WorldWideScience

Sample records for clinical assessment protocol

  1. Welfare assessment: correlations and integration between a Qualitative Behavioural Assessment and a clinical/ health protocol applied in veal calves farms

    Directory of Open Access Journals (Sweden)

    Cornelis G. Van Reenen

    2010-01-01

    Full Text Available This study is aimed at finding correlations and possible integration among Qualitative Behavioural Assessment (QBA and a specific protocol of clinical/health evaluation. Both welfare assessment methods were based on direct animal observation and were applied in 24 Italian veal calves farms at 3 weeks (wks of rearing. Principal component analysis (PCA summarized 20 QBA descriptors on two main components (PC1 and PC2 with eigenvalues above 4 and explaining 29.6 and 20.3% of the variation respectively. PCA on residuals obtained after correcting for housing condition yielded highly similar results, indicating that the rearing environment of the calves was not an important determinant of the observer reliability of QBA. A relationship was found between QBA PC2 and the presence of signs of cross-sucking recorded during the clinical visit (presence PC2=1.11 vs. absence PC2=-1.55, P<0.001. There were no other relations between the quantitative clinical measures and QBA PC’s. The frequency of farmer, veterinarian, or industry technician visits to the veal unit significantly affected QBA PC1 and PC2 scores. These results suggest that the 2 methods provide complementary types of information and can each make valid a contribution to an integrated animal welfare monitoring scheme.

  2. Care planning needs of palliative home care clients: Development of the interRAI palliative care assessment clinical assessment protocols (CAPs)

    OpenAIRE

    Freeman, Shannon; Hirdes, John P; Stolee, Paul; Garcia, John; Smith, Trevor Frise; Steel, Knight; Morris, John N.

    2014-01-01

    Background The interRAI Palliative Care (interRAI PC) assessment instrument provides a standardized, comprehensive means to identify person-specific need and supports clinicians to address important factors such as aspects of function, health, and social support. The interRAI Clinical Assessment Protocols (CAPs) inform clinicians of priority issues requiring further investigation where specific intervention may be warranted and equip clinicians with evidence to better inform development of a ...

  3. Implementing a clinical assessment protocol for sensory and skeletal function in diabetic neuropathy patients at a university hospital in Brazil

    Directory of Open Access Journals (Sweden)

    Isabel de Camargo Neves Sacco

    Full Text Available CONTEXT AND OBJECTIVE: Physiotherapy can contribute towards recovering or preventing physical and sensory alterations in diabetic neuropathy patients. Our objective was to create and apply a protocol for functional assessment of diabetic neuropathy patients' lower limbs, to guide future physiotherapy. DESIGN AND SETTING: Clinical study at the University Hospital and teaching/research center of Universidade de São Paulo. METHODS: An intentional sample of diabetic neuropathy patients was utilized. The protocol was divided into: (1 preliminary investigation with identification of relevant clinical diabetes and neuropathy characteristics; (2 thermal, tactile and proprioceptive sensitivity tests on the feet; (3 evaluations of muscle function, range of motion, lower limb function, foot anthropometry. RESULTS: The patients' mean age was 57 years, and they had had the diagnosis for 13 years on average. Distal numbness and tingling/prickling were present in 62% and 67%, respectively. There were tactile sensitivity alterations above the heel in 50%, with thermal sensitivity in 40% to 60%. The worst muscle function test responses were at the triceps surae and foot intrinsic muscles. Longitudinal plantar arches were lowered in 50%. Decreased thermal and tactile sensitivity of the heels was found. There was a general reduction in range of motion. CONCLUSIONS: The results provided detailed characterization of the patients. This protocol may be easily applied in healthcare services, since it requires little equipment, at low cost, and it is well understood by patients.

  4. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I; Gøtzsche, Peter C

    2016-01-01

    group were more severe. None of this was stated in the CSR or in the published paper. Our analysis was restricted to one drug tested in the mid-1990s; our results might therefore not be applicable for newer drugs. CONCLUSIONS: In the orlistat trials, we identified important disparities in the reporting...... the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. METHODS AND FINDINGS: We received...... the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on Pub...

  5. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis

    Science.gov (United States)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I.; Gøtzsche, Peter C.

    2016-01-01

    Background Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. Methods and Findings We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were “bothersome,” a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc

  6. Using a clinical protocol for orthognathic surgery and assessing a 3-dimensional virtual approach: current therapy.

    Science.gov (United States)

    Quevedo, Luis A; Ruiz, Jessica V; Quevedo, Cristobal A

    2011-03-01

    Oral and maxillofacial surgeons who perform orthognathic surgery face major changes in their practices, and these challenges will increase in the near future, because the extraordinary advances in technology applied to our profession are not only amazing but are becoming the standard of care as they promote improved outcomes for our patients. Orthognathic surgery is one of the favorite areas of practicing within the scope of practice of an oral and maxillofacial surgeon. Our own practice in orthognathic surgery has completed over 1,000 surgeries of this type. Success is directly related to the consistency and capability of the surgical-orthodontic team to achieve predictable, stable results, and our hypothesis is that a successful result is directly related to the way we take our records and perform diagnosis and treatment planning following basic general principles. Now that we have the opportunity to plan and treat 3-dimensional (3D) problems with 3D technology, we should enter into this new era with appropriate standards to ensure better results, instead of simply enjoying these new tools, which will clearly show not only us but everyone what we do when we perform orthognathic surgery. Appropriate principles need to be taken into account when implementing this new technology. In other words, new technology is welcome, but we do not have to reinvent the wheel. The purpose of this article is to review the current protocol that we use for orthognathic surgery and compare it with published protocols that incorporate new 3D and virtual technology. This report also describes our approach to this new technology.

  7. Assessment of Established Survey Protocols

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — A form and instructions for quickly and briefly assessing a previously (prior to 2013) reviewed or approved survey protocol for use as a National or Regional survey...

  8. Development and Evaluation of Evidence-Informed Clinical Nursing Protocols for Remote Assessment, Triage and Support of Cancer Treatment-Induced Symptoms

    Directory of Open Access Journals (Sweden)

    Dawn Stacey

    2013-01-01

    Full Text Available The study objective was to develop and evaluate a template for evidence-informed symptom protocols for use by nurses over the telephone for the assessment, triage, and management of patients experiencing cancer treatment-related symptoms. Guided by the CAN-IMPLEMENT© methodology, symptom protocols were developed by, conducting a systematic review of the literature to identify clinical practice guidelines and systematic reviews, appraising their quality, reaching consensus on the protocol template, and evaluating the two symptom protocols for acceptability and usability. After excluding one guideline due to poor overall quality, the symptom protocols were developed using 12 clinical practice guidelines (8 for diarrhea and 4 for fever. AGREE Instrument (Appraisal of Guidelines for Research and Evaluation rigour domain subscale ratings ranged from 8% to 86% (median 60.1 diarrhea; 40.5 fever. Included guidelines were used to inform the protocols along with the Edmonton Symptom Assessment System questionnaire to assess symptom severity. Acceptability and usability testing of the symptom populated template with 12 practicing oncology nurses revealed high readability (n=12, just the right amount of information (n=10, appropriate terms (n=10, fit with clinical work flow (n=8, and being self-evident for how to complete (n=5. Five nurses made suggestions and 11 rated patient self-management strategies the highest for usefulness. This new template for symptom protocols can be populated with symptom-specific evidence that nurses can use when assessing, triaging, documenting, and guiding patients to manage their-cancer treatment-related symptoms.

  9. Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM).

    Science.gov (United States)

    Huser, Vojtech; Sastry, Chandan; Breymaier, Matthew; Idriss, Asma; Cimino, James J

    2015-10-01

    Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM's initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements. Using a case study approach, we evaluated ODM's ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard.

  10. Gamma camera performance: technical assessment protocol

    Energy Technology Data Exchange (ETDEWEB)

    Bolster, A.A. [West Glasgow Hospitals NHS Trust, London (United Kingdom). Dept. of Clinical Physics; Waddington, W.A. [University College London Hospitals NHS Trust, London (United Kingdom). Inst. of Nuclear Medicine

    1996-12-31

    This protocol addresses the performance assessment of single and dual headed gamma cameras. No attempt is made to assess the performance of any associated computing systems. Evaluations are usually performed on a gamma camera commercially available within the United Kingdom and recently installed at a clinical site. In consultation with the manufacturer, GCAT selects the site and liaises with local staff to arrange a mutually convenient time for assessment. The manufacturer is encouraged to have a representative present during the evaluation. Three to four days are typically required for the evaluation team to perform the necessary measurements. When access time is limited, the team will modify the protocol to test the camera as thoroughly as possible. Data are acquired on the camera`s computer system and are subsequently transferred to the independent GCAT computer system for analysis. This transfer from site computer to the independent system is effected via a hardware interface and Interfile data transfer. (author).

  11. Protocol Writing in Clinical Research

    Science.gov (United States)

    Al-Jundi, Azzam

    2016-01-01

    Writing a research proposal is probably one of the most challenging and difficult task as research is a new area for the majority of postgraduates and new researchers. The purpose of this article is to summarize the most important steps and necessary guidelines for producing a standard research protocol. Academic and administrative success of any project is usually determined by acquiring a grant for the related field of research. Hence, the quality of a protocol is primarily required to achieve success in this scientific competition. PMID:28050522

  12. The influence of different contrast medium concentrations and injection protocols on quantitative and clinical assessment of FDG–PET/CT in lung cancer

    Energy Technology Data Exchange (ETDEWEB)

    Verburg, Frederik A., E-mail: fverburg@ukaachen.de [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany); Maastricht University Medical Center, Department of Nuclear Medicine, P. Debyelaan 25, 6229 HX Maastricht (Netherlands); Kuhl, Christiane K. [RWTH Aachen University Hospital, Department of Diagnostic and Interventional Radiology, Pauwelsstraße 30, 52074 Aachen (Germany); Pietsch, Hubertus [Bayer Pharma AG, Berlin, Müllerstrasse 178, 13353 Berlin (Germany); Palmowski, Moritz [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany); Mottaghy, Felix M. [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany); Maastricht University Medical Center, Department of Nuclear Medicine, P. Debyelaan 25, 6229 HX Maastricht (Netherlands); Behrendt, Florian F. [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany)

    2013-10-01

    Objectives: To compare the effects of two different contrast medium concentrations for use in computed X-ray tomography (CT) employing two different injection protocols on positron emission tomography (PET) reconstruction in combined 2-{sup 18}F-desoxyglucose (FDG) PET/CT in patients with a suspicion of lung cancer. Methods: 120 patients with a suspicion of lung cancer were enrolled prospectively. PET images were reconstructed with the non-enhanced and venous phase contrast CT obtained after injection of iopromide 300 mg/ml or 370 mg/ml using either a fixed-dose or a body surface area adapted injection protocol. Maximum and mean standardized uptake values (SUVmax and SUVmean) and contrast enhancement (HU) were determined in the subclavian vein, ascending aorta, abdominal aorta, inferior vena cava, portal vein, liver and kidney and in the suspicious lung lesion. PET data were evaluated visually for the presence of malignancy and image quality. Results: At none of the sites a significant difference in the extent of the contrast enhancement between the four different protocols was found. However, the variability of the contrast enhancement at several anatomical sites was significantly greater in the fixed dose groups than in the BSA groups for both contrast medium concentrations. At none of the sites a significant difference was found in the extent of the SUVmax and SUVmean increase as a result of the use of the venous phase contrast enhanced CT for attenuation. Visual clinical evaluation of lesions showed no differences between contrast and non-contrast PET/CT (P = 0.32). Conclusions: Contrast enhanced CT for attenuation correction in combined PET/CT in lung cancer affects neither the clinical assessment nor image quality of the PET-images. A body surface adapted contrast medium protocol reduces the interpatient variability in contrast enhancement.

  13. Welfare monitroing system : assessment protocol for horses

    NARCIS (Netherlands)

    Livestock Research,

    2012-01-01

    This document describes the protocol for horses in more detail. For the development of the protocol the Welfare Quality® framework was used. For each measure there is a description how to assess the measure including the method of classification.

  14. Clinical guidelines, clinical pathways and protocols of care

    OpenAIRE

    Angélica Román

    2012-01-01

    The article points out that the importance of standardization of clinical practices has been established in clinical management, which helps solve the problems of variability by developing documents based on the available scientific evidence. The article claims that healthcare culture has increasingly recognized the importance of standardization of clinical practices and provides a conceptual difference between clinical practice guidelines, protocols and algorithms. Clinical pathways and clin...

  15. The Acute Asthma Severity Assessment Protocol (AASAP) Study: Objectives and Methods of a Study to Develop an Acute Asthma Clinical Prediction Rule

    OpenAIRE

    2011-01-01

    Acute asthma exacerbations are one of the most common reasons for pediatric emergency department (PED) visits and hospitalizations, and relapse frequently necessitates repeat urgent care. While care plans exist, there are no acute asthma prediction rules (APR)to assess severity and predict outcome. The primary objective of the Acute Asthma Severity Assessment Protocol (AASAP) study is to develop a multivariable APR for acute asthma exacerbations in the pediatric patient.

  16. Effects of tailored neck-shoulder pain treatment based on a decision model guided by clinical assessments and standardized functional tests : a study protocol of a randomized controlled trial

    OpenAIRE

    2012-01-01

    Abstract Background A major problem with rehabilitation interventions for neck pain is that the condition may have multiple causes, thus a single treatment approach is seldom efficient. The present study protocol outlines a single blinded randomised controlled trial evaluating the effect of tailored treatment for neck-shoulder pain. The treatment is based on a decision model guided by standardized clinical assessment and functional tests with cut-off values. Our main hypothesis is that the ta...

  17. Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees

    OpenAIRE

    Li, Rebecca H.; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann

    2016-01-01

    A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency...

  18. Assessment time of the Welfare Quality protocol for dairy cattle

    NARCIS (Netherlands)

    Vries, de M.; Engel, B.; Uijl, I.; Schaik, van G.; Dijkstra, T.; Boer, de I.J.M.; Bokkers, E.A.M.

    2013-01-01

    The Welfare Quality® (WQ) protocols are increasingly used for assessing welfare of farm animals. These protocols are time consuming (about one day per farm) and, therefore, costly. Our aim was to assess the scope for reduction of on-farm assessment time of the WQ protocol for dairy cattle. Seven tra

  19. The clinical assessment study of the foot (CASF: study protocol for a prospective observational study of foot pain and foot osteoarthritis in the general population

    Directory of Open Access Journals (Sweden)

    Menz Hylton B

    2011-09-01

    Full Text Available Abstract Background Symptomatic osteoarthritis (OA affects approximately 10% of adults aged over 60 years. The foot joint complex is commonly affected by OA, yet there is relatively little research into OA of the foot, compared with other frequently affected sites such as the knee and hand. Existing epidemiological studies of foot OA have focussed predominantly on the first metatarsophalangeal joint at the expense of other joints. This three-year prospective population-based observational cohort study will describe the prevalence of symptomatic radiographic foot OA, relate its occurrence to symptoms, examination findings and life-style-factors, describe the natural history of foot OA, and examine how it presents to, and is diagnosed and managed in primary care. Methods All adults aged 50 years and over registered with four general practices in North Staffordshire, UK, will be invited to participate in a postal Health Survey questionnaire. Respondents to the questionnaire who indicate that they have experienced foot pain in the preceding twelve months will be invited to attend a research clinic for a detailed clinical assessment. This assessment will consist of: clinical interview; physical examination; digital photography of both feet and ankles; plain x-rays of both feet, ankles and hands; ultrasound examination of the plantar fascia; anthropometric measurement; and a further self-complete questionnaire. Follow-up will be undertaken in consenting participants by postal questionnaire at 18 months (clinic attenders only and three years (clinic attenders and survey participants, and also by review of medical records. Discussion This three-year prospective epidemiological study will combine survey data, comprehensive clinical, x-ray and ultrasound assessment, and review of primary care records to identify radiographic phenotypes of foot OA in a population of community-dwelling older adults, and describe their impact on symptoms, function and

  20. Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

    Science.gov (United States)

    Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

    2016-04-01

    A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval.

  1. Protocol for the Quick Clinical study: a randomised controlled trial to assess the impact of an online evidence retrieval system on decision-making in general practice

    Directory of Open Access Journals (Sweden)

    Kidd Michael R

    2006-08-01

    Full Text Available Abstract Background Online information retrieval systems have the potential to improve patient care but there are few comparative studies of the impact of online evidence on clinicians' decision-making behaviour in routine clinical work. Methods/design A randomized controlled parallel design is employed to assess the effectiveness of an online evidence retrieval system, Quick Clinical (QC in improving clinical decision-making processes in general practice. Eligible clinicians are randomised either to receive access or not to receive access to QC in their consulting rooms for 12 months. Participants complete pre- and post trial surveys. Two-hundred general practitioners are recruited. Participants must be registered to practice in Australia, have a computer with Internet access in their consulting room and use electronic prescribing. Clinicians planning to retire or move to another practice within 12 months or participating in any other clinical trial involving electronic extraction of prescriptions data are excluded from the study. The primary end-points for the study is clinician acceptance and use of QC and the resulting change in decision-making behaviour. The study will examine prescribing patterns related to frequently prescribed medications where there has been a recent significant shift in recommendations regarding their use based upon new evidence. Secondary outcome measures include self-reported changes in diagnosis, patient education, prescriptions written, investigations and referrals. Discussion A trial under experimental conditions is an effective way of examining the impact of using QC in routine general practice consultations.

  2. Structured assessments of clinical competence.

    Science.gov (United States)

    Boursicot, Katharine A M

    2010-06-01

    Clinical teachers are often involved in assessing clinical competence in the workplace, in universities and colleges. Assessments commonly used to formally assess clinical competence include long and short cases and the objective structured clinical examination which, if well designed, is a fair and reliable method of assessing clinical competence.

  3. Protocol for cardiac assessment of recreational athletes.

    Science.gov (United States)

    Chinea, Ana M; Lollett, Carlos; Herrera, Hector; Passariello, Gianfranco; Wong, Sara

    2012-01-01

    In this work, the development of a database on physical fitness is presented. As initial population to fill this database, people who practice recreational sports at the Universidad Simon Bolivar (USB) were chosen. The goal was studying individual physical fitness in order to structure exercise routines that gives certain benefits without risking the individual health, promoting a less sedentary way of life. Before the study, a low-cost noninvasive protocol was designed to determine the level of physical fitness. The methodology consisted of four steps: a) A review of existing protocols to propose a set of physical fitness (International Physical Activity Questionnaire (IPAQ)), cardiovascular (heart rate variability, heart rate recovery time and arterial blood pressure), anthropomorphic, aerobic (maximum oxygen consumption) and mood state (Profile of Mood State (POMS)) measurements, which allow sketching a complete profile on the sportsman physical fitness. b) Instrumental data collection. c) Electrocardiographic signal processing. d) Data post-processing using multivariate analysis. The database was composed of 26 subject from USB. Ten subjects were soccer players, ten were mountain climbers and six were sedentary people. Results showed that the heart rate recover time after 2-3 min, IPAQ and maximum oxygen consumption have higher weights for classifying individuals according to their habitual physical activity. Heart rate variability, as well as, POMS did not contribute greatly for discriminating recreational sport from sedentary persons.

  4. Development of low-dose protocols for thin-section CT assessment of cystic fibrosis in pediatric patients.

    LENUS (Irish Health Repository)

    O'Connor, Owen J

    2010-12-01

    To develop low-dose thin-section computed tomographic (CT) protocols for assessment of cystic fibrosis (CF) in pediatric patients and determine the clinical usefulness thereof compared with chest radiography.

  5. Whole Body Vibration Exercise Protocol versus a Standard Exercise Protocol after ACL Reconstruction: A Clinical Randomized Controlled Trial with Short Term Follow-Up

    Directory of Open Access Journals (Sweden)

    Gereon Berschin

    2014-09-01

    Full Text Available The suitability and effectiveness of whole body vibration (WBV exercise in rehabilitation after injury of the anterior cruciate ligament (ACL was studied using a specially designed WBV protocol. We wanted to test the hypothesis if WBV leads to superior short term results regarding neuromuscular performance (strength and coordination and would be less time consuming than a current standard muscle strengthening protocol. In this prospective randomized controlled clinical trial, forty patients who tore their ACL and underwent subsequent ligament reconstruction were enrolled. Patients were randomized to the whole body vibration (n=20 or standard rehabilitation exercise protocol (n=20. Both protocols started in the 2nd week after surgery. Isometric and isokinetic strength measurements, clinical assessment, Lysholm score, neuromuscular performance were conducted weeks 2, 5, 8 and 11 after surgery. Time spent for rehabilitation exercise was reduced to less than a half in the WBV group. There were no statistically significant differences in terms of clinical assessment, Lysholm score, isokinetic and isometric strength. The WBV group displayed significant better results in the stability test. In conclusion, preliminary data indicate that our whole body vibration muscle exercise protocol seems to be a good alternative to a standard exercise program in ACL-rehabilitation. Despite of its significant reduced time requirement it is at least equally effective compared to a standard rehabilitation protocol.

  6. A Sustainability Assessment Protocol for Geothermal Utilization

    OpenAIRE

    Shortall, Ruth, 1981-

    2010-01-01

    Sustainable development calls for the use of sustainable energy systems. However, the way in which a geothermal resource is utilized will ultimately determine whether or not it is sustainable. Sustainable utilization of geothermal energy means that it is produced and used in such a way that is compatible with the well-being of future generations and the environment (UNDP, 2000). A measurement and assessment framework is needed for a sustainable energy development strategy, as it can prov...

  7. OCONUS Compliance Assessment Protocols Air Force Supplement

    Science.gov (United States)

    2009-09-01

    effective - Nonconformance and Checking and Corrective Actions: assessing the installation’s compliance with regula- tory requirements and conformance with...below 100 °F (37.8 °C) and having a vapor pressure not exceeding 40 pounds per square inch, guage (psig) (2068 mm Hg) at 100 °F (37.8 °C). Flammable...accordance with the DOD 4500.9R, DTR (AFI 32-7086, para 2.7) - coordinates with the installation Force Protection Working Group and the HMMP team (see

  8. Classification and clinical assessment

    Directory of Open Access Journals (Sweden)

    F. Cantini

    2012-06-01

    Full Text Available There are at least nine classification criteria for psoriatic arthritis (PsA that have been proposed and used in clinical studies. With the exception of the ESSG and Bennett rules, all of the other criteria sets have a good performance in identifying PsA patients. As the CASPAR criteria are based on a robust study methodology, they are considered the current reference standard. However, if there seems to be no doubt that they are very good to classify PsA patients (very high specificity, they might be not sensitive enough to diagnose patients with unknown early PsA. The vast clinical heterogeneity of PsA makes its assessment very challenging. Peripheral joint involvement is measured by 78/76 joint counts, spine involvement by the instruments used for ankylosing spondylitis (AS, dactylitis by involved digit count or by the Leeds dactylitis index, enthesitis by the number of affected entheses (several indices available and psoriasis by the Psoriasis Area and Severity Index (PASI. Peripheral joint damage can be assessed by a modified van der Heijde-Sharp scoring system and axial damage by the methods used for AS or by the Psoriatic Arthritis Spondylitis Radiology Index (PASRI. As in other arthritides, global evaluation of disease activity and severity by patient and physician and assessment of disability and quality of life are widely used. Finally, composite indices that capture several clinical manifestations of PsA have been proposed and a new instrument, the Psoriatic ARthritis Disease Activity Score (PASDAS, is currently being developed.

  9. Harmonization of international risk assessment protocol

    Energy Technology Data Exchange (ETDEWEB)

    Toyofuku, Hajime [Food Safety Department, WHO, Geneva (Switzerland)]. E-mail toyofuku@nihs.go.jp

    2006-07-01

    For over centuries developments in food production and new food safety management systems in most developed countries have been perceived by many to be efficient in the prevention of food-borne disease. Nevertheless a number of problems remain dominant, one of these being the high level of food-borne microbiological disease which seems, for some pathogens, to have increased over the last decades. The development of an interdisciplinary approach with direct interaction between surveillance and risk analysis systems is described as a potential basis for improved prevention of food-borne disease. Quantitative microbiological risk assessment is a relatively new scientific approach, able to link data from food within the entire food chain and the various data on human disease to provide a clear estimation of risk. Today food safety is one of the WHOs top eleven priorities; the Organization calls for more systematic and aggressive steps to be taken to reduce significantly the risk of microbiological food-borne diseases. Dealing with this challenge is one of the major challenges for the 21st century in regard to food safety, implying a significant re-direction of food microbiology efforts in many parts of the world.

  10. Assessing competence: The European survey on aging protocol (ESAP)

    NARCIS (Netherlands)

    Fernandez-Ballesteros, R.; Zamarron, M.D.; Rudinger, G.; Schroots, J.J.F.

    2004-01-01

    Objectives: The main goal of this research project was to translate and adapt the European Survey on Ageing Protocol (ESAP) to 7 European countries/cultures. This article presents preliminary results from the ESAP, the basic assessment instrument of EXCELSA (European Longitudinal Study of Aging). Me

  11. Wolbachia detection: an assessment of standard PCR protocols.

    Science.gov (United States)

    Simões, P M; Mialdea, G; Reiss, D; Sagot, M-F; Charlat, S

    2011-05-01

    Wolbachia is a large monophyletic genus of intracellular bacteria, traditionally detected using PCR assays. Its considerable phylogenetic diversity and impact on arthropods and nematodes make it urgent to assess the efficiency of these screening protocols. The sensitivity and range of commonly used PCR primers and of a new set of 16S primers were evaluated on a wide range of hosts and Wolbachia strains. We show that certain primer sets are significantly more efficient than others but that no single protocol can ensure the specific detection of all known Wolbachia infections.

  12. Effects of tailored neck-shoulder pain treatment based on a decision model guided by clinical assessments and standardized functional tests. A study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Björklund Martin

    2012-05-01

    Full Text Available Abstract Background A major problem with rehabilitation interventions for neck pain is that the condition may have multiple causes, thus a single treatment approach is seldom efficient. The present study protocol outlines a single blinded randomised controlled trial evaluating the effect of tailored treatment for neck-shoulder pain. The treatment is based on a decision model guided by standardized clinical assessment and functional tests with cut-off values. Our main hypothesis is that the tailored treatment has better short, intermediate and long-term effects than either non-tailored treatment or treatment-as-usual (TAU on pain and function. We sub-sequentially hypothesize that tailored and non-tailored treatment both have better effect than TAU. Methods/Design 120 working women with minimum six weeks of nonspecific neck-shoulder pain aged 20–65, are allocated by minimisation with the factors age, duration of pain, pain intensity and disability in to the groups tailored treatment (T, non-tailored treatment (NT or treatment-as-usual (TAU. Treatment is given to the groups T and NT for 11 weeks (27 sessions evenly distributed. An extensive presentation of the tests and treatment decision model is provided. The main treatment components are manual therapy, cranio-cervical flexion exercise and strength training, EMG-biofeedback training, treatment for cervicogenic headache, neck motor control training. A decision algorithm based on the baseline assessment determines the treatment components given to each participant of T- and NT-groups. Primary outcome measures are physical functioning (Neck Disability Index and average pain intensity last week (Numeric Rating Scale. Secondary outcomes are general improvement (Patient Global Impression of Change scale, symptoms (Profile Fitness Mapping neck questionnaire, capacity to work in the last 6 weeks (quality and quantity and pressure pain threshold of m. trapezius. Primary and secondary outcomes will

  13. Responsive Assessment: Assessing Student Nurses' Clinical Competence.

    Science.gov (United States)

    Neary, Mary

    2001-01-01

    A study involving 300 nursing students, 155 nurse practitioners, and 80 assessors tested a model of responsive assessment that includes identification of learning needs and potential, assignment to suitable placements, continuous assessment of clinical practice and patient care, and alignment of teaching and assessment with patient needs and…

  14. Constantly evolving safety assessment protocols for GM foods.

    Science.gov (United States)

    Sesikeran, B; Vasanthi, Siruguri

    2008-01-01

    he introduction of GM foods has led to the evolution of a food safety assessment paradigm that establishes safety of the GM food relative to its conventional counterpart. The GM foods currently approved and marketed in several countries have undergone extensive safety testing under a structured safety assessment framework evolved by international organizations like FAO, WHO, Codex and OECD. The major elements of safety assessment include molecular characterization of inserted genes and stability of the trait, toxicity and allergenicity potential of the expressed substances, compositional analysis, potential for gene transfer to gut microflora and unintentional effects of the genetic modification. As more number and type of food crops are being brought under the genetic modification regime, the adequacy of existing safety assessment protocols for establishing safety of these foods has been questioned. Such crops comprise GM crops with higher agronomic vigour, nutritional or health benefit/ by modification of plant metabolic pathways and those expressing bioactive substances and pharmaceuticals. The safety assessment challenges of these foods are the potential of the methods to detect unintentional effects with higher sensitivity and rigor. Development of databases on food compositions, toxicants and allergens is currently seen as an important aid to development of safety protocols. With the changing global trends in genetic modification technology future challenge would be to develop GM crops with minimum amount of inserted foreign DNA so as to reduce the burden of complex safety assessments while ensuring safety and utility of the technology.

  15. PROPOSAL OF GUIDELINE FOR CLINICAL TRIAL PROTOCOLS WITH HERBAL DRUGS

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    Migdacelys Arboláez Estrada.

    2007-04-01

    Full Text Available SUMMARYCuba has extensive experience about herbal drugs, however only a few products get to the clinical phase of drug development. Our objective was to design new guidelines for clinical trials with herbal drugs.A detailed bibliographic search about regulatory aspects about clinical trials in Cuba and the world was done for development of the guideline. The guideline's proposed format includes: 1 Index, including the classification of the content. 2 Summary, 3 Fifteen chapters, related to the clinical trials. The guideline also propose the inclusion of annexes.A new guideline containing 15 chapters allows for writing more clear and detailed clinical trial protocols. The guideline contains the information required to guide the research staff who is interested in the validation of herbal drugs pharmacological activations from the perspective of clinical trials. RESUMEN Cuba tiene experiencia extensa sobre plantas medicinales, aunque solo algunos productos llegan a una fase clínica del desarrollo. Nuestro objetivo fué diseñar una nueva guía para ensayos clínicos con plantas medicinales.Hemos realizado una detallada búsqueda bibliográfica sobre aspectos reguladores de ensayos clínicos en Cuba y el resto del mundo para el desarrollo de la guía. El formato propuesto de la guia incluye: 1 Índice, incluyendo la clasificación de los contenidos. 2 Resumen, 3 Quince capítulos, relacionados con los ensayos clínicos. La guía también propone la inclusión de anexos.La nueva guía que contiene 15 capítulos que orientan la redacción de protocolos de ensayos clínicos más claros y más detallados. La guía contiene la información requerida para orientar al personal investigador interesado en la validación de la actividad farmacológica de las plantas medicinales desde la perspectiva de los ensayos clínicos.

  16. Assessing an improved protocol for plasma microRNA extraction.

    Directory of Open Access Journals (Sweden)

    Inés Moret

    Full Text Available The first step in biomarkers discovery is to identify the best protocols for their purification and analysis. This issue is critical when considering peripheral blood samples (plasma and serum that are clinically interesting but meet several methodological problems, mainly complexity and low biomarker concentration. Analysis of small molecules, such as circulating microRNAs, should overcome these disadvantages. The present study describes an optimal RNA extraction method of microRNAs from human plasma samples. Different reagents and commercially available kits have been analyzed, identifying also the best pre-analytical conditions for plasma isolation. Between all of them, the column-based approaches were shown to be the most effective. In this context, miRNeasy Serum/Plasma Kit (from Qiagen rendered more concentrated RNA, that was better suited for microarrays studies and did not require extra purification steps for sample concentration and purification than phenol based extraction methods. We also present evidences that the addition of low doses of an RNA carrier before starting the extraction process improves microRNA purification while an already published carrier dose can result in significant bias over microRNA profiles. Quality controls for best protocol selection were developed by spectrophotometry measurement of contaminants and microfluidics electrophoresis (Agilent 2100 Bioanalyzer for RNA integrity. Selected donor and patient plasma samples and matched biopsies were tested by Affymetrix microarray technology to compare differentially expressed microRNAs. In summary, this study defines an optimized protocol for microRNA purification from human blood samples, increasing the performance of assays and shedding light over the best way to discover and use these biomarkers in clinical practice.

  17. Assessment of Clinical Competence.

    Science.gov (United States)

    Newble, David I.

    1979-01-01

    Reviews current approaches to the examination of medical students' clinical competence, mentioning differences in approaches adopted in Australia, Great Britain, and North America. Test methods used in examination are discussed critically and their separate strengths and weaknesses are highlighted. Newer approaches involving multiple methods and…

  18. Physical and clinical implications of radiotherapy treatment of prostate cancer using a full bladder protocol

    Energy Technology Data Exchange (ETDEWEB)

    Cambria, Raffaella; Cattani, Federica; Luraschi, Rosa; Pedroli, Guido [Istituto Europeo di Oncologia, Milan (Italy). Dept. of Medical Physics; Jereczek-Fossa, Barbara A.; Orecchia, Roberto [Istituto Europeo di Oncologia, Milan (Italy). Dept. of Radiation Oncology; Univ. degli Studi of Milano, Milan (Italy); Zerini, Dario [Istituto Europeo di Oncologia, Milan (Italy). Dept. of Radiation Oncology; Serafini, Flavia [Unita operativa di radioterapia, Azienda Ospedaliera Sant' Anna, Como (Italy)

    2011-12-15

    To assess the dosimetric and clinical implication when applying the full bladder protocol for the treatment of the localized prostate cancer (PCA). A total of 26 consecutive patients were selected for the present study. Patients underwent two series of CT scans: the day of the simulation and after 40 Gy. Each series consisted of two consecutive scans: (1) full bladder (FB) and (2) empty bladder (EB). The contouring of clinical target volumes (CTVs) and organs at risk (OAR) were compared to evaluate organ motion. Treatment plans were compared by dose distribution and dose-volume histograms (DVH). CTV shifts were negligible in the laterolateral and superior-inferior directions (the maximum shift was 1.85 mm). Larger shifts were recorded in the anterior-posterior direction (95% CI, 0.83-4.41 mm). From the dosimetric point of view, shifts are negligible: the minimum dose to the CTV was 98.5% (median; 95%CI, 95-99%). The potential advantage for GU toxicity in applying the FB treatment protocol was measured: the ratio between full and empty bladder dose-volume points (selected from our protocol) is below 0.61, excluding the higher dose region where DVHs converge. Having a FB during radiotherapy does not affect treatment effectiveness, on the contrary it helps achieve a more favorable DVH and lower GU toxicities.

  19. Nutrition assessment outcomes: a protocol for Native American hospitals.

    Science.gov (United States)

    Bickford, G R; Brugler, L J; Gannon, C

    2000-12-01

    The incorporation of visceral protein testing into nutrition assessment protocols can help all hospitals rapidly and accurately identify patients in need of restorative nutrition therapy. Reilly showed that a 3- to 5-day delay in identifying malnutrition has a direct variable cost of $1,500 per case. Studies by Brugler, Mears, and Reilly have demonstrated longer lengths of stay and increased care costs because of nosocomial complications (i.e., infections, pressure ulcers, wound dehiscence, dyspnea, system failures) related to malnutrition. Brugler showed that functionality--a measure of a patient's independence and ability to perform daily activities--both at admission and discharge, the number of care interventions, the occurrence of complications, the level of nutrition treatment needed, and the patient's discharge disposition were strongly associated with their admission albumin value. Conversely, nutrition restoration leads to improved patient outcomes, reduced costs, maximization of care reimbursement, and fulfillment of regulatory requirements. Adoption of this protocol by other hospitals should allow them to demonstrate comparable results, thereby justifying the incorporation of visceral protein testing into their nutrition assessment methods.

  20. Assessment of Clinical Supervisor Competencies.

    Science.gov (United States)

    Getz, Hildy

    1999-01-01

    Presents a focus and process to assist those training clinical supervisors to assess competencies of the supervisor. States that process creates a practical framework that can be adapted for supervision competencies in other fields. Concludes that assessment methodology gives meaning to the support and structure vital at all levels of training…

  1. Assessment of smear layer removal protocols in curved root canals.

    Science.gov (United States)

    Yeung, William; Raldi, Denise Pontes; Cunha, Rodrigo Sanches; Mello, Isabel

    2014-08-01

    This study sought to assess if the final rinse protocol interferes with the smear layer removal in the apical area of curved canals. Sixty-four extracted human mandibular molars with curved mesial roots were instrumented with rotary files and divided into six experimental groups for final rinse: 1EDTA (syringe irrigation with 1 mL of 17% ethylenediaminetetraacetic acid (EDTA) ), 5EDTA (syringe irrigation with 5 mL of 17% EDTA), 1EDTA-P (syringe irrigation with 1 mL of 17% EDTA + pumping with gutta-percha point), 5EDTA-P (syringe irrigation with 5 mL of 17% EDTA + pumping with gutta-percha point), 1EDTA-EA (syringe irrigation with 1 mL of 17% EDTA + EndoActivator) and 5EDTA-EA (syringe irrigation with 5 mL of 17% EDTA + EndoActivator). Final rinsing was carried out over 3 min. The specimens were split lengthwise and observed under a scanning electron microscope using a score criterion. Comparison among the groups showed statistically significant difference only between the 5EDTA-EA group and the other groups (Kruskal-Wallis and Dunn's post-hoc tests, P protocols used.

  2. Clinical examination protocol to detect atypical and classical scrapie in sheep.

    Science.gov (United States)

    Konold, Timm; Phelan, Laura

    2014-01-19

    The diagnosis of scrapie, a transmissible spongiform encephalopathy (TSEs) of sheep and goats, is currently based on the detection of disease-associated prion protein by post mortem tests. Unless a random sample of the sheep or goat population is actively monitored for scrapie, identification of scrapie cases relies on the reporting of clinical suspects, which is dependent on the individual's familiarization with the disease and ability to recognize clinical signs associated with scrapie. Scrapie may not be considered in the differential diagnosis of neurological diseases in small ruminants, particularly in countries with low scrapie prevalence, or not recognized if it presents as nonpruritic form like atypical scrapie. To aid in the identification of clinical suspects, a short examination protocol is presented to assess the display of specific clinical signs associated with pruritic and nonpruritic forms of TSEs in sheep, which could also be applied to goats. This includes assessment of behavior, vision (by testing of the menace response), pruritus (by testing the response to scratching), and movement (with and without blindfolding). This may lead to a more detailed neurologic examination of reporting animals as scrapie suspects. It could also be used in experimental TSE studies of sheep or goats to evaluate disease progression or to identify clinical end-point.

  3. Protocol-writing support conferences for investigator-initiated clinical trials

    Directory of Open Access Journals (Sweden)

    Goto M

    2016-04-01

    Full Text Available Masaya Goto,1 Yoshihiro Muragaki,2 Atsushi Aruga1 1Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo Women's Medical University and Waseda University, 2Intelligent Clinical Research and Innovation Center, Tokyo Women's Medical University, Tokyo, Japan Abstract: In investigator-initiated clinical trials, protocols with inappropriate methods might cause bias. However, insufficient data are available to determine which items are important or difficult to discuss in protocol development. We recorded protocol-writing support conferences to determine what items methodologists and investigators discussed. We obtained approval from all applicants to attend our Intelligent Clinical Research and Innovation Center writing support conferences, recorded all the discussions, characterized them, and sorted the items iteratively. In 1 year, we had 18 conferences: nine early protocol conferences and nine rejected protocol conferences. The latter were rejected by the institutional review board, which requested consultation. The most discussed item was outcomes, accounting for ~20% of the total discussion time. In three trials, the main problem was multiple primary outcomes. The second most discussed item was control. Early protocol conferences had more non-preliminary proposal items than rejected ones (P<0.001. This study showed important items (especially outcomes and control for investigators to write protocols. Early protocol-writing conferences helped investigators find questionable items. Keywords: investigator-initiated clinical trials, support, protocol-writing, conferences, recording

  4. Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis

    Directory of Open Access Journals (Sweden)

    Ali Ather

    2012-10-01

    Full Text Available Abstract Background Clinical trial design of manual therapies may be especially challenging as techniques are often individualized and practitioner-dependent. This paper describes our methods in creating a standardized Swedish massage protocol tailored to subjects with osteoarthritis of the knee while respectful of the individualized nature of massage therapy, as well as implementation of this protocol in two randomized clinical trials. Methods The manualization process involved a collaborative process between methodologic and clinical experts, with the explicit goals of creating a reproducible semi-structured protocol for massage therapy, while allowing some latitude for therapists’ clinical judgment and maintaining consistency with a prior pilot study. Results The manualized protocol addressed identical specified body regions with distinct 30- and 60-min protocols, using standard Swedish strokes. Each protocol specifies the time allocated to each body region. The manualized 30- and 60-min protocols were implemented in a dual-site 24-week randomized dose-finding trial in patients with osteoarthritis of the knee, and is currently being implemented in a three-site 52-week efficacy trial of manualized Swedish massage therapy. In the dose-finding study, therapists adhered to the protocols and significant treatment effects were demonstrated. Conclusions The massage protocol was manualized, using standard techniques, and made flexible for individual practitioner and subject needs. The protocol has been applied in two randomized clinical trials. This manualized Swedish massage protocol has real-world utility and can be readily utilized both in the research and clinical settings. Trial registration Clinicaltrials.gov NCT00970008 (18 August 2009

  5. Reduced-dose CT protocol for the assessment of cerebral vasospasm

    Energy Technology Data Exchange (ETDEWEB)

    Bricout, N.; Estrade, L.; Boustia, F.; Kalsoum, E.; Pruvo, J.P.; Leclerc, X. [Hopital Roger Salengro, CHRU de Lille, Department of Neuroradiology, Universite Lille Nord de France, Lille cedex (France)

    2015-12-15

    Despite the increased radiation dose, multimodal CT including noncontrast CT (NCT), CT angiography (CTA), and perfusion CT (PCT) remains a useful tool for the diagnosis of delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage (aSAH). The aim of this study was to assess the radiation dose and the image quality between a standard-dose and a reduced-dose multimodal CT protocol. The study group consisted of 26 aSAH patients with a suspicion of DCI on clinical examination and transcranial doppler. Two different CT protocols were used: a standard-dose protocol (NCT 120 kV, 350 mAs; CTA 100 kV, 250 mAs; PCT 80 kV, 200 mAs) from August 2011 to October 2013 (n = 13) and a reduced-dose protocol (NCT 100 kV, 400 mAs; CTA 100 kV, 220 mAs; PCT 80 kV, 180 mAs) from November 2013 to May 2014 (n = 13). Dose-length product (DLP), effective dose, volume CT dose index (CTDI), signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), and overall image quality were determined for each examination. The overall image quality was judged as good or excellent in all cases. The reduced-dose protocol allowed a 15 % decrease in both the median total DLP (2438 vs 2898 mGy cm, p < 0.0001) and the effective dose as well as a significant decrease in median CTDI of 23, 31, and 10 % for NCT, CTA, and CTP, respectively. This dose reduction did not result in significant alteration of SNR (except for NCT) or CNR between groups. The present study showed that the reduced-dose multimodal CT protocol enabled a significant reduction of radiation dose without image quality impairment. (orig.)

  6. Alternative Physical Therapy Protocol Using a Cycle Ergometer During Hospital Rehabilitation of Coronary Artery Bypass Grafting: a Clinical Trial

    Science.gov (United States)

    Trevisan, Margarete Diprat; Lopes, Diene Gomes Colvara; de Mello, Renato Gorga Bandeira; Macagnan, Fabrício Edler; Kessler, Adriana

    2015-01-01

    OBJECTIVE To compare the efficacy of a cycle ergometer-based exercise program to a standard protocol on the increment of the maximum distance walked during the six-minute walk test in the postoperative rehabilitation of patients submitted to coronary artery bypass grafting. METHODS A controlled clinical trial pilot, blinded to the outcome, enrolled subjects who underwent coronary artery bypass grafting in a hospital from Southern Brazil. Subjects were designated for the standard physical rehabilitation protocol or to an alternative cycle ergometer-based protocol through simple random sampling. The primary outcome was the difference in the maximum distance walked in the six-minute walk test before and after the allocated intervention. RESULTS Twenty-four patients were included in the analysis, 10 in the standard protocol and 14 in the alternative protocol group. There was an increment in the maximum distance walked in both groups, and borderline superiority in the intervention group comparing to the control group (312.2 vs. 249.7; P=0.06). CONCLUSION There was an increase in the maximum distance walked in the alternative protocol compared to the standard protocol. Thus, it is postulated that the use of a cycle ergometer can be included in physical rehabilitation in the hospital phase of postoperative coronary artery bypass grafting. However, randomized studies with larger sample size should be conducted to assess the significance of these findings. PMID:26934400

  7. To assess whether indoor residual spraying can provide additional protection against clinical malaria over current best practice of long-lasting insecticidal mosquito nets in The Gambia: study protocol for a two-armed cluster-randomised trial

    Directory of Open Access Journals (Sweden)

    Parker David

    2011-06-01

    Full Text Available Abstract Background Recently, there has been mounting interest in scaling-up vector control against malaria in Africa. It needs to be determined if indoor residual spraying (IRS with DDT will provide significant marginal protection against malaria over current best practice of long-lasting insecticidal nets (LLINs and prompt treatment in a controlled trial, given that DDT is currently the most persistent insecticide for IRS. Methods A 2 armed cluster-randomised controlled trial will be conducted to assess whether DDT IRS and LLINs combined provide better protection against clinical malaria in children than LLINs alone in rural Gambia. Each cluster will be a village, or a group of small adjacent villages; all clusters will receive LLINs and half will receive IRS in addition. Study children, aged 6 months to 13 years, will be enrolled from all clusters and followed for clinical malaria using passive case detection to estimate malaria incidence for 2 malaria transmission seasons in 2010 and 2011. This will be the primary endpoint. Exposure to malaria parasites will be assessed using light and exit traps followed by detection of Anopheles gambiae species and sporozoite infection. Study children will be surveyed at the end of each transmission season to estimate the prevalence of Plasmodium falciparum infection and the prevalence of anaemia. Discussion Practical issues concerning intervention implementation, as well as the potential benefits and risks of the study, are discussed. Trial Registration ISRCTN01738840 - Spraying And Nets Towards malaria Elimination (SANTE

  8. Assessment of the effectiveness and safety of Ethosuximide in the Treatment of non-Diabetic Peripheral Neuropathic Pain: EDONOT—protocol of a randomised, parallel, controlled, double-blinded and multicentre clinical trial

    Science.gov (United States)

    Kerckhove, Nicolas; Mallet, Christophe; Pereira, Bruno; Chenaf, Chouki; Duale, Christian; Dubray, Claude; Eschalier, Alain

    2016-01-01

    Introduction Currently available analgesics are ineffective in 30–50% of patients suffering from neuropathic pain and often induce deleterious side effects. T-type calcium channel blockers (mibefradil, ethosuximide, NNC 55-0396) are of great interest for the development of new symptomatic treatments of neuropathic pain, due to their various effects on pain perception. Interestingly, ethosuximide, which has already been approved for treating epilepsy, is available on the European market for clinical use. Despite numerous preclinical data demonstrating an antinociceptive effect of ethosuximide in various animal models of neuropathic pain, no clinical studies have been published to date on the analgesic efficacy of ethosuximide in patients with neuropathic pain. Methods and analysis The Ethosuximide in the Treatment of non-Diabetic Peripheral Neuropathic Pain (EDONOT) trial is a randomised, parallel, controlled, double-blinded, multicentre clinical study. It is the first clinical trial to evaluate the efficacy and safety of ethosuximide in the treatment of non-diabetic peripheral neuropathic pain. Adult patients exhibiting peripheral neuropathic pain (Numeric Rating Scale (NRS) ≥4 and Douleur Neuropathique 4 (DN4)≥4) for at least 3 months and under stable analgesic treatment for at least 1 month will be included. Patients (n=220) will be randomly assigned to receive either ethosuximide or control treatment for 6 weeks following a 1 week run-in period. The primary end point is the intensity of neuropathic pain, assessed by NRS (0–10) before and after 6 weeks of treatment. The secondary end points are safety (adverse events are collected during the study: daily by the patient on the logbook and during planned phone calls by investigators), the intensity and features of neuropathic pain (assessed by Brief Pain Inventory (BPI) and Neuropathic Pain Symptom Inventory (NPSI) questionnaires) and health-related quality of life (assessed by Medical Outcome

  9. Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol

    Science.gov (United States)

    Ahmed, Khaled; Kyte, Derek; Keeley, Thomas; Efficace, Fabio; Armes, Jo; Brown, Julia M; Calman, Lynn; Copland, Chris; Gavin, Anna; Glaser, Adam; Greenfield, Diana M; Lanceley, Anne; Taylor, Rachel; Velikova, Galina; Brundage, Michael; Mercieca-Bebber, Rebecca; King, Madeleine T

    2016-01-01

    Introduction Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Hypothesis: Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points. Methods and analysis Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion. Ethics and dissemination The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer

  10. A CAD system and quality assurance protocol for bone age assessment utilizing digital hand atlas

    Science.gov (United States)

    Gertych, Arakadiusz; Zhang, Aifeng; Ferrara, Benjamin; Liu, Brent J.

    2007-03-01

    Determination of bone age assessment (BAA) in pediatric radiology is a task based on detailed analysis of patient's left hand X-ray. The current standard utilized in clinical practice relies on a subjective comparison of the hand with patterns in the book atlas. The computerized approach to BAA (CBAA) utilizes automatic analysis of the regions of interest in the hand image. This procedure is followed by extraction of quantitative features sensitive to skeletal development that are further converted to a bone age value utilizing knowledge from the digital hand atlas (DHA). This also allows providing BAA results resembling current clinical approach. All developed methodologies have been combined into one CAD module with a graphical user interface (GUI). CBAA can also improve the statistical and analytical accuracy based on a clinical work-flow analysis. For this purpose a quality assurance protocol (QAP) has been developed. Implementation of the QAP helped to make the CAD more robust and find images that cannot meet conditions required by DHA standards. Moreover, the entire CAD-DHA system may gain further benefits if clinical acquisition protocol is modified. The goal of this study is to present the performance improvement of the overall CAD-DHA system with QAP and the comparison of the CAD results with chronological age of 1390 normal subjects from the DHA. The CAD workstation can process images from local image database or from a PACS server.

  11. Characterizing College Science Assessments: The Three-Dimensional Learning Assessment Protocol.

    Science.gov (United States)

    Laverty, James T; Underwood, Sonia M; Matz, Rebecca L; Posey, Lynmarie A; Carmel, Justin H; Caballero, Marcos D; Fata-Hartley, Cori L; Ebert-May, Diane; Jardeleza, Sarah E; Cooper, Melanie M

    2016-01-01

    Many calls to improve science education in college and university settings have focused on improving instructor pedagogy. Meanwhile, science education at the K-12 level is undergoing significant changes as a result of the emphasis on scientific and engineering practices, crosscutting concepts, and disciplinary core ideas. This framework of "three-dimensional learning" is based on the literature about how people learn science and how we can help students put their knowledge to use. Recently, similar changes are underway in higher education by incorporating three-dimensional learning into college science courses. As these transformations move forward, it will become important to assess three-dimensional learning both to align assessments with the learning environment, and to assess the extent of the transformations. In this paper we introduce the Three-Dimensional Learning Assessment Protocol (3D-LAP), which is designed to characterize and support the development of assessment tasks in biology, chemistry, and physics that align with transformation efforts. We describe the development process used by our interdisciplinary team, discuss the validity and reliability of the protocol, and provide evidence that the protocol can distinguish between assessments that have the potential to elicit evidence of three-dimensional learning and those that do not.

  12. Serial extraction protocol for partial arches in implant dentistry: principles and clinical methodology.

    Science.gov (United States)

    Cavallaro, John S; Greenstein, Gary; Greenstein, Ben

    2010-01-01

    Serial extraction protocol (SEP) is a clinical technique that facilitates using natural tooth abutments to support a fixed interim resin prosthesis, while inserting a sufficient number of implants to retain a definitive fixed prosthesis. A Class 1 protocol allows all necessary implants to be placed during one surgical appointment, while a Class 2 protocol requires two or more rounds of implant installation to achieve sufficient support for a definitive fixed prosthesis. The SEP methodology can be used to restore full and partially edentulous dentitions. This article addresses rehabilitation of partial arches using an SEP protocol.

  13. Axon clinical chemistry analyzer evaluated according to ECCLS protocol.

    Science.gov (United States)

    Brenna, S; Prencipe, L

    1992-10-01

    We assessed the analytical performance of the Axon system (Bayer Diagnostici), according to the European Committee for Clinical Laboratory Standards guidelines, for assay of 12 analytes: cholesterol, creatinine, glucose, total protein, urea, uric acid, alkaline phosphatase, alpha-amylase, aspartate aminotransferase, creatine kinase, sodium, and potassium. The field evaluation lasted approximately 5 months and involved the collection of approximately 10,000 data points with the Axon. The following results were obtained: The highest CVs for controls and human sera at different concentration/activity values were 2.2% for within-run imprecision (n = 60; 3 days, pooled estimate) and 3.5% for the between-day imprecision (n = 20 days). Close correlation was found with results for patients' specimens assayed with comparative instruments (Hitachi 717 for substrates and enzymes, Beckman Synchron EL/E4A for electrolytes). No drift was observed during 8 h of operation. The linearity range was broad, sometimes exceeding the manufacturer's claims. No sample-, reagent-, or cuvette-related carryover was found. Measurement of control sera gave results within +/- 5% of the assigned values. We conclude that good reliability and practicability make the Axon system suitable for laboratories with various needs.

  14. ASSESSMENT OF RIP-V1 AND OSPF-V2 PROTOCOL WITH CONSIDERATION OF CONVERGENCE CRITERIA AND SENDING PROTOCOLS TRAFFIC

    Directory of Open Access Journals (Sweden)

    Hamed Jelodar

    2014-03-01

    Full Text Available Routing Protocols are underlying principles in networks like internet, transport and mobile. Routing Protocols include a series of rules and algorithms that consider routing metric and select the best way for sending healthy data packets from origin to destination. Dynamic routing protocol compatible to topology has a changeable state. RIP and OSPF are dynamic routing protocol that we consider criteria like convergence and sending protocols traffic assessment RIP first version and OSPF second version. By the test we have done on OPNET stimulation we understood that the OSPF protocol was more efficient than RIP protocol.

  15. Evaluation of two clinical protocols for the management of women with vaginal discharge in southern Thailand

    OpenAIRE

    Chandeying, V; Skov, S.; Kemapunmanus, M.; Law, M; Geater, A.; P. Rowe

    1998-01-01

    OBJECTIVES: (1) To compare the effectiveness of two clinical protocols for the management of vaginal discharge in the situations where no laboratory facilities are available but speculum examination is possible and where basic laboratory facilities are available. (2) To determine clinical and simple laboratory indicators for diagnosis of patients with vaginal discharge in the local setting. DESIGN: Alternate allocation of subjects to one of two management protocols. SUBJECTS: Women pres...

  16. Using plant clinic registers to assess the quality of diagnoses and advice given to farmers

    DEFF Research Database (Denmark)

    Danielsen, Solveig; Boa, Eric; Mafabi, Moses;

    2012-01-01

    Purpose: This study developed a framework for quality assessment of diagnoses and advice given at plant clinics. Design/methodology/approach: Clinic registers from five plant clinics in Uganda (2006-2010) were used to develop quality assessment protocols for diagnoses and advice given by plant do...

  17. Research on vaccines during pregnancy: protocol design and assessment of safety.

    Science.gov (United States)

    Munoz, Flor M; Sheffield, Jeanne S; Beigi, Richard H; Read, Jennifer S; Swamy, Geeta K; Jevaji, Indira; Rasmussen, Sonja A; Edwards, Kathryn M; Fortner, Kimberly B; Patel, Shital M; Spong, Catherine Y; Ault, Kevin; Heine, R Philips; Nesin, Mirjana

    2013-09-13

    The Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health organized a series of conferences, entitled "Enrolling Pregnant Women in Clinical Trials of Vaccines and Therapeutics", to discuss study design and the assessment of safety in clinical trials conducted in pregnant women. A panel of experts was charged with developing guiding principles for the design of clinical trials and the assessment of safety of vaccines during pregnancy. Definitions and a grading system to evaluate local and systemic reactogenicity, adverse events, and other events associated with pregnancy and delivery were developed. The purpose of this report is to provide investigators interested in vaccine research in pregnancy with a basic set of tools to design and implement maternal immunization studies which may be conducted more efficiently using consistent definitions and grading of adverse events to allow the comparison of safety reports from different trials. These guidelines and safety assessment tools may be modified to meet the needs of each particular protocol based on evidence collected as investigators use them in clinical trials in different settings and share their findings and expertise.

  18. Clinical exam protocol for the equine thoracolumbar spine

    OpenAIRE

    da Fonseca, Brunna Patricia Almeida; Alves, Ana Liz Garcia [UNESP; Hussni, Carlos Alberto

    2011-01-01

    Thoracolumbar injuries represent a challenge to the veterinarian that seeks to eliminate the pain, reinstitute the athletic use of the horse and minimize economic losses. The percentage of lost training days due to orthopedic conditions in race horses is of 72.1% and within those conditions is back pain, whicht represents from 4.35% to 20% of the lameness cases. The present study searched to establish a protocol based on score points for the thoracolumbar physical exam, by which it is able to...

  19. Feasibility of Automatic Extraction of Electronic Health Data to Evaluate a Status Epilepticus Clinical Protocol.

    Science.gov (United States)

    Hafeez, Baria; Paolicchi, Juliann; Pon, Steven; Howell, Joy D; Grinspan, Zachary M

    2016-05-01

    Status epilepticus is a common neurologic emergency in children. Pediatric medical centers often develop protocols to standardize care. Widespread adoption of electronic health records by hospitals affords the opportunity for clinicians to rapidly, and electronically evaluate protocol adherence. We reviewed the clinical data of a small sample of 7 children with status epilepticus, in order to (1) qualitatively determine the feasibility of automated data extraction and (2) demonstrate a timeline-style visualization of each patient's first 24 hours of care. Qualitatively, our observations indicate that most clinical data are well labeled in structured fields within the electronic health record, though some important information, particularly electroencephalography (EEG) data, may require manual abstraction. We conclude that a visualization that clarifies a patient's clinical course can be automatically created using the patient's electronic clinical data, supplemented with some manually abstracted data. Future work could use this timeline to evaluate adherence to status epilepticus clinical protocols.

