compatible with the standard method. Evaluation using larger numbers of incompatible pairings is needed to assess diagnostic utility. The gel tube method results were difficult to categorize due to sample spreading. Weak agglutination reactions or other factors such as centrifuge model may be responsible. © 2016 American Society for Veterinary Clinical Pathology.

Retractions of the gingival margins evaluated by holographic methods

NASA Astrophysics Data System (ADS)

Sinescu, Cosmin; Negrutiu, Meda Lavinia; Manole, Marius; de Sabata, Aldo; Rusu, Laura-Cristina; Stratul, Stefan; Dudea, Diana; Dughir, Ciprian; Duma, Virgil-Florin

2015-05-01

The periodontal disease is one of the most common pathological states of the teeth and gums system. The issue is that its evaluation is a subjective one, i.e. it is based on the skills of the dental medical doctor. As for any clinical condition, a quantitative evaluation and monitoring in time of the retraction of the gingival margins is desired. This phenomenon was evaluated in this study with a holographic method by using a He-Ne laser with a power of 13 mW. The holographic system we have utilized - adapted for dentistry applications - is described. Several patients were considered in a comparative study of their state of health - regarding their oral cavity. The impressions of the maxillary dental arch were taken from a patient during his/her first visit and after a period of six months. The hologram of the first model was superposed on the model cast after the second visit. The retractions of the gingival margins could be thus evaluated three-dimensionally in every point of interest. An evaluation of the retraction has thus been made. Conclusions can thus be drawn for the clinical evaluation of the health of the teeth and gums system of each patient.

The case for randomized controlled trials to assess the impact of clinical information systems.

PubMed

Liu, Joseph L Y; Wyatt, Jeremy C

2011-01-01

There is a persistent view of a significant minority in the medical informatics community that the randomized controlled trial (RCT) has a limited role to play in evaluating clinical information systems. A common reason voiced by skeptics is that these systems are fundamentally different from drug interventions, so the RCT is irrelevant. There is an urgent need to promote the use of RCTs, given the shift to evidence-based policy and the need to demonstrate cost-effectiveness of these systems. The authors suggest returning to first principles and argue that what is required is clarity about how to match methods to evaluation questions. The authors address common concerns about RCTs, and the extent to which they are fallacious, and also discuss the challenges of conducting RCTs in informatics and alternative study designs when randomized trials are infeasible. While neither a perfect nor universal evaluation method, RCTs form an important part of an evaluator's toolkit.

Magnetic resonance imaging of articular cartilage: trauma, degeneration, and repair.

PubMed

Potter, Hollis G; Foo, Li F

2006-04-01

The assessment of articular cartilage using magnetic resonance imaging has seen considerable advances in recent years. Cartilage morphologic characteristics can now be evaluated with a high degree of accuracy and reproducibility using dedicated pulse sequences, which are becoming standard at many institutions. These techniques detect clinically unsuspected traumatic cartilage lesions, allowing the physician to study their natural history with longitudinal evaluation and also to assess disease status in degenerative osteoarthritis. Magnetic resonance imaging also provides a more objective assessment of cartilage repair to augment the information obtained from more subjective clinical outcome instruments. Newly developed methods that provide detail at an ultrastructural level offer an important addition to cartilage evaluation, particularly in the detection of early alterations in the extracellular matrix. These methods have created an undeniably important role for magnetic resonance imaging in the reproducible, noninvasive, and objective evaluation and monitoring of cartilage. An overview of the advances, current techniques, and impact of magnetic resonance imaging in the setting of trauma, degenerative arthritides, and surgical treatment for cartilage injury is presented.

The case for randomized controlled trials to assess the impact of clinical information systems

PubMed Central

Wyatt, Jeremy C

2011-01-01

There is a persistent view of a significant minority in the medical informatics community that the randomized controlled trial (RCT) has a limited role to play in evaluating clinical information systems. A common reason voiced by skeptics is that these systems are fundamentally different from drug interventions, so the RCT is irrelevant. There is an urgent need to promote the use of RCTs, given the shift to evidence-based policy and the need to demonstrate cost-effectiveness of these systems. The authors suggest returning to first principles and argue that what is required is clarity about how to match methods to evaluation questions. The authors address common concerns about RCTs, and the extent to which they are fallacious, and also discuss the challenges of conducting RCTs in informatics and alternative study designs when randomized trials are infeasible. While neither a perfect nor universal evaluation method, RCTs form an important part of an evaluator's toolkit. PMID:21270132

Portfolio as a tool to evaluate clinical competences of traumatology in medical students

PubMed Central

Santonja-Medina, Fernando; García-Sanz, M Paz; Martínez-Martínez, Francisco; Bó, David; García-Estañ, Joaquín

2016-01-01

This article investigates whether a reflexive portfolio is instrumental in determining the level of acquisition of clinical competences in traumatology, a subject in the 5th year of the degree of medicine. A total of 131 students used the portfolio during their clinical rotation of traumatology. The students’ portfolios were blind evaluated by four professors who annotated the existence (yes/no) of 23 learning outcomes. The reliability of the portfolio was moderate, according to the kappa index (0.48), but the evaluation scores between evaluators were very similar. Considering the mean percentage, 59.8% of the students obtained all the competences established and only 13 of the 23 learning outcomes (56.5%) were fulfilled by >50% of the students. Our study suggests that the portfolio may be an important tool to quantitatively analyze the acquisition of traumatology competences of medical students, thus allowing the implementation of methods to improve its teaching. PMID:26929675

Exercise intolerance in pulmonary hypertension: mechanism, evaluation and clinical implications.

PubMed

Babu, Abraham Samuel; Arena, Ross; Myers, Jonathan; Padmakumar, Ramachandran; Maiya, Arun G; Cahalin, Lawrence P; Waxman, Aaron B; Lavie, Carl J

2016-09-01

Exercise intolerance in pulmonary hypertension (PH) is a major factor affecting activities of daily living and quality of life. Evaluation strategies (i.e., non-invasive and invasive tests) are integral to providing a comprehensive assessment of clinical and functional status. Despite a growing body of literature on the clinical consequences of PH, there are limited studies discussing the contribution of various physiological systems to exercise intolerance in this patient population. This review, through a search of various databases, describes the physiological basis for exercise intolerance across the various PH etiologies, highlights the various exercise evaluation methods and discusses the rationale for exercise training amongst those diagnosed with PH. Expert commentary: With the growing importance of evaluating exercise capacity in PH (class 1, Level C recommendation), understanding why exercise performance is altered in PH is crucial. Thus, the further study is required for better quality evidence in this area.

Clinical peer review program self-evaluation for US hospitals.

PubMed

Edwards, Marc T

2010-01-01

Prior research has shown wide variation in clinical peer review program structure, process, governance, and perceived effectiveness. This study sought to validate the utility of a Peer Review Program Self-Evaluation Tool as a potential guide to physician and hospital leaders seeking greater program value. Data from 330 hospitals show that the total score from the self-evaluation tool is strongly associated with perceived quality impact. Organizational culture also plays a significant role. When controlling for these factors, there was no evidence of benefit from a multispecialty review process. Physicians do not generally use reliable methods to measure clinical performance. A high rate of change since 2007 has not produced much improvement. The Peer Review Program Self-Evaluation Tool reliably differentiates hospitals along a continuum of perceived program performance. The full potential of peer review as a process to improve the quality and safety of care has yet to be realized.

Portfolio as a tool to evaluate clinical competences of traumatology in medical students.

PubMed

Santonja-Medina, Fernando; García-Sanz, M Paz; Martínez-Martínez, Francisco; Bó, David; García-Estañ, Joaquín

2016-01-01

This article investigates whether a reflexive portfolio is instrumental in determining the level of acquisition of clinical competences in traumatology, a subject in the 5th year of the degree of medicine. A total of 131 students used the portfolio during their clinical rotation of traumatology. The students' portfolios were blind evaluated by four professors who annotated the existence (yes/no) of 23 learning outcomes. The reliability of the portfolio was moderate, according to the kappa index (0.48), but the evaluation scores between evaluators were very similar. Considering the mean percentage, 59.8% of the students obtained all the competences established and only 13 of the 23 learning outcomes (56.5%) were fulfilled by >50% of the students. Our study suggests that the portfolio may be an important tool to quantitatively analyze the acquisition of traumatology competences of medical students, thus allowing the implementation of methods to improve its teaching.

Risk factors for incidence and severity of white spot lesions during treatment with fixed orthodontic appliances.

PubMed

Chapman, Joshua A; Roberts, W Eugene; Eckert, George J; Kula, Katherine S; González-Cabezas, Carlos

2010-08-01

The development of incipient caries, or white spot lesions (WSLs), is a significant clinical problem in orthodontics. The purpose of this study was to retrospectively determine the incidence and severity of WSLs by examining pretreatment and posttreatment digital photographs. A total of 332 consecutive finished patients from a university graduate orthodontic clinic were evaluated. Initial and final digital images were compared to assess WSLs. The facial surfaces of the anterior 8 maxillary teeth were analyzed. The percentage area of WSL per total facial tooth surface was calculated to control for magnification differences. Reliability of the method was assessed by comparison with direct clinical examination data. Patient and operator factors, and treatment complexity and outcomes were evaluated as predictors of WSL incidence and severity. Agreement between direct clinical examination and digital photo data was excellent, with an intraclass correlation coefficient 0.88 and a 0.3% average difference between methods. The incidence of at least 1 WSL on the labial surface of the anterior 8 maxillary teeth was 36%. The order of incidence was lateral incisor (34%), canine (31%), premolar (28%), and central incisor (17%). Risk factors for the development of incipient caries during orthodontic treatment were young age (preadolescent) at the start of treatment, number of poor hygiene citations during treatment, unfavorable clinical outcome score, white ethnic group, and inadequate oral hygiene at the initial pretreatment examination. The use of computer software to evaluate digital photos retrospectively is a valid method for assessing the incidence and severity of WSLs on the maxillary anterior incisors, canines, and premolars. Copyright (c) 2010 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Novel method for evaluation of eye movements in patients with narcolepsy.

PubMed

Christensen, Julie A E; Kempfner, Lykke; Leonthin, Helle L; Hvidtfelt, Mathias; Nikolic, Miki; Kornum, Birgitte Rahbek; Jennum, Poul

2017-05-01

Narcolepsy causes abnormalities in the control of wake-sleep, non-rapid-eye-movement (non-REM) sleep and REM sleep, which includes specific eye movements (EMs). In this study, we aim to evaluate EM characteristics in narcolepsy as compared to controls using an automated detector. We developed a data-driven method to detect EMs during sleep based on two EOG signals recorded as part of a polysomnography (PSG). The method was optimized using the manually scored hypnograms from 36 control subjects. The detector was applied on a clinical sample with subjects suspected for central hypersomnias. Based on PSG, multiple sleep latency test and cerebrospinal fluid hypocretin-1 measures, they were divided into clinical controls (N = 20), narcolepsy type 2 (NT2, N = 19), and narcolepsy type 1 (NT1, N = 28). We investigated the distribution of EMs across sleep stages and cycles. NT1 patients had significantly less EMs during wake, N1, and N2 sleep and more EMs during REM sleep compared to clinical controls, and significantly less EMs during wake and N1 sleep compared to NT2 patients. Furthermore, NT1 patients showed less EMs during NREM sleep in the first sleep cycle and more EMs during NREM sleep in the second sleep cycle compared to clinical controls and NT2 patients. NT1 patients show an altered distribution of EMs across sleep stages and cycles compared to NT2 patients and clinical controls, suggesting that EMs are directly or indirectly controlled by the hypocretinergic system. A data-driven EM detector may contribute to the evaluation of narcolepsy and other disorders involving the control of EMs. Copyright © 2016 Elsevier B.V. All rights reserved.

Extracting similar terms from multiple EMR-based semantic embeddings to support chart reviews.

PubMed

Cheng Ye, M S; Fabbri, Daniel

2018-05-21

Word embeddings project semantically similar terms into nearby points in a vector space. When trained on clinical text, these embeddings can be leveraged to improve keyword search and text highlighting. In this paper, we present methods to refine the selection process of similar terms from multiple EMR-based word embeddings, and evaluate their performance quantitatively and qualitatively across multiple chart review tasks. Word embeddings were trained on each clinical note type in an EMR. These embeddings were then combined, weighted, and truncated to select a refined set of similar terms to be used in keyword search and text highlighting. To evaluate their quality, we measured the similar terms' information retrieval (IR) performance using precision-at-K (P@5, P@10). Additionally a user study evaluated users' search term preferences, while a timing study measured the time to answer a question from a clinical chart. The refined terms outperformed the baseline method's information retrieval performance (e.g., increasing the average P@5 from 0.48 to 0.60). Additionally, the refined terms were preferred by most users, and reduced the average time to answer a question. Clinical information can be more quickly retrieved and synthesized when using semantically similar term from multiple embeddings. Copyright © 2018. Published by Elsevier Inc.

Identification of design features to enhance utilization and acceptance of systems for Internet-based decision support at the point of care.

PubMed Central

Gadd, C. S.; Baskaran, P.; Lobach, D. F.

1998-01-01

Extensive utilization of point-of-care decision support systems will be largely dependent on the development of user interaction capabilities that make them effective clinical tools in patient care settings. This research identified critical design features of point-of-care decision support systems that are preferred by physicians, through a multi-method formative evaluation of an evolving prototype of an Internet-based clinical decision support system. Clinicians used four versions of the system--each highlighting a different functionality. Surveys and qualitative evaluation methodologies assessed clinicians' perceptions regarding system usability and usefulness. Our analyses identified features that improve perceived usability, such as telegraphic representations of guideline-related information, facile navigation, and a forgiving, flexible interface. Users also preferred features that enhance usefulness and motivate use, such as an encounter documentation tool and the availability of physician instruction and patient education materials. In addition to identifying design features that are relevant to efforts to develop clinical systems for point-of-care decision support, this study demonstrates the value of combining quantitative and qualitative methods of formative evaluation with an iterative system development strategy to implement new information technology in complex clinical settings. Images Figure 1 PMID:9929188

Using phrases and document metadata to improve topic modeling of clinical reports.

PubMed

Speier, William; Ong, Michael K; Arnold, Corey W

2016-06-01

Probabilistic topic models provide an unsupervised method for analyzing unstructured text, which have the potential to be integrated into clinical automatic summarization systems. Clinical documents are accompanied by metadata in a patient's medical history and frequently contains multiword concepts that can be valuable for accurately interpreting the included text. While existing methods have attempted to address these problems individually, we present a unified model for free-text clinical documents that integrates contextual patient- and document-level data, and discovers multi-word concepts. In the proposed model, phrases are represented by chained n-grams and a Dirichlet hyper-parameter is weighted by both document-level and patient-level context. This method and three other Latent Dirichlet allocation models were fit to a large collection of clinical reports. Examples of resulting topics demonstrate the results of the new model and the quality of the representations are evaluated using empirical log likelihood. The proposed model was able to create informative prior probabilities based on patient and document information, and captured phrases that represented various clinical concepts. The representation using the proposed model had a significantly higher empirical log likelihood than the compared methods. Integrating document metadata and capturing phrases in clinical text greatly improves the topic representation of clinical documents. The resulting clinically informative topics may effectively serve as the basis for an automatic summarization system for clinical reports. Copyright © 2016 Elsevier Inc. All rights reserved.

Expert Systems In Medical Studies - A New Twist

NASA Astrophysics Data System (ADS)

Slagle, James R.; Long, John M.; Wick, Michael R.; Matts, John P.; Leon, Arthur S.

1986-03-01

The use of experts to evaluate large amounts of trial data results in increasingly expensive and time consuming research. We are investigating the role expert systems can play in reducing the time and expense of research projects. Current methods in large clinical studies for evaluating data are often crude and superficial. We have developed, for a large clinical trial, an expert system for analysis of treadmill exercise ECG test results. In the cases we are studying, a patient is given a treadmill exercise ECG test once a year for five years. Pairs of these exercise tests are then evaluated by cardiologists to determine the condition of the patient's heart. The results of our system show great promise for the use of expert systems in reducing the time and expense of large clinical trials.

[Evaluation on methodological problems in reports concerning quantitative analysis of syndrome differentiation of diabetes mellitus].

PubMed

Chen, Bi-Cang; Wu, Qiu-Ying; Xiang, Cheng-Bin; Zhou, Yi; Guo, Ling-Xiang; Zhao, Neng-Jiang; Yang, Shu-Yu

2006-01-01

To evaluate the quality of reports published in recent 10 years in China about quantitative analysis of syndrome differentiation for diabetes mellitus (DM) in order to explore the methodological problems in these reports and find possible solutions. The main medical literature databases in China were searched. Thirty-one articles were included and evaluated by the principles of clinical epidemiology. There were many mistakes and deficiencies in these articles, such as clinical trial designs, diagnosis criteria for DM, standards of syndrome differentiation of DM, case inclusive and exclusive criteria, sample size and estimation, data comparability and statistical methods. It is necessary and important to improve the quality of reports concerning quantitative analysis of syndrome differentiation of DM in light of the principles of clinical epidemiology.

Software-assisted post-interventional assessment of radiofrequency ablation

NASA Astrophysics Data System (ADS)

Rieder, Christian; Geisler, Benjamin; Bruners, Philipp; Isfort, Peter; Na, Hong-Sik; Mahnken, Andreas H.; Hahn, Horst K.

2014-03-01

Radiofrequency ablation (RFA) is becoming a standard procedure for minimally invasive tumor treatment in clinical practice. Due to its common technical procedure, low complication rate, and low cost, RFA has become an alternative to surgical resection in the liver. To evaluate the therapy success of RFA, thorough follow-up imaging is essential. Conventionally, shape, size, and position of tumor and coagulation are visually compared in a side-by-side manner using pre- and post-interventional images. To objectify the verification of the treatment success, a novel software assistant allowing for fast and accurate comparison of tumor and coagulation is proposed. In this work, the clinical value of the proposed assessment software is evaluated. In a retrospective clinical study, 39 cases of hepatic tumor ablation are evaluated using the prototype software and conventional image comparison by four radiologists with different levels of experience. The cases are randomized and evaluated in two sessions to avoid any recall-bias. Self-confidence of correct diagnosis (local recurrence vs. no local recurrence) on a six-point scale is given for each case by the radiologists. Sensitivity, specificity, positive and negative predictive values as well as receiver operating curves are calculated for both methods. It is shown that the software-assisted method allows physicians to correctly identify local tumor recurrence with a higher percentage than the conventional method (sensitivity: 0.6 vs. 0.35), whereas the percentage of correctly identified successful ablations is slightly reduced (specificity: 0.83 vs. 0.89).

Clinical guideline for nurse-led early extubation after coronary artery bypass: an evaluation.

PubMed

Hawkes, Claire; Foxcroft, David R; Yerrell, Paul

2010-09-01

This paper is a report of an investigation of the development, implementation and outcomes of a clinical guideline for nurse-led early extubation of adult coronary artery bypass graft patients. Healthcare knowledge translation and utilization is an emerging but under-developed research area. The complex context for guideline development and use is methodologically challenging for robust and rigorous evaluation. This study contributes one such evaluation. This was a mixed methods evaluation, with a dominant quantitative study with a secondary qualitative study in a single UK cardiac surgery centre. An interrupted time series study (N = 567 elective coronary artery bypass graft patients) with concurrent within person controls was used to measure the impact of the guideline on the primary outcome: time to extubation. Semi-structured interviews with 11 clinical staff, informed by applied practitioner ethnography, explored the process of guideline development and implementation. The data were collected between January 2001 and January 2003. There was no change in the interrupted time series study primary outcome as a consequence of the guideline implementation. The qualitative study identified three themes: context, process and tensions highlighting that the guideline did not require clinicians to change their practice, although it may have helped maintain practice through its educative role. Further investigation and development of appropriate methods to capture the dynamism in healthcare contexts and its impact on guideline implementation seems warranted. Multi-site mixed methods investigations and programmes of research exploring knowledge translation and utilization initiatives, such as guideline implementation, are needed.

Grading Medical Students in a Psychiatry Clerkship: Correlation with the NBME Subject Examination Scores and Its Implications

ERIC Educational Resources Information Center

Ramchandani, Dilip

2011-01-01

Background/Objective: The author analyzed and compared various assessment methods for assessment of medical students; these methods included clinical assessment and the standardized National Board of Medical Education (NBME) subject examination. Method: Students were evaluated on their 6-week clerkship in psychiatry by both their clinical…

Economic Analysis of Centralized vs. Decentralized Electronic Data Capture in Multi-Center Clinical Studies

PubMed Central

Walden, Anita; Nahm, Meredith; Barnett, M. Edwina; Conde, Jose G.; Dent, Andrew; Fadiel, Ahmed; Perry, Theresa; Tolk, Chris; Tcheng, James E.; Eisenstein, Eric L.

2012-01-01

Background New data management models are emerging in multi-center clinical studies. We evaluated the incremental costs associated with decentralized vs. centralized models. Methods We developed clinical research network economic models to evaluate three data management models: centralized, decentralized with local software, and decentralized with shared database. Descriptive information from three clinical research studies served as inputs for these models. Main Outcome Measures The primary outcome was total data management costs. Secondary outcomes included: data management costs for sites, local data centers, and central coordinating centers. Results Both decentralized models were more costly than the centralized model for each clinical research study: the decentralized with local software model was the most expensive. Decreasing the number of local data centers and case book pages reduced cost differentials between models. Conclusion Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs. PMID:21335692

Comparing and combining biomarkers as principle surrogates for time-to-event clinical endpoints.

PubMed

Gabriel, Erin E; Sachs, Michael C; Gilbert, Peter B

2015-02-10

Principal surrogate endpoints are useful as targets for phase I and II trials. In many recent trials, multiple post-randomization biomarkers are measured. However, few statistical methods exist for comparison of or combination of biomarkers as principal surrogates, and none of these methods to our knowledge utilize time-to-event clinical endpoint information. We propose a Weibull model extension of the semi-parametric estimated maximum likelihood method that allows for the inclusion of multiple biomarkers in the same risk model as multivariate candidate principal surrogates. We propose several methods for comparing candidate principal surrogates and evaluating multivariate principal surrogates. These include the time-dependent and surrogate-dependent true and false positive fraction, the time-dependent and the integrated standardized total gain, and the cumulative distribution function of the risk difference. We illustrate the operating characteristics of our proposed methods in simulations and outline how these statistics can be used to evaluate and compare candidate principal surrogates. We use these methods to investigate candidate surrogates in the Diabetes Control and Complications Trial. Copyright © 2014 John Wiley & Sons, Ltd.

An investigation into the two-stage meta-analytic copula modelling approach for evaluating time-to-event surrogate endpoints which comprise of one or more events of interest.

PubMed

Dimier, Natalie; Todd, Susan

2017-09-01

Clinical trials of experimental treatments must be designed with primary endpoints that directly measure clinical benefit for patients. In many disease areas, the recognised gold standard primary endpoint can take many years to mature, leading to challenges in the conduct and quality of clinical studies. There is increasing interest in using shorter-term surrogate endpoints as substitutes for costly long-term clinical trial endpoints; such surrogates need to be selected according to biological plausibility, as well as the ability to reliably predict the unobserved treatment effect on the long-term endpoint. A number of statistical methods to evaluate this prediction have been proposed; this paper uses a simulation study to explore one such method in the context of time-to-event surrogates for a time-to-event true endpoint. This two-stage meta-analytic copula method has been extensively studied for time-to-event surrogate endpoints with one event of interest, but thus far has not been explored for the assessment of surrogates which have multiple events of interest, such as those incorporating information directly from the true clinical endpoint. We assess the sensitivity of the method to various factors including strength of association between endpoints, the quantity of data available, and the effect of censoring. In particular, we consider scenarios where there exist very little data on which to assess surrogacy. Results show that the two-stage meta-analytic copula method performs well under certain circumstances and could be considered useful in practice, but demonstrates limitations that may prevent universal use. Copyright © 2017 John Wiley & Sons, Ltd.

Evaluation of gastric emptying function in clinical practice.

PubMed

Poitras, P; Picard, M; Déry, R; Giguère, A; Picard, D; Morais, J; Plourde, V; Boivin, M

1997-11-01

In this retrospective analysis, we compared different methods to evaluate gastric emptying function, aiming to improve the sensitivity and the clinical availability of our diagnostic testing. In the first study, we compared, in 72 patients clinically suspected of gastroparesis, the emptying of a meal containing two solid nutrients with different disintegration rates: 111In-labeled scrambled eggs and 99Tc-labeled liver cubes. Gastric emptying of 111In-labeled egg was delayed in 12 of our patients and the evacuation of the 99Tc-labeled liver was prolonged in 19 patients. The choice of the nutrient was not important for the identification of diabetic gastroparesis (43% vs 57%; NS), but it was determinant in the case of patients suspected of idiopathic gastroparesis (12% were positive with the egg and 25% with the liver; P < 0.05). In the second study, we compared two different diagnostic methods in 46 patients: a simple radiological detection of the gastric emptying of radiopaque pellets, and the scintigraphic emptying of a solid meal containing 99Tc-labeled liver cubes. Both tests correlated perfectly in 78% of our patients. In 15% of the population (six of these seven patients were diabetics suspected of gastroparesis) the scintigraphic method was normal, while the evacuation of radiopaque pellets was delayed. For clinical purposes, we therefore propose: (1) the scintigraphic method should use liver rather than egg as a radiolabeled tracer in order to improve the sensitivity of the test for detection of gastroparesis; and (2) the radiological detection of radiopaque markers is a reliable and convenient method for the detection of gastroparesis in clinical practice. It is possibly more sensitive than scintigraphy.

Recognition of medication information from discharge summaries using ensembles of classifiers.

PubMed

Doan, Son; Collier, Nigel; Xu, Hua; Pham, Hoang Duy; Tu, Minh Phuong

2012-05-07

Extraction of clinical information such as medications or problems from clinical text is an important task of clinical natural language processing (NLP). Rule-based methods are often used in clinical NLP systems because they are easy to adapt and customize. Recently, supervised machine learning methods have proven to be effective in clinical NLP as well. However, combining different classifiers to further improve the performance of clinical entity recognition systems has not been investigated extensively. Combining classifiers into an ensemble classifier presents both challenges and opportunities to improve performance in such NLP tasks. We investigated ensemble classifiers that used different voting strategies to combine outputs from three individual classifiers: a rule-based system, a support vector machine (SVM) based system, and a conditional random field (CRF) based system. Three voting methods were proposed and evaluated using the annotated data sets from the 2009 i2b2 NLP challenge: simple majority, local SVM-based voting, and local CRF-based voting. Evaluation on 268 manually annotated discharge summaries from the i2b2 challenge showed that the local CRF-based voting method achieved the best F-score of 90.84% (94.11% Precision, 87.81% Recall) for 10-fold cross-validation. We then compared our systems with the first-ranked system in the challenge by using the same training and test sets. Our system based on majority voting achieved a better F-score of 89.65% (93.91% Precision, 85.76% Recall) than the previously reported F-score of 89.19% (93.78% Precision, 85.03% Recall) by the first-ranked system in the challenge. Our experimental results using the 2009 i2b2 challenge datasets showed that ensemble classifiers that combine individual classifiers into a voting system could achieve better performance than a single classifier in recognizing medication information from clinical text. It suggests that simple strategies that can be easily implemented such as majority voting could have the potential to significantly improve clinical entity recognition.

Evaluation of a Computerized Clinical Information System (Micromedex).

PubMed Central

Lundsgaarde, H. P.; Moreshead, G. E.

1991-01-01

This paper summarizes data collected as part of a project designed to identify and assess the technical and organizational problems associated with the implementation and evaluation of a Computerized Clinical Information System (CCIS), Micromedex, in three U.S. Department of Veterans Affairs Medical Centers (VAMCs). The study began in 1987 as a national effort to implement decision support technologies in the Veterans Administration Decentralized Hospital Computer Program (DHCP). The specific objectives of this project were to (1) examine one particular decision support technology, (2) identify the technical and organizational barriers to the implementation of a CCIS in the VA host environment, (3) assess the possible benefits of this system to VA clinicians in terms of therapeutic decision making, and (4) develop new methods for identifying the clinical utility of a computer program designed to provide clinicians with a new information tool. The project was conducted intermittently over a three-year period at three VA medical centers chosen as implementation and evaluation test sites for Micromedex. Findings from the Kansas City Medical Center in Missouri are presented to illustrate some of the technical problems associated with the implementation of a commercial database program in the DHCP host environment, the organizational factors influencing clinical use of the system, and the methods used to evaluate its use. Data from 4581 provider encounters with the CCIS are summarized. Usage statistics are presented to illustrate the methodological possibilities for assessing the "benefits and burdens" of a computerized information system by using an automated collection of user demographics and program audit trails that allow evaluators to monitor user interactions with different segments of the database. PMID:1807583

Evaluation of a Computerized Clinical Information System (Micromedex).

PubMed

Lundsgaarde, H P; Moreshead, G E

1991-01-01

This paper summarizes data collected as part of a project designed to identify and assess the technical and organizational problems associated with the implementation and evaluation of a Computerized Clinical Information System (CCIS), Micromedex, in three U.S. Department of Veterans Affairs Medical Centers (VAMCs). The study began in 1987 as a national effort to implement decision support technologies in the Veterans Administration Decentralized Hospital Computer Program (DHCP). The specific objectives of this project were to (1) examine one particular decision support technology, (2) identify the technical and organizational barriers to the implementation of a CCIS in the VA host environment, (3) assess the possible benefits of this system to VA clinicians in terms of therapeutic decision making, and (4) develop new methods for identifying the clinical utility of a computer program designed to provide clinicians with a new information tool. The project was conducted intermittently over a three-year period at three VA medical centers chosen as implementation and evaluation test sites for Micromedex. Findings from the Kansas City Medical Center in Missouri are presented to illustrate some of the technical problems associated with the implementation of a commercial database program in the DHCP host environment, the organizational factors influencing clinical use of the system, and the methods used to evaluate its use. Data from 4581 provider encounters with the CCIS are summarized. Usage statistics are presented to illustrate the methodological possibilities for assessing the "benefits and burdens" of a computerized information system by using an automated collection of user demographics and program audit trails that allow evaluators to monitor user interactions with different segments of the database.

A Clinic-Based Assessment for Evaluating Job-Related Social Skills in Adolescents and Adults with Autism.

PubMed

Lerman, Dorothea C; White, Bridgette; Grob, Carolyn; Laudont, Courtney

2017-12-01

Many individuals with autism spectrum disorder (ASD) have difficulties obtaining and maintaining employment, yet little research has evaluated methods for assessing and improving critical vocational skills. In this study, we evaluated an assessment of job-related social skills for individuals with ASD by arranging conditions that simulated on-the-job experiences in a clinic setting. The experimenter contrived situations to assess a variety of social skills, including asking for help, asking for more materials, and responding to corrective feedback. A total of eight individuals, aged 16 to 32 years, participated. Results suggested that the assessment was useful for identifying specific social skills that could be targeted for intervention to increase success in the work environment. These findings add to the current literature by demonstrating an objective method for assessing a variety of job-related social skills under controlled, naturalistic conditions.

Clinical evaluation of the Jay Sensitivity Sensor Probe: a new microprocessor-controlled instrument to evaluate dentin hypersensitivity.

PubMed

Sowinski, Joseph A; Kakar, Ashish; Kakar, Kanupriya

2013-05-01

To compare the Jay Sensitivity Sensor Probe (Jay Probe), a new microprocessor-based, pre-calibrated instrument, with well accepted methods used to evaluate sensitivity, i.e. tactile response to the Yeaple Probe, air blast (Schiff scale), and patient responses by Visual Analog Score (VAS). Jay Probe assessments were accomplished using several approaches. With a cohort of 12 subjects, two clinical examiners compared the repeatability of the Jay and Yeaple Probes. A second evaluation of both probes was conducted during two independent parallel design clinical studies each enrolling 100 adults with dentin hypersensitivity (DH). In each study, subjects were evaluated for DH responses after twice daily oral hygiene with a negative control fluoride dentifrice or a positive control dentifrice formulated with ingredients proven to reduce sensitivity, i.e. potassium nitrate or 8.0% arginine with calcium carbonate. Tactile evaluations by the Jay and Yeaple Probes were conducted at baseline and recall visits over the 8-week duration of each study. Also evaluated at each visit were responses to air blast and to patient reported DH assessment by VAS. Low inter-examiner variability with no significant differences between replicate measurements (P > 0.05) was observed with the Jay Probe. Consistent with results from previous studies, subjects assigned dentifrices formulated with potassium nitrate or 8% arginine/calcium carbonate demonstrated improvements in Yeaple, air blast and VAS responses in comparison to those assigned the fluoride dentifrice (P < 0.05). Jay Probe responses correlated significantly with all other sensitivity measures (P < 0.05). Differences between these treatments were observed at all post-treatment evaluations using these methods.

Publications in anesthesia journals: quality and clinical relevance.

PubMed

Lauritsen, Jakob; Moller, Ann M

2004-11-01

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

Evaluating the effectiveness of clinical medical librarian programs: a systematic review of the literature*

PubMed Central

Wagner, Kay Cimpl; Byrd, Gary D.

2004-01-01

Objective: This study was undertaken to determine if a systematic review of the evidence from thirty years of literature evaluating clinical medical librarian (CML) programs could help clarify the effectiveness of this outreach service model. Methods: A descriptive review of the CML literature describes the general characteristics of these services as they have been implemented, primarily in teaching-hospital settings. Comprehensive searches for CML studies using quantitative or qualitative evaluation methods were conducted in the medical, allied health, librarianship, and social sciences literature. Findings: Thirty-five studies published between 1974 and 2001 met the review criteria. Most (30) evaluated single, active programs and used descriptive research methods (e.g., use statistics or surveys/questionnaires). A weighted average of 89% of users in twelve studies found CML services useful and of high quality, and 65% of users in another overlapping, but not identical, twelve studies said these services contributed to improved patient care. Conclusions: The total amount of research evidence for CML program effectiveness is not great and most of it is descriptive rather than comparative or analytically qualitative. Standards are needed to consistently evaluate CML or informationist programs in the future. A carefully structured multiprogram study including three to five of the best current programs is needed to define the true value of these services. PMID:14762460

A framework for telepsychiatric training and e-health: Competency-based education, evaluation and implications.

PubMed

Hilty, Donald M; Crawford, Allison; Teshima, John; Chan, Steven; Sunderji, Nadiya; Yellowlees, Peter M; Kramer, Greg; O'neill, Patrick; Fore, Chris; Luo, John; Li, Su-Ting

2015-01-01

Telepsychiatry (TP; video; synchronous) is effective, well received and a standard way to practice. Best practices in TP education, but not its desired outcomes, have been published. This paper proposes competencies for trainees and clinicians, with TP situated within the broader landscape of e-mental health (e-MH) care. TP competencies are organized using the US Accreditation Council of Graduate Medical Education framework, with input from the CanMEDS framework. Teaching and assessment methods are aligned with target competencies, learning contexts, and evaluation options. Case examples help to apply concepts to clinical and institutional contexts. Competencies can be identified, measured and evaluated. Novice or advanced beginner, competent/proficient, and expert levels were outlined. Andragogical (i.e. pedagogical) methods are used in clinical care, seminar, and other educational contexts. Cross-sectional and longitudinal evaluation using quantitative and qualitative measures promotes skills development via iterative feedback from patients, trainees, and faculty staff. TP and e-MH care significantly overlap, such that institutional leaders may use a common approach for change management and an e-platform to prioritize resources. TP training and assessment methods need to be implemented and evaluated. Institutional approaches to patient care, education, faculty development, and funding also need to be studied.

Comparison of automated volumetry of the hippocampus using NeuroQuant® and visual assessment of the medial temporal lobe in Alzheimer's disease.

PubMed

Persson, Karin; Barca, Maria Lage; Cavallin, Lena; Brækhus, Anne; Knapskog, Anne-Brita; Selbæk, Geir; Engedal, Knut

2017-01-01

Background Different clinically feasible methods for evaluation of medial temporal lobe atrophy exists and are useful in diagnostic work-up of Alzheimer's disease (AD). Purpose To compare the diagnostic properties of two clinically available magnetic resonance imaging (MRI)-based methods-an automated volumetric software, NeuroQuant® (NQ) (evaluation of hippocampus volume) and the Scheltens scale (visual evaluation of medial temporal lobe atrophy [MTA])-in patients with AD dementia, and subjective and mild cognitive impairment (non-dementia). Material and Methods MRIs from 56 patients (31 AD, 25 non-dementia) were assessed with both methods. Correlations between the methods were calculated and receiver operating curve (ROC) analyses that yield area under the curve (AUC) statistics were conducted. Results High correlations were found between the two MRI assessments for the total hippocampal volume measured with NQ and mean MTA score (-0.753, P < 0.001), for the right (-0.767, P < 0.001), and for the left (-0.675, P < 0.001) sides. The NQ total measure yielded somewhat higher AUC (0.88, "good") compared to the MTA mean measure (0.80, "good") in the comparison of patients with AD and non-dementia, but the accuracy was in favor of the MTA scale. Conclusion The two methods correlated highly and both methods reached equally "good" power.

Evaluating a mobile application for improving clinical laboratory test ordering and diagnosis.

PubMed

Meyer, Ashley N D; Thompson, Pamela J; Khanna, Arushi; Desai, Samir; Mathews, Benji K; Yousef, Elham; Kusnoor, Anita V; Singh, Hardeep

2018-04-20

Mobile applications for improving diagnostic decision making often lack clinical evaluation. We evaluated if a mobile application improves generalist physicians' appropriate laboratory test ordering and diagnosis decisions and assessed if physicians perceive it as useful for learning. In an experimental, vignette study, physicians diagnosed 8 patient vignettes with normal prothrombin times (PT) and abnormal partial thromboplastin times (PTT). Physicians made test ordering and diagnosis decisions for 4 vignettes using each resource: a mobile app, PTT Advisor, developed by the Centers for Disease Control and Prevention (CDC)'s Clinical Laboratory Integration into Healthcare Collaborative (CLIHC); and usual clinical decision support. Then, physicians answered questions regarding their perceptions of the app's usefulness for diagnostic decision making and learning using a modified Kirkpatrick Training Evaluation Framework. Data from 368 vignettes solved by 46 physicians at 7 US health care institutions show advantages for using PTT Advisor over usual clinical decision support on test ordering and diagnostic decision accuracy (82.6 vs 70.2% correct; P < .001), confidence in decisions (7.5 vs 6.3 out of 10; P < .001), and vignette completion time (3:02 vs 3:53 min.; P = .06). Physicians reported positive perceptions of the app's potential for improved clinical decision making, and recommended it be used to address broader diagnostic challenges. A mobile app, PTT Advisor, may contribute to better test ordering and diagnosis, serve as a learning tool for diagnostic evaluation of certain clinical disorders, and improve patient outcomes. Similar methods could be useful for evaluating apps aimed at improving testing and diagnosis for other conditions.

Using gEUD based plan analysis method to evaluate proton vs. photon plans for lung cancer radiation therapy.

PubMed

Xiao, Zhiyan; Zou, Wei J; Chen, Ting; Yue, Ning J; Jabbour, Salma K; Parikh, Rahul; Zhang, Miao

2018-03-01

The goal of this study was to exam the efficacy of current DVH based clinical guidelines draw from photon experience for lung cancer radiation therapy on proton therapy. Comparison proton plans and IMRT plans were generated for 10 lung patients treated in our proton facility. A gEUD based plan evaluation method was developed for plan evaluation. This evaluation method used normal lung gEUD(a) curve in which the model parameter "a" was sampled from the literature reported value. For all patients, the proton plans delivered lower normal lung V 5 Gy with similar V 20 Gy and similar target coverage. Based on current clinical guidelines, proton plans were ranked superior to IMRT plans for all 10 patients. However, the proton and IMRT normal lung gEUD(a) curves crossed for 8 patients within the tested range of "a", which means there was a possibility that proton plan would be worse than IMRT plan for lung sparing. A concept of deficiency index (DI) was introduced to quantify the probability of proton plans doing worse than IMRT plans. By applying threshold on DI, four patients' proton plan was ranked inferior to the IMRT plan. Meanwhile if a threshold to the location of curve crossing was applied, 6 patients' proton plan was ranked inferior to the IMRT plan. The contradictory ranking results between the current clinical guidelines and the gEUD(a) curve analysis demonstrated there is potential pitfalls by applying photon experience directly to the proton world. A comprehensive plan evaluation based on radio-biological models should be carried out to decide if a lung patient would really be benefit from proton therapy. © 2018 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

Recommendations for imaging tumor response in neurofibromatosis clinical trials

PubMed Central

Ardern-Holmes, Simone L.; Babovic-Vuksanovic, Dusica; Barker, Fred G.; Connor, Steve; Evans, D. Gareth; Fisher, Michael J.; Goutagny, Stephane; Harris, Gordon J.; Jaramillo, Diego; Karajannis, Matthias A.; Korf, Bruce R.; Mautner, Victor; Plotkin, Scott R.; Poussaint, Tina Y.; Robertson, Kent; Shih, Chie-Schin; Widemann, Brigitte C.