  20. WelFur - mink: development of on-farm welfare assessment protocols for mink

    DEFF Research Database (Denmark)

    Møller, Steen Henrik; Hansen, Steffen W; Rousing, Tine

    2012-01-01

    European Fur Breeder's Association initiated the "WelFur" project in 2009 in order to develop a welfare assessment protocol for mink and fox farms after the Welfare Quality® standards. The assessment is based on four welfare principles (Good feeding, good housing, good health and appropriate...... behaviour) and 12 underlying criteria, to be measured on-farm. The major steps in the development of the WelFur mink protocols are described: (1) Writing leterature reviews and listing potential measures. (2) Identifying valid, reliable and feasable welfare measures. (3) Developing registration protocols......, descriptions, and schemes. (4) Testing preliminary protocols in relevant seasons of the annual production. This paper focus on the evaluation of validity, reliability anf feasibility of the 22 measures that have been selected for the WelFur assessment protocols. These protocols haev been tested in the three...

  1. Characterizing College Science Assessments: The Three-Dimensional Learning Assessment Protocol

    CERN Document Server

    Laverty, James T; Matz, Rebecca L; Posey, Lynmarie A; Carmel, Justin H; Caballero, Marcos D; Fata-Hartley, Cori L; Ebert-May, Diane; Jardeleza, Sarah E; Cooper, Melanie M

    2016-01-01

    Many calls to improve science education in college and university settings have focused on improving instructor pedagogy. Meanwhile, science education at the K-12 level is undergoing significant changes as a result of the emphasis on scientific and engineering practices, crosscutting concepts, and disciplinary core ideas. This framework of "three-dimensional learning" is based on the literature about how people learn science and how we can help students put their knowledge to use. Recently, calls have been made to bring similar changes to higher education by incorporating three-dimensional learning into college science courses. As these transformations move forward, it will become important to assess three-dimensional learning both to align assessments with the learning environment, and to assess the extent of the transformations. In this paper, we introduce the Three-Dimensional Learning Assessment Protocol (3D-LAP), which is designed to characterize and support the development of assessment tasks in biology...

  2. Clinical validation protocols for noninvasive blood pressure monitors and their recognition by regulatory authorities and professional organizations: rationale and considerations for a single unified protocol or standard.

    Science.gov (United States)

    Ng, Kim-Gau

    2013-10-01

    Standardized protocols for validating the clinical accuracy of noninvasive blood pressure (NIBP) monitors have been available since 1987. Some of them were developed by standards bodies and others by professional organizations. They have been well-tested through use and progressively improved through multiple revisions; however, many methodological differences exist between them. In addition, for the purpose of regulatory approval or marketing clearance, some protocols are recognized in some countries but not in others; thus, manufacturers have to validate their NIBP monitors to more than one protocol in order to market them worldwide. The use of different protocols not only makes it difficult to compare one device with another but also complicates the validation, regulatory approval, marketing, and public acceptance of NIBP monitors, creating undue burden on manufacturers and unnecessary confusion among users. There is a need for protocol developers, standards bodies, and regulatory authorities to work together to develop and agree on a single unified protocol or standard, one that builds on the strengths of the various protocols that have been developed so far. It is apparent that there is already a trend toward convergence of the various protocols into two protocols, namely, the ISO 81060-2:2009 standard and the 2010 European Society of Hypertension International Protocol. With further reconciliation and consensus, it should be possible to integrate the best features of the ISO, European Society of Hypertension, and other protocols, along with further improvements, into a single unified protocol or standard.

  3. Developing a guideline for clinical trial protocol content: Delphi consensus survey

    Directory of Open Access Journals (Sweden)

    Tetzlaff Jennifer

    2012-09-01

    Full Text Available Abstract Background Recent evidence has highlighted deficiencies in clinical trial protocols, having implications for many groups. Existing guidelines for randomized clinical trial (RCT protocol content vary substantially and most do not describe systematic methodology for their development. As one of three prespecified steps for the systematic development of a guideline for trial protocol content, the objective of this study was to conduct a three-round Delphi consensus survey to develop and refine minimum content for RCT protocols. Methods Panellists were identified using a multistep iterative approach, met prespecified minimum criteria and represented key stakeholders who develop or use clinical trial protocols. They were asked to rate concepts for importance in a minimum set of items for RCT protocols. The main outcome measures were degree of importance (scale of 1 to 10; higher scores indicating higher importance and level of consensus for items. Results were presented as medians, interquartile ranges, counts and percentages. Results Ninety-six expert panellists participated in the Delphi consensus survey including trial investigators, methodologists, research ethics board members, funders, industry, regulators and journal editors. Response rates were between 88 and 93% per round. Overall, panellists rated 63 of 88 concepts of high importance (of which 50 had a 25th percentile rating of 8 or greater, 13 of moderate importance (median 6 or 7 and 12 of low importance (median less than or equal to 5 for minimum trial protocol content. General and item-specific comments and subgroup results provided valuable insight for further discussions. Conclusions This Delphi process achieved consensus from a large panel of experts from diverse stakeholder groups on essential content for RCT protocols. It also highlights areas of divergence. These results, complemented by other empirical research and consensus meetings, are helping guide the development of

  4. Remotely-Supervised Transcranial Direct Current Stimulation (tDCS for Clinical Trials: Guidelines for Technology and Protocols

    Directory of Open Access Journals (Sweden)

    Leigh E Charvet

    2015-03-01

    Full Text Available The effect of transcranial direct current stimulation (tDCS is cumulative. Treatment protocols typically require multiple consecutive sessions spanning weeks or months. However, traveling to clinic for a tDCS session can present an obstacle to subjects and their caregivers. With modified devices and headgear, tDCS treatment can be administered remotely under clinical supervision, potentially enhancing recruitment, throughput, and convenience. Here we propose standards and protocols for clinical trials utilizing remotely-supervised tDCS with the goal of providing safe, reproducible and well-tolerated stimulation therapy outside of the clinic. The recommendations include: 1 training of staff in tDCS treatment and supervision, 2 assessment of the user’s capability to participate in tDCS remotely, 3 ongoing training procedures and materials including assessments of the user and/or caregiver, 4 simple and fail-safe electrode preparation techniques and tDCS headgear, 5 strict dose control for each session, 6 ongoing monitoring to quantify compliance (device preparation, electrode saturation/placement, stimulation protocol, with corresponding corrective steps as required, 7 monitoring for treatment-emergent adverse effects, 8 guidelines for discontinuation of a session and/or study participation including emergency failsafe procedures tailored to the treatment population’s level of need. These guidelines are intended to provide a minimal level of methodological rigor for clinical trials seeking to apply tDCS outside a specialized treatment center. We outline indication-specific applications (Attention Deficit Hyperactivity Disorder, Depression, Multiple Sclerosis, Palliative Care following these recommendations that support a standardized framework for evaluating the tolerability and reproducibility of remote-supervised tDCS that, once established, will allow for translation of tDCS clinical trials to a greater size and range of patient populations.

  5. Craniosacral therapy for migraine: Protocol development for an exploratory controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Coeytaux Remy R

    2008-06-01

    Full Text Available Abstract Background Migraine affects approximately 20% of the population. Conventional care for migraine is suboptimal; overuse of medications for the treatment of episodic migraines is a risk factor for developing chronic daily headache. The study of non-pharmaceutical approaches for prevention of migraine headaches is therefore warranted. Craniosacral therapy (CST is a popular non-pharmacological approach to the treatment or prevention of migraine headaches for which there is limited evidence of safety and efficacy. In this paper, we describe an ongoing feasibility study to assess the safety and efficacy of CST in the treatment of migraine, using a rigorous and innovative randomized controlled study design involving low-strength static magnets (LSSM as an attention control intervention. Methods The trial is designed to test the hypothesis that, compared to those receiving usual care plus a treatment with low-strength static magnets (attention-control complementary therapy, subjects receiving usual medical care plus CST will demonstrate significant improvement in: quality-of-life as measured by the Headache Impact Test (HIT-6; reduced frequency of migraine; and a perception of clinical benefit. Criteria for inclusion are either gender, age > 11, English or Spanish speaking, meeting the International Classification of Headache Disorders (ICHD criteria for migraine with or without aura, a headache frequency of 5 to 15 per month over at least two years. After an 8 week baseline phase, eligible subjects are randomized to either CST or an attention control intervention, low strength static magnets (LSSM. To evaluate possible therapist bias, videotaped encounters are analyzed to assess for any systematic group differences in interactions with subjects. Results 169 individuals have been screened for eligibility, of which 109 were eligible for the study. Five did not qualify during the baseline phase because of inadequate headache frequency. Nineteen

  6. Body surface area adapted iopromide 300 mg/ml versus 370 mg/ml contrast medium injection protocol: Influence on quantitative and clinical assessment in combined PET/CT

    Energy Technology Data Exchange (ETDEWEB)

    Verburg, Frederik A., E-mail: fverburg@ukaachen.de [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany); Maastricht University Medical Center, Department of Nuclear Medicine, P. Debyelaan 25, 6229 HX Maastricht (Netherlands); Apitzsch, Jonas [RWTH Aachen University Hospital, Department of Diagnostic and Interventional Radiology, Pauwelsstraße 30, 52074 Aachen (Germany); Lensing, Carina [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany); Kuhl, Christiane K. [RWTH Aachen University Hospital, Department of Diagnostic and Interventional Radiology, Pauwelsstraße 30, 52074 Aachen (Germany); Pietsch, Hubertus [Bayer Pharma AG, Müllerstrasse 178, 13353 Berlin (Germany); Mottaghy, Felix M. [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany); Maastricht University Medical Center, Department of Nuclear Medicine, P. Debyelaan 25, 6229 HX Maastricht (Netherlands); Behrendt, Florian F. [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany)

    2013-12-01

    Purpose: To investigate the quantitative and qualitative differences between combined positron emission tomography and computed X-ray tomography (PET/CT) enhanced with contrast medium with either an iodine concentration 300 mg/ml or 370 mg/ml. Materials and methods: 120 consecutive patients scheduled for F-18-Fluorodeoxyglucose (FDG) PET/CT were included. The first (second) 60 patients received contrast medium with 300 (370) mg iodine/ml. Intravenous injection protocols were adapted for an identical iodine delivery rate (1.3 mg/s) and body surface area (BSA) adapted iodine dose (22.26 g I/m{sup 2}). Maximum and mean standardized uptake values (SUV{sub max}; SUV{sub mean}) and contrast enhancement (HU) were determined in the ascending aorta, the abdominal aorta, the inferior vena cava, the portal vein, the liver and the right kidney in the venous contrast medium phase. PET data were evaluated visually for the presence of malignancy and image quality. Results: Both media caused significantly higher values for HU, SUV{sub mean} and SUV{sub max} for the enhanced PET/CT than the non-enhanced one (all p < 0.01). There were no significant differences in the degree of increase of HU, SUV{sub mean} and SUV{sub max} between the two contrast media at any anatomic site (all p > 0.05). Visual evaluation of lesions showed no differences between contrast and non-contrast PET/CT or between the two different contrast media (p = 0.77). Conclusion: When using a constant iodine delivery rate and total iodine dose in a BSA adapted injection protocol, there are no quantitative or qualitative differences in either CT or PET between contrast media with an iodine concentration of 300 mg/ml and 370 mg/ml, respectively.

  7. Evaluation of a welfare indicator protocol for assessing animal welfare in AMS herds: researcher, production advisor and veterinary practitioner opinion

    DEFF Research Database (Denmark)

    Rousing, Tine; Jakobsen, Iben Alber; Hindhede, Jens

    2007-01-01

    of the welfare indicator protocol as basis for on-farm welfare assessment have been carried out; one study focused on the opinion of 21 AMS researchers; the other on that of 14 AMS production advisors and 15 veterinary practitioners. The researchers were asked to score the individual welfare relevance of the 38......A welfare indicator protocol integrating a total of 38 measures from 4 information sources: housing system, management, animal behaviour and clinical health has been developed for decision support in Automatic Milking System (AMS) herds. Two expert opinion studies focusing on the relevance...... measures. Furthermore, both the panels were asked to prioritise the 10 most important measures. The 21 researchers generally appreciated the listed protocol measures as highly relevant. The researcher and advisor panels agreed on prioritised measures from all 4 information sources among the 10 most...

  8. Assessing health systems for type 1 diabetes in sub-Saharan Africa: developing a 'Rapid Assessment Protocol for Insulin Access'

    DEFF Research Database (Denmark)

    Beran, David; Yudkin, John S; de Courten, Maximilian

    2006-01-01

    In order to improve the health of people with Type 1 diabetes in developing countries, a clear analysis of the constraints to insulin access and diabetes care is needed. We developed a Rapid Assessment Protocol for Insulin Access, comprising a series of questionnaires as well as a protocol for th...

  9. Using Plant Clinic Registers to Assess the Quality of Diagnoses and Advice Given to Farmers: A Case Study from Uganda

    Science.gov (United States)

    Danielsen, Solveig; Boa, Eric; Mafabi, Moses; Mutebi, Emmanuel; Reeder, Robert; Kabeere, Flavia; Karyeija, Robert

    2013-01-01

    Purpose: This study developed a framework for quality assessment of diagnoses and advice given at plant clinics. Design/methodology/approach: Clinic registers from five plant clinics in Uganda (2006-2010) were used to develop quality assessment protocols for diagnoses and advice given by plant doctors. Assessment of quality of diagnoses was based…

  10. An assessment of the economic impacts of the Kyoto Protocol

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2002-05-01

    In December 2001, the government of Alberta reviewed the costs of implementing the Kyoto Protocol which sets out a specific target for greenhouse gas reduction. It was determined that there is a wide range of estimated costs of implementing the Protocol. One of the reasons why the costs vary is that it is not fully known how Canada's competitiveness will be affected by the US withdrawal from the agreement. It was cautioned that the risk of creating different rules and different costs for competitors in the broad North American market would result in decreased competitiveness, loss of investment and loss of trade. If the Kyoto Protocol is ratified, Canada would become the only partner in within NAFTA that is subject to an emissions target. Canada's commitment to a Kyoto target would also jeopardize a continental energy policy. Other reasons for the varying costs include that the size of the challenge is a moving target, the price range for offsets on international markets will directly impact Canada's cost of compliance, and there is a need for jurisdictions to commit to a process to jointly determine a national climate change plan with clear rules that will limit costs, liability and competitiveness risks. The risk to the Alberta and Canadian economies are that current optimistic assumptions will not be fulfilled and that the reduction burden is greater than forecasted, therefore reduction prices will also be greater than expected. In addition, policy uncertainty would impose costs that would discourage investment. The measures that must be taken to improve confidence in understanding the risks to the Canadian economy include a further analysis of the costs based on very specific policy options, informed consultation with stakeholders, and both federal and provincial agreements on specific policies to reduce uncertainty and manage the risks associated with the Kyoto Protocol. 1 tab., 8 figs.

  11. Integrating authentic assessment with competency based learning: the Protocol Portfolio Scoring.

    NARCIS (Netherlands)

    Sluijsmans, Dominique; Straetmans, Gerard; Van Merriënboer, Jeroen

    2009-01-01

    Sluijsmans, D. M. A., Straetmans, G., & Van Merriënboer, J. (2008). Integrating authentic assessment with competency based learning: the Protocol Portfolio Scoring. Journal of Vocational Education and Training, 60(2), 157-172.

  12. Nausea and vomiting in advanced cancer: the Cleveland Clinic protocol.

    Science.gov (United States)

    Gupta, Mona; Davis, Mellar; LeGrand, Susan; Walsh, Declan; Lagman, Ruth

    2013-03-01

    Nausea and vomiting are common and distressing symptoms in advanced cancer. Both are multifactorial and cause significant morbidity, nutritional failure, and reduced quality of life. Assessment includes a detailed history, physical examination and investigations for reversible causes. Assessment and management will be influenced by performance status, prognosis, and goals of care. Several drug classes are effective with some having the added benefit of multiple routes of administration. It is our institution's practice to recommend metoclopramide as the first drug with haloperidol as an alternative antiemetic. Dexamethasone should be used for patients with central nervous system metastases or bowel obstruction. If your patient is near death, empiric metoclopramide, haloperidol or chlorpromazine is used without further investigation. For patients with a better prognosis, we exclude reversible causes and use the same first-line antiemetics, metoclopramide and haloperidol. For those who do not respond to first-line single antiemetics, olanzapine is second line and ondansetron is third. Rarely do we use combination therapy or cannabinoids. Olanzapine as a single agent has a distinct advantage over antiemetic combinations. It improves compliance, reduces drug interactions and has several routes of administration. Antiemetics, anticholinergics, octreotide and dexamethasone are used in combination to treat bowel obstruction. In opiod-na'ive patients, we prefer haloperidol, glycopyrrolate and an opioid as the first-line treatment and add or substitute octreotide and dexamethasone in those who do not respond. Non-pharmacologic interventions (mechanical stents and percutaneous endoscopic gastrostomy tubes) are used when nausea is refractory to medical management or for home-going management to relieve symptoms, reduce drug costs and rehospitalization.

  13. Students' Assessment and Self-assessment of Nursing Clinical Faculty Competencies: Important Feedback in Clinical Education?

    Science.gov (United States)

    Lovrić, Robert; Prlić, Nada; Zec, Davor; Pušeljić, Silvija; Žvanut, Boštjan

    2015-01-01

    The students' assessment of clinical faculty competencies and the faculty members' self-assessment can provide important information about nursing clinical education. The aim of this study was to identify the differences between the students' assessment of the clinical faculty member's competencies and the faculty member's self-assessment. These differences can reveal interesting insights relevant for improving clinical practice.

  14. Determinants of tinnitus’ impact in Quality of Life in an outpatient clinic protocol.

    NARCIS (Netherlands)

    Magali Roggerone, [No Value

    2010-01-01

    Summary Background: Tinnitus is a chronic condition that can cause substantial handicap for certain patients and affects their Quality of Life. Our study focuses on Quality of Life for the tinnitus patients who participated in the protocol of an outpatient clinic established at the ENT department of

  15. A new Hydrocephalus Clinical Research Network protocol to reduce cerebrospinal fluid shunt infection.

    Science.gov (United States)

    Kestle, John R W; Holubkov, Richard; Douglas Cochrane, D; Kulkarni, Abhaya V; Limbrick, David D; Luerssen, Thomas G; Jerry Oakes, W; Riva-Cambrin, Jay; Rozzelle, Curtis; Simon, Tamara D; Walker, Marion L; Wellons, John C; Browd, Samuel R; Drake, James M; Shannon, Chevis N; Tamber, Mandeep S; Whitehead, William E

    2016-04-01

    OBJECT In a previous report by the same research group (Kestle et al., 2011), compliance with an 11-step protocol was shown to reduce CSF shunt infection at Hydrocephalus Clinical Research Network (HCRN) centers (from 8.7% to 5.7%). Antibiotic-impregnated catheters (AICs) were not part of the protocol but were used off protocol by some surgeons. The authors therefore began using a new protocol that included AICs in an effort to reduce the infection rate further. METHODS The new protocol was implemented at HCRN centers on January 1, 2012, for all shunt procedures (excluding external ventricular drains [EVDs], ventricular reservoirs, and subgaleal shunts). Procedures performed up to September 30, 2013, were included (21 months). Compliance with the protocol and outcome events up to March 30, 2014, were recorded. The definition of infection was unchanged from the authors' previous report. RESULTS A total of 1935 procedures were performed on 1670 patients at 8 HCRN centers. The overall infection rate was 6.0% (95% CI 5.1%-7.2%). Procedure-specific infection rates varied (insertion 5.0%, revision 5.4%, insertion after EVD 8.3%, and insertion after treatment of infection 12.6%). Full compliance with the protocol occurred in 77% of procedures. The infection rate was 5.0% after compliant procedures and 8.7% after noncompliant procedures (p = 0.005). The infection rate when using this new protocol (6.0%, 95% CI 5.1%-7.2%) was similar to the infection rate observed using the authors' old protocol (5.7%, 95% CI 4.6%-7.0%). CONCLUSIONS CSF shunt procedures performed in compliance with a new infection prevention protocol at HCRN centers had a lower infection rate than noncompliant procedures. Implementation of the new protocol (including AICs) was associated with a 6.0% infection rate, similar to the infection rate of 5.7% from the authors' previously reported protocol. Based on the current data, the role of AICs compared with other infection prevention measures is unclear.

  16. Economic evaluation of a clinical protocol for diagnosing emergency patients with suspected pulmonary embolism

    Directory of Open Access Journals (Sweden)

    Wolfe Rory

    2006-06-01

    Full Text Available Abstract Background The objective of this paper is to estimate the amount of cost-savings to the Australian health care system from implementing an evidence-based clinical protocol for diagnosing emergency patients with suspected pulmonary embolism (PE at the Emergency department of a Victorian public hospital with 50,000 presentations in 2001–2002. Methods A cost-minimisation study used the data collected in a controlled clinical trial of a clinical protocol for diagnosing patients with suspected PE. Thenumber and type of diagnostic tests in a historic cohort of 185 randomly selected patients, who presented to the emergency department with suspectedPE during an eight month period prior to the clinical trial (January 2002 -August 2002 were compared with the number and type of diagnostic tests in745 patients, who presented to the emergency department with suspected PE from November 2002 to August 2003. Current Medicare fees per test were usedas unit costs to calculate the mean aggregated cost of diagnostic investigation per patient in both study groups. A t-test was used to estimate the statistical significance of the difference in the cost of resources used for diagnosing PE in the control and in the intervention group. Results The trial demonstrated that diagnosing PE using an evidence-based clinical protocol was as effective as the existing clinical practice. The clinical protocol offers the advantage of reducing the use of diagnostic imaging, resulting in an average cost savings of at least $59.30 per patient. Conclusion Extrapolating the observed cost-savings of $59.30 per patient to the wholeof Australia could potentially result in annual savings between $3.1 million to $3.7 million.

  17. The Clinical Threat Assessment of the Lone-Actor Terrorist.

    Science.gov (United States)

    Meloy, J Reid; Genzman, Jacqueline

    2016-12-01

    The Terrorist Radicalization Assessment Protocol (TRAP-18) is a structured professional judgment instrument for the assessment of individuals who present a concern for lone-actor terrorism. It consists of eight proximal warning behaviors and 10 distal characteristics. Previous research has demonstrated its interrater reliability and some concurrent and postdictive validity. In this article, TRAP-18 is retrospectively applied to the case of US Army psychiatrist and jihadist Malik Nidal Hasan, who committed a mass murder at Fort Hood, Texas in 2009. The strengths and limitations of TRAP-18 as a structured professional judgment instrument for mental health clinicians are discussed, and clinical risk management suggestions are made.

  18. Correction: PAIS: paracetamol (acetaminophen in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480

    Directory of Open Access Journals (Sweden)

    Kappelle L Jaap

    2008-11-01

    Full Text Available Abstract Background The Paracetamol (Acetaminophen In Stroke (PAIS study is a phase III multicenter, double blind, randomized, placebo-controlled clinical trial of high-dose acetaminophen in patients with acute stroke. The trial compares treatment with a daily dose of 6 g acetaminophen, started within 12 hours after the onset of symptoms, with matched placebo. The purpose of this study is to assess whether treatment with acetaminophen for 3 days will result in improved functional outcome through a modest reduction in body temperature and prevention of fever. The previously planned statistical analysis based on a dichotomization of the scores on the modified Rankin Scale (mRS may not make the most efficient use of the available baseline information. Therefore, the planned primary analysis of the PAIS study has been changed from fixed dichotomization of the mRS to a sliding dichotomy analysis. Methods Instead of taking a single definition of good outcome for all patients, the definition is tailored to each individual patient's baseline prognosis on entry into the trial. Conclusion The protocol change was initiated because of both advances in statistical approaches and to increase the efficiency of the trial by improving statistical power. Trial Registration Current Controlled Trials [ISCRTN74418480

  19. A Protocol for the Global Sensitivity Analysis of Impact Assessment Models in Life Cycle Assessment.

    Science.gov (United States)

    Cucurachi, S; Borgonovo, E; Heijungs, R

    2016-02-01

    The life cycle assessment (LCA) framework has established itself as the leading tool for the assessment of the environmental impact of products. Several works have established the need of integrating the LCA and risk analysis methodologies, due to the several common aspects. One of the ways to reach such integration is through guaranteeing that uncertainties in LCA modeling are carefully treated. It has been claimed that more attention should be paid to quantifying the uncertainties present in the various phases of LCA. Though the topic has been attracting increasing attention of practitioners and experts in LCA, there is still a lack of understanding and a limited use of the available statistical tools. In this work, we introduce a protocol to conduct global sensitivity analysis in LCA. The article focuses on the life cycle impact assessment (LCIA), and particularly on the relevance of global techniques for the development of trustable impact assessment models. We use a novel characterization model developed for the quantification of the impacts of noise on humans as a test case. We show that global SA is fundamental to guarantee that the modeler has a complete understanding of: (i) the structure of the model and (ii) the importance of uncertain model inputs and the interaction among them.

  20. Mindfulness for irritable bowel syndrome: protocol development for a controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Garland Eric L

    2009-07-01

    Full Text Available Abstract Background Irritable bowel syndrome (IBS, a functional bowel disorder with symptoms of abdominal pain and disturbed defecation experienced by 10% of U.S. adults, results in significant disability, impaired quality of life, and health-care burden. Conventional medical care focusing on pharmacological approaches, diet, and lifestyle management has been partially effective in controlling symptoms. Behavioral treatments, such as cognitive-behavioral therapy and hypnosis, are promising. This paper describes an on-going feasibility study to assess the efficacy of mindfulness training, a behavioral treatment involving directing and sustaining attention to present-moment experience, for the treatment of IBS. Methods/Design The study design involves randomization of adult women with IBS according to Rome II criteria, to either an eight-week mindfulness training group (based on a Mindfulness-based Stress Reduction [MBSR] format or a previously validated IBS social-support group as an attention-control condition. The primary hypothesis is that, compared to Support Group participants, those in the Mindfulness Program will demonstrate significant improvement in IBS symptoms as measured by the IBS Symptom Severity Scale 1. Discussion 214 individuals have been screened for eligibility, of whom 148 were eligible for the study. Of those, 87 were enrolled, with 21 withdrawing after having given consent. 66 have completed or are in the process of completing the interventions. It is feasible to undertake a rigorous randomized clinical trial of mindfulness training for people with IBS, using a standardized MBSR protocol adapted for those experiencing IBS, compared to a control social-support group previously utilized in IBS studies. Trial Registration Clinical Trials.gov Identifier: NCT00680693

  1. Chronic hand eczema - self-management and prognosis: a study protocol for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Mollerup Annette

    2012-06-01

    Full Text Available Abstract Background Hand eczema has a one-year prevalence of approximately 10 % in the general Danish population. Often the disease becomes chronic with numerous implications for the individual’s daily life, occupation and quality of life. However, no guidelines of self-management recommendations beyond the acute stage are given. Self-management of the disease is pivotal and involves self-monitoring of the condition, medication adherence, and preventive behaviour. Interventions best to support the individual in this ongoing process need to be developed. Methods/design This paper describes the design of a randomised clinical trial to test a newly developed intervention of individual counselling versus conventional information. 300 patients consecutively referred to dermatologic treatment at two different settings are individually randomised to either the intervention programme, named ‘The Healthy Skin Clinic’ or to the control group. Block-wise randomisation according to setting and gender is carried out. The intervention offers a tool for self-monitoring; basic and specific individual counselling; the possibility of asynchronous communication with the intervention team; and an electronic patient dialogue forum. Primary outcome variable is objective assessment of the hand eczema severity performed at baseline prior to randomisation, and repeated at six months follow-up. Secondary outcome variables are dermatology related life quality and perceived global burden of disease. Discussion The trial aims at evaluating a newly developed guidance programme which is expected to support self-management of patients referred to dermatology treatment due to chronic hand eczema. The design of the protocol is pragmatic with blinding of neither participants nor the investigator. Thus, in the interpretation of the results, the investigator takes into account effects that may be attributed to actors of the interventions rather than the intervention per se as

  2. Analysis Treatment Guideline versus Clinical Practice Protocol in Patients Hospitalized due to Heart Failure

    Directory of Open Access Journals (Sweden)

    Alessandra da Graça Corrêa

    2016-01-01

    Full Text Available Background: Despite the availability of guidelines for treatment of heart failure (HF, only a few studies have assessed how hospitals adhere to the recommended therapies. Objectives: Compare the rates of adherence to the prescription of angiotensin-converting enzyme inhibitor or angiotensin II receptor blockers (ACEI/ARB at hospital discharge, which is considered a quality indicator by the Joint Commission International, and to the prescription of beta-blockers at hospital discharge, which is recommended by national and international guidelines, in a hospital with a case management program to supervise the implementation of a clinical practice protocol (HCP and another hospital that follows treatment guidelines (HCG. Methods: Prospective observational study that evaluated patients consecutively admitted to both hospitals due to decompensated HF between August 1st, 2006, and December 31st, 2008. We used as comparing parameters the prescription rates of beta-blockers and ACEI/ARB at hospital discharge and in-hospital mortality. Results: We analyzed 1,052 patients (30% female, mean age 70.6 ± 14.1 years, 381 (36% of whom were seen at HCG and 781 (64% at HCP. The prescription rates of beta-blockers at discharge at HCG and HCP were both 69% (p = 0.458, whereas those of ACEI/ARB were 83% and 86%, respectively (p = 0.162. In-hospital mortality rates were 16.5% at HCP and 27.8% at HCG (p < 0.001. Conclusion: There was no difference in prescription rates of beta-blocker and ACEI/ARB at hospital discharge between the institutions, but HCP had lower in-hospital mortality. This difference in mortality may be attributed to different clinical characteristics of the patients in both hospitals.

  3. Diffusion weighted magnetic resonance imaging of the breast: protocol optimization, interpretation, and clinical applications.

    Science.gov (United States)

    Partridge, Savannah C; McDonald, Elizabeth S

    2013-08-01

    Diffusion-weighted magnetic resonance (MR) imaging (DWI) has shown promise for improving the positive predictive value of breast MR imaging for detection of breast cancer, evaluating tumor response to neoadjuvant chemotherapy, and as a noncontrast alternative to MR imaging in screening for breast cancer. However, data quality varies widely. Before implementing DWI into clinical practice, one must understand the pertinent technical considerations and current evidence regarding clinical applications of breast DWI. This article provides an overview of basic principles of DWI, optimization of breast DWI protocols, imaging features of benign and malignant breast lesions, promising clinical applications, and potential future directions.

  4. The California Multimedia Risk Assessment Protocol for Alternative Fuels

    Science.gov (United States)

    Hatch, T.; Ginn, T. R.; McKone, T. E.; Rice, D. W.

    2013-12-01

    Any new fuel in California requires approval by the state agencies overseeing human and environmental health. In order to provide a systematic evaluation of new fuel impacts, California now requires a multimedia risk assessment (MMRA) for fuel approval. The fuel MMRA involves all relevant state agencies including: the California Air Resources Board (CARB), the State Water Resources Control Board (SWRCB), the Office of Environmental Health Hazards Assessment (OEHHA), and the Department of Toxic Substances Control (DTSC) overseen by the California Environmental Protection Agency (CalEPA). The lead agency for MMRAs is the CARB. The original law requiring a multimedia assessment is California Health and Safety Code 43830.8. In addition, the low carbon fuel standard (LCFS), the Global Warming Solutions Act (AB32), and the Verified Diesel Emission Control Strategy (VDECS) have provisions that can require a multimedia assessment. In this presentation, I give an overview of the California multimedia risk assessment (MMRA) for new fuels that has been recently developed and applied to several alternative fuels. The objective of the California MMRA is to assess risk of potential impacts of new fuels to multiple environmental media including: air, water, and soil. Attainment of this objective involves many challenges, including varying levels of uncertainty, relative comparison of incommensurate risk factors, and differing levels of priority assigned to risk factors. The MMRA is based on a strategy of relative risk assessment and flexible accommodation of distinct and diverse fuel formulations. The approach is tiered by design, in order to allow for sequentially more sophisticated investigations as knowledge gaps are identified and re-prioritized by the ongoing research. The assessment also involves peer review in order to provide coupling between risk assessment and stakeholder investment, as well as constructive or confrontational feedback. The multimedia assessment

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

    Science.gov (United States)

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

    2006-01-01

    Objective: The paper compares the speed, validity, and applicability of two different protocols for searching the primary medical literature. Design: A randomized trial involving medicine residents was performed. Setting: An inpatient general medicine rotation was used. Participants: Thirty-two internal medicine residents were block randomized into four groups of eight. Main Outcome Measures: Success rate of each search protocol was measured by perceived search time, number of questions answered, and proportion of articles that were applicable and valid. Results: Residents randomized to the MEDLINE-first (protocol A) group searched 120 questions, and residents randomized to the MEDLINE-last (protocol B) searched 133 questions. In protocol A, 104 answers (86.7%) and, in protocol B, 117 answers (88%) were found to clinical questions. In protocol A, residents reported that 26 (25.2%) of the answers were obtained quickly or rated as “fast” (<5 minutes) as opposed to 55 (51.9%) in protocol B, (P = 0.0004). A subset of questions and articles (n = 79) were reviewed by faculty who found that both protocols identified similar numbers of answer articles that addressed the questions and were felt to be valid using critical appraisal criteria. Conclusion: For resident-generated clinical questions, both protocols produced a similarly high percentage of applicable and valid articles. The MEDLINE-last search protocol was perceived to be faster. However, in the MEDLINE-last protocol, a significant portion of questions (23%) still required searching MEDLINE to find an answer. PMID:17082828

  6. Students' Attitudes toward a Group Coursework Protocol and Peer Assessment System

    Science.gov (United States)

    Moraes, Caroline; Michaelidou, Nina; Canning, Louise

    2016-01-01

    This paper addresses a knowledge gap by presenting an empirical investigation of a group coursework protocol and peer assessment system (GCP&PAS) used in a UK university to support postgraduate marketing students in their assessed group activities. The aim of the research was to examine students' understanding of the GCP&PAS and their…

  7. Implementation of a preoperative briefing protocol improves accuracy of teamwork assessment in the operating room.

    Science.gov (United States)

    Paige, John T; Aaron, Deborah L; Yang, Tong; Howell, D Shannon; Hilton, Charles W; Cohn, Isidore; Chauvin, Sheila W

    2008-09-01

    This study examined the effect of implementing a new preoperative briefing protocol on self- and peer-assessments of individual operating room (OR) teamwork behaviors. From July 2006 to February 2007, OR teamwork performance at a rural community hospital was evaluated before and after training and implementation of the protocol. After each case, every member on the team completed a 360-degree type teamwork behavior evaluation containing both self- and peer-assessments using a six-point Likert type scale (1 = definitely no to 6 = definitely yes). Individual behavior change was measured using the mean scale score of pre and postprotocol assessments. Statistical analysis included t test for both pre/post and self/peer differences. Data were available for one general surgeon and nine OR staff (pre = 20 cases, post = 16 cases). The preprotocol self-assessment mean score was significantly higher than peer-assessment (5.63 vs 5.29, P teamwork behaviors. No difference was observed in postassessment mean scores for self- and peer-assessments. Individuals overestimated their teamwork behaviors before protocol implementation. Using a preoperative protocol seems to improve OR staff teamwork behaviors and self-assessment accuracy. The use of a 360-degree assessment method targeting specific, observable behaviors may be useful in evaluating team-based interventions and enhancing teamwork effectiveness.

  8. Adoption of the children's obesity clinic's treatment (TCOCT) protocol into another Danish pediatric obesity treatment clinic

    DEFF Research Database (Denmark)

    Most, Sebastian W; Højgaard, Birgitte; Teilmann, Grete Katrine

    2015-01-01

    BACKGROUND: Treating severe childhood obesity has proven difficult with inconsistent treatment results. This study reports the results of the implementation of a childhood obesity chronic care treatment protocol. METHODS: Patients aged 5 to 18 years with a body mass index (BMI) above the 99th......, but independent of baseline BMI SDS, age, co-morbidity, SES, pubertal stage, place of referral, hours of treatment per year, and mean visit interval time. CONCLUSIONS: The systematic use of the TCOCT protocol reduced the degree of childhood obesity with acceptable retention rates with a modest time...

  9. The Promises and Challenges of Ecological Momentary Assessment in Schizophrenia: Development of an Initial Experimental Protocol

    Directory of Open Access Journals (Sweden)

    Brandon A. Gaudiano

    2015-07-01

    Full Text Available Severe mental illnesses, including schizophrenia and other psychotic-spectrum disorders, are a major cause of disability worldwide. Although efficacious pharmacological and psychosocial interventions have been developed for treating patients with schizophrenia, relapse rates are high and long-term recovery remains elusive for many individuals. Furthermore, little is still known about the underlying mechanisms of these illnesses. Thus, there is an urgent need to better understand the contextual factors that contribute to psychosis so that they can be better targeted in future interventions. Ecological Momentary Assessment (EMA is a dynamic procedure that permits the measurement of variables in natural settings in real-time through the use of brief assessments delivered via mobile electronic devices (i.e., smartphones. One advantage of EMA is that it is less subject to retrospective memory biases and highly sensitive to fluctuating environmental factors. In the current article, we describe the research-to-date using EMA to better understand fluctuating symptoms and functioning in patients with schizophrenia and other psychotic disorders and potential applications to treatment. In addition, we describe a novel EMA protocol that we have been employing to study the outcomes of patients with schizophrenia following a hospital discharge. We also report the lessons we have learned thus far using EMA methods in this challenging clinical population.

  10. Protocol to assess covering products for roofing slates

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    De la Horra, R.

    2008-06-01

    Full Text Available Spain is a world-wide leader in roofing slate production, quarriying more than 600,000 tons of slate of great quality and generating around 300 euros million in sales each year. However, an enormous quantity of slate plates is considered as a low quality product or discarded every year as waste. The application of protective products on roofing slate tiles helps to commercialise slate with higher oxidation rates, reducing wastes and environmental problems. The present protocol serves to evaluate the new protective products that are now used by slate producers. A combination of three technological tests is proposed here, along with a visual questionnaire to grant quality indices. Each test is oriented to clarify critical properties for the future use of the roofing slate, as follows: (i Thermal cycles were used to determine the oxidation rate of iron sulphides; (ii Slate behaviour in acid urban atmospheres was interpreted by exposition of slate tiles to SO2 gas; (iii Effectiveness of the protective layer under saline corrosion and solar radiation was obtained by exposition to saline fog and UV-irradiation. Physico-chemical tests have been performed in the Technological Centre of the Slate (Orense, Spain whereas the chemical-structural characterizations of natural, impregnated and altered slate plates were carried out by X-ray diffraction and optical and electronic microscopy in the University of Santiago de Compostela (NW Spain. The quantitative analyses of the alteration grades have been determined using a freeware program (IMAGEJ on the scanned images of roofing slate tiles. The protocol here presented has been experienced with the more important protective slate products nowadays, i.e., siloxanes, organic resins and polyurethanes.España es líder mundial en producción de pizarras de techar; la producción supera las 600.000 toneladas de pizarra de gran calidad, suponiendo mas de 300 millones euros. La aplicación de la pizarra con productos

  11. Toward an HRD Auditing Protocol: Assessing HRD Risk Management Practices

    Science.gov (United States)

    Clardy, Alan

    2004-01-01

    Even though HRD-related programs and activities carry risks that should be monitored and assessed, there is little literature on how auditing applies to the HRD function; the existing literature on the topic defines HRD auditing in widely different ways. The nature of risk for organizational process is discussed, followed by a review of the…

  12. The Development of an Assessment Protocol for Reactive Attachment Disorder.

    Science.gov (United States)

    Sheperis, Carl J.; Doggett, R. Anthony; Hoda, Nicholas E.; Blanchard, Tracy; Renfro-Michel, Edina L.; Holdiness, Sacky H.; Schlagheck, Robyn

    2003-01-01

    Proposes a battery of semi-structured interviews, global assessment scales, attachment-specific scales, and behavioral observations to help mental health counselors identify Reactive Attachment Disorder, a syndrome associated with extreme attachment problems. (Contains 25 references and 2 tables.) (GCP)

  13. A Systematic Review of Protocols for the Three-Dimensional Morphologic Assessment of Abdominal Aortic Aneurysms Using Computed Tomographic Angiography

    Energy Technology Data Exchange (ETDEWEB)

    Ghatwary, Tamer M. H.; Patterson, Benjamin O.; Karthikesalingam, Alan; Hinchliffe, Robert J.; Loftus, Ian M. [St. George' s Vascular Institute, St. George' s Hospital, Department of Outcomes Research (United Kingdom); Morgan, Robert [St. George' s Hospital, Department of Radiology (United Kingdom); Thompson, Matt M.; Holt, Peter J. E., E-mail: pholt@sgul.ac.uk [St. George' s Vascular Institute, St. George' s Hospital, Department of Outcomes Research (United Kingdom)

    2013-02-15

    The morphology of infrarenal abdominal aortic aneurysms (AAAs) directly influences the perioperative outcome and long-term durability of endovascular aneurysm repair. A variety of methods have been proposed for the characterization of AAA morphology using reconstructed three-dimensional (3D) computed tomography (CT) images. At present, there is lack of consensus as to which of these methods is most applicable to clinical practice or research. The purpose of this review was to evaluate existing protocols that used 3D CT images in the assessment of various aspects of AAA morphology. An electronic search was performed, from January 1996 to the end of October 2010, using the Embase and Medline databases. The literature review conformed to PRISMA statement standards. The literature search identified 604 articles, of which 31 studies met inclusion criteria. Only 15 of 31 studies objectively assessed reproducibility. Existing published protocols were insufficient to define a single evidence-based methodology for preoperative assessment of AAA morphology. Further development and expert consensus are required to establish a standardized and validated protocol to determine precisely how morphology relates to outcomes after endovascular aneurysm repair.

  14. Comparison of subjective assessment protocols for digital cinema applications

    Science.gov (United States)

    Larabi, M.-C.

    2010-01-01

    Quality assessment is becoming an important issue in the framework of image processing. This need is expressed by the fact that the quality threshold of end-users has been shifted up because of the large availability of high fidelity sensors at very affordable price. This observation has been made for different application domains such as printing, compression, transmission, and so on. Starting from this, it becomes very important to manufacturers and producers to provide products of high quality to attract the consumer. This high interest on quality means that tools to measure it have to be available. This work is dedicated to the comparison of subjective methodologies in the digital cinema framework. The main goal is to determine with a group of observers, which methodology is better for assessing digital cinema content and what is the annoyance level associated to each of them. Several configurations are tested side by side, Butterfly, one by one, Horizontal scroll, vertical scroll, Horizontal and vertical scroll.

  15. A protocol for classifying normal- and flat-arched foot posture for research studies using clinical and radiographic measurements

    Directory of Open Access Journals (Sweden)

    Menz Hylton B

    2009-07-01

    Full Text Available Abstract Background There are several clinical and radiological methods available to classify foot posture in research, however there is no clear strategy for selecting the most appropriate measurements. Therefore, the aim of this study was to develop a foot screening protocol to distinguish between participants with normal- and flat-arched feet who would then subsequently be recruited into a series of laboratory-based gait studies. Methods The foot posture of ninety-one asymptomatic young adults was assessed using two clinical measurements (normalised navicular height and arch index and four radiological measurements taken from antero-posterior and lateral x-rays (talus-second metatarsal angle, talo-navicular coverage angle, calcaneal inclination angle and calcaneal-first metatarsal angle. Normative foot posture values were taken from the literature and used to recruit participants with normal-arched feet. Data from these participants were subsequently used to define the boundary between normal- and flat-arched feet. This information was then used to recruit participants with flat-arched feet. The relationship between the clinical and radiographic measures of foot posture was also explored. Results Thirty-two participants were recruited to the normal-arched study, 31 qualified for the flat-arched study and 28 participants were classified as having neither normal- or flat-arched feet and were not suitable for either study. The values obtained from the two clinical and four radiological measurements established two clearly defined foot posture groups. Correlations among clinical and radiological measures were significant (p r = 0.24 to 0.70. Interestingly, the clinical measures were more strongly associated with the radiographic angles obtained from the lateral view. Conclusion This foot screening protocol provides a coherent strategy for researchers planning to recruit participants with normal- and flat-arched feet. However, further research is

  16. Acupuncture in Patients with a Vertebral Compression Fracture: A Protocol for a Randomized, Controlled, Pilot Clinical Trial

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    Hyun-jong Lee

    2015-03-01

    Full Text Available Objectives: A vertebral compression fracture (VCF is characterized by back pain and fracture of a vertebral body on spinal radiography. VCFs of the thoraco lumbar spine are common in the elderly. In general, appropriate analgesics should be prescribed to reduce pain and, thus, promote early mobilization. The ideal treatment approach for VCFs has not been determined. In Korea, acupuncture and herbal medication have been used to treat VCFs for many years. There is empirical evidence that acupuncture might benefit patients with a VCF. However, no randomized, controlled, clinical trials evaluating the efficacy and the safety of acupuncture for treating a VCF have been published. Therefore, we designed a randomized, controlled, pilot, clinical trial to obtain information for the design of a further full scale trial. Methods: A five week protocol for a randomized, controlled, pilot, clinical trial is presented. Fourteen patients will be recruited and randomly allocated to two groups: a control group receiving interlaminar epidural steroid injections once a week for three weeks, and an experimental group receiving interlaminar epidural steroid injections plus acupuncture treatment (three acupuncture sessions per week for three weeks, nine sessions in total. The primary outcomes will be the pain intensity (visual analogue scale and PainVisionTM system. The secondary outcome measurements will be the answers on the short form McGill pain questionnaire and the oswestry disability index. Assessments will be made at baseline and at one, three, and five weeks. The last assessment (week five will take place two weeks after treatment cessation. This study will provide both an indication of feasibility and a clinical foundation for a future large scale trial. The outcomes will provide additional resources for incorporating acupuncture into existing treatments, such as nonsteroidal anti-inflammatory medications, narcotics and vertebral augmentation. This article

  17. A conceptual framework and protocol for defining clinical decision support objectives applicable to medical specialties

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    Timbie Justin W

    2012-09-01

    Full Text Available Abstract Background The U.S. Centers for Medicare and Medicaid Services established the Electronic Health Record (EHR Incentive Program in 2009 to stimulate the adoption of EHRs. One component of the program requires eligible providers to implement clinical decision support (CDS interventions that can improve performance on one or more quality measures pre-selected for each specialty. Because the unique decision-making challenges and existing HIT capabilities vary widely across specialties, the development of meaningful objectives for CDS within such programs must be supported by deliberative analysis. Design We developed a conceptual framework and protocol that combines evidence review with expert opinion to elicit clinically meaningful objectives for CDS directly from specialists. The framework links objectives for CDS to specialty-specific performance gaps while ensuring that a workable set of CDS opportunities are available to providers to address each performance gap. Performance gaps may include those with well-established quality measures but also priorities identified by specialists based on their clinical experience. Moreover, objectives are not constrained to performance gaps with existing CDS technologies, but rather may include those for which CDS tools might reasonably be expected to be developed in the near term, for example, by the beginning of Stage 3 of the EHR Incentive program. The protocol uses a modified Delphi expert panel process to elicit and prioritize CDS meaningful use objectives. Experts first rate the importance of performance gaps, beginning with a candidate list generated through an environmental scan and supplemented through nominations by panelists. For the highest priority performance gaps, panelists then rate the extent to which existing or future CDS interventions, characterized jointly as “CDS opportunities,” might impact each performance gap and the extent to which each CDS opportunity is compatible with

  18. The Clinical Assessment and Remote Administration Tablet

    Directory of Open Access Journals (Sweden)

    Jessica A Turner

    2011-12-01

    Full Text Available Electronic data capture of case report forms (CRFs, demographic, neuropsychiatric, or clinical assessments, can vary from scanning hand-written forms into databases to fully electronic systems. Web-based forms can be extremely useful for self-assessment; however, in the case of neuropsychiatric assessments, self-assessment is often not an option. The clinician often must be the person either summarizing or making their best judgment about the subject’s response in order to complete an assessment, and having the clinician turn away to type into a web browser may be disruptive to the flow of the interview. The Mind Research Network (MRN has developed a prototype for a software tool for the real-time acquisition and validation of clinical assessments in remote environments. We have developed the Clinical Assessment and Remote Administration Tablet (CARAT on a Microsoft Windows PC tablet system, which has been adapted to interact with various data models already in use in several large-scale databases of neuroimaging studies in clinical populations. The tablet has been used successfully to collect and administer clinical assessments in several large-scale studies, so that the correct clinical measures are integrated with the correct imaging and other data. It has proven to be incredibly valuable in confirming that data collection across multiple research groups is performed similarly, quickly, and with accountability for incomplete datasets. We present the overall architecture and an evaluation of its use.

  19. A proposed protocol for the standardized preparation of PRF membranes for clinical use.

    Science.gov (United States)

    Kobayashi, Mito; Kawase, Tomoyuki; Horimizu, Makoto; Okuda, Kazuhiro; Wolff, Larry F; Yoshie, Hiromasa

    2012-09-01

    Upon clinical application, thick platelet-rich fibrin (PRF) is usually compressed to fit the implantation site. However, it is speculated that the preservation of platelets and plasma content depends on the compression methods used. To accurately evaluate the clinical outcome of PRF, the preparation protocol should be standardized. Freshly prepared PRF clots were compressed into a thin membrane by our novel PRF compression device. The localization of platelets was examined by SEM and immunostaining. Growth factor levels were evaluated by bioassays and cytokine-antibody array techniques. The angiogenic activity was examined by the chick chorioallantoic membrane assay and the scratch assay using HUVEC cultures. Platelets were concentrated on the surface of the region adjacent to the red thrombus and this region was subjected to the experiments. Compared to the PRF membrane compressed by dry gauze (G-PRF), the preservation of the plasma content, 3D-fibrin meshwork, and platelets was more intact in the compressor-prepared PRF membrane (C-PRF). Among the growth factors tested, C-PRF contained PDGF isoforms at higher levels, and significantly stimulated cell proliferation and neovascularization. C-PRF may be useful for grafting while minimizing the loss of bioactive factors. This C-PRF preparation protocol is proposed as a standardized protocol for PRF membrane preparation.

  20. A Protocol for Functional Assessment of Whole-Protein Saturation Mutagenesis Libraries Utilizing High-Throughput Sequencing.

    Science.gov (United States)

    Stiffler, Michael A; Subramanian, Subu K; Salinas, Victor H; Ranganathan, Rama

    2016-07-03

    Site-directed mutagenesis has long been used as a method to interrogate protein structure, function and evolution. Recent advances in massively-parallel sequencing technology have opened up the possibility of assessing the functional or fitness effects of large numbers of mutations simultaneously. Here, we present a protocol for experimentally determining the effects of all possible single amino acid mutations in a protein of interest utilizing high-throughput sequencing technology, using the 263 amino acid antibiotic resistance enzyme TEM-1 β-lactamase as an example. In this approach, a whole-protein saturation mutagenesis library is constructed by site-directed mutagenic PCR, randomizing each position individually to all possible amino acids. The library is then transformed into bacteria, and selected for the ability to confer resistance to β-lactam antibiotics. The fitness effect of each mutation is then determined by deep sequencing of the library before and after selection. Importantly, this protocol introduces methods which maximize sequencing read depth and permit the simultaneous selection of the entire mutation library, by mixing adjacent positions into groups of length accommodated by high-throughput sequencing read length and utilizing orthogonal primers to barcode each group. Representative results using this protocol are provided by assessing the fitness effects of all single amino acid mutations in TEM-1 at a clinically relevant dosage of ampicillin. The method should be easily extendable to other proteins for which a high-throughput selection assay is in place.

  1. Reliability and criterion validity of an observation protocol for working technique assessments in cash register work.

    Science.gov (United States)

    Palm, Peter; Josephson, Malin; Mathiassen, Svend Erik; Kjellberg, Katarina

    2016-06-01

    We evaluated the intra- and inter-observer reliability and criterion validity of an observation protocol, developed in an iterative process involving practicing ergonomists, for assessment of working technique during cash register work for the purpose of preventing upper extremity symptoms. Two ergonomists independently assessed 17 15-min videos of cash register work on two occasions each, as a basis for examining reliability. Criterion validity was assessed by comparing these assessments with meticulous video-based analyses by researchers. Intra-observer reliability was acceptable (i.e. proportional agreement >0.7 and kappa >0.4) for 10/10 questions. Inter-observer reliability was acceptable for only 3/10 questions. An acceptable inter-observer reliability combined with an acceptable criterion validity was obtained only for one working technique aspect, 'Quality of movements'. Thus, major elements of the cashiers' working technique could not be assessed with an acceptable accuracy from short periods of observations by one observer, such as often desired by practitioners. Practitioner Summary: We examined an observation protocol for assessing working technique in cash register work. It was feasible in use, but inter-observer reliability and criterion validity were generally not acceptable when working technique aspects were assessed from short periods of work. We recommend the protocol to be used for educational purposes only.

  2. Using Simple Linear Regression to Assess the Success of the Montreal Protocol in Reducing Atmospheric Chlorofluorocarbons

    Science.gov (United States)

    Nelson, Dean

    2009-01-01

    Following the Guidelines for Assessment and Instruction in Statistics Education (GAISE) recommendation to use real data, an example is presented in which simple linear regression is used to evaluate the effect of the Montreal Protocol on atmospheric concentration of chlorofluorocarbons. This simple set of data, obtained from a public archive, can…

  3. Protocols to Assess Coagulation Following In Vitro Infection with Hemorrhagic Fever Viruses

    Science.gov (United States)

    2016-05-25

    Protocols to assess coagulation following in vitro infection with hemorrhagic fever viruses Tursiella ML, Taylor SL, Schmaljohn CS* *denotes...Shannon L. Taylor Connie S. Schmaljohn USAMRIID connie.s.schmaljohn.civ@mail.mil...alterations of arenavirus-induced hemorrhagic fevers. Viruses 5:340-351. 10. Taylor SL, Wahl-Jensen V, Copeland AM, Jahrling PB, Schmaljohn CS. 2013

  4. Halitose: proposta de um protocolo de avaliação Halitosis: an assessment protocol proposal

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    Ana Cristina Coelho Dal Rio

    2007-12-01

    the authors’ personal experiences, adopting an evidence-based anamnesis. RESULTS: There are many causes of halitosis and most of them are related to the oral cavity; others are related to otolaryngologic and respiratory diseases. Gastrointestinal diseases, liver/renal impairment and other metabolic syndromes are less frequent, but also important causes of halitosis. CONCLUSION: There are important costs involved in halitosis assessment and treatment, including medical appointments, specialist assessment, and complementary tests. Such costs would be minimized by adopting a protocol of evidence-based anamnesis and a flowchart for a rational clinical investigation.

  5. Analysis of Requirements for the Medication Profile to Be Used in Clinical Research: Protocol Feasibility Studies and Patient Recruitment

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    Julie M. James

    2015-01-01

    Full Text Available A “Medication Profile,” the information about the medicines a person is using and has used, is a core part of many electronic health record systems and summaries. However, there is little objective research into the data elements that the profile should contain to support the uses it must serve. With the increasing emphasis on secondary uses of electronic health information, as well as supporting the requirements to support direct to patient care, the Medication Profile should also support the requirements from clinical research. However, there is little, if any, description of these available. This paper describes an analysis of a set of study eligibility criteria that was undertaken to investigate which medication-related data elements would be required to support two clinical research use cases: the parameters to query a patient’s Medication Profile to assess their suitability for entry into a trial (patient recruitment and the parameters to query a set of Medication Profiles in a data warehouse to assess whether the eligibility criteria as described would yield a reasonable cohort of patients as potential subjects (protocol feasibility. These medication-related data elements then become information requirements that a Medication Profile should ideally meet, in order to be able to support these two uses in the clinical research domain.

  6. Assessment and risk classification protocol for patients in emergency units1

    Science.gov (United States)

    Silva, Michele de Freitas Neves; Oliveira, Gabriela Novelli; Pergola-Marconato, Aline Maino; Marconato, Rafael Silva; Bargas, Eliete Boaventura; Araujo, Izilda Esmenia Muglia

    2014-01-01

    Objective to develop, validate the contents and verify the reliability of a risk classification protocol for an Emergency Unit. Method the content validation was developed in a University Hospital in a country town located in the state of Sao Paulo and was carried out in two stages: the first with the individual assessment of specialists and the second with the meeting between the researchers and the specialists. The use of the protocol followed a specific guide. Concerning reliability, the concordance or equivalent method among observers was used. Results the protocol developed showed to have content validity and, after the suggested changes were made, there were excellent results concerning reliability. Conclusion the assistance flow chart was shown to be easy to use, and facilitate the search for the complaint in each assistance priority. PMID:26107828

  7. Assessing health systems for type 1 diabetes in sub-Saharan Africa: developing a 'Rapid Assessment Protocol for Insulin Access'

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    de Courten Maximilian

    2006-02-01

    Full Text Available Abstract Background In order to improve the health of people with Type 1 diabetes in developing countries, a clear analysis of the constraints to insulin access and diabetes care is needed. We developed a Rapid Assessment Protocol for Insulin Access, comprising a series of questionnaires as well as a protocol for the gathering of other data through site visits, discussions, and document reviews. Methods The Rapid Assessment Protocol for Insulin Access draws on the principles of Rapid Assessment Protocols which have been developed and implemented in several different areas. This protocol was adapted through a thorough literature review on diabetes, chronic condition management and medicine supply in developing countries. A visit to three countries in sub-Saharan Africa and meetings with different experts in the field of diabetes helped refine the questionnaires. Following the development of the questionnaires these were tested with various people familiar with diabetes and/or healthcare in developing countries. The Protocol was piloted in Mozambique then refined and had two further iterations in Zambia and Mali. Translations of questionnaires were made into local languages when necessary, with back translation to ensure precision. Results In each country the protocol was implemented in 3 areas – the capital city, a large urban centre and a predominantly rural area and their respective surroundings. Interviews were carried out by local teams trained on how to use the tool. Data was then collected and entered into a database for analysis. Conclusion The Rapid Assessment Protocol for Insulin Access was developed to provide a situational analysis of Type 1 diabetes, in order to make recommendations to the national Ministries of Health and Diabetes Associations. It provided valuable information on patients' access to insulin, syringes, monitoring and care. It was thus able to sketch a picture of the health care system with regards to its ability to

  8. Assessing clinical competency in the health sciences

    Science.gov (United States)

    Panzarella, Karen Joanne

    To test the success of integrated curricula in schools of health sciences, meaningful measurements of student performance are required to assess clinical competency. This research project analyzed a new performance assessment tool, the Integrated Standardized Patient Examination (ISPE), for assessing clinical competency: specifically, to assess Doctor of Physical Therapy (DPT) students' clinical competence as the ability to integrate basic science knowledge with clinical communication skills. Thirty-four DPT students performed two ISPE cases, one of a patient who sustained a stroke and the other a patient with a herniated lumbar disc. Cases were portrayed by standardized patients (SPs) in a simulated clinical setting. Each case was scored by an expert evaluator in the exam room and then by one investigator and the students themselves via videotape. The SPs scored each student on an overall encounter rubric. Written feedback was obtained from all participants in the study. Acceptable reliability was demonstrated via inter-rater agreement as well as inter-rater correlations on items that used a dichotomous scale, whereas the items requiring the use of the 4-point rubric were somewhat less reliable. For the entire scale both cases had a significant correlation between the Expert-Investigator pair of raters, for the CVA case r = .547, p clinical competence, while done in the mind of the student, can be practiced, learned and assessed.