2013-01-01

Objective: Neurofibromatosis (NF)-related benign tumors such as plexiform neurofibromas (PN) and vestibular schwannomas (VS) can cause substantial morbidity. Clinical trials directed at these tumors have become available. Due to differences in disease manifestations and the natural history of NF-related tumors, response criteria used for solid cancers (1-dimensional/RECIST [Response Evaluation Criteria in Solid Tumors] and bidimensional/World Health Organization) have limited applicability. No standardized response criteria for benign NF tumors exist. The goal of the Tumor Measurement Working Group of the REiNS (Response Evaluation in Neurofibromatosis and Schwannomatosis) committee is to propose consensus guidelines for the evaluation of imaging response in clinical trials for NF tumors. Methods: Currently used imaging endpoints, designs of NF clinical trials, and knowledge of the natural history of NF-related tumors, in particular PN and VS, were reviewed. Consensus recommendations for response evaluation for future studies were developed based on this review and the expertise of group members. Results: MRI with volumetric analysis is recommended to sensitively and reproducibly evaluate changes in tumor size in clinical trials. Volumetric analysis requires adherence to specific imaging recommendations. A 20% volume change was chosen to indicate a decrease or increase in tumor size. Use of these criteria in future trials will enable meaningful comparison of results across studies. Conclusions: The proposed imaging response evaluation guidelines, along with validated clinical outcome measures, will maximize the ability to identify potentially active agents for patients with NF and benign tumors. PMID:24249804

A low-complexity 2-point step size gradient projection method with selective function evaluations for smoothed total variation based CBCT reconstructions

NASA Astrophysics Data System (ADS)

Song, Bongyong; Park, Justin C.; Song, William Y.

2014-11-01

The Barzilai-Borwein (BB) 2-point step size gradient method is receiving attention for accelerating Total Variation (TV) based CBCT reconstructions. In order to become truly viable for clinical applications, however, its convergence property needs to be properly addressed. We propose a novel fast converging gradient projection BB method that requires ‘at most one function evaluation’ in each iterative step. This Selective Function Evaluation method, referred to as GPBB-SFE in this paper, exhibits the desired convergence property when it is combined with a ‘smoothed TV’ or any other differentiable prior. This way, the proposed GPBB-SFE algorithm offers fast and guaranteed convergence to the desired 3DCBCT image with minimal computational complexity. We first applied this algorithm to a Shepp-Logan numerical phantom. We then applied to a CatPhan 600 physical phantom (The Phantom Laboratory, Salem, NY) and a clinically-treated head-and-neck patient, both acquired from the TrueBeam™ system (Varian Medical Systems, Palo Alto, CA). Furthermore, we accelerated the reconstruction by implementing the algorithm on NVIDIA GTX 480 GPU card. We first compared GPBB-SFE with three recently proposed BB-based CBCT reconstruction methods available in the literature using Shepp-Logan numerical phantom with 40 projections. It is found that GPBB-SFE shows either faster convergence speed/time or superior convergence property compared to existing BB-based algorithms. With the CatPhan 600 physical phantom, the GPBB-SFE algorithm requires only 3 function evaluations in 30 iterations and reconstructs the standard, 364-projection FDK reconstruction quality image using only 60 projections. We then applied the algorithm to a clinically-treated head-and-neck patient. It was observed that the GPBB-SFE algorithm requires only 18 function evaluations in 30 iterations. Compared with the FDK algorithm with 364 projections, the GPBB-SFE algorithm produces visibly equivalent quality CBCT image for the head-and-neck patient with only 180 projections, in 131.7 s, further supporting its clinical applicability.

Incorporation of stochastic engineering models as prior information in Bayesian medical device trials.

PubMed

Haddad, Tarek; Himes, Adam; Thompson, Laura; Irony, Telba; Nair, Rajesh

2017-01-01

Evaluation of medical devices via clinical trial is often a necessary step in the process of bringing a new product to market. In recent years, device manufacturers are increasingly using stochastic engineering models during the product development process. These models have the capability to simulate virtual patient outcomes. This article presents a novel method based on the power prior for augmenting a clinical trial using virtual patient data. To properly inform clinical evaluation, the virtual patient model must simulate the clinical outcome of interest, incorporating patient variability, as well as the uncertainty in the engineering model and in its input parameters. The number of virtual patients is controlled by a discount function which uses the similarity between modeled and observed data. This method is illustrated by a case study of cardiac lead fracture. Different discount functions are used to cover a wide range of scenarios in which the type I error rates and power vary for the same number of enrolled patients. Incorporation of engineering models as prior knowledge in a Bayesian clinical trial design can provide benefits of decreased sample size and trial length while still controlling type I error rate and power.

Standardization of Clinical Skill Evaluation in Physical/Occupational Therapist Education –Effects of Introduction of an Education System Using OSCE–

PubMed Central

Sakurai, Hiroaki; Kanada, Yoshikiyo; Sugiura, Yoshito; Motoya, Ikuo; Yamada, Masayuki; Tomita, Masao; Naka, Toru; Teranishi, Toshio; Tanabe, Shigeo; Tsujimura, Toru; Okanishi, Tetsuo

2013-01-01

[Purpose] A major issue in physical/occupational therapist education is the improvement of students' clinical techniques. In this study, we introduced an education system using an Objective Structured Clinical Examination (OSCE), and made an attempt at standardization of its evaluation. [Subjects] The subjects were 227 students in the classes of 2008 to 2010 who enrolled at our university between 2004 and 2006, before the introduction of the education system using OSCE, and 221 students in the classes of 2011 to 2013 who enrolled between 2007 and 2009, after the introduction. [Methods] Performances in attitude and skills (performance in clinical training and OSCE) were compared between before and after the introduction of OSCE. OSCE results were compared between before and after clinical trainings at each OSCE Level; and the correlation of between performances in clinical training and OSCE was examined. [Results] Performances in OSCE and clinical training (attitude, skills) were improved by the introduction of the education system using OSCE, but no significant correlation was observed in the relationship between performances in OSCE and clinical training. [Conclusion] Further studies should be conducted aiming at the standardization of clinical skill evaluation in postgraduate education to establish an education system using OSCE. PMID:24259918

Changes in information behavior in clinical teams after introduction of a clinical librarian service

PubMed Central

Urquhart, Christine; Turner, Janet; Durbin, Jane; Ryan, Jean

2007-01-01

Objectives: The eighteen-month evaluation of a clinical librarian project (October 2003–March 2005) conducted in North Wales, United Kingdom (UK) assessed the benefits of clinical librarian support to clinical teams, the impact of mediated searching services, and the effectiveness of information skills training, including journal club support. Methods: The evaluation assessed changes in teams' information-seeking behavior and their willingness to delegate searching to a clinical librarian. Baseline (n = 69 responses, 73% response rate) and final questionnaire (n = 57, 77% response rate) surveys were complemented by telephone and face-to-face interviews (n = 33) among 3 sites served. Those attending information skills training sessions (n = 130) completed evaluations at the session and were surveyed 1 month after training (n = 24 questionnaire responses, n = 12 interviews). Results: Health professionals in clinical teams reported that they were more willing to undertake their own searching, but also more willing to delegate some literature searching, than at the start of the project. The extent of change depended on the team and the type of information required. Information skills training was particularly effective when organized around journal clubs. Conclusions: Collaboration with a clinical librarian increased clinician willingness to seek information. Clinical librarian services should leverage structured training opportunities such as journal clubs. PMID:17252062

State-of-the-Science of Patient Navigation as a Strategy for Enhancing Minority Clinical Trial Accrual

PubMed Central

Ghebre, Rahel G.; Jones, Lovell A.; Wenzel, Jennifer; Martin, Michelle Y.; Durant, Raegan; Ford, Jean G.

2014-01-01

Background Patient navigation programs are emerging, that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process, as well as outcome measures to evaluate program effectiveness. Methods A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. Results The eligible studies reported on development of programs for patient navigation in cancer clinical trials, including training and implementation among African American, American Indian and Native Hawaiians. Low clinical trial refusal, 4% to 6%, was reported among patients enrolled in patient navigation program. However, few studies reported on the efficacy of patient navigation on increasing clinical treatment trial enrollment. Conclusion Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. PMID:24643650

Nursing students' viewpoints toward two methods of clinical conference and clinical nursing round.

PubMed

Gheidanzadeh, Maryam; Baghersad, Zahra; Abazari, Parvaneh

2017-01-01

Clinical education provides a chance to combine theoretical knowledge and clinical skills. Students are the key elements in the evaluation of clinical education efficacy. The present study was aimed to define nursing students' viewpoints concerning conformity to the characteristics of clinical conference and clinical round. This descriptive analytical study was conducted on the bachelor's students of the 4 th -6 th semester of nursing. Sampling was conducted using census sampling method during the 2 nd semester of 2014-2015 school year. Data collection tool was a three-section researcher-made questionnaire containing demographic, nursing round, and clinical conference characteristics. Descriptive and inferential statistical tests (independent t -test, ANOVA, and Spearman and Pearson correlation coefficients) were used for data analysis. Participants were 134 bachelor's students of the 4 th -6 th semester of nursing. According to half of the participants, conformity to the characteristics of clinical conference (45.5%, 53%) and clinical round (44%, 51.5%) were poor and medium, respectively. Paired t -test showed a significant difference between students' viewpoints toward the planning of clinical conference and clinical nursing round ( P = 0.006, t = 2.77). According to the results of the present study on students' viewpoints, clinical education faces a serious challenge with regard to clinical education methods. Considering the necessity and importance of clinical education, more investigation should be conducted to detect its relevant factors and plan for its improvement.

The Identification and Assessment of Late-life ADHD in Memory Clinics

PubMed Central

Fischer, Barbara L.; Gunter-Hunt, Gail; Steinhafel, Courtney Holm; Howell, Timothy

2013-01-01

INTRODUCTION Little data exists about attention deficit hyperactivity disorder (ADHD) in late life. While evaluating patients’ memory problems, our Memory Clinic staff has periodically identified ADHD in previously undiagnosed adults. We conducted a survey to assess the extent to which other memory clinics view ADHD as a relevant clinical issue. METHOD We developed and sent a questionnaire to Memory Clinics in the United States to ascertain how ADHD was identified and addressed. The percentage of responding memory clinics’ means of assessing and managing late-life ADHD comprised the measurements for this study. RESULTS Approximately one-half of responding memory clinics reported seeing ADHD patients. Of these, one-half reported identifying previously diagnosed cases, and almost one-half reported diagnosing ADHD themselves. One fifth of clinics reported screening regularly for ADHD, and few clinics described treatment methods. CONCLUSION Our results suggest that U.S. memory clinics may not adequately identify and address ADHD in late life. PMID:22173147

A Mixed Methods Approach to Evaluate Partnerships and Implementation of the Massachusetts Prevention and Wellness Trust Fund.

PubMed

Lee, Rebekka M; Ramanadhan, Shoba; Kruse, Gina R; Deutsch, Charles

2018-01-01

Background: Strong partnerships are critical to integrate evidence-based prevention interventions within clinical and community-based settings, offering multilevel and sustainable solutions to complex health issues. As part of Massachusetts' 2012 health reform, The Prevention and Wellness Trust Fund (PWTF) funded nine local partnerships throughout the state to address hypertension, pediatric asthma, falls among older adults, and tobacco use. The initiative was designed to improve health outcomes through prevention and disease management strategies and reduce healthcare costs. Purpose: Describe the mixed-methods study design for investigating PWTF implementation. Methods: The Consolidated Framework for Implementation Research guided the development of this evaluation. First, the study team conducted semi-structured qualitative interviews with leaders from each of nine partnerships to document partnership development and function, intervention adaptation and delivery, and the influence of contextual factors on implementation. The interview findings were used to develop a quantitative survey to assess the implementation experiences of 172 staff from clinical and community-based settings and a social network analysis to assess changes in the relationships among 72 PWTF partner organizations. The quantitative survey data on ratings of perceived implementation success were used to purposively select 24 staff for interviews to explore the most successful experiences of implementing evidence-based interventions for each of the four conditions. Conclusions: This mixed-methods approach for evaluation of implementation of evidence-based prevention interventions by PWTF partnerships can help decision-makers set future priorities for implementing and assessing clinical-community partnerships focused on prevention.

Design of the multicenter standardized supervised exercise training intervention for the claudication: exercise vs endoluminal revascularization (CLEVER) study.

PubMed

Bronas, Ulf G; Hirsch, Alan T; Murphy, Timothy; Badenhop, Dalynn; Collins, Tracie C; Ehrman, Jonathan K; Ershow, Abby G; Lewis, Beth; Treat-Jacobson, Diane J; Walsh, M Eileen; Oldenburg, Niki; Regensteiner, Judith G

2009-11-01

The CLaudication: Exercise Vs Endoluminal Revascularization (CLEVER) study is the first randomized, controlled, clinical, multicenter trial that is evaluating a supervised exercise program compared with revascularization procedures to treat claudication. In this report, the methods and dissemination techniques of the supervised exercise training intervention are described. A total of 217 participants are being recruited and randomized to one of three arms: (1) optimal medical care; (2) aortoiliac revascularization with stent; or (3) supervised exercise training. Of the enrolled patients, 84 will receive supervised exercise therapy. Supervised exercise will be administered according to a protocol designed by a central CLEVER exercise training committee based on validated methods previously used in single center randomized control trials. The protocol will be implemented at each site by an exercise committee member using training methods developed and standardized by the exercise training committee. The exercise training committee reviews progress and compliance with the protocol of each participant weekly. In conclusion, a multicenter approach to disseminate the supervised exercise training technique and to evaluate its efficacy, safety and cost-effectiveness for patients with claudication due to peripheral arterial disease (PAD) is being evaluated for the first time in CLEVER. The CLEVER study will further establish the role of supervised exercise training in the treatment of claudication resulting from PAD and provide standardized methods for use of supervised exercise training in future PAD clinical trials as well as in clinical practice.

Evaluation of dysphagia in early stroke patients by bedside, endoscopic, and electrophysiological methods.

PubMed

Umay, Ebru Karaca; Unlu, Ece; Saylam, Guleser Kılıc; Cakci, Aytul; Korkmaz, Hakan

2013-09-01

We aimed in this study to evaluate dysphagia in early stroke patients using a bedside screening test and flexible fiberoptic endoscopic evaluation of swallowing (FFEES) and electrophysiological evaluation (EE) methods and to compare the effectiveness of these methods. Twenty-four patients who were hospitalized in our clinic within the first 3 months after stroke were included in this study. Patients were evaluated using a bedside screening test [including bedside dysphagia score (BDS), neurological examination dysphagia score (NEDS), and total dysphagia score (TDS)] and FFEES and EE methods. Patients were divided into normal-swallowing and dysphagia groups according to the results of the evaluation methods. Patients with dysphagia as determined by any of these methods were compared to the patients with normal swallowing based on the results of the other two methods. Based on the results of our study, a high BDS was positively correlated with dysphagia identified by FFEES and EE methods. Moreover, the FFEES and EE methods were positively correlated. There was no significant correlation between NEDS and TDS levels and either EE or FFEES method. Bedside screening tests should be used mainly as an initial screening test; then FFEES and EE methods should be combined in patients who show risks. This diagnostic algorithm may provide a practical and fast solution for selected stroke patients.

Hospital-Based Clinical Pharmacy Services to Improve Ambulatory Management of Chronic Obstructive Pulmonary Disease

PubMed Central

Smith, Amber Lanae; Palmer, Valerie; Farhat, Nada; Kalus, James S.; Thavarajah, Krishna; DiGiovine, Bruno; MacDonald, Nancy C.

2016-01-01

Background: No systematic evaluations of a comprehensive clinical pharmacy process measures currently exist to determine an optimal ambulatory care collaboration model for chronic obstructive pulmonary disease (COPD) patients. Objective: Describe the impact of a pharmacist-provided clinical COPD bundle on the management of COPD in a hospital-based ambulatory care clinic. Methods: This retrospective cohort analysis evaluated patients with COPD managed in an outpatient pulmonary clinic. The primary objective of this study was to assess the completion of 4 metrics known to improve the management of COPD: (1) medication therapy management, (2) quality measures including smoking cessation and vaccines, (3) patient adherence, and (4) patient education. The secondary objective was to evaluate the impact of the clinical COPD bundle on clinical and economic outcomes at 30 and 90 days post–initial visit. Results: A total of 138 patients were included in the study; 70 patients served as controls and 68 patients received the COPD bundle from the clinical pharmacist. No patients from the control group had all 4 metrics completed as documented, compared to 66 of the COPD bundle group (P < .0001). Additionally, a statistically significant difference was found in all 4 metrics when evaluated individually. Clinical pharmacy services reduced the number of phone call consults at 90 days (P = .04) but did not have a statistically significant impact on any additional pre-identified clinical outcomes. Conclusion: A pharmacist-driven clinical COPD bundle was associated with significant increases in the completion and documentation of 4 metrics known to improve the outpatient management of COPD.

Service impact of a national clinical leadership development programme: findings from a qualitative study.

PubMed

Fealy, Gerard M; McNamara, Martin S; Casey, Mary; O'Connor, Tom; Patton, Declan; Doyle, Louise; Quinlan, Christina

2015-04-01

The study reported here was part of a larger study, which evaluated a national clinical leadership development programme with reference to resources, participant experiences, participant outcomes and service impact. The aim of the present study was to evaluate the programme's service impact. Clinical leadership development develops competencies that are expressed in context. The outcomes of clinical leadership development occur at individual, departmental and organisational levels. The methods used to evaluate the service impact were focus groups, group interviews and individual interviews. Seventy participants provided data in 18 separate qualitative data collection events. The data contained numerous accounts of service development activities, initiated by programme participants, which improved service and/or improved the culture of the work setting. Clinical leadership development programmes that incorporate a deliberate service impact element can result in identifiable positive service outcomes. The nuanced relationship between leader development and service development warrants further investigation. This study demonstrates that clinical leadership development can impact on service in distinct and identifiable ways. Clinical leadership development programmes should focus on the setting in which the leadership competencies will be demonstrated. © 2013 John Wiley & Sons Ltd.

Recruiting US Chinese Elders Into Clinical Research for Dementia.

PubMed

Li, Clara; Neugroschl, Judith; Umpierre, Mari; Martin, Jane; Huang, QiYing; Zeng, Xiaoyi; Cai, Dongming; Sano, Mary

2016-01-01

This study described and evaluated the rapid recruitment of elderly Chinese into clinical research at the Mount Sinai Alzheimer's Disease Research Center (MSADRC). Methods of publicizing the study included lectures to local senior centers/churches and publications in local Chinese newspapers. The amount of time and success of these methods were evaluated. A "go to them" model of evaluation was used to enable participants to complete the study visit at locations where they were comfortable. From January to December 2015, we recruited 98 participants aged 65 years or older who primarily speak Mandarin/Cantonese and reside in New York. The mean age and years of education was 73.93±6.34 and 12.79±4.58, respectively. The majority of participants were female (65.3%) and primarily Mandarin speaking (53.1%). Of all enrollees, 54.1% were recruited from community lectures, 29.6% through newspapers, 10.2% through word of mouth, and 6.1% from our clinical services. About 40.8% of participants underwent evaluations at the MSADRC, 44.9% at local senior centers/churches, and 14.3% at home. Given that the majority of our participants had low English proficiency, the use of bilingual recruiters probably allowed us to overcome the language barrier, facilitating recruitment. Our "go to them" model of evaluation is another important factor contributing to our successful recruitment.

A Course Model for Teaching Research Evaluation in Colleges of Pharmacy.

ERIC Educational Resources Information Center

Draugalis, JoLaine R.; Slack, Marion K.

1992-01-01

A University of Arizona undergraduate pharmacy course designed to develop student skills in evaluation of research has five parts: introduction to the scientific method; statistical techniques/data analysis review; research design; fundamentals of clinical studies; and practical applications. Prerequisites include biostatistics and drug…

Clinical and Diagnostic Aspects of Brucellosis and Antimicrobial Susceptibility of Brucella Isolates in Hamedan, Iran.

PubMed

Torkaman Asadi, Fatemeh; Hashemi, Seyyed Hamid; Alikhani, Mohammad Yousef; Moghimbeigi, Abbas; Naseri, Zahra

2017-05-24

Current drug regimens for brucellosis are associated with relatively high rates of therapeutic failure or relapse. Reduced antimicrobial susceptibility of Brucella spp. has been proposed recently as a potential cause of therapeutic failure. The aim of this study was to evaluate the antibiotic resistance pattern of Brucella melitensis clinical isolates by E-test method in Hamadan, west of Iran. In a 15-month period, all patients with suspected brucellosis were enrolled. Blood specimens were collected for diagnosis of brucellosis by BACTEC system and serological tests. Antimicrobial susceptibility of clinical isolates to 7 antibiotics was assessed by the E-test method. One hundred forty-nine patients with brucellosis were evaluated. 38.3% of cultures of clinical samples were positive for BACTEC system, of which 91.2% were associated with a positive serological test result. No significant associations were found between serology and the culture method. All Brucella isolates were susceptible to doxycycline, streptomycin, gentamicin, ciprofloxacin, and moxifloxacin. However, decreased sensitivity to rifampin and trimethoprim-sulfamethoxazole was found in 35.1% and 3.5% of isolates, respectively. Because of the high rates of intermediate sensitivity to rifampin among Brucella isolates, this drug should be prescribed with caution. We recommend restricting the use of rifampin for treatment of brucellosis except as an alternative drug for special situations.

A systematic review of gait analysis methods based on inertial sensors and adaptive algorithms.

PubMed

Caldas, Rafael; Mundt, Marion; Potthast, Wolfgang; Buarque de Lima Neto, Fernando; Markert, Bernd

2017-09-01

The conventional methods to assess human gait are either expensive or complex to be applied regularly in clinical practice. To reduce the cost and simplify the evaluation, inertial sensors and adaptive algorithms have been utilized, respectively. This paper aims to summarize studies that applied adaptive also called artificial intelligence (AI) algorithms to gait analysis based on inertial sensor data, verifying if they can support the clinical evaluation. Articles were identified through searches of the main databases, which were encompassed from 1968 to October 2016. We have identified 22 studies that met the inclusion criteria. The included papers were analyzed due to their data acquisition and processing methods with specific questionnaires. Concerning the data acquisition, the mean score is 6.1±1.62, what implies that 13 of 22 papers failed to report relevant outcomes. The quality assessment of AI algorithms presents an above-average rating (8.2±1.84). Therefore, AI algorithms seem to be able to support gait analysis based on inertial sensor data. Further research, however, is necessary to enhance and standardize the application in patients, since most of the studies used distinct methods to evaluate healthy subjects. Copyright © 2017 Elsevier B.V. All rights reserved.

Measuring Resident Physicians' Performance of Preventive Care

PubMed Central

Palonen, Katri P; Allison, Jeroan J; Heudebert, Gustavo R; Willett, Lisa L; Kiefe, Catarina I; Wall, Terry C; Houston, Thomas K

2006-01-01

BACKGROUND The Accreditation Council for Graduate Medical Education has suggested various methods for evaluation of practice-based learning and improvement competency, but data on implementation of these methods are limited. OBJECTIVE To compare medical record review and patient surveys on evaluating physician performance in preventive services in an outpatient resident clinic. DESIGN Within an ongoing quality improvement project, we collected baseline performance data on preventive services provided for patients at the University of Alabama at Birmingham (UAB) Internal Medicine Residents' ambulatory clinic. PARTICIPANTS Seventy internal medicine and medicine-pediatrics residents from the UAB Internal Medicine Residency program. MEASUREMENTS Resident- and clinic-level comparisons of aggregated patient survey and chart documentation rates of (1) screening for smoking status, (2) advising smokers to quit, (3) cholesterol screening, (4) mammography screening, and (5) pneumonia vaccination. RESULTS Six hundred and fifty-nine patient surveys and 761 charts were abstracted. At the clinic level, rates for screening of smoking status, recommending mammogram, and for cholesterol screening were similar (difference <5%) between the 2 methods. Higher rates for pneumonia vaccination (76% vs 67%) and advice to quit smoking (66% vs 52%) were seen on medical record review versus patient surveys. However, within-resident (N=70) comparison of 2 methods of estimating screening rates contained significant variability. The cost of medical record review was substantially higher ($107 vs $17/physician). CONCLUSIONS Medical record review and patient surveys provided similar rates for selected preventive health measures at the clinic level, with the exception of pneumonia vaccination and advising to quit smoking. A large variation among individual resident providers was noted. PMID:16499544

Comparative Studies of Collaborative Team Depression Care Adoption in Safety Net Clinics

ERIC Educational Resources Information Center

Ell, Kathleen; Wu, Shinyi; Guterman, Jeffrey; Schulman, Sandra-Gross; Sklaroff, Laura; Lee, Pey-Jiuan

2018-01-01

Purpose: To evaluate three approaches adopting collaborative depression care model in Los Angeles County safety net clinics with predominantly Latino type 2 diabetes patients. Methods: Pre-post differences in treatment rates and symptom reductions were compared between baseline, 6-month, and 12-month follow-ups for each approach: (a) Multifaceted…

Introducing the Objective Structured Clinical Examination (OSCE) in the Undergraduate Psychiatric Curriculum: Evaluation after One Year

ERIC Educational Resources Information Center

Zahid, Muhammad Ajmal; Al-Zayed, Adel; Ohaeri, Jude; Varghese, Ramani

2011-01-01

Objective: The Objective Structured Clinical Examination (OSCE) was introduced in undergraduate psychiatry clerkship in 2008. The authors studied the effect of OSCE on the students' performance. Methods: The "short case" (SC) and "oral examination" (OE), two of the five components of the previous assessment format, were…

Mandibular bone structure, bone mineral density, and clinical variables as fracture predictors: a 15-year follow-up of female patients in a dental clinic.

PubMed

Jonasson, Grethe; Billhult, Annika

2013-09-01

To compare three mandibular trabeculation evaluation methods, clinical variables, and osteoporosis as fracture predictors in women. One hundred and thirty-six female dental patients (35-94 years) answered a questionnaire in 1996 and 2011. Using intra-oral radiographs from 1996, five methods were compared as fracture predictors: (1) mandibular bone structure evaluated with a visual radiographic index, (2) bone texture, (3) size and number of intertrabecular spaces calculated with Jaw-X software, (4) fracture probability calculated with a fracture risk assessment tool (FRAX), and (5) osteoporosis diagnosis based on dual-energy-X-ray absorptiometry. Differences were assessed with the Mann-Whitney test and relative risk calculated. Previous fracture, gluco-corticoid medication, and bone texture were significant indicators of future and total (previous plus future) fracture. Osteoporosis diagnosis, sparse trabeculation, Jaw-X, and FRAX were significant predictors of total but not future fracture. Clinical and oral bone variables may identify individuals at greatest risk of fracture. Copyright © 2013 Elsevier Inc. All rights reserved.

Clinical relevance of model based computer-assisted diagnosis and therapy

NASA Astrophysics Data System (ADS)

Schenk, Andrea; Zidowitz, Stephan; Bourquain, Holger; Hindennach, Milo; Hansen, Christian; Hahn, Horst K.; Peitgen, Heinz-Otto

2008-03-01

The ability to acquire and store radiological images digitally has made this data available to mathematical and scientific methods. With the step from subjective interpretation to reproducible measurements and knowledge, it is also possible to develop and apply models that give additional information which is not directly visible in the data. In this context, it is important to know the characteristics and limitations of each model. Four characteristics assure the clinical relevance of models for computer-assisted diagnosis and therapy: ability of patient individual adaptation, treatment of errors and uncertainty, dynamic behavior, and in-depth evaluation. We demonstrate the development and clinical application of a model in the context of liver surgery. Here, a model for intrahepatic vascular structures is combined with individual, but in the degree of vascular details limited anatomical information from radiological images. As a result, the model allows for a dedicated risk analysis and preoperative planning of oncologic resections as well as for living donor liver transplantations. The clinical relevance of the method was approved in several evaluation studies of our medical partners and more than 2900 complex surgical cases have been analyzed since 2002.

Method for evaluation of predictive models of microwave ablation via post-procedural clinical imaging

NASA Astrophysics Data System (ADS)

Collins, Jarrod A.; Brown, Daniel; Kingham, T. Peter; Jarnagin, William R.; Miga, Michael I.; Clements, Logan W.

2015-03-01

Development of a clinically accurate predictive model of microwave ablation (MWA) procedures would represent a significant advancement and facilitate an implementation of patient-specific treatment planning to achieve optimal probe placement and ablation outcomes. While studies have been performed to evaluate predictive models of MWA, the ability to quantify the performance of predictive models via clinical data has been limited to comparing geometric measurements of the predicted and actual ablation zones. The accuracy of placement, as determined by the degree of spatial overlap between ablation zones, has not been achieved. In order to overcome this limitation, a method of evaluation is proposed where the actual location of the MWA antenna is tracked and recorded during the procedure via a surgical navigation system. Predictive models of the MWA are then computed using the known position of the antenna within the preoperative image space. Two different predictive MWA models were used for the preliminary evaluation of the proposed method: (1) a geometric model based on the labeling associated with the ablation antenna and (2) a 3-D finite element method based computational model of MWA using COMSOL. Given the follow-up tomographic images that are acquired at approximately 30 days after the procedure, a 3-D surface model of the necrotic zone was generated to represent the true ablation zone. A quantification of the overlap between the predicted ablation zones and the true ablation zone was performed after a rigid registration was computed between the pre- and post-procedural tomograms. While both model show significant overlap with the true ablation zone, these preliminary results suggest a slightly higher degree of overlap with the geometric model.

Pre-clinical and Clinical Evaluation of High Resolution, Mobile Gamma Camera and Positron Imaging Devices

DTIC Science & Technology

2010-10-01

Downloaded on February 20,2010 at 10:55:59 EST from IEEE Xplore . Restrictions apply. STUDENSKI et al.: ACQUISITION AND PROCESSING METHODS FOR A BEDSIDE...February 20,2010 at 10:55:59 EST from IEEE Xplore . Restrictions apply. 208 IEEE TRANSACTIONS ON NUCLEAR SCIENCE, VOL. 57, NO. 1, FEBRUARY 2010 from the...59 EST from IEEE Xplore . Restrictions apply. STUDENSKI et al.: ACQUISITION AND PROCESSING METHODS FOR A BEDSIDE CARDIAC SPECT IMAGING SYSTEM 209

Flexible Reporting of Clinical Data

PubMed Central

Andrews, Robert D.

1987-01-01

Two prototype methods have been developed to aid in the presentation of relevant clinical data: 1) an integrated report that displays results from a patient's computer-stored data and also allows manual entry of data, and 2) a graph program that plots results of multiple kinds of tests. These reports provide a flexible means of displaying data to help evaluate patient treatment. The two methods also explore ways of integrating the display of data from multiple components of the Veterans Administration's (VA) Decentralized Hospital Computer Program (DHCP) database.

A Brief Course on Clinical Communication Skills: A Multi- Centered Study.

PubMed

Franco, Camila; Franco, Renato; Severo, Milton; Ferreira, Maria Amélia

2016-12-30

This paper describes and analyses the results of a multicenter course on clinical communication skills with the use of the learning in small groups, patient actors and feedback. The aim of the course was to encourage participants to develop a more effective clinical communication to recognize the different manifestations of the same disease in different patients (disease versus illness). The course was applied to third and fourth year medical students in three Brazilian universities and one university in Portugal. The evaluation was performed using scales regarding the participants' point of view, multiple choice questionnaire, a self-efficacy and attitudinal questionnaire. The study was conducted in 69 participants at the four universities. The overall evaluation of the course (from 1 - 5) was 4.70 (SD 0.494), the self-evaluation on participation was 4.07 (SD 0.671); and the evaluation about the use of simulated patients 4.51 (SD 0.501). The multiple choice questionnaire and self-efficacy scale showed significant improvement. The course methods had an excellent evaluation by students regardless of the context in which the course has been applied. Furthermore, it allowed an improvement on the knowledge and attitude of students regarding clinical communication. It was possible to develop a multi-centric learning strategy for clinical communication with a high evaluation by students who came from a Portuguese university in a cooperation project with teachers from Brazilian universities.

Identifying emerging research collaborations and networks: method development.

PubMed

Dozier, Ann M; Martina, Camille A; O'Dell, Nicole L; Fogg, Thomas T; Lurie, Stephen J; Rubinstein, Eric P; Pearson, Thomas A

2014-03-01

Clinical and translational research is a multidisciplinary, collaborative team process. To evaluate this process, we developed a method to document emerging research networks and collaborations in our medical center to describe their productivity and viability over time. Using an e-mail survey, sent to 1,620 clinical and basic science full- and part-time faculty members, respondents identified their research collaborators. Initial analyses, using Pajek software, assessed the feasibility of using social network analysis (SNA) methods with these data. Nearly 400 respondents identified 1,594 collaborators across 28 medical center departments resulting in 309 networks with 5 or more collaborators. This low-burden approach yielded a rich data set useful for evaluation using SNA to: (a) assess networks at several levels of the organization, including intrapersonal (individuals), interpersonal (social), organizational/institutional leadership (tenure and promotion), and physical/environmental (spatial proximity) and (b) link with other data to assess the evolution of these networks.

Advanced image fusion algorithms for Gamma Knife treatment planning. Evaluation and proposal for clinical use.

PubMed

Apostolou, N; Papazoglou, Th; Koutsouris, D

2006-01-01

Image fusion is a process of combining information from multiple sensors. It is a useful tool implemented in the treatment planning programme of Gamma Knife Radiosurgery. In this paper we evaluate advanced image fusion algorithms for Matlab platform and head images. We develop nine level grayscale image fusion methods: average, principal component analysis (PCA), discrete wavelet transform (DWT) and Laplacian, filter - subtract - decimate (FSD), contrast, gradient, morphological pyramid and a shift invariant discrete wavelet transform (SIDWT) method in Matlab platform. We test these methods qualitatively and quantitatively. The quantitative criteria we use are the Root Mean Square Error (RMSE), the Mutual Information (MI), the Standard Deviation (STD), the Entropy (H), the Difference Entropy (DH) and the Cross Entropy (CEN). The qualitative are: natural appearance, brilliance contrast, presence of complementary features and enhancement of common features. Finally we make clinically useful suggestions.

Adjusting survival time estimates to account for treatment switching in randomized controlled trials--an economic evaluation context: methods, limitations, and recommendations.

PubMed

Latimer, Nicholas R; Abrams, Keith R; Lambert, Paul C; Crowther, Michael J; Wailoo, Allan J; Morden, James P; Akehurst, Ron L; Campbell, Michael J

2014-04-01

Treatment switching commonly occurs in clinical trials of novel interventions in the advanced or metastatic cancer setting. However, methods to adjust for switching have been used inconsistently and potentially inappropriately in health technology assessments (HTAs). We present recommendations on the use of methods to adjust survival estimates in the presence of treatment switching in the context of economic evaluations. We provide background on the treatment switching issue and summarize methods used to adjust for it in HTAs. We discuss the assumptions and limitations associated with adjustment methods and draw on results of a simulation study to make recommendations on their use. We demonstrate that methods used to adjust for treatment switching have important limitations and often produce bias in realistic scenarios. We present an analysis framework that aims to increase the probability that suitable adjustment methods can be identified on a case-by-case basis. We recommend that the characteristics of clinical trials, and the treatment switching mechanism observed within them, should be considered alongside the key assumptions of the adjustment methods. Key assumptions include the "no unmeasured confounders" assumption associated with the inverse probability of censoring weights (IPCW) method and the "common treatment effect" assumption associated with the rank preserving structural failure time model (RPSFTM). The limitations associated with switching adjustment methods such as the RPSFTM and IPCW mean that they are appropriate in different scenarios. In some scenarios, both methods may be prone to bias; "2-stage" methods should be considered, and intention-to-treat analyses may sometimes produce the least bias. The data requirements of adjustment methods also have important implications for clinical trialists.

“Kinect-ing” With Clinicians: A Knowledge Translation Resource to Support Decision Making About Video Game Use in Rehabilitation

PubMed Central

Levac, Danielle; Espy, Deborah; Fox, Emily; Pradhan, Sujata

2015-01-01

Microsoft's Kinect for Xbox 360 virtual reality (VR) video games are promising rehabilitation options because they involve motivating, full-body movement practice. However, these games were designed for recreational use, which creates challenges for clinical implementation. Busy clinicians require decision-making support to inform game selection and implementation that address individual therapeutic goals. This article describes the development and preliminary evaluation of a knowledge translation (KT) resource to support clinical decision making about selection and use of Kinect games in physical therapy. The knowledge-to-action framework guided the development of the Kinecting With Clinicians (KWiC) resource. Five physical therapists with VR and video game expertise analyzed the Kinect Adventure games. A consensus-building method was used to arrive at categories to organize clinically relevant attributes guiding game selection and game play. The process and results of an exploratory usability evaluation of the KWiC resource by clinicians through interviews and focus groups at 4 clinical sites is described. Subsequent steps in the evaluation and KT process are proposed, including making the KWiC resource Web-based and evaluating the utility of the online resource in clinical practice. PMID:25256741

"Kinect-ing" with clinicians: a knowledge translation resource to support decision making about video game use in rehabilitation.

PubMed

Levac, Danielle; Espy, Deborah; Fox, Emily; Pradhan, Sujata; Deutsch, Judith E

2015-03-01

Microsoft's Kinect for Xbox 360 virtual reality (VR) video games are promising rehabilitation options because they involve motivating, full-body movement practice. However, these games were designed for recreational use, which creates challenges for clinical implementation. Busy clinicians require decision-making support to inform game selection and implementation that address individual therapeutic goals. This article describes the development and preliminary evaluation of a knowledge translation (KT) resource to support clinical decision making about selection and use of Kinect games in physical therapy. The knowledge-to-action framework guided the development of the Kinecting With Clinicians (KWiC) resource. Five physical therapists with VR and video game expertise analyzed the Kinect Adventure games. A consensus-building method was used to arrive at categories to organize clinically relevant attributes guiding game selection and game play. The process and results of an exploratory usability evaluation of the KWiC resource by clinicians through interviews and focus groups at 4 clinical sites is described. Subsequent steps in the evaluation and KT process are proposed, including making the KWiC resource Web-based and evaluating the utility of the online resource in clinical practice. © 2015 American Physical Therapy Association.

Mayo clinical Text Analysis and Knowledge Extraction System (cTAKES): architecture, component evaluation and applications

PubMed Central

Masanz, James J; Ogren, Philip V; Zheng, Jiaping; Sohn, Sunghwan; Kipper-Schuler, Karin C; Chute, Christopher G

2010-01-01

We aim to build and evaluate an open-source natural language processing system for information extraction from electronic medical record clinical free-text. We describe and evaluate our system, the clinical Text Analysis and Knowledge Extraction System (cTAKES), released open-source at http://www.ohnlp.org. The cTAKES builds on existing open-source technologies—the Unstructured Information Management Architecture framework and OpenNLP natural language processing toolkit. Its components, specifically trained for the clinical domain, create rich linguistic and semantic annotations. Performance of individual components: sentence boundary detector accuracy=0.949; tokenizer accuracy=0.949; part-of-speech tagger accuracy=0.936; shallow parser F-score=0.924; named entity recognizer and system-level evaluation F-score=0.715 for exact and 0.824 for overlapping spans, and accuracy for concept mapping, negation, and status attributes for exact and overlapping spans of 0.957, 0.943, 0.859, and 0.580, 0.939, and 0.839, respectively. Overall performance is discussed against five applications. The cTAKES annotations are the foundation for methods and modules for higher-level semantic processing of clinical free-text. PMID:20819853

Method Development for Clinical Comprehensive Evaluation of Pediatric Drugs Based on Multi-Criteria Decision Analysis: Application to Inhaled Corticosteroids for Children with Asthma.

PubMed

Yu, Yuncui; Jia, Lulu; Meng, Yao; Hu, Lihua; Liu, Yiwei; Nie, Xiaolu; Zhang, Meng; Zhang, Xuan; Han, Sheng; Peng, Xiaoxia; Wang, Xiaoling

2018-04-01

Establishing a comprehensive clinical evaluation system is critical in enacting national drug policy and promoting rational drug use. In China, the 'Clinical Comprehensive Evaluation System for Pediatric Drugs' (CCES-P) project, which aims to compare drugs based on clinical efficacy and cost effectiveness to help decision makers, was recently proposed; therefore, a systematic and objective method is required to guide the process. An evidence-based multi-criteria decision analysis model that involved an analytic hierarchy process (AHP) was developed, consisting of nine steps: (1) select the drugs to be reviewed; (2) establish the evaluation criterion system; (3) determine the criterion weight based on the AHP; (4) construct the evidence body for each drug under evaluation; (5) select comparative measures and calculate the original utility score; (6) place a common utility scale and calculate the standardized utility score; (7) calculate the comprehensive utility score; (8) rank the drugs; and (9) perform a sensitivity analysis. The model was applied to the evaluation of three different inhaled corticosteroids (ICSs) used for asthma management in children (a total of 16 drugs with different dosage forms and strengths or different manufacturers). By applying the drug analysis model, the 16 ICSs under review were successfully scored and evaluated. Budesonide suspension for inhalation (drug ID number: 7) ranked the highest, with comprehensive utility score of 80.23, followed by fluticasone propionate inhaled aerosol (drug ID number: 16), with a score of 79.59, and budesonide inhalation powder (drug ID number: 6), with a score of 78.98. In the sensitivity analysis, the ranking of the top five and lowest five drugs remains unchanged, suggesting this model is generally robust. An evidence-based drug evaluation model based on AHP was successfully developed. The model incorporates sufficient utility and flexibility for aiding the decision-making process, and can be a useful tool for the CCES-P.

Nurse-led Multidisciplinary Heart Failure Group Clinic Appointments: Methods, Materials and Outcomes Used in the Clinical Trial

PubMed Central

Smith, C. E.; Piamjariyakul, U.; Dalton, K. M.; Russell, C.; Wick, J.; Ellerbeck, E.F.