  9. Assessment of paediatric clinical audit.

    LENUS (Irish Health Repository)

    Perrem, L M

    2012-02-01

    Consultant paediatricians in Ireland were surveyed to evaluate their perceptions of the hospital audit environment and assess their involvement in the audit process. Eighty nine (77%) replied of whom 66 (74%) had an audit department and 23 (26%) did not. Sixteen (18%) felt their hospital was well resourced for audit and 25 (28%) felt the culture was very positive but only 1 (1%) had protected time. For 61 (69%) consultants audit was very important with 38 (43%) being very actively involved in the process. The most frequent trigger for audit was non consultant hospital doctor (NCHD) career development, cited by 77 (87%). The new Professional Competence Scheme and the National Quality and Risk Management Standards will require the deficiencies identified in this survey be addressed.

  10. Determining the Optimal Protocol for Measuring an Albuminuria Class Transition in Clinical Trials in Diabetic Kidney Disease

    DEFF Research Database (Denmark)

    Kröpelin, Tobias F; de Zeeuw, Dick; Remuzzi, Giuseppe;

    2016-01-01

    clinical trials testing the effect of renin-angiotensin-aldosterone system intervention on albuminuria class transition in patients with diabetes: the BENEDICT, the DIRECT, the ALTITUDE, and the IRMA-2 Trial. The definition of albuminuria class transition used in each trial differed from the definitions...... used in the other trials by the number (one, two, or three) of consecutively collected urine samples at each study visit, the time interval between study visits, the requirement of an additional visit to confirm the class transition, and the requirement of a percentage increase in albuminuria from......Albuminuria class transition (normo- to micro- to macroalbuminuria) is used as an intermediate end point to assess renoprotective drug efficacy. However, definitions of such class transition vary between trials. To determine the most optimal protocol, we evaluated the approaches used in four...

  11. Dynamic whole-body PET parametric imaging: I. Concept, acquisition protocol optimization and clinical application.

    Science.gov (United States)

    Karakatsanis, Nicolas A; Lodge, Martin A; Tahari, Abdel K; Zhou, Y; Wahl, Richard L; Rahmim, Arman

    2013-10-21

    Static whole-body PET/CT, employing the standardized uptake value (SUV), is considered the standard clinical approach to diagnosis and treatment response monitoring for a wide range of oncologic malignancies. Alternative PET protocols involving dynamic acquisition of temporal images have been implemented in the research setting, allowing quantification of tracer dynamics, an important capability for tumor characterization and treatment response monitoring. Nonetheless, dynamic protocols have been confined to single-bed-coverage limiting the axial field-of-view to ~15-20 cm, and have not been translated to the routine clinical context of whole-body PET imaging for the inspection of disseminated disease. Here, we pursue a transition to dynamic whole-body PET parametric imaging, by presenting, within a unified framework, clinically feasible multi-bed dynamic PET acquisition protocols and parametric imaging methods. We investigate solutions to address the challenges of: (i) long acquisitions, (ii) small number of dynamic frames per bed, and (iii) non-invasive quantification of kinetics in the plasma. In the present study, a novel dynamic (4D) whole-body PET acquisition protocol of ~45 min total length is presented, composed of (i) an initial 6 min dynamic PET scan (24 frames) over the heart, followed by (ii) a sequence of multi-pass multi-bed PET scans (six passes × seven bed positions, each scanned for 45 s). Standard Patlak linear graphical analysis modeling was employed, coupled with image-derived plasma input function measurements. Ordinary least squares Patlak estimation was used as the baseline regression method to quantify the physiological parameters of tracer uptake rate Ki and total blood distribution volume V on an individual voxel basis. Extensive Monte Carlo simulation studies, using a wide set of published kinetic FDG parameters and GATE and XCAT platforms, were conducted to optimize the acquisition protocol from a range of ten different clinically

  12. A Randomized Trial of Comparing the Efficacy of Two Neurofeedback Protocols for Treatment of Clinical and Cognitive Symptoms of ADHD: Theta Suppression/Beta Enhancement and Theta Suppression/Alpha Enhancement

    Directory of Open Access Journals (Sweden)

    Arash Mohagheghi

    2017-01-01

    Full Text Available Introduction. Neurofeedback (NF is an adjuvant or alternative therapy for children with Attention Deficit Hyperactivity Disorder (ADHD. This study intended to compare the efficacy of two different NF protocols on clinical and cognitive symptoms of ADHD. Materials and Methods. In this clinical trial, sixty children with ADHD aged 7 to 10 years old were randomly grouped to receive two different NF treatments (theta suppression/beta enhancement protocol and theta suppression/alpha enhancement protocol. Clinical and cognitive assessments were conducted prior to and following the treatment and also after an eight-week follow-up. Results. Both protocols alleviated the symptoms of ADHD in general (p<0.001, hyperactivity (p<0.001, inattention (p<0.001, and omission errors (p<0.001; however, they did not affect the oppositional and impulsive scales nor commission errors. These effects were maintained after an eight-week intervention-free period. The only significant difference between the two NF protocols was that high-frequency alpha enhancement protocol performed better in suppressing omission errors (p<0.001. Conclusion. The two NF protocols with theta suppression/beta enhancement and theta suppression/alpha enhancement have considerable and comparable effect on clinical symptoms of ADHD. Alpha enhancement protocol was more effective in suppressing omission errors.

  13. Assessment of welfare of Brazilian and Belgian broiler flocks using the Welfare Quality protocol.

    Science.gov (United States)

    Tuyttens, F A M; Federici, J F; Vanderhasselt, R F; Goethals, K; Duchateau, L; Sans, E C O; Molento, C F M

    2015-08-01

    The Welfare Quality consortium has proposed a science-based protocol for assessing broiler chicken welfare on farms. Innovative features make the protocols particularly suited for comparative studies, such as the focus on animal-based welfare measures and an integration procedure for calculating an overall welfare status. These protocols reflect the scientific status up to 2009 but are meant to be updated on the basis of inter alia implementation studies. Because only few such studies have been done, we applied the Welfare Quality protocol to compare the welfare of broiler flocks in Belgium (representing a typical European Union (EU) country which implies stringent animal welfare legislation) versus Brazil (the major broiler meat exporter to the EU and with minimal animal welfare legislation). Two trained observers performed broiler Welfare Quality assessments on a total of 22 farms in Belgium and south Brazil. All of the farms produced for the EU market. Although the overall welfare was categorized as 'acceptable' on all farms, many country differences were observed at the level of the welfare principles, criteria, and measures. Brazilian farms obtained higher scores for 3 of the 4 welfare principles: 'good feeding' (P = 0.007), 'good housing' (P potential of the protocol. The results also call for more research into the effect of animal welfare legislation as broiler welfare on the south Brazilian farms appeared to be superior to that on the Belgian farms. Animal-based welfare assessments on a larger sample of farms are needed to evaluate to what extent these findings may be generalized.

  14. Algorithm of clinical protocol lowering the risk of systemic Mycosis infections in allografts recipients.

    Science.gov (United States)

    Swoboda-Kopec, E; Netsvyetayeva, I; Paczek, L; Dabkowska, M; Kwiatkowski, A; Jaworska-Zaremba, M; Mierzwinska-Nastalska, E; Sikora, M; Blachnio, S; Mlynarczyk, G; Fiedor, P

    2009-10-01

    The aim of the study was to describe a diagnostic protocol to lower the risk of a mycotic invasive infection among allotransplant recipients and to suggest the use of preoperative prophylaxis and/or empiric therapy. We chose a group of 268 allograft recipients with transient or constant yeast colonization or confirmed yeast infection. Among 7744 clinical samples, 475 were positive for fungi. We used conventional fungal laboratory diagnosis, enzymatic activity tests, serologic tests, molecular diagnosis of samples from sterile body sites, and histopathologic examinations. The following clinical samples were examined: blood samples; swabs from mouth lesions, throat, and rectum; and sputum, urine, and fecal samples from kidney transplant recipients and simultaneous pancreas-kidney transplantation recipients who are highly predisposed to mycotic infections. We established microbiologic criteria of a systemic mycosis and principles to distinguish colonization from infection.

  15. Clinical gait analysis for amputees: innovation wishlist and the perspectives offered by the outwalk protocol.

    Science.gov (United States)

    Cutti, Andrea Giovanni; Raggi, Michele; Andreoni, Giuseppe; Sacchetti, Rinaldo

    2015-01-01

    Clinical gait analysis (CGA) has shown potentials for the prosthetics field and has been found effective for scientific purposes and to design general rehabilitation models. However, intrinsic limitations of the "artificial" laboratory environment usually result in recording performances not representative patients' real-life gait. In order to promote the diffusion of CGA in the clinical decision-making process, a framework for developing novel, more ecological CGA applications is presented. Moreover, the Outwalk protocol, based on wearable sensors and developed within this framework guidelines, is described and validated for its inter-rater agreement on a population of transtibial amputees walking in a real-life scenario. Results show the possibility of drawing precise conclusions over different aspects of amputees' gait and prostheses' performance in every-day life conditions.

  16. Barriers and strategies for the clinical translation of advanced orthopaedic tissue engineering protocols

    Directory of Open Access Journals (Sweden)

    H Madry

    2014-05-01

    Full Text Available Research in orthopaedic tissue engineering has intensified over the last decade and new protocols continue to emerge. The clinical translation of these new applications, however, remains associated with a number of obstacles. This report highlights the major issues that impede the clinical translation of advanced tissue engineering concepts, discusses strategies to overcome these barriers, and examines the need to increase incentives for translational strategies. The statements are based on presentations and discussions held at the AO Foundation-sponsored symposium "Where Science meets Clinics 2013" held at the Congress Center in Davos, Switzerland, in September, 2013. The event organisers convened a diverse group of over one hundred stakeholders involved in clinical translation of orthopaedic tissue engineering, including scientists, clinicians, healthcare industry professionals and regulatory agency representatives. A major point that emerged from the discussions was that there continues to be a critical need for early trans-disciplinary communication and collaboration in the development and execution of research approaches. Equally importantly was the need to address the shortage of sustained funding programs for multidisciplinary teams conducting translational research. Such detailed discussions between experts contribute towards the development of a roadmap to more successfully advance the clinical translation of novel tissue engineering concepts and ultimately improve patient care in orthopaedic and trauma surgery.

  17. Implementing an Assessment Clinic in a Residential PTSD Program

    Directory of Open Access Journals (Sweden)

    Joan McDowell

    2014-08-01

    Full Text Available Creating useful treatment plans can help improve services to consumers of mental health services. As more evidence-based practices are implemented, deciding what treatment, at what time, for whom becomes an important factor in facilitating positive outcomes. Readiness for trauma-focused treatments for Posttraumatic Stress Disorder (PTSD such as Cognitive Processing Therapy or Prolonged Exposure Therapy may influence whether an individual can successfully complete either protocol. In addition, components of adjunctive therapies such as Acceptance and Commitment Therapy or Dialectical Behavior Therapy may be useful in moving a particular patient toward readiness and successful completion of treatment. Psychological assessment adds valuable data to inform these types of treatment decisions. This paper describes the implementation of a psychological assessment clinic in a residential PTSD treatment setting. Barriers to implementation, use of the data, and Veterans’ reactions to the feedback provided to them are included.

  18. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials.

    Directory of Open Access Journals (Sweden)

    Benjamin Kasenda

    2016-06-01

    Full Text Available Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i the existence and types of publication agreements in trial protocols, (ii the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii the frequency of co-authorship by industry employees.We used a retrospective cohort of randomized clinical trials (RCTs based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5% mentioned an agreement regarding publication of results. Of these 456, 393 (86.2% documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6% agreements were without constraints of publication. The remaining 24 (5.3% protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0% trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]. Of 71 agreements reported in publications, 52 (73.2% were concordant with those documented in the protocol. In 14 of 37 (37.8% publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements.Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do

  19. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials

    Science.gov (United States)

    Kasenda, Benjamin; von Elm, Erik; You, John J.; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J.; Stegert, Mihaela; Olu, Kelechi K.; Tikkinen, Kari A. O.; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M.; Mertz, Dominik; Akl, Elie A.; Bassler, Dirk; Busse, Jason W.; Nordmann, Alain; Gloy, Viktoria; Ebrahim, Shanil; Schandelmaier, Stefan; Sun, Xin; Vandvik, Per O.; Johnston, Bradley C.; Walter, Martin A.; Burnand, Bernard; Hemkens, Lars G.; Bucher, Heiner C.; Guyatt, Gordon H.; Briel, Matthias

    2016-01-01

    Background Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner’s right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions Publication agreements constraining academic authors’ independence are common. Journal articles seldom report on

  20. Adoption of the children's obesity clinic's treatment (TCOCT) protocol into another Danish pediatric obesity treatment clinic

    DEFF Research Database (Denmark)

    Most, Sebastian W; Højgaard, Birgitte; Teilmann, Grete Katrine;

    2015-01-01

    was developed in collaboration with the patient and the family. Patients' height and weight were measured at subsequent visits. There were no exclusion criteria. RESULTS: Three-hundred-thirteen (141 boys) were seen in the clinic in the period of February 2010 to March 2013. At inclusion, the median age......, the mean BMI SDS difference was -0.40 (95% CI: -0.56; -0.25, p intervention 120 patients stopped treatment. Retention rates were 0.76 (95% CI: 0.71; 0.81) after one year and 0.57 (95% CI: 0.51; 0.63) after two years...

  1. The clinical viva: an assessment of clinical thinking.

    Science.gov (United States)

    Roberts, Debbie

    2013-04-01

    In order to enable Masters level pre-registration students to demonstrate sophisticated cognitive abilities, integration of knowledge, complex problem solving, critical opinion, lateral thinking and innovative action; an innovative assessment tool is required (Sadler, 2009). A clinical viva was devised to enable third year students in their final transitional placement prior to qualifying demonstrate both the art and science of nursing practice. The assessment combines some of the viva element of an Australian assessment model described by Levett-Jones et al. (2011), together with the think aloud approach suggested by Banning (2008); whereby the think aloud model acts as a catalyst for eliciting students' understandings and knowledge and the SOAP model is a mechanism for the assessment of students' understandings and knowledge. Rust (2002) calls for students to be afforded opportunities for regular formative feedback; therefore, the assessment includes a replica formative assessment, one week prior to the summative assessment. This formative test prevents assessment being seen as a snapshot of the student's development and encourages assessment for learning and is an approach which is suggested to discourage surface learning (Rust, 2002). A holistic rubric was developed in an attempt to capture the students' abilities against the six cognitive operators or heuristics suggested by Banning (2008). Open-ended questions were devised to be asked of the students as advocated by Levett-Jones et al. (2011), to uncover the student's cognitive abilities, integration of knowledge, complex problem solving, critical opinion, lateral thinking and innovative action. Roberts (2011) calls for new and innovative ways of assessing student learning which bridges the artificial divide between theory and practice and enables students to demonstrate both the art and science of nursing practice (p610). The clinical viva has the potential to be one such mechanism.

  2. Assessing registered nurses' clinical skills in orthopaedics.

    Science.gov (United States)

    Clarke, Sonya; McDonald, Sinead; Rainey, Debbie

    The aim of this article is to explore the views of registered nurses undertaking the new Objective Structured Clinical Examination (OSCE), incorporating an integrated preparatory skills workshop. The workshop and the OSCE were audited with particular regard to the student experience. This article describes the audit process and the results of three questionnaires: one carried out before the OSCE assessment, a second immediately after the workshop and a third four days after the assessment. The results provide an insight into the student experience.

  3. Assessment of cardiorespiratory fitness using submaximal protocol in older adults with mood disorder and Parkinson's disease

    Directory of Open Access Journals (Sweden)

    Natacha Alves de Oliveira

    2013-01-01

    Full Text Available BACKGROUND: Evidence has shown benefits for mental health through aerobic training oriented in percentage of VO2max, indicating the importance of this variable for clinical practice. OBJECTIVE: To validate a method for estimating VO2max using a submaximal protocol in elderly patients with clinically diagnosis as major depressive disorder (MDD and Parkinson's disease (PD. METHODS: The sample comprised 18 patients (64.22 ± 9.92 years with MDD (n = 7 and with PD (n = 11. Three evaluations were performed: I disease staging, II direct measurement of VO2max and III submaximal exercise test. Linear regression was performed to verify the accuracy of estimation in VO2max established in ergospirometry and the predicted VO2max from the submaximal test measurement. We also analyzed the correlation between the Bland-Altman procedures. RESULTS: The regression analysis showed that VO2max values estimated by submaximal protocol associated with the VO2max measured, both in absolute values (R² = 0.65; SEE = 0.26; p < 0.001 and the relative (R² = 0.56; SEE = 3.70; p < 0.001. The Bland-Altman plots for analysis of agreement of showed a good correlation between the two measures. DISCUSSION: The VO2max predicted by submaximal protocol demonstrated satisfactory criterion validity and simple execution compared to ergospirometry.

  4. Assessing clinical competency: reports from discussion groups.

    Science.gov (United States)

    Turnwald, Grant; Stone, Elizabeth; Bristol, David; Fuentealba, Carmen; Hardie, Lizette; Hellyer, Peter; Jaeger, Laurie; Kerwin, Sharon; Kochevar, Deborah; Lissemore, Kerry; Olsen, Christopher; Rogers, Kenita; Sabin, Beth; Swanson, Cliff; Warner, Angeline

    2008-01-01

    This report describes proposed new models for assessment of eight of the nine clinical competencies the American Veterinary Medical Association Council on Education requires for accreditation. The models were developed by discussion groups at the Association of American Veterinary Medical Colleges' Clinical Competency Symposium. Clinical competencies and proposed models (in parentheses) are described. Competency 1: comprehensive patient diagnosis (neurologic examination on a dog, clinical reasoning skills); Competency 2: comprehensive treatment planning (concept mapping, computerized case studies); Competency 3: anesthesia, pain management (student portfolio); Competency 4: surgery skills (objective structured clinical examination, cased-based examination, "super dog" model); Competency 5: medicine skills (clinical reasoning and case management, skills checklist); Competency 6: emergency and intensive care case management (computerized case study or scenario); Competency 7: health promotion, disease prevention/biosecurity (360 degrees evaluation, case-based computer simulation); Competency 8: client communications and ethical conduct (Web-based evaluation forms, client survey, communicating with stakeholders, telephone conversation, written scenario-based cases). The report also describes faculty recognition for participating in clinical competency assessments.

  5. A Field-Based Testing Protocol for Assessing Gross Motor Skills in Preschool Children: The Children's Activity and Movement in Preschool Study Motor Skills Protocol

    Science.gov (United States)

    Williams, Harriet G.; Pfeiffer, Karin A.; Dowda, Marsha; Jeter, Chevy; Jones, Shaverra; Pate, Russell R.

    2009-01-01

    The purpose of this study was to develop a valid and reliable tool for use in assessing motor skills in preschool children in field-based settings. The development of the Children's Activity and Movement in Preschool Study Motor Skills Protocol included evidence of its reliability and validity for use in field-based environments as part of large…

  6. Sagittal spine posture assessment: feasibility of a protocol based on intersegmental moments.

    Science.gov (United States)

    Blondel, B; Pomero, V; Moal, B; Lafage, V; Jouve, J-L; Tropiano, P; Bollini, G; Dumas, R; Viehweger, E

    2012-02-01

    Evaluation of spinal posture has recently benefited from the contribution of three-dimensional reconstruction technologies that have helped improve our understanding of this dynamic balance. The aim of this study was to present the preliminary results of a three-dimensional protocol to analyze postural balance. This analytical method is not limited by certain constraints of the radiological approach and evaluates postural balance using a new approach taking into account the net efforts of different intersegmental centers. These preliminary results show the technical feasibility of the protocol. Its future development and clinical use could provide a better understanding of postural balance disorders, and help evaluate the impact of surgical correction on spinal balance.

  7. A feasible repetitive transcranial magnetic stimulation clinical protocol in migraine prevention

    Directory of Open Access Journals (Sweden)

    Shawn Zardouz

    2016-10-01

    Full Text Available Objective: This case series was conducted to determine the clinical feasibility of a repetitive transcranial magnetic stimulation protocol for the prevention of migraine (with and without aura. Methods: Five patients with migraines underwent five repetitive transcranial magnetic stimulation sessions separated in 1- to 2-week intervals for a period of 2 months at a single tertiary medical center. Repetitive transcranial magnetic stimulation was applied to the left motor cortex with 2000 pulses (20 trains with 1s inter-train interval delivered per session, at a frequency of 10 Hz and 80% resting motor threshold. Pre- and post-treatment numerical rating pain scales were collected, and percent reductions in intensity, frequency, and duration were generated. Results: An average decrease in 37.8%, 32.1%, and 31.2% were noted in the intensity, frequency, and duration of migraines post-repetitive transcranial magnetic stimulation, respectively. A mean decrease in 1.9±1.0 (numerical rating pain scale ± standard deviation; range: 0.4–2.8 in headache intensity scores was noted after the repetitive transcranial magnetic stimulation sessions. Conclusion: The tested repetitive transcranial magnetic stimulation protocol is a well-tolerated, safe, and effective method for migraine prevention.

  8. SCISSOR—Spinal Cord Injury Study on Small molecule-derived Rho inhibition: a clinical study protocol

    Science.gov (United States)

    Kopp, Marcel A; Liebscher, Thomas; Watzlawick, Ralf; Martus, Peter; Laufer, Stefan; Blex, Christian; Schindler, Ralf; Jungehulsing, Gerhard J; Knüppel, Sven; Kreutzträger, Martin; Ekkernkamp, Axel; Dirnagl, Ulrich; Strittmatter, Stephen M; Niedeggen, Andreas; Schwab, Jan M

    2016-01-01

    Introduction The approved analgesic and anti-inflammatory drugs ibuprofen and indometacin block the small GTPase RhoA, a key enzyme that impedes axonal sprouting after axonal damage. Inhibition of the Rho pathway in a central nervous system-effective manner requires higher dosages compared with orthodox cyclooxygenase-blocking effects. Preclinical studies on spinal cord injury (SCI) imply improved motor recovery after ibuprofen/indometacin-mediated Rho inhibition. This has been reassessed by a meta-analysis of the underlying experimental evidence, which indicates an overall effect size of 20.2% regarding motor outcome achieved after ibuprofen/indometacin treatment compared with vehicle controls. In addition, ibuprofen/indometacin may also limit sickness behaviour, non-neurogenic systemic inflammatory response syndrome (SIRS), neuropathic pain and heterotopic ossifications after SCI. Consequently, ‘small molecule’-mediated Rho inhibition after acute SCI warrants clinical investigation. Methods and analysis Protocol of an investigator-initiated clinical open-label pilot trial on high-dose ibuprofen treatment after acute traumatic, motor-complete SCI. A sample of n=12 patients will be enrolled in two cohorts treated with 2400 mg/day ibuprofen for 4 or 12 weeks, respectively. The primary safety end point is an occurrence of serious adverse events, primarily gastroduodenal bleedings. Secondary end points are pharmacokinetics, feasibility and preliminary effects on neurological recovery, neuropathic pain and heterotopic ossifications. The primary safety analysis is based on the incidence of severe gastrointestinal bleedings. Additional analyses will be mainly descriptive and casuistic. Ethics and dissemination The clinical trial protocol was approved by the responsible German state Ethics Board, and the Federal Institute for Drugs and Medical Devices. The study complies with the Declaration of Helsinki, the principles of Good Clinical Practice and all further

  9. Mapping and assessing clinical handover training interventions

    NARCIS (Netherlands)

    Stoyanov, Slavi; Boshuizen, Els; Groene, Oliver; Van der Klink, Marcel; Kicken, Wendy; Drachsler, Hendrik; Barach, Paul

    2013-01-01

    Stoyanov, S., Boshuizen, H. P. A., Groene, O., Van der Klink, M., Kicken, W., Drachsler, H., & Barach, P. (2012). Mapping and assessing clinical handover training interventions. British Medical Journal Quality & Safety, 21, i50-i57. doi:10.1136/bmjqs-2012-001169

  10. Personality Assessment Use by Clinical Neuropsychologists

    Science.gov (United States)

    Smith, Steven R.; Gorske, Tad T.; Wiggins, Chauntel; Little, Jessica A.

    2010-01-01

    The present study is an exploration of the personality assessment practices of clinical neuropsychologists. Professional members of the National Academy of Neuropsychology and the International Neuropsychological Society (N = 404) were surveyed to examine use of several forms of personality, behavior, and emotional function measures. Results…

  11. "Absolute" quantification in magnetic resonance spectroscopy: validation of a clinical protocol in multiple sclerosis.

    Science.gov (United States)

    Bagory, Matthieu; Durand-Dubief, Françoise; Ibarrola, Danielle; Confavreux, Christian; Sappey-Marinier, Dominique

    2007-01-01

    MRS allows to measure cerebral metabolites, thus helping to characterize brain disease diagnosis and followup. Metabolite concentration quantification is usually based on metabolite ratio referring to creatine. If this metabolite concentration is supposed to be constant, it may vary in pathological processes. Therefore, "absolute" concentration methodology is needed. The aim of this study is to validate a clinical "absolute" quantification protocol through the development of an external metabolic phantom, calibration and correction, and the investigation of reproducibility issues. When phantom stability was investigated by a short-term and a long-term reproducibility study, both Standard Deviations (SD) were in agreement with literature values. This "absolute" quantification method was applied to patients with Multiple Sclerosis (MS). The results show a significant decrease in both N-Acetyl Aspartate (NAA) and choline concentrations.

  12. Triangular model integrating clinical teaching and assessment.

    Science.gov (United States)

    Abdelaziz, Adel; Koshak, Emad

    2014-01-01

    Structuring clinical teaching is a challenge facing medical education curriculum designers. A variety of instructional methods on different domains of learning are indicated to accommodate different learning styles. Conventional methods of clinical teaching, like training in ambulatory care settings, are prone to the factor of coincidence in having varieties of patient presentations. Accordingly, alternative methods of instruction are indicated to compensate for the deficiencies of these conventional methods. This paper presents an initiative that can be used to design a checklist as a blueprint to guide appropriate selection and implementation of teaching/learning and assessment methods in each of the educational courses and modules based on educational objectives. Three categories of instructional methods were identified, and within each a variety of methods were included. These categories are classroom-type settings, health services-based settings, and community service-based settings. Such categories have framed our triangular model of clinical teaching and assessment.

  13. Investigating the validity of a structured interview protocol for assessing the preferences of children with autism spectrum disorders

    NARCIS (Netherlands)

    Verschuur, R.; Didden, H.C.M.; Meer, L. van der; Achmadi, D.; Kagohara, D.; Green, V.A.; Lang, R.; Lancioni, G.E.

    2011-01-01

    PURPOSE: To investigate the congruent validity of a structured interview protocol for assessing the preferences of seven children with autism spectrum disorder (ASD). METHOD: Using the structured interview protocol described by Green et al., parents were asked to provide a rank ordering of their chi

  14. Design and Evaluation of a Protocol to Assess Electronic Travel Aids for Persons Who Are Visually Impaired

    Science.gov (United States)

    Havik, Else M.; Steyvers, Frank J. J. M.; van der Velde, Hanneke; Pinkster, J. Christiaan; Kooijman, Aart C.

    2010-01-01

    This study evaluated a protocol that was developed to assess how beneficial electronic travel aids are for persons who are visually impaired. Twenty persons with visual impairments used an electronic travel device (Trekker) for six weeks to conform to the protocol, which proved useful in identifying successful users of the device. (Contains 2…

  15. Clinical outcomes assessment in clinical trials to assess treatment of femoroacetabular impingement

    DEFF Research Database (Denmark)

    Harris-Hayes, Marcie; McDonough, Christine M; Leunig, Michael

    2013-01-01

    Patient-reported outcome measures are an important component of outcomes assessment in clinical trials to assess the treatment of femoroacetabular impingement (FAI). This review of disease-specific measures and instruments used to assess the generic quality of life and physical activity levels...

  16. Automation of sample preparation for mass cytometry barcoding in support of clinical research: protocol optimization.

    Science.gov (United States)

    Nassar, Ala F; Wisnewski, Adam V; Raddassi, Khadir

    2017-03-01

    Analysis of multiplexed assays is highly important for clinical diagnostics and other analytical applications. Mass cytometry enables multi-dimensional, single-cell analysis of cell type and state. In mass cytometry, the rare earth metals used as reporters on antibodies allow determination of marker expression in individual cells. Barcode-based bioassays for CyTOF are able to encode and decode for different experimental conditions or samples within the same experiment, facilitating progress in producing straightforward and consistent results. Herein, an integrated protocol for automated sample preparation for barcoding used in conjunction with mass cytometry for clinical bioanalysis samples is described; we offer results of our work with barcoding protocol optimization. In addition, we present some points to be considered in order to minimize the variability of quantitative mass cytometry measurements. For example, we discuss the importance of having multiple populations during titration of the antibodies and effect of storage and shipping of labelled samples on the stability of staining for purposes of CyTOF analysis. Data quality is not affected when labelled samples are stored either frozen or at 4 °C and used within 10 days; we observed that cell loss is greater if cells are washed with deionized water prior to shipment or are shipped in lower concentration. Once the labelled samples for CyTOF are suspended in deionized water, the analysis should be performed expeditiously, preferably within the first hour. Damage can be minimized if the cells are resuspended in phosphate-buffered saline (PBS) rather than deionized water while waiting for data acquisition.

  17. Assessing Students – Clinical Competence Versus Performance

    Directory of Open Access Journals (Sweden)

    John Ruedy

    2007-06-01

    Full Text Available The recent elaboration of the range of physiciancompetencies upon which the quality of health care isdependent has fostered the development of a variety ofmethods of assessing medical student competencies andperformance. Such assessments are essential inproviding feedback to students to guide their learningand to faculty on the success of the curriculum inachieving competency outcomes. In addition theyprovide evidence that students have achieved minimumrequirements for progressing. Well-designed ObservedStructured Clinical Examinations (OSCEs, MiniClinical Examinations (Mini-CEXs and some forms ofMulti-Source Feedback (MSF can meet acceptablestandards of validity and reliability and are feasible.Competency assessments are limited in predicting howa student will actually act in the work situationparticularly in humanistic skills. More emphasis needsto be placed on student performance, in suchcompetencies as communication and professionalism, ina variety of settings by a number of observers.

  18. Characterisation of a behavioural protocol for the assessment of nociception in normal and inflamed porcine skin

    DEFF Research Database (Denmark)

    di Giminiani, Pierpaolo

    2012-01-01

    of behavioural cutaneous nociception was performed via the assessment of differences in cutaneous pain sensitivity as determined by the body size of the animals, the anatomical locations of interest and the sensory modalities involved. Consequently, this new protocol allowed measuring the change in cutaneous...... pain sensitivity following ultraviolet-B and capsaicin-induced inflammation in porcine skin. A series of experiments was performed to characterise the new experimental protocol, which included (1) the identification and quantification of reflexive behavioural responses indicative of the nociceptive...... pain sensitivity, although associated with high levels of individual variability. The nociceptive assays proved to be valuable in measuring the development of altered cutaneous pain sensitivity following two inflammatory challenges. Behavioural signs of hyperalgesia were recorded in pigs exposed...

  19. International Study to Predict Optimized Treatment for Depression (iSPOT-D, a randomized clinical trial: rationale and protocol

    Directory of Open Access Journals (Sweden)

    Cooper Nicholas J

    2011-01-01

    Full Text Available Abstract Background Clinically useful treatment moderators of Major Depressive Disorder (MDD have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine; and develop a model that incorporates multiple predictors and moderators. Methods/Design The International Study to Predict Optimized Treatment - in Depression (iSPOT-D is a multi-centre, international, randomized, prospective, open-label trial. It is enrolling 2016 MDD outpatients (ages 18-65 from primary or specialty care practices (672 per treatment arm; 672 age-, sex- and education-matched healthy controls. Study-eligible patients are antidepressant medication (ADM naïve or willing to undergo a one-week wash-out of any non-protocol ADM, and cannot have had an inadequate response to protocol ADM. Baseline assessments include symptoms; distress; daily function; cognitive performance; electroencephalogram and event-related potentials; heart rate and genetic measures. A subset of these baseline assessments are repeated after eight weeks of treatment. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary and self-reported depressive symptoms, social functioning, quality of life, emotional regulation, and side-effect burden (secondary. Participants may then enter a naturalistic telephone follow-up at weeks 12, 16, 24 and 52. The first half of the sample will be used to identify potential predictors and moderators, and the second half to replicate and confirm. Discussion First enrolment was in December 2008, and is ongoing. iSPOT-D evaluates clinical and biological predictors of treatment response in the largest known sample of MDD collected worldwide. Trial registration International Study to Predict Optimised Treatment - in Depression (iSPOT-D ClinicalTrials.gov Identifier

  20. Yoga for Health Care in Korea: A Protocol for Systematic Review of Clinical Trials.

    Science.gov (United States)

    Choi, Jiae; Jun, Ji Hee; Lee, Ju Ah; Lee, Myeong Soo

    2016-08-01

    This systematic review aims to evaluate the therapeutic effects of yoga therapy using an evidence-based approach and investigates the relationship between yoga and the meridian energies based on all available clinical studies in Korea. Sixteen electronic databases will be searched from the inception of the study until January 2016. All clinical evidences that evaluate any type of yoga and any type of control in individuals with any type of condition will be eligible. The methodological quality will be assessed using the Cochrane risk of bias tool for randomized clinical trials and the Newcastle-Ottawa scale for nonrandomized studies. Two authors will independently assess each study for eligibility and the risk of bias, and then they will extract the data. With its extensive, unbiased search of the Korean literature from various databases without any language restrictions, this systematic review will be useful for both practitioners in the field of yoga research as well as for patients.

  1. [Development of clinical trial education program for pharmaceutical science students through small group discussion and role-playing using protocol].

    Science.gov (United States)

    Imakyure, Osamu; Shuto, Hideki; Nishikawa, Fumi; Hagiwara, Yoshifuka; Inoue, Sachiko; Koyanagi, Taeko; Hirakawa, Masaaki; Kataoka, Yasufumi

    2010-08-01

    The acquirement of basic knowledge of clinical trials and professional attitude in their practices is a general instructional objective in the Model Core Curriculum for Pharmaceutical Education. Unfortunately, the previous program of clinical trial education was not effective in the acquirement of a professional attitude in their practices. Then, we developed the new clinical trial education program using protocol through small group discussion (SGD) and roll-playing. Our program consists of 7 steps of practical training. In step 1, the students find some problems after presentation of the protocol including case and prescription. In step 2, they analyse the extracted problems and share the information obtained in SGD. In steps 3 and 5, five clinical case scenarios are presented to the students and they discuss which case is suitable for entry to the clinical trial or which case corresponds to the discontinuance criteria in the present designed protocol. In steps 4 and 6, the roll-playing is performed by teachers and students as doctors and clinical research coordinators (CRC) respectively. Further, we conducted a trial practice based on this program for the students. In the student's self-evaluation into five grades, the average score of the skill acquisition level in each step was 3.8-4.7 grade. Our clinical trial education program could be effective in educating the candidates for CRC or clinical pharmacists.

  2. Lower limbs kinematic assessment of the effect of a gym and hydrotherapy rehabilitation protocol after knee megaprosthesis: a case report

    OpenAIRE

    2016-01-01

    [Purpose] To quantitatively assess the effect of a personalized rehabilitation protocol after knee megaprosthesis. [Subject and Methods] The gait patterns of a 33-year-old male patient with knee synovial sarcoma were assessed by a computerized analysis before and after 40 rehabilitation sessions. [Results] The rehabilitation protocol improved the gait pattern. After rehabilitation, hip flexion was nearly symmetric, with normalized affected limb hip flexion, and improved ankle flexion. Ankle i...

  3. Practical way to develop 10-color flow cytometry protocols for the clinical laboratory

    Science.gov (United States)

    Tárnok, Attila; Bocsi, Jozsef

    2010-02-01

    The latest development of commercial routine flow cytometers (FCM) is that they are equipped with three (blue, red, violet) or more lasers and many PMT detectors. Nowadays routine clinical instruments are capable of detecting 10 or more fluorescence colors simultaneously. Thereby, presenting opportunities for getting detailed information on the single cell level for cytomics and systems biology for improve diagnostics and monitoring of patients. The University Leipzig, Germany) recently started a cluster of excellence to study the molecular background of life style and environment associated diseases, enrolling 25000 individuals (LIFE). To this end the most comprehensive FCM protocol has to be developed for this study. We aimed to optimize fluorochrome and antibody combinations to the characteristics of the instrument for successful 10-color FCM. Systematic review of issues related to sampling, preparation, instrument settings, spillover and compensation matrix, reagent performance, and general principles of panel construction was performed. 10-color FCM enables for increased accuracy in cell subpopulation identification, the ability to obtain detailed information from blood specimens, improved laboratory efficiency, and the means to consistently detect major and rare cell populations. Careful attention to details of instrument and reagent performance allows for the development of panels suitable for screening of samples from healthy and diseased donors. The characteristics of this technique are particularly well suited for the analysis of broad human population cohorts and have the potential to reach the everyday practice in a standardized way for the clinical laboratory.

  4. Risks to the fetus from diagnostic imaging during pregnancy: review and proposal of a clinical protocol

    Energy Technology Data Exchange (ETDEWEB)

    Gomes, Mafalda; Matias, Alexandra [University of Porto, Faculty of Medicine, Porto (Portugal); Macedo, Filipe [SMIC, Porto (Portugal)

    2015-12-15

    Every day, medical practitioners face the dilemma of exposing pregnant or possibly pregnant patients to radiation from diagnostic examinations. Both doctors and patients often have questions about the risks of radiation. The most vulnerable period is between the 8th and 15th weeks of gestation. Deterministic effects like pregnancy loss, congenital malformations, growth retardation and neurobehavioral abnormalities have threshold doses above 100-200 mGy. The risk is considered negligible at 50 mGy and in reality no diagnostic examination exceeds this limit. The risk of carcinogenesis is slightly higher than in the general population. Intravenous iodinated contrast is discouraged, except in highly selected patients. Considering all the possible noxious effects of radiation exposure, measures to diminish radiation are essential and affect the fetal outcome. Nonionizing procedures should be considered whenever possible and every radiology center should have its own data analysis on fetal radiation exposure. In this review, we analyze existing literature on fetal risks due to radiation exposure, producing a clinical protocol to guide safe radiation use in a clinical setting. (orig.)

  5. Using broadband spatially resolved NIRS to assess muscle oxygenation during altered running protocols

    Science.gov (United States)

    Koukourakis, Georg; Vafiadou, Maria; Steimers, André; Geraskin, Dmitri; Neary, Patrick; Kohl-Bareis, Matthias

    2009-07-01

    We used spatially resolved near-infrared spectroscopy (SRS-NIRS) to assess calf and thigh muscle oxygenation during running on a motor-driven treadmill. Two protocols were used: An incremental speed protocol (velocity = 6 - 12 km/h, ▵v = 2 km/h) was performed in 3 minute stages, while a pacing paradigm modulated step frequency alternatively (2.3 Hz [SLow]; 3.3 Hz [SHigh]) during a constant velocity for 2 minutes each. A SRS-NIRS broadband system (600 - 1000 nm) was used to measure total haemoglobin concentration and oxygen saturation (SO2). An accelerometer was placed on the hip joints to measure limb acceleration through the experiment. The data showed that the calf (SO2 58 to 42%) desaturated to a significantly lower level than the thigh (61 to 54%). During the pacing protocol, SO2 was significantly different between the SLow vs. SHigh trials. Additionally, physiological data as measured by spirometry were different between the SLow vs. SHigh pacing trials (VO2 (2563+/- 586 vs. 2503 +/- 605 mL/min). Significant differences in VO2 at the same workload (speed) indicate alterations in mechanical efficiency. These data suggest that SRS broadband NIRS can be used to discern small changes in muscle oxygenation, making this device useful for metabolic exercise studies in addition to spirometry and movement monitoring by accelerometers.

  6. Assessment of an extraction protocol to detect the major mastitis-causing pathogens in bovine milk.

    Science.gov (United States)

    Cressier, B; Bissonnette, N

    2011-05-01

    Despite all efforts to control its spread, mastitis remains the most costly disease for dairy farmers worldwide. One key component of better control of this disease is identification of the causative bacterial agent during udder infections in cows. Mastitis is complex, however, given the diversity of pathogens that must be identified. Development of a rapid and efficient bacterial species identification tool is thus necessary. This study was conducted to demonstrate the feasibility of bacterial DNA extraction for the automated molecular detection of major mastitis-causing pathogens directly in milk samples to complement traditional microbiological identification. Extraction and detection procedures were designed and optimized to achieve detection in a respectable time frame, at a reasonable cost, and with a high throughput capacity. The following species were identified: Staphylococcus aureus, Escherichia coli, Streptococcus uberis, Streptococcus agalactiae, Streptococcus dysgalactiae, and Klebsiella spp. (including Klebsiella oxytoca and Klebsiella pneumoniae). The detection procedure includes specific genomic DNA amplification by multiplex PCR for each species, separation by capillary electrophoresis, and laser-assisted automated detection. The specificity of the primers was assessed with a panel of bacteria representing mastitis-negative control species. The extraction protocol comprised multiple steps, starting with centrifugation for fat removal, followed by heating in the presence of a cation exchange resin to trap divalent ions. The analytical sensitivity was 100 cfu/mL for milk samples spiked with Staph. aureus, Strep. dysgalactiae, and E. coli, with a tendency for K. pneumoniae. The detection limit was 500 cfu/mL for Strep. uberis and Strep. agalactiae. The overall diagnostic sensitivity (95.4%) and specificity (97.3%) were determined in a double-blind randomized assay by processing 172 clinical milk samples with microbiological characterization as the

  7. Assessing the need for a protocol in monitoring weight loss and nutritional status in orthognathic surgery based on patients experiences

    Science.gov (United States)

    Dekker, Hannah; Tuinzing, Dirk B.; Forouzanfar, Tymour

    2017-01-01

    Background To investigate retrospectively the orthognathic surgery (OGS) patients experience in weight loss and the influence of gender, age, duration of the surgical procedure, length of hospital stay, location of surgery and use of intermaxillary fixation (IMF) or without IMF on postoperative weight loss. Material and Methods A total of 4487 patients treated by OGS where all patients visited the outpatient clinic one, three and six weeks after the surgical procedure. After six weeks, patients filled out a questionnaire in which weight loss was addressed. The patients were asked to give an estimate of their experiences weight loss. The population was first divided in two groups weight loss and no weight loss. Results In the weight loss group there is no significant difference in weight loss between patients with IMF and patients without IMF. In the weight loss group there were significantly more females then males. Further, in the subgroup IMF the operation time was significantly longer compared with the subgroup without IMF. The other parameters including age and hospital stay were not different in the groups. Conclusions IMF in orthognathic treatment does not result in a difference self-reported loss of body weight compared to patients without IMF. Treatment protocols should include pre- and post-operative dietician consultations and possible indications for medical nutrition and vitamins. Key words:Assessing, protocol, weight loss, experiences, orthognathic surgery. PMID:28210448

  8. A quality control program within a clinical trial Consortium for PCR protocols to detect Plasmodium species.

    Science.gov (United States)

    Taylor, Steve M; Mayor, Alfredo; Mombo-Ngoma, Ghyslain; Kenguele, Hilaire M; Ouédraogo, Smaïla; Ndam, Nicaise Tuikue; Mkali, Happy; Mwangoka, Grace; Valecha, Neena; Singh, Jai Prakash Narayan; Clark, Martha A; Verweij, Jaco J; Adegnika, Ayola Akim; Severini, Carlo; Menegon, Michela; Macete, Eusebio; Menendez, Clara; Cisteró, Pau; Njie, Fanta; Affara, Muna; Otieno, Kephas; Kariuki, Simon; ter Kuile, Feiko O; Meshnick, Steven R

    2014-06-01

    Malaria parasite infections that are only detectable by molecular methods are highly prevalent and represent a potential transmission reservoir. The methods used to detect these infections are not standardized, and their operating characteristics are often unknown. We designed a proficiency panel of Plasmodium spp. in order to compare the accuracy of parasite detection of molecular protocols used by labs in a clinical trial consortium. Ten dried blood spots (DBSs) were assembled that contained P. falciparum, P. vivax, P. malariae, and P. ovale; DBSs contained either a single species or a species mixed with P. falciparum. DBS panels were tested in 9 participating laboratories in a masked fashion. Of 90 tests, 68 (75.6%) were correct; there were 20 false-negative results and 2 false positives. The detection rate was 77.8% (49/63) for P. falciparum, 91.7% (11/12) for P. vivax, 83.3% (10/12) for P. malariae, and 70% (7/10) for P. ovale. Most false-negative P. falciparum results were from samples with an estimated ≤ 5 parasites per μl of blood. Between labs, accuracy ranged from 100% to 50%. In one lab, the inability to detect species in mixed-species infections prompted a redesign and improvement of the assay. Most PCR-based protocols were able to detect P. falciparum and P. vivax at higher densities, but these assays may not reliably detect parasites in samples with low P. falciparum densities. Accordingly, formal quality assurance for PCR should be employed whenever this method is used for diagnosis or surveillance. Such efforts will be important if PCR is to be widely employed to assist malaria elimination efforts.

  9. 'Outwalk': a protocol for clinical gait analysis based on inertial and magnetic sensors.

    Science.gov (United States)

    Cutti, Andrea Giovanni; Ferrari, Alberto; Garofalo, Pietro; Raggi, Michele; Cappello, Angelo; Ferrari, Adriano

    2010-01-01

    A protocol named Outwalk was developed to easily measure the thorax-pelvis and lower-limb 3D kinematics on children with cerebral palsy (CP) and amputees during gait in free-living conditions, by means of an Inertial and Magnetic Measurement System (IMMS). Outwalk defines the anatomical/functional coordinate systems (CS) for each body segment through three steps: (1) positioning the sensing units (SUs) of the IMMS on the subjects' thorax, pelvis, thighs, shanks and feet, following simple rules; (2) computing the orientation of the mean flexion-extension axis of the knees; (3) measuring the SUs' orientation while the subject's body is oriented in a predefined posture, either upright or supine. If the supine posture is chosen, e.g. when spasticity does not allow to maintain the upright posture, hips and knees static flexion angles must be measured through a standard goniometer and input into the equations that define Outwalk anatomical CSs. In order to test for the inter-rater measurement reliability of these angles, a study was carried out involving nine healthy children (7.9 +/- 2 years old) and two physical therapists as raters. Results showed RMS error of 1.4 degrees and 1.8 degrees and a negligible worst-case standard error of measurement of 2.0 degrees and 2.5 degrees for hip and knee angles, respectively. Results were thus smaller than those reported for the same measures when performed through an optoelectronic system with the CAST protocol and support the beginning of clinical trials of Outwalk with children with CP.

  10. Triangular model integrating clinical teaching and assessment

    Directory of Open Access Journals (Sweden)

    Abdelaziz A

    2014-03-01

    Full Text Available Adel Abdelaziz,1,2 Emad Koshak3 1Medical Education Development Unit, Faculty of Medicine, Al Baha University, Al Baha, Saudi Arabia; 2Medical Education Department, Faculty of Medicine, Suez Canal University, Egypt; 3Dean and Internal Medicine Department, Faculty of Medicine, Al Baha University, Al Baha, Saudi Arabia Abstract: Structuring clinical teaching is a challenge facing medical education curriculum designers. A variety of instructional methods on different domains of learning are indicated to accommodate different learning styles. Conventional methods of clinical teaching, like training in ambulatory care settings, are prone to the factor of coincidence in having varieties of patient presentations. Accordingly, alternative methods of instruction are indicated to compensate for the deficiencies of these conventional methods. This paper presents an initiative that can be used to design a checklist as a blueprint to guide appropriate selection and implementation of teaching/learning and assessment methods in each of the educational courses and modules based on educational objectives. Three categories of instructional methods were identified, and within each a variety of methods were included. These categories are classroom-type settings, health services-based settings, and community service-based settings. Such categories have framed our triangular model of clinical teaching and assessment. Keywords: curriculum development, teaching, learning, assessment, apprenticeship, community-based settings, health service-based settings

  11. Low-dose single acquisition rest {sup 99m}Tc/stress {sup 201}Tl myocardial perfusion SPECT protocol: phantom studies and clinical validation

    Energy Technology Data Exchange (ETDEWEB)

    Dey, Thomas [RWTH Aachen University, Institute of Imaging and Computer Vision, Aachen (Germany); Backus, Barbra E.; Romijn, R.Leo [St. Antonius Hospital, Department of Nuclear Medicine, Nieuwegein (Netherlands); Wieczorek, Herfried [Philips Research, Eindhoven (Netherlands); Verzijlbergen, J.F. [St. Antonius Hospital, Department of Nuclear Medicine, Nieuwegein (Netherlands); Erasmus Medical Center, Department of Nuclear Medicine, Rotterdam (Netherlands)

    2014-03-15

    We developed and tested a single acquisition rest {sup 99m}Tc-sestamibi/stress {sup 201}Tl dual isotope protocol (SDI) with the intention of improving the clinical workflow and patient comfort of myocardial perfusion single photon emission computed tomography (SPECT). The technical feasibility of SDI was evaluated by a series of anthropomorphic phantom studies on a standard SPECT camera. The attenuation map was created by a moving transmission line source. Iterative reconstruction including attenuation correction, resolution recovery and Monte Carlo simulation of scatter was used for simultaneous reconstruction of dual tracer distribution. For clinical evaluation, patient studies were compared to stress {sup 99m}Tc and rest {sup 99m}Tc reference images acquired in a 2-day protocol. Clinical follow-up examinations like coronary angiography (CAG) and fractional flow reserve (FFR) were included in the assessment if available. Phantom studies demonstrated the technical feasibility of SDI. Artificial lesions inserted in the phantom mimicking ischaemia could be clearly identified. In 51/53 patients, the image quality was adequate for clinical evaluation. For the remaining two obese patients with body mass index > 32 the injected {sup 201}Tl dose of 74 MBq was insufficient for clinical assessment. In answer to this the {sup 201}Tl dose was adapted for obese patients in the rest of the study. In 31 patients, SDI and {sup 99m}Tc reference images resulted in equivalent clinical assessment. Significant differences were found in 20 patients. In 18 of these 20 patients additional examinations were available. In 15 patients the diagnosis based on the SDI images was confirmed by the results of CAG or FFR. In these patients the SDI images were more accurate than the {sup 99m}Tc reference study. In three patients minor ischaemic lesions were detected by SDI but were not confirmed by CAG. In one of these cases this was probably caused by pronounced apical thinning. For two patients

  12. Yoga for Health Care in Korea: A Protocol for Systematic Review of Clinical Trials

    Directory of Open Access Journals (Sweden)

    Jiae Choi

    2016-08-01

    Sixteen electronic databases will be searched from the inception of the study until January 2016. All clinical evidences that evaluate any type of yoga and any type of control in individuals with any type of condition will be eligible. The methodological quality will be assessed using the Cochrane risk of bias tool for randomized clinical trials and the Newcastle–Ottawa scale for nonrandomized studies. Two authors will independently assess each study for eligibility and the risk of bias, and then they will extract the data. With its extensive, unbiased search of the Korean literature from various databases without any language restrictions, this systematic review will be useful for both practitioners in the field of yoga research as well as for patients.

  13. Hydrogeomorphic Approach to Assessing Wetland Functions: Guidelines for Developing Regional Guidelines: Chapter 8, Developing the Assessment Protocol

    Science.gov (United States)

    2009-07-01

    Chapter 8 Developing the Assessment Protocol Record the species (optional) and dbh (cm) of all trees (i.e., woody stems  10 cm or 4 in dbh ) in the...in Column 3 by 0.00196 to get m2/ha per tree Species Code (optional) dbh (cm) Square the Value in Column 2 ( dbh x dbh ) Multiply the...Figure 9. Example of table that can be used to calculate dbh ...................12 Figure 10. Example of a spreadsheet for calculating variable

  14. Passive movement therapy in patients with moderate to severe paratonia; study protocol of a randomised clinical trial (ISRCTN43069940

    Directory of Open Access Journals (Sweden)

    de Bie Rob A

    2007-12-01

    Full Text Available Abstract Background Paratonia, a form of hypertonia, is associated with loss of mobility and with the development of contractures especially in the late stages of the dementia. Passive movement therapy (PMT currently is the main physiotherapeutic intervention. General doubt about the beneficial effects of this widely used therapy necessitates a randomised clinical trial (RCT to study the efficacy of PMT on the severity of paratonia and on the improvement of daily care. Methods/Design A RCT with a 4-week follow-up period. Patients with dementia (according to the DSM-IV-TR Criteria and moderate to severe paratonia are included in the study after proxy consent. By means of computerised and concealed block randomisation (block-size of 4 patients are included in one of two groups. The first group receives PMT, the second group receives usual care without PMT. PMT is given according to a protocol by physical therapist three times a week for four weeks in a row. The severity of paratonia (Modified Ashworth scale, the severity of the dementia (Global Deterioration Scale, the clinical improvement (Clinical Global Impressions, the difficulty in daily care (Patient Specific Complaints and the experienced pain in daily care of the participant (PACSLAC-D is assessed by assessors blind to treatment allocation at baseline, after 6 and 12 treatments. Success of the intervention is defined as a significant increase of decline on the modified Ashworth scale. The 'proportion of change' in two and four weeks time on this scale will be analysed. Also a multiple logistic regression analysis using declined/not declined criteria as dependent variable with correction for relevant confounders (e.g. stage of dementia, medication, co-morbidity will be used. Discussion This study is the first RCT of this size to gain further insight on the effect of passive movement therapy on the severity of paratonia. Trial registration Current Controlled Trials ISRCTN43069940

  15. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40

    Science.gov (United States)

    Boone, Margaret; Brown, Nancy J.; Moon, Mary A.; Schuman, Deborah J.; Thomas, Josephine; Wright, Denise L.

    2004-01-01

    This Treatment Improvement Protocol (TIP) addresses the clinical use of buprenorphine in the treatment of opioid addiction. TIPs are best-practice guidelines for the treatment of substance use disorders that make the latest research in substance abuse treatment available to counselors and educators. The content was generated by a panel of experts…

  16. Nursing students' views of clinical competence assessment.

    Science.gov (United States)

    Bradshaw, Carmel; O'Connor, Maureen; Egan, Geraldine; Tierney, Katie; Butler, Mary Pat; Fahy, Anne; Tuohy, Dympna; Cassidy, Irene; Quillinan, Bernie; McNamara, Mary C

    This paper reports on some outcomes of a research study evaluating a new assessment framework of clinical competence used in undergraduate nursing programmes in the Mid West Region of Ireland. First, this paper presents both the strengths and weaknesses of the present model, as articulated by student nurses. Second, it generates a broader critical debate around the concept of competency assessment. The model of competence in question was developed by the Irish Nursing Board then elaborated on by the University of Limerick in partnership with local health service providers in 2002. Methodology involved a triangulated approach, comprising a series of focus group interviews with students (n=13) and preceptors (n=16) followed by a survey of students (n=232) and preceptors (n=837). Findings from the student focus groups are reported here. Themes identified using Burnard's (1991) framework for analysis are preparation for competency assessment, competency documentation, supporting assessment in practice, organisational and resource factors and the competency assessment structure and process. Results from this research have implications for refinement and revision of the present competency assessment framework, for student and staff preparation and for collaboration between stakeholders.

  17. Concepts of Causality in Psychopathology: Applications in Clinical Assessment, Clinical Case Formulation and Functional Analysis

    NARCIS (Netherlands)

    Haynes, S.H.; O'Brien, W.H.; Kaholokula, J.K.; Witteman, C.L.M.

    2012-01-01

    This paper discusses and integrates concepts of causality in psychopathology, clinical assessment, clinical case formulation and the functional analysis. We propose that identifying causal variables, relations and mechanisms in psychopathology and clinical assessment can lead to more powerful and e

  18. Assessing Juvenile Salmonid Passage Through Culverts: Field Research in Support of Protocol Development

    Energy Technology Data Exchange (ETDEWEB)

    Williams, Greg D.; Evans, Nathan R.; Pearson, Walter H.; Southard, John A.

    2001-10-30

    The primary goal of our research this spring/ summer was to refine techniques and examine scenarios under which a standardized protocol could be applied to assess juvenile coho salmon (O. kisutch) passage through road culverts. Field evaluations focused on capture-mark- recapture methods that allowed analysis of fish movement patterns, estimates of culvert passability, and potential identification of cues inducing these movements. At this stage, 0+ age coho salmon fry 30 mm to 65 mm long (fork length) were the species and age class of interest. Ultimately, the protocol will provide rapid, statistically rigorous methods for trained personnel to perform standardized biological assessments of culvert passability to a number of juvenile salmon species. Questions to be addressed by the research include the following: ? Do hydraulic structures such as culverts restrict habitat for juvenile salmonids? ? How do existing culverts and retrofits perform relative to juvenile salmonid passage? ? Do some culvert characteristics and hydraulic conditions provide better passage than others? ? Does the culvert represent a barrier to certain size classes of fish? Recommendations addressed issues of study site selection, initial capture, marking, recapture/observations, and estimating movement.