2015-01-01

Background The Self-Management and Care of Heart Failure through Group Clinics Trial (SMAC-HF) evaluated the effects of multidisciplinary group clinic appointments on self-care skills and rehospitalizations in high risk heart failure (HF) patients. Objective The purpose of this article is to: (1) describe key SMAC-HF group clinic interactive learning strategies; (2) describe resources and materials used in the group clinic appointment; and (3) present results supporting this patient-centered group intervention. Methods This clinical trial included 198 HF patients (randomized to either group clinical appointments or to standard care). Data were collected from 72 group clinic appointments via patients’: (1) group clinic session evaluations; (2) HF Self-Care Behaviors Skills; (3) HF related discouragement and quality of life scores and (4) HF related reshopitalizations during the 12 month follow-up. Also the costs of delivery of the group clinical appointments were tabulated. Results Overall, patients rated group appointments as 4.8 out of 5 on the “helpfulness” in managing HF score. The statistical model showed a 33% decrease in the rate of rehospitalizations (incidence rate ratio (IRR) = 0.67) associated with the intervention over the 12-month follow-up period when compared with control patients (χ2(1) = 3.9, p = 0.04). The total cost for implementing five group appointments was $243.58 per patient. Conclusion The intervention was associated with improvements in HF self-care knowledge and home care behavior skills and managing their for HF care. In turn, better self-care was associated with reductions in HF related hospitalizations. PMID:25774836

Improving performance of natural language processing part-of-speech tagging on clinical narratives through domain adaptation.

PubMed

Ferraro, Jeffrey P; Daumé, Hal; Duvall, Scott L; Chapman, Wendy W; Harkema, Henk; Haug, Peter J

2013-01-01

Natural language processing (NLP) tasks are commonly decomposed into subtasks, chained together to form processing pipelines. The residual error produced in these subtasks propagates, adversely affecting the end objectives. Limited availability of annotated clinical data remains a barrier to reaching state-of-the-art operating characteristics using statistically based NLP tools in the clinical domain. Here we explore the unique linguistic constructions of clinical texts and demonstrate the loss in operating characteristics when out-of-the-box part-of-speech (POS) tagging tools are applied to the clinical domain. We test a domain adaptation approach integrating a novel lexical-generation probability rule used in a transformation-based learner to boost POS performance on clinical narratives. Two target corpora from independent healthcare institutions were constructed from high frequency clinical narratives. Four leading POS taggers with their out-of-the-box models trained from general English and biomedical abstracts were evaluated against these clinical corpora. A high performing domain adaptation method, Easy Adapt, was compared to our newly proposed method ClinAdapt. The evaluated POS taggers drop in accuracy by 8.5-15% when tested on clinical narratives. The highest performing tagger reports an accuracy of 88.6%. Domain adaptation with Easy Adapt reports accuracies of 88.3-91.0% on clinical texts. ClinAdapt reports 93.2-93.9%. ClinAdapt successfully boosts POS tagging performance through domain adaptation requiring a modest amount of annotated clinical data. Improving the performance of critical NLP subtasks is expected to reduce pipeline error propagation leading to better overall results on complex processing tasks.

Logic Learning Machine and standard supervised methods for Hodgkin's lymphoma prognosis using gene expression data and clinical variables.

PubMed

Parodi, Stefano; Manneschi, Chiara; Verda, Damiano; Ferrari, Enrico; Muselli, Marco

2018-03-01

This study evaluates the performance of a set of machine learning techniques in predicting the prognosis of Hodgkin's lymphoma using clinical factors and gene expression data. Analysed samples from 130 Hodgkin's lymphoma patients included a small set of clinical variables and more than 54,000 gene features. Machine learning classifiers included three black-box algorithms ( k-nearest neighbour, Artificial Neural Network, and Support Vector Machine) and two methods based on intelligible rules (Decision Tree and the innovative Logic Learning Machine method). Support Vector Machine clearly outperformed any of the other methods. Among the two rule-based algorithms, Logic Learning Machine performed better and identified a set of simple intelligible rules based on a combination of clinical variables and gene expressions. Decision Tree identified a non-coding gene ( XIST) involved in the early phases of X chromosome inactivation that was overexpressed in females and in non-relapsed patients. XIST expression might be responsible for the better prognosis of female Hodgkin's lymphoma patients.

Clinical Decision Support Alert Appropriateness: A Review and Proposal for Improvement

PubMed Central

McCoy, Allison B.; Thomas, Eric J.; Krousel-Wood, Marie; Sittig, Dean F.

2014-01-01

Background Many healthcare providers are adopting clinical decision support (CDS) systems to improve patient safety and meet meaningful use requirements. Computerized alerts that prompt clinicians about drug-allergy, drug-drug, and drug-disease warnings or provide dosing guidance are most commonly implemented. Alert overrides, which occur when clinicians do not follow the guidance presented by the alert, can hinder improved patient outcomes. Methods We present a review of CDS alerts and describe a proposal to develop novel methods for evaluating and improving CDS alerts that builds upon traditional informatics approaches. Our proposal incorporates previously described models for predicting alert overrides that utilize retrospective chart review to determine which alerts are clinically relevant and which overrides are justifiable. Results Despite increasing implementations of CDS alerts, detailed evaluations rarely occur because of the extensive labor involved in manual chart reviews to determine alert and response appropriateness. Further, most studies have solely evaluated alert overrides that are appropriate or justifiable. Our proposal expands the use of web-based monitoring tools with an interactive dashboard for evaluating CDS alert and response appropriateness that incorporates the predictive models. The dashboard provides 2 views, an alert detail view and a patient detail view, to provide a full history of alerts and help put the patient's events in context. Conclusion The proposed research introduces several innovations to address the challenges and gaps in alert evaluations. This research can transform alert evaluation processes across healthcare settings, leading to improved CDS, reduced alert fatigue, and increased patient safety. PMID:24940129

New calibration method for I-scan sensors to enable the precise measurement of pressures delivered by 'pressure garments'.

PubMed

Macintyre, Lisa

2011-11-01

Accurate measurement of the pressure delivered by medical compression products is highly desirable both in monitoring treatment and in developing new pressure inducing garments or products. There are several complications in measuring pressure at the garment/body interface and at present no ideal pressure measurement tool exists for this purpose. This paper summarises a thorough evaluation of the accuracy and reproducibility of measurements taken following both of Tekscan Inc.'s recommended calibration procedures for I-scan sensors; and presents an improved method for calibrating and using I-scan pressure sensors. The proposed calibration method enables accurate (±2.1 mmHg) measurement of pressures delivered by pressure garments to body parts with a circumference ≥30 cm. This method is too cumbersome for routine clinical use but is very useful, accurate and reproducible for product development or clinical evaluation purposes. Copyright © 2011 Elsevier Ltd and ISBI. All rights reserved.

Eye-tracking for clinical decision support: A method to capture automatically what physicians are viewing in the EMR.

PubMed

King, Andrew J; Hochheiser, Harry; Visweswaran, Shyam; Clermont, Gilles; Cooper, Gregory F

2017-01-01

Eye-tracking is a valuable research tool that is used in laboratory and limited field environments. We take steps toward developing methods that enable widespread adoption of eye-tracking and its real-time application in clinical decision support. Eye-tracking will enhance awareness and enable intelligent views, more precise alerts, and other forms of decision support in the Electronic Medical Record (EMR). We evaluated a low-cost eye-tracking device and found the device's accuracy to be non-inferior to a more expensive device. We also developed and evaluated an automatic method for mapping eye-tracking data to interface elements in the EMR (e.g., a displayed laboratory test value). Mapping was 88% accurate across the six participants in our experiment. Finally, we piloted the use of the low-cost device and the automatic mapping method to label training data for a Learning EMR (LEMR) which is a system that highlights the EMR elements a physician is predicted to use.

Eye-tracking for clinical decision support: A method to capture automatically what physicians are viewing in the EMR

PubMed Central

King, Andrew J.; Hochheiser, Harry; Visweswaran, Shyam; Clermont, Gilles; Cooper, Gregory F.

2017-01-01

Eye-tracking is a valuable research tool that is used in laboratory and limited field environments. We take steps toward developing methods that enable widespread adoption of eye-tracking and its real-time application in clinical decision support. Eye-tracking will enhance awareness and enable intelligent views, more precise alerts, and other forms of decision support in the Electronic Medical Record (EMR). We evaluated a low-cost eye-tracking device and found the device’s accuracy to be non-inferior to a more expensive device. We also developed and evaluated an automatic method for mapping eye-tracking data to interface elements in the EMR (e.g., a displayed laboratory test value). Mapping was 88% accurate across the six participants in our experiment. Finally, we piloted the use of the low-cost device and the automatic mapping method to label training data for a Learning EMR (LEMR) which is a system that highlights the EMR elements a physician is predicted to use. PMID:28815151

Automation of CT-based haemorrhagic stroke assessment for improved clinical outcomes: study protocol and design

PubMed Central

Chinda, Betty; Medvedev, George; Siu, William; Ester, Martin; Arab, Ali; Gu, Tao; Moreno, Sylvain; D’Arcy, Ryan C N; Song, Xiaowei

2018-01-01

Introduction Haemorrhagic stroke is of significant healthcare concern due to its association with high mortality and lasting impact on the survivors’ quality of life. Treatment decisions and clinical outcomes depend strongly on the size, spread and location of the haematoma. Non-contrast CT (NCCT) is the primary neuroimaging modality for haematoma assessment in haemorrhagic stroke diagnosis. Current procedures do not allow convenient NCCT-based haemorrhage volume calculation in clinical settings, while research-based approaches are yet to be tested for clinical utility; there is a demonstrated need for developing effective solutions. The project under review investigates the development of an automatic NCCT-based haematoma computation tool in support of accurate quantification of haematoma volumes. Methods and analysis Several existing research methods for haematoma volume estimation are studied. Selected methods are tested using NCCT images of patients diagnosed with acute haemorrhagic stroke. For inter-rater and intrarater reliability evaluation, different raters will analyse haemorrhage volumes independently. The efficiency with respect to time of haematoma volume assessments will be examined to compare with the results from routine clinical evaluations and planimetry assessment that are known to be more accurate. The project will target the development of an enhanced solution by adapting existing methods and integrating machine learning algorithms. NCCT-based information of brain haemorrhage (eg, size, volume, location) and other relevant information (eg, age, sex, risk factor, comorbidities) will be used in relation to clinical outcomes with future project development. Validity and reliability of the solution will be examined for potential clinical utility. Ethics and dissemination The project including procedures for deidentification of NCCT data has been ethically approved. The study involves secondary use of existing data and does not require new consent of participation. The team consists of clinical neuroimaging scientists, computing scientists and clinical professionals in neurology and neuroradiology and includes patient representatives. Research outputs will be disseminated following knowledge translation plans towards improving stroke patient care. Significant findings will be published in scientific journals. Anticipated deliverables include computer solutions for improved clinical assessment of haematoma using NCCT. PMID:29674371

Description and pilot results from a novel method for evaluating return of incidental findings from next-generation sequencing technologies.

PubMed

Goddard, Katrina A B; Whitlock, Evelyn P; Berg, Jonathan S; Williams, Marc S; Webber, Elizabeth M; Webster, Jennifer A; Lin, Jennifer S; Schrader, Kasmintan A; Campos-Outcalt, Doug; Offit, Kenneth; Feigelson, Heather Spencer; Hollombe, Celine

2013-09-01

The aim of this study was to develop, operationalize, and pilot test a transparent, reproducible, and evidence-informed method to determine when to report incidental findings from next-generation sequencing technologies. Using evidence-based principles, we proposed a three-stage process. Stage I "rules out" incidental findings below a minimal threshold of evidence and is evaluated using inter-rater agreement and comparison with an expert-based approach. Stage II documents criteria for clinical actionability using a standardized approach to allow experts to consistently consider and recommend whether results should be routinely reported (stage III). We used expert opinion to determine the face validity of stages II and III using three case studies. We evaluated the time and effort for stages I and II. For stage I, we assessed 99 conditions and found high inter-rater agreement (89%), and strong agreement with a separate expert-based method. Case studies for familial adenomatous polyposis, hereditary hemochromatosis, and α1-antitrypsin deficiency were all recommended for routine reporting as incidental findings. The method requires <3 days per topic. We establish an operational definition of clinically actionable incidental findings and provide documentation and pilot testing of a feasible method that is scalable to the whole genome.

Reference-free ground truth metric for metal artifact evaluation in CT images.

PubMed

Kratz, Bärbel; Ens, Svitlana; Müller, Jan; Buzug, Thorsten M

2011-07-01

In computed tomography (CT), metal objects in the region of interest introduce data inconsistencies during acquisition. Reconstructing these data results in an image with star shaped artifacts induced by the metal inconsistencies. To enhance image quality, the influence of the metal objects can be reduced by different metal artifact reduction (MAR) strategies. For an adequate evaluation of new MAR approaches a ground truth reference data set is needed. In technical evaluations, where phantoms can be measured with and without metal inserts, ground truth data can easily be obtained by a second reference data acquisition. Obviously, this is not possible for clinical data. Here, an alternative evaluation method is presented without the need of an additionally acquired reference data set. The proposed metric is based on an inherent ground truth for metal artifacts as well as MAR methods comparison, where no reference information in terms of a second acquisition is needed. The method is based on the forward projection of a reconstructed image, which is compared to the actually measured projection data. The new evaluation technique is performed on phantom and on clinical CT data with and without MAR. The metric results are then compared with methods using a reference data set as well as an expert-based classification. It is shown that the new approach is an adequate quantification technique for artifact strength in reconstructed metal or MAR CT images. The presented method works solely on the original projection data itself, which yields some advantages compared to distance measures in image domain using two data sets. Beside this, no parameters have to be manually chosen. The new metric is a useful evaluation alternative when no reference data are available.

Laser safety in dentistry

NASA Astrophysics Data System (ADS)

Wigdor, Harvey A.

1997-05-01

One of the major causes of anxiety in the dental clinic is the dental handpiece. Because dentists wish to provide a method which can replace the drill there has often been a premature use of the laser in dentistry. Various lasers have been introduced into the clinic before research has shown the laser used is of clinical benefit. Any new treatment method must not compromise the health of the patient being treated. Thus a method of evaluating the clinical abilities of dentists and their understanding the limitations of the laser used must be developed. Dentist must be trained in the basic interaction of the laser on oral tissues. The training has to concentrate on the variation of the laser wavelength absorption in the different tissues of the oral cavity. Because of the differences in the optical properties of these tissues great care must be exercised by practitioners using lasers on patients.

Increasing conclusiveness of clinical breath analysis by improved baseline correction of multi capillary column - ion mobility spectrometry (MCC-IMS) data.

PubMed

Szymańska, Ewa; Tinnevelt, Gerjen H; Brodrick, Emma; Williams, Mark; Davies, Antony N; van Manen, Henk-Jan; Buydens, Lutgarde M C

2016-08-05

Current challenges of clinical breath analysis include large data size and non-clinically relevant variations observed in exhaled breath measurements, which should be urgently addressed with competent scientific data tools. In this study, three different baseline correction methods are evaluated within a previously developed data size reduction strategy for multi capillary column - ion mobility spectrometry (MCC-IMS) datasets. Introduced for the first time in breath data analysis, the Top-hat method is presented as the optimum baseline correction method. A refined data size reduction strategy is employed in the analysis of a large breathomic dataset on a healthy and respiratory disease population. New insights into MCC-IMS spectra differences associated with respiratory diseases are provided, demonstrating the additional value of the refined data analysis strategy in clinical breath analysis. Copyright © 2016 Elsevier B.V. All rights reserved.

Metadata registry and management system based on ISO 11179 for cancer clinical trials information system

PubMed Central

Park, Yu Rang; Kim*, Ju Han

2006-01-01

Standardized management of data elements (DEs) for Case Report Form (CRF) is crucial in Clinical Trials Information System (CTIS). Traditional CTISs utilize organization-specific definitions and storage methods for Des and CRFs. We developed metadata-based DE management system for clinical trials, Clinical and Histopathological Metadata Registry (CHMR), using international standard for metadata registry (ISO 11179) for the management of cancer clinical trials information. CHMR was evaluated in cancer clinical trials with 1625 DEs extracted from the College of American Pathologists Cancer Protocols for 20 major cancers. PMID:17238675

Elastography in clinical practice.

PubMed

Barr, Richard G

2014-11-01

Elastography is a new technique that evaluates tissue stiffness. There are two elastography methods, strain and shear wave elastography. Both techniques are being used to evaluate a wide range of applications in medical imaging. Elastography of breast masses and prostates have been shown to have high accuracy for characterizing masses and can significantly decrease the need for biopsies. Shear wave elastography has been shown to be able to detect and grade liver fibrosis and may decrease the need for liver biopsy. Evaluation of other organs is still preliminary. This article reviews the principles of elastography and its potential clinical applications. Copyright © 2014 Elsevier Inc. All rights reserved.

Methods to improve patient recruitment and retention in stroke trials.

PubMed

Berge, Eivind; Stapf, Christian; Al-Shahi Salman, Rustam; Ford, Gary A; Sandercock, Peter; van der Worp, H Bart; Petersson, Jesper; Dippel, Diederik Wj; Krieger, Derk W; Lees, Kennedy R

2016-08-01

The success of randomized-controlled stroke trials is dependent on the recruitment and retention of a sufficient number of patients, but fewer than half of all trials meet their target number of patients. We performed a search and review of the literature, and conducted a survey and workshop among 56 European stroke trialists, to identify barriers, suggest methods to improve recruitment and retention, and make a priority list of interventions that merit further evaluation. The survey and workshop identified a number of barriers to patient recruitment and retention, from patients' incapacity to consent, to handicaps that prevent patients from participation in trial-specific follow-up. Methods to improve recruitment and retention may include simple interventions with individual participants, funding of research networks, and reimbursement of new treatments by health services only when delivered within clinical trials. The literature review revealed that few methods have been formally evaluated. The top five priorities for evaluation identified in the workshop were as follows: short and illustrated patient information leaflets, nonwritten consent, reimbursement for new interventions only within a study, and monetary incentives to institutions taking part in research (for recruitment); and involvement of patient groups, remote and central follow-up, use of mobile devices, and reminders to patients about their consent to participate (for retention). Many interventions have been used with the aim of improving recruitment and retention of patients in stroke studies, but only a minority has been evaluated. We have identified methods that could be tested, and propose that such evaluations may be nested within on-going clinical trials. © 2016 World Stroke Organization.

Three-dimensional self-gated cardiac MR imaging for the evaluation of myocardial infarction in mouse model on a 3T clinical MR system.

PubMed

Zhang, Xiaoyong; Qiu, Bensheng; Wei, Zijun; Yan, Fei; Shi, Caiyun; Su, Shi; Liu, Xin; Ji, Jim X; Xie, Guoxi

2017-01-01

To develop and assess a three-dimensional (3D) self-gated technique for the evaluation of myocardial infarction (MI) in mouse model without the use of external electrocardiogram (ECG) trigger and respiratory motion sensor on a 3T clinical MR system. A 3D T1-weighted GRE sequence with stack-of-stars sampling trajectories was developed and performed on six mice with MIs that were injected with a gadolinium-based contrast agent at a 3T clinical MR system. Respiratory and cardiac self-gating signals were derived from the Cartesian mapping of the k-space center along the partition encoding direction by bandpass filtering in image domain. The data were then realigned according to the predetermined self-gating signals for the following image reconstruction. In order to accelerate the data acquisition, image reconstruction was based on compressed sensing (CS) theory by exploiting temporal sparsity of the reconstructed images. In addition, images were also reconstructed from the same realigned data by conventional regridding method for demonstrating the advantageous of the proposed reconstruction method. Furthermore, the accuracy of detecting MI by the proposed method was assessed using histological analysis as the standard reference. Linear regression and Bland-Altman analysis were used to assess the agreement between the proposed method and the histological analysis. Compared to the conventional regridding method, the proposed CS method reconstructed images with much less streaking artifact, as well as a better contrast-to-noise ratio (CNR) between the blood and myocardium (4.1 ± 2.1 vs. 2.9 ± 1.1, p = 0.031). Linear regression and Bland-Altman analysis demonstrated that excellent correlation was obtained between infarct sizes derived from the proposed method and histology analysis. A 3D T1-weighted self-gating technique for mouse cardiac imaging was developed, which has potential for accurately evaluating MIs in mice at 3T clinical MR system without the use of external ECG trigger and respiratory motion sensor.

Using Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes: A Step toward Pragmatism in Benefit:risk Evaluation.

PubMed

Evans, Scott R; Follmann, Dean

2016-01-01

In the future, clinical trials will have an increased emphasis on pragmatism, providing a practical description of the effects of new treatments in realistic clinical settings. Accomplishing pragmatism requires better summaries of the totality of the evidence in ways that clinical trials consumers---patients, physicians, insurers---find transparent and allow for informed benefit:risk decision-making. The current approach to the analysis of clinical trials is to analyze efficacy and safety separately and then combine these analyses into a benefit:risk assessment. Many assume that this will effectively describe the impact on patients. But this approach is suboptimal for evaluating the totality of effects on patients. We discuss methods for benefit:risk assessment that have greater pragmatism than methods that separately analyze efficacy and safety. These include the concepts of within-patient analyses and composite benefit:risk endpoints with a goal of understanding how to analyze one patient before trying to figure out how to analyze many. We discuss the desirability of outcome ranking (DOOR) and introduce the partial credit strategy using an example in a clinical trial evaluating the effects of a new antibiotic. As part of the example we introduce a strategy to engage patients as a resource to inform benefit:risk analyses consistent with the goal of measuring and weighing outcomes that are most important from the patient's perspective. We describe a broad vision for the future of clinical trials consistent with increased pragmatism. Greater focus on using endpoints to analyze patients rather than patients to analyze endpoints particularly in late-phase/stage clinical trials is an important part of this vision.

Evaluation of direct-to-consumer low-volume lab tests in healthy adults

PubMed Central

Kidd, Brian A.; Hoffman, Gabriel; Zimmerman, Noah; Li, Li; Morgan, Joseph W.; Glowe, Patricia K.; Botwin, Gregory J.; Parekh, Samir; Babic, Nikolina; Doust, Matthew W.; Stock, Gregory B.; Schadt, Eric E.; Dudley, Joel T.

2016-01-01

BACKGROUND. Clinical laboratory tests are now being prescribed and made directly available to consumers through retail outlets in the USA. Concerns with these test have been raised regarding the uncertainty of testing methods used in these venues and a lack of open, scientific validation of the technical accuracy and clinical equivalency of results obtained through these services. METHODS. We conducted a cohort study of 60 healthy adults to compare the uncertainty and accuracy in 22 common clinical lab tests between one company offering blood tests obtained from finger prick (Theranos) and 2 major clinical testing services that require standard venipuncture draws (Quest and LabCorp). Samples were collected in Phoenix, Arizona, at an ambulatory clinic and at retail outlets with point-of-care services. RESULTS. Theranos flagged tests outside their normal range 1.6× more often than other testing services (P < 0.0001). Of the 22 lab measurements evaluated, 15 (68%) showed significant interservice variability (P < 0.002). We found nonequivalent lipid panel test results between Theranos and other clinical services. Variability in testing services, sample collection times, and subjects markedly influenced lab results. CONCLUSION. While laboratory practice standards exist to control this variability, the disparities between testing services we observed could potentially alter clinical interpretation and health care utilization. Greater transparency and evaluation of testing technologies would increase their utility in personalized health management. FUNDING. This work was supported by the Icahn Institute for Genomics and Multiscale Biology, a gift from the Harris Family Charitable Foundation (to J.T. Dudley), and grants from the NIH (R01 DK098242 and U54 CA189201, to J.T. Dudley, and R01 AG046170 and U01 AI111598, to E.E. Schadt). PMID:27018593

Using Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes: A Step toward Pragmatism in Benefit:risk Evaluation

PubMed Central

Evans, Scott R.; Follmann, Dean

2016-01-01

In the future, clinical trials will have an increased emphasis on pragmatism, providing a practical description of the effects of new treatments in realistic clinical settings. Accomplishing pragmatism requires better summaries of the totality of the evidence in ways that clinical trials consumers---patients, physicians, insurers---find transparent and allow for informed benefit:risk decision-making. The current approach to the analysis of clinical trials is to analyze efficacy and safety separately and then combine these analyses into a benefit:risk assessment. Many assume that this will effectively describe the impact on patients. But this approach is suboptimal for evaluating the totality of effects on patients. We discuss methods for benefit:risk assessment that have greater pragmatism than methods that separately analyze efficacy and safety. These include the concepts of within-patient analyses and composite benefit:risk endpoints with a goal of understanding how to analyze one patient before trying to figure out how to analyze many. We discuss the desirability of outcome ranking (DOOR) and introduce the partial credit strategy using an example in a clinical trial evaluating the effects of a new antibiotic. As part of the example we introduce a strategy to engage patients as a resource to inform benefit:risk analyses consistent with the goal of measuring and weighing outcomes that are most important from the patient’s perspective. We describe a broad vision for the future of clinical trials consistent with increased pragmatism. Greater focus on using endpoints to analyze patients rather than patients to analyze endpoints particularly in late-phase/stage clinical trials is an important part of this vision. PMID:28435515

Web-based computer-aided-diagnosis (CAD) system for bone age assessment (BAA) of children

NASA Astrophysics Data System (ADS)

Zhang, Aifeng; Uyeda, Joshua; Tsao, Sinchai; Ma, Kevin; Vachon, Linda A.; Liu, Brent J.; Huang, H. K.

2008-03-01

Bone age assessment (BAA) of children is a clinical procedure frequently performed in pediatric radiology to evaluate the stage of skeletal maturation based on a left hand and wrist radiograph. The most commonly used standard: Greulich and Pyle (G&P) Hand Atlas was developed 50 years ago and exclusively based on Caucasian population. Moreover, inter- & intra-observer discrepancies using this method create a need of an objective and automatic BAA method. A digital hand atlas (DHA) has been collected with 1,400 hand images of normal children from Asian, African American, Caucasian and Hispanic descends. Based on DHA, a fully automatic, objective computer-aided-diagnosis (CAD) method was developed and it was adapted to specific population. To bring DHA and CAD method to the clinical environment as a useful tool in assisting radiologist to achieve higher accuracy in BAA, a web-based system with direct connection to a clinical site is designed as a novel clinical implementation approach for online and real time BAA. The core of the system, a CAD server receives the image from clinical site, processes it by the CAD method and finally, generates report. A web service publishes the results and radiologists at the clinical site can review it online within minutes. This prototype can be easily extended to multiple clinical sites and will provide the foundation for broader use of the CAD system for BAA.

A mixed methods approach to adapting health-related quality of life measures for use in routine oncology clinical practice.

PubMed

Harley, Clare; Takeuchi, Elena; Taylor, Sally; Keding, Ada; Absolom, Kate; Brown, Julia; Velikova, Galina

2012-04-01

The current study reviewed and adapted existing health-related quality of life (HRQoL) instruments for use in routine clinical practice delivering outpatient chemotherapy for colorectal, breast and gynaecological cancers. 564 (288 gynaecological, 208 breast and 68 colorectal) outpatient consultations of 141 patients were audio-recorded and analysed to identify discussed issues. Issues were ranked from most to least commonly discussed within each disease group. Existing HRQoL instruments were evaluated against these lists and best fitting items entered into cancer-specific item banks. Item banks were evaluated during semi-structured interviews by twenty-one oncologists (13 consultants and 8 specialist registrars), four clinical nurse specialists and thirty patients, from breast, gynaecological and colorectal cancer practices. Pilot questionnaires were completed by 448 (145 breast, 148 gynaecological and 155 colorectal) patients attending outpatient clinics. Item selection and scale reliability was explored using descriptive data and psychometric methods alongside qualitative patient and clinician ratings. Each questionnaire includes five physical and three psychosocial function scales each with good internal consistency reliability (α > 0.70) plus disease-specific individual-symptom items identified as useful in clinical practice. Three cancer-specific health-related quality of life measures were developed for use in routine clinical practice. Initial analyses suggest good clinical utility and acceptable psychometric properties for the new instruments.

Mentoring, coaching and action learning: interventions in a national clinical leadership development programme.

PubMed

McNamara, Martin S; Fealy, Gerard M; Casey, Mary; O'Connor, Tom; Patton, Declan; Doyle, Louise; Quinlan, Christina

2014-09-01

To evaluate mentoring, coaching and action learning interventions used to develop nurses' and midwives' clinical leadership competencies and to describe the programme participants' experiences of the interventions. Mentoring, coaching and action learning are effective interventions in clinical leadership development and were used in a new national clinical leadership development programme, introduced in Ireland in 2011. An evaluation of the programme focused on how participants experienced the interventions. A qualitative design, using multiple data sources and multiple data collection methods. Methods used to generate data on participant experiences of individual interventions included focus groups, individual interviews and nonparticipant observation. Seventy participants, including 50 programme participants and those providing the interventions, contributed to the data collection. Mentoring, coaching and action learning were positively experienced by participants and contributed to the development of clinical leadership competencies, as attested to by the programme participants and intervention facilitators. The use of interventions that are action-oriented and focused on service development, such as mentoring, coaching and action learning, should be supported in clinical leadership development programmes. Being quite different to short attendance courses, these interventions require longer-term commitment on the part of both individuals and their organisations. In using mentoring, coaching and action learning interventions, the focus should be on each participant's current role and everyday practice and on helping the participant to develop and demonstrate clinical leadership skills in these contexts. © 2014 John Wiley & Sons Ltd.

Comparison of Standardized Clinical Classification with Fundus Photograph Grading for the assessment of Diabetic Retinopathy and Diabetic Macular Edema Severity

PubMed Central

Gangaputra, Sapna; Lovato, James F.; Hubbard, Larry; Davis, Matthew D; Esser, Barbara A; Ambrosius, Walter T.; Chew, Emily Y.; Greven, Craig; Perdue, Letitia H; Wong, Wai T.; Condren, Audree; Wilkinson, Charles P.; Agrón, Elvira; Adler, Sharon; Danis, Ronald P

2013-01-01

Purpose To compare evaluation by clinical examination with image grading at a reading center (RC) for the classification of diabetic retinopathy (DR) and diabetic macular edema (DME). Methods ACCORD and FIND had similar methods of clinical and fundus photograph evaluation. For analysis purposes the photographic grading scales were condensed to correspond to the clinical scales and agreement between clinicians and reading center classification were compared. Results 6902 eyes of ACCORD participants and 3638 eyes of FIND participants were analyzed for agreement (percent, kappa) on DR on a 5 level scale. Exact agreement between clinicians and RC on DR severity category was 69% in ACCORD and 74% in FIND (Kappa 0.42 and 0.65). Sensitivity of the clinical grading to identify presence of mild nonproliferative retinopathy or worse was 0.53 in ACCORD and 0.84 in FIND. Specificities were 0.97 and 0.96, respectively. DME agreement in 6649 eyes of ACCORD participants and 3366 eyes of FIND participants was similar in both studies (Kappa 0.35 and 0.41). Sensitivities of the clinical grading to identify DME were 0.44 and 0.53 and specificities were 0.99 and 0.94, respectively. Conclusion Our results support the use of clinical information for defining broad severity categories, but not for documenting small to moderate changes in DR over time. PMID:23615341

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis.

PubMed

Salinas-Jazmín, Nohemi; González-González, Edith; Vásquez-Bochm, Luz X; Pérez-Tapia, Sonia M; Velasco-Velázquez, Marco A

2017-05-04

Therapeutic monoclonal antibodies (mAbs) are relevant to the treatment of different pathologies, including cancers. The development of biosimilar mAbs by pharmaceutical companies is a market opportunity, but it is also a strategy to increase drug accessibility and reduce therapy-associated costs. The protocols detailed here describe the evaluation of target binding and CDC induction by rituximab in Daudi cells. These two functions require different structural regions of the antibody and are relevant to the clinical effect induced by rituximab. The protocols allow the side-to-side comparison of a reference rituximab and a marketed rituximab biosimilar. The evaluated products showed differences both in target binding and CDC induction, suggesting that there are underlying physicochemical differences and highlighting the need to analyze the impact of those differences in the clinical setting. The methods reported here constitute simple and inexpensive in vitro models for the evaluation of the activity of rituximab biosimilars. Thus, they can be useful during biosimilar development, as well as for quality control in biosimilar production. Furthermore, the presented methods can be extrapolated to other therapeutic mAbs.

Mid-Level Healthcare Personnel Training: An Evaluation of the Revised, Nationally-Standardized, Pre-Service Curriculum for Clinical Officers in Mozambique

PubMed Central

Feldacker, Caryl; Chicumbe, Sergio; Dgedge, Martinho; Augusto, Gerito; Cesar, Freide; Robertson, Molly; Mbofana, Francisco; O'Malley, Gabrielle

2014-01-01

Introduction Mozambique suffers from a critical shortage of healthcare workers. Mid-level healthcare workers, (Tecnicos de Medicina Geral (TMG)), in Mozambique require less money and time to train than physicians. From 2009–2010, the Mozambique Ministry of Health (MoH) and the International Training and Education Center for Health (I-TECH), University of Washington, Seattle, revised the TMG curriculum. To evaluate the effect of the curriculum revision, we used mixed methods to determine: 1) if TMGs meet the MoH's basic standards of clinical competency; and 2) do scores on measurements of clinical knowledge, physical exam, and clinical case scenarios differ by curriculum? Methods T-tests of differences in means examined differences in continuous score variables between curriculum groups. Univariate and multivariate linear regression models assess curriculum-related and demographic factors associated with assessment scores on each of the three evaluation methods at the p<0.05 level. Qualitative interviews and focus groups inform interpretation. Results We found no significant differences in sex, marital status and age between the 112 and 189 TMGs in initial and revised curriculum, respectively. Mean scores at graduation of initial curriculum TMGs were 56.7%, 63.5%, and 49.1% on the clinical cases, knowledge test, and physical exam, respectively. Scores did not differ significantly from TMGs in the revised curriculum. Results from linear regression models find that training institute was the most significant predictor of TMG scores on both the clinical cases and physical exam. Conclusion TMGs trained in either curriculum may be inadequately prepared to provide quality care. Curriculum changes are a necessary, but insufficient, part of improving TMG knowledge and skills overall. A more comprehensive, multi-level approach to improving TMG training that includes post-graduation mentoring, strengthening the pre-service internship training, and greater resources for training institute faculty may result in improvements in TMG capacity and patient care over time. PMID:25068590

[Medical rehabilitation group-programmes concerning health promotion, patient education and psychoeducation - a 2010 national survey].

PubMed

Reusch, A; Schug, M; Küffner, R; Vogel, H; Faller, H

2013-08-01

High quality demands are being placed on concepts of educational group programmes in medical rehabilitation as well as the related trainer qualifications. A nationwide survey of German medical rehabilitation clinics in 2005 had revealed a need for improving educational practice according to these quality criteria. An updated investigation was performed in 2010 aiming at describing group programmes used in medical rehabilitation. 1 473 inpatient and outpatient medical rehabilitation clinics were invited to participate. 908 clinics reported on their training programmes. Data from clinics caring for patients with somatic disorders could be compared to the 2005 survey. Data from clinics for both psychosomatic and substance abuse disorders was collected for the first time in 2010. Overall, psychologists and physicians were reported to be the most frequent conductors of educative programmes. In somatic clinics, psychologists, dieticians and occupational therapists or physiotherapists were the most common conductors. Two-thirds of the institutions reported no training prerequisites for staff members to perform patient education. 80% of the education programmes were categorized post hoc into 3 classes: "generic health education", "disorder-specific patient education", and "psychoeducational group programmes". Almost two-thirds of all programmes were carried out with 8-15 participants, and many used several interactive didactic methods. Programmes conducted in small groups (<8 participants) used significantly more interactive methods than those conducted in larger groups did (>15 participants). Only half of the programmes were manualized. Significantly more interactive methods were used in completely manualized programmes. Only about half of the programmes were evaluated, and only very few evaluation studies were published. The institutions wished additional support by workshops especially concerning qualification of their staff and concerning educational concepts. A need for further improvement and support exists relative to the training of educators and the development of manuals as well as evaluation and publication of the programmes. © Georg Thieme Verlag KG Stuttgart · New York.

Evaluation of Automated and Semi-Automated Scoring of Polysomnographic Recordings from a Clinical Trial Using Zolpidem in the Treatment of Insomnia

PubMed Central

Svetnik, Vladimir; Ma, Junshui; Soper, Keith A.; Doran, Scott; Renger, John J.; Deacon, Steve; Koblan, Ken S.

2007-01-01

Objective: To evaluate the performance of 2 automated systems, Morpheus and Somnolyzer24X7, with various levels of human review/editing, in scoring polysomnographic (PSG) recordings from a clinical trial using zolpidem in a model of transient insomnia. Methods: 164 all-night PSG recordings from 82 subjects collected during 2 nights of sleep, one under placebo and one under zolpidem (10 mg) treatment were used. For each recording, 6 different methods were used to provide sleep stage scores based on Rechtschaffen & Kales criteria: 1) full manual scoring, 2) automated scoring by Morpheus 3) automated scoring by Somnolyzer24X7, 4) automated scoring by Morpheus with full manual review, 5) automated scoring by Morpheus with partial manual review, 6) automated scoring by Somnolyzer24X7 with partial manual review. Ten traditional clinical efficacy measures of sleep initiation, maintenance, and architecture were calculated. Results: Pair-wise epoch-by-epoch agreements between fully automated and manual scores were in the range of intersite manual scoring agreements reported in the literature (70%-72%). Pair-wise epoch-by-epoch agreements between automated scores manually reviewed were higher (73%-76%). The direction and statistical significance of treatment effect sizes using traditional efficacy endpoints were essentially the same whichever method was used. As the degree of manual review increased, the magnitude of the effect size approached those estimated with fully manual scoring. Conclusion: Automated or semi-automated sleep PSG scoring offers valuable alternatives to costly, time consuming, and intrasite and intersite variable manual scoring, especially in large multicenter clinical trials. Reduction in scoring variability may also reduce the sample size of a clinical trial. Citation: Svetnik V; Ma J; Soper KA; Doran S; Renger JJ; Deacon S; Koblan KS. Evaluation of automated and semi-automated scoring of polysomnographic recordings from a clinical trial using zolpidem in the treatment of insomnia. SLEEP 2007;30(11):1562-1574. PMID:18041489

Assessment of the interns’ ability based on Dundee model in Shiraz University of Medical Sciences

PubMed Central

AMINI, MITRA; ABIRI, SAMANEH; NABEIEI, PARISA; GHANAVATI, SHIRIN; HAYAT, ALI ASGHAR; KOJURI, JAVAD

2015-01-01

Introduction The importance of medical profession and the role of the physician in society is no secret to anyone. Skills and competencies in clinical practice are necessary for the medical profession. In fact, in patient care, doctors require practical skills in addition to scientific knowledge. This study examines the potentials of medical school students in three areas of doing the right thing, doing the right thing in an intermediate range, and doing the right thing by the right person. Methods This study was done in a descriptive-analytical and sectional model. The population of this study was all interns of Shiraz University of Medical Sciences who were passing internship at Internal Medicine, Surgery, Pediatrics, Obstetrics and Emergency wards. About 100 persons were selected by simple randomization. In order to collect data, a questionnaire with 12 questions was designed in two parts. The questionnaire was approved by 7 Faculty members of Clinical Medicine and Medical Education, and its reliability was approved by test-retest method on 20 medical students in the form of a pilot study and through Cronbach's alpha (82%). Collected data were analyzed by SPSS software version 14 using descriptive statistical methods. Results Results showed that within the inner circle, interns evaluated their skills in surgery, internal medicine, and gynecology wards, intermediate and at other wards as weak. Also within the center circle, interns evaluated adequate educational evidence-based training in the field of medicine, and sufficiency of educational training in the field of clinical decision making and clinical care as suitable. Conclusion According to the results, it seems that medical interns' skills in performing most medical skills are moderate. So teaching students by new educational methods and workshop techniques, using experienced teachers will be effective. The use of clinical skills training centers and objective assessment methods for the students' skills, especially before entering the clinical departments, is very important. PMID:26457317

Development and evaluation of an interactive dental video game to teach dentin bonding.

PubMed

Amer, Rafat S; Denehy, Gerald E; Cobb, Deborah S; Dawson, Deborah V; Cunningham-Ford, Marsha A; Bergeron, Cathia

2011-06-01

Written and clinical tests compared the change in clinical knowledge and practical clinical skill of first-year dental students watching a clinical video recording of the three-step etch-and-rinse resin bonding system to those using an interactive dental video game teaching the same procedure. The research design was a randomized controlled trial with eighty first-year dental students enrolled in the preclinical operative dentistry course. Students' change in knowledge was measured through written examination using a pre-test and a post-test, as well as clinical tests in the form of a benchtop shear bond strength test. There was no statistically significant difference between teaching methods in regards to change in either knowledge or clinical skills, with one minor exception relating to the wetness of dentin following etching. Students expressed their preference for an interactive self-paced method of teaching.

Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial

PubMed Central

Amrutesh, Sunita; Malini, J; Tandur, Prakash S; Patki, Pralhad S

2010-01-01

Background The aim of this study was to evaluate the efficacy and safety of herbal dental cream in comparison to fluoride dental cream. Objectives Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial. Methods One hundred and two patients with established dental plaque were randomly assigned to either herbal dental group or fluoride dental group for six weeks in a double-blind design. Improvement in plaque index, oral hygiene status, bleeding index, and gingival index was evaluated in these patients along with microbiological study. Results Results indicated a significant reduction in plaque index, gingival index, oral hygiene index, and microbial growth in both groups. Difference between the groups was not significant. There was no significant change in bleeding index. No adverse events were reported and both the dental creams were well tolerated. Conclusion The finding of this preliminary study indicates that herbal dental cream is as safe and effective as fluoride dental cream, but not superior to it. PMID:27186096

Diet and Colorectal Cancer Risk: Evaluation of a Nutrition Education Leaflet

ERIC Educational Resources Information Center

Dyer, K. J.; Fearon, K. C. H.; Buckner, K.; Richardson, R. A.