  19. Data for improvement and clinical excellence: protocol for an audit with feedback intervention in long-term care

    Directory of Open Access Journals (Sweden)

    Schalm Corinne

    2010-10-01

    Full Text Available Abstract Background There is considerable evidence about the effectiveness of audit coupled with feedback, although few audit with feedback interventions have been conducted in long-term care (LTC settings to date. In general, the effects have been found to be modest at best, although in settings where there has been little history of audit and feedback, the effects may be greater, at least initially. The primary purpose of the Data for Improvement and Clinical Excellence (DICE Long-Term Care project is to assess the effects of an audit with feedback intervention delivered monthly over 13 months in four LTC facilities. The research questions we addressed are: 1. What effects do feedback reports have on processes and outcomes over time? 2. How do different provider groups in LTC and home care respond to feedback reports based on data targeted at improving quality of care? Methods/design The research team conducting this study comprises researchers and decision makers in continuing care in the province of Alberta, Canada. The intervention consists of monthly feedback reports in nine LTC units in four facilities in Edmonton, Alberta. Data for the feedback reports comes from the Resident Assessment Instrument Minimum Data Set (RAI version 2.0, a standardized instrument mandated for use in LTC facilities throughout Alberta. Feedback reports consist of one page, front and back, presenting both graphic and textual information. Reports are delivered to all staff working in the four LTC facilities. The primary evaluation uses a controlled interrupted time series design both adjusted and unadjusted for covariates. The concurrent process evaluation uses observation and self-report to assess uptake of the feedback reports. Following the project phase described in this protocol, a similar intervention will be conducted in home care settings in Alberta. Depending on project findings, if they are judged useful by decision makers participating in this research

  20. Clinical risk assessment in intensive care unit

    Directory of Open Access Journals (Sweden)

    Saeed Asefzadeh

    2013-01-01

    Full Text Available Background: Clinical risk management focuses on improving the quality and safety of health care services by identifying the circumstances and opportunities that put patients at risk of harm and acting to prevent or control those risks. The goal of this study is to identify and assess the failure modes in the ICU of Qazvin′s Social Security Hospital (Razi Hospital through Failure Mode and Effect Analysis (FMEA. Methods: This was a qualitative-quantitative research by Focus Discussion Group (FDG performed in Qazvin Province, Iran during 2011. The study population included all individuals and owners who are familiar with the process in ICU. Sampling method was purposeful and the FDG group members were selected by the researcher. The research instrument was standard worksheet that has been used by several researchers. Data was analyzed by FMEA technique. Results: Forty eight clinical errors and failure modes identified, results showed that the highest risk probability number (RPN was in respiratory care "Ventilator′s alarm malfunction (no alarm" with the score 288, and the lowest was in gastrointestinal "not washing the NG-Tube" with the score 8. Conclusions: Many of the identified errors can be prevented by group members. Clinical risk assessment and management is the key to delivery of effective health care.

  1. Diversity in clinical management and protocols for the treatment of major bleeding trauma patients across European level I Trauma Centres

    DEFF Research Database (Denmark)

    Schäfer, Nadine; Driessen, Arne; Fröhlich, Matthias

    2015-01-01

    centre provided their locally applied massive transfusion protocol. RESULTS: All participating trauma centres have developed and implemented a local algorithm and protocol for the bleeding trauma patient. These are uniformly activated by clinical triggers and deactivated once the bleeding has stopped...... resuscitation is started either pre-hospital or after hospital admission by using transfusion packages with pre-fixed universal blood product combinations and ratios following the concept of "damage control resuscitation" at which applied ratios substantially vary. Two centres initially start with transfusion...

  2. Assessing transportation infrastructure impacts on rangelands: test of a standard rangeland assessment protocol

    Science.gov (United States)

    Duniway, Michael C.; Herrick, Jeffrey E.; Pyke, David A.; Toledo, David

    2010-01-01

    Linear disturbances associated with on- and off-road vehicle use on rangelands has increased dramatically throughout the world in recent decades. This increase is due to a variety of factors including increased availability of all-terrain vehicles, infrastructure development (oil, gas, renewable energy, and ex-urban), and recreational activities. In addition to the direct impacts of road development, the presence and use of roads may alter resilience of adjoining areas through indirect effects such as altered site hydrologic and eolian processes, invasive seed dispersal, and sediment transport. There are few standardized methods for assessing impacts of transportation-related land-use activities on soils and vegetation in arid and semi-arid rangelands. Interpreting Indicators of Rangeland Health (IIRH) is an internationally accepted qualitative assessment that is applied widely to rangelands. We tested the sensitivity of IIRH to impacts of roads, trails, and pipelines on adjacent lands by surveying plots at three distances from these linear disturbances. We performed tests at 16 randomly selected sites in each of three ecosystems (Northern High Plains, Colorado Plateau, and Chihuahuan Desert) for a total of 208 evaluation plots. We also evaluated the repeatability of IIRH when applied to road-related disturbance gradients. Finally, we tested extent of correlations between IIRH plot attribute departure classes and trends in a suite of quantitative indicators. Results indicated that the IIRH technique is sensitive to direct and indirect impacts of transportation activities with greater departure from reference condition near disturbances than far from disturbances. Trends in degradation of ecological processes detected with qualitative assessments were highly correlated with quantitative data. Qualitative and quantitative assessments employed in this study can be used to assess impacts of transportation features at the plot scale. Through integration with remote

  3. The development of on-farm welfare assessment protocols for foxes and mink: the WelFur project

    DEFF Research Database (Denmark)

    Mononen, J; Møller, Steen Henrik; Hansen, Steffen W;

    2012-01-01

    The WelFur project aims at the development of on-farm welfare assessment protocols for farmed foxes (the blue fox [Vulpes lagopus], the silver fox [Vulpes vulpes]) and mink (Neovison vison). The WelFur protocols are based on Welfare Quality® (WQ) principles and criteria. Here, we describe the Wel......Fur protocols after two years of developmental work. Reviews for each of the 12 WQ welfare criteria were written for foxes and mink to identify the welfare measures that have been used in scientific studies. The reviews formed the basis for potential measures to be included in the WelFur protocols. All measures...... which the welfare of animals on European fur farms can be assessed....

  4. Kinect One-based biomechanical assessment of upper-limb performance compared to clinical scales in post-stroke patients.

    Science.gov (United States)

    Scano, Alessandro; Caimmi, Marco; Chiavenna, Andrea; Malosio, Matteo; Tosatti, Lorenzo Molinari

    2015-08-01

    This paper presents a Kinect One sensor-based protocol for the evaluation of the motor-performances of the upper limb of neurological patients during rehabilitative sessions. The assessment provides evaluations of kinematic, dynamic, motor and postural control variables. A pilot study was conducted on three post-stroke neurological patients, comparing Kinect-One biomechanical assessment with the outcomes of some of the most common clinical scales for the evaluation of the upper-limb functionality. Preliminary results indicate coherency between the clinical and instrumental evaluation. Moreover, the Kinect-One assessment seems to provide some complementary quantitative information, consistently integrating the clinical assessment.

  5. A Video Recording and Viewing Protocol for Student Group Presentations: Assisting Self-Assessment through a Wiki Environment

    Science.gov (United States)

    Barry, Shane

    2012-01-01

    The purpose of this research was to firstly develop a protocol for video recording student group oral presentations, for later viewing and self-assessment by student group members. Secondly, evaluations of students' experiences of this process were undertaken to determine if this self-assessment method was a positive experience for them in gaining…

  6. MENTAL AND PSYCHOMOTOR RETARDATION IN EARLY CHILDHOOD: Overview and development of a protocol for neuropsychological assessment.

    Directory of Open Access Journals (Sweden)

    María del Mar Sánchez-Joya

    2010-12-01

    Full Text Available Introduction: The last decades have brought great advances in the understanding of child neurodevelopment and knowledge of cognitive processes that occur in the brain from an early age. As a result and thanks to the large number of standardized and scientifically guaranteed neuropsychological tests that are available today, we can assess and diagnose with high specificity, deficits or delays in the acquisition of cognitive functions. Besides, it allows knowing the strengths or normality points of children with various pathologies. Objective: To present the concepts and a neuropsychological assessment protocol for mental retardation, pervasive developmental disorder and psychomotor retardation. Development: First, the authors present a general model of neuropsychological assessment in childhood. Second, he concept, classification and aetiology of mental retardation is revised and it is proposed a neuropsychological profile. Finally, the paradigms of pervasive developmental disorder and psychomotor retardation are shown. Conclusion: Based on standardized and validated test for child neuropsychological assessment, children cognitive disorders can be accurately identified to plan each child's cognitive stimulation, and thus optimize the results of the therapy.

  7. A real-time, quantitative PCR protocol for assessing the relative parasitemia of Leucocytozoon in waterfowl

    Science.gov (United States)

    Smith, Matthew M.; Schmutz, Joel A.; Apelgren, Chloe; Ramey, Andy M.

    2015-01-01

    Microscopic examination of blood smears can be effective at diagnosing and quantifying hematozoa infections. However, this method requires highly trained observers, is time consuming, and may be inaccurate for detection of infections at low levels of parasitemia. To develop a molecular methodology for identifying and quantifying Leucocytozoon parasite infection in wild waterfowl (Anseriformes), we designed a real-time, quantitative PCR protocol to amplify Leucocytozoon mitochondrial DNA using TaqMan fluorogenic probes and validated our methodology using blood samples collected from waterfowl in interior Alaska during late summer and autumn (n = 105). By comparing our qPCR results to those derived from a widely used nested PCR protocol, we determined that our assay showed high levels of sensitivity (91%) and specificity (100%) in detecting Leucocytozoon DNA from host blood samples. Additionally, results of a linear regression revealed significant correlation between the raw measure of parasitemia produced by our qPCR assay (Ct values) and numbers of parasites observed on blood smears (R2 = 0.694, P = 0.003), indicating that our assay can reliably determine the relative parasitemia levels among samples. This methodology provides a powerful new tool for studies assessing effects of haemosporidian infection in wild avian species.

  8. Children with intellectual disabilities and pain perception: a review and suggestions for future assessment protocols

    NARCIS (Netherlands)

    van Dijk, M.; Valkenburg, A.; Boerlage, A.A.; Tibboel, D.; Veerkamp, J.S.

    2009-01-01

    AIM: This was to review what is known about pain assessment in children with intellectual disabilities and to translate findings into clinical dental practice. Methods: Literature review. Review: The association between anxiety and pain as reported in the literature was explored. The specific pain e

  9. Parents as Agents of Change (PAC in pediatric weight management: The protocol for the PAC randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Ball Geoff D C

    2012-08-01

    Full Text Available Abstract Background There is an urgent need to develop and evaluate weight management interventions to address childhood obesity. Recent research suggests that interventions designed for parents exclusively, which have been named parents as agents of change (PAC approaches, have yielded positive outcomes for managing pediatric obesity. To date, no research has combined a PAC intervention approach with cognitive behavioural therapy (CBT to examine whether these combined elements enhance intervention effectiveness. This paper describes the protocol our team is using to examine two PAC-based interventions for pediatric weight management. We hypothesize that children with obesity whose parents complete a CBT-based PAC intervention will achieve greater reductions in adiposity and improvements in cardiometabolic risk factors, lifestyle behaviours, and psychosocial outcomes than children whose parents complete a psycho-education-based PAC intervention (PEP. Methods/Design This study is a pragmatic, two-armed, parallel, single-blinded, superiority, randomized clinical trial. The primary objective is to examine the differential effects of a CBT-based PAC vs PEP-based PAC intervention on children’s BMI z-score (primary outcome. Secondary objectives are to assess intervention-mediated changes in cardiometabolic, lifestyle, and psychosocial variables in children and parents. Both interventions are similar in frequency of contact, session duration, group facilitation, lifestyle behaviour goals, and educational content. However, the interventions differ insofar as the CBT-based intervention incorporates theory-based concepts to help parents link their thoughts, feelings, and behaviours; these cognitive activities are enabled by group leaders who possess formal training in CBT. Mothers and fathers of children (8–12 years of age; BMI ≥85th percentile are eligible to participate if they are proficient in English (written and spoken and agree for at least

  10. Clinical assessment of bone mass in children

    Directory of Open Access Journals (Sweden)

    L A Sheplyagina

    2005-01-01

    Full Text Available Objective. To give clinical assessment of bone mass main indices in healthy children living in Moscow and Moscow region. Material and methods. 357 healthy children aged 5-16 years (194 male, 163 female were included. Physical development, bone mineral density (BMD by 2-power radiological absorptiometry, bone mineral content (BMC were evaluated. Results. Significant variability of height in children age groups was revealed. 40,2% had disharmonious physical development. BMC and BMD were closely associated with height (r=0,8, p=0,0001 and body mass (r=0,7, p=0,0001. Bone mass indices were proved to be significantly less in children with height and body mass less then 10% percentile. BMD growth rate was less than mineral accumulation rate. Method of body mass clinical assessment in children was elaborated. Conclusion. Application of elaborated tables of conjugated values of anthropometric and densitometric indices allows to decrease of osteopenia overdiagnosis in children and determine causes of insufficient bone mineral content.

  11. Revised Recommendations of the Consortium of MS Centers Task Force for a Standardized MRI Protocol and Clinical Guidelines for the Diagnosis and Follow-Up of Multiple Sclerosis

    Science.gov (United States)

    Traboulsee, A.; Simon, J.H.; Stone, L.; Fisher, E.; Jones, D.E.; Malhotra, A.; Newsome, S.D.; Oh, J.; Reich, D.S.; Richert, N.; Rammohan, K.; Khan, O.; Radue, E.-W.; Ford, C.; Halper, J.; Li, D.

    2016-01-01

    SUMMARY An international group of neurologists and radiologists developed revised guidelines for standardized brain and spinal cord MR imaging for the diagnosis and follow-up of MS. A brain MR imaging with gadolinium is recommended for the diagnosis of MS. A spinal cord MR imaging is recommended if the brain MR imaging is nondiagnostic or if the presenting symptoms are at the level of the spinal cord. A follow-up brain MR imaging with gadolinium is recommended to demonstrate dissemination in time and ongoing clinically silent disease activity while on treatment, to evaluate unexpected clinical worsening, to re-assess the original diagnosis, and as a new baseline before starting or modifying therapy. A routine brain MR imaging should be considered every 6 months to 2 years for all patients with relapsing MS. The brain MR imaging protocol includes 3D T1-weighted, 3D T2-FLAIR, 3D T2-weighted, post-single-dose gadolinium-enhanced T1-weighted sequences, and a DWI sequence. The progressive multifocal leukoencephalopathy surveillance protocol includes FLAIR and DWI sequences only. The spinal cord MR imaging protocol includes sagittal T1-weighted and proton attenuation, STIR or phase-sensitive inversion recovery, axial T2- or T2*-weighted imaging through suspicious lesions, and, in some cases, postcontrast gadolinium-enhanced T1-weighted imaging. The clinical question being addressed should be provided in the requisition for the MR imaging. The radiology report should be descriptive, with results referenced to previous studies. MR imaging studies should be permanently retained and available. The current revision incorporates new clinical information and imaging techniques that have become more available. PMID:26564433

  12. Quantitative assessment of in-solution digestion efficiency identifies optimal protocols for unbiased protein analysis

    DEFF Research Database (Denmark)

    Leon, Ileana R; Schwämmle, Veit; Jensen, Ole N;

    2013-01-01

    a combination of qualitative and quantitative LC-MS/MS methods and statistical data analysis. In contrast to previous studies we employed both standard qualitative as well as data-independent quantitative workflows to systematically assess trypsin digestion efficiency and bias using mitochondrial protein...... conditions (buffer, RapiGest, deoxycholate, urea), and two methods for removal of detergents prior to analysis of peptides (acid precipitation or phase separation with ethyl acetate). Our data-independent quantitative LC-MS/MS workflow quantified over 3700 distinct peptides with 96% completeness between all...... protocols and replicates, with an average 40% protein sequence coverage and an average of 11 peptides identified per protein. Systematic quantitative and statistical analysis of physicochemical parameters demonstrated that deoxycholate-assisted in-solution digestion combined with phase transfer allows...

  13. Human Y chromosome microdeletion analysis by PCR multiplex protocols identifying only clinically relevant AZF microdeletions.

    Science.gov (United States)

    Vogt, Peter H; Bender, Ulrike

    2013-01-01

    PCR multiplex assays are the method of choice for quickly revealing genomic microdeletions in the large repetitive genomic sequence blocks on the long arm of the human Y chromosome. They harbor the Azoospermia Factor (AZF) genes, which cause male infertility when functionally disrupted. These protein encoding Y genes are expressed exclusively or predominantly during male germ cell development, i.e., at different phases of human spermatogenesis. They are located in three distinct genomic sequence regions designated AZFa, AZFb, and AZFc, respectively. Complete deletion of an AZF region, also called "classical" AZF microdeletion, is always associated with male infertility and a distinct testicular pathology. Partial AZF deletions including single AZF Y genes can cause the same testicular pathology as the corresponding complete deletion (e.g., DDX3Y gene deletions in AZFa), or might not be associated with male infertility at all (e.g., some BPY2, CDY1, DAZ gene deletions in AZFc). We therefore propose that a PCR multiplex assay aimed to reduce only those AZF microdeletions causing a specific testicular pathology-thus relevant for clinical applications. It only includes Sequence Tagged Site (STS) deletion markers inside the exon structures of the Y genes known to be expressed in male germ cells and located in the three AZF regions. They were integrated in a robust standard protocol for four PCR multiplex mixtures which also include the basic principles of quality control according to the strict guidelines of the European Molecular Genetics Quality Network (EMQN: http://www.emqn.org). In case all Y genes of one AZF region are deleted the molecular extension of this AZF microdeletion is diagnosed to be yes or no comparable to that of the "classical" AZF microdeletion by an additional PCR multiplex assay analyzing the putative AZF breakpoint borderlines.

  14. Group differences in physician responses to handheld presentation of clinical evidence: a verbal protocol analysis

    Directory of Open Access Journals (Sweden)

    Pavlovic Nada J

    2007-07-01

    Full Text Available Abstract Background To identify individual differences in physicians' needs for the presentation of evidence resources and preferences for mobile devices. Methods Within-groups analysis of responses to semi-structured interviews. Interviews consisted of using prototypes in response to task-based scenarios. The prototypes were implemented on two different form factors: a tablet style PC and a pocketPC. Participants were from three user groups: general internists, family physicians and medicine residents, and from two different settings: urban and semi-urban. Verbal protocol analysis, which consists of coding utterances, was conducted on the transcripts of the testing sessions. Statistical relationships were investigated between staff physicians' and residents' background variables, self-reported experiences with the interfaces, and verbal code frequencies. Results 47 physicians were recruited from general internal medicine, family practice clinics and a residency training program. The mean age of participants was 42.6 years. Physician specialty had a greater effect on device and information-presentation preferences than gender, age, setting or previous technical experience. Family physicians preferred the screen size of the tablet computer and were less concerned about its portability. Residents liked the screen size of the tablet, but preferred the portability of the pocketPC. Internists liked the portability of the pocketPC, but saw less advantage to the large screen of the tablet computer (F[2,44] = 4.94, p = .012. Conclusion Different types of physicians have different needs and preferences for evidence-based resources and handheld devices. This study shows how user testing can be incorporated into the process of design to inform group-based customization.

  15. EXACKTE2: Exploiting the clinical consultation as a knowledge transfer and exchange environment: a study protocol

    Directory of Open Access Journals (Sweden)

    Ouimet Mathieu

    2009-03-01

    Full Text Available Abstract Background While the evidence suggests that the way physicians provide information to patients is crucial in helping patients decide upon a course of action, the field of knowledge translation and exchange (KTE is silent about how the physician and the patient influence each other during clinical interactions and decision-making. Consequently, based on a novel relationship-centered model, EXACKTE2 (EXploiting the clinicAl Consultation as a Knowledge Transfer and Exchange Environment, this study proposes to assess how patients and physicians influence each other in consultations. Methods We will employ a cross-sectional study design involving 300 pairs of patients and family physicians from two primary care practice-based research networks. The consultation between patient and physician will be audio-taped and transcribed. Following the consultation, patients and physicians will complete a set of questionnaires based on the EXACKTE2 model. All questionnaires will be similar for patients and physicians. These questionnaires will assess the key concepts of our proposed model based on the essential elements of shared decision-making (SDM: definition and explanation of problem; presentation of options; discussion of pros and cons; clarification of patient values and preferences; discussion of patient ability and self-efficacy; presentation of doctor knowledge and recommendation; and checking and clarifying understanding. Patients will be contacted by phone two weeks later and asked to complete questionnaires on decisional regret and quality of life. The analysis will be conducted to compare the key concepts in the EXACKTE2 model between patients and physicians. It will also allow the assessment of how patients and physicians influence each other in consultations. Discussion Our proposed model, EXACKTE2, is aimed at advancing the science of KTE based on a relationship process when decision-making has to take place. It fosters a new KTE

  16. Data for improvement and clinical excellence: protocol for an audit with feedback intervention in home care and supportive living

    Directory of Open Access Journals (Sweden)

    Fraser Kimberly D

    2012-01-01

    Full Text Available Abstract Background Although considerable evidence exists about the effectiveness of audit coupled with feedback, very few audit-with-feedback interventions have been done in either home care or supportive living settings to date. With little history of audit and feedback in home care or supportive living there is potential for greater effects, at least initially. This study extends the work of an earlier study designed to assess the effects of an audit-with-feedback intervention. It will be delivered quarterly over a one-year period in seven home care offices and 11 supportive living sites. The research questions are the same as in the first study but in a different environment. They are as follows: 1. What effects do feedback reports have on processes and outcomes over time? 2. How do different provider groups in home care and supportive living sites respond to feedback reports based on quality indicator data? Methods The research team conducting this study includes researchers and decision makers in continuing care in the province of Alberta, Canada. The intervention consists of quarterly feedback reports in 19 home care offices and supportive living sites across Alberta. Data for the feedback reports are based on the Resident Assessment Instrument Home Care tool, a standardized instrument mandated for use in home care and supportive living environments throughout Alberta. The feedback reports consist of one page, printed front and back, presenting both graphic and textual information. Reports are delivered to all employees working in each site. The primary evaluation uses a controlled interrupted time-series design, both adjusted and unadjusted for covariates. The concurrent process evaluation includes observation, focus groups, and self-reports to assess uptake of the feedback reports. The project described in this protocol follows a similar intervention conducted in our previous study, Data for Improvement and Clinical Excellence

  17. PROFILE: Environmental Impact Assessment Under the National Environmental Policy Act and the Protocol on Environmental Protection to the Antarctic Treaty.

    Science.gov (United States)

    Ensminger; McCold; Webb

    1999-07-01

    / Antarctica has been set aside by the international community for protection as a natural reserve and a place for scientific research. Through the Antarctic Treaty of 1961, the signing nations agreed to cooperate in protecting the antarctic environment, in conducting scientific studies, and in abstaining from the exercise of territorial claims. The 1991 signing of the Protocol on Environmental Protection to the Antarctic Treaty (Protocol) by representatives of the 26 nations comprising the Antarctic Treaty Consultative Parties (Parties) significantly strengthened environmental protection measures for the continent. The Protocol required ratification by each of the governments individually prior to official implementation. The US government ratified the Protocol by passage of the Antarctic Science, Tourism, and Conservation Act of 1997. Japan completed the process by ratifying the Protocol on December 15, 1997. US government actions undertaken in Antarctica are subject to the requirements of both the Protocol and the US National Environmental Policy Act (NEPA). There are differences in the scope and intent of the Protocol and NEPA; however, both require environmental impact assessment (EIA) as part of the planning process for proposed actions that have the potential for environmental impacts. In this paper we describe the two instruments and highlight key similarities and differences with particular attention to EIA. Through this comparison of the EIA requirements of NEPA and the Protocol, we show how the requirements of each can be used in concert to provide enhanced environmental protection for the antarctic environment. NEPA applies only to actions of the US government; therefore, because NEPA includes certain desirable attributes that have been refined and clarified through numerous court cases, and because the Protocol is just entering implementation internationally, some recommendations are made for strengthening the procedural requirements of the Protocol

  18. Development of a Standard Protocol for the Harmonic Analysis of Radial Pulse Wave and Assessing Its Reliability in Healthy Humans

    OpenAIRE

    ,

    2015-01-01

    This study was aimed to establish a standard protocol and to quantitatively assess the reliability of harmonic analysis of the radial pulse wave measured by a harmonic wave analyzer (TD01C system). Both intraobserver and interobserver assessments were conducted to investigate whether the values of harmonics are stable in successive measurements. An intraclass correlation coefficient (ICC) and a Bland–Altman plot were used for this purpose. For the reliability assessments of the intraobserver ...

  19. Development of a standardized protocol for reproducible generation of matured monocyte-derived dendritic cells suitable for clinical application

    OpenAIRE

    Bohnenkamp, H.R.; Noll, T.

    2003-01-01

    There is increasing interest in the generation of dendritic cells (DC) for cancer immunotherapy. In order to utilize DC in clinical trials it is necessary to have standardized, reproducible and easy to use protocols. We describe here the process development for the generation of DC as the result of investigation of culture conditions as well as consumption rates of medium and cytokines. Our studies demonstrate that highly viable DC (93 ± 2%) can be produced from CD14+ enriched monocytes via i...

  20. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    to subjects treated in the control group. Outcomes The primary outcome is the Alzheimer’s Disease Cooperative Studies Group Activities of Daily Living Scale; secondary outcome measures are two performance-based measures including the Short Physical Performance Battery and Short Portable Sarcopenia Measure. Outcome assessments for both the caregiver-reported scale and subjects’ physical performance scales are completed in the subject’s home. Randomization Eligible patient-care giver dyads will be stratified by clinic type and block randomized with a computer developed randomization scheme using a 1:1 allocation ratio. Blinding Single blinded. Research assistants completing the outcome assessments were blinded to the subjects’ treatment group. Trial status Ongoing ClinicalTrial.Gov identifier NCT01314950; date of completed registration 10 March 2011; date first patient randomized 9 March 2011

  1. The clubfoot assessment protocol (CAP; description and reliability of a structured multi-level instrument for follow-up

    Directory of Open Access Journals (Sweden)

    Jarnlo Gun-Britt

    2005-07-01

    Full Text Available Abstract Background In most clubfoot studies, the outcome instruments used are designed to evaluate classification or long-term cross-sectional results. Variables deal mainly with factors on body function/structure level. Wide scorings intervals and total sum scores increase the risk that important changes and information are not detected. Studies of the reliability, validity and responsiveness of these instruments are sparse. The lack of an instrument for longitudinal follow-up led the investigators to develop the Clubfoot Assessment Protocol (CAP. The aim of this article is to introduce and describe the CAP and evaluate the items inter- and intra reliability in relation to patient age. Methods The CAP was created from 22 items divided between body function/structure (three subgroups and activity (one subgroup levels according to the International Classification of Function, Disability and Health (ICF. The focus is on item and subgroup development. Two experienced examiners assessed 69 clubfeet in 48 children who had a median age of 2.1 years (range, 0 to 6.7 years. Both treated and untreated feet with different grades of severity were included. Three age groups were constructed for studying the influence of age on reliability. The intra- rater study included 32 feet in 20 children who had a median age of 2.5 years (range, 4 months to 6.8 years. The Unweighted Kappa statistics, percentage observer agreement, and amount of categories defined how reliability was to be interpreted. Results The inter-rater reliability was assessed as moderate to good for all but one item. Eighteen items had kappa values > 0.40. Three items varied from 0.35 to 0.38. The mean percentage observed agreement was 82% (range, 62 to 95%. Different age groups showed sufficient agreement. Intra- rater; all items had kappa values > 0.40 [range, 0.54 to 1.00] and a mean percentage agreement of 89.5%. Categories varied from 3 to 5. Conclusion The CAP contains more detailed

  2. Effectiveness of individualized physiotherapy on pain and functioning compared to a standard exercise protocol in patients presenting with clinical signs of subacromial impingement syndrome. A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    de Bie Rob A

    2010-06-01

    Full Text Available Abstract Background Shoulder impingement syndrome is a common musculoskeletal complaint leading to significant reduction of health and disability. Physiotherapy is often the first choice of treatment although its effectiveness is still under debate. Systematic reviews in this field highlight the need for more high quality trials to investigate the effectiveness of physiotherapy interventions in patients with subacromial impingement syndrome. Methods/Design This randomized controlled trial will investigate the effectiveness of individualized physiotherapy in patients presenting with clinical signs and symptoms of subacromial impingement, involving 90 participants aged 18-75. Participants are recruited from outpatient physiotherapy clinics, general practitioners, and orthopaedic surgeons in Germany. Eligible participants will be randomly allocated to either individualized physiotherapy or to a standard exercise protocol using central randomization. The control group will perform the standard exercise protocol aiming to restore muscular deficits in strength, mobility, and coordination of the rotator cuff and the shoulder girdle muscles to unload the subacromial space during active movements. Participants of the intervention group will perform the standard exercise protocol as a home program, and will additionally be treated with individualized physiotherapy based on clinical examination results, and guided by a decision tree. After the intervention phase both groups will continue their home program for another 7 weeks. Outcome will be measured at 5 weeks and at 3 and 12 months after inclusion using the shoulder pain and disability index and patients' global impression of change, the generic patient-specific scale, the average weekly pain score, and patient satisfaction with treatment. Additionally, the fear avoidance beliefs questionnaire, the pain catastrophizing scale, and patients' expectancies of treatment effect are assessed. Participants

  3. Adapting a rapid river assessment protocols to be used by elementary school children

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    Guilherme Malafaia

    2012-12-01

    Full Text Available The present study aimed to adapt a rapid river assessment protocols (RAP to be used by elementary school children. The study was conducted in Ipameri, GO and the RAP was adapted for the evaluation of streams in the Cerrado biome. Based on two protocol models, the developed RAP included: physical parameters that affect the functioning of streams, language adapted to the educational level of elementary school and the presence of drawings that could facilitate the field application of RAP by the students. For consolidation of the adapted instrument, it was offered a monitoring workshop to 95 students from two public education institutions, and developed an analysis and interpretation of the pattern of responses obtained during the practical step of the workshop. The Bartlett and Levene tests revealed no statistical differences between the response patterns of the students, allowing to infer that the developed RAP was understandable by the evaluators. The application of the RAP was fast (20 to 40 minutes and the students reported that the developed instrument helped them to familiarize with environmental issues. In addition, the monitoring workshop helped them to understand the instrument and the available illustrations facilitated the field evaluation. In addition, the students concluded that they have become aware of the issues related to the water resource preservation and also that participation in the environmental monitoring workshop allowed the appropriation of knowledge about the river system functioning. It was concluded that adapted RAP has been proved to be a useful and interesting tool for using in environmental education projects and programs.

  4. The recent findings of the "Scientific Assessment of Ozone Depletion: 2010" and the World Avoided by the Montreal Protocol

    Science.gov (United States)

    Newman, P. A.; Scientific Assessment Panel to the Montreal Protocol

    2011-12-01

    The ozone layer is the Earth's natural sunscreen, blocking harmful solar ultraviolet radiation. In 1974, Mario Molina and F. Sherwood Rowland proposed that the ozone layer could be depleted by chlorine released from human-produced chlorofluorocarbons (CFCs). Follow-up science investigations supported this hypothesis, leading to the landmark 1987 Montreal Protocol on Substances That Deplete the Ozone Layer (a protocol to the Vienna Convention for the Protection of the Ozone Layer). One of the Montreal Protocol provisions is that science assessments on ozone depletion be written and submitted to the signatory Parties every 4 years. In this talk, I will primarily focus on the science findings from the recently published "Scientific Assessment of Ozone Depletion: 2010". This assessment is written and reviewed (multiple times) by the international science community. The 2010 assessment is the latest in a long series of reports that provide the science foundation for the Montreal Protocol. This assessment demonstrates that the Montreal Protocol is working, and that there are early signs that ozone is beginning to respond to decreasing CFC levels. There are now state-of-the-art simulations that show that the ozone layer would have been largely destroyed if CFCs had not been regulated, and therefore extreme levels of UV radiation have been avoided. The 2010 assessment also spotlights new insights into the impact of ozone depletion on surface climate, and climate impacts on ozone. However, the assessment also reveals that greenhouse gases are modifying the stratosphere and that the ozone layer will evolve into a different state than its pre-industrial values - you can't go home again.

  5. Perfusion computed tomography in colorectal cancer: Protocols, clinical applications and emerging trends

    Institute of Scientific and Technical Information of China (English)

    Guang-Yao Wu; Prasanna Ghimire

    2009-01-01

    Perfusion computed tomography (CT) has emerged as a novel functional imaging technique with gradually increasing importance in the management of colorectal cancer (CRC). By providing the functional tumor microvasculature, it also helps the assessment of therapeutic response of anti-angiogenic drugs as it may reflect tumor angiogenesis. Perfusion CT has been applied in clinical practice to delineate inflammatory or neoplastic lymph nodes irrespective of their size,identify micro-metastases and to predict metastases in advance of their development. It is of increasing significance for preoperative adjuvant therapies and avoidance of unnecessary interventions. Despite controversies regarding the techniques employed, its validity and reproducibility, it can be advantageous in the management of CRCs in which the prognosis is dependent on preoperative staging. With recent advances in the perfusion CT techniques, and incorporation to other modalities like positron emission tomography, perfusion CT will be a novel tool in the overall management of CRCs. This article aims at reviewing the existing clinical applications and recent advances of perfusion CT with a reference to future development in the management of CRCs.

  6. Theoretical foundations of personality assessment in clinical psychology

    Directory of Open Access Journals (Sweden)

    Emil Benedik

    2010-07-01

    Full Text Available The paper emphasizes an important role of personality assessment in clinical psychology, leading theoretical and methodological perspectives, as well as the need for integrating different concepts and methods in personality assessment. Personality assessment in clinical psychology represents methodological frame for better understanding and treatment of psychological (mental disorders. Two principles for personality assessment prevail: one is based on psychological concepts of personality and statistical methodology, and the other relies on findings from clinical practice (clinical psychology, psychiatry and related fields. Since we do not yet have a generally accepted paradigm of personality assessment, clinical psychology needs unified concepts and methodology for personality assessment. Several authors have attempted to integrate and unify psychological concepts and methodology of assessment in the last decade. This is the path to development of clinical psychology and psychological science in general.

  7. Differences in quantitative assessment of myocardial scar and gray zone by LGE-CMR imaging using established gray zone protocols.

    Science.gov (United States)

    Mesubi, Olurotimi; Ego-Osuala, Kelechi; Jeudy, Jean; Purtilo, James; Synowski, Stephen; Abutaleb, Ameer; Niekoop, Michelle; Abdulghani, Mohammed; Asoglu, Ramazan; See, Vincent; Saliaris, Anastasios; Shorofsky, Stephen; Dickfeld, Timm

    2015-02-01

    Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) imaging is the gold standard for myocardial scar evaluation. Heterogeneous areas of scar ('gray zone'), may serve as arrhythmogenic substrate. Various gray zone protocols have been correlated to clinical outcomes and ventricular tachycardia channels. This study assessed the quantitative differences in gray zone and scar core sizes as defined by previously validated signal intensity (SI) threshold algorithms. High quality LGE-CMR images performed in 41 cardiomyopathy patients [ischemic (33) or non-ischemic (8)] were analyzed using previously validated SI threshold methods [Full Width at Half Maximum (FWHM), n-standard deviation (NSD) and modified-FWHM]. Myocardial scar was defined as scar core and gray zone using SI thresholds based on these methods. Scar core, gray zone and total scar sizes were then computed and compared among these models. The median gray zone mass was 2-3 times larger with FWHM (15 g, IQR: 8-26 g) compared to NSD or modified-FWHM (5 g, IQR: 3-9 g; and 8 g. IQR: 6-12 g respectively, p scar that was gray zone) also varied significantly among the three methods, 51 % (IQR: 42-61 %), 17 % (IQR: 11-21 %) versus 38 % (IQR: 33-43 %) for FWHM, NSD and modified-FWHM respectively (p scar core. Infarct core and total myocardial scar mass also differ using these methods. Further evaluation of the most accurate quantification method is needed.

  8. A Framework for Group Key Management Protocol Assessment Independent of View Synchrony

    Directory of Open Access Journals (Sweden)

    David Manz

    2010-01-01

    Full Text Available Problem statement: As group key management extended into the area of large dynamic networks, complex issues emerged involving the many operations that run over several network topologies. The issues that occurred due to multiple topologies were also compounded by differing views of the network, taken at different time slices or positions within the network. This was especially complex when figuring in mobile, ad-hoc networks. View synchrony is the current operational technique, or assumption, applied to group key exchange protocols. However, before this analysis view synchrony was just that, an assumption and the literature for group key exchange lacked an inquiry into what could happen when view synchrony was removed. Current group key management protocols rely on view synchrony and yet all protocols vary in requisite operational descriptions and performance measures. In this study, a framework for group key management protocol operations and performance measures was defined and examined how that framework could be used to compare and contrast existing protocols with and, more importantly, without view synchrony. Approach: Current literature lacked categories by which to quantify the performance metric of the protocols. This study first defined the dynamic key operations that all protocols share. By these definitions, group key management protocols were directly compared. Once definitions existed, this study assembled a list of costs that every protocol requires to establish and share keys across the dynamic group. These results provided an understanding of view synchrony's role and whether or not it should be solely relied on in these current protocols. Results: The prior conclusion that view synchrony was an integral part of all group key management protocols was shattered, when seen through the lens of communication costs and assumptions in wireless ad-hoc networks. View synchrony, as an assumed part of all group key management was

  9. Clinical application of Assessment of Parenting Competencies (APC)

    DEFF Research Database (Denmark)

    Jacobsen, Stine Lindahl

    (numbers, graphs, and descriptions) of parent-child interaction and parenting competencies including nonverbal communication, level of attunement in the dyad, and level of emotional support from the parent. It is based on video analysis and a fixed assessment protocol. It was developed through a completed...

  10. Testing the WelFur assessment protocol for mink on-farm in three seasons of production

    DEFF Research Database (Denmark)

    Møller, Steen Henrik; Hansen, Steffen W

    2011-01-01

    Welfare Quality® seems to develop into a standard for farm animal welfare assessment and European Fur Breeders’ Association initiated the “WelFur” project in 2009 in order to develop a welfare assessment protocol for mink and fox farms after the WQ standards. The assessment is based on four...... principles and 12 underlying criteria, to be measured at the farm. Based on validity, reliability and feasibility 22 measures have been selected for use in the three seasons of mink production: 1. Breeders during winter, 2. Dams with kits during spring, and 3. Juveniles during growth in the autumn, in order...... to cover the life cycle of the mink. The final welfare assessment is categorised as: ’Excellent’, ’Above average’, ’Acceptable’ or ’Not classified’ according to the welfare score for each of the four principles. The protocols for the three seasons are being tested in several countries and the Danish...

  11. Protocol for Bone Augmentation with Simultaneous Early Implant Placement: A Retrospective Multicenter Clinical Study

    Directory of Open Access Journals (Sweden)

    Peter Fairbairn

    2015-01-01

    Full Text Available Purpose. To present a novel protocol for alveolar bone regeneration in parallel to early implant placement. Methods. 497 patients in need of extraction and early implant placement with simultaneous bone augmentation were treated in a period of 10 years. In all patients the same specific method was followed and grafting was performed utilizing in situ hardening fully resorbable alloplastic grafting materials consisting of β-tricalcium phosphate and calcium sulfate. The protocol involved atraumatic extraction, implant placement after 4 weeks with simultaneous bone augmentation, and loading of the implant 12 weeks after placement and grafting. Follow-up periods ranged from 6 months to 10 years (mean of 4 years. Results. A total of 601 postextraction sites were rehabilitated in 497 patients utilizing the novel protocol. Three implants failed before loading and three implants failed one year after loading, leaving an overall survival rate of 99.0%. Conclusions. This standardized protocol allows successful long-term functional results regarding alveolar bone regeneration and implant rehabilitation. The concept of placing the implant 4 weeks after extraction, augmenting the bone around the implant utilizing fully resorbable, biomechanically stable, alloplastic materials, and loading the implant at 12 weeks seems to offer advantages when compared with traditional treatment modalities.

  12. Simplified protocol for clinical-grade tumor-infiltrating lymphocyte manufacturing with use of the Wave bioreactor

    DEFF Research Database (Denmark)

    Donia, Marco; Larsen, Signe Møllebæk; Met, Ozcan

    2014-01-01

    BACKGROUND AIMS: The high level of complexity of current Good Manufacturing Practice-compliant methods of manufacturing hampers rapid and broad application of treatment with tumor-infiltrating lymphocytes (TILs). METHODS: To ensure higher applicability of TIL production to laboratory routine......, a practical and simple protocol of TIL manufacturing with the use of a closed-system bioreactor was developed and implemented at our institution. RESULTS: This protocol enabled significant work load reduction during the most labor-intense step of TIL expansion, and allowed generation of high-quality TIL...... products, which mediated clinical regression in patients with metastatic melanoma. CONCLUSIONS: Implementation of simplified methods of TIL expansion will speed up dissemination of TIL methods worldwide and will increase patient access to this highly effective treatment....

  13. Falls and mobility in Parkinson's disease: protocol for a randomised controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Murphy Anna T

    2011-07-01

    Full Text Available Abstract Background Although physical therapy and falls prevention education are argued to reduce falls and disability in people with idiopathic Parkinson's disease, this has not yet been confirmed with a large scale randomised controlled clinical trial. The study will investigate the effects on falls, mobility and quality of life of (i movement strategy training combined with falls prevention education, (ii progressive resistance strength training combined with falls prevention education, (iii a generic life-skills social program (control group. Methods/Design People with idiopathic Parkinson's disease who live at home will be recruited and randomly allocated to one of three groups. Each person shall receive therapy in an out-patient setting in groups of 3-4. Each group shall be scheduled to meet once per week for 2 hours for 8 consecutive weeks. All participants will also have a structured 2 hour home practice program for each week during the 8 week intervention phase. Assessments will occur before therapy, after the 8 week therapy program, and at 3 and 12 months after the intervention. A falls calendar will be kept by each participant for 12 months after outpatient therapy. Consistent with the recommendations of the Prevention of Falls Network Europe group, three falls variables will be used as the primary outcome measures: the number of fallers, the number of multiple fallers and the falls rate. In addition to quantifying falls, we shall measure mobility, activity limitations and quality of life as secondary outcomes. Discussion This study has the potential to determine whether outpatient movement strategy training combined with falls prevention education or progressive resistance strength training combined with falls prevention education are effective for reducing falls and improving mobility and life quality in people with Parkinson's disease who live at home. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR

  14. Glenoid version by CT scan: an analysis of clinical measurement error and introduction of a protocol to reduce variability

    Energy Technology Data Exchange (ETDEWEB)

    Bunt, Fabian van de [VU University Medical Center, Amsterdam (Netherlands); Pearl, Michael L.; Lee, Eric K.; Peng, Lauren; Didomenico, Paul [Kaiser Permanente, Los Angeles, CA (United States)

    2015-11-15

    Recent studies have challenged the accuracy of conventional measurements of glenoid version. Variability in the orientation of the scapula from individual anatomical differences and patient positioning, combined with differences in observer measurement practices, have been identified as sources of variability. The purpose of this study was to explore the utility and reliability of clinically available software that allows manipulation of three-dimensional images in order to bridge the variance between clinical and anatomic version in a clinical setting. Twenty CT scans of normal glenoids of patients who had proximal humerus fractures were measured for version. Four reviewers first measured version in a conventional manner (clinical version), measurements were made again (anatomic version) after employing a protocol for reformatting the CT data to align the coronal and sagittal planes with the superior-inferior axis of the glenoid, and the scapular body, respectively. The average value of clinical retroversion for all reviewers and all subjects was -1.4 (range, -16 to 21 ), as compared to -3.2 (range, -21 to 6 ) when measured from reformatted images. The mean difference between anatomical and clinical version was 1.9 ± 5.6 but ranged on individual measurements from -13 to 26 . In no instance did all four observers choose the same image slice from the sequence of images. This study confirmed the variation in glenoid version dependent on scapular orientation previously identified in other studies using scapular models, and presents a clinically accessible protocol to correct for scapular orientation from the patient's CT data. (orig.)

  15. Comparative assessment of various lipid extraction protocols and optimization of transesterification process for microalgal biodiesel production.

    Science.gov (United States)

    Mandal, Shovon; Patnaik, Reeza; Singh, Amit Kumar; Mallick, Nirupama

    2013-01-01

    Biodiesel, using microalgae as feedstocks, is being explored as the most potent form of alternative diesel fuel for sustainable economic development. A comparative assessment of various protocols for microalgal lipid extraction was carried out using five green algae, six blue-green algae and two diatom species treated with different single and binary solvents both at room temperature and using a soxhlet. Lipid recovery was maximum with chloroform-methanol in the soxhlet extractor. Pretreatments ofbiomass, such as sonication, homogenization, bead-beating, lyophilization, autoclaving, microwave treatment and osmotic shock did not register any significant rise in lipid recovery. As lipid recovery using chloroform-methanol at room temperature demonstrated a marginally lower value than that obtained under the soxhlet extractor, on economical point of view, the former is recommended for microalgal total lipid extraction. Transesterification process enhances the quality of biodiesel. Experiments were designed to determine the effects of catalyst type and quantity, methanol to oil ratio, reaction temperature and time on the transesterification process using response surface methodology. Fatty acid methyl ester yield reached up to 91% with methanol:HCl:oil molar ratio of 82:4:1 at 65 degrees C for 6.4h reaction time. The biodiesel yield relative to the weight of the oil was found to be 69%.

  16. Assessing the Fecal Microbiota: An Optimized Ion Torrent 16S rRNA Gene-Based Analysis Protocol

    Science.gov (United States)

    Foroni, Elena; Duranti, Sabrina; Turroni, Francesca; Lugli, Gabriele Andrea; Sanchez, Borja; Martín, Rebeca; Gueimonde, Miguel; van Sinderen, Douwe; Margolles, Abelardo; Ventura, Marco

    2013-01-01

    Assessing the distribution of 16S rRNA gene sequences within a biological sample represents the current state-of-the-art for determination of human gut microbiota composition. Advances in dissecting the microbial biodiversity of this ecosystem have very much been dependent on the development of novel high-throughput DNA sequencing technologies, like the Ion Torrent. However, the precise representation of this bacterial community may be affected by the protocols used for DNA extraction as well as by the PCR primers employed in the amplification reaction. Here, we describe an optimized protocol for 16S rRNA gene-based profiling of the fecal microbiota. PMID:23869230

  17. Assessing the fecal microbiota: an optimized ion torrent 16S rRNA gene-based analysis protocol.

    Directory of Open Access Journals (Sweden)

    Christian Milani

    Full Text Available Assessing the distribution of 16S rRNA gene sequences within a biological sample represents the current state-of-the-art for determination of human gut microbiota composition. Advances in dissecting the microbial biodiversity of this ecosystem have very much been dependent on the development of novel high-throughput DNA sequencing technologies, like the Ion Torrent. However, the precise representation of this bacterial community may be affected by the protocols used for DNA extraction as well as by the PCR primers employed in the amplification reaction. Here, we describe an optimized protocol for 16S rRNA gene-based profiling of the fecal microbiota.

  18. Design of a Medical Triage Evidence-Based Clinical Management Protocol and Implementation of Medical Triage On-Line Training for Use by Mission of Mercy Volunteers.

    Science.gov (United States)

    Allen, Kimberly D; DiBartolo, Mary C; Welsh, Debra L; Brown, Voncelia

    2015-01-01

    Evidence-based protocols in safety net settings can help standardize care practices, increase organizational workflow, and enhance quality outcomes for those receiving services. The purpose of this quality improvement project is two-fold: to design an evidence-based medical triage clinical management protocol, and, to influence adherence to that protocol by safety net medical triage volunteers through an on-line volunteer orientation. Leadership skills were required to help translate evidence-based practice recommendations into useful tools to assist in directing practice. Project outcomes included successful multidisciplinary practice change, significantly improved volunteer knowledge surrounding medical triage protocol parameters, increased organizational workflow, and enhanced quality client outcomes.

  19. Assessment of scapular positioning and function as future effect measure of shoulder interventions – an inter-examiner reliability study of the clinical assessment methods

    DEFF Research Database (Denmark)

    Larsen, Camilla Marie; Eshøj, Henrik; Ingwersen, Kim Gordon

    2015-01-01

    only been tested for intra-examiner reliability. The objective was to investigate the inter-examiner reliability of an extended battery of clinical tests for assessing scapular positioning and function. Methods A standardized three-phase protocol for clinical reliability studies was conducted......Assessment of scapular positioning and function as future effect measure of shoulder interventions – an inter-examiner reliability study of the clinical assessment methods Eshøj H1, Ingwersen KG1, Larsen CM1, 2, Søgaard K1, Juul-Kristensen B1, 3 1 University of Southern Denmark, Institute of Sports...... in three tests due to constant measurements from one of the testers. Conclusion An extended assessment battery to investigate the inter-examiner reliability for assessing the scapular positioning and function were compiled. Systematic bias between testers appeared in some, but not all assessment methods...

  20. Development of a first-contact protocol to guide assessment of adult patients in rehabilitation services networks

    Science.gov (United States)

    Souza, Mariana A. P.; Ferreira, Fabiane R.; César, Cibele C.; Furtado, Sheyla R. C.; Coster, Wendy J.; Mancini, Marisa C.; Sampaio, Rosana F.

    2016-01-01

    Objective: This paper describes the development of the Protocol for Identification of Problems for Rehabilitation (PLPR), a tool to standardize collection of functional information based on the International Classification of Functioning, Disability and Health (ICF). Development of the protocol: The PLPR was developed for use during the initial contact with adult patients within a public network of rehabilitation services. Steps to develop the protocol included: survey of the ICF codes most used by clinical professionals; compilation of data from functional instruments; development and pilot testing of a preliminary version in the service settings; discussion with professionals and development of the final version. The final version includes: user identification; social and health information; brief functional description (BFD); summary of the BFD; and PLPR results. Further testing of the final version will be conducted. Conclusions: The protocol standardizes the first contact between the user and the rehabilitation service. Systematic use of the protocol could also help to create a functional database that would allow comparisons between rehabilitation services and countries over time. PMID:26786075

  1. Development of a first-contact protocol to guide assessment of adult patients in rehabilitation services networks

    Directory of Open Access Journals (Sweden)

    Mariana A. P. Souza

    2016-01-01

    Full Text Available Objective: This paper describes the development of the Protocol for Identification of Problems for Rehabilitation (PLPR, a tool to standardize collection of functional information based on the International Classification of Functioning, Disability and Health (ICF. Development of the protocol : The PLPR was developed for use during the initial contact with adult patients within a public network of rehabilitation services. Steps to develop the protocol included: survey of the ICF codes most used by clinical professionals; compilation of data from functional instruments; development and pilot testing of a preliminary version in the service settings; discussion with professionals and development of the final version. The final version includes: user identification; social and health information; brief functional description (BFD; summary of the BFD; and PLPR results. Further testing of the final version will be conducted. Conclusions: The protocol standardizes the first contact between the user and the rehabilitation service. Systematic use of the protocol could also help to create a functional database that would allow comparisons between rehabilitation services and countries over time.

  2. Histomorphometric assessment of bone necrosis produced by two cryosurgery protocols using liquid nitrogen: an experimental study on rat femurs

    Directory of Open Access Journals (Sweden)

    Fábio Wildson Gurgel Costa

    2011-12-01

    Full Text Available OBJECTIVE: The aim of this study was to evaluate the effects of liquid nitrogen cryosurgery on the femoral diaphysis of rats. MATERIAL AND METHODS: The femoral diaphyses of 42 Wistar rats were exposed to three local and sequential applications of liquid nitrogen for 1 or 2 min, intercalated with periods of 5 min of passive thawing. The animals were sacrificed after 1, 2, 4 and 12 weeks and the specimens obtained were processed and analyzed histomorphometrically. RESULTS: The depth and extent of peak bone necrosis were 124.509 µm and 2087.094 µm for the 1-min protocol, respectively, and 436.424 µm and 12046.426 µm for the 2-min protocol. Peak necrosis was observed in the second experimental week with both cryotherapy protocols. CONCLUSIONS: The present results indicate that the 2-min protocol produced more marked bone necrosis than the 1-min protocol. Although our results cannot be entirely extrapolated to clinical practice, they contribute to the understanding of the behavior of bone tissue submitted to different cycles of liquid nitrogen freezing and may serve as a basis for new studies.

  3. Self-care assessment as an indicator for clinical supervision in nursing

    Directory of Open Access Journals (Sweden)

    Sílvia Marlene Monteiro Teixeira

    2016-01-01

    Full Text Available Objective : to evaluate the needs of clinical supervision for nurses to assess the degree of dependence on self- care and planning of nursing interventions. Methods : analytical study, cross-cutting nature, collecting data from a sample of 110 patients. Results : it was shown the differences in the identification of the degree of dependence between registers and experts, as well as the selection of operations for each self-care and failures to the original assessment of the filling level (no evaluation self-care/no identification of the degree of dependence. Conclusion : there were gaps in the nursing process; they have proposed strategies such as clinical supervision sessions, training, case studies, protocols and guidance documents, to be included in a clinical supervision in nursing model.

  4. Self-care assessment as an indicator for clinical supervision in nursing

    Directory of Open Access Journals (Sweden)

    Sílvia Marlene Monteiro Teixeira

    2016-06-01

    Full Text Available Objective: to evaluate the needs of clinical supervision for nurses to assess the degree of dependence on self-care and planning of nursing interventions. Methods: analytical study, cross-cutting nature, collecting data from a sample of 110 patients. Results: it was shown the differences in the identification of the degree of dependence between registers and experts, as well as the selection of operations for each self-care and failures to the original assessment of the filling level (no evaluation self-care/no identification of the degree of dependence. Conclusion: there were gaps in the nursing process; they have proposed strategies such as clinical supervision sessions, training, case studies, protocols and guidance documents, to be included in a clinical supervision in nursing model.

  5. Weight Care Project: Health professionals' attitudes and ability to assess body weight status - Study protocol

    LENUS (Irish Health Repository)

    Moorhead, Anne

    2011-03-31

    Abstract Background Health professionals working in primary care and public health have opportunities to address body weight status issues with their patients through face-to-face contact. The objectives of this all-Ireland project are: 1. to assess the attitudes, current practices\\/behaviours and knowledge of key health professional groups on body weight status; 2. to assess the health professional groups\\' ability to identify body weight status in both adults and children. The health professional groups are: (a) community related public health nurses; (b) school public health nurses; (c) GPs and practice nurses (primary care); and (d) occupational health nurses (workplace) from both Northern Ireland and the Republic of Ireland. Methods\\/Design This all-Ireland multi-disciplinary project follows a mixed methods approach using both quantitative and qualitative methodologies, and consists of four components: 1. Literature review - to explore the role of health professionals in managing obesity through spontaneous intervention in a variety of health promotion settings. 2. Telephone interviews and focus groups - to gain an in-depth insight into the views of health professionals in assessing body weight status. 3. Survey (primarily online but also paper-based) - to determine the attitudes, current practices\\/behaviours and knowledge of health professionals in assessing body weight status. 4. Online evaluation study - an online interactive programme will be developed to assess health professionals\\' ability to identify the body weight status of adults and children. Discussion This project will assess and report the attitudes, current practices\\/behaviours and knowledge of key health professional groups within Northern Ireland and the Republic of Ireland on body weight status, and their ability to identify body weight status in both adults and children. The results of this project will generate recommendations for clinical practice in managing obesity, which may

  6. Weight Care Project: Health professionals' attitudes and ability to assess body weight status - Study protocol

    Directory of Open Access Journals (Sweden)

    Murphy Kathy

    2011-03-01

    Full Text Available Abstract Background Health professionals working in primary care and public health have opportunities to address body weight status issues with their patients through face-to-face contact. The objectives of this all-Ireland project are: 1. to assess the attitudes, current practices/behaviours and knowledge of key health professional groups on body weight status; 2. to assess the health professional groups' ability to identify body weight status in both adults and children. The health professional groups are: (a community related public health nurses; (b school public health nurses; (c GPs and practice nurses (primary care; and (d occupational health nurses (workplace from both Northern Ireland and the Republic of Ireland. Methods/Design This all-Ireland multi-disciplinary project follows a mixed methods approach using both quantitative and qualitative methodologies, and consists of four components: 1. Literature review - to explore the role of health professionals in managing obesity through spontaneous intervention in a variety of health promotion settings. 2. Telephone interviews and focus groups - to gain an in-depth insight into the views of health professionals in assessing body weight status. 3. Survey (primarily online but also paper-based - to determine the attitudes, current practices/behaviours and knowledge of health professionals in assessing body weight status. 4. Online evaluation study - an online interactive programme will be developed to assess health professionals' ability to identify the body weight status of adults and children. Discussion This project will assess and report the attitudes, current practices/behaviours and knowledge of key health professional groups within Northern Ireland and the Republic of Ireland on body weight status, and their ability to identify body weight status in both adults and children. The results of this project will generate recommendations for clinical practice in managing obesity, which may

  7. Apyrase treatment of myocardial infarction according to a clinically applicable protocol fails to reduce myocardial injury in a porcine model

    Directory of Open Access Journals (Sweden)

    Otto Andreas

    2010-01-01

    Full Text Available Abstract Background Ectonucleotidase dependent adenosine generation has been implicated in preconditioning related cardioprotection against ischemia-reperfusion injury, and treatment with a soluble ectonucleotidase has been shown to reduce myocardial infarct size (IS when applied prior to induction of ischemia. However, ectonucleotidase treatment according to a clinically applicable protocol, with administration only after induction of ischemia, has not previously been evaluated. We therefore investigated if treatment with the ectonucleotidase apyrase, according to a clinically applicable protocol, would reduce IS and microvascular obstruction (MO in a large animal model. Methods A percutaneous coronary intervention balloon was inflated in the left anterior descending artery for 40 min, in 16 anesthetized pigs (40-50 kg. The pigs were randomized to 40 min of 1 ml/min intracoronary infusion of apyrase (10 U/ml, n = 8 or saline (0.9 mg/ml, n = 8, twenty minutes after balloon inflation. Area at risk (AAR was evaluated by ex vivo SPECT. IS and MO were evaluated by ex vivo MRI. Results No differences were observed between the apyrase group and saline group with respect to IS/AAR (75.7 ± 4.2% vs 69.4 ± 5.0%, p = NS or MO (10.7 ± 4.8% vs 11.4 ± 4.8%, p = NS, but apyrase prolonged the post-ischemic reactive hyperemia. Conclusion Apyrase treatment according to a clinically applicable protocol, with administration of apyrase after induction of ischemia, does not reduce myocardial infarct size or microvascular obstruction.