2005-01-01

Objective: To evaluate the effect of a needs-based, nutrition education leaflet on nutritional knowledge. Design: Comparison of nutritional knowledge levels before and after exposure to a nutrition education leaflet. Setting: A regional colorectal out-patient clinic in Edinburgh. Method: A nutrition education leaflet, based on an earlier…

Adolescent Depression: Evaluating Pediatric Residents' Knowledge, Confidence, and Interpersonal Skills Using Standardized Patients

ERIC Educational Resources Information Center

Lewy, Colleen; Sells, C. Wayne; Gilhooly, Jennifer; McKelvey, Robert

2009-01-01

Objective: The authors aim to determine whether pediatric residents used DSM-IV criteria to diagnose major depressive disorder and how this related to residents' confidence in diagnosis and treatment skills before and after clinical training with depressed adolescents. Methods: Pediatric residents evaluated two different standardized patients…

Evaluating biomarkers for prognostic enrichment of clinical trials.

PubMed

Kerr, Kathleen F; Roth, Jeremy; Zhu, Kehao; Thiessen-Philbrook, Heather; Meisner, Allison; Wilson, Francis Perry; Coca, Steven; Parikh, Chirag R

2017-12-01

A potential use of biomarkers is to assist in prognostic enrichment of clinical trials, where only patients at relatively higher risk for an outcome of interest are eligible for the trial. We investigated methods for evaluating biomarkers for prognostic enrichment. We identified five key considerations when considering a biomarker and a screening threshold for prognostic enrichment: (1) clinical trial sample size, (2) calendar time to enroll the trial, (3) total patient screening costs and the total per-patient trial costs, (4) generalizability of trial results, and (5) ethical evaluation of trial eligibility criteria. Items (1)-(3) are amenable to quantitative analysis. We developed the Biomarker Prognostic Enrichment Tool for evaluating biomarkers for prognostic enrichment at varying levels of screening stringency. We demonstrate that both modestly prognostic and strongly prognostic biomarkers can improve trial metrics using Biomarker Prognostic Enrichment Tool. Biomarker Prognostic Enrichment Tool is available as a webtool at http://prognosticenrichment.com and as a package for the R statistical computing platform. In some clinical settings, even biomarkers with modest prognostic performance can be useful for prognostic enrichment. In addition to the quantitative analysis provided by Biomarker Prognostic Enrichment Tool, investigators must consider the generalizability of trial results and evaluate the ethics of trial eligibility criteria.

Evaluation of laboratory tests for dengue diagnosis in clinical specimens from consecutive patients with suspected dengue in Belo Horizonte, Brazil.

PubMed

Ferraz, Fernanda Oliveira; Bomfim, Maria Rosa Quaresma; Totola, Antônio Helvécio; Ávila, Thiago Vinícius; Cisalpino, Daniel; Pessanha, José Eduardo Marques; da Glória de Souza, Danielle; Teixeira Júnior, Antônio Lúcio; Nogueira, Maurício Lacerda; Bruna-Romero, Oscar; Teixeira, Mauro Martins

2013-09-01

Dengue is a widely spread arboviral disease in tropical and subtropical regions of the world. Dengue fever presents clinical characteristics similar to other febrile illness. Thus laboratory diagnosis is important for adequate management of the disease. The present study was designed to evaluate the diagnostic performance of real-time PCR and serological methods for dengue in a real epidemic context. Clinical data and blood samples were collected from consecutive patients with suspected dengue who attended a primary health care unit in Belo Horizonte, Brazil. Serologic methods and real-time PCR were performed in serum samples to confirm dengue diagnosis. Among the 181 consecutive patients enrolled in this study with suspected dengue, 146 were considered positive by serological criteria (positive NS1 ELISA and/or anti-dengue IgM ELISA) and 138 were positive by real-time PCR. Clinical criteria were not sufficient for distinguishing between dengue and non-dengue febrile illness. The PCR reaction was pre-optimized using samples from patients with known viral infection. It had similar sensitivity compared to NS1 ELISA (88% and 89%, respectively). We also evaluated three commercial lateral flow immunochromatographic tests for NS1 detection (BIOEASY, BIORAD and PANBIO). All three tests showed high sensitivity (94%, 91% and 81%, respectively) for dengue diagnosis. According to our results it can be suggested that lateral flow tests for NS1 detection are the most feasible methods for early diagnosis of dengue. Copyright © 2013 Elsevier B.V. All rights reserved.

An Interactive Teddy Bear Clinic Tour: Teaching Veterinary Students How to Interact with Young Children.

PubMed

Dalley, Jessica S; Creary, Patricia R; Durzi, Tiffany; McMurtry, C Meghan

Although there are existing guidelines for teaching and learning skillful client communication, there remains a need to integrate a developmental focus into veterinary medical curricula to prepare students for interactions with children who accompany their companion animals. The objectives of this teaching tip are (1) to describe the use of a Teddy Bear Clinic Tour as an innovative, applied practice method for teaching veterinary students about clinical communication with children, and (2) to provide accompanying resources to enable use of this method to teach clinical communication at other facilities. This paper includes practical guidelines for organizing a Teddy Bear Clinic Tour at training clinics or colleges of veterinary medicine; an anecdotal description of a pilot study at the Ontario Veterinary College Smith Lane Animal Hospital; and printable resources, including a list of specific clinical communication skills, a sample evaluation sheet for supervisors and students, recommendations for creating a child-friendly environment, examples of child-friendly veterinary vocabulary, and a sample script for a Teddy Bear Clinic Tour. Informed by the resources provided in this teaching tip paper, the Teddy Bear Clinic Tour can be used at your facility as a unique teaching method for clinical communication with children and as a community outreach program to advertise the services at the facility.

Radiologic evaluation of nonalcoholic fatty liver disease

PubMed Central

Lee, Seung Soo; Park, Seong Ho

2014-01-01

Nonalcoholic fatty liver disease (NAFLD) is a frequent cause of chronic liver diseases, ranging from simple steatosis to nonalcoholic steatohepatitis (NASH)-related liver cirrhosis. Although liver biopsy is still the gold standard for the diagnosis of NAFLD, especially for the diagnosis of NASH, imaging methods have been increasingly accepted as noninvasive alternatives to liver biopsy. Ultrasonography is a well-established and cost-effective imaging technique for the diagnosis of hepatic steatosis, especially for screening a large population at risk of NAFLD. Ultrasonography has a reasonable accuracy in detecting moderate-to-severe hepatic steatosis although it is less accurate for detecting mild hepatic steatosis, operator-dependent, and rather qualitative. Computed tomography is not appropriate for general population assessment of hepatic steatosis given its inaccuracy in detecting mild hepatic steatosis and potential radiation hazard. However, computed tomography may be effective in specific clinical situations, such as evaluation of donor candidates for hepatic transplantation. Magnetic resonance spectroscopy and magnetic resonance imaging are now regarded as the most accurate practical methods of measuring liver fat in clinical practice, especially for longitudinal follow-up of patients with NAFLD. Ultrasound elastography and magnetic resonance elastography are increasingly used to evaluate the degree of liver fibrosis in patients with NAFLD and to differentiate NASH from simple steatosis. This article will review current imaging methods used to evaluate hepatic steatosis, including the diagnostic accuracy, limitations, and practical applicability of each method. It will also briefly describe the potential role of elastography techniques in the evaluation of patients with NAFLD. PMID:24966609

[Economic analysis of multinational clinical trials in oncology].

PubMed

Lejeune, Catherine; Lueza, Béranger; Bonastre, Julia

2018-02-01

In oncology, as in other fields of medicine, international multicentre clinical trials came into being so as to include a sufficient number of subjects to investigate a clinical situation. The existence of tight budgetary constraints and the desire to make the best use of the resources available have resulted in the development of economic evaluations associated with these trials, which, thanks to their level of evidence and their size, provide particularly relevant material. Nonetheless, economic evaluations alongside international clinical trials raise specific questions of methodology with regard to both the design and the analysis of the results. Indeed, the costs of goods and services consumed, the types and quantities of resources, and medical practices vary from one country to another and within an individual country. Economic data from the different countries involved must be available so as to study and to take into account this variability, and appropriate techniques for cost estimations and analysis must be implemented to aggregate the results from several countries. From a review of the literature, the aim of this work was to provide an overview of the specific methodological features of economic evaluations alongside international clinical trials: analysis of efficacy data from several countries, collection of resources and real costs, methods to establish the monetary value of resources, methods to aggregate results accounting for the trial effect. Copyright © 2017 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

SPIDERplan: A tool to support decision-making in radiation therapy treatment plan assessment.

PubMed

Ventura, Tiago; Lopes, Maria do Carmo; Ferreira, Brigida Costa; Khouri, Leila

2016-01-01

In this work, a graphical method for radiotherapy treatment plan assessment and comparison, named SPIDERplan, is proposed. It aims to support plan approval allowing independent and consistent comparisons of different treatment techniques, algorithms or treatment planning systems. Optimized plans from modern radiotherapy are not easy to evaluate and compare because of their inherent multicriterial nature. The clinical decision on the best treatment plan is mostly based on subjective options. SPIDERplan combines a graphical analysis with a scoring index. Customized radar plots based on the categorization of structures into groups and on the determination of individual structures scores are generated. To each group and structure, an angular amplitude is assigned expressing the clinical importance defined by the radiation oncologist. Completing the graphical evaluation, a global plan score, based on the structures score and their clinical weights, is determined. After a necessary clinical validation of the group weights, SPIDERplan efficacy, to compare and rank different plans, was tested through a planning exercise where plans had been generated for a nasal cavity case using different treatment planning systems. SPIDERplan method was applied to the dose metrics achieved by the nasal cavity test plans. The generated diagrams and scores successfully ranked the plans according to the prescribed dose objectives and constraints and the radiation oncologist priorities, after a necessary clinical validation process. SPIDERplan enables a fast and consistent evaluation of plan quality considering all targets and organs at risk.

Student assessment by objective structured examination in a neurology clerkship

PubMed Central

Adesoye, Taiwo; Smith, Sandy; Blood, Angela; Brorson, James R.

2012-01-01

Objectives: We evaluated the reliability and predictive ability of an objective structured clinical examination (OSCE) in the assessment of medical students at the completion of a neurology clerkship. Methods: We analyzed data from 195 third-year medical students who took the OSCE. For each student, the OSCE consisted of 2 standardized patient encounters. The scores obtained from each encounter were compared. Faculty clinical evaluations of each student for 2 clinical inpatient rotations were also compared. Hierarchical regression analysis was applied to test the ability of the averaged OSCE scores to predict standardized written examination scores and composite clinical scores. Results: Students' OSCE scores from the 2 standardized patient encounters were significantly correlated with each other (r = 0.347, p < 0.001), and the scores for all students were normally distributed. In contrast, students' faculty clinical evaluation scores from 2 different clinical inpatient rotations were uncorrelated, and scores were skewed toward the highest ratings. After accounting for clerkship order, better OSCE scores were predictive of better National Board of Medical Examiners standardized examination scores (R2Δ = 0.131, p < 0.001) and of better faculty clinical scores (R2Δ = 0.078, p < 0.001). Conclusions: Student assessment by an OSCE provides a reliable and predictive objective assessment of clinical performance in a neurology clerkship. PMID:22855865

Comparative evaluation of topographical data of dental implant surfaces applying optical interferometry and scanning electron microscopy.

PubMed

Kournetas, N; Spintzyk, S; Schweizer, E; Sawada, T; Said, F; Schmid, P; Geis-Gerstorfer, J; Eliades, G; Rupp, F

2017-08-01

Comparability of topographical data of implant surfaces in literature is low and their clinical relevance often equivocal. The aim of this study was to investigate the ability of scanning electron microscopy and optical interferometry to assess statistically similar 3-dimensional roughness parameter results and to evaluate these data based on predefined criteria regarded relevant for a favorable biological response. Four different commercial dental screw-type implants (NanoTite Certain Prevail, TiUnite Brånemark Mk III, XiVE S Plus and SLA Standard Plus) were analyzed by stereo scanning electron microscopy and white light interferometry. Surface height, spatial and hybrid roughness parameters (Sa, Sz, Ssk, Sku, Sal, Str, Sdr) were assessed from raw and filtered data (Gaussian 50μm and 5μm cut-off-filters), respectively. Data were statistically compared by one-way ANOVA and Tukey-Kramer post-hoc test. For a clinically relevant interpretation, a categorizing evaluation approach was used based on predefined threshold criteria for each roughness parameter. The two methods exhibited predominantly statistical differences. Dependent on roughness parameters and filter settings, both methods showed variations in rankings of the implant surfaces and differed in their ability to discriminate the different topographies. Overall, the analyses revealed scale-dependent roughness data. Compared to the pure statistical approach, the categorizing evaluation resulted in much more similarities between the two methods. This study suggests to reconsider current approaches for the topographical evaluation of implant surfaces and to further seek after proper experimental settings. Furthermore, the specific role of different roughness parameters for the bioresponse has to be studied in detail in order to better define clinically relevant, scale-dependent and parameter-specific thresholds and ranges. Copyright © 2017 The Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Evaluation of Collaterals and Clot Burden Using Time-Resolved C-Arm Conebeam CT Angiography in the Angiography Suite: A Feasibility Study.

PubMed

Yang, P; Niu, K; Wu, Y; Struffert, T; Doerfler, A; Holter, P; Aagaard-Kienitz, B; Strother, C; Chen, G-H

2017-04-01

The assessment of collaterals and clot burden in patients with acute ischemic stroke provides important information about treatment options and clinical outcome. Time-resolved C-arm conebeam CT angiography has the potential to provide accurate and reliable evaluations of collaterals and clot burden in the angiographic suite. Experience with this technique is extremely limited, and feasibility studies are needed to validate this technique. Our purpose was to present such a feasibility study. Ten C-arm conebeam CT perfusion datasets from 10 subjects with acute ischemic stroke acquired before endovascular treatment were retrospectively processed to generate time-resolved conebeam CTA. From time-resolved conebeam CTA, 2 experienced readers evaluated the clot burden and collateral flow in consensus by using previously reported scoring systems and assessed the clinical value of this novel imaging technique independently. Interobserver agreement was analyzed by using the intraclass correlation analysis method. Clot burden and collateral flow can be assessed by using the commonly accepted scoring systems for all eligible cases. Additional clinical information (eg, the quantitative dynamic information of collateral flow) can be obtained from this new imaging technique. Two readers agreed that time-revolved C-arm conebeam CTA is the preferred method for evaluating the clot burden and collateral flow compared with other conventional imaging methods. Comprehensive evaluations of clot burden and collateral flow are feasible by using time-resolved C-arm conebeam CTA data acquired in the angiography suite. This technique further enriches the imaging tools in the angiography suite to enable a "one-stop- shop" imaging workflow for patients with acute ischemic stroke. © 2017 by American Journal of Neuroradiology.

Feasibility of a Respiratory Movement Evaluation Tool to Quantify Thoracoabdominal Movement for Neuromuscular Diseases.

PubMed

Liu, Fumio; Kawakami, Michiyuki; Tamura, Kimimasa; Taki, Yoshihito; Shimizu, Katsumi; Otsuka, Tomoyoshi; Tsuji, Tetsuya; Miyata, Chieko; Tashiro, Syoichi; Wada, Ayako; Mizuno, Katsuhiro; Aoki, Yoshimitsu; Liu, Meigen

2017-04-01

An objective method to evaluate thoracoabdominal movement is needed in daily clinical practice to detect patients at risk of hypoventilation and to allow for timely interventions in neuromuscular diseases. The clinical feasibility, reliability, and validity of a newly developed method for quantifying respiratory movement using fiber grating sensors, called the Respiratory Movement Evaluation Tool (RMET), was evaluated. The time needed to measure respiratory movement and the usability of the measurement were determined by 5 clinicians using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) 2.0 questionnaire. Thoracoabdominal movement was measured using RMET 3 times in 10 healthy subjects to evaluate intraclass correlation coefficients (ICC). The subjects were encouraged to breathe 10 times while voluntarily changing the amount of air during ventilation simultaneously with the RMET and a spirometer, and their correlations were evaluated to test validity using Pearson's product-moment correlation coefficients. The same measurements were also performed in 10 subjects with Duchenne muscular dystrophy. Real-time recordings of thoracoabdominal movements were obtained over a mean time of 374 ± 23.9 s. With QUEST 2.0, the median score of each item exceeded 3 (more or less satisfied). In healthy subjects, ICC(1,1) ranged from 0.82 to 0.99, and ICC(2,1) ranged from 0.83 to 0.97. Significant correlations were observed between the respiratory amplitudes measured with RMET, and the amount of air during ventilation was measured with a spirometer (r = 0.995, P < .001). In subjects with Duchenne muscular dystrophy, ICC(1,1) ranged from 0.87 to 0.97, and ICC(2,1) ranged from 0.84 to 0.99. The respiratory amplitudes measured with RMET correlated significantly with the amount of air during ventilation with a spirometer (r = 0.957, P < .001). We developed a novel method of quantifying respiratory movement called RMET that was feasible to use in daily clinical practice. Copyright © 2017 by Daedalus Enterprises.

Radiopaque markers equal gastrografin in the study of small bowel obstructions (SBO): a preliminary study.

PubMed

Basile, Marco; Galica, Vikiela

2013-01-01

To compare the diagnostic accuracy of a consolidated method (i.e.gastrografin) and a new one (i.e.radiopaque markers) in detecting complete intestinal obstruction. Twenty-one patients with suspected small bowel obstruction were enrolled and received at admission orally 100 ml of Gastrografin and 10 radiopaque markers at the same time. A series of plain abdominal radiograms was taked and evaluated to decide whether the obstruction was complete or not. The results of radiological evaluations were not disclosed to the surgeons responsible for the patient's treatment, therefore clinical decisions were assumed on clinical grounds only. In 16 out of the 21 enrolled patients both methods demonstrated only a partial obstruction; clinically none of them required surgery. Five patients showed complete bowel obstruction by the radiopaque markers method; out of those the gastrografin study showed a complete obstruction in four of them. All of them were operated on. In the fifth case it was not clear if the gastrografin had passed through the ileum-cecal valve or not. The unclear clinical picture induced to perform a TC that revealed that a small quantity of gastrografin had passed the ileo-cecal valve but there was a complete small bowel occlusion due to an internal hernia requiring a surgical treatment (thus implying a false negative picture). This preliminary study showed that both methods are effective in the early diagnosis of complete SBO. The use of radiopaque markers could avoid some false negatives of the gastrografin method and is significantly less expensive.

Evaluating Student Performance and Qualifications in Rehabilitation Counseling

ERIC Educational Resources Information Center

Fleming, Allison R.; Kline, Katherine M.; Phillips, Brian N.

2017-01-01

Purpose: To determine methods of student learning assessment and clinical training in rehabilitation counseling programs. With many shifts occurring in postsecondary education and in rehabilitation counseling, it is critical to understand these current practices. Method: The authors used an Internet-based survey design to solicit program…

Objective evaluation of antitussive agents under clinical conditions.

PubMed

Beumer, H M; Hardonk, H J; Boter, J; van Eijnsbergen, B

1976-01-01

A new method for objective assessment of cough under normal or pathological conditions is described. Thoracic coughing can be discriminated from any other pressure wave because of its relatively high frequency. This method was applied in a double blind crossover trial in 18 patients with respiratory disease.

Validation of a 3D CT method for measurement of linear wear of acetabular cups.

PubMed

Jedenmalm, Anneli; Nilsson, Fritjof; Noz, Marilyn E; Green, Douglas D; Gedde, Ulf W; Clarke, Ian C; Stark, Andreas; Maguire, Gerald Q; Zeleznik, Michael P; Olivecrona, Henrik

2011-02-01

We evaluated the accuracy and repeatability of a 3D method for polyethylene acetabular cup wear measurements using computed tomography (CT). We propose that the method be used for clinical in vivo assessment of wear in acetabular cups. Ultra-high molecular weight polyethylene cups with a titanium mesh molded on the outside were subjected to wear using a hip simulator. Before and after wear, they were (1) imaged with a CT scanner using a phantom model device, (2) measured using a coordinate measurement machine (CMM), and (3) weighed. CMM was used as the reference method for measurement of femoral head penetration into the cup and for comparison with CT, and gravimetric measurements were used as a reference for both CT and CMM. Femoral head penetration and wear vector angle were studied. The head diameters were also measured with both CMM and CT. The repeatability of the method proposed was evaluated with two repeated measurements using different positions of the phantom in the CT scanner. The accuracy of the 3D CT method for evaluation of linear wear was 0.51 mm and the repeatability was 0.39 mm. Repeatability for wear vector angle was 17°. This study of metal-meshed hip-simulated acetabular cups shows that CT has the capacity for reliable measurement of linear wear of acetabular cups at a clinically relevant level of accuracy.