  8. Non-Intrusive Load Monitoring Assessment: Literature Review and Laboratory Protocol

    Energy Technology Data Exchange (ETDEWEB)

    Butner, R. Scott; Reid, Douglas J.; Hoffman, Michael G.; Sullivan, Greg; Blanchard, Jeremy

    2013-07-01

    To evaluate the accuracy of NILM technologies, a literature review was conducted to identify any test protocols or standardized testing approaches currently in use. The literature review indicated that no consistent conventions were currently in place for measuring the accuracy of these technologies. Consequently, PNNL developed a testing protocol and metrics to provide the basis for quantifying and analyzing the accuracy of commercially available NILM technologies. This report discusses the results of the literature review and the proposed test protocol and metrics in more detail.

  9. PErineal Assessment and Repair Longitudinal Study (PEARLS: protocol for a matched pair cluster trial

    Directory of Open Access Journals (Sweden)

    Thomas Peter W

    2010-02-01

    Full Text Available Abstract Background The Perineal Assessment and Repair Longitudinal Study (PEARLS is a national clinical quality improvement initiative designed to improve the assessment and management of perineal trauma. Perineal trauma affects around 85% of women who have a vaginal birth in the UK each year and millions more world-wide. Continuous suturing techniques compared with traditional interrupted methods are more effective in reducing pain and postnatal morbidity, however they are not widely used by clinicians despite recommendations of evidence based national clinical guidelines. Perineal suturing skills and postnatal management of trauma remain highly variable within and between maternity units in the UK as well as worldwide. Implementation of a standardised training package to support effective perineal management practices could reduce perineal pain and other related postnatal morbidity for a substantial number of women. Methods/Design PEARLS is a matched pair cluster trial, which is being conducted in maternity units across the UK. Units within a matched pair will be randomised to implement the study intervention either early or late in the study period. The intervention will include the cascading of a multi-professional training package to enhance midwifery and obstetric skills in the assessment, repair and postnatal management of perineal trauma. Women who have had an episiotomy or second degree perineal tear will be eligible for recruitment. Prior to developing the intervention and deciding on study outcomes, a Delphi survey and a consensus conference were held to identify what women, who previously suffered perineal trauma during childbirth, considered to be important outcomes for them. Findings from this preliminary work (which will be reported elsewhere and other outcomes including women's experiences of perineal pain and pain on activity, breastfeeding uptake and duration and psychological well-being as assessed using the Edinburgh

  10. Ultrasonographic assessment of flexor tendon mobilization: Effect of different protocols on tendon excursion

    NARCIS (Netherlands)

    J.-W.H. Korstanje (Jan-Wiebe); J. Soeters (Johannes); A.R. Schreuders (Ton); P.C. Amadio (Peter ); S.E.R. Hovius (Steven); H.J. Stam (Henk); R.W. Selles (Ruud)

    2012-01-01

    textabstractBackground: Different mobilization protocols have been proposed for rehabilitation after hand flexor tendon repair to provide tendon excursion sufficient to prevent adhesions. Several cadaver studies have shown that the position of the neighboring fingers influences tendon excursions of

  11. Using Think Aloud Protocols to Assess E-Prescribing in Community Pharmacies

    Directory of Open Access Journals (Sweden)

    Olufunmilola K. Odukoya, BPharm, MS

    2012-01-01

    Full Text Available Introduction: Think aloud protocol has rarely been used as a method of data collection in community pharmacies.Purpose: The aim of the report is to describe how think aloud protocols were used to identify issues that arise when using e-prescribing technology in pharmacies. In this paper, we report on the benefits and challenges of using think aloud protocols in pharmacies to examine the use of e-prescribing systems.Methods: Sixteen pharmacists and pharmacy technicians were recruited from seven community pharmacies in Wisconsin. Data were collected using direct observation alongside think aloud protocol. Direct observations and think aloud protocols took place between January-February, 2011. Participants were asked to verbalize their thoughts as they process electronic prescriptions.Results: Participants identified weaknesses in e-prescribing that they had previously not conceived. This created heightened awareness for vigilance when processing e-prescriptions. The main challenge with using think aloud protocols was due to interruptions in the pharmacies. Also, a few participants found it challenging to remember to continue verbalizing their thought process during think aloud sessions.Conclusion: The use of think aloud protocols as method of data collection is a new way for understanding the issues related to technology use in community pharmacy practice. Think aloud protocol was beneficial in providing objective information on e-prescribing use not solely based on pharmacist’s or technician’s opinion of the technology. This method provided detailed information on a wide variety of real time challenges with e-prescribing technology use in community pharmacies. Using this data collection method can help identify potential patient safety issues when using e-prescribing and suggestions for redesign.

  12. 'PhysioDirect' telephone assessment and advice services for physiotherapy: protocol for a pragmatic randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hopper Cherida

    2009-08-01

    Full Text Available Abstract Background Providing timely access to physiotherapy has long been a problem for the National Health Service in the United Kingdom. In an attempt to improve access some physiotherapy services have introduced a new treatment pathway known as PhysioDirect. Physiotherapists offer initial assessment and advice by telephone, supported by computerised algorithms, and patients are sent written self-management and exercise advice by post. They are invited for face-to-face treatment only when necessary. Although several such services have been developed, there is no robust evidence regarding clinical and cost-effectiveness, nor the acceptability of PhysioDirect. Methods/Design This protocol describes a multi-centre pragmatic individually randomised trial, with nested qualitative research. The aim is to determine the effectiveness, cost-effectiveness, and acceptability of PhysioDirect compared with usual models of physiotherapy based on patients going onto a waiting list and receiving face-to-face care. PhysioDirect services will be established in four areas in England. Adult patients in these areas with musculoskeletal problems who refer themselves or are referred by a primary care practitioner for physiotherapy will be invited to participate in the trial. About 1875 consenting patients will be randomised in a 2:1 ratio to PhysioDirect or usual care. Data about outcome measures will be collected at baseline and 6 weeks and 6 months after randomisation. The primary outcome is clinical improvement at 6 months; secondary outcomes include cost, waiting times, time lost from work and usual activities, patient satisfaction and preference. The impact of PhysioDirect on patients in different age-groups and with different conditions will also be examined. Incremental cost-effectiveness will be assessed in terms of quality adjusted life years in relation to cost. Qualitative methods will be used to explore factors associated with the success or failure of

  13. Clinical Considerations in the Assessment of Adolescent Chemical Dependency.

    Science.gov (United States)

    Winters, Ken

    1990-01-01

    Discusses relevant research findings of clinical assessment of adolescent chemical dependency so that service providers can better address these concerns. Three major issues are discussed: the definition of adolescent chemical dependency, clinical domains of assessment (chemical use problem severity, precipitating and perpetuating risk factors,…

  14. [Assessing the clinical competence of dental students].

    Science.gov (United States)

    Schoonheim-Klein, M E; van Selms, M K A; Volgenant, C M C; Wiegman, H P; Vervoorn, J M

    2012-06-01

    Nowadays, the competences of dental students are tested more on the basis of quality of their achievements than the quantity. 'Objective Structured Clinical Examinations' (OSCEs) can be used in a pre-clinical phase to test these clinical competences. For the clinical phase, the general examination and the digital portfolio have been developed. Tests are used to stimulate the learning process and to determine whether students are ready for the next step; in addition, the quality of the programme is protected by the set of examinations. The results of the last 5 general examinations reveal the pattern that the number of correct answers increases as the study progresses. The Amsterdam Academic Centre for Dentistry (ACTA) introduced a digital portfolio which was evaluated 1 year later with the help ofan anonymous questionnaire. Students judged the use of the digital portfolio in the clinic to be useful but also costly in time.

  15. Assessment of a sequential extraction protocol by examining solution chemistry and mineralogical evolution

    Science.gov (United States)

    Maubec, Nicolas; Pauwels, Hélène; Noël, Hervé; Bourrat, Xavier

    2015-04-01

    Knowledge of the behavior of heavy metals, such as copper and zinc in sediments, is a key factor to improve the management of rivers. The mobility of these metals, which may be harmful to the environment, depends directly on their concentration and speciation , which in turn depend on physico-chemical parameters such as mineralogy of the sediment fraction, pH, redox potential, salinity etc ... (Anderson et al., 2000; Sterckeman et al., 2004; Van Oort et al., 2008). Several methods based on chemical extractions are currently applied to assess the behavior of heavy metals in soils and sediments. Among them, sequential extraction procedure is widely used in soil and sediment science and provides details about the origin, biological and physicochemical availability, mobilization and transports of trace metals elements. It is based on the use of a series of extracting reagents to extract selectively heavy metals according to their association within the solid phase (Cornu and Clozel, 2000) including the following different fraction : exchangeable, bound to carbonates, associated to oxides (reducible fraction), linked to organic matter and sulfides (oxidizable fraction) as well as silicate minerals so called residual fraction (Hickey and Kittrick, 1984; Tessier et al., 1979). Consequently sequential extraction method is expected to simulate a lot of potential natural and anthropogenic modifications of environmental conditions (Arey et al., 1999; Brannon and Patrick, 1987; Hickey and Kittrick, 1984; La Force et al., 1999; Tessier et al., 1979). For three decades, a large number of protocols has been proposed, characterized by specific reagents and experimental conditions (concentrations, number of steps, extraction orders and solid/solution ratio) (Das et al., 1995; Gomez Ariza et al., 2000; Quevauviller et al., 1994; Rauret, 1998; Tack and Verloo, 1995), but it appeared that several of them suffer from a lack of selectivity of applied reagents: besides target ones, some

  16. A protocol for clinical evaluation of the carrying angle of the elbow by anatomic landmarks.

    Science.gov (United States)

    Zampagni, Maria Luisa; Casino, Daniela; Martelli, Sandra; Visani, Andrea; Marcacci, Maurilio

    2008-01-01

    The aim of this work was to present an in vivo protocol to estimate the carrying angle of the elbow in full extension. Forty-four arms were measured by using an electrogoniometer to acquire 3-dimensional coordinates of the landmarks. An algorithm based on the Cardan decomposition method was used to compute the carrying angle and the flexion and pronation angles of the elbow. The mean carrying angle was 12.42 degrees +/- 4.06 degrees , in agreement with the literature and with values obtained by a standard goniometer (r = 0.46; P = .000). Our protocol provided excellent repeatability (interclass correlation coefficient [ICC] = 0.85), greater than a goniometer (ICC = 0.76), and a standard error of measurement of only 1.62 degrees . Flexion was a significant factor (P = .01) in carrying angle estimation. This study suggests that the carrying angle cannot be estimated independently by the flexion angle, even when measured in apparently full extension, and it could be useful in elbow disorders, such as fractures or epicondylar disease management and evaluation of elbow reconstruction.

  17. Consensus recommendations for a standardized Brain Tumor Imaging Protocol in clinical trials

    NARCIS (Netherlands)

    B.M. Ellingson (Benjamin M.); M. Bendszus (Martin); J. Boxerman (Jerrold); D. Barboriak (Daniel); B.J. Erickson (Bradley J.); M. Smits (Marion); S.J. Nelson (Sarah J.); E. Gerstner (Elizabeth); B. Alexander (Brian); G. Goldmacher (Gregory); W. Wick (Wolfgang); M.A. Vogelbaum (Michael); M. Weller (Michael); E. Galanis (Evanthia); J. Kalpathy-Cramer (Jayashree); L. Shankar; P. Jacobs (Paula); W.B. Pope (Whitney B.); D. Yang (Dewen); C. Chung (Caroline); R.H. Knopp; S. Cha (Soonme); M.J. van den Bent (Martin); S.M. Chang (Susan); W.K. Al Yung; T.F. Cloughesy (Timothy F.); P.Y. Wen (Patrick Y.); M.R. Gilbert (Mark R.); A. Whitney (Andrew); D. Sandak (David); A. Musella (Al); C. Haynes (Chas); M. Wallace (Max); D.F. Arons (David F.); A. Kingston (Ann)

    2015-01-01

    textabstractA recent joint meeting was held on January 30, 2014, with the US Food and Drug Administration (FDA), National Cancer Institute (NCI), clinical scientists, imaging experts, pharmaceutical and biotech companies, clinical trials cooperative groups, and patient advocate groups to discuss ima

  18. Updating magnetic resonance imaging of small bowel: Imaging protocols and clinical indications

    Institute of Scientific and Technical Information of China (English)

    Jiong Zhu; Jian-Rong Xu; Hong-Xia Gong; Yan Zhou

    2008-01-01

    High soft tissue contrast resolution,acquisition of multi-planar images and the possibility to obtain functional information make magnetic resonance an interesting imaging technique to evaluate the small bowel disease.The absence of ionizing radiation is an important feature of magnetic resonance imaging (MRI) examinations because inflammatory diseases such as Crohn's disease (CD) are studied most frequently,which are prevalent among children and young adults.MRI,using modern equipment and a rigorous technical approach,can offer detailed morphologic information and functional data on the small bowel.This article discusses the MRI protocols for small bowel and the MR imaging findings of small bowel diseases,such as CD and small bowel neoplasms.

  19. Inventory development and protocol testing for the assessment of environmental conditions of drilling sumps in the Inuvialuit settlement region

    Energy Technology Data Exchange (ETDEWEB)

    Wall, D. [AMEC Earth and Environmental, Nelson, BC (Canada); Wenzel, C. [AMEC Earth and Environmental Ltd., Calgary, AB (Canada); Taylor, T. [Petro-Canada Oil and Gas, Inc., Calgary, AB (Canada)

    2005-07-01

    This paper presents the results of a study evaluating the environmental performance of historic drilling sump caps in the Inuvialuit Settlement Region (ISR). The study was conducted in order to assist in decision-making related to oil and gas exploration and development in Canada's frontier lands. The purpose of the study was to inventory and test a protocol to assess the environmental conditions of drilling sump caps. A background of historic practices for the disposal of waste drilling fluids in the area was presented, as well as details of initial assessments. The objective of the inventory was to identify all recorded oil and gas wells in the ISR and provide relevant data associated with the wells, including the identification of current owners through the use of public records as well as working with company representatives. Results indicated that 15 companies owned major interest in the wells. Member companies were asked to volunteer sites for detailed drilling waste sump assessment. Fifteen well sites were selected. The sump assessment protocol consisted of the following components: soil and water sampling and analysis; vegetation surveys; digital photography; site description; survey of active-layer thickness; on the ground location and data logging; development of digital data maps; and ground conductivity (EM38) surveys. It was concluded that extensive sump cap subsidence had occurred at 3 sites. Elevated chloride levels were present in surface soil and water at 8 sites. There was no evidence of contaminant related impacts beyond the immediate sump area. Small adjacent areas exhibited soil quality degradation. It was recommended that the protocol be used as the first screening procedure in future drilling sump assessment work. It was also recommended that soil-ice content be assessed and adjusted for, when placing frozen materials in the active layer. Designers should consider the potential for natural soil salinity impacts when relocating frozen

  20. Clinical Examination Protocol to Detect Atypical and Classical Scrapie in Sheep

    OpenAIRE

    Konold, Timm; Phelan, Laura

    2014-01-01

    The diagnosis of scrapie, a transmissible spongiform encephalopathy (TSEs) of sheep and goats, is currently based on the detection of disease-associated prion protein by post mortem tests. Unless a random sample of the sheep or goat population is actively monitored for scrapie, identification of scrapie cases relies on the reporting of clinical suspects, which is dependent on the individual's familiarization with the disease and ability to recognize clinical signs associated with scrapie. Scr...

  1. Assessing most practical and effective protocols to sanitize hands of poultry catching crew members.

    Science.gov (United States)

    Racicot, M; Kocher, A; Beauchamp, G; Letellier, A; Vaillancourt, J-P

    2013-08-01

    Catching crew members can heavily contaminate their hands with organic material. They can act as mechanical vector and spread diseases between farms. Hand hygiene is an important issue for the industry as a whole and for human health by reducing contamination risks. Many studies, in human medicine, tend to make hand rub a standard for hand hygiene. However, few studies have tested the effectiveness of hand hygiene products on visibly contaminated hands. The objective of this study was to evaluate the effectiveness of practical hand sanitization protocols: water and soap, degreasing cream and hand wipes, all combined with alcohol-based hand gel. The use of alcohol-based gel alone was also evaluated. For the reduction of coliforms after washing, there was no statistically significant difference between protocols when the initial level of bacterial contamination was low to moderate. When hands were highly contaminated, the alcohol-based gel alone was less effective than the degreasing cream combined with the alcohol-based gel (p=0.002). As for the reduction in total aerobic bacteria counts, there was no difference between protocols when the initial level of bacterial contamination was low. The water, soap and alcohol-based gel protocol was more effective than the scrubbing wipes and alcohol-based gel protocol when hands were moderately (p=0.002) and highly contaminated (p=0.001). All protocols were effective in neutralizing Salmonella on hands. Reducing the level of bacterial contamination on hands before using an alcohol-based gel seems important to ensure effective hand sanitation for highly and moderately contaminated hands. This can be done by using a degreasing cream or water and soap. Based on the survey, catching crew members preferred using warm water and soap compared to a degreasing cream.

  2. Conceptual Models and Guidelines for Clinical Assessment of Financial Capacity.

    Science.gov (United States)

    Marson, Daniel

    2016-09-01

    The ability to manage financial affairs is a life skill of critical importance, and neuropsychologists are increasingly asked to assess financial capacity across a variety of settings. Sound clinical assessment of financial capacity requires knowledge and appreciation of applicable clinical conceptual models and principles. However, the literature has presented relatively little conceptual guidance for clinicians concerning financial capacity and its assessment. This article seeks to address this gap. The article presents six clinical models of financial capacity : (1) the early gerontological IADL model of Lawton, (2) the clinical skills model and (3) related cognitive psychological model developed by Marson and colleagues, (4) a financial decision-making model adapting earlier decisional capacity work of Appelbaum and Grisso, (5) a person-centered model of financial decision-making developed by Lichtenberg and colleagues, and (6) a recent model of financial capacity in the real world developed through the Institute of Medicine. Accompanying presentation of the models is discussion of conceptual and practical perspectives they represent for clinician assessment. Based on the models, the article concludes by presenting a series of conceptually oriented guidelines for clinical assessment of financial capacity. In summary, sound assessment of financial capacity requires knowledge and appreciation of clinical conceptual models and principles. Awareness of such models, principles and guidelines will strengthen and advance clinical assessment of financial capacity.

  3. Control protocol: large scale implementation at the CERN PS complex - a first assessment

    Energy Technology Data Exchange (ETDEWEB)

    Abie, H. (CERN, 1211, Geneva 23 (Switzerland)); Benincasa, G. (CERN, 1211, Geneva 23 (Switzerland)); Coudert, G. (CERN, 1211, Geneva 23 (Switzerland)); Davydenko, Y. (CERN, 1211, Geneva 23 (Switzerland)); Dehavay, C. (CERN, 1211, Geneva 23 (Switzerland)); Gavaggio, R. (CERN, 1211, Geneva 23 (Switzerland)); Gelato, G. (CERN, 1211, Geneva 23 (Switzerland)); Heinze, W. (CERN, 1211, Geneva 23 (Switzerland)); Legras, M. (CERN, 1211, Geneva 23 (Switzerland)); Lustig, H. (CERN, 1211, Geneva 23 (Switzerland)); Merard, L. (CERN, 1211, Geneva 23 (Switzerland)); Pearson, T. (CERN, 1211, Geneva 23 (Switzerland)); Strubin, P. (CERN, 1211, Geneva 23 (Switzerland)); Tedesco, J. (CERN, 1211, Geneva 23 (Switzerland))

    1994-12-15

    The Control Protocol is a model-based, uniform access procedure from a control system to accelerator equipment. It was proposed at CERN about 5 years ago and prototypes were developed in the following years. More recently, this procedure has been finalized and implemented at a large scale in the PS Complex. More than 300 pieces of equipment are now using this protocol in normal operation and another 300 are under implementation. These include power converters, vacuum systems, beam instrumentation devices, RF equipment, etc. This paper describes how the single general procedure is applied to the different kinds of equipment. The advantages obtained are also discussed. ((orig.))

  4. Control protocol: large scale implementation at the CERN PS complex — a first assessment

    Science.gov (United States)

    Abie, H.; Benincasa, G.; Coudert, G.; Davydenko, Y.; Dehavay, C.; Gavaggio, R.; Gelato, G.; Heinze, W.; Legras, M.; Lustig, H.; Merard, L.; Pearson, T.; Strubin, P.; Tedesco, J.

    1994-12-01

    The Control Protocol is a model-based, uniform access procedure from a control system to accelerator equipment. It was proposed at CERN about 5 years ago and prototypes were developed in the following years. More recently, this procedure has been finalized and implemented at a large scale in the PS Complex. More than 300 pieces of equipment are now using this protocol in normal operation and another 300 are under implementation. These include power converters, vacuum systems, beam instrumentation devices, RF equipment, etc. This paper describes how the single general procedure is applied to the different kinds of equipment. The advantages obtained are also discussed.

  5. Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial.

    Science.gov (United States)

    Al Balushi, Ruqaiya M; Paratz, Jennifer D; Cohen, Jeremy; Banks, Merrilyn; Dulhunty, Joel; Roberts, Jason A; Lipman, Jeffrey

    2011-01-01

    Background Trauma patients are characterised by alterations in the immune system, increased exposure to infectious complications, sepsis and potentially organ failure and death. Glutamine supplementation to parenteral nutrition has been proven to be associated with improved clinical outcomes. However, glutamine supplementation in patients receiving enteral nutrition and its best route are still controversial. Previous trials have been limited by a small sample size, use of surrogate outcomes or a limited period of supplementation. The aim of this trial is to investigate if intravenous glutamine supplementation to trauma patients receiving enteral nutrition is associated with improved clinical outcomes in terms of decreased organ dysfunction, infectious complications and other secondary outcomes. Methods/design Eighty-eight critically ill patients with multiple trauma receiving enteral nutrition will be recruited in this prospective, triple-blind, block-randomised, placebo-controlled clinical trial to receive either 0.5 g/kg/day intravenous undiluted alanyl-glutamine or intravenous placebo by continuous infusion (24 h/day). Both groups will be receiving the same standard enteral nutrition protocol and the same standard intensive care unit care. Supplementation will continue until discharge from the intensive care unit, death or a maximum duration of 3 weeks. The primary outcome will be organ-dysfunction evaluation assessed by the pattern of change in sequential organ failure assessment score over a 10-day period. The secondary outcomes are: the changes in total sequential organ failure assessment score on the last day of treatment, infectious complications during the ICU stay, 60-day mortality, length of stay in the intensive care unit and body-composition analysis. Discussion This study is the first trial to investigate the effect of intravenous alanyl-glutamine supplementation in multiple trauma patients receiving enteral nutrition on reducing severity of organ

  6.  Objective Structured Clinical Examination: The Assessment of Choice

    Directory of Open Access Journals (Sweden)

    Marliyya Zayyan

    2011-07-01

    Full Text Available  The Objective Structured Clinical Examination is a versatile multipurpose evaluative tool that can be utilized to assess health care professionals in a clinical setting. It assesses competency, based on objective testing through direct observation. It is precise, objective, and reproducible allowing uniform testing of students for a wide range of clinical skills. Unlike the traditional clinical exam, the OSCE could evaluate areas most critical to performance of health care professionals such as communication skills and ability to handle unpredictable patient behavior.

  7. ABM Clinical Protocol #1: Guidelines for Blood Glucose Monitoring and Treatment of Hypoglycemia in Term and Late-Preterm Neonates, Revised 2014

    Science.gov (United States)

    Wight, Nancy

    2014-01-01

    A central goal of The Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient. PMID:24823918

  8. The Copenhagen Standardised MRI protocol to assess the pubic symphysis and adductor regions of athletes

    DEFF Research Database (Denmark)

    Branci, Sonia; Thorborg, Kristian; Bech, Birthe Højlund;

    2015-01-01

    radiologists developed an 11-element MRI evaluation protocol defined according to precise criteria and illustrated in a pictorial atlas. Eighty-six male athletes (soccer players and non-soccer players) underwent standardised 3 Tesla MRI of the pelvis. Two external musculoskeletal radiologists were trained...

  9. The Reliability and Validity of Protocols for the Assessment of Endurance Sports Performance: An Updated Review

    Science.gov (United States)

    Stevens, Christopher John; Dascombe, Ben James

    2015-01-01

    Sports performance testing is one of the most common and important measures used in sport science. Performance testing protocols must have high reliability to ensure any changes are not due to measurement error or inter-individual differences. High validity is also important to ensure test performance reflects true performance. Time-trial…

  10. Effect of back school protocol on the referral rate of patients with low back pain to an industrial physiotherapy clinic

    Directory of Open Access Journals (Sweden)

    D. O. Odebiyi

    2006-02-01

    Full Text Available Back schools are educational programmes originally developed in a work place (Volvo factory in Sweden for patients with back pain, to enable them to manage their own back problems better. ‘Back school’ was originally aimed at modifying the behaviours of patients with low back pain (LBP, with the view to prevent relapses. In an effort to encourage and stimulate the use of ‘back school’ among health workers in Nigeria, this study was designed to evaluate the efficacy of a back school protocol in a Soap Making Industry in Lagos, Nigeria. One hundred and ten (110 workers of a Soap Making Industry in Lagos, Nigeria,  participated in this study. A pre-test, post-test experimental design was employed. The participants were divided into two groups - office workers and factory workers for the purpose of the training in the content of the back school protocol. The ‘back school’ consisted of classroom teaching and the use of two videotapes titled “lifting technique” and “back pain”. Data on demographic information, knowledge of back structures and back care were collected using a questionnaire with closed ended questions, which was completed before, immediately after and 8 weeks after the administrations of the contents of the back school protocol (Akinpelu and Odebiyi, 2004. The records of the factory’s clinic were also reviewed for the 12-months before and 12 months after the study. The mean values of the participants’ age, height, weight and body mass index (BMI were 36.60 ± 9.10 years, 1.65 ± 0.10 m,69.13 ± 7.70 kg and 25.40 ± 3.30 kg/m2 respectively. The results showed that the 12-months prevalence of low back pain (LBP among the workers was 71%. The result also showed that over 50% of the participants never had any  information or lesson on back care, and those that had some form of information obtained it by chance. There was 23% reduction in referral for care of back pain 12 months after the administration of the back

  11. Assessing the Effectiveness of the NICHD Investigative Interview Protocol when Interviewing French-Speaking Alleged Victims of Child Sexual Abuse in Quebec

    Science.gov (United States)

    Cyr, Mireille; Lamb, Michael E.

    2009-01-01

    Objectives: The study was designed to assess the effectiveness of the flexibly structured NICHD Investigative Interview Protocol for child sexual abuse (CSA) investigative interviews by police officers and mental health workers in Quebec. The NICHD Protocol was designed to operationalize "best practice" guidelines and to help forensic…

  12. A Participatory Approach to Develop the Power Mobility Screening Tool and the Power Mobility Clinical Driving Assessment Tool

    Directory of Open Access Journals (Sweden)

    Deepan C. Kamaraj

    2014-01-01

    Full Text Available The electric powered wheelchair (EPW is an indispensable assistive device that increases participation among individuals with disabilities. However, due to lack of standardized assessment tools, developing evidence based training protocols for EPW users to improve driving skills has been a challenge. In this study, we adopt the principles of participatory research and employ qualitative methods to develop the Power Mobility Screening Tool (PMST and Power Mobility Clinical Driving Assessment (PMCDA. Qualitative data from professional experts and expert EPW users who participated in a focus group and a discussion forum were used to establish content validity of the PMCDA and the PMST. These tools collectively could assess a user’s current level of bodily function and their current EPW driving capacity. Further multicenter studies are necessary to evaluate the psychometric properties of these tests and develop EPW driving training protocols based on these assessment tools.

  13. Clinical practice of risk assessment of sexual violence

    OpenAIRE

    Judge, Joseph Gerard

    2012-01-01

    Background: Risk assessment of sexual violence involves evidence based evaluation of the risks posed by sexual offenders. It informs risk management; the provision of treatment that reduces the risk of future sexual violence. Previous research has focused on assessment of the predictive accuracy of different risk assessment tools, as well as the identification of risk factors that are associated with recidivism. In contrast, the clinical practice of risk assessment is a research a...

  14. Development of a standardized protocol for reproducible generation of matured monocyte-derived dendritic cells suitable for clinical application.

    Science.gov (United States)

    Bohnenkamp, H R; Noll, T

    2003-09-01

    There is increasing interest in the generation of dendritic cells (DC) for cancer immunotherapy. In order to utilize DC in clinical trials it is necessary to have standardized, reproducible and easy to use protocols. We describe here the process development for the generation of DC as the result of investigation of culture conditions as well as consumption rates of medium and cytokines. Our studies demonstrate that highly viable DC (93 +/- 2%) can be produced from CD14(+) enriched monocytes via immunomagnetic beads in a high yield (31 +/- 6%) with X-VIVO 15, 400 U ml(-1) GM-CSF and 2000 U ml(-1) IL-4 without serum and feeding. For the maturation of DC different cocktails (TNF-alpha, IL-1beta, IL-6, PGE(2) and TNF-alpha, PGE(2)) were compared. In both cases cells expressed typical surface molecules of mature DC and induced high proliferative responses in mixed lymphocyte reactions which led to IFN-gamma producing T-lymphocytes. The data suggest that the use of this optimized, easy to use protocol results in highly mature DC.

  15. Clinical Assessment And Diagnosis Of Dementia

    Directory of Open Access Journals (Sweden)

    Srikanth S

    2005-01-01

    Full Text Available Dementia is characterized by progressive decline in an alert individual, leading to loss of independence in day-to-day functioning. It is a generic term for a condition that has various causes and hence myriad clinical presentations. It has to be distinguished from age-related cognitive decline, depression and delirium all of which are common in the elderly population. Detailed history and mental status examination are necessary to identify dementia, fit it into one of the various bedside classifications and pursue the differential diagnosis. This teaching review summarizes current information on definition, differential diagnosis and classification of dementia and presents a brief elaboration of bedside cognitive testing pertaining to dementia. A bird′s eye view of the profiles of various dementia subtypes is also provided so that after reading this article the reader will able to recognize dementia, conduct clinical examination to identify the characteristic cognitive profile and formulate the differential diagnosis with confidence.

  16. De-escalation treatment protocols for human papillomavirus-associated oropharyngeal squamous cell carcinoma: a systematic review and meta-analysis of current clinical trials.

    Science.gov (United States)

    Masterson, Liam; Moualed, Daniel; Liu, Zi Wei; Howard, James E F; Dwivedi, Raghav C; Tysome, James R; Benson, Richard; Sterling, Jane C; Sudhoff, Holger; Jani, Piyush; Goon, Peter K C

    2014-10-01

    Iatrogenic complications associated with current treatment protocols for oropharyngeal squamous cell carcinoma are noted to cause high rates of acute and chronic morbidity. The aims of this study are to provide an overview of the current de-escalation trials for human papillomavirus positive (HPV+) oropharyngeal carcinoma and to evaluate the evidence supporting improved response to treatment of patients within this viral cohort. This study reviewed all completed or in progress randomised controlled trials (RCTs) assessing clinical interventions for human papillomavirus-associated locally advanced oropharyngeal squamous cell carcinoma. We utilised a validated 'risk of bias' tool to assess study quality. We identified nine RCTs that met the full inclusion criteria for this review (all of which are currently on-going and will report from 2015 onwards). Five RCTs performed a post hoc analysis by HPV status, which allowed meta-analysis of 1130 patients. The data reveal a significant difference in overall survival (hazard ratio (HR) 0.49 [95% confidence interval (CI) 0.35-0.69]), loco-regional failure (HR 0.43 [95% CI 0.17-1.11]) and disease specific survival (0.41 [95% 0.3-0.56]) in favour of the HPV+ category. In considering de-escalation treatment protocols, nine studies are currently ongoing. Our meta-analysis provides strong evidence for an improved prognosis in the viral associated cohort when treated by platinum based chemotherapy in combination with radiotherapy or primary radiotherapy. So far, one trial (with moderate to high risk of bias) suggests a reduced survival outcome for the HPV+ population when using the epidermal growth factor receptor (EGFR) inhibitor cetuximab.

  17. Clinical Assessment Applications of Ambulatory Biosensors

    Science.gov (United States)

    Haynes, Stephen N.; Yoshioka, Dawn T.

    2007-01-01

    Ambulatory biosensor assessment includes a diverse set of rapidly developing and increasingly technologically sophisticated strategies to acquire minimally disruptive measures of physiological and motor variables of persons in their natural environments. Numerous studies have measured cardiovascular variables, physical activity, and biochemicals…

  18. Development of clinical assessment criteria for postgraduate nursing students.

    Science.gov (United States)

    Tolhurst, B G; Bonner, A

    2000-04-01

    This paper explores the development and implementation of specific criteria to determine the level of clinical performance of postgraduate nursing students during the first year of a Master of Nursing course. The authors describe two commonly used clinical skill assessment tools and identify limitations of these tools for postgraduate nursing students. As a result of these limitations, Clinical Assessment Criteria (CAC) utilising the framework of Benner (1984) was developed. Inherent within the CAC is four levels of clinical nursing performance, which enable the nurse teacher and student to monitor the progression from novice to proficient levels of practice within a specialty area. Following a successful pilot study, the CAC was incorporated into clinical assessments in nine specialty postgraduate courses. Furthermore, the framework developed for the CAC can also be integrated into a variety of professional development domains.

  19. Clinical assessment of transthoracic echocardiography skills: a generalizability study

    DEFF Research Database (Denmark)

    Nielsen, Dorte Guldbrand; O'Neill, Lotte; Jensen, Signe

    2015-01-01

    Context: Transthoracic echocardiography (TTE) is a widely used cardiac imaging technique that all cardiologists should be able to perform competently. Traditionally, TTE competence has been assessed by unstructured observation or in test situations separated from daily clinical practice. An objec...

  20. Ahmedabad tolerance induction protocol and chronic renal allograft dysfunction: pathologic observations and clinical implications

    Directory of Open Access Journals (Sweden)

    Trivedi Hargovind L

    2009-01-01

    Full Text Available Abstract Background Chronic Renal Allograft Dysfunction (CRAD is responsible for a large number of graft failures. We have abrogated acute T-cell rejections using Ahmedabad Tolerance Induction Protocol (ATIP with hematopoietic stem cell transplantation (HSCT under non-myeloablative conditioning pre-transplant. However B-cell mediated rejections and CRAD continue to haunt us. We carried out retrospective analysis of renal allograft biopsies performed in the last 4 years to evaluate the effect of ATIP on CRAD. Materials and methods Biopsies diagnosed as per modified Banff criteria belonged to 2 groups: ATIP under low dose immunosuppression of cyclosporine/Azathioprine/Mycofenolate mofetil+ Prednisolone, subjected to donor leucocyte transfusion, anti-T/B cell antibodies, low dose target specific irradiation, cyclophosphamide, cyclosporin followed by HSCT pre-transplant; controls who opted out of ATIP were transplanted under standard triple drug immunosuppression. Demographics of both groups were comparable. Results Incidence of chronic changes was higher in controls (17.5% vs. 10.98% in ATIP over a mean follow up of 151.9 months in the former and 130.9 months in the latter. Proteinuria and hypertension were higher in controls (48.4% vs. ATIP (32.7% with chronic transplant glomerulopathy, focal global sclerosis in 67.7% in controls vs. 46.7% in ATIP, acute on chronic T/B cell rejection in 51.6% controls vs. 28.1% ATIP, with peritubular capillary C4d deposits in 19.4% controls vs. 1.9% ATIP biopsies. Acute on chronic calcineurin inhibitor toxicity was higher in ATIP (71.9% vs. 48.4% in controls. Conclusion Chronic immune injury was less with ATIP vs controls as compared to a higher incidence of chronic calcineurin inhibitor toxicity in the former.

  1. Computerised triage in a prostate assessment clinic.

    Science.gov (United States)

    Rajkumar, G N; Small, D R; Conn, I G

    2004-01-01

    An MS Office package has been developed to score IPSS, take a patient history, compare flows with nomograms and decide on interim management. This is based on these scores, residual volume and laboratory results. A clearly formatted GP letter is produced. The patient uses a touch screen to answer questions on the IPSS and other medical history. These questions and responses are stored in Excel spread sheets. Clinic staff then enter results of flow studies, urinalysis, U&E and PSA. Excel Visual Basic creates a detailed printout for the notes and the MS Office mail merge facility creates a summary printout, which also serves as a letter to the GP. Excel allows embedding of formulae and program code to implement the rules for management. Based on these rules, the program either generates a request for an urgent appointment in the clinic or recommends the use of either an alpha blocker (if not contraindicated by medical history) or 5 alpha reductase inhibitors in the interim period before they are reviewed in clinic. A total of 139 patients have been seen and the computer decisions compared with those of a consultant urologist. Agreement was found in 106, disagreement in 33. However, 21 of the 33 involved computer oversensitivity to flow results. We do not anticipate difficulty improving this and are investigating using an artificial neural network. Of the other 12 patients, the urologist departed from the fixed rules for IPSS, creatinine, PSA and residual urine when only one variable was slightly abnormal. To conclude, this novel user-friendly system shows great potential in the management of prostate outpatients. Some tuning is needed, with particular respect to uroflow results.

  2. The clinical and molecular genetic approach to Duchenne and Becker muscular dystrophy : an updated protocol

    NARCIS (Netherlands)

    vanEssen, AJ; Kneppers, ALJ; vanderHout, AH; Scheffer, H; Ginjaar, IB; tenKate, LP; vanOmmen, GJB; Buys, CHCM; Bakker, E

    1997-01-01

    Detection of large rearrangements in the dystrophin gene in Duchenne and Becker muscular dystrophy is possible in about 65-70% of patients by Southern blotting or multiplex PCR. Subsequently, carrier detection is possible by assessing the intensity of relevant bands, but preferably by a non-quantita

  3. [Brain metastasis: clinical and cognitive assessments].

    Science.gov (United States)

    Ramirez, Carole; Blonski, Marie; Belin, Catherine; Carpentier, Antoine; Taillia, Hervé

    2013-01-01

    The incidence of brain metastases (BM) has increased due to the improvement of therapeutics and diagnostic imaging, but also to an aging population. The initial symptoms may develop suddenly or insidiously over weeks or months. The symptoms depend on the location of the BM and related complications (hydrocephalus, tumor hemorrhage, cerebral herniation). Headaches are the most frequent symptoms (50%); they are related to intracranial hypertension. Cognitive deficits are commonly described at diagnosis (67 to 90.5%). Cognitive assessment is essential because of its impact on patients' prognosis and quality of life. Nevertheless, these deficits remain underestimated. The Karnofsky Perfomance Scale and the Mini Mental State Examination (MMSE) seem inadequate. A short battery was proposed and internationally validated, assessing seven domains: attention (Digit Symbol Test WAIS-III), episodic memory (Hopkins Verbal Learning Test [HVLT]), working memory (Digit Span Test WAIS-III), verbal fluency (Controlled Oral Word Association Test [COWA]), fine motor dexterity (Grooved Pegboard Test), information processing speed (Trail Making Test [TMT] A) and executive functions (TMT B). This battery is relevant, feasible and associated with a good compliance. These cognitive tests are currently recommended to assess cognitive functions in patients with BM.

  4. In-Suit Light Exercise (ISLE) Prebreathe Protocol Peer Review Assessment. Part 2; Appendices

    Science.gov (United States)

    Brady, Timothy K.; Polk, James D.

    2011-01-01

    The performance of extravehicular activity (EVA) by National Aeronautics and Space Administration astronauts involves the risk of decompression sickness. This risk has been mitigated by the use of oxygen "prebreathe" to effectively wash out tissue nitrogen prior to each EVA. Now that the Space Shuttle Program (SSP) is being retired, high-pressure oxygen will become a limited resource. The In-Suit Light Exercise (ISLE) Prebreathe Protocol offers several potential benefits including its potential to save 6 pounds of oxygen per EVA. At the request of the NASA Engineering and Safety Center, the peer review convened on October 14, 2010. The major recommendation of the Review Committee was that the ISLE protocol was acceptable for operational use as a prebreathe option prior to EVA. The appendices to Volume I of the report are contained in this document.

  5. In-Suit Light Exercise (ISLE) Prebreathe Protocol Peer Review Assessment. Volume 1

    Science.gov (United States)

    Brady, Timothy K.; Polk, James D.

    2011-01-01

    The performance of extravehicular activity (EVA) by National Aeronautics and Space Administration astronauts involves the risk of decompression sickness. This risk has been mitigated by the use of oxygen "prebreathe" to effectively wash out tissue nitrogen prior to each EVA. Now that the Space Shuttle Program (SSP) is being retired, high-pressure oxygen will become a limited resource. The In-Suit Light Exercise (ISLE) Prebreathe Protocol offers several potential benefits including its potential to save 6 pounds of oxygen per EVA. At the request of the NASA Engineering and Safety Center, the peer review convened on October 14, 2010. The major recommendation of the Review Committee was that the ISLE protocol was acceptable for operational use as a prebreathe option prior to EVA. The results from the peer review are contained in this document.

  6. Comparing single-site with multisite rTMS for the treatment of chronic tinnitus – clinical effects and neuroscientific insights: study protocol for a randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Several years ago, repetitive transcranial magnetic stimulation (rTMS) of the auditory cortex has been introduced as a treatment approach for chronic tinnitus. Even if this treatment is beneficial for a subgroup of patients, the overall effects are limited. This limitation may be due to the fact that the auditory cortex is only one of several brain areas involved in tinnitus. Whereas auditory areas are considered to code for tinnitus loudness, conscious perception of and attention allocation to tinnitus is supposed to be reflected by network activity involving frontal and parietal cortical areas. The aim of the present study is to influence this frontoparietal network more efficiently by perturbing the most important nodes with rTMS. Methods/design This is a randomized, double-blind, parallel-group study. Patients receive rTMS treatment on 10 consecutive working days using either the multisite rTMS protocol (left dorsolateral prefrontal, 1,000 stimuli, 20 Hz; left temporoparietal, 1,000 stimuli, 1 Hz; right temporoparietal stimulation, 1,000 stimuli, 1 Hz) or a single-site protocol (unilateral stimulation of the temporoparietal cortex, 3,000 stimuli, 1 Hz). Individuals aged 18 to 70 years with chronic tinnitus ≥6-month duration and a Tinnitus Handicap Inventory score ≥38 are recruited for the study. A total of 50 patients are needed to detect a clinical relevant change of tinnitus severity (α = 0.05; 1 – β = 0.80). Primary outcome measures are the change in the Tinnitus Questionnaire score from baseline to the end of treatment as well as the number of treatment responders as defined by a reduction in the Tinnitus Questionnaire score of ≥5 points. Furthermore, changes in brain structure and activity are assessed using (functional) magnetic resonance imaging and electroencephalography in the resting state. Those measurements are also performed in 25 healthy control subjects. Discussion This study is designed to reveal whether network

  7. Shock wave therapy associated with eccentric strengthening versus isolated eccentric strengthening for Achilles insertional tendinopathy treatment: a double-blinded randomised clinical trial protocol

    Science.gov (United States)

    Mansur, Nacime Salomão Barbachan; Faloppa, Flávio; Belloti, João Carlos; Ingham, Sheila J McNeill; Matsunaga, Fabio Teruo; dos Santos, Paulo Roberto Dias; dos Santos, Bruno Schiefer; Carrazzone, Oreste Lemos; Peixoto, Gabriel; Aoyama, Bruno Takeshi; Tamaoki, Marcel Jun Sugawara

    2017-01-01

    Background There is no consensus regarding the treatment of Achilles insertional tendinopathies. Eccentric training remains the main choice in the conservative treatment of this illness; however, the good results in the management of non-insertional Achilles tendinopathy were not replicated in the insertional condition. Low energy shock wave therapy has been described as an alternative to these patients, but has yet to be empirically tested. Hypothesis Shock wave therapy, adjunctive to the eccentric strengthening protocol, will improve measures of pain and function. Design Double blind, placebo-controlled, parallel groups, randomised clinical trial. Materials and methods 93 patients with a diagnosis of chronic insertional tendinopathy, referred from primary or secondary healthcare services, will be assessed and enrolled in this study. They will be divided into two groups (randomised by sequentially numbered identical envelopes, which will be administered serially to participants), one containing the combination of low energy shock wave and eccentric exercises, as treatment and the other comprehending the exercises and the placebo treatment (an apparatus placed in the therapeutic head). The assessments will occur in 2, 4, 6, 12 and 24 weeks. Patients will be evaluated primarily by the Victorian Institute of Sport Assessment-Achilles questionnaire and secondarily by the visual analogue scale, Algometry, the American Orthopedic Foot and Ankle Society scale, the Foot and Ankle Outcome Score and the 12-item Short Form Health Survey. We will use comparison of two proportions via relative frequency analysis, the Pearson Correlation the χ2 test and the analysis of variance for statistical analyses. Discussion This study intends to demonstrate if the association of the eccentric exercise programme with the shock wave therapy can produce good results regarding the treatment of the Achilles insertional tendinopathy. In an attempt to prevent the high costs and complications

  8. Assessing Self-Regulation as a Cyclical, Context-Specific Phenomenon: Overview and Analysis of SRL Microanalytic Protocols

    Directory of Open Access Journals (Sweden)

    Timothy J. Cleary

    2012-01-01

    Full Text Available The primary purpose of this paper is to review relevant research related to the use of an assessment technique, called Self-Regulated Learning (SRL Microanalysis. This structured interview is grounded in social-cognitive theory and research and thus seeks to evaluate students' regulatory processes as they engage in well-defined academic or nonacademic tasks and activities. We illustrate the essential features of this contextualized assessment approach and detail a simple five-step process that researchers can use to apply this approach to their work. Example questions and administration procedures for five key self-regulation subprocesses (i.e., including goal-setting, strategic planning, monitoring, self-evaluation, and attributions are highlighted, with particular emphasis placed on causal attributions. The psychometric properties of SRL microanalytic assessment protocols and potential areas of future research are presented.

  9. Effect of different financial competing interest statements on readers' perceptions of clinical educational articles: study protocol for a randomised controlled trial

    Science.gov (United States)

    Schroter, Sara; Pakpoor, Julia; Morris, Julie; Chew, Mabel; Godlee, Fiona

    2016-01-01

    Introduction Financial ties with industry are varied and common among academics, doctors and institutions. Clinical educational articles are intended to guide patient care and convey authors' own interpretation of selected data. Author biases in educational articles tend to be less visible to readers compared to those in research papers. Little is known about which types of competing interest statements affect readers' interpretation of the credibility of these articles. This study aims to investigate how different competing interest statements in educational articles affect clinical readers' perceptions of the articles. Methods and analysis 2040 doctors who are members of the British Medical Association (BMA) and receive a copy of the British Medical Journal (The BMJ) each week will be randomly selected and invited by an email to participate in the study. They will be randomised to receive 1 of 2 Clinical Reviews, each with 1 of 4 possible competing interest statements. Versions of each review will be identical except for permutations of the competing interest statement. Study participants will be asked to read their article and complete an online questionnaire. The questionnaire will ask participants to rate their confidence in the conclusions drawn in the article, the importance of the article, their level of interest in the article and their likeliness to change their practice from the article. Factorial analyses of variance and analyses of covariance will be carried out to assess the impact of the type of competing interest statement and Clinical Review on level of confidence, importance, interest and likeliness to change practice. Ethics and dissemination The study protocol, questionnaire and letter of invitation to participants have been reviewed by members of The BMJ's Ethics Committee for ethical concerns. The trial results will be disseminated to participants and published in a peer-reviewed journal. Trial registration number NCT02548312; Pre

  10. Validation of a clinical assessment tool for spinal anaesthesia.

    LENUS (Irish Health Repository)

    Breen, D

    2011-07-01

    There is a need for a procedure-specific means of assessment of clinical performance in anaesthesia. The aim of this study was to devise a tool for assessing the performance of spinal anaesthesia, which has both content and construct validity.

  11. Large observer variation of clinical assessment of dyspnoeic wheezing children

    NARCIS (Netherlands)

    Bekhof, Jolita; Reimink, Roelien; Bartels, Ine-Marije; Eggink, Hendriekje; Brand, Paul L. P.

    2015-01-01

    Background In children with acute dyspnoea, the assessment of severity of dyspnoea and response to treatment is often performed by different professionals, implying that knowledge of the interobserver variation of this clinical assessment is important. Objective To determine intraobserver and intero

  12. The Fertility Assessment and Counselling Clinic - does the concept work?

    DEFF Research Database (Denmark)

    Petersen, Kathrine Birch; Maltesen, Thomas; Forman, Julie L.

    2017-01-01

    INTRODUCTION: The Fertility Assessment and Counselling (FAC) Clinic was initiated to provide women information about their current fertility status to prevent infertility and smaller families than desired. The aim was to study the predictive value of a risk assessment score based on known fertility...

  13. A novel staining protocol for multiparameter assessment of cell heterogeneity in Phormidium populations (cyanobacteria employing fluorescent dyes.

    Directory of Open Access Journals (Sweden)

    Daria Tashyreva

    Full Text Available Bacterial populations display high heterogeneity in viability and physiological activity at the single-cell level, especially under stressful conditions. We demonstrate a novel staining protocol for multiparameter assessment of individual cells in physiologically heterogeneous populations of cyanobacteria. The protocol employs fluorescent probes, i.e., redox dye 5-cyano-2,3-ditolyl tetrazolium chloride, 'dead cell' nucleic acid stain SYTOX Green, and DNA-specific fluorochrome 4',6-diamidino-2-phenylindole, combined with microscopy image analysis. Our method allows simultaneous estimates of cellular respiration activity, membrane and nucleoid integrity, and allows the detection of photosynthetic pigments fluorescence along with morphological observations. The staining protocol has been adjusted for, both, laboratory and natural populations of the genus Phormidium (Oscillatoriales, and tested on 4 field-collected samples and 12 laboratory strains of cyanobacteria. Based on the mentioned cellular functions we suggest classification of cells in cyanobacterial populations into four categories: (i active and intact; (ii injured but active; (iii metabolically inactive but intact; (iv inactive and injured, or dead.

  14. lower limbs kinematic assessment of the effect of a gym and hydrotherapy rehabilitation protocol after knee megaprosthesis: a case report.

    Science.gov (United States)

    Lovecchio, Nicola; Sciumè, Luciana; Zago, Matteo; Panella, Lorenzo; Lopresti, Maurizio; Sforza, Chiarella

    2016-03-01

    [Purpose] To quantitatively assess the effect of a personalized rehabilitation protocol after knee megaprosthesis. [Subject and Methods] The gait patterns of a 33-year-old male patient with knee synovial sarcoma were assessed by a computerized analysis before and after 40 rehabilitation sessions. [Results] The rehabilitation protocol improved the gait pattern. After rehabilitation, hip flexion was nearly symmetric, with normalized affected limb hip flexion, and improved ankle flexion. Ankle in/eversion was asymmetric and did not improve after physiotherapy. Before physiotherapy, the hip flexion on the affected side anticipated the movement but nearly normalized in the follow-up assessment. Hip abduction range of motion increased, with wider movements and good balance. Knee range of motion nearly symmetrized, but maintained an anticipated behavior, without shock absorption at heel-strike. [Conclusion] Instrumental gait analysis allowed us to gain evidence about the training and how to expand rehabilitative interventions to improve efficacy. In particular, we recommend quadriceps and gastrocnemius eccentric contraction training (to improve the shock absorption phase, preventing early failures of the prosthesis); one-leg standing performance (to improve the support phase of the affected limb); adductor strength training (to aid in hip control during the swing phase); and peroneus strength training (to increase ankle joint stabilization).

  15. Influence of societal and practice contexts on health professionals’ clinical reasoning: a scoping study protocol

    Science.gov (United States)

    Carrier, Annie; Levasseur, Mélanie; Freeman, Andrew; Mullins, Gary; Quénec'hdu, Suzanne; Lalonde, Louise; Gagnon, Michaël; Lacasse, Francis

    2013-01-01

    Introduction In a context of constrained resources, the efficacy of interventions is a pivotal aim of healthcare systems worldwide. Efficacy of healthcare interventions is highly compromised if clinical reasoning (CR), the process that practitioners use to plan, direct, perform and reflect on client care, is not optimal. The CR process of health professionals is influenced by the institutional dimension (ie, legal, regulatory, administrative and organisational aspects) of their societal and practice contexts. Although several studies have been conducted with respect to the institutional dimension influencing health professionals’ CR, no clear integration of their results is yet available. The aim of this study is to synthesise and disseminate current knowledge on the influence of the institutional dimension of contexts on health professionals’ CR. Methods and analysis A scoping study of the scientific literature from January 1980 to March 2013 will be undertaken to summarise and disseminate research findings about the influence of the institutional dimension on CR. Numerous databases (n=18) from three relevant fields (healthcare, health law and politics and management) will be searched. Extended search strategies will include the manual search of bibliographies, health-related websites, public registries and journals of interest. Data will be collected and analysed using a thematic chart and content analysis. A systematic multidisciplinary team approach will allow optimal identification of relevant studies, as well as effective and valid content analysis and dissemination of the results. Discussion This scoping study will provide a rigorous, accurate and up-to-date synthesis of existing knowledge regarding: (1) those aspects of the institutional dimension of health professionals’ societal and practice contexts that impact their CR and (2) how these aspects influence health professionals’ CR. Through the synergy of a multidisciplinary research team from a

  16. Liver iron concentration quantification by MRI: are recommended protocols accurate enough for clinical practice?

    Energy Technology Data Exchange (ETDEWEB)

    Castiella, Agustin; Zapata, Eva M. [Mendaro Hospital, Gastroenterology Service, Mendaro (Spain); Alustiza, Jose M. [Osatek Donostia, Radiology Service, Donostia (Spain); Emparanza, Jose I. [Donostia Hospital CASPe, CIBER-ESP, Clinical Epidemiology Unit, Donostia (Spain); Costero, Belen [Principe de Asturias Hospital, Gastroenterology Service, Alcala de Henares (Spain); Diez, Maria I. [Principe de Asturias Hospital, Radiology Service, Alcala de Henares (Spain)

    2011-01-15

    To assess the accuracy of quantification of liver iron concentration (LIC) by MRI using the Rennes University (URennes) algorithm. In the overall study period 1999-2006 the LIC in 171 patients was calculated with the URennes model and the results were compared with LIC measured by liver biopsy. The biopsy showed that 107 patients had no overload, 38 moderate overload and 26 high overload. The correlation between MRI and biopsy was r = 0.86. MRI correctly classified 105 patients according to the various levels of LIC. Diagnostic accuracy was 61.4%, with a tendency to overestimate overload: 43% of patients with no overload were diagnosed as having overload, and 44.7% of patients with moderate overload were diagnosed as having high overload. The sensitivity of the URennes method for high overload was 92.3%, and the specificity for the absence of overload was 57.0%. MRI values greater than 170 {mu}mol Fe/g revealed a positive predictive value (PPV) for haemochromatosis of 100% (n = 18); concentrations below 60 {mu}mol Fe/g had a negative predictive value (NPV) of 100% for haemochromatosis (n = 101). The diagnosis in 44 patients with intermediate values remained uncertain. The assessment of LIC with the URennes method was useful in 74.3% of the patients to rule out or to diagnose high iron overload. The method has a tendency to overestimate overload, which limits its diagnostic performance. (orig.)

  17. The treatment of super-refractory status epilepticus: a critical review of available therapies and a clinical treatment protocol.

    Science.gov (United States)

    Shorvon, Simon; Ferlisi, Monica

    2011-10-01

    Super-refractory status epilepticus is defined as status epilepticus that continues or recurs 24 h or more after the onset of anaesthetic therapy, including those cases where status epilepticus recurs on the reduction or withdrawal of anaesthesia. It is an uncommon but important clinical problem with high mortality and morbidity rates. This article reviews the treatment approaches. There are no controlled or randomized studies, and so therapy has to be based on clinical reports and opinion. The published world literature on the following treatments was critically evaluated: anaesthetic agents, anti-epileptic drugs, magnesium infusion, pyridoxine, steroids and immunotherapy, ketogenic diet, hypothermia, emergency resective neurosurgery and multiple subpial transection, transcranial magnetic stimulation, vagal nerve stimulation, deep brain stimulation, electroconvulsive therapy, drainage of the cerebrospinal fluid and other older drug therapies. The importance of treating the identifying cause is stressed. A protocol and flowchart for managing super-refractory status epilepticus is suggested. In view of the small number of published reports, there is an urgent need for the establishment of a database of outcomes of individual therapies.

  18. Assessment of compliance regarding the protocol for the prevention of pneumonia associated with ventilator

    Directory of Open Access Journals (Sweden)

    Aikaterini Revenioti

    2015-01-01

    Full Text Available The hospital-acquired pneumonia is the most frequent cause of death and is associated with mortality rates up to 30%. Aim: The aim of the present study was to explore the degree of compliance with the protocol on the prevention of VAP by nurses in ICU. Material and methods: The studied sample consisted of 164 nurses (response rate 76.6% working in ICU of nine (9 Hospitals in Attica. For data collection it was used a special designed questionnaire. Data analysis was performed by the statistical package SPSS ver. 15. Results: 25.6% (n = 42 of the sample were men. 43.9% (n = 72 had experience in ICU <5 years, 30.5% (n = 50 6-10 years and 25.6% (n = 42 11-15 years. The compliance rate of the sample with the instructions of the protocol on the prevention of VAP was 69.3 ± 17.2%. Men complied significantly more (69.3 ± 17.2% than women (68.5 ± 18.2% (p <0.001. Nurses with less experience in ICU complied significantly less than the others (p <0.001. The compliance of the respiratory ICU nurses was significantly greater than in other ICUs (p <0.001. Conclusions: The compliance rate for ICU nurses with protocols to prevent VAP is satisfactory. The role of nurses in the prevention of VAP is very important and can help reduce morbidity, mortality, length of patient stay in hospital and reduce health care costs.

  19. Initial recommendations for higher-tier risk assessment protocols for bumble bees, Bombus spp. (Hymenoptera: Apidae).

    Science.gov (United States)

    Cabrera, Ana R; Almanza, Maria Teresa; Cutler, G Christopher; Fischer, David L; Hinarejos, Silvia; Lewis, Gavin; Nigro, Daniel; Olmstead, Allen; Overmyer, Jay; Potter, Daniel A; Raine, Nigel E; Stanley-Stahr, Cory; Thompson, Helen; van der Steen, Jozef

    2016-04-01

    Global declines of bumble bees and other pollinator populations are of concern because of their critical role for crop production and maintenance of wild plant biodiversity. Although the consensus among scientists is that the interaction of many factors, including habitat loss, forage scarcity, diseases, parasites, and pesticides, potentially plays a role in causing these declines, pesticides have received considerable attention and scrutiny. In response, regulatory agencies have introduced more stringent pollinator testing requirements for registration and reregistration of pesticides, to ensure that the risks to pollinators are minimized. In this context, guidelines for testing bumble bees (Bombus spp.) in regulatory studies are not yet available, and a pressing need exists to develop suitable protocols for routine higher-tier studies with these non-Apis sp., social bees. To meet this need, Bayer CropScience LP, Syngenta Crop Protection LLC US, and Valent USA. Corporation organized a workshop bringing together a group of global experts on bumble bee behavior, ecology, and ecotoxicology to discuss and develop draft protocols for both semi-field (Tier II) and field (Tier III) studies. The workshop was held May 8-9, 2014, at the Bayer Bee Care Center, North Carolina, USA. The participants represented academic, consulting, and industry scientists from Europe, Canada, the United States, and Brazil. The workshop identified a clear protection goal and generated proposals for basic experimental designs, relevant measurements, and endpoints for both semifield (tunnel) and field tests. These initial recommendations are intended to form the basis of discussions to help advance the development of appropriate protocol guidelines.

  20. Comparison of student self-assessment with faculty assessment of clinical competence.

    Science.gov (United States)

    Root Kustritz, Margaret V; Molgaard, Laura K; Rendahl, Aaron

    2011-01-01

    At the University of Minnesota, fourth-year veterinary students assessed their clinical competence after completion of a small-animal, internal-medicine clinical rotation using the same rotation assessment form used by supervising faculty. Grades were compared between the two groups. Students identified by faculty as low-performing were more likely to overestimate their competence in the areas of knowledge, clinical skill, and professionalism than were students identified by faculty as higher performing. This finding mirrors research results in human health professional training. Self-assessment should not be used as the primary or sole measure of clinical competence in veterinary medical training without the introduction of measures to ensure the accuracy of student self-assessment, measures that include active faculty mentoring of student self-assessment, student goal-setting and reflection, and availability of subsequent opportunities to practice additional self-assessment.

  1. Involving patient in the early stages of health technology assessment (HTA): a study protocol

    OpenAIRE

    Gagnon, Marie-Pierre; Candas, Bernard; Desmartis, Marie; Gagnon, Johanne; Roche, Daniel La; Rhainds, Marc; Coulombe, Martin; Dipankui, Mylène Tantchou; Légaré, France

    2014-01-01

    Background Public and patient involvement in the different stages of the health technology assessment (HTA) process is increasingly encouraged. The selection of topics for assessment, which includes identifying and prioritizing HTA questions, is a constant challenge for HTA agencies because the number of technologies requiring an assessment exceeds the resources available. Public and patient involvement in these early stages of HTA could make assessments more relevant and acceptable to them. ...

  2. Towards Enhanced Second Language Reading Comprehension Assessment: Computerized versus Manual Scoring of Written Recall Protocols

    Science.gov (United States)

    Heinz, Peter J.

    2004-01-01

    Second language (L2) reading comprehension assessment has long relied upon classical quantitative, product-oriented measurement techniques (i.e., multiple-choice and cloze) in both research and classroom assessment. As Bernhardt (1991) clearly demonstrated, these traditionally employed assessment methods are unable to capture the complex processes…

  3. The effectiveness of a health promotion with group intervention by clinical trial. Study protocol

    Directory of Open Access Journals (Sweden)

    Campo Osaba Maria-Antonia

    2012-03-01

    Full Text Available Abstract Background The promotion of health and the interventions in community health continue to be one of the pending subjects of our health system. The most prevalent health problems (cardiovascular diseases, cancer, diabetes... are for the most part related to life habits. We propose a holistic and integral approach as the best option for tackling behavior and its determinants. The research team has elaborated the necessary educational material to realize group teaching, which we call "Health Workshops". The goal of the present study is to evaluate the effectiveness of these Health Workshops in the following terms: Health Related Quality of Life (HRQOL, incorporate and maintain a balanced diet, do physical activity regularly, maintain risk factors such as tension, weight, cholesterol within normal limits and diminish cardiovascular risk. Methods/Design Controlled and random clinical testing, comparing a group of persons who have participated in the Health Workshops with a control group of similar characteristics who have not participated in the Health Workshops. Field of study: the research is being done in Health Centers of the city of Barcelona, Spain. Population studied: The group is composed of 108 persons that are actually doing the Health Workshops, and 108 that are not and form the control group. They are assigned at random to one group or the other. Data Analysis: With Student's t-distribution test to compare the differences between numerical variables or their non parametric equivalent if the variable does not comply with the criteria of normality. (Kolmogorov-Smirnof test. Chi-square test to compare the differences between categorical variables and the Logistic Regression Model to analyze different meaningful variables by dichotomous analysis related to the intervention. Discussion The Health Workshop proposed in the present study constitutes an innovative approach in health promotion, placing the emphasis on the person's self

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

    Science.gov (United States)

    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).

  5. Current protocols in the generation of pluripotent stem cells: theoretical, methodological and clinical considerations

    Directory of Open Access Journals (Sweden)

    Brad B Swelstad

    2009-12-01

    Full Text Available Brad B Swelstad, Candace L KerrInstitute for Cell Engineering, Department of Obstetrics and Gynecology, Johns Hopkins University, Baltimore, MA, USAAbstract: Pluripotent stem cells have been derived from various embryonic, fetal and adult sources. Embryonic stem cells (ESCs and parthenogenic ESCs (pESCs are derived from the embryo proper while embryonic germ cells (EGCs, embryonal carcinoma cells (ECCs, and germ-line stem cells (GSC are produced from germ cells. ECCs were the first pluripotent stem cell lines established from adult testicular tumors while EGCs are generated in vitro from primordial germ cells (PGCs isolated in late embryonic development. More recently, studies have also demonstrated the ability to produce GSCs from adult germ cells, known as spermatogonial stem cells. Unlike ECCs, the source of GSCs are normal, non-cancerous adult tissue. The study of these unique cell lines has provided information that has led to the ability to reprogram somatic cells into an ESC-like state. These cells, called induced pluripotent stem cells (iPSCs, have been derived from a number of human fetal and adult origins. With the promises pluripotent stem cells bring to cell-based therapies there remain several considerations that need to be carefully studied prior to their clinical use. Many of these issues involve understanding key factors regulating their generation, including those which define pluripotency. In this regard, the following article discusses critical aspects of pluripotent stem cell derivation and current issues about their therapeutic potential.Keywords: pluripotency, stem cells, derivation, human

  6. Current protocols in the generation of pluripotent stem cells: theoretical, methodological and clinical considerations.

    Science.gov (United States)

    Swelstad, Brad B; Kerr, Candace L

    2009-12-22

    Pluripotent stem cells have been derived from various embryonic, fetal and adult sources. Embryonic stem cells (ESCs) and parthenogenic ESCs (pESCs) are derived from the embryo proper while embryonic germ cells (EGCs), embryonal carcinoma cells (ECCs), and germ-line stem cells (GSC) are produced from germ cells. ECCs were the first pluripotent stem cell lines established from adult testicular tumors while EGCs are generated in vitro from primordial germ cells (PGCs) isolated in late embryonic development. More recently, studies have also demonstrated the ability to produce GSCs from adult germ cells, known as spermatogonial stem cells. Unlike ECCs, the source of GSCs are normal, non-cancerous adult tissue. The study of these unique cell lines has provided information that has led to the ability to reprogram somatic cells into an ESC-like state. These cells, called induced pluripotent stem cells (iPSCs), have been derived from a number of human fetal and adult origins. With the promises pluripotent stem cells bring to cell-based therapies there remain several considerations that need to be carefully studied prior to their clinical use. Many of these issues involve understanding key factors regulating their generation, including those which define pluripotency. In this regard, the following article discusses critical aspects of pluripotent stem cell derivation and current issues about their therapeutic potential.

  7. Clinical assessment of selenium status of livestock.

    Science.gov (United States)

    Stowe, H D; Herdt, T H

    1992-12-01

    Assessment of the selenium status of livestock is an important aspect of production medicine, but variations in reported values between laboratories and between methods may be > 30%. Reliable interpretations require considerable experience with an assay and an extensive database from field and research case samples of a variety of species. The Michigan State University Animal Health Diagnostic Laboratory (MSU-ADHL) has offered Se analyses by acid-digestion and fluorometric detection since 1982. This laboratory expects serum Se values (nanograms per milliliter) of livestock to increase gradually with age from starting ranges for neonates of 50 to 80 for calves and sheep and 70 to 90 for foals and pigs. Expected or "normal" values for the adults are in the ranges of 70 to 100 for cattle, 120 to 150 for sheep, 130 to 160 for horses, and 180 to 220 for swine. Normal liver Se concentrations are considered to range between 1.2 and 2.0 micrograms/g on a dry weight basis, regardless of the species or age. Based on samples submitted to MSU-AHDL between September 1990 and August 1991, contemporary feeding practices in the Michigan area resulted in mean serum Se values (nanograms per milliliter) of 75 +/- 19 for adult Holsteins, 170 +/- 27 for adult swine (mixed breeds), and 137 +/- 30 for adult race horses. Within that period of time, two field cases of Se toxicity were diagnosed. One involved feeder pigs with a recorded high serum Se value of 1,525 ng/mL due to a commercial premix manufacturing error.(ABSTRACT TRUNCATED AT 250 WORDS)

  8. Assessment of High and Low Rate Protocol-based Attacks on Ethernet Networks

    Directory of Open Access Journals (Sweden)

    Mina Malekzadeh

    2015-07-01

    Full Text Available The Internet and Web have significantly transformed the world’s communication system. The capability of the Internet to instantly access information at anytime from anywhere has brought benefit for a wide variety of areas including business, government, education, institutions, medical, and entertainment services. However, the Internet has also opened up the possibilities for hackers to exploit flaws and limitations in the target networks to attack and break in without gaining physical access to the target systems. The OSI layer protocol-based attacks are among them. In this work we investigate feasibility as well as severity of the attacks against three common layering protocols including TCP, UDP, and ICMP on Ethernet-based networks in the real world through a testbed. Then a simulation environment is designed to implement the exact same attacks under similar conditions using NS2 network simulator. The testbed results and simulation results are compared with each other to explore the accuracy of the findings and measure the damages the attacks caused to the network.

  9. Assessment of the antifungal susceptibility of Malassezia pachydermatis in various media using a CLSI protocol.

    Science.gov (United States)

    Cafarchia, Claudia; Figueredo, Luciana A; Favuzzi, Vincenza; Surico, Mariannna R; Colao, Valeriana; Iatta, Roberta; Montagna, Maria Teresa; Otranto, Domenico

    2012-10-12

    The microdilution antifungal method (CLSI BMD, M27-A3) was used for testing the antifungal susceptibility of Malassezia species. However, optimal broth media that allow sufficient growth of M. pachydermatitis and produce reliable and reproducible MICs using the CLSI BMD protocol are yet to be established. In this study, the susceptibility of M. pachydermatis isolates to ketoconazole (KTZ), itraconazole (ITZ) and fluconazole (FLZ) was evaluated in vitro by the CLSI BMD test using Christensen's urea broth (CUB) and mRPMI 1640 containing lipid supplementation, Sabouraud dextrose broth with 1% tween 80 (SDB), and Dixon broth (DXB). A FLZ-resistant M. pachydermatis was generated in vitro and tested under the same conditions. A good growth of M. pachydermatis incubated for 48 and 72 h, respectively, was observed in CUB, SDB and DXB and not in mRPMI 1640 (p64 mg/L was observed only when the FLZ-resistant M. pachydermatis isolate was tested in SDB. Based on the results obtained herein, culture in SDB, stock inoculum suspensions of 1-5 × 10(6)CFU/ml, and an incubation time of 48 h are proposed as optimal conditions for the evaluation of the in vitro antifungal susceptibility of M. pachydermatis using a modified CLSI BMD protocol.

  10. Clinical Study of Endostar Combined with DP Protocol in Treatment of Advanced Esophageal Cancer

    Directory of Open Access Journals (Sweden)

    Wen-ying DENG

    2015-09-01

    Full Text Available Objective: To observe the clinical outcomes of Endostar combined with DP regimen for treating advanced esophageal cancer.Methods: A total of 62 patients with advanced esophageal cancer admitted from May, 2011 to May, 2013 were enrolled for a prospective, randomized controlled trial and 2 cases were excluded from the study because of Ⅳ degree of digestive tract reaction and myelosuppression. Therefore, 60 cases could be evaluated, and then divided into combined group (given Endostar+DP plan and single chemotherapy group, 30 cases in each group. The level of VEGF, tumor size and CT perfusion (CTP parameters, including blood flow (BF, blood volume (BV, mean transit time (MTT, and permeability surface (PS before and after treatment were determined for comparison. Kaplan-Merier method was used to analyze the overall survival (OS of 2 groups.Results: The efficacy of combined group was superior to single chemotherapy group. The level of vascular endothelial growth factor (VEGF in combined group was obviously lower than that in single chemotherapy group after treatment (P<0.01. Compared with treatment before in combined group, BF, BV and PS decreased while MTT increased after treatment (P<0.05. However, there were no significant differences in single chemotherapygroup before and after treatment (P>0.05. The median OS was 30 months (95%CI: 20.935-39.065 for combined group and 21 months (95%CI: 15.109-26.591 for single chemotherapy group, respectively (P=0.048. The 1-, 2- and 3-year survival rates were 86.2%, 59.3% and 36.6% in combined group, and 70.8%, 32.1% and 17.8% in single chemotherapy group, respectively.Conclusion: Endostar can down-regulate the expression of VEGF, improve the state of hypertransfusion and high permeability of tumor vessels, has better curative effect without slighter adverse reactions, and prolong the survival time of patients with advanced esophageal cancer when combined with chemotherapy.

  11. Clinical Study of Endostar Combined with DP Protocol in Treatment of Advanced Esophageal Cancer

    Institute of Scientific and Technical Information of China (English)

    DENG Wen-ying; LI Ning; LUO Su-xia

    2015-01-01

    Objective: To observe the clinical outcomes of Endostar combined with DP regimen for treating advanced esophageal cancer. Methods: A total of 62 patients with advanced esophageal cancer admitted from May, 2011 to May, 2013 were enrolled for a prospective, randomized controlled trial and 2 cases were excluded from the study because ofⅣ degree of digestive tract reaction and myelosuppression. Therefore, 60 cases could be evaluated, and then divided into combined group (given Endostar+DP plan) and single chemotherapy group, 30 cases in each group. The level of VEGF, tumor size and CT perfusion (CTP) parameters, including blood flow (BF), blood volume (BV), mean transit time (MTT), and permeability surface (PS) before and after treatment were determined for comparison. Kaplan-Merier method was used to analyze the overall survival (OS) of 2 groups. Results:The efifcacy of combined group was superior to single chemotherapy group. The level of vascular endothelial growth factor (VEGF) in combined group was obviously lower than that in single chemotherapy group after treatment (P0.05). The median OS was 30 months (95%CI: 20.935-39.065) for combined group and 21 months (95%CI: 15.109-26.591) for single chemotherapy group, respectively (P=0.048). The 1-, 2- and 3-year survival rates were 86.2%, 59.3% and 36.6% in combined group, and 70.8%, 32.1% and 17.8% in single chemotherapy group, respectively. Conclusion: Endostar can down-regulate the expression of VEGF, improve the state of hypertransfusion and high permeability of tumor vessels, has better curative effect without slighter adverse reactions, and prolong the survival time of patients with advanced esophageal cancer when combined with chemotherapy.

  12. Hepatocellular carcinoma: From clinical practice to evidence-based treatment protocols

    Institute of Scientific and Technical Information of China (English)

    Danijel; Galun; Dragan; Basaric; Marinko; Zuvela; Predrag; Bulajic; Aleksandar; Bogdanovic; Nemanja; Bidzic; Miroslav; Milicevic

    2015-01-01

    Hepatocellular carcinoma(HCC) is one of the major malignant diseases in many healthcare systems. The growing number of new cases diagnosed each year is nearly equal to the number of deaths from this cancer. Worldwide, HCC is a leading cause of cancerrelated deaths, as it is the fifth most common cancer and the third most important cause of cancer related death in men. Among various risk factors the two are prevailing: viral hepatitis, namely chronic hepatitis C virus is a well-established risk factor contributing to the rising incidence of HCC. The epidemic of obesity and the metabolic syndrome, not only in the United States but also in Asia, tend to become the leading cause of the long-term rise in the HCC incidence. Today, the diagnosis of HCC is established within the national surveillance programs in developed countries while the diagnosis of symptomatic, advanced stage disease still remains the characteristic of underdeveloped countries. Although many different staging systems have been developed and evaluated the BarcelonaClinic Liver Cancer staging system has emerged as the most useful to guide HCC treatment. Treatment allocation should be decided by a multidisciplinary board involving hepatologists, pathologists, radiologists, liver surgeons and oncologists guided by personalized-based medicine. This approach is important not only to balance between different oncologic treatments strategies but also due to the complexity of the disease(chronic liver disease and the cancer) and due to the large number of potentially efficient therapies. Careful patient selection and a tailored treatment modality for every patient, either potentially curative(surgical treatment and tumor ablation) or palliative(transarterial therapy, radioembolization and medical treatment, i.e., sorafenib) is mandatory to achieve the best treatment outcome.

  13. Cognitive Assessment of Elderly Inpatients: A Clinical Audit

    Directory of Open Access Journals (Sweden)

    Elizabeth Shermon

    2015-01-01

    Full Text Available Background: Comprehensive geriatric assessment including cognitive assessment results in better outcomes and quality of life through facilitating access to support and further care. The National Audit of Dementia Care revealed too few patients were being assessed for cognition and therefore failing to receive adequate care. Methods: This was a retrospective clinical audit in a district general hospital with systematic sampling of the clinical records of 50 inpatients on an elderly care ward. A descriptive analysis of the results was performed. Results: Despite guidance that cognitive assessment should be performed on admission, this was only documented in 22% of the medical notes. However, this rate improved to 56% by discharge. The most commonly used tool was the Abbreviated Mental Test (AMT 10. Assessment completion was independent of gender or social support, but only patients aged over 75 years were assessed. Of those, 75% had some level of cognitive impairment and 36.8% received a new or suspected diagnosis of dementia. Discussion: Cognitive assessment rates continue to be low. Our findings support the need for increased education regarding the importance and benefits of assessment as well as how to complete and document the assessment correctly. Conclusion: Cognitive assessment rates need to be further improved to promote better outcomes for patients with dementia.

  14. Assessment of the arteriovenous cerebrovascular system by multi-slice CT. A single-bolus, monophasic protocol

    Energy Technology Data Exchange (ETDEWEB)

    Klingebiel, R.; Zimmer, C. [Charite CM, Humboldt Univ., Berlin (Germany). Neuroradiology Section; Rogalla, P.; Kivelitz, D. [Charite CM, Humboldt Univ., Berlin (Germany). Dept. of Radiology; Bohner, G. [Charite CM, Humboldt Univ., Berlin (Germany). Neuroradiology Section; Goetze, R. [Charite CM, Humboldt Univ., Berlin (Germany). Dept. of Radiology; Lehmann, R. [Charite CM, Humboldt Univ., Berlin (Germany). Neuroradiology Section

    2001-11-01

    Purpose: We present a protocol for the non-invasive angiographic assessment of the arterial and venous cerebrovascular (CV) system by multi-slice CT. Material and Methods: Data acquisition was performed in a multi-slice CT scanner with a scan range from the carotid bifurcation to the vertex and manual scan start following i.v. administration of 120 ml iodinated contrast medium with a flow rate of 4 ml/s. This protocol was applied in 12 patients with symptoms of acute CV insufficiency. Results: In all patients, comprehensive imaging of the arteriovenous CV system was achieved including the common carotid bifurcation, the third segment of the major cerebral arteries, the dural sinus and the internal cerebral veins. Various CV pathologies, such as a territorial artery occlusion, a thrombotic obstruction of the internal carotid artery, an intracranial arteriovenous malformation and a sinus vein thrombosis, were successfully evaluated. Conclusion: Comprehensive assessment of the arteriovenous CV system is possible by the use of a single-bolus, monophasic multi-slice scan technique.

  15. Energy efficiency and pollution prevention assessment protocol in the polymer processing industries. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Nardone, John; Sansone, Leonard; Kenney, William; Christodoulatos, Christos; Koutsospyros, Agamemnon

    1998-03-31

    This report was developed from experiences with three New Jersey firms and is intended to be a guide for conducting analyses on resource (energy and raw materials) utilization and pollution (solid waste, air and water emissions) prevention in plastics processing plants. The protocol is written on the assumption that the analysis is to be done by an outside agency such as a consulting firm, but it also can be used for internal audits by plant teams. Key concepts in this analysis were adapted from life cycle analysis. Because of the small sample of companies studied, the results have to be considered high preliminary, but some of the conclusions will probably be confirmed by further work.

  16. Integrating Authentic Assessment with Competence-Based Learning in Vocational Education: The Protocol Portfolio Scoring

    Science.gov (United States)

    Sluijsmans, Dominique M. A.; Straetmans, Gerard J. J. M.; van Merrienboer, Jeroen J. G.

    2008-01-01

    This article describes how competence-based learning (CBL) can be organised in vocational education by integrating elements from a holistic instructional design model with recent ideas on assessment. A curriculum based on this model is pre-eminently suitable for an assessment approach emphasising that proof of competence is gathered by having…

  17. Using systematically observed clinical encounters (SOCEs to assess medical students’ skills in clinical settings

    Directory of Open Access Journals (Sweden)

    George R Bergus

    2010-11-01

    Full Text Available George R Bergus1–3, Jerold C Woodhead4, Clarence D Kreiter2,51Performance Based Assessment Program, Office of Student Affairs and Curriculum, 2Department of Family Medicine, 3Department of Psychiatry, 4Department of Pediatrics, 5Office of Consultation and Research in Medical Education, Roy J and Lucille A Carver College of Medicine, The University of Iowa, Iowa City, IA, USAIntroduction: The Objective Structured Clinical Examination (OSCE is widely used to assess the clinical performance of medical students. However, concerns related to cost, availability, and validity, have led educators to investigate alternatives to the OSCE. Some alternatives involve assessing students while they provide care to patients – the mini-CEX (mini-Clinical Evaluation Exercise and the Long Case are examples. We investigated the psychometrics of systematically observed clinical encounters (SOCEs, in which physicians are supplemented by lay trained observers, as a means of assessing the clinical performances of medical students.Methods: During the pediatrics clerkship at the University of Iowa, trained lay observers assessed the communication skills of third-year medical students using a communication checklist while the students interviewed and examined pediatric patients. Students then verbally presented their findings to faculty, who assessed students’ clinical skills using a standardized form. The reliability of the combined communication and clinical skills scores was calculated using generalizability theory.Results: Fifty-one medical students completed 199 observed patient encounters. The mean combined clinical and communication skills score (out of a maximum 45 points was 40.8 (standard deviation 3.3. The calculated reliability of the SOCE scores, using generalizability theory, from 10 observed patient encounters was 0.81. Students reported receiving helpful feedback from faculty after 97% of their observed clinical encounters.Conclusion: The SOCE can

  18. Clinically assessed mediolateral knee motion: impact on gait

    DEFF Research Database (Denmark)

    Thorlund, Jonas Bloch; Creaby, Mark W; Simic, Milena;

    2011-01-01

    Mediolateral knee movement can be assessed visually with clinical tests. A knee-medial-to-foot position is associated with an increased risk of knee injuries and pathologies. However, the implications of such findings on daily tasks are not well understood. The aim of this study was to investigate...... if a knee-medial-to-foot position assessed during a clinical test was associated with altered hip and knee joint kinematics and knee joint kinetics during gait compared with those with a knee-over-foot position....

  19. An exploration of the role of pharmacists within general practice clinics: the protocol for the pharmacists in practice study (PIPS

    Directory of Open Access Journals (Sweden)

    Tan Edwin

    2012-08-01

    Full Text Available Abstract Background Medication-related problems are a serious concern in Australian primary care. Pharmacist interventions have been shown to be effective in identifying and resolving these problems. Collaborative general practitioner-pharmacist services currently available in Australia are limited and underused. Limitations include geographical isolation of pharmacists and lack of communication and access to patient information. Co-location of pharmacists within the general practice clinics is a possible solution. There have been no studies in the Australian setting exploring the role of pharmacists within general practice clinics. The aim of this study is to develop and test a multifaceted practice pharmacist role in primary care practices to improve the quality use of medicines by patients and clinic staff. Methods/design This is a multi-centre, prospective intervention study with a pre-post design and a qualitative component. A practice pharmacist will be located in each of two clinics and provide short and long patient consultations, drug information services and quality assurance activities. Patients receiving long consultation with a pharmacist will be followed up at 3 and 6 months. Based on sample size calculations, at least 50 patients will be recruited for long patient consultations across both sites. Outcome measures include the number, type and severity of medication-related problems identified and resolved; medication adherence; and patient satisfaction. Brief structured interviews will be conducted with patients participating in the study to evaluate their experiences with the service. Staff collaboration and satisfaction with the service will be assessed. Discussion This intervention has the potential to optimise medication use in primary care clinics leading to better health outcomes. This study will provide data about the effectiveness of the proposed model for pharmacist involvement in Australian general practice clinics

  20. Protocol for the BAG-RECALL clinical trial: a prospective, multi-center, randomized, controlled trial to determine whether a bispectral index-guided protocol is superior to an anesthesia gas-guided protocol in reducing intraoperative awareness with explicit recall in high risk surgical patients

    Directory of Open Access Journals (Sweden)

    Villafranca Alex

    2009-11-01

    Full Text Available Abstract Background Awareness with explicit recall of intra-operative events is a rare and distressing complication that may lead to severe psychological symptoms. Candidate depth of anesthesia monitors have been developed, partly with the aim of preventing this complication. Despite conflicting results from clinical trials and the lack of incisive validation, such monitors have enjoyed widespread clinical adoption, in particular the bispectral index. The American Society of Anesthesiologists has called for adequately powered and rigorously designed clinical trials to determine whether the use of such monitors decreases the incidence of awareness in various settings. The aim of this study is to determine with increased precision whether incorporating the bispectral index into a structured general anesthesia protocol decreases the incidence of awareness with explicit recall among a subset of surgical patients at increased risk for awareness and scheduled to receive an inhalation gas-based general anesthetic. Methods/Design BAG-RECALL is a multi-center, randomized, controlled clinical trial, in which 6,000 patients are being assigned to bispectral index-guided anesthesia (target range, 40 to 60 or end-tidal anesthetic gas-guided anesthesia (target range, 0.7 to 1.3 age-adjusted minimum alveolar concentration. Postoperatively, patients are being assessed for explicit recall at two intervals (0 to 72 hours, and 30 days after extubation. The primary outcome of the trial is awareness with explicit recall. Secondary outcomes include postoperative mortality, psychological symptoms, intensive care and hospital length of stay, average anesthetic gas administration, postoperative pain and nausea and vomiting, duration of stay in the recovery area, intra-operative dreaming, and postoperative delirium. Discussion This trial has been designed to complement two other clinical trials: B-Unaware and MACS (ClinicalTrials.gov numbers, NCT00281489 and NCT00689091

  1. STUDENTS' SELF-ASSESSMENT IN PRE-CLINICAL AND CLINICAL EDUCATION OF PROSTHETIC DENTISTRY

    Directory of Open Access Journals (Sweden)

    Dimiter Kirov

    2014-09-01

    Full Text Available Background: The ability to self-assess is a critical skill that all health professionals must be able to do, in order to achieve competence. This is essential for the doctors of dental medicine. During their education and practice they apply different clinical and para-clinical procedures. The aim is to evaluate the students' self-assessment skills during the education of clinic and pre-clinic of prosthetic dentistry. Material and methods: After the completion of certain work - preparation for full veneer crown, a questionnaire was provided to each student in preclinical course (n=30 and clinical course (n=30 for self-evaluation. The questionnaire involved: axial reduction, occlusal reduction, facial and lingual reduction, smoothing and finishing. The answers were based on the standard for the university grading scale. Than, the same questionnaire was fulfilled by the assistant professor without seeing students' self-evaluation. Results and Discussion: Results have been reported in percentages. 100% respond rate has been achieved. The students from the preclinical course tend to overestimate their performance (50%. The students from the clinical course tend to submit overall lower grades than the faculty evaluation (25%. Conclusions: The students from clinics have better self-assessment skills. The discrepancy was most pronounced in the junior students. The different evaluations (self-assessment and assistant professor's help students to improve their understanding of certain principles and improve the teaching effectiveness of education of prosthetic dentistry.

  2. Surgical Protocol and Short-Term Clinical Outcome of Immediate Placement in Molar Extraction Sockets Using a Wide Body Implant

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    Stefan Vandeweghe

    2011-08-01

    Full Text Available Objectives: Implant placement in molar extraction sockets can be difficult due to complex multi-root anatomy and the lack of predictable primary stability. The aim of this study was to evaluate the outcome of an 8 - 9 mm diameter tapered implant, designed to be placed in molar extraction sockets.Material and methods: Patients treated at least 1 year before with a Max® implant (Southern Implants, Irene, South Africa were invited for a clinical examination. Variables collected were surgical and prosthetic protocol, implant dimension and smoking habits. Peri-implant bone level was determined on peri-apical radiographs and compared to baseline, being implant insertion.Results: 98 implants had been placed in 89 patients. One implant had failed. Thirty eight patients representing 47 implants (maxilla 26, mandible 21 were available for clinical examination. Mean bone loss was 0.38 mm (SD 0.48; range - 0.50 – 1.95 after a mean follow-up of 20 months (range 12 - 35. Implant success was 97.9%. Around 30 implants, a bone substitute was used to fill the residual space, but this did not affect the bone loss outcome. Bone loss was only significantly different between maxilla and mandible (0.48 mm vs. 0.27 mm and between the 8 and 9 mm diameter implants (0.23 mm vs. 0.55 mm. A full papilla was present at 71% of the interproximal sites and irrespective of bone loss.Conclusions: The Max® implant demonstrated good primary stability, when placed in molar extraction sockets, with limited bone loss over time.

  3. Parthenium dermatitis severity score to assess clinical severity of disease

    OpenAIRE

    Kaushal K Verma; Arika Bansal; Neetu Bhari; Gomathy Sethuraman

    2017-01-01

    Background: Parthenium dermatitis is the most common type of airborne contact dermatitis in India. It is a chronic disease of a remitting and relapsing course with significant morbidity and distress, but there is no scoring system to assess its severity. Aim: To design a scoring system for the assessment of clinical severity of disease in Parthenium dermatitis and to use this scoring system in various studies to determine its sensitivity, specificity, and reproducibility. Methods and Results:...

  4. Comparative of three sampling protocols for water quality assessment using macro invertebrates; Comparacion de tres protocolos de muestreo de macroinvertebrados para determinar la calidad del agua

    Energy Technology Data Exchange (ETDEWEB)

    Puertolas Domenech, L.; Rieradevall Sant, M.; Prat Fornells, N.

    2007-07-01

    The implementation of the Water Framework directive (WFD, Directive 2000/60/CE) requires the establishment of standardized sampling protocols for the assessment of benthic fauna. In this paper, a comparative study of several sampling protocols that are used currently in Spain and Europe (AQEM, EPA and Guadalmed) has been carried out. Evaluating the three protocols with a list of 12 criteria, Guadalmed fits better to the most of them. therefore it appears as an efficient tool in the determination of Ecological Status. (Author)

  5. Do pressure ulcer risk assessment scales improve clinical practice?

    Directory of Open Access Journals (Sweden)

    Jan Kottner

    2010-07-01

    Full Text Available Jan Kottner1, Katrin Balzer21Department of Nursing Science, Charité-Universitätsmedizin Berlin, Germany; 2Nursing Research Group, Institute for Social Medicine, Universitätsklinikum Schleswig-Holstein, Lübeck, GermanyAbstract: Standardized assessment instruments are deemed important for estimating pressure ulcer risk. Today, more than 40 so-called pressure ulcer risk assessment scales are available but still there is an ongoing debate about their usefulness. From a measurement point of view pressure ulcer (PU risk assessment scales have serious limitations. Empirical evidence supporting the validity of PU risk assessment scale scores is weak and obtained scores contain varying amounts of measurement error. The concept of pressure ulcer risk is strongly related to the general health status and severity of illness. A clinical impact due do the application of these scales could also not be demonstrated. It is questionable whether completion of standardized pressure ulcer risk scales in clinical practice is really needed.Keywords: Braden pressure ulcer, prevention, risk assessment, nursing assessment, predictive value, clinical effectiveness, review

  6. HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial

    NARCIS (Netherlands)

    Wijk, R.M. van; Boere-Boonekamp, M.M.; Groothuis-Oudshoorn, C.G.; Vlimmeren, L.A. van; MJ, I.J.

    2012-01-01

    BACKGROUND: In The Netherlands, helmet therapy is a commonly used treatment in infants with skull deformation (deformational plagiocephaly or deformational brachycephaly). However, evidence of the effectiveness of this treatment remains lacking. The HEADS study (HElmet therapy Assessment in Deformed

  7. HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial

    NARCIS (Netherlands)

    Wijk, van R.M.; Boonekamp, M.M.; Groothuis-Oudshoorn, C.G.M.; Vlimmeren, van L.A.; IJzerman, M.J.

    2012-01-01

    Background In The Netherlands, helmet therapy is a commonly used treatment in infants with skull deformation (deformational plagiocephaly or deformational brachycephaly). However, evidence of the effectiveness of this treatment remains lacking. The HEADS study (HElmet therapy Assessment in Deformed

  8. A protocol for assessment of uncertainty and strength of emissions data

    NARCIS (Netherlands)

    Risbey, James S.; Sluijs, J.P. van der; Ravetz, Jerome R.

    2006-01-01

    This method is intended to assist in characterizing uncertainties in emissions data for the Mileubalans and to identify critical issues related to uncertainty. The method assesses both quantitative and qualitative dimensions of uncertainty. Quantitative uncertainties are expressed by assigning proba

  9. Relationship of opioid analgesic protocols to assessed pain and length of stay in the pediatric postanesthesia unit following tonsillectomy.

    Science.gov (United States)

    Smith, Jana; Newcomb, Patricia; Sundberg, Erin; Shaffer, Paul

    2009-04-01

    After tonsillectomy and adenoidectomy in children, postoperative pain management is an essential, yet often challenging, task. In addition to discomfort, lack of pain management can lead to delays in oral intake of patients, resulting in extended stays and increased costs. At one North Texas pediatric facility, postoperative coblation tonsillectomy and adenoidectomy pain management orders include the as-needed use of both intravenous fentanyl and intravenous morphine. Both drugs are effective and both have potential side effects that might prolong the recovery period. Nurses in the postanesthesia care unit retrospectively compared a fentanyl and morphine regimen with a morphine-only regimen to determine whether either protocol made a difference in length-of-stay or pain relief. Analysis of available data revealed no statistically significant differences in length of stay between the groups and trivial differences thought to be clinically irrelevant on other variables.

  10. Suicide Risk Protocols: Addressing the Needs of High Risk Youths Identified through Suicide Prevention Efforts and in Clinical Settings

    Science.gov (United States)

    Heilbron, Nicole; Goldston, David; Walrath, Christine; Rodi, Michael; McKeon, Richard

    2013-01-01

    Several agencies have emphasized the importance of establishing clear protocols or procedures to address the needs of youths who are identified as suicidal through suicide prevention programs or in emergency department settings. What constitutes optimal guidelines for developing and implementing such protocols, however, is unclear. At the request…

  11. Upper Limb Assessment in Tetraplegia: Clinical, Functional and Kinematic Correlations

    Science.gov (United States)

    Cacho, Enio Walker Azevedo; de Oliveira, Roberta; Ortolan, Rodrigo L.; Varoto, Renato; Cliquet, Alberto

    2011-01-01

    The aim of this study was to correlate clinical and functional evaluations with kinematic variables of upper limp reach-to-grasp movement in patients with tetraplegia. Twenty chronic patients were selected to perform reach-to-grasp kinematic assessment using a target placed at a distance equal to the arm's length. Kinematic variables (hand peak…

  12. Assessment of Clinical Competence: Written and Computer-Based Simulations.

    Science.gov (United States)

    Swanson, David B.; And Others

    1987-01-01

    Literature concerning the validity and reliability of both written and computer-based simulations in assessing clinical competence in the health professions is reviewed, and suggestions are given for the improvement of the psychometric qualities of simulation-based tests. (MSE)

  13. Deviant Adolescent Subcultures: Assessment Strategies and Clinical Interventions.

    Science.gov (United States)

    Clark, Cynthia M.

    1992-01-01

    Presents assessment strategies, preventive methods, and clinical interventions to assist clinicians working with teenagers involved with deviant subcultures: Satanism, the neo-Nazi skinhead movement, and violent street gangs. Considers role of alienation as contributing factor in adolescents' participation in these subcultures. Advises therapists…

  14. Assessment of competence and progressive independence in postgraduate clinical training.

    NARCIS (Netherlands)

    Dijksterhuis, M.G.; Voorhuis, M.; Teunissen, P.W.; Schuwirth, L.W.; Cate, O.T.J. ten; Braat, D.D.M.; Scheele, F.

    2009-01-01

    CONTEXT: At present, competency-based, outcome-focused training is gradually replacing more traditional master-apprentice teaching in postgraduate training. This change requires a different approach to the assessment of clinical competence, especially given the decisions that must be made about the

  15. Challenges assessing clinical endpoints in early Huntington disease

    Science.gov (United States)

    Paulsen, Jane S.; Wang, Chiachi; Duff, Kevin; Barker, Roger; Nance, Martha; Beglinger, Leigh; Moser, David; Williams, Janet K.; Simpson, Sheila; Langbehn, Douglas; van Kammen, Daniel P.

    2010-01-01

    The primary aim of this study was to evaluate the current accepted standard clinical endpoint for the earliest-studied HD participants likely to be recruited into clinical trials. Since the advent of genetic testing for HD, it is possible to identify gene carriers prior to the diagnosis of disease, which opens up the possibility of clinical trials of disease-modifying treatments in clinically asymptomatic persons. Current accepted standard clinical endpoints were examined as part of a multi-national, 32-site, longitudinal, observational study of 786 research participants currently in the HD prodrome (gene-positive but not clinically diagnosed). Clinical signs and symptoms were used to prospectively predict functional loss as assessed by current accepted standard endpoints over 8 years of follow up. Functional capacity measures were not sensitive for HD in the prodrome; over 88% scored at ceiling. Prospective evaluation revealed that the first functional loss was in their accustomed work. In a survival analysis, motor, cognitive, and psychiatric measures were all predictors of job change. To our knowledge, this is the first prospective study ever conducted on the emergence of functional loss secondary to brain disease. We conclude that future clinical trials designed for very early disease will require the development of new and more sensitive measures of real-life function. PMID:20623772

  16. Clinical assessment of intraarterial blood gas monitor accuracy

    Science.gov (United States)

    Aziz, Salim; Spiess, R.; Roby, Paul; Kenny, Margaret

    1993-08-01

    The accuracy of intraarterial blood gas monitoring (IABGM) devices is challenging to assess under routine clinical conditions. When comparing discrete measurements by blood gas analyzer (BGA) to IABGM values, it is important that the BGA determinations (reference method) be as accurate as possible. In vitro decay of gas tensions caused by delay in BGA analysis is particularly problematic for specimens with high arterial oxygen tension (PaO2) values. Clinical instability of blood gases in the acutely ill patient may cause disagreement between BGA and IABGM values because of IABGM response time lag, particularly in the measurement of arterial blood carbon dioxide tension (PaCO2). We recommend that clinical assessments of IABGM accuracy by comparison with BGA use multiple bedside BGA instruments, and that blood sampling only occur during periods when IABGM values appear stable.

  17. Varied Search Protocols Lead to Clinically Relevant Results. A review of: Patel, Manesh R., Connie M. Schardt, Linda L. Sanders, and Sheri A. Keitz. “Randomized Trial for Answers to Clinical Questions: Evaluating a Pre‐Appraised Versus a MEDLINE Search Protocol.” Journal of the Medical Library Association 94.4 (2006: 382‐6.

    Directory of Open Access Journals (Sweden)

    Marcy L. Brown

    2008-03-01

    Full Text Available Objective – To determine the success rate of electronic resources for answering clinical questions by comparing speed, validity, and applicability of two different protocols for searching the medical literature.Design – Randomized trial with results judged by blinded panel.Setting – Duke University Medical Center in Durham, North Carolina, United States ofAmerica.Subjects – Thirty‐two 2nd and 3rd year internal medicine residents on an eight week general medicine rotation at the Duke University Medical Center.Methods – Two search protocols were developed:Protocol A: Participants searched MEDLINE first, and then searched pre‐appraised resources if needed.Protocol B: Participants searched pre‐appraised resources first, which included UpToDate, ACP JournalClub, Cochrane Database of Systematic Reviews, and DARE. The residents then searched MEDLINE if an answer could not be found in the 66 initial group of pre‐appraised resources. Residents were randomised by computer-assisted block order into four blocks of eight residents each. Two blocks were assigned to Protocol A, and two to Protocol B. Each day, residents developed at least one clinical question related to caring for patients. The questions were transcribed onto pocket-sized cards, with the answer sought later using the assigned protocol. If answers weren’t found using either protocol, searches were permitted in other available resources. When an article that answered a question was found, the resident recorded basic information about the question and the answer as well as the time required to find the answer (less than five minutes; between five and ten minutes; or more than ten minutes. Residents were to select answers that were “methodologically sound and clinically important” (384. Ten faculty members formally trained in evidence‐based medicine (EBM reviewed a subset of therapy‐related questions and answers. The reviewers, who were blinded to the search protocols

  18. Dysphonia risk screening protocol

    Directory of Open Access Journals (Sweden)

    Katia Nemr

    2016-03-01

    Full Text Available OBJECTIVE: To propose and test the applicability of a dysphonia risk screening protocol with score calculation in individuals with and without dysphonia. METHOD: This descriptive cross-sectional study included 365 individuals (41 children, 142 adult women, 91 adult men and 91 seniors divided into a dysphonic group and a non-dysphonic group. The protocol consisted of 18 questions and a score was calculated using a 10-cm visual analog scale. The measured value on the visual analog scale was added to the overall score, along with other partial scores. Speech samples allowed for analysis/assessment of the overall degree of vocal deviation and initial definition of the respective groups and after six months, the separation of the groups was confirmed using an acoustic analysis. RESULTS: The mean total scores were different between the groups in all samples. Values ranged between 37.0 and 57.85 in the dysphonic group and between 12.95 and 19.28 in the non-dysphonic group, with overall means of 46.09 and 15.55, respectively. High sensitivity and specificity were demonstrated when discriminating between the groups with the following cut-off points: 22.50 (children, 29.25 (adult women, 22.75 (adult men, and 27.10 (seniors. CONCLUSION: The protocol demonstrated high sensitivity and specificity in differentiating groups of individuals with and without dysphonia in different sample groups and is thus an effective instrument for use in voice clinics.

  19. Assessing function in patients undergoing joint replacement: a study protocol for a cohort study

    Directory of Open Access Journals (Sweden)

    Wylde Vikki

    2012-11-01

    Full Text Available Abstract Background Joint replacement is an effective intervention for people with advanced arthritis, although there is an important minority of patients who do not improve post-operatively. There is a need for robust evidence on outcomes after surgery, but there are a number of measures that assess function after joint replacement, many of which lack any clear theoretical basis. The World Health Organisation has introduced the International Classification of Functioning, Disability and Health (ICF, which divides function into three separate domains: Impairment, activity limitations and participation restrictions. The aim of this study is to compare the properties and responsiveness of a selection of commonly used outcome tools that assess function, examine how well they relate to the ICF concepts, and to explore the changes in the measures over time. Methods/design Two hundred and sixty three patients listed for lower limb joint replacement at an elective orthopaedic centre have been recruited into this study. Participants attend the hospital for a research appointment prior to surgery and then at 3-months and 1-year after surgery. At each assessment time, function is assessed using a range of measures. Self-report function is assessed using the WOMAC, Aberdeen Impairment, Activity Limitation and Participation Restriction Measure, SF-12 and Measure Yourself Medical Outcome Profile 2. Clinician-administered measures of function include the American Knee Society Score for knee patients and the Harris Hip Score for hip patients. Performance tests include the timed 20-metre walk, timed get up and go, sit-to-stand-to-sit, step tests and single stance balance test. During the performance tests, participants wear an inertial sensor and data from motion analysis are collected. Statistical analysis will include exploring the relationship between measures describing the same ICF concepts, assessing responsiveness, and studying changes in measures over

  20. Aneurysmal sizing after endovascular repair in patients with abdominal aortic aneurysm: interobserver variability of various measurement protocols and its clinical relevance

    Energy Technology Data Exchange (ETDEWEB)

    Abada, Hicham T.; Sapoval, Marc R.; Mousseaux, Elie; Gaux, Jean-Claude [Department of Cardiovascular and Interventional Radiology, Hopital Europeen Georges Pompidou, 20 rue Leblanc, 75015, Paris (France); Paul, Jean-Francois [Department of Cardiovascular and Interventional Radiology, Hopital Europeen Georges Pompidou, 20 rue Leblanc, 75015, Paris (France); Department of Radiology, Centre Chirugical Marie Lannelongue, 92350, Le Plessis-Robinson (France); De Maertelaer, Viviane [Statistical Unit, Interdisciplinary Research in Human Biology and Nuclear Medicine, University of Brussels, 1070, Brussels (Belgium)

    2003-12-01

    The aim of this study was to determine the variability of various measurement protocols for measurement of abdominal aortic aneurysm (AAA) and the clinical relevance of variability. Three radiologists performed computed tomographic angiography measurements of both the aorta and the largest portion of the aneurysm on selected axial slices. Then measurements of the largest portion of the aneurysm were performed on unselected axial slices, sagittal and coronal reformatted. Finally, aortic volume was calculated. Measurements and volume calculation were performed before and after endovascular repair and assessed: Part 1: interobserver variability for maximum anteroposterior (MAP) and maximum transverse (MTR) diameters on selected slices; part 2: interobserver variability for unselected slices considering MAP and MTR; part 3: interobserver variability considering maximum diameter in any direction (MAD); part 4: interobserver variability for sagittal (SAG) and coronal (COR) free curved multiplanar reformation (MPR); and part 5: volume calculations. We then determined which technique of measurement was the most clinically relevant for detecting changes in aneurysm size or aortic volume. Parts 1 and 2: interobserver variability was 4.1 mm for both MAP and MTR; part 3: interobserver variability was 7 mm for MAD; part 4: interobserver variability was 5.5 mm (COR) and 4.9 mm (SAG); part 5: interobserver variability for volume was 5.5 ml. A combination of MAP and MTR was the most useful for detecting aortic modification. Volume calculation was needed in only a few cases. We recommend avoiding MAD and MPR measurements and suggest instead measuring both maximum anteroposterior and maximum transverse diameters. If aneurysm size remains stable after endovascular repair, aneurysm volume should be measured. (orig.)

  1. Toward a Best-Practice Protocol for Assessment of Sensory Features in ASD

    Science.gov (United States)

    Schaaf, Roseann C.; Lane, Alison E.

    2015-01-01

    Sensory difficulties are a commonly occurring feature of autism spectrum disorders and are now included as one manifestation of the "restricted, repetitive patterns of behavior, interests, or activities" diagnostic criteria of the DSM5 necessitating guidelines for comprehensive assessment of these features. To facilitate the development…

  2. Combining Quality and Curriculum-Based Measurement: A Suggested Assessment Protocol in Writing

    Science.gov (United States)

    Ganzeveld, Paula

    2015-01-01

    Curriculum-Based Measures in writing (CBM-W) assesses a variety of fluency-based components of writing. While support exists for the use of CBM measures in the area of writing, there is a need to conduct further validation studies to investigate the utility of these measures within elementary and secondary classrooms. Since only countable indices…

  3. HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial

    NARCIS (Netherlands)

    Wijk, R.M. van; Boere-Boonekamp, M.M.; Groothuis-Oudshoorn, C.G. van; Vlimmeren, L.A. van; IJzerman, M.J.

    2012-01-01

    In The Netherlands helmet therapy is a commonly used treatment in infants with skull deformation (deformational plagiocephaly or deformational brachycephaly). However, evidence on the effectiveness of this treatment is lacking. The HEADS study (Helmet therapy Assessment in Deformed Skulls) aims to d

  4. Caries assessment: establishing mathematical link of clinical and benchtop method

    Science.gov (United States)

    Amaechi, Bennett T.

    2009-02-01

    It is well established that the development of new technologies for early detection and quantitative monitoring of dental caries at its early stage could provide health and economic benefits ranging from timely preventive interventions to reduction of the time required for clinical trials of anti-caries agents. However, the new technologies currently used in clinical setting cannot assess and monitor caries using the actual mineral concentration within the lesion, while a laboratory-based microcomputed tomography (MCT) has been shown to possess this capability. Thus we envision the establishment of mathematical equations relating the measurements of each of the clinical technologies to that of MCT will enable the mineral concentration of lesions detected and assessed in clinical practice to be extrapolated from the equation, and this will facilitate preventitive care in dentistry to lower treatment cost. We utilize MCT and the two prominent clinical caries assessment devices (Quantitative Light-induced Fluorescence [QLF] and Diagnodent) to longitudinally monitor the development of caries in a continuous flow mixed-organisms biofilm model (artificial mouth), and then used the collected data to establish mathematical equation relating the measurements of each of the clinical technologies to that of MCT. A linear correlation was observed between the measurements of MicroCT and that of QLF and Diagnodent. Thus mineral density in a carious lesion detected and measured using QLF or Diagnodent can be extrapolated using the developed equation. This highlights the usefulness of MCT for monitoring the progress of an early caries being treated with therapeutic agents in clinical practice or trials.

  5. Evaluating process and clinical outcomes of a primary care mental health integration project in rural Rwanda: a prospective mixed-methods protocol

    Science.gov (United States)

    Smith, Stephanie L; Misago, Claire Nancy; Osrow, Robyn A; Franke, Molly F; Iyamuremye, Jean Damascene; Dusabeyezu, Jeanne D'Arc; Mohand, Achour A; Anatole, Manzi; Kayiteshonga, Yvonne; Raviola, Giuseppe J

    2017-01-01

    Introduction Integrating mental healthcare into primary care can reduce the global burden of mental disorders. Yet data on the effective implementation of real-world task-shared mental health programmes are limited. In 2012, the Rwandan Ministry of Health and the international healthcare organisation Partners in Health collaboratively adapted the Mentoring and Enhanced Supervision at Health Centers (MESH) programme, a successful programme of supported supervision based on task-sharing for HIV/AIDS care, to include care of neuropsychiatric disorders within primary care settings (MESH Mental Health). We propose 1 of the first studies in a rural low-income country to assess the implementation and clinical outcomes of a programme integrating neuropsychiatric care into a public primary care system. Methods and analysis A mixed-methods evaluation will be conducted. First, we will conduct a quantitative outcomes evaluation using a pretest and post-test design at 4 purposively selected MESH MH participating health centres. At least 112 consecutive adults with schizophrenia, bipolar disorder, depression or epilepsy will be enrolled. Primary outcomes are symptoms and functioning measured at baseline, 8 weeks and 6 months using clinician-administered scales: the General Health Questionnaire and the brief WHO Disability Assessment Scale. We hypothesise that service users will experience at least a 25% improvement in symptoms and functioning from baseline after MESH MH programme participation. To understand any outcome improvements under the intervention, we will evaluate programme processes using (1) quantitative analyses of routine service utilisation data and supervision checklist data and (2) qualitative semistructured interviews with primary care nurses, service users and family members. Ethics and dissemination This evaluation was approved by the Rwanda National Ethics Committee (Protocol #736/RNEC/2016) and deemed exempt by the Harvard University Institutional Review

  6. Promoting Assessment Efficacy through an Integrated System for Online Clinical Assessment of Practical Skills

    Science.gov (United States)

    Hay, Peter J.; Engstrom, Craig; Green, Anita; Friis, Peter; Dickens, Sue; Macdonald, Doune

    2013-01-01

    This paper presents evaluation outcomes from an externally funded research project involving the online clinical assessment of practical skills (eCAPS) using web-based video technologies within a university medical programme. eCAPS was implemented to trial this web-based approach for promoting the efficacy of "practical" skills assessment in knee…

  7. IMPACT OF PHYSIOTHERAPIST-DESIGNED SUPERVISED EXERCISE PROTOCOL ON MUSCLE STRENGTH, AND AUTONOMIC PARAMETERS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS: A CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    Renu B. Pattanshetty

    2015-04-01

    Full Text Available Background and Objectives: Type 2 diabetes mellitus is a heterogeneous group of disorders characterized by variable degree of insulin resistance, impaired insulin secretion, and increased glucose production. Physical activity is central to the management type 2 diabetes. There is less evidence to suggest the efficacy of combined effect of physiotherapist- designed supervised exercise protocol on muscle strength and autonomic parameters in such subjects. Hence, the present study was designed to evaluate effect of physiotherapist designed supervised exercise protocol of muscle strength and autonomic parameters in this subject population. Material and Methods: This clinical trial was conducted in thirty (30 adult subjects with type 2 diabetes mellitus including both males and females in the age group of 18 to 65 years. All subjects received physiotherapist designed supervised exercise training protocol consisting of aerobic, resistance & flexibility training. Pre-exercise and post-exercise outcome measurements were taken at baseline, 7th & 14th day in the form of 1-RM for muscle strength and autonomic parameters. Results: Statistical analysis of outcomes at baseline, 7th day and 14th day showed statistically significant difference in strength (p=0.0001, and reduction in autonomic parameters (p=0.0001 Conclusion: The therapist designed exercise protocol has shown to improve muscle strength , mean systolic blood pressure, diastolic blood pressure, pulse rate, pulse pressure, mean arterial pressure, rate pressure product. The protocol has also proved to be safe since no adverse event was noted post exercise.

  8. Standardizing the protocol for hemispherical photographs: accuracy assessment of binarization algorithms.

    Science.gov (United States)

    Glatthorn, Jonas; Beckschäfer, Philip

    2014-01-01

    Hemispherical photography is a well-established method to optically assess ecological parameters related to plant canopies; e.g. ground-level light regimes and the distribution of foliage within the crown space. Interpreting hemispherical photographs involves classifying pixels as either sky or vegetation. A wide range of automatic thresholding or binarization algorithms exists to classify the photographs. The variety in methodology hampers ability to compare results across studies. To identify an optimal threshold selection method, this study assessed the accuracy of seven binarization methods implemented in software currently available for the processing of hemispherical photographs. Therefore, binarizations obtained by the algorithms were compared to reference data generated through a manual binarization of a stratified random selection of pixels. This approach was adopted from the accuracy assessment of map classifications known from remote sensing studies. Percentage correct (Pc) and kappa-statistics (K) were calculated. The accuracy of the algorithms was assessed for photographs taken with automatic exposure settings (auto-exposure) and photographs taken with settings which avoid overexposure (histogram-exposure). In addition, gap fraction values derived from hemispherical photographs were compared with estimates derived from the manually classified reference pixels. All tested algorithms were shown to be sensitive to overexposure. Three of the algorithms showed an accuracy which was high enough to be recommended for the processing of histogram-exposed hemispherical photographs: "Minimum" (Pc 98.8%; K 0.952), "Edge Detection" (Pc 98.1%; K 0.950), and "Minimum Histogram" (Pc 98.1%; K 0.947). The Minimum algorithm overestimated gap fraction least of all (11%). The overestimation by the algorithms Edge Detection (63%) and Minimum Histogram (67%) were considerably larger. For the remaining four evaluated algorithms (IsoData, Maximum Entropy, MinError, and Otsu

  9. The Assessment of Military Multitasking Performance: Validation of a Dual Task and Multitask Protocol

    Science.gov (United States)

    2013-09-01

    gaze instability, and motion intolerance? and emotional reactions. 4 Symptom identification and monitoring after mTBI are important to both medical...31 Bleiberg J, Halpern EL, Reeves D, Daniel JC. Future directions for the neuropsycho- logical assessment of sports concussion. J Head Trauma Rehabil...1998;13:36–44. 32 Reeves DL, Winter KP, Bleiberg J, Kane RL. ANAM genogram: historical perspec- tives, description, and current endeavors. Arch Clin

  10. Assessment of the quality of sample labelling for clinical research

    Directory of Open Access Journals (Sweden)

    Pablo Pérez-Huertas

    2016-03-01

    Full Text Available Objective: To assess the quality of the labels for clinical trial samples through current regulations, and to analyze its potential correlation with the specific characteristics of each sample. Method: A transversal multicenter study where the clinical trial samples from two third level hospitals were analyzed. The eleven items from Directive 2003/94/EC, as well as the name of the clinical trial and the dose on the label cover, were considered variables for labelling quality. The influence of the characteristics of each sample on labelling quality was also analyzed. Outcome: The study included 503 samples from 220 clinical trials. The mean quality of labelling, understood as the proportion of items from Appendix 13, was of 91.9%. Out of these, 6.6% did not include the name of the sample in the outer face of the label, while in 9.7% the dose was missing. The samples with clinical trial-type samples presented a higher quality (p < 0.049, blinding reduced their quality (p = 0.017, and identification by kit number or by patient increased it (p < 0.01. The promoter was the variable which introduced the highest variability into the analysis. Conclusions: The mean quality of labelling is adequate in the majority of clinical trial samples. The lack of essential information in some samples, such as the clinical trial code and the period of validity, is alarming and might be the potential source for dispensing or administration errors.

  11. Optimization and clinical validation of a Real-Time PCR protocol for direct detection of Trichomonas vaginalis in pooled urine samples

    Directory of Open Access Journals (Sweden)

    WHA Zandijk

    2009-12-01

    Full Text Available Background and Objectives: A new Real- Time PCR protocol for the detection of Trichomonas vaginalis in pooled urine"nsamples has been optimized and validated."nMaterials and Methods: The amplification protocol, targeting a 2kb repeated gene in the T. vaginalis genome, was optimized"nby varying PCR parameters. As a reference method, a Real-Time PCR protocol targeting the beta-tubulin gene (Y. Versluis"net al, 2006, Int J STD AIDS 17:642 was used. Clinical validation was performed with pooled urine samples obtained from"npatients of the sexually transmitted diseases clinic of a university hospital (n=963; from February – June 2007."nResults: Positive samples with the new optimized technique is 1.1% (n=10, while the beta-tubulin real-time PCR method"ngenerated four positives (0.3%."nConclusion: The new RT- PCR protocol is a sensitive (1.000 and specific (0.993 procedure to detect and to identify T."nvaginalis in urine samples.