Development of duplex real-time PCR for the detection of WSSV and PstDV1 in cultivated shrimp.

PubMed

Leal, Carlos A G; Carvalho, Alex F; Leite, Rômulo C; Figueiredo, Henrique C P

2014-07-05

The White spot syndrome virus (WSSV) and Penaeus stylirostris penstyldensovirus 1 (previously named Infectious hypodermal and hematopoietic necrosis virus-IHHNV) are two of the most important viral pathogens of penaeid shrimp. Different methods have been applied for diagnosis of these viruses, including Real-time PCR (qPCR) assays. A duplex qPCR method allows the simultaneous detection of two viruses in the same sample, which is more cost-effective than assaying for each virus separately. Currently, an assay for the simultaneous detection of the WSSV and the PstDV1 in shrimp is unavailable. The aim of this study was to develop and standardize a duplex qPCR assay for the simultaneous detection of the WSSV and the PstDV1 in clinical samples of diseased L. vannamei. In addition, to evaluate the performance of two qPCR master mixes with regard to the clinical sensitivity of the qPCR assay, as well as, different methods for qPCR results evaluation. The duplex qPCR assay for detecting WSSV and PstDV1 in clinical samples was successfully standardized. No difference in the amplification of the standard curves was observed between the duplex and singleplex assays. Specificities and sensitivities similar to those of the singleplex assays were obtained using the optimized duplex qPCR. The analytical sensitivities of duplex qPCR were two copies of WSSV control plasmid and 20 copies of PstDV1 control plasmid. The standardized duplex qPCR confirmed the presence of viral DNA in 28 from 43 samples tested. There was no difference for WSSV detection using the two kits and the distinct methods for qPCR results evaluation. High clinical sensitivity for PstDV1 was obtained with TaqMan Universal Master Mix associated with relative threshold evaluation. Three cases of simultaneous infection by the WSSV and the PstDV1 were identified with duplex qPCR. The standardized duplex qPCR was shown to be a robust, highly sensitive, and feasible diagnostic tool for the simultaneous detection of the WSSV and the PstDV1 in whiteleg shrimp. The use of the TaqMan Universal Master Mix and the relative threshold method of data analysis in our duplex qPCR method provided optimal levels of sensitivity and specificity.

Evaluation of two main RNA-seq approaches for gene quantification in clinical RNA sequencing: polyA+ selection versus rRNA depletion.

PubMed

Zhao, Shanrong; Zhang, Ying; Gamini, Ramya; Zhang, Baohong; von Schack, David

2018-03-19

To allow efficient transcript/gene detection, highly abundant ribosomal RNAs (rRNA) are generally removed from total RNA either by positive polyA+ selection or by rRNA depletion (negative selection) before sequencing. Comparisons between the two methods have been carried out by various groups, but the assessments have relied largely on non-clinical samples. In this study, we evaluated these two RNA sequencing approaches using human blood and colon tissue samples. Our analyses showed that rRNA depletion captured more unique transcriptome features, whereas polyA+ selection outperformed rRNA depletion with higher exonic coverage and better accuracy of gene quantification. For blood- and colon-derived RNAs, we found that 220% and 50% more reads, respectively, would have to be sequenced to achieve the same level of exonic coverage in the rRNA depletion method compared with the polyA+ selection method. Therefore, in most cases we strongly recommend polyA+ selection over rRNA depletion for gene quantification in clinical RNA sequencing. Our evaluation revealed that a small number of lncRNAs and small RNAs made up a large fraction of the reads in the rRNA depletion RNA sequencing data. Thus, we recommend that these RNAs are specifically depleted to improve the sequencing depth of the remaining RNAs.

A Causal Model for Joint Evaluation of Placebo and Treatment-Specific Effects in Clinical Trials

PubMed Central

Zhang, Zhiwei; Kotz, Richard M.; Wang, Chenguang; Ruan, Shiling; Ho, Martin

2014-01-01

Summary Evaluation of medical treatments is frequently complicated by the presence of substantial placebo effects, especially on relatively subjective endpoints, and the standard solution to this problem is a randomized, double-blinded, placebo-controlled clinical trial. However, effective blinding does not guarantee that all patients have the same belief or mentality about which treatment they have received (or treatmentality, for brevity), making it difficult to interpret the usual intent-to-treat effect as a causal effect. We discuss the causal relationships among treatment, treatmentality and the clinical outcome of interest, and propose a causal model for joint evaluation of placebo and treatment-specific effects. The model highlights the importance of measuring and incorporating patient treatmentality and suggests that each treatment group should be considered a separate observational study with a patient's treatmentality playing the role of an uncontrolled exposure. This perspective allows us to adapt existing methods for dealing with confounding to joint estimation of placebo and treatment-specific effects using measured treatmentality data, commonly known as blinding assessment data. We first apply this approach to the most common type of blinding assessment data, which is categorical, and illustrate the methods using an example from asthma. We then propose that blinding assessment data can be collected as a continuous variable, specifically when a patient's treatmentality is measured as a subjective probability, and describe analytic methods for that case. PMID:23432119

A Comparison of Evaluation Metrics for Biomedical Journals, Articles, and Websites in Terms of Sensitivity to Topic

PubMed Central

Fu, Lawrence D.; Aphinyanaphongs, Yindalon; Wang, Lily; Aliferis, Constantin F.

2011-01-01

Evaluating the biomedical literature and health-related websites for quality are challenging information retrieval tasks. Current commonly used methods include impact factor for journals, PubMed’s clinical query filters and machine learning-based filter models for articles, and PageRank for websites. Previous work has focused on the average performance of these methods without considering the topic, and it is unknown how performance varies for specific topics or focused searches. Clinicians, researchers, and users should be aware when expected performance is not achieved for specific topics. The present work analyzes the behavior of these methods for a variety of topics. Impact factor, clinical query filters, and PageRank vary widely across different topics while a topic-specific impact factor and machine learning-based filter models are more stable. The results demonstrate that a method may perform excellently on average but struggle when used on a number of narrower topics. Topic adjusted metrics and other topic robust methods have an advantage in such situations. Users of traditional topic-sensitive metrics should be aware of their limitations. PMID:21419864

Clinical supervision of allied health professionals in country South Australia: A mixed methods pilot study.

PubMed

Kumar, Saravana; Osborne, Kate; Lehmann, Tanya

2015-10-01

Recent times have witnessed dramatic changes in health care with overt recognition for quality and safety to underpin health care service delivery. In addition to systems-wide focus, the importance of supporting and mentoring people delivering the care has also been recognised. This can be achieved through quality clinical supervision. In 2010, Country Health South Australia Local Health Network developed a holistic allied health clinical governance structure, which was implemented in 2011. This research reports on emergent findings from the evaluation of the clinical governance structure, which included mandating clinical supervision for all allied health staff. A mixed method approach was chosen with evaluation of the impact of clinical supervision undertaken by a psychometrically sound instrument (Manchester Clinical Supervision Scale 26-item version), collected through an anonymous online survey and qualitative data collected through semistructured interviews and focus groups. Overall, 189 allied health professionals responded to the survey. Survey responses indicated allied health professionals recognised the importance of and valued receiving clinical supervision (normative domain), had levels of trust and rapport with, and were supported by supervisors (restorative domain) and positively affected their delivery of care and improvement in skills (formative domain). Qualitative data identified enablers such as profession specific gains, improved opportunities and consistency for clinical supervision and barriers such as persistent organisational issues, lack of clarity (delineation of roles) and communication issues. The findings from this research highlight that while clinical supervision has an important role to play, it is not a panacea for all the ills of the health care system. © 2015 National Rural Health Alliance Inc.

"Unscrambling what's in your head": A mixed method evaluation of clinical supervision for midwives.

PubMed

Love, Bev; Sidebotham, Mary; Fenwick, Jennifer; Harvey, Susan; Fairbrother, Greg

2017-08-01

As a strategy to promote workforce sustainability a number of midwives working in one health district in New South Wales, Australia were trained to offer a reflective model of clinical supervision. The expectation was that these midwives would then be equipped to facilitate clinical supervision for their colleagues with the organisational aim of supporting professional development and promoting emotional well-being. To identify understanding, uptake, perceptions of impact, and the experiences of midwives accessing clinical supervision. Mixed Methods. In phase one 225 midwives were invited to complete a self-administered survey. Descriptive and inferential statistics were used to analyse the data. In phase two 12 midwives were interviewed. Thematic analysis was used to deepen understanding of midwives' experiences of receiving clinical supervision. Sixty percent of midwives responding in phase one had some experience of clinical supervision. Findings from both phases were complementary with midwives reporting a positive impact on their work, interpersonal skills, situational responses and career goals. Midwives described clinical supervision as a formal, structured and confidential space for 'safe reflection' that was valued as an opportunity for self-care. Barriers included misconceptions, perceived work related pressures and a sense that taking time out was unjustifiable. Education, awareness raising and further research into reflective clinical supervision, to support emotional well-being and professional midwifery practice is needed. In addition, health organisations need to design, implement and evaluate strategies that support the embedding of clinical supervision within midwives' clinical practice. Copyright © 2016 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

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

Development and pilot testing of an interprofessional patient-centered team training programme in medical rehabilitation clinics in Germany: a process evaluation.

PubMed

Becker, Sonja; Körner, Mirjam; Müller, Christian; Lippenberger, Corinna; Rundel, Manfred; Zimmermann, Linda

2017-07-14

Interprofessional teamwork is considered to be a key component of patient-centred treatment in healthcare, and especially in the rehabilitation sector. To date, however, no interventions exist for improving teamwork in rehabilitation clinics in Germany. A team training programme was therefore designed that is individualised in content but standardised regarding methods and process. It is clinic specific, task related, solution focused and context oriented. The aim of the study was to implement and evaluate this training for interprofessional teams in rehabilitation clinics in Germany. The measure consists of a training of a varying number of sessions with rehabilitation teams that consists of four distinct phases. Those are undergone chronologically, each with clinic-specific contents. It was implemented between 2013 and 2014 in five rehabilitation clinics in Germany and evaluated by the participants via questionnaire (n = 52). Staff in three clinics evaluated the programme as helpful, in particular rating moderation, discussions and communication during the training positively. Staff in the remaining two clinics rated it as not very or not helpful and mentioned long-term structural problems or a lack of need for team training as a reason for this. The team training is applicable and accepted by staff. It should, however, be tested in a greater sample and compared with a control group. Processes should be studied in more detail in order to determine what differentiates successful from non-successful interventions and the different requirements each of these might have.

RAPA: a novel in vitro method to evaluate anti-bacterial skin cleansing products.

PubMed

Ansari, S A; Gafur, R B; Jones, K; Espada, L A; Polefka, T G

2010-04-01

Development of efficacious anti-bacterial skin cleansing products has been limited by the availability of a pre-clinical (in vitro) method to predict clinical efficacy adequately. We report a simple and rapid method, designated as rapid agar plate assay (RAPA), that uses the bacteriological agar surface as a surrogate substrate for skin and combines elements of two widely used in vivo (clinical) methods (Agar Patch and Cup Scrub). To simulate the washing of the human hand or forearm skin with the test product, trypticase soy agar plates were directly washed with the test product and rinsed under running tap water. After air-drying the washed plates, test bacteria (Staphylococcus aureus or Escherichia coli) were applied and the plates were incubated at 37 degrees C for 18-24 h. Using S. aureus as the test organism, anti-bacterial bar soap containing triclocarbanilide showed a strong linear relationship (R(2) = 0.97) between bacterial dose and their per cent reduction. A similar dose-response relationship (R(2) = 0.96) was observed for anti-bacterial liquid hand soap against E. coli. RAPA was able to distinguish between anti-bacterial products based on the nature and level of actives in them. In limited comparative tests, results obtained by RAPA were comparable with the results obtained by clinical agar patch and clinical cup scrub methods. In conclusion, RAPA provides a simple, rugged and reproducible in vitro method for testing the relative efficacy of anti-bacterial skin cleansing products with a likelihood of comparable clinical efficacy. Further testing is warranted to improve the clinical predictability of this method.

Anxiety and Mood Clinical Profile following Sport-related Concussion: From Risk Factors to Treatment.

PubMed

Sandel, Natalie; Reynolds, Erin; Cohen, Paul E; Gillie, Brandon L; Kontos, Anthony P

2017-08-01

Conceptual models for assessing and treating sport-related concussion (SRC) have evolved from a homogenous approach to include different clinical profiles that reflect the heterogeneous nature of this injury and its effects. There are six identified clinical profiles, or subtypes from SRC, and one such clinical profile is the anxiety/mood profile. Athletes with this profile experience predominant emotional disturbance and anxiety following SRC. The purpose of this targeted review was to present an overview of the empirical evidence to support factors contributing to the anxiety/mood profile, along with methods of evaluation and treatment of this clinical profile following SRC. We discuss the potential underlying mechanisms and risk factors for this clinical profile, describe comprehensive assessments to evaluate concussed athletes with an anxiety/mood clinical profile, and explore behavioral and other interventions for treating these athletes. Although there is limited, but growing empirical evidence for the anxiety/mood clinical profile following SRC, understanding this clinical profile is germane for clinicians who are treating athletes with emotional sequelae after SRC.

The Dutch Hospital Standardised Mortality Ratio (HSMR) method and cardiac surgery: benchmarking in a national cohort using hospital administration data versus a clinical database

PubMed Central

Siregar, S; Pouw, M E; Moons, K G M; Versteegh, M I M; Bots, M L; van der Graaf, Y; Kalkman, C J; van Herwerden, L A; Groenwold, R H H

2014-01-01

Objective To compare the accuracy of data from hospital administration databases and a national clinical cardiac surgery database and to compare the performance of the Dutch hospital standardised mortality ratio (HSMR) method and the logistic European System for Cardiac Operative Risk Evaluation, for the purpose of benchmarking of mortality across hospitals. Methods Information on all patients undergoing cardiac surgery between 1 January 2007 and 31 December 2010 in 10 centres was extracted from The Netherlands Association for Cardio-Thoracic Surgery database and the Hospital Discharge Registry. The number of cardiac surgery interventions was compared between both databases. The European System for Cardiac Operative Risk Evaluation and hospital standardised mortality ratio models were updated in the study population and compared using the C-statistic, calibration plots and the Brier-score. Results The number of cardiac surgery interventions performed could not be assessed using the administrative database as the intervention code was incorrect in 1.4–26.3%, depending on the type of intervention. In 7.3% no intervention code was registered. The updated administrative model was inferior to the updated clinical model with respect to discrimination (c-statistic of 0.77 vs 0.85, p<0.001) and calibration (Brier Score of 2.8% vs 2.6%, p<0.001, maximum score 3.0%). Two average performing hospitals according to the clinical model became outliers when benchmarking was performed using the administrative model. Conclusions In cardiac surgery, administrative data are less suitable than clinical data for the purpose of benchmarking. The use of either administrative or clinical risk-adjustment models can affect the outlier status of hospitals. Risk-adjustment models including procedure-specific clinical risk factors are recommended. PMID:24334377

Neonatal peripheral facial paralysis' evaluation with photogrammetry: A case report.

PubMed

da Fonseca Filho, Gentil Gomes; de Medeiros Cirne, Gabriele Natane; Cacho, Roberta Oliveira; de Souza, Jane Carla; Nagem, Danilo; Cacho, Enio Walker Azevedo; Moran, Cristiane Aparecida; Abreu, Bruna; Pereira, Silvana Alves

2015-12-01

Facial paralysis in newborns can leave functional sequelae. Determining the evolution and amount of functional losses requires consistent evaluation methods that measure, quantitatively, the evolution of clinical functionality. This paper reports an innovative method of facial assessment for the case of a child 28 days of age with unilateral facial paralysis. The child had difficulty breast feeding, and quickly responded to the physical therapy treatment. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

An Evaluation Model for a Multidisciplinary Chronic Pelvic Pain Clinic: Application of the RE-AIM Framework.

PubMed

Chen, Innie; Money, Deborah; Yong, Paul; Williams, Christina; Allaire, Catherine

2015-09-01

Chronic pelvic pain (CPP) is a prevalent, debilitating, and costly condition. Although national guidelines and empiric evidence support the use of a multidisciplinary model of care for such patients, such clinics are uncommon in Canada. The BC Women's Centre for Pelvic Pain and Endometriosis was created to respond to this need, and there is interest in this model of care's impact on the burden of disease in British Columbia. We sought to create an approach to its evaluation using the RE-AIM (Reach, Efficacy, Adoption, Implementation, Maintenance) evaluation framework to assess the impact of the care model and to guide clinical decision-making and policy. The RE-AIM evaluation framework was applied to consider the different dimensions of impact of the BC Centre. The proposed measures, data sources, and data management strategies for this mixed-methods approach were identified. The five dimensions of impact were considered at individual and organizational levels, and corresponding indicators were proposed to enable integration into existing data infrastructure to facilitate collection and early program evaluation. The RE-AIM framework can be applied to the evaluation of a multidisciplinary chronic pelvic pain clinic. This will allow better assessment of the impact of innovative models of care for women with chronic pelvic pain.

Assessment methods for the evaluation of vitiligo.

PubMed

Alghamdi, K M; Kumar, A; Taïeb, A; Ezzedine, K

2012-12-01

There is no standardized method for assessing vitiligo. In this article, we review the literature from 1981 to 2011 on different vitiligo assessment methods. We aim to classify the techniques available for vitiligo assessment as subjective, semi-objective or objective; microscopic or macroscopic; and as based on morphometry or colorimetry. Macroscopic morphological measurements include visual assessment, photography in natural or ultraviolet light, photography with computerized image analysis and tristimulus colorimetry or spectrophotometry. Non-invasive micromorphological methods include confocal laser microscopy (CLM). Subjective methods include clinical evaluation by a dermatologist and a vitiligo disease activity score. Semi-objective methods include the Vitiligo Area Scoring Index (VASI) and point-counting methods. Objective methods include software-based image analysis, tristimulus colorimetry, spectrophotometry and CLM. Morphometry is the measurement of the vitiliginous surface area, whereas colorimetry quantitatively analyses skin colour changes caused by erythema or pigment. Most methods involve morphometry, except for the chromameter method, which assesses colorimetry. Some image analysis software programs can assess both morphometry and colorimetry. The details of these programs (Corel Draw, Image Pro Plus, AutoCad and Photoshop) are discussed in the review. Reflectance confocal microscopy provides real-time images and has great potential for the non-invasive assessment of pigmentary lesions. In conclusion, there is no single best method for assessing vitiligo. This review revealed that VASI, the rule of nine and Wood's lamp are likely to be the best techniques available for assessing the degree of pigmentary lesions and measuring the extent and progression of vitiligo in the clinic and in clinical trials. © 2012 The Authors. Journal of the European Academy of Dermatology and Venereology © 2012 European Academy of Dermatology and Venereology.

Evaluation of beam wobbling methods for heavy-ion radiotherapy.

PubMed

Yonai, Shunsuke; Kanematsu, Nobuyuki; Komori, Masataka; Kanai, Tatsuaki; Takei, Yuka; Takahashi, Osamu; Isobe, Yoshiharu; Tashiro, Mutsumi; Koikegami, Hajime; Tomita, Hideki

2008-03-01

The National Institute of Radiological Sciences (NIRS) has extensively studied carbon-ion radiotherapy at the Heavy-Ion Medical Accelerator in Chiba (HIMAC) with some positive outcomes, and has established its efficacy. Therefore, efforts to distribute the therapy to the general public should be made, for which it is essential to enable direct application of clinical and technological experiences obtained at NIRS. For widespread use, it is very important to reduce the cost through facility downsizing with minimal acceleration energy to deliver the HIMAC-equivalent clinical beams. For the beam delivery system, the requirement of miniaturization is translated to reduction in length while maintaining the clinically available field size and penetration range for range-modulated uniform broad beams of regular fields that are either circular or square for simplicity. In this paper, we evaluate the various wobbling methods including original improvements, especially for application to the compact facilities through the experimental and computational studies. The single-ring wobbling method used at HIMAC is the best one including a lot of experience at HIMAC but the residual range is a fatal problem in the case of a compact facility. On the other hand, uniform wobbling methods such as the spiral and zigzag wobbling methods are effective and suitable for a compact facility. Furthermore, these methods can be applied for treatment with passive range modulation including respiratory gated irradiation. In theory, the choice between the spiral and zigzag wobbling methods depends on the shape of the required irradiation field. However, we found that it is better to use the zigzag wobbling method with transformation of the wobbling pattern even when a circular uniform irradiation field is required, because it is difficult to maintain the stability of the wobbler magnet due to the rapid change of the wobbler current in the spiral wobbling method. The regulated wobbling method, which is our improvement, can well expand the uniform irradiation field and lead to reducing the power requirement of the wobbler magnets. Our evaluations showed that the regulated zigzag wobbling method is the most suitable method for use in currently designed compact carbon-therapy facilities.