  12. A comprehensive clinical competency-based assessment in periodontics.

    Science.gov (United States)

    Shiloah, J; Scarbecz, M; Bland, P S; Hottel, T L

    2017-05-01

    Traditional periodontics clinical examinations in dental education frequently assess a narrow set of clinical skills and do not adequately assess the ability of students to independently manage a periodontal patient. As an alternative, the authors developed a comprehensive periodontics competency case experience (CCCE) for senior dental students and surveyed students regarding their experience with the CCCE. Students challenging the CCCE must treat a patient with moderate periodontitis and must independently decide when a state of periodontal and oral health has been achieved. Students are also required to conduct an oral presentation to periodontology faculty. Dental students who completed the CCCE had a favourable impression of the experience, compared with the traditional clinical examinations taken in the junior year. The majority of students rated all the components of the CCCE as 'somewhat' or 'very helpful'. About 72.4% of students felt that being able to work independently on the examination was very helpful for learning about the clinical management of patients with periodontal disease, followed by 'simulation of care in private practice' (65.5%), and oral photography experience (55.2%). The greatest difficulty reported by students was finding an acceptable patient. About 62.1% of students rated 'finding the right patient' as very difficult. Students reported having to screen a mean of 5.9 patients (SD: 4.5) to find a qualified patient. The results of the survey will be useful in improving the examination as an assessment tool in periodontal therapy.

  13. Evaluation of a low-dose CT protocol with oral contrast for assessment of acute appendicitis

    Energy Technology Data Exchange (ETDEWEB)

    Platon, Alexandra; Jlassi, Helmi; Becker, Christoph D.; Poletti, Pierre-Alexandre [University Hospital of Geneva, Department of Radiology, Geneva 14 (Switzerland); Rutschmann, Olivier T. [University Hospital of Geneva, Emergency Center, Geneva (Switzerland); Verdun, Francis R. [University Institute for Radiation Physics, Lausanne (Switzerland); Gervaz, Pascal [University Hospital of Geneva, Clinic of Digestive Surgery, Geneva (Switzerland)

    2009-02-15

    The aim of this study was to evaluate a low-dose CT with oral contrast medium (LDCT) for the diagnosis of acute appendicitis and compare its performance with standard-dose i.v. contrast-enhanced CT (standard CT) according to patients' BMIs. Eighty-six consecutive patients admitted with suspicion of acute appendicitis underwent LDCT (30 mAs), followed by standard CT (180 mAs). Both examinations were reviewed by two experienced radiologists for direct and indirect signs of appendicitis. Clinical and surgical follow-up was considered as the reference standard. Appendicitis was confirmed by surgery in 37 (43%) of the 86 patients. Twenty-nine (34%) patients eventually had an alternative discharge diagnosis to explain their abdominal pain. Clinical and biological follow-up was uneventful in 20 (23%) patients. LDCT and standard CT had the same sensitivity (100%, 33/33) and specificity (98%, 45/46) to diagnose appendicitis in patients with a body mass index (BMI) {>=} 18.5. In slim patients (BMI < 18.5), sensitivity to diagnose appendicitis was 50% (2/4) for LDCT and 100% (4/4) for standard CT, while specificity was identical for both techniques (67%, 2/3). LDCT may play a role in the diagnostic workup of patients with a BMI {>=} 18.5. (orig.)

  14. Evaluation of a low-dose CT protocol with oral contrast for assessment of acute appendicitis.

    Science.gov (United States)

    Platon, Alexandra; Jlassi, Helmi; Rutschmann, Olivier T; Becker, Christoph D; Verdun, Francis R; Gervaz, Pascal; Poletti, Pierre-Alexandre

    2009-02-01

    The aim of this study was to evaluate a low-dose CT with oral contrast medium (LDCT) for the diagnosis of acute appendicitis and compare its performance with standard-dose i.v. contrast-enhanced CT (standard CT) according to patients' BMIs. Eighty-six consecutive patients admitted with suspicion of acute appendicitis underwent LDCT (30 mAs), followed by standard CT (180 mAs). Both examinations were reviewed by two experienced radiologists for direct and indirect signs of appendicitis. Clinical and surgical follow-up was considered as the reference standard. Appendicitis was confirmed by surgery in 37 (43%) of the 86 patients. Twenty-nine (34%) patients eventually had an alternative discharge diagnosis to explain their abdominal pain. Clinical and biological follow-up was uneventful in 20 (23%) patients. LDCT and standard CT had the same sensitivity (100%, 33/33) and specificity (98%, 45/46) to diagnose appendicitis in patients with a body mass index (BMI) >or= 18.5. In slim patients (BMIor= 18.5.

  15. Manual Linear Movements to Assess Spasticity in a Clinical Setting

    Science.gov (United States)

    Marinelli, Lucio; Trompetto, Carlo; Mori, Laura; Vigo, Gabriele; Traverso, Elisabetta; Colombano, Federica; Abbruzzese, Giovanni

    2013-01-01

    In a clinical setting, where motor-driven systems are not readily available, the major difficulty in the assessment of the stretch reflex lies in the control of passive limb displacement velocity. A potential approach to this problem arises from the use of manual sinusoidal movements (made by continuous alternating flexions and extensions) paced by an external stimulus. Unfortunately, there are conditions in which sinusoidal movements induce interfering phenomena such as the shortening reaction or postactivation depression. In the present paper, a novel manual method to control the velocity of passive linear movements is described and the results obtained from both healthy subjects and spastic patients are reported. This method is based on the synchronisation of movements with tones played by a metronome at different speeds. In a first set of experiments performed in healthy subjects, we demonstrated consistent control of velocity during passive limb movements using this method. Four joints usually examined during muscle tone assessment were tested: wrist, elbow, knee and ankle joints. Following this, we conducted a longitudinal assessment of the stretch reflex amplitude in wrist flexor muscles in patients with spasticity treated with botulinum toxin type A. The evaluators were not only able to vary the movement velocity based on the metronome speed, but also could reproduce the respective speeds two weeks later, despite the changing degree of hypertonia. This method is easy to perform in a clinical setting and hardware requirements are minimal, making it an attractive and robust procedure for the widespread clinical assessment of reflex hypertonia. PMID:23335966

  16. A protocol for a randomized clinical trial of interactive video dance: potential for effects on cognitive function

    Directory of Open Access Journals (Sweden)

    Jovancevic Jelena

    2012-06-01

    Full Text Available Abstract Background Physical exercise has the potential to affect cognitive function, but most evidence to date focuses on cognitive effects of fitness training. Cognitive exercise also may influence cognitive function, but many cognitive training paradigms have failed to provide carry-over to daily cognitive function. Video games provide a broader, more contextual approach to cognitive training that may induce cognitive gains and have carry over to daily function. Most video games do not involve physical exercise, but some novel forms of interactive video games combine physical activity and cognitive challenge. Methods/Design This paper describes a randomized clinical trial in 168 postmenopausal sedentary overweight women that compares an interactive video dance game with brisk walking and delayed entry controls. The primary endpoint is adherence to activity at six months. Additional endpoints include aspects of physical and mental health. We focus this report primarily on the rationale and plans for assessment of multiple cognitive functions. Discussion This randomized clinical trial may provide new information about the cognitive effects of interactive videodance. It is also the first trial to examine physical and cognitive effects in older women. Interactive video games may offer novel strategies to promote physical activity and health across the life span. The study is IRB approved and the number is: PRO08080012 ClinicalTrials.gov Identifier: NCT01443455

  17. Clinical Decision Making and Outcome in Routine Care for People with Severe Mental Illness (CEDAR: Study protocol

    Directory of Open Access Journals (Sweden)

    Nemes Zoltan

    2010-11-01

    Full Text Available Abstract Background A considerable amount of research has been conducted on clinical decision making (CDM in short-term physical conditions. However, there is a lack of knowledge on CDM and its outcome in long-term illnesses, especially in care for people with severe mental illness. Methods/Design The study entitled "Clinical decision making and outcome in routine care for people with severe mental illness" (CEDAR is carried out in six European countries (Denmark, Germany, Hungary, Italy, Switzerland and UK. First, CEDAR establishes a methodology to assess CDM in people with severe mental illness. Specific instruments are developed (and psychometric properties established to measure CDM style, key elements of CDM in routine care, as well as CDM involvement and satisfaction from patient and therapist perspectives. Second, these instruments are being put to use in a multi-national prospective observational study (bimonthly assessments during a one-year observation period; N = 560. This study investigates the immediate, short- and long-term effect of CDM on crucial dimensions of clinical outcome (symptom level, quality of life, needs by taking into account significant variables moderating the relationship between CDM and outcome. Discussion The results of this study will make possible to delineate quality indicators of CDM, as well as to specify prime areas for further improvement. Ingredients of best practice in CDM in the routine care for people with severe mental illness will be extracted and recommendations formulated. With its explicit focus on the patient role in CDM, CEDAR will also contribute to strengthening the service user perspective. This project will substantially add to improving the practice of CDM in mental health care across Europe. Trial register ISRCTN75841675.

  18. Breast clinic triage tool: telephone assessment of new referrals.

    Science.gov (United States)

    Cusack, Leila; Brennan, Meagan; Weissenberg, Leisha; Moore, Katrina

    2012-04-01

    Efficient systems to triage increasing numbers of new referrals to breast clinics are needed, to optimise the management of patients with cancer and benign disease. A tool was developed to triage the urgency of referrals and allocate the most appropriate clinician consultation (surgeon or breast physician (BP)). 259 consecutive new referrals were triaged using the tool. 100% new cancers and 256 (98.8%) referrals overall were triaged to both appropriate category of urgency and the appropriate clinician. This triage tool provides a simple method for assessing new referrals to a breast clinic and can be easily delivered by trained administrative staff by telephone.

  19. Protocol of the project pain & disasters: assessment of critical issues and possible solutions

    Directory of Open Access Journals (Sweden)

    Daniele Mipatrini

    2016-03-01

    Full Text Available Background: Disasters cause almost 100 thousand deaths and affect 200 million people every year. Operators working in disaster zones reported problems in importing medications, in particular pain killers and narcotics, in areas of disasters. The importance of ensuring access to painkillers, including major analgesics, is pinpointed by the World Health Organization which through its “Access to Controlled Medications Programme” provides normative guidance, policy analysis and training of healthcare workers on this issue. Nevertheless the little evidence available on the assessment and treatment of pain in disasters suggests that the management of pain in disaster zones may be affected by several factors mainly due to the availability of drugs, the skills of health personnel and cultural issues. Aim:The main aims of this project are: evaluating whether pain is correctly assessed and treated in disaster zones, assessing which are the main limitations to its treatment and producing suggestions and reccomandations to improve its treatment. Materials & Methods: In order to achieve our aims we will adopt a combined approach made by: A systematic review of the evidence will be conducted in the scientific databases Medline and Scopus. A review of grey literature concerning the issue on the Web pages of international organizations and NGOs working in the field of humanitarian aid. A survey among healthcare workers who took part to the international humanitarian actions. A survey among expert of the humanitarian field not necessary involved in projects on the field e.g. lawyer expert in international law, international organizations representatives working in the headquarters etc. A technical table with European experts in the field of pain treatment and/or disaster reaponse.

  20. Manufacturing and use of human placenta-derived mesenchymal stromal cells for phase I clinical trials: Establishment and evaluation of a protocol

    Directory of Open Access Journals (Sweden)

    Ilić Nina

    2014-01-01

    Full Text Available Background/Aim. Mesenchymal stromal cells (MSCs have been utilised in many clinical trials as an experimental treatment in numerous clinical settings. Bone marrow remains the traditional source tissue for MSCs but is relatively hard to access in large volumes. Alternatively, MSCs may be derived from other tissues including the placenta and adipose tissue. In an initial study no obvious differences in parameters such as cell surface phenotype, chemokine receptor display, mesodermal differentiation capacity or immunosuppressive ability, were detected when we compared human marrow derived- MSCs to human placenta-derived MSCs. The aim of this study was to establish and evaluate a protocol and related processes for preparation placenta-derived MSCs for early phase clinical trials. Methods. A full-term placenta was taken after delivery of the baby as a source of MSCs. Isolation, seeding, incubation, cryopreservation of human placentaderived MSCs and used production release criteria were in accordance with the complex regulatory requirements applicable to Code of Good Manufacturing Practice manufacturing of ex vivo expanded cells. Results. We established and evaluated instructions for MSCs preparation protocol and gave an overview of the three clinical areas application. In the first trial, MSCs were co-transplanted iv to patient receiving an allogeneic cord blood transplant as therapy for treatmentrefractory acute myeloid leukemia. In the second trial, MSCs were administered iv in the treatment of idiopathic pulmonary fibrosis and without serious adverse effects. In the third trial, MSCs were injected directly into the site of tendon damage using ultrasound guidance in the treatment of chronic refractory tendinopathy. Conclusion. Clinical trials using both allogeneic and autologous cells demonstrated MSCs to be safe. A described protocol for human placenta-derived MSCs is appropriate for use in a clinical setting, relatively inexpensive and can be

  1. Assessment of lectin and HILIC based enrichment protocols for characterization of serum glycoproteins by mass spectrometry

    DEFF Research Database (Denmark)

    Calvano, Cosima D; Zambonin, Carlo G; Jensen, Ole Nørregaard

    2008-01-01

    glycosylation profiles are associated with certain human ailments. Glycoprotein analysis by mass spectrometry of biological samples, such as blood serum, is hampered by sample complexity and the low concentration of the potentially informative glycopeptides and -proteins. We assessed the utility of lectin...... of 63 glycosylation sites in 38 proteins were identified by both methods, demonstrating distinct differences and complementarity. Serial application of custom-made microcolumns of mixed, immobilized lectins proved efficient for recovery and analysis of glycopeptides from serum samples of breast cancer...

  2. HElmet therapy Assessment in infants with Deformed Skulls (HEADS: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    van Wijk Renske M

    2012-07-01

    Full Text Available Abstract Background In The Netherlands, helmet therapy is a commonly used treatment in infants with skull deformation (deformational plagiocephaly or deformational brachycephaly. However, evidence of the effectiveness of this treatment remains lacking. The HEADS study (HElmet therapy Assessment in Deformed Skulls aims to determine the effects and costs of helmet therapy compared to no helmet therapy in infants with moderate to severe skull deformation. Methods/design Pragmatic randomised controlled trial (RCT nested in a cohort study. The cohort study included infants with a positional preference and/or skull deformation at two to four months (first assessment. At 5 months of age, all children were assessed again and infants meeting the criteria for helmet therapy were asked to participate in the RCT. Participants were randomly allocated to either helmet therapy or no helmet therapy. Parents of eligible infants that do not agree with enrolment in the RCT were invited to stay enrolled for follow up in a non-randomisedrandomised controlled trial (nRCT; they were then free to make the decision to start helmet therapy or not. Follow-up assessments took place at 8, 12 and 24 months of age. The main outcome will be head shape at 24 months that is measured using plagiocephalometry. Secondary outcomes will be satisfaction of parents and professionals with the appearance of the child, parental concerns about the future, anxiety level and satisfaction with the treatment, motor development and quality of life of the infant. Finally, compliance and costs will also be determined. Discussion HEADS will be the first study presenting data from an RCT on the effectiveness of helmet therapy. Outcomes will be important for affected children and their parents, health care professionals and future treatment policies. Our findings are likely to influence the reimbursement policies of health insurance companies. Besides these health outcomes, we will be able to

  3. Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials.

    Science.gov (United States)

    Avigan, Mark I; Bjornsson, Einar S; Pasanen, Markku; Cooper, Charles; Andrade, Raul J; Watkins, Paul B; Lewis, James H; Merz, Michael

    2014-11-01

    A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials. In a breakout session, workshop attendees discussed necessary data elements and standards for the accurate measurement of DILI risk associated with new therapeutic agents in clinical trials. There was agreement that in order to achieve this goal the systematic acquisition of protocol-specified clinical measures and lab specimens from all study subjects is crucial. In addition, standard DILI terms that address the diverse clinical and pathologic signatures of DILI were considered essential. There was a strong consensus that clinical and lab analyses necessary for the evaluation of cases of acute liver injury should be consistent with the US Food and Drug Administration (FDA) guidance on pre-marketing risk assessment of DILI in clinical trials issued in 2009. A recommendation that liver injury case review and management be guided by clinicians with hepatologic expertise was made. Of note, there was agreement that emerging DILI signals should prompt the systematic collection of candidate pharmacogenomic, proteomic and/or metabonomic biomarkers from all study subjects. The use of emerging standardized clinical terminology, CRFs and graphic tools for data review to enable harmonization across clinical trials was strongly encouraged. Many of the recommendations made in the breakout session are in alignment with those made in the other parallel sessions on methodology to assess clinical liver safety data, causality assessment for suspected DILI, and liver safety assessment in special populations (hepatitis B, C, and oncology trials). Nonetheless, a few outstanding issues remain for future consideration.

  4. Mimics: a symbolic conflict/cooperation simulation program, with embedded protocol recording and automatic psychometric assessment.

    Science.gov (United States)

    Aidman, Eugene V; Shmelyov, Alexander G

    2002-02-01

    This paper describes an interactive software environment designed as a social interaction simulator with embedded comprehensive recording and flexible assessment facilities. Using schematized visual sketches similar to cross-cultural facial universals (Ekman, 1999), Mimics (Shmelyov & Aidman, 1997) employs a computer-game-like scenario that requires the subject to identify with an avatar and navigate it through a playing field inhabited by hosts who display a range of facial expressions. From these expressions (which are highly consequential), the player has to anticipate the hosts' reactions to the avatar (which may vary from friendly to obstructing or aggressive) and choose between negotiating with a host (by altering the avatar's facial expression), attacking it, or searching for an escape route. Comprehensive recording of player moves and interactions has enabled computation of several finegrained indices of interactive behavior, such as aggressive response styles, efficiency, and motivation in conflict/cooperation contexts. Initial validation data and potential applications of the method in the assessment of personality and social behavior are discussed.

  5. Brief intervention for alcohol misuse in people attending sexual health clinics: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sanatinia Rahil

    2012-08-01

    Full Text Available Abstract Background Over the last 30 years the number of people who drink alcohol at harmful levels has increased in many countries. There have also been large increases in rates of sexually transmitted infections. Available evidence suggests that excessive alcohol consumption and poor sexual health may be linked. The prevalence of harmful alcohol use is higher among people attending sexual health clinics than in the general population, and a third of those attending clinics state that alcohol use affects whether they have unprotected sex. Previous research has demonstrated that brief intervention for alcohol misuse in other medical settings can lead to behavioral change, but the clinical- and cost-effectiveness of this intervention on sexual behavior have not been examined. Methods We will conduct a two parallel-arm, randomized trial. A consecutive sample of people attending three sexual health clinics in London and willing to participate in the study will be screened for excessive alcohol consumption. Participants identified as drinking excessively will then be allocated to either active treatment (Brief Advice and referral for Brief Intervention or control treatment (a leaflet on healthy living. Randomization will be via an independent and remote telephone randomization service and will be stratified by study clinic. Brief Advice will comprise feedback on the possible health consequences of excessive alcohol consumption, written information about alcohol and the offer of an appointment for further assessment and Brief Intervention. Follow-up data on alcohol use, sexual behavior, health related quality of life and service use will be collected by a researcher masked to allocation status six months later. The primary outcome for the study is mean weekly alcohol consumption during the previous three months, and the main secondary outcome is the proportion of participants who report unprotected sex during this period. Discussion Opportunistic

  6. Assessing Binocular Interaction in Amblyopia and Its Clinical Feasibility

    OpenAIRE

    MiYoung Kwon; Zhong-Lin Lu; Alexandra Miller; Melanie Kazlas; Hunter, David G.; Peter J. Bex

    2014-01-01

    PURPOSE: To measure binocular interaction in amblyopes using a rapid and patient-friendly computer-based method, and to test the feasibility of the assessment in the clinic. METHODS: Binocular interaction was assessed in subjects with strabismic amblyopia (n = 7), anisometropic amblyopia (n = 6), strabismus without amblyopia (n = 15) and normal vision (n = 40). Binocular interaction was measured with a dichoptic phase matching task in which subjects matched the position of a binocular probe t...

  7. Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220

    Directory of Open Access Journals (Sweden)

    Jimenez Carmen

    2005-10-01

    Full Text Available Abstract Background Although the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis. Methods/design Randomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis. The patients will be randomised into two groups: 1 experimental (acupuncture + physiotherapy; 2 control (TENS-placebo + physiotherapy; the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA Scale

  8. Peer review in Clinical Pharmacology using the 8-D Assessment

    Science.gov (United States)

    Woodcock, Barry G.

    2017-01-01

    The requirement for editors of clinical pharmacology journals to maintain an overview of the peer review process for manuscripts submitted can be facilitated by use of the 8-D Assessment. The 8-D Assessment comprises peer review criteria to determine if the:1. Design of the study, 2. Diagnoses employed, 3. Drug molecules involved, 4. Dosages applied, 5. Data collected, 6. Discussion of the findings, 7. Deductions made, and 8. Documentation are in accord with the objectives of the study and meet the requirements of evidence-based medicine. This tool, although easy to apply, requires a high level of clinical pharmacology expertise, especially in the fields of drug disposition, pharmacokinetics, and drug action. PMID:28218890

  9. Biomarkers for Uranium Risk Assessment for the Development of the CURE (Concerted Uranium Research in Europe) Molecular Epidemiological Protocol.

    Science.gov (United States)

    Guéguen, Yann; Roy, Laurence; Hornhardt, Sabine; Badie, Christophe; Hall, Janet; Baatout, Sarah; Pernot, Eileen; Tomasek, Ladislav; Laurent, Olivier; Ebrahimian, Teni; Ibanez, Chrystelle; Grison, Stephane; Kabacik, Sylwia; Laurier, Dominique; Gomolka, Maria

    2017-01-01

    Despite substantial experimental and epidemiological research, there is limited knowledge of the uranium-induce health effects after chronic low-dose exposures in humans. Biological markers can objectively characterize pathological processes or environmental responses to uranium and confounding agents. The integration of such biological markers into a molecular epidemiological study would be a useful approach to improve and refine estimations of uranium-induced health risks. To initiate such a study, Concerted Uranium Research in Europe (CURE) was established, and involves biologists, epidemiologists and dosimetrists. The aims of the biological work package of CURE were: 1. To identify biomarkers and biological specimens relevant to uranium exposure; 2. To define standard operating procedures (SOPs); and 3. To set up a common protocol (logistic, questionnaire, ethical aspects) to perform a large-scale molecular epidemiologic study in uranium-exposed cohorts. An intensive literature review was performed and led to the identification of biomarkers related to: 1. retention organs (lungs, kidneys and bone); 2. other systems/organs with suspected effects (cardiovascular system, central nervous system and lympho-hematopoietic system); 3. target molecules (DNA damage, genomic instability); and 4. high-throughput methods for the identification of new biomarkers. To obtain high-quality biological materials, SOPs were established for the sampling and storage of different biospecimens. A questionnaire was developed to assess potential confounding factors. The proposed strategy can be adapted to other internal exposures and should improve the characterization of the biological and health effects that are relevant for risk assessment.

  10. Face symmetry assessment abilities: Clinical implications for diagnosing asymmetry

    Science.gov (United States)

    Jackson, Tate H.; Mitroff, Stephen R.; Clark, Kait; Proffit, William R.; Lee, Jessica Y.; Nguyen, Tung T.

    2014-01-01

    Introduction An accurate assessment of face symmetry is necessary for the development of a dentofacial diagnosis in orthodontics, and an understanding of individual differences in perception of face symmetry between patients and providers is needed to facilitate successful treatment. Methods Orthodontists, general dentists, and control participants completed a series of tasks to assess symmetry. Judgments were made on pairs of upright faces (similar to the longitudinal assessment of photographic patient records), inverted faces, and dot patterns. Participants completed questionnaires regarding clinical practice, education level, and self-confidence ratings for symmetry assessment abilities. Results Orthodontists showed expertise compared with controls (P <0.001), whereas dentists showed no advantage over controls. Orthodontists performed better than dentists, however, in only the most difficult face symmetry judgments (P = 0.006). For both orthodontists and dentists, accuracy increased significantly when assessing symmetry in upright vs inverted faces (t = 3.7, P = 0.001; t = 2.7, P = 0.02, respectively). Conclusions Orthodontists showed expertise in assessing face symmetry compared with both laypersons and general dentists, and they were more accurate when judging upright than inverted faces. When using accurate longitudinal photographic records to assess changing face symmetry, orthodontists are likely to be incorrect in less than 15% of cases, suggesting that assistance from some additional technology is infrequently needed for diagnosis. PMID:24182582

  11. Trial Protocol: Communicating DNA-based risk assessments for Crohn's disease: a randomised controlled trial assessing impact upon stopping smoking

    Directory of Open Access Journals (Sweden)

    Armstrong David

    2011-01-01

    Full Text Available Abstract Background Estimates of the risk of developing Crohn's disease (CD can be made using DNA testing for mutations in the NOD2 (CARD15 gene, family history, and smoking status. Smoking doubles the risk of CD, a risk that is reduced by stopping. CD therefore serves as a timely and novel paradigm within which to assess the utility of predictive genetic testing to motivate behaviour change to reduce the risk of disease. The aim of the study is to describe the impact upon stopping smoking of communicating a risk of developing CD that incorporates DNA analysis. We will test the following main hypothesis: Smokers who are first degree relatives (FDRs of CD probands are more likely to make smoking cessation attempts following communication of risk estimates of developing CD that incorporate DNA analysis, compared with an equivalent communication that does not incorporate DNA analysis. Methods/design A parallel groups randomised controlled trial in which smokers who are FDRs of probands with CD are randomly allocated in families to undergo one of two types of assessment of risk for developing CD based on either: i. DNA analysis, family history of CD and smoking status, or ii. Family history of CD and smoking status The primary outcome is stopping smoking for 24 hours or longer in the six months following provision of risk information. The secondary outcomes are seven-day smoking abstinence at one week and six month follow-ups. Randomisation of 470 smoking FDRs of CD probands, with 400 followed up (85%, provides 80% power to detect a difference in the primary outcome of 14% between randomised arms, at the 5% significance level. Discussion This trial provides one of the strongest tests to date of the impact of communicating DNA-based risk assessment on risk-reducing behaviour change. Specific issues regarding the choice of trial design are discussed. Trial Registration ISRCTN: ISRCTN21633644

  12. Do Clinical Clerks Provide Candidates with Adequate Formative Assessment during Objective Structured Clinical Examinations?

    Science.gov (United States)

    Reiter, Harold I.; Rosenfeld, Jack; Nandagopal, Kiruthiga; Eva, Kevin W.

    2004-01-01

    Context: Various research studies have examined the question of whether expert or non-expert raters, faculty or students, evaluators or standardized patients, give more reliable and valid summative assessments of performance on Objective Structured Clinical Examinations (OSCEs). Less studied has been the question of whether or not non-faculty…

  13. Ultrasonic elastography in clinical quantitative assessment of fatty liver

    Institute of Scientific and Technical Information of China (English)

    2010-01-01

    AIM: To investigate the clinical application of ultrasonic elastography in quantitative assessment of fatty liver grading. METHODS: A total of 105 patients with fatty liver were divided into mild group (n = 46), moderate group (n = 39), and severe group (n = 20). Forty-five healthy individuals served as a normal control group. All patients who underwent routine ultrasound scan and further ultrasonic elastography were evaluated accordingly to the evaluation standards for ultrasonic elastography. The ratio of...

  14. Alflutop clinical efficacy assessment in osteoarthritis (two-years study)

    OpenAIRE

    V. N. Chodyrev; N I Znaisheva; G M Lobanova; L M Ridnyak

    2003-01-01

    Objective. To assess alflutop clinical efficacy and safety during long-term course treatment of knee osteoarthritis. Methods. 51 pts with definite knee osteoarthritis of I-III stage according to Kellgren-Lawrence classification were included in an open controlled study. 20 pts received 6 intra-articular injections of alflutop 2 ml with subsequent intramuscular treatment during 3 months. Such courses were repeated 6 months apart for 2 years. 31 pts of control group received nonsteroidal anti-i...

  15. Assessing biocomputational modelling in transforming clinical guidelines for osteoporosis management.

    Science.gov (United States)

    Thiel, Rainer; Viceconti, Marco; Stroetmann, Karl

    2011-01-01

    Biocomputational modelling as developed by the European Virtual Physiological Human (VPH) Initiative is the area of ICT most likely to revolutionise in the longer term the practice of medicine. Using the example of osteoporosis management, a socio-economic assessment framework is presented that captures how the transformation of clinical guidelines through VPH models can be evaluated. Applied to the Osteoporotic Virtual Physiological Human Project, a consequent benefit-cost analysis delivers promising results, both methodologically and substantially.

  16. Assessing binocular interaction in amblyopia and its clinical feasibility.

    Directory of Open Access Journals (Sweden)

    MiYoung Kwon

    Full Text Available PURPOSE: To measure binocular interaction in amblyopes using a rapid and patient-friendly computer-based method, and to test the feasibility of the assessment in the clinic. METHODS: Binocular interaction was assessed in subjects with strabismic amblyopia (n = 7, anisometropic amblyopia (n = 6, strabismus without amblyopia (n = 15 and normal vision (n = 40. Binocular interaction was measured with a dichoptic phase matching task in which subjects matched the position of a binocular probe to the cyclopean perceived phase of a dichoptic pair of gratings whose contrast ratios were systematically varied. The resulting effective contrast ratio of the weak eye was taken as an indicator of interocular imbalance. Testing was performed in an ophthalmology clinic under 8 mins. We examined the relationships between our binocular interaction measure and standard clinical measures indicating abnormal binocularity such as interocular acuity difference and stereoacuity. The test-retest reliability of the testing method was also evaluated. RESULTS: Compared to normally-sighted controls, amblyopes exhibited significantly reduced effective contrast (∼20% of the weak eye, suggesting a higher contrast requirement for the amblyopic eye compared to the fellow eye. We found that the effective contrast ratio of the weak eye covaried with standard clincal measures of binocular vision. Our results showed that there was a high correlation between the 1st and 2nd measurements (r = 0.94, p<0.001 but without any significant bias between the two. CONCLUSIONS: Our findings demonstrate that abnormal binocular interaction can be reliably captured by measuring the effective contrast ratio of the weak eye and quantitative assessment of binocular interaction is a quick and simple test that can be performed in the clinic. We believe that reliable and timely assessment of deficits in a binocular interaction may improve detection and treatment of amblyopia.

  17. Assessment scales in stroke: clinimetric and clinical considerations

    Directory of Open Access Journals (Sweden)

    Harrison JK

    2013-02-01

    Full Text Available Jennifer K Harrison,1 Katherine S McArthur,2 Terence J Quinn21Department of Cardiovascular Sciences, University of Leicester, Leicester, UK; 2Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UKAbstract: As stroke care has developed, there has been a need to robustly assess the efficacy of interventions both at the level of the individual stroke survivor and in the context of clinical trials. To describe stroke-survivor recovery meaningfully, more sophisticated measures are required than simple dichotomous end points, such as mortality or stroke recurrence. As stroke is an exemplar disabling long-term condition, measures of function are well suited as outcome assessment. In this review, we will describe functional assessment scales in stroke, concentrating on three of the more commonly used tools: the National Institutes of Health Stroke Scale, the modified Rankin Scale, and the Barthel Index. We will discuss the strengths, limitations, and application of these scales and use the scales to highlight important properties that are relevant to all assessment tools. We will frame much of this discussion in the context of "clinimetric" analysis. As they are increasingly used to inform stroke-survivor assessments, we will also discuss some of the commonly used quality-of-life measures. A recurring theme when considering functional assessment is that no tool suits all situations. Clinicians and researchers should chose their assessment tool based on the question of interest and the evidence base around clinimetric properties.Keywords: Barthel Index, clinimetrics, clinical trial, disability, methodology, modified Rankin Scale, National Institutes Health Stroke Scale, scales, stroke, outcomes

  18. Alflutop clinical efficacy assessment in osteoarthritis (two-years study

    Directory of Open Access Journals (Sweden)

    V. N. Chodyrev

    2003-01-01

    Full Text Available Objective. To assess alflutop clinical efficacy and safety during long-term course treatment of knee osteoarthritis. Methods. 51 pts with definite knee osteoarthritis of I-III stage according to Kellgren-Lawrence classification were included in an open controlled study. 20 pts received 6 intra-articular injections of alflutop 2 ml with subsequent intramuscular treatment during 3 months. Such courses were repeated 6 months apart for 2 years. 31 pts of control group received nonsteroidal anti-inflammatory drugs (NSAID only. Pain on visual analog scale, Leken functional score, changes of NSAID treatment and radiological picture were used for assessment of efficacy. Clinical examination was performed before and after every treatment course and 3 months after the last course. Results. Every alflutop treatment course provided significant stepwise decrease of pain with improvement of mobility, reduction of NSAID requirement and absence of osteoarthritis radiological progression. Doctor and pts clinical efficacy and safety assessment coincided. Conclusion. Alflutop is an effective drug for knee osteoarthritis treatment. It has anti-inflammatory and probably chondroprotective activity with good safety.

  19. Embedded performance validity testing in neuropsychological assessment: Potential clinical tools.

    Science.gov (United States)

    Rickards, Tyler A; Cranston, Christopher C; Touradji, Pegah; Bechtold, Kathleen T

    2017-01-31

    The article aims to suggest clinically-useful tools in neuropsychological assessment for efficient use of embedded measures of performance validity. To accomplish this, we integrated available validity-related and statistical research from the literature, consensus statements, and survey-based data from practicing neuropsychologists. We provide recommendations for use of 1) Cutoffs for embedded performance validity tests including Reliable Digit Span, California Verbal Learning Test (Second Edition) Forced Choice Recognition, Rey-Osterrieth Complex Figure Test Combination Score, Wisconsin Card Sorting Test Failure to Maintain Set, and the Finger Tapping Test; 2) Selecting number of performance validity measures to administer in an assessment; and 3) Hypothetical clinical decision-making models for use of performance validity testing in a neuropsychological assessment collectively considering behavior, patient reporting, and data indicating invalid or noncredible performance. Performance validity testing helps inform the clinician about an individual's general approach to tasks: response to failure, task engagement and persistence, compliance with task demands. Data-driven clinical suggestions provide a resource to clinicians and to instigate conversation within the field to make more uniform, testable decisions to further the discussion, and guide future research in this area.

  20. Clinical assessment of social cognitive function in neurological disorders.

    Science.gov (United States)

    Henry, Julie D; von Hippel, William; Molenberghs, Pascal; Lee, Teresa; Sachdev, Perminder S

    2016-01-01

    Social cognition broadly refers to the processing of social information in the brain that underlies abilities such as the detection of others' emotions and responding appropriately to these emotions. Social cognitive skills are critical for successful communication and, consequently, mental health and wellbeing. Disturbances of social cognition are early and salient features of many neuropsychiatric, neurodevelopmental and neurodegenerative disorders, and often occur after acute brain injury. Its assessment in the clinic is, therefore, of paramount importance. Indeed, the most recent edition of the American Psychiatric Association's Diagnostic and Statistical Manual for Mental Disorders (DSM-5) introduced social cognition as one of six core components of neurocognitive function, alongside memory and executive control. Failures of social cognition most often present as poor theory of mind, reduced affective empathy, impaired social perception or abnormal social behaviour. Standard neuropsychological assessments lack the precision and sensitivity needed to adequately inform treatment of these failures. In this Review, we present appropriate methods of assessment for each of the four domains, using an example disorder to illustrate the value of these approaches. We discuss the clinical applications of testing for social cognitive function, and finally suggest a five-step algorithm for the evaluation and treatment of impairments, providing quantitative evidence to guide the selection of social cognitive measures in clinical practice.

  1. Protocol of the baseline assessment for the Environments for Healthy Living (EHL Wales cohort study

    Directory of Open Access Journals (Sweden)

    Dunstan Frank

    2010-03-01

    Full Text Available Abstract Background Health is a result of influences operating at multiple levels. For example, inadequate housing, poor educational attainment, and reduced access to health care are clustered together, and are all associated with reduced health. Policies which try to change individual people's behaviour have limited effect when people have little control over their environment. However, structural environmental change and an understanding of the way that influences interact with each other, has the potential to facilitate healthy choices irrespective of personal resources. The aim of Environments for Healthy Living (EHL is to investigate the impact of gestational and postnatal environments on health, and to examine where structural change can be brought about to optimise health outcomes. The baseline assessment will focus on birth outcomes and maternal and infant health. Methods/Design EHL is a longitudinal birth cohort study. We aim to recruit 1000 pregnant women in the period April 2010 to March 2013. We will examine the impact of the gestational environment (maternal health and the postnatal environment (housing and neighbourhood conditions on subsequent health outcomes for the infants born to these women. Data collection will commence during the participants' pregnancy, from approximately 20 weeks gestation. Participants will complete a questionnaire, undergo anthropometric measurements, wear an accelerometer, compile a food diary, and have environmental measures taken within their home. They will also be asked to consent to having a sample of umbilical cord blood taken following delivery of their baby. These data will be complemented by routinely collected electronic data such as health records from GP surgeries, hospital admissions, and child health and development records. Thereafter, participants will be visited annually for follow-up of subsequent exposures and child health outcomes. Discussion The baseline assessment of EHL will

  2. SheppHeartCABG trial—comprehensive early rehabilitation after coronary artery bypass grafting: a protocol for a randomised clinical trial

    Science.gov (United States)

    Moons, Philip; Hansen, Niels Viggo; La Cour, Søren; Olsen, Peter Skov; Gluud, Christian; Winkel, Per; Lindschou, Jane; Thygesen, Lau Caspar; Egerod, Ingrid; Berg, Selina Kikkenborg

    2017-01-01

    Introduction Patients undergoing coronary artery bypass graft surgery often experience a range of symptoms. Studies indicate that non-pharmacological interventions such as exercise training and psychoeducation have a positive physiological and psychological effect in early outpatient rehabilitation. The SheppHeartCABG trial will investigate the effect of early comprehensive rehabilitation in early phase rehabilitation versus usual care. The aim of this paper is to present the protocol for the SheppHeartCABG trial. Methods/analysis SheppHeartCABG is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, employing 1:1 central randomisation to rehabilitation plus usual care versus usual care alone. On the basis of a sample size calculation, 326 patients undergoing coronary artery bypass grafting will be included from two clinical sites. All patients receive usual care and patients allocated to the experimental intervention follow 4 weeks rehabilitation consisting of an exercise programme, psycho-educative consultations and a compact mindfulness programme. The primary outcome is physical function measured by the 6-min walk test. The secondary outcomes are mental health and physical activity measured by the Medical Outcome Study Short Form (SF-12), anxiety and depression measured by the Hospital Anxiety and Depression Scale questionnaire, physical, emotional and global scores by the HeartQoL questionnaire, sleep measured by the Pittsburgh Sleep Quality Index, pain measured by the Örebro Musculoskeletal Screening Questionnaire and muscle endurance measured by the sit-to-stand test. A number of explorative analyses will also be conducted. Ethics and dissemination SheppHeartCABG is approved by the regional ethics committee (no. H-4-2014-109) and the Danish Data Protection Agency (no. 30-1309) and is performed in accordance with good clinical practice and the Declaration of Helsinki in its latest form. Positive, neutral and

  3. Brain imaging with synthetic MR in children: clinical quality assessment

    Energy Technology Data Exchange (ETDEWEB)

    Betts, Aaron M.; Serai, Suraj [Cincinnati Children' s Hospital Medical Center, Department of Radiology, Cincinnati, OH (United States); Leach, James L.; Jones, Blaise V. [Cincinnati Children' s Hospital Medical Center, Department of Radiology, Cincinnati, OH (United States); University of Cincinnati College of Medicine, Cincinnati, OH (United States); Zhang, Bin [Cincinnati Children' s Hospital Medical Center, Biostatistics and Epidemiology, Cincinnati, OH (United States)

    2016-10-15

    Synthetic magnetic resonance imaging is a quantitative imaging technique that measures inherent T1-relaxation, T2-relaxation, and proton density. These inherent tissue properties allow synthesis of various imaging sequences from a single acquisition. Clinical use of synthetic MR imaging has been described in adult populations. However, use of synthetic MR imaging has not been previously reported in children. The purpose of this study is to report our assessment of diagnostic image quality using synthetic MR imaging in children. Synthetic MR acquisition was obtained in a sample of children undergoing brain MR imaging. Image quality assessments were performed on conventional and synthetic T1-weighted, T2-weighted, and FLAIR images. Standardized linear measurements were performed on conventional and synthetic T2 images. Estimates of patient age based upon myelination patterns were also performed. Conventional and synthetic MR images were evaluated on 30 children. Using a 4-point assessment scale, conventional imaging performed better than synthetic imaging for T1-weighted, T2-weighted, and FLAIR images. When the assessment was simplified to a dichotomized scale, the conventional and synthetic T1-weighted and T2-weighted images performed similarly. However, the superiority of conventional FLAIR images persisted in the dichotomized assessment. There were no statistically significant differences between linear measurements made on T2-weighted images. Estimates of patient age based upon pattern of myelination were also similar between conventional and synthetic techniques. Synthetic MR imaging may be acceptable for clinical use in children. However, users should be aware of current limitations that could impact clinical utility in the software version used in this study. (orig.)

  4. A protocol to assess insect resistance to heat waves, applied to bumblebees (Bombus Latreille, 1802).

    Science.gov (United States)

    Martinet, Baptiste; Lecocq, Thomas; Smet, Jérémy; Rasmont, Pierre

    2015-01-01

    Insect decline results from numerous interacting factors including climate change. One of the major phenomena related to climate change is the increase of the frequency of extreme events such as heat waves. Since heat waves are suspected to dramatically increase insect mortality, there is an urgent need to assess their potential impact. Here, we determined and compared the resistance to heat waves of insects under hyperthermic stress through their time before heat stupor (THS) when they are exposed to an extreme temperature (40°C). For this, we used a new experimental standardised device available in the field or in locations close to the field collecting sites. We applied this approach on different Arctic, Boreo-Alpine and Widespread bumblebee species in order to predict consequences of heat waves. Our results show a heat resistance gradient: the heat stress resistance of species with a centred arctic distribution is weaker than the heat resistance of the Boreo-Alpine species with a larger distribution which is itself lower than the heat stress resistance of the ubiquitous species.

  5. Understanding the relationship between the perceived characteristics of clinical practice guidelines and their uptake: protocol for a realist review

    Directory of Open Access Journals (Sweden)

    Grimshaw Jeremy

    2011-07-01

    Full Text Available Abstract Background Clinical practice guidelines have the potential to facilitate the implementation of evidence into practice, support clinical decision making, specify beneficial therapeutic approaches, and influence public policy. However, these potential benefits have not been consistently achieved. The limited impact of guidelines can be attributed to organisational constraints, the complexity of the guidelines, and the lack of usability testing or end-user involvement in their development. Implementability has been referred to as the perceived characteristics of guidelines that predict the relative ease of their implementation at the clinical level, but this concept is as yet poorly defined. The objective of our study is to identify guideline attributes that affect uptake in practice by considering evidence from four disciplines (medicine, psychology, management, human factors engineering to determine the relationship between the perceived characteristics of recommendations and their uptake and to develop a framework of implementability. Methods A realist-review approach to knowledge synthesis will be used to understand attributes of guidelines (e.g., its text and content and how changing these elements might impact clinical practice and clinical decision making. It also allows for the exploration of 'what works for whom, in what circumstances, and in what respects'. The realist review will be structured according to Pawson's five practical steps in realist reviews: (1 clarifying the scope of the review, (2 determining the search strategy, (3 ensuring proper article selection and study quality assessment, (4 extracting and organising data, and (5 synthesising the evidence and drawing conclusions. Data will be synthesised according to a two-stage analysis: (1 we will extract and define all relevant guideline attributes from the different disciplines, then create a shortlist of unique attributes and investigate their relationships with

  6. Health technology assessment in Australia: a role for clinical registries?

    Science.gov (United States)

    Scott, Anna Mae

    2016-03-31

    Objective Health technology assessment (HTA) is a process of assessing evidence to inform policy decisions about public subsidy of new drugs and medical procedures. Where evidence is uncertain but the technology itself is promising, funders may recommend funding on an interim basis. It is unknown whether evidence from clinical registries is used to resolve uncertainties identified in interim-funded decisions made by Australian HTA bodies. Therefore, the present study evaluated the role of evidence from clinical registries in resolving evidence uncertainties identified by the Medical Services Advisory Committee (MSAC).Methods All HTAs considered by MSAC between 1998 and 2015 were reviewed and assessments that recommended interim funding were identified. The MSAC website was searched to identify reassessments of these recommendations and sources of evidence used to resolve the uncertainties were identified.Results Of 173 HTA reports considered by MSAC, 17 (10%) contained an interim funding recommendation. Eight recommendations cited uncertainty around safety, 15 cited uncertainty around clinical effectiveness and 13 cited uncertainty around economics (cost-effectiveness and/or budget impact). Of the 17 interim funding recommendations, 11 (65%) have been reassessed. Only two reassessments relied on clinical registry evidence to resolve evidence gaps identified at the time of the interim funding recommendation.Conclusions Clinical registries are underused as a source of evidence for resolving uncertainties around promising new health technologies in Australia. An open dialogue between stakeholders on the role of registries in this context is needed.What is known about the topic? HTA is a process of assessing the evidence to inform policy decisions about public subsidy of new health technologies (e.g. pharmaceuticals, diagnostic tests, medical procedures). Where evidence is uncertain but the technology under evaluation is promising, funders may recommend the funding of

  7. Measurement properties of self-report physical activity assessment tools in stroke: a protocol for a systematic review

    Science.gov (United States)

    Martins, Júlia Caetano; Aguiar, Larissa Tavares; Nadeau, Sylvie; Scianni, Aline Alvim; Teixeira-Salmela, Luci Fuscaldi; Faria, Christina Danielli Coelho de Morais

    2017-01-01

    Introduction Self-report physical activity assessment tools are commonly used for the evaluation of physical activity levels in individuals with stroke. A great variety of these tools have been developed and widely used in recent years, which justify the need to examine their measurement properties and clinical utility. Therefore, the main objectives of this systematic review are to examine the measurement properties and clinical utility of self-report measures of physical activity and discuss the strengths and limitations of the identified tools. Methods and analysis A systematic review of studies that investigated the measurement properties and/or clinical utility of self-report physical activity assessment tools in stroke will be conducted. Electronic searches will be performed in five databases: Medical Literature Analysis and Retrieval System Online (MEDLINE) (PubMed), Excerpta Medica Database (EMBASE), Physiotherapy Evidence Database (PEDro), Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) and Scientific Electronic Library Online (SciELO), followed by hand searches of the reference lists of the included studies. Two independent reviewers will screen all retrieve titles, abstracts, and full texts, according to the inclusion criteria and will also extract the data. A third reviewer will be referred to solve any disagreement. A descriptive summary of the included studies will contain the design, participants, as well as the characteristics, measurement properties, and clinical utility of the self-report tools. The methodological quality of the studies will be evaluated using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist and the clinical utility of the identified tools will be assessed considering predefined criteria. This systematic review will follow the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) statement. Discussion This systematic review will

  8. Clinical significance of computed tomography assessment for third molar surgery

    Institute of Scientific and Technical Information of China (English)

    Kenji; Nakamori; Kei; Tomihara; Makoto; Noguchi

    2014-01-01

    Surgical extraction of the third molar is the most commonly performed surgical procedure in the clinical practice of oral surgery.Third molar surgery is warranted when there is inadequate space for eruption,malpositioning,or risk for cyst or odontogenic tumor formation.Preoperative assessment should include a detailed morphologic analysis of the third molar and its relationship to adjacent structures and surrounding tissues.Due to developments in medical engineering technology,computed tomography(CT)now plays a critical role in providing the clear images required for adequate assessment prior to third molar surgery.Removal of the maxillary third molar is associated with a risk for maxillary sinus perforation,whereas removal of the mandibular third molar can put patients at risk for a neurosensory deficit from damage to the lingual nerve or inferior alveolar nerve.Multiple factors,including demographic,anatomic,and treatment-related factors,influence the incidence of nerve injury during or following removal of the third molar.CT assessment of the third molar prior to surgery can identify some of these risk factors,such as the absence of cortication between themandibular third molar and the inferior alveolar canal,prior to surgery to reduce the risk for nerve damage.This topic highlight presents an overview of the clinical significance of CT assessment in third molar surgery.

  9. Clinical significance of computed tomography assessment for third molar surgery.

    Science.gov (United States)

    Nakamori, Kenji; Tomihara, Kei; Noguchi, Makoto

    2014-07-28

    Surgical extraction of the third molar is the most commonly performed surgical procedure in the clinical practice of oral surgery. Third molar surgery is warranted when there is inadequate space for eruption, malpositioning, or risk for cyst or odontogenic tumor formation. Preoperative assessment should include a detailed morphologic analysis of the third molar and its relationship to adjacent structures and surrounding tissues. Due to developments in medical engineering technology, computed tomography (CT) now plays a critical role in providing the clear images required for adequate assessment prior to third molar surgery. Removal of the maxillary third molar is associated with a risk for maxillary sinus perforation, whereas removal of the mandibular third molar can put patients at risk for a neurosensory deficit from damage to the lingual nerve or inferior alveolar nerve. Multiple factors, including demographic, anatomic, and treatment-related factors, influence the incidence of nerve injury during or following removal of the third molar. CT assessment of the third molar prior to surgery can identify some of these risk factors, such as the absence of cortication between the mandibular third molar and the inferior alveolar canal, prior to surgery to reduce the risk for nerve damage. This topic highlight presents an overview of the clinical significance of CT assessment in third molar surgery.

  10. A model-based framework for the quality assessment of surface albedo in situ measurement protocols

    Science.gov (United States)

    Adams, Jennifer; Gobron, Nadine; Widlowski, Jean-Luc; Mio, Corrado

    2016-09-01

    Satellite-based retrievals of land surface albedo are essential for climate and environmental modelling communities. To be of use, satellite-retrievals are required to comply to given accuracy requirements, mainly achieved through comparison with in situ measurements. Differences between in situ and satellite-based retrievals depend on their actual difference and their associated uncertainties. It is essential that these uncertainties can be computed to properly understand the differences between satellite-based and in situ measurements of albedo, however quantifying the individual contributions of uncertainty is difficult. This study introduces a model-based framework for assessing the quality of in situ albedo measurements. A 3D Monte Carlo Ray Tracing (MCRT) radiative transfer model is used to simulate field measurements of surface albedo, and is able to identify and quantify potential sources of error in the field measurement. Compliance with the World Meteorological Organisation (WMO) requirement for 3% accuracy is tested. 8 scenarios were investigated, covering a range of ecosystem types and canopy structures, seasons, illumination angles and tree heights. Results indicate that height of measurement above the canopy is the controlling factor in accuracy, with each canopy scenario reaching the WMO requirement at different heights. Increasing canopy heterogeneity and tree height noticeably reduces the accuracy, whereas changing seasonality from summer to winter in a deciduous forest increases accuracy. For canopies with a row structure, illumination angle can significantly impact accuracy as a result of shadowing effects. Tests were made on the potential use of multiple in situ measurements, indicating considerably increased accuracy if two or more in situ measurements can be made.

  11. Incorporation of expert variability into breast cancer treatment recommendation in designing clinical protocol guided fuzzy rule system models.

    Science.gov (United States)

    Garibaldi, Jonathan M; Zhou, Shang-Ming; Wang, Xiao-Ying; John, Robert I; Ellis, Ian O

    2012-06-01

    It has been often demonstrated that clinicians exhibit both inter-expert and intra-expert variability when making difficult decisions. In contrast, the vast majority of computerized models that aim to provide automated support for such decisions do not explicitly recognize or replicate this variability. Furthermore, the perfect consistency of computerized models is often presented as a de facto benefit. In this paper, we describe a novel approach to incorporate variability within a fuzzy inference system using non-stationary fuzzy sets in order to replicate human variability. We apply our approach to a decision problem concerning the recommendation of post-operative breast cancer treatment; specifically, whether or not to administer chemotherapy based on assessment of five clinical variables: NPI (the Nottingham Prognostic Index), estrogen receptor status, vascular invasion, age and lymph node status. In doing so, we explore whether such explicit modeling of variability provides any performance advantage over a more conventional fuzzy approach, when tested on a set of 1310 unselected cases collected over a fourteen year period at the Nottingham University Hospitals NHS Trust, UK. The experimental results show that the standard fuzzy inference system (that does not model variability) achieves overall agreement to clinical practice around 84.6% (95% CI: 84.1-84.9%), while the non-stationary fuzzy model can significantly increase performance to around 88.1% (95% CI: 88.0-88.2%), p<0.001. We conclude that non-stationary fuzzy models provide a valuable new approach that may be applied to clinical decision support systems in any application domain.

  12. Study Protocol on Ecological Momentary Assessment of Health-Related Quality of Life using a Smartphone Application

    Directory of Open Access Journals (Sweden)

    Silvana Mareva

    2016-07-01

    Full Text Available Health-Related Quality of Life (HRQoL is a construct of increasing importance in modern healthcare, and has typically been assessed using retrospective instruments. While such measures have been shown to have predictive utility for clinical outcomes, several cognitive biases associated with human recall and current mood state may undermine their validity and reliability. Retrospective tools can be further criticized for their lack of ecology, as individuals are usually assessed in less natural settings such as hospitals and health centers, and may be obliged to spend time and money travelling to receive assessment. Ecological Momentary Assessment (EMA is an alternative, as mobile assessment using mobile health (mHealth technology has the potential to minimize biases and overcome many of these limitations. Employing an EMA methodology, we will use a smartphone application to collect data on real-time HRQoL, with an adapted version of the widely used WHOQOL-BREF questionnaire. We aim to recruit a total of 420 students from seven different universities across Europe. Participants will be prompted by the application to report their real-time HRQoL over two weeks together with information on mood and current activities. At the end of two weeks, students will complete a retrospective assessment of their HRQoL and provide information about their sleep quality and perceived stress. The psychometric properties of real-time HRQoL will be assessed, including analysis of the factorial structure, reliability and validity of the measure, and compared with retrospective HRQoL responses for the same two-week testing period. Further, we aim to identify factors associated with real-time HRQoL (e.g. mood, activities, the feasibility of the application, and within- and between-person variability in real-time HRQoL. We expect real-time HRQoL to have adequate validity and reliability, and positive responses on the feasibility of using a smartphone application for

  13. Study Protocol on Ecological Momentary Assessment of Health-Related Quality of Life Using a Smartphone Application.

    Science.gov (United States)

    Mareva, Silvana; Thomson, David; Marenco, Pietro; Estal Muñoz, Víctor; Ott, Caroline V; Schmidt, Barbara; Wingen, Tobias; Kassianos, Angelos P

    2016-01-01

    Health-Related Quality of Life (HRQoL) is a construct of increasing importance in modern healthcare, and has typically been assessed using retrospective instruments. While such measures have been shown to have predictive utility for clinical outcomes, several cognitive biases associated with human recall and current mood state may undermine their validity and reliability. Retrospective tools can be further criticized for their lack of ecology, as individuals are usually assessed in less natural settings such as hospitals and health centers, and may be obliged to spend time and money traveling to receive assessment. Ecological momentary assessment (EMA) is an alternative, as mobile assessment using mobile health (mHealth) technology has the potential to minimize biases and overcome many of these limitations. Employing an EMA methodology, we will use a smartphone application to collect data on real-time HRQoL, with an adapted version of the widely used WHOQOL-BREF questionnaire. We aim to recruit a total of 450 healthy participants. Participants will be prompted by the application to report their real-time HRQoL over 2 weeks together with information on mood and current activities. At the end of 2 weeks, they will complete a retrospective assessment of their HRQoL and they will provide information about their sleep quality and perceived stress. The psychometric properties of real-time HRQoL will be assessed, including analysis of the factorial structure, reliability and validity of the measure, and compared with retrospective HRQoL responses for the same 2-week testing period. Further, we aim to identify factors associated with real-time HRQoL (e.g., mood, activities), the feasibility of the application, and within- and between-person variability in real-time HRQoL. We expect real-time HRQoL to have adequate validity and reliability, and positive responses on the feasibility of using a smartphone application for routine HRQoL assessment. The direct comparison of real

  14. Pediatric insomnia: new insights in clinical assessment and treatment options.

    Science.gov (United States)

    Bruni, Oliviero; Angriman, Marco

    2015-01-01

    Sleep disorders in children can compromise quality of life of both children and families and chronic sleep deprivations is associated with poorer developmental outcome, overweight and behavioral disturbances. Clinicians should incorporate questions about sleep into their routine health assessment, and the assessment of insomnia should follow a medical approach primary and secondary contributing factors should be assessed, as well as maladaptive behaviors related to sleep. A careful examination of sleep/wake schedule, abnormal movements or behavior during sleep, and daytime consequences of sleep disruption or deprivation is mandatory. Sleeping environment, and bedtime routines should be examined to identify behavioral issues related to sleep. Polysomnography is not routinely indicated for children with insomnia, but actigraphy can give an objective estimation of sleep parameters. The Authors propose a new classification of pediatric insomnia, based on both genetic and clinical aspects, and suggest specific treatment options, including sleep hygiene, behavioral strategies and pharmacological treatment.

  15. Protocol of a feasibility study for cognitive assessment of an ageing cohort within the Southeast Asia Community Observatory (SEACO), Malaysia

    Science.gov (United States)

    Mohan, Devi; Stephan, Blossom C M; Allotey, Pascale; Jagger, Carol; Pearce, Mark; Siervo, Mario; Reidpath, Daniel D

    2017-01-01

    Introduction There is a growing proportion of population aged 65 years and older in low-income and middle-income countries. In Malaysia, this proportion is predicted to increase from 5.1% in 2010 to more than 15.4% by 2050. Cognitive ageing and dementia are global health priorities. However, risk factors and disease associations in a multiethnic, middle-income country like Malaysia may not be consistent with those reported in other world regions. Knowing the burden of cognitive impairment and its risk factors in Malaysia is necessary for the development of management strategies and would provide valuable information for other transitional economies. Methods and analysis This is a community-based feasibility study focused on the assessment of cognition, embedded in the longitudinal study of health and demographic surveillance site of the South East Asia Community Observatory (SEACO), in Malaysia. In total, 200 adults aged ≥50 years are selected for an in-depth health and cognitive assessment including the Mini Mental State Examination, the Montreal Cognitive Assessment, blood pressure, anthropometry, gait speed, hand grip strength, Depression Anxiety Stress Score and dried blood spots. Discussion and conclusions The results will inform the feasibility, response rates and operational challenges for establishing an ageing study focused on cognitive function in similar middle-income country settings. Knowing the burden of cognitive impairment and dementia and risk factors for disease will inform local health priorities and management, and place these within the context of increasing life expectancy. Ethics and dissemination The study protocol is approved by the Monash University Human Research Ethics Committee. Informed consent is obtained from all the participants. The project's analysed data and findings will be made available through publications and conference presentations and a data sharing archive. Reports on key findings will be made available as

  16. Direct, quantitative clinical assessment of hand function: usefulness and reproducibility.

    Science.gov (United States)

    Goodson, Alexander; McGregor, Alison H; Douglas, Jane; Taylor, Peter

    2007-05-01

    Methods of assessing functional impairment in arthritic hands include pain assessments and disability scoring scales which are subjective, variable over time and fail to take account of the patients' need to adapt to deformities. The aim of this study was to evaluate measures of functional strength and joint motion in the assessment of the rheumatoid (RA) and osteoarthritic (OA) hand. Ten control subjects, ten RA and ten OA patients were recruited for the study. All underwent pain and disability scoring and functional assessment of the hand using measures of pinch/grip strength and range of joint motion (ROM). Functional assessments including ROM analyses at interphalangeal (IP), metacarpophalangeal (MCP) and wrist joints along with pinch/grip strength clearly discriminated between patient groups (RA vs. OA MCP ROM P<0.0001), pain and disability scales were unable to. In the RA there were demonstrable relationships between ROM measurements and disability (R2=0.31) as well as disease duration (R2=0.37). Intra-patient measures of strength were robust whereas inter-patient comparisons showed variability. In conclusion, pinch/grip strength and ROM are clinically reproducible assessments that may more accurately reflect functional impairment associated with arthritis.

  17. In-vitro assessment of a registration protocol for image guided implant dentistry.

    Science.gov (United States)

    Birkfellner, W; Solar, P; Gahleitner, A; Huber, K; Kainberger, F; Kettenbach, J; Homolka, P; Diemling, M; Watzek, G; Bergmann, H

    2001-02-01

    In this study a computer aided navigation technique for accurate positioning of oral implants was assessed. An optical tracking system with specially designed tools for monitoring the position of surgical instruments relative to the patient was used to register 5 partially or completely edentulous jaw models. Besides the accuracy of the tracking system, the precision of localizing a specific position on 3-dimensional preoperative imagery is governed by the registration algorithm which conveys the coordinate system of the preoperative computed tomography (CT) scan to the actual patient position. Two different point-to-point registration algorithms were compared for their suitability for this application. The accuracy was determined separately for the localization error of the position measurement hardware (fiducial localization error-FLE) and the error as reported by the registration algorithm (fiducial registration error-FRE). The overall error of the navigation procedure was determined as the localization error of additional landmarks (steel spheres, 0.5 mm diameter) after registration (target registration error-TRE). Images of the jaw models were obtained using a high resolution CT scan (1.5 mm slice thickness, 1 mm table feed, incremental scanning, 120 kV, 150 mAs, 512 x 512 matrix, FOV 120 mm). The accuracy of the position measurement probes was 0.69 +/- 0.15 mm (FLE). Using 3 implanted fiducial markers, FRE was 0.71 +/- 0.12 mm on average and 1.00 +/- 0.13 mm maximum. TRE was found to be 1.23 +/- 0.28 mm average and 1.87 +/- 0.47 mm maximum. Increasing the number of fiducial markers to a total of 5 did not significantly improve precision. Furthermore it was found that a registration algorithm based on solving an eigenvalue problem is the superior approach for point-to-point matching in terms of mathematical stability. The experimental results indicate that positioning accuracy of oral implants may benefit from computer aided intraoperative navigation. The

  18. Clinical assessment tools identify functional deficits in fragility fracture patients

    Directory of Open Access Journals (Sweden)

    Ames TD

    2016-05-01

    Full Text Available Tyler D Ames,1 Corinne E Wee,1 Khoi M Le,1 Tiffany L Wang,1 Julie Y Bishop,2 Laura S Phieffer,2 Carmen E Quatman2 1The Ohio State University College of Medicine, 2Department of Orthopaedics, The Ohio State University Wexner Medical Center, Columbus, OH, USA Purpose: To identify inexpensive, noninvasive, portable, clinical assessment tools that can be used to assess functional performance measures that may put older patients at risk for falls such as balance, handgrip strength, and lumbopelvic control.Patients and methods: Twenty fragility fracture patients and 21 healthy control subjects were evaluated using clinical assessment tools (Nintendo Wii Balance Board [WBB], a handheld dynamometer, and an application for the Apple iPod Touch, the Level Belt that measure functional performance during activity of daily living tasks. The main outcome measurements were balance (WBB, handgrip strength (handheld dynamometer, and lumbopelvic control (iPod Touch Level Belt, which were compared between fragility fracture patients and healthy controls.Results: Fragility fracture patients had lower scores on the vertical component of the WBB Torso Twist task (P=0.042 and greater medial–lateral lumbopelvic sway during a 40 m walk (P=0.026 when compared to healthy controls. Unexpectedly, the fracture patients had significantly higher scores on the left leg (P=0.020 and total components (P=0.010 of the WBB Single Leg Stand task as well as less faults during the left Single Leg Stand task (P=0.003.Conclusion: The clinical assessment tools utilized in this study are relatively inexpensive and portable tools of performance measures capable of detecting differences in postural sway between fragility fracture patients and controls. Keywords: fall risk, geriatric fracture, Nintendo Wii Balance Board, Level Belt, fragility fracture

  19. Acupuncture for lateral epicondylitis (tennis elbow): study protocol for a randomized, practitioner-assessor blinded, controlled pilot clinical trial

    Science.gov (United States)

    2013-01-01

    Background Lateral epicondylitis is the most frequent cause of pain around the elbow joint. It causes pain in the region of the elbow joint and results in dysfunction of the elbow and deterioration of the quality of life. The purpose of this study is to compare the effects of ipsilateral acupuncture, contralateral acupuncture and sham acupuncture on lateral epicondylitis. Methods/design Forty-five subjects with lateral epicondylitis will be randomized into three groups: the ipsilateral acupuncture group, contralateral acupuncture group and the sham acupuncture group. The inclusion criteria will be as follows: (1) age between 19 and 65 years with pain due to one-sided lateral epicondylitis that persisted for at least four weeks, (2) with tenderness on pressure limited to regions around the elbow joint, (3) complaining of pain during resistive extension of the middle finger or the wrist, (4) with average pain of NRS 4 or higher during the last one week at a screening visit and (5) voluntarily agree to this study and sign a written consent. Acupuncture treatment will be given 10 times in total for 4 weeks to all groups. Follow up observations will be conducted after the completion of the treatment, 8 weeks and 12 weeks after the random assignment. Ipsilateral acupuncture group and contralateral acupuncture group will receive acupuncture on LI4, TE5, LI10, LI11, LU5, LI12 and two Ashi points. The sham acupuncture group will receive treatment on acupuncture points not related to the lateral epicondylitis using a non-invasive method. The needles will be maintained for 20 minutes. The primary outcome will be differences in the visual analogue scale (VAS) for elbow pain between the groups. The secondary outcome will be differences in patient-rated tennis elbow evaluation (PRTEE), pain-free/maximum grip strength (Dynamometer), pressure pain threshold, clinically relevant improvement, patient global assessment, and the EQ-5D. The data will be analyzed with the paired t

  20. Parthenium dermatitis severity score to assess clinical severity of disease

    Directory of Open Access Journals (Sweden)

    Kaushal K Verma

    2017-01-01

    Full Text Available Background: Parthenium dermatitis is the most common type of airborne contact dermatitis in India. It is a chronic disease of a remitting and relapsing course with significant morbidity and distress, but there is no scoring system to assess its severity. Aim: To design a scoring system for the assessment of clinical severity of disease in Parthenium dermatitis and to use this scoring system in various studies to determine its sensitivity, specificity, and reproducibility. Methods and Results: In our first few studies on Parthenium dermatitis, we designed and used a basic clinical severity scoring system based on itching, morphology of the lesions, and areas involved. However, in subsequent studies, we modified it to the present scoring system as Parthenium dermatitis severity score (PDSS. Our studies showed the high sensitivity of PDSS in characterization of the disease severity at the given point of time, as well as to determine the efficacy of a prescribed treatment modality which was reliable and reproducible. Conclusion: Thus, PDSS may be used by clinicians for appropriate scoring of the clinical severity of Parthenium dermatitis and in monitoring the disease response to therapy.

  1. Clinical Assessment of Risk Management: an INtegrated Approach (CARMINA).

    Science.gov (United States)

    Tricarico, Pierfrancesco; Tardivo, Stefano; Sotgiu, Giovanni; Moretti, Francesca; Poletti, Piera; Fiore, Alberto; Monturano, Massimo; Mura, Ida; Privitera, Gaetano; Brusaferro, Silvio

    2016-08-08

    Purpose - The European Union recommendations for patient safety calls for shared clinical risk management (CRM) safety standards able to guide organizations in CRM implementation. The purpose of this paper is to develop a self-evaluation tool to measure healthcare organization performance on CRM and guide improvements over time. Design/methodology/approach - A multi-step approach was implemented including: a systematic literature review; consensus meetings with an expert panel from eight Italian leader organizations to get to an agreement on the first version; field testing to test instrument feasibility and flexibility; Delphi strategy with a second expert panel for content validation and balanced scoring system development. Findings - The self-assessment tool - Clinical Assessment of Risk Management: an INtegrated Approach includes seven areas (governance, communication, knowledge and skills, safe environment, care processes, adverse event management, learning from experience) and 52 standards. Each standard is evaluated according to four performance levels: minimum; monitoring; outcomes; and improvement actions, which resulted in a feasible, flexible and valid instrument to be used throughout different organizations. Practical implications - This tool allows practitioners to assess their CRM activities compared to minimum levels, monitor performance, benchmarking with other institutions and spreading results to different stakeholders. Originality/value - The multi-step approach allowed us to identify core minimum CRM levels in a field where no consensus has been reached. Most standards may be easily adopted in other countries.

  2. Osteogenesis imperfecta: clinical diagnosis, nomenclature and severity assessment.

    Science.gov (United States)

    Van Dijk, F S; Sillence, D O

    2014-06-01

    Recently, the genetic heterogeneity in osteogenesis imperfecta (OI), proposed in 1979 by Sillence et al., has been confirmed with molecular genetic studies. At present, 17 genetic causes of OI and closely related disorders have been identified and it is expected that more will follow. Unlike most reviews that have been published in the last decade on the genetic causes and biochemical processes leading to OI, this review focuses on the clinical classification of OI and elaborates on the newly proposed OI classification from 2010, which returned to a descriptive and numerical grouping of five OI syndromic groups. The new OI nomenclature and the pre-and postnatal severity assessment introduced in this review, emphasize the importance of phenotyping in order to diagnose, classify, and assess severity of OI. This will provide patients and their families with insight into the probable course of the disorder and it will allow physicians to evaluate the effect of therapy. A careful clinical description in combination with knowledge of the specific molecular genetic cause is the starting point for development and assessment of therapy in patients with heritable disorders including OI. © 2014 The Authors. American Journal of Medical Genetics Published by Wiley Periodicals, Inc. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

  3. Use of clinical simulation for assessment in EHR-procurement

    DEFF Research Database (Denmark)

    Jensen, Sanne; Rasmussen, Stine L.; Lyng, Karen M.

    2013-01-01

    design methods are widely described, there are very limited descriptions of how to assess and compare different EHR-platforms and their support in work processes upon its procurement. This paper describes the method we have developed to undertake this task. It is discussed how the method differs and how......In Denmark, two large regions cooperate in a public intervention process of acquiring a new eHealth-platform to support the daily clinical work of approximately 40,000 users in 14 hospitals. It is essential that the new platform, besides fulfilling comprehensive detailed specifications, supports...... the daily work practice consisting of numerous mixed tasks executed by many different clinical actors in various settings. Within health informatics it has proven beneficial to use human factors approaches in the design process to secure systems that are responsive to the actual field of application. While...

  4. The process of clinical assessment: cognitions of the evaluator

    Directory of Open Access Journals (Sweden)

    Carmelo Ibáñez Aguirre

    2013-08-01

    Full Text Available The cognitive paradigm of the past few decades opens several new possibilities for psychological evaluation.  The objective of this essay is to emphasize the possibilities related to the quality of self-evaluation, specifically professional self-assessment, meaning a critical analysis of one’s own evaluation process. In this essay, metacognition activities and strategies are examined, as are the ways in which these activities and strategies relate to metacognition and cognitive skills. The intent of this theoretical essay is to offer answers to the clinical evaluator’s professional experience. The results indicate that the clinical professional must consider strategies to improve metacognition and cognitive skills through reflection, self-analysis and self-criticism to improve the quality and efficiency of their work.

  5. MR imaging assessment of clinical problems in rheumatoid arthritis

    Energy Technology Data Exchange (ETDEWEB)

    Narvaez, Jose A.; Roca, Yolanda; Aguilera, Carlos [Department of CT and MR Imaging, Hospital Duran i Reynals, Universitaria de Bellvitge, Barcelona (Spain); Narvaez, Javier [Department of Medicine, Delfos Medical Center, Barcelona (Spain)

    2002-07-01

    Although MR imaging has been increasingly recognized as a useful tool in the diagnosis of early rheumatoid arthritis (RA) and in the assessment of disease activity, these applications have not yet been usually included in the routine management of this condition. Our goal is to review the current role of MRI in the everyday clinical management of patients with RA. The usefulness of MRI in the evaluation of articular and para-articular changes in specific locations, mainly the craniocervical region and the temporomandibular joint, are reviewed. Clinical problems derived from local extra-articular involvement, such as tenosynovitis, ''rice-bodies'' bursitis, and Baker's cyst rupture, are also described. Finally, we also review the value of MRI in evaluation of some complications of RA such as tendinous rupture, osteonecrosis, stress fracture, and septic arthritis/osteomyelitis. (orig.)

  6. Observation and execution of upper-limb movements as a tool for rehabilitation of motor deficits in paretic stroke patients: protocol of a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Ertelt Denis

    2012-06-01

    Full Text Available Abstract Background Evidence exist that motor observation activates the same cortical motor areas that are involved in the performance of the observed actions. The so called “mirror neuron system” has been proposed to be responsible for this phenomenon. We employ this neural system and its capability to re-enact stored motor representations as a tool for rehabilitating motor control. In our new neurorehabilitative schema (videotherapy we combine observation of daily actions with concomitant physical training of the observed actions focusing on the upper limbs. Following a pilot study in chronic patients in an ambulatory setting, we currently designed a new multicenter clinical study dedicated to patients in the sub-acute state after stroke using a home-based self-induced training. Within our protocol we assess 1 the capability of action observation to elicit rehabilitational effects in the motor system, and 2 the capacity of this schema to be performed by patients without assistance from a physiotherapist. The results of this study would be of high health and economical relevance. Methods/design A controlled, randomized, multicenter, paralleled, 6 month follow-up study will be conducted on three groups of patients: one group will be given the experimental treatment whereas the other two will participate in control treatments. All patients will undergo their usual rehabilitative treatment beside participation in the study. The experimental condition consists in the observation and immediate imitation of common daily hand and arm actions. The two parallel control groups are a placebo group and a group receiving usual rehabilitation without any trial-related treatment. Trial randomization is provided via external data management. The primary efficacy endpoint is the improvement of the experimental group in a standardized motor function test (Wolf Motor Function Test relative to control groups. Further assessments refer to subjective and

  7. Assessment of protocols in cone beam CT with symmetric and asymmetric beam using effective dose and P{sub ka}

    Energy Technology Data Exchange (ETDEWEB)

    Batista, W. O.; Linhares de O, M. V. [Instituto Federal da Bahia, Rua Emidio dos Santos s/n, Barbalho, Salvador, 40301015 Bahia (Brazil); Soares, M. R.; Maia, A. F. [Universidade Federal de Sergipe, Departamento de Fisica, Cidade Universitaria Prof. Jose Aloisio de Campos, Marechal Rondon s/n, Jardim Rosa Elze, 49-100000 Sao Cristovao, Sergipe (Brazil); Caldas, L. V. E., E-mail: wilsonottobatista@gmail.com [Instituto de Pesquisas Energeticas e Nucleares / CNEN, Av. Lineu Prestes 2242, Cidade Universitaria, 05508-000 Sao Paulo (Brazil)

    2014-08-15

    The cone beam CT is an emerging technology in dental radiology with significant differences the point of view of design technology between the various manufacturers on the world market. This study aims to evaluate and compare protocols with similar purposes in a cone beam CT scanner using TLDs and air kerma - area product (P{sub ka}) as kerma index. Measurements were performed on two protocols used to obtain the image the maxilla-mandible in equipment Gendex GXCB 500: Protocol [GX1] extended diameter and asymmetric beam (14 cm x 8.5 cm - maxilla / mandible) and protocol [GX2] symmetrical beam (8.5 cm x 8.5 cm - maxillary / mandible). Was used LiF dosimeters (TLD 100) inserted into a female anthropomorphic phantom manufactured by Radiology Support Devices. For all protocols evaluated the value of P{sub ka} using a meter Diamentor E2 and PTW system Radcal Rapidose. The results obtained for Effective Dose / P{sub ka} these measurements were separated by protocol image. Protocol [GX1]: 44.5 μSv/478 mGy cm{sup 2}; protocol [GX2]: 54.8 μSv/507 mGy cm{sup 2}. These values indicate that the relationship between the diameter of the image acquired in the protocol [GX1] and the diameter of the image in the protocol [GX2] is equal to 1.65, the Effective Dose for the first protocol has lower value at 18%. P{sub ka} values reveal very similar results between the two protocols, although, common sense leads to the interpretation that imaging protocols with field of view (Fov) of large diameters imply high values of effective dose when compared to small diameters. However, in this particular case, this is not true due to the asymmetrical beam technology. Conclude that for the cases where the scanner uses asymmetric beam to obtain images with large diameters that cover the entire face there are advantages from the point of view of reducing the exposure of patients with respect to the use of symmetrical beam and / or to Fov images with a smaller diameter. (Author)

  8. PERSONALITY AND CLINICAL TESTS IN SPANISH FOR ASSESSING JUVENILE OFFENDERS

    Directory of Open Access Journals (Sweden)

    Lorena Wenger

    2016-05-01

    Full Text Available The psychological assessment of offenders throughout the different stages in the juvenile justice system is essential. It ensures the adequacy of the legal and educational measures to be applied in the process. This paper reviews the main tests of psychological assessment available in Spanish, suitable for use by psychology professionals who work with young offenders in the juvenile justice services in Spanish-speaking countries. We classify these tools into three groups: a personological, i.e. generic tools, suitable for any professional context in psychology, b clinical, i.e. tools whose initial use has been limited to working with adolescents with mental health needs, and c forensic, tools that have been specially developed for use in the juvenile justice population. This last group is described in the second part of this article (which appears in this same issue. The most important instruments of proven utility are presented and reviewed for each group.

  9. Clinical and psychometric validation of the psychotic depression assessment scale

    DEFF Research Database (Denmark)

    Østergaard, Søren Dinesen; Pedersen, Christina H; Uggerby, Peter

    2015-01-01

    recordings of these interviews were assessed by two experienced psychiatrists (global severity rating of psychotic depression, depressive symptoms and psychotic symptoms) and by two young physicians (rating on 27 symptom items, including the 11 PDAS items). The clinical validity and responsiveness......BACKGROUND: Recent studies have indicated that the 11-item Psychotic Depression Assessment Scale (PDAS), consisting of the 6-item melancholia subscale (HAM-D6) of the Hamilton Depression Rating Scale and 5 psychosis items from the Brief Psychiatric Rating Scale (BPRS), is a valid measure...... for the severity of psychotic depression. The aim of this study was to subject the PDAS, and its depression (HAM-D6) and psychosis (BPRS5) subscales to further validation. METHODS: Patients diagnosed with psychotic depression at Danish psychiatric hospitals participated in semi-structured interviews. Video...

  10. Efficacy of three treatment protocols for adolescents with social anxiety disorder: a 5-year follow-up assessment.

    Science.gov (United States)

    Garcia-Lopez, Luis-Joaquin; Olivares, Jose; Beidel, Deborah; Albano, Anne-Marie; Turner, Samuel; Rosa, Ana I

    2006-01-01

    Few studies have reported long-term follow-up data in adults and even fewer in adolescents. The purpose of this work is to report on the longest follow-up assessment in the literature on treatments for adolescents with social phobia. A 5-year follow-up assessment was conducted with subjects who originally received either Cognitive Behavioral Group Therapy for Adolescents (CBGT-A), Social Effectiveness Therapy for Adolescents--Spanish version (SET-Asv), or Intervención en Adolescentes con Fobia Social--Treatment for Adolescents with Social Phobia (IAFS) in a controlled clinical trial. Twenty-three subjects completing the treatment conditions were available for the 5-year follow-up. Results demonstrate that subjects treated either with CBGT-A, SET-Asv and IAFS continued to maintain their gains after treatments were terminated. Either the CBGT-A, SET-Asv and IAFS can provide lasting effects to the majority of adolescents with social anxiety. Issues that may contribute to future research and clinical implications are discussed.

  11. Model-Driven Paediatric Cardiomyopathy Pathways - A Clinical Impact Assessment.

    Science.gov (United States)

    Stroetmann, Karl A; Thiel, Rainer

    2017-01-01

    Intermediate results from an ongoing health technology assessment exercise of a simulation model of paediatric cardiomyopathy are reported. Comprehensive data on paediatric cardiomyopathy/heart failure, treatment options, incidence and prevalence, prognoses for different outcomes to be expected were collected. Based on this knowledge, a detailed clinical pathway model was developed and validated against the clinical workflow in a tertiary paediatric care hospital. It combines three disease stages and various treatment options with estimates of the probabilities of a child moving from one stage to another. To reflect the complexity of initial decision taking by clinicians, a three-stage Markov model was combined with a decision tree approach - a Markov decision process. A Markov Chain simulation tool was applied to compare estimates of transition probabilities and cost data of present standard of care treatment options for a cohort of children over ten years with expected improvements from using a clinical decision support tool based on the disease model under development. Early results indicate a slight increase of overall costs resulting from the extra cost of using such a tool in spite of some savings to be expected from improved care. However, the intangible benefits in life years saved of severely ill children and the improvement in QoL to be expected for moderately ill ones should more than compensate for this.

  12. Subgroup analyses of clinical effectiveness to support health technology assessments.

    Science.gov (United States)

    Paget, Marie-Ange; Chuang-Stein, Christy; Fletcher, Christine; Reid, Carol

    2011-01-01

    Subgroup analysis is an integral part of access and reimbursement dossiers, in particular health technology assessment (HTA), and their HTA recommendations are often limited to subpopulations. HTA recommendations for subpopulations are not always clear and without controversies. In this paper, we review several HTA guidelines regarding subgroup analyses. We describe good statistical principles for subgroup analyses of clinical effectiveness to support HTAs and include case examples where HTA recommendations were given to subpopulations only. Unlike regulatory submissions, pharmaceutical statisticians in most companies have had limited involvement in the planning, design and preparation of HTA/payers submissions. We hope to change this by highlighting how pharmaceutical statisticians should contribute to payers' submissions. This includes early engagement in reimbursement strategy discussions to influence the design, analysis and interpretation of phase III randomized clinical trials as well as meta-analyses/network meta-analyses. The focus on this paper is on subgroup analyses relating to clinical effectiveness as we believe this is the first key step of statistical involvement and influence in the preparation of HTA and reimbursement submissions.

  13. Reactivity to smartphone-based ecological momentary assessment of depressive symptoms (MoodMonitor: protocol of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Wouter van Ballegooijen

    2016-10-01

    Full Text Available Abstract Background Ecological momentary assessment (EMA of mental health symptoms may influence the symptoms that it measures, i.e. assessment reactivity. In the field of depression, EMA reactivity has received little attention. We aim to investigate whether EMA of depressive symptoms induces assessment reactivity. Reactivity will be operationalised as an effect of EMA on depressive symptoms measured by a retrospective questionnaire, and, secondly, as a change in response rate and variance of the EMA ratings. Methods This study is a 12-week randomised controlled trial comprising three groups: group 1 carries out EMA of mood and completes a retrospective questionnaire, group 2 carries out EMA of how energetic they feel and completes a retrospective questionnaire, group 3 is the control group, which completes only the retrospective questionnaire. The retrospective questionnaire (Centre for Epidemiologic Studies Depression scale; CES-D assesses depressive symptoms and is administered at baseline, 6 weeks after baseline and 12 weeks after baseline. We aim to recruit 160 participants who experience mild to moderate depressive symptoms, defined as a Patient Health Questionnaire (PHQ-9 score of 5 to 15. This study is powered to detect a small between-groups effect, where no clinically relevant effect is defined as the effect size margin −0.25< d <0.25. Discussion To our knowledge, this is the first study to investigate whether self-rated EMA of depressive symptoms could induce assessment reactivity among mildly depressed individuals. Trial registration Netherlands Trial Register NTR5803. Registered 12 April 2016. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5803 .

  14. Consistency of DIAGNOdent instruments for clinical assessment of fissure caries.

    Science.gov (United States)

    Astvaldsdóttir, Alfheidur; Holbrook, W Peter; Tranaeus, Sofia

    2004-08-01

    DIAGNOdent (KaVo, Biberach, Germany) has shown high diagnostic accuracy and intra-operator agreement for caries detection, both in vitro and in vivo. The aims of this study were to compare DIAGNOdent with visual examination (VI) and bitewing radiographs (BW) for clinical assessment of occlusal fissures, and to evaluate inter-device consistency of clinical recording using four different DIAGNOdent instruments; secondly, to correlate DIAGNOdent readings with microbial culture of the measured site. The subjects were young adults, the material comprising 34 occlusal fissures, scheduled for restorative treatment at the Dental School Clinic of the University of Iceland. Two examiners conducted visual and radiographic assessments. One examiner measured each site with four DIAGNOdent instruments in random order. The fissure was then opened and lesion depth was classified on a 4-point scale. Bacterial samples were taken from the fissure before and after opening. Intra-operator agreement was high (r = 0.85-0.98). Inter-device correlation for the four DIAGNOdent instruments was significant in all cases (r = 0.81-0.92). However, a common cut-off point could not be determined. There was weak but significant correlation between DIAGNOdent readings and all three classes of lesion depth. Level of infection showed very weak correlation with the DIAGNOdent readings. It was concluded that DIAGNOdent is more reliable in detecting dentinal caries if a proper cut-off point is used than in indicating actual lesion depth. Readings from the different instruments were not directly comparable, however, owing to the lack of a common cut-off point.

  15. Transport Protocol Throughput Fairness

    Directory of Open Access Journals (Sweden)

    Saleem Bhatti

    2009-11-01

    Full Text Available Interest continues to grow in alternative transport protocols to the Transmission Control Protocol (TCP. These alternatives include protocols designed to give greater efficiency in high-speed, high-delay environments (so-called high-speed TCP variants, and protocols that provide congestion control without reliability. For the former category, along with the deployed base of ‘vanilla’ TCP – TCP NewReno – the TCP variants BIC and CUBIC are widely used within Linux: for the latter category, the Datagram Congestion Control Protocol (DCCP is currently on the IETF Standards Track. It is clear that future traffic patterns will consist of a mix of flows from these protocols (and others. So, it is important for users and network operators to be aware of the impact that these protocols may have on users. We show the measurement of fairness in throughput performance of DCCP Congestion Control ID 2 (CCID2 relative to TCP NewReno, and variants Binary Increase Congestion control (BIC, CUBIC and Compound, all in “out-of-the box” configurations. We use a testbed and endto- end measurements to assess overall throughput, and also to assess fairness – how well these protocols might respond to each other when operating over the same end-to-end network path. We find that, in our testbed, DCCP CCID2 shows good fairness with NewReno, while BIC, CUBIC and Compound show unfairness above round-trip times of 25ms.

  16. Training professionals' communication and motivation skills to improve spinal cord injury patients' satisfaction and clinical outcomes: Study protocol of the ESPELMA trial.

    Science.gov (United States)

    Lusilla-Palacios, Pilar; Castellano-Tejedor, Carmina; Lucrecia-Ramírez-Garcerán; Navarro-Sanchís, José A; Rodríguez-Urrutia, Amanda; Parramon-Puig, Gemma; Valero-Ventura, Sergi; Cuxart-Fina, Ampar

    2015-10-01

    Acute spinal cord injury leaves patients severely impaired and generates high levels of psychological distress among them and their families, which can cause a less active role in rehabilitation, worse functional recovery, and less perceived satisfaction with the results. Additionally, rehabilitation professionals who deal with this psychological distress could ultimately experience higher stress and more risk of burnout. This article presents the study protocol of the ESPELMA project, aimed to train rehabilitation professionals in the clinical management of acute spinal cord injury-associated psychological distress, and to measure the impact of this training on the patients' perceived satisfaction with treatment.

  17. From Clinical-Developmental Theory to Assessment: The Holistic Student Assessment Tool

    Directory of Open Access Journals (Sweden)

    Gil Noam

    2012-12-01

    Full Text Available A description and test of the Holistic Student Assessment Tool (HSA, an assessment tool to measure children’s and adolescents’ resiliencies in relation to externalizing and internalizing problem behaviors. The HSA is based on the authors’ research-based clinical-developmental Clover Leaf Model of resilience and psychopathology, and is one of the first attempts at closing the gap between risk and resilience approaches in developmental assessment. The HSA was tested in a cross-sectional sample of 423 children and adolescents.The results lend support to the HSA as a valid measure of children’s and adolescents’ resiliencies. Furthermore, the resilience scales mostly exhibited the theoretically expected convergent and divergent relationships with the psychopathology scales. In addition, we show how the resilience scales predict adolescents’ externalizing and internalizing symptoms. We contend that evidence-based intervention to address youth aggression needs to be based on sounddevelopmental assessment.

  18. Clinical Validation of a New Tinnitus Assessment Technology

    Science.gov (United States)

    Hébert, Sylvie; Fournier, Philippe

    2017-01-01

    Current clinical assessment of tinnitus relies mainly on self-report. Psychoacoustic assessment of tinnitus pitch and loudness are recommended but methods yield variable results. Herein, we investigated the proposition that a previously validated fixed laboratory-based method (Touchscreen) and a newly developed clinically relevant portable prototype (Stand-alone) yield comparable results in the assessment of psychoacoustic tinnitus pitch and loudness. Participants with tinnitus [N = 15, 7 with normal hearing and 8 with hearing loss (HL)] and participants simulating tinnitus (simulators, N = 15) were instructed to rate the likeness of pure tones (250—16 kHz) to their tinnitus pitch and match their loudness using both methods presented in a counterbalanced order. Results indicate that simulators rated their “tinnitus” at lower frequencies and at louder levels (~10 dB) compared to tinnitus participants. Tinnitus subgroups (with vs. without HL) differed in their predominant tinnitus pitch (i.e., lower in the tinnitus with HL subgroups), but not in their loudness matching in decibel SL. Loudness at the predominant pitch was identified as a factor yielding significant sensitivity and specificity in discriminating between the two groups of participants. Importantly, despite differences in the devices’ physical presentations, likeness and loudness ratings were globally consistent between the two methods and, moreover, highly reproducible from one method to the other in both groups. All in all, both methods yielded robust tinnitus data in less than 12 min, with the Stand-alone having the advantage of not being dependent of learning effects, being user-friendly, and being adapted to the audiogram of each patient to further reduce testing time. PMID:28270792

  19. Comparative evaluation of a chromogenic agar medium-PCR protocol with a conventional method for isolation of Vibrio parahaemolyticus strains from environmental and clinical samples.

    Science.gov (United States)

    Canizalez-Roman, Adrian; Flores-Villaseñor, Héctor; Zazueta-Beltran, Jorge; Muro-Amador, Secundino; León-Sicairos, Nidia

    2011-02-01

    Screening for pathogenic Vibrio parahaemolyticus has become routine in certain areas associated with food-borne outbreaks. This study is an evaluation of the CHROMagar Vibrio (CV) medium-PCR protocol and the conventional method (TCBS (thiosulfate-citrate-bile salts-sucrose) agar plus biochemical and Wagatsuma agar tests) for detection of V. parahaemolyticus in shrimp, water, sediment, and stool samples collected for biosurveillance in an endemic area of northwestern Mexico. A total of 131 environmental and clinical samples were evaluated. The CV medium-PCR protocol showed a significantly improved ability (P TDH) in developing countries. In our results, Wagatsuma agar showed low sensitivity (65.4% at 24 h and 75.6% at 48 h) and specificity (52.4% at 48 h) for identifying V. parahaemolyticus positive for TDH. Overall, our data support the use of the CV medium-PCR protocol in place of the conventional method (TCBS-biochemical tests-Wagatsuma agar) for detection of pathogenic V. parahaemolyticus, both in terms of effectiveness and cost efficiency.

  20. Gated SPECT evaluation of left ventricular function using a CZT camera and a fast low-dose clinical protocol: comparison to cardiac magnetic resonance imaging

    Energy Technology Data Exchange (ETDEWEB)

    Giorgetti, Assuero; Masci, Pier Giorgio; Marras, Gavino; Gimelli, Alessia; Genovesi, Dario; Lombardi, Massimo [Fondazione CNR/Regione Toscana ' ' G. Monasterio' ' , Pisa (Italy); Rustamova, Yasmine K. [Azerbaijan Medical University, Department of internal medicine Central Customs Hospital, Baku (Azerbaijan); Marzullo, Paolo [Istituto di Fisiologia Clinica del CNR, Pisa (Italy)

    2013-12-15

    CZT technology allows ultrafast low-dose myocardial scintigraphy but its accuracy in assessing left ventricular function is still to be defined. The study group comprised 55 patients (23 women, mean age 63 {+-} 9 years) referred for myocardial perfusion scintigraphy. The patients were studied at rest using a CZT camera (Discovery NM530c; GE Healthcare) and a low-dose {sup 99m}Tc-tetrofosmin clinical protocol (mean dose 264 {+-} 38 MBq). Gated SPECT imaging was performed as a 6-min list-mode acquisition, 15 min after radiotracer injection. Images were reformatted (8-frame to 16-frame) using Lister software on a Xeleris workstation (GE Healthcare) and then reconstructed with a dedicated iterative algorithm. Analysis was performed using Quantitative Gated SPECT (QGS) software. Within 2 weeks patients underwent cardiac magnetic resonance imaging (cMRI, 1.5-T unit CVi; GE Healthcare) using a 30-frame acquisition protocol and dedicated software for analysis (MASS 6.1; Medis). The ventricular volumes obtained with 8-frame QGS showed excellent correlations with the cMRI volumes (end-diastolic volume (EDV), r = 0.90; end-systolic volume (ESV), r = 0.94; p < 0.001). However, QGS significantly underestimated the ventricular volumes (mean differences: EDV, -39.5 {+-} 29 mL; ESV, -15.4 {+-} 22 mL; p < 0.001). Similarly, the ventricular volumes obtained with 16-frame QGS showed an excellent correlations with the cMRI volumes (EDV, r = 0.92; ESV, r = 0.95; p < 0.001) but with significant underestimations (mean differences: EDV, -33.2 {+-} 26 mL; ESV, -17.9 {+-} 20 mL; p < 0.001). Despite significantly lower values (47.9 {+-} 16 % vs. 51.2 {+-} 15 %, p < 0.008), 8-frame QGS mean ejection fraction (EF) was closely correlated with the cMRI values (r = 0.84, p < 0.001). The mean EF with 16-frame QGS showed the best correlation with the cMRI values (r = 0.91, p < 0.001) and was similar to the mean cMRI value (49.6 {+-} 16 %, p not significant). Regional analysis showed a good

  1. Diagnostic accuracy of refractometer and Brix refractometer to assess failure of passive transfer in calves: protocol for a systematic review and meta-analysis.

    Science.gov (United States)

    Buczinski, S; Fecteau, G; Chigerwe, M; Vandeweerd, J M

    2016-06-01

    Calves are highly dependent of colostrum (and antibody) intake because they are born agammaglobulinemic. The transfer of passive immunity in calves can be assessed directly by dosing immunoglobulin G (IgG) or by refractometry or Brix refractometry. The latter are easier to perform routinely in the field. This paper presents a protocol for a systematic review meta-analysis to assess the diagnostic accuracy of refractometry or Brix refractometry versus dosage of IgG as a reference standard test. With this review protocol we aim to be able to report refractometer and Brix refractometer accuracy in terms of sensitivity and specificity as well as to quantify the impact of any study characteristic on test accuracy.

  2. Efficacy of combined conservative therapies on clinical outcomes in patients with thumb base osteoarthritis: protocol for a randomised, controlled trial (COMBO)

    Science.gov (United States)

    Deveza, Leticia A; Wajon, Anne; Bennell, Kim L; Vicenzino, Bill; Hodges, Paul; Eyles, Jillian P; Jongs, Ray; Riordan, Edward A; Duong, Vicky; Min Oo, Win; O'Connell, Rachel; Meneses, Sarah R F

    2017-01-01

    Introduction Management of thumb base osteoarthritis (OA) using a combination of therapies is common in clinical practice; however, evidence for the efficacy of this approach is lacking. The aim of this study is to determine the effect of a combination of conservative therapies for the treatment of thumb base OA compared with an education control group. Methods and analysis This is a randomised, controlled, single-centre, two-arm superiority trial with 1:1 allocation ratio; with assessor and statistician blinded. Participants are blinded to the trial's hypothesis and to the interventions received by the opposite group. A total of 204 participants will be recruited from the community and randomised using a computer-generated schedule. The intervention group will receive education for joint protection and OA, a splint for the base of the thumb, hand exercises and topical diclofenac sodium 1% gel over 6 weeks. The control group will receive education for joint protection and OA alone. Main inclusion criteria are pain ≥40 mm (Visual Analogue Scale, 0–100) at the base of the thumb, impairment in hand function ≥6 (Functional Index for Hand Osteoarthritis, 0–30) and radiographic thumb base OA (Kellgren Lawrence grade ≥2). Participants currently receiving any of the intervention components will be excluded. Outcomes will be measured at 2, 6 and 12 weeks. The primary outcome is change in pain and hand function from baseline to 6 weeks. Other outcomes include changes in grip and pinch strength, quality of life, presence of joint swelling and tenderness, duration of joint stiffness, patient's global assessment and use of rescue medication. Analysis will be performed according to the intention-to-treat principle. Adverse events will be monitored throughout the study. Ethics and dissemination This protocol is approved by the local ethics committee (HREC/15/HAWKE/479). Dissemination will occur through presentations at international conferences and publication

  3. Establishing a family risk assessment clinic for breast cancer.

    LENUS (Irish Health Repository)

    Mulsow, Jurgen

    2012-02-01

    Breast cancer is the most common cancer affecting European women and the leading cause of cancer-related death. A total of 15-20% of women who develop breast cancer have a family history and 5-10% a true genetic predisposition. The identification and screening of women at increased risk may allow early detection of breast cancer and improve prognosis. We established a family risk assessment clinic in May 2005 to assess and counsel women with a family history of breast cancer, to initiate surveillance, and to offer risk-reducing strategies for selected high-risk patients. Patients at medium or high risk of developing breast cancer according to NICE guidelines were accepted. Family history was determined by structured questionnaire and interview. Lifetime risk of developing breast cancer was calculated using Claus and Tyrer-Cuzick scoring. Risk of carrying a breast cancer-related gene mutation was calculated using the Manchester system. One thousand two hundred and forty-three patients have been referred. Ninety-two percent were at medium or high risk of developing breast cancer. Formal assessment of risk has been performed in 368 patients, 73% have a high lifetime risk of developing breast cancer, and 72% a Manchester score >or=16. BRCA1\\/2 mutations have been identified in 14 patients and breast cancer diagnosed in two. Our initial experience of family risk assessment has shown there to be a significant demand for this service. Identification of patients at increased risk of developing breast cancer allows us to provide individuals with accurate risk profiles, and enables patients to make informed choices regarding their follow-up and management.

  4. Methyldibromo glutaronitrile: clinical experience and exposure-based risk assessment.

    Science.gov (United States)

    Zachariae, Claus; Rastogi, Suresh; Devantier, Charlotte; Menné, Torkil; Johansen, Jeanne Duus

    2003-03-01

    In the year 2000, the level of methyldibromo glutaronitrile (MDGN) allergy in dermatology clinics in Europe exceeded the level of allergies to all other preservatives, with a prevalence of 3.5%. In the present study, cases of primary sensitization and elicitation to MDGN due to cosmetic products were collected over an 8-month period at the Department of Dermatology, Gentofte University Hospital. The aim was to identify the products related to hand eczema, assess exposure to MDGN in these products and relate the findings to results from a newly developed updated risk assessment model for contact allergy. Out of 24 patients with a positive patch test to MDGN, 17 patients with hand eczema were identified. In 11 of these patients, cosmetic products used in relation to the onset of the disease were shown to contain MDGN (65%). In 8 of these 11 cases, primary sensitization was probable, 5 due to hand/body lotions and 3 due to lotions and/or liquid hand soap. Chemical analysis of 12 products showed that lotions contained 149-390 ppm of MDGN, liquid hand soap 144-399 ppm, a rinsing cream 293 ppm and shampoos 78-79 ppm. The shampoo exposure was not of certain relevance to the eczema. Applying the newly developed updated risk assessment model showed that the concentrations of MDGN in lotions of 149-390 ppm exceeded the calculated maximum acceptable exposure level for MDGN, which would be expected to lead to sensitization in consumers using such products, as seen in the current study. The present cases and updated exposure-based risk assessment process add to the evidence and need for re-defining safe-use concentrations of MDGN in cosmetic products.

  5. Clinical assessment of the impact of pelvic pain on women.

    Science.gov (United States)

    Chalmers, K Jane; Catley, Mark J; Evans, Susan F; Moseley, G Lorimer

    2017-03-01

    We aimed to develop a questionnaire that assesses the impact of pelvic pain on women, regardless of diagnosis, that has high utility, sound psychometric performance, easy scoring, and high reliability. Two studies, with 3 separate cohorts, were undertaken. Both studies were completed online. Studies included women with self-reported pelvic pain. Women were eligible to participate regardless of whether their pelvic pain was undiagnosed, self-diagnosed, or diagnosed by a clinician. Study 1 used a 3-round "patient-as-expert" Delphi technique. These rounds defined the 10 aspects of life with the self-reported greatest impact on the lives of women with pelvic pain, which formed the questionnaire. Study 2 used Rasch analysis to assess the psychometric properties of the resultant 10-item questionnaire. To assess its reliability, a subgroup completed the questionnaire 3 times over a 3-week period. In study 1, 443 women with pelvic pain participated. The resultant 10-item questionnaire consisted of 8 Likert questions and 2 supplemental, nonscored questions. In study 2, 1203 women with pelvic pain completed the questionnaire. Rasch analysis showed that the questionnaire targeted the pelvic pain population well, had appropriate Likert categories, constituted a unidimensional scale, and showed internal consistency. Twenty-seven women with pelvic pain completed the reliability trial. Test-retest reliability was high (intraclass correlation coefficient 0.91, P Pelvic Pain Impact Questionnaire assesses the life impact of pelvic pain. It uses patient-generated language, is easily administered and scored, has very strong psychometric properties, and it is suitable for research and clinical settings across primary, secondary, and tertiary care.

  6. Quality assessment of clinical guidelines in China: 1993-2010

    Institute of Scientific and Technical Information of China (English)

    CHEN Yao-long; XIE Chang-chun; YANG Ke-hu; YAO Liang; XIAO Xiao-juan; WANG Qi; WANG Ze-hao; LIANG Fu-xiang; LIANG Hui; WANG Xin; SHEN Xi-ping

    2012-01-01

    Background Clinical practice guidelines (CPGs) play an important role in healthcare in China as well as in the world.However,the current status and trends of Chinese CPGs are unknown.The aim of this study was to systematically review the present situation and the quality of Chinese CPGs published in the peer-reviewed medical literature.Methods To identify Chinese CPGs,a systematic search of relevant literature databases (CBM,WANFANG,VIP,and CNKI) was performed for the period January 1978 to December 2010.We used the AGREE Ⅱ instrument to assess the quality of the included guidelines.Results We evaluated 269 guidelines published in 115 medical journals from 1993 to 2010 and produced by 256different developers.Only four guidelines (1%) described the systematic methods for searching and selecting the evidence,14 (5%) guidelines indicated an explicit link between the supporting evidence and the recommendations,only one guideline used the Grading of Recommendations Assessment,Development and Evaluation (GRADE) system.Thirty-one guidelines (12%) mentioned updates and the average frequency of update was 5.5 years; none described a procedure for updating the guideline.From the assessment with the Appraisal of Guidelines for Research and Ecaluation Ⅱ (AGREE Ⅱ),the mean scores were low for the domains "scope and purpose" (19%) and "clarity of presentation" (26%)and very low for the other domains ("rigour of development" 7%,"stakeholder involvement" 8%,"applicability" 6% and "editorial independence" 2%).Conclusions Compared with other studies on the quality of guidelines assessed with the AGREE instrument in other countries,Chinese CPGs received lower scores,which indicates a relatively poor quality of the guidelines.However,there was some increase over time.

  7. Adopting a Clinical Assessment Framework in Older Adult Mental Health.

    Science.gov (United States)

    Hung, Lillian; Lee, Patience Anne; Au-Yeung, Andy T; Kucherova, Irina; Harrigan, MaryLou

    2016-07-01

    Obtaining new knowledge accepted and used by practitioners remains a slow process. A dearth of knowledge translation research exists that explores how to effectively move knowledge to practice in the field of older adult mental health. The current article reports findings of a knowledge translation study that examined what factors enabled the adoption of a new clinical assessment framework, P.I.E.C.E.S.™, into practice in an older adult tertiary mental health unit. Theoretical insights of appreciative inquiry were used to guide the study. Qualitative methods were used, including focus groups with 20 staff and individual interviews with three leaders. The appreciative inquiry approach helped researchers successfully facilitate knowledge translation. Enabling factors included: (a) fostering positive energy to make continuous improvement, (b) working with team members across disciplines at all levels, and (c) using knowledge translation tools to enable and sustain the new practice. [Journal of Psychosocial Nursing and Mental Health Services, 54 (7), 26-31.].

  8. Prehospital randomised assessment of a mechanical compression device in cardiac arrest (PaRAMeDIC trial protocol

    Directory of Open Access Journals (Sweden)

    McCabe Chris

    2010-11-01

    Full Text Available Abstract Background Survival after out-of-hospital cardiac arrest is closely linked to the quality of CPR, but in real life, resuscitation during prehospital care and ambulance transport is often suboptimal. Mechanical chest compression devices deliver consistent chest compressions, are not prone to fatigue and could potentially overcome some of the limitations of manual chest compression. However, there is no high-quality evidence that they improve clinical outcomes, or that they are cost effective. The Prehospital Randomised Assessment of a Mechanical Compression Device In Cardiac Arrest (PARAMEDIC trial is a pragmatic cluster randomised study of the LUCAS-2 device in adult patients with non-traumatic out-of-hospital cardiac arrest. Methods/design The primary objective of this trial is to evaluate the effect of chest compression using LUCAS-2 on mortality at 30 days post out-of-hospital cardiac arrest, compared with manual chest compression. Secondary objectives of the study are to evaluate the effects of LUCAS-2 on survival to 12 months, cognitive and quality of life outcomes and cost-effectiveness. Methods: Ambulance service vehicles will be randomised to either manual compression (control or LUCAS arms. Adult patients in out-of-hospital cardiac arrest, attended by a trial vehicle will be eligible for inclusion. Patients with traumatic cardiac arrest or who are pregnant will be excluded. The trial will recruit approximately 4000 patients from England, Wales and Scotland. A waiver of initial consent has been approved by the Research Ethics Committees. Consent will be sought from survivors for participation in the follow-up phase. Conclusion The trial will assess the clinical and cost effectiveness of the LUCAS-2 mechanical chest compression device. Trial Registration: The trial is registered on the International Standard Randomised Controlled Trial Number Registry (ISRCTN08233942.

  9. Addendum to the AAPM's TG-51 protocol for clinical reference dosimetry of high-energy photon beams

    Energy Technology Data Exchange (ETDEWEB)

    McEwen, Malcolm, E-mail: malcolm.mcewen@nrc-cnrc.gc.ca [National Research Council, 1200 Montreal Road, Ottawa, Ontario (Canada); DeWerd, Larry [University of Wisconsin, 1111 Highland Avenue, Madison, Wisconsin 53705 (United States); Ibbott, Geoffrey [Department of Radiation Physics, M D Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, Texas 77030 (United States); Followill, David [IROC Houston QA Center, Radiological Physics Center, 8060 El Rio Street, Houston, Texas 77054 (United States); Rogers, David W. O. [Carleton Laboratory for Radiotherapy Physics, Physics Department, Carleton University, 1125 Colonel By Drive, Ottawa, Ontario (Canada); Seltzer, Stephen [National Institute of Standards and Technology, Gaithersburg, Maryland 20899 (United States); Seuntjens, Jan [Medical Physics Unit, McGill University, 1650 Cedar Avenue, Montreal, Québec (Canada)

    2014-04-15

    An addendum to the AAPM's TG-51 protocol for the determination of absorbed dose to water in megavoltage photon beams is presented. This addendum continues the procedure laid out in TG-51 but new k{sub Q} data for photon beams, based on Monte Carlo simulations, are presented and recommendations are given to improve the accuracy and consistency of the protocol's implementation. The components of the uncertainty budget in determining absorbed dose to water at the reference point are introduced and the magnitude of each component discussed. Finally, the consistency of experimental determination of N{sub D,w} coefficients is discussed. It is expected that the implementation of this addendum will be straightforward, assuming that the user is already familiar with TG-51. The changes introduced by this report are generally minor, although new recommendations could result in procedural changes for individual users. It is expected that the effort on the medical physicist's part to implement this addendum will not be significant and could be done as part of the annual linac calibration.

  10. The benefit of combining clinical and radiological assessments in diagnosis of inherited muscle diseases

    OpenAIRE

    Ahmed Wafaie; Ahmed Aboumousa

    2014-01-01

    Purpose: To study the benefit of combining clinical and radiological assessments in the diagnosis of inherited muscle diseases. Subjects and methods: This cross sectional study included 45 patients presenting with manifestations of muscle disease. They were subjected to thorough clinical assessment and MRI examination of thigh and leg muscles. Independent clinical and radiological assessments were performed followed by combining the clinical categorization and radiological signs together t...

  11. Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol

    Directory of Open Access Journals (Sweden)

    Pérula-de-Torres LuisÁ

    2012-10-01

    Full Text Available Abstract Background Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. Methods/design An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group. As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group. Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis. Discussion If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. Trial registration The study is registered as NCT01291953 (ClinicalTrials.gob

  12. Effects of an adapted physical activity program in a group of elderly subjects with flexed posture: clinical and instrumental assessment

    Directory of Open Access Journals (Sweden)

    Frizziero Antonio

    2008-11-01

    Full Text Available Abstract Background Flexed posture commonly increases with age and is related to musculoskeletal impairment and reduced physical performance. The purpose of this clinical study was to systematically compare the effects of a physical activity program that specifically address the flexed posture that marks a certain percentage of elderly individuals with a non specific exercise program for 3 months. Methods Participants were randomly divided into two groups: one followed an Adapted Physical Activity program for flexed posture and the other one completed a non-specific physical activity protocol for the elderly. A multidimensional clinical assessment was performed at baseline and at 3 months including anthropometric data, clinical profile, measures of musculoskeletal impairment and disability. The instrumental assessment of posture was realized using a stereophotogrammetric system and a specific biomechanical model designed to describe the reciprocal position of the body segments on the sagittal plane in a upright posture. Results The Adapted Physical Activity program determined a significant improvement in several key parameters of the multidimensional assessment in comparison to the non-specific protocol: decreased occiput-to-wall distance, greater lower limb range of motion, better flexibility of pectoralis, hamstrings and hip flexor muscles, increased spine extensor muscles strength. Stereophotogrammetric analysis confirmed a reduced protrusion of the head and revealed a reduction in compensative postural adaptations to flexed posture characterized by knee flexion and ankle dorsiflexion in the participants of the specific program. Conclusion The Adapted Physical Activity program for flexed posture significantly improved postural alignment and musculoskeletal impairment of the elderly. The stereophotogrammetric evaluation of posture was useful to measure the global postural alignment and especially to analyse the possible compensatory strategies

  13. Filtering Medline for a clinical discipline: diagnostic test assessment framework

    Science.gov (United States)

    Iansavichus, Arthur V; Wilczynski, Nancy L; Kastner, Monika; Baier, Leslie A; Shariff, Salimah Z; Rehman, Faisal; Weir, Matthew; McKibbon, K Ann; Haynes, R Brian

    2009-01-01

    Objective To develop and test a Medline filter that allows clinicians to search for articles within a clinical discipline, rather than searching the entire Medline database. Design Diagnostic test assessment framework with development and validation phases. Setting Sample of 4657 articles published in 2006 from 40 journals. Reviews Each article was manually reviewed, and 19.8% contained information relevant to the discipline of nephrology. The performance of 1 155 087 unique renal filters was compared with the manual review. Main outcome measures Sensitivity, specificity, precision, and accuracy of each filter. Results The best renal filters combined two to 14 terms or phrases and included the terms “kidney” with multiple endings (that is, truncation), “renal replacement therapy”, “renal dialysis”, “kidney function tests”, “renal”, “nephr” truncated, “glomerul” truncated, and “proteinuria”. These filters achieved peak sensitivities of 97.8% and specificities of 98.5%. Performance of filters remained excellent in the validation phase. Conclusions Medline can be filtered for the discipline of nephrology in a reliable manner. Storing these high performance renal filters in PubMed could help clinicians with their everyday searching. Filters can also be developed for other clinical disciplines by using similar methods. PMID:19767336

  14. Feedback and assessment for clinical placements: achieving the right balance

    Directory of Open Access Journals (Sweden)

    Burgess A

    2015-05-01

    Full Text Available Annette Burgess, Craig Mellis Central Clinical School, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia Abstract: During clinical placements, the provision of feedback forms an integral part of the learning process and enriches students' learning experiences. The purpose of feedback is to improve the learner's knowledge, skills, or behavior. Receipt of accurate feedback can help to narrow the gap between actual and desired performance. Effective and regular feedback has the potential to reinforce good practice and motivate the learner toward the desired outcome. Despite the obvious role of feedback in effective teaching and learning, a common complaint from students is that they do not receive adequate feedback. Unfortunately, skills in giving and receiving feedback are rarely taught to students or clinicians. This study aims to provide an understanding of the role of feedback within the learning process, consider consequences of inadequate or poorly given feedback, consider the barriers to the feedback process, provide practical guidelines for providing feedback, and consider the need for student and faculty development in feedback skills. Keywords: medical students, formative, summative, assessment

  15. Biochemical and Clinical Assessments of Segmental Maxillary Posterior Tooth Intrusion

    Science.gov (United States)

    Tasanapanont, Jintana; Wattanachai, Tanapan; Apisariyakul, Janya; Pothacharoen, Peraphan; Kongtawelert, Prachya; Midtbø, Marit

    2017-01-01

    Objective. To compare chondroitin sulphate (CS) levels around maxillary second premolars, first molars, and second molars between the unloaded and the loaded periods and to measure the rates of intrusion of maxillary posterior teeth during segmental posterior tooth intrusion. Materials and Methods. In this prospective clinical study, 105 teeth (from 15 patients exhibiting anterior open bite and requiring maxillary posterior tooth intrusion) were studied. Competitive ELISA was used to detect CS levels. Dental casts (during the unloaded and loaded periods) were scanned, and posterior tooth intrusion distances were measured. Results. During the unloaded period, the median CS levels around maxillary second premolars, first molars, second molars (experimental teeth), and mandibular first molars (negative control) were 0.006, 0.055, 0.056, and 0.012 and during the loaded period were 2.592, 5.738, 4.727, and 0.163 ng/μg of total protein, respectively. The median CS levels around experimental teeth were significantly elevated during the loaded period. The mean rates of maxillary second premolar and first and second molar intrusion were 0.72, 0.58, and 0.40 mm/12 weeks, respectively. Conclusions. Biochemical and clinical assessments suggested that the segmental posterior tooth intrusion treatment modality with 50 g of vertical force per side was sufficient. Trial Registration. The study is registered as TCTR20170206006. PMID:28321256

  16. Clinical evaluation of dengue and identification of risk factors for severe disease : protocol for a multicentre study in 8 countries

    NARCIS (Netherlands)

    Jaenisch, Thomas; Tam, Dong Thi Hoai; Kieu, Nguyen Tan Thanh; Van Ngoc, Tran; Nam, Nguyen Tran; Van Kinh, Nguyen; Yacoub, Sophie; Chanpheaktra, Ngoun; Kumar, Varun; See, Lucy Lum Chai; Sathar, Jameela; Sandoval, Ernesto Pleités; Alfaro, Gabriela Maria Marón; Laksono, Ida Safitri; Mahendradhata, Yodi; Sarker, Malabika; Ahmed, Firoz; Caprara, Andrea; Benevides, Bruno Souza; Marques, Ernesto T A; Magalhaes, Tereza; Brasil, Patricia; Netto, Marco; Tami, Adriana; Bethencourt, Sarah E; Guzman, Maria; Simmons, Cameron; Quyen, Nguyen Thanh Ha; Merson, Laura; Dung, Nguyen Thi Phuong; Beck, Dorothea; Wirths, Marius; Wolbers, Marcel; Lam, Phung Khanh; Rosenberger, Kerstin; Wills, Bridget

    2016-01-01

    BACKGROUND: The burden of dengue continues to increase globally, with an estimated 100 million clinically apparent infections occurring each year. Although most dengue infections are asymptomatic, patients can present with a wide spectrum of clinical symptoms ranging from mild febrile illness throug

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

    NARCIS (Netherlands)

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

    2010-01-01

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

  18. Application of ''Earl's Assessment "as", Assessment "for", and Assessment "of" Learning Model'' with Orthopaedic Assessment Clinical Competence

    Science.gov (United States)

    Lafave, Mark R.; Katz, Larry; Vaughn, Norman

    2013-01-01

    Context: In order to study the efficacy of assessment methods, a theoretical framework of Earl's model of assessment was introduced. Objective: (1) Introduce the predictive learning assessment model (PLAM) as an application of Earl's model of learning; (2) test Earl's model of learning through the use of the Standardized Orthopedic Assessment Tool…

  19. Effectiveness of problem gambling interventions in a service setting: a protocol for a pragmatic randomised controlled clinical trial

    Science.gov (United States)

    Abbott, M; Bellringer, M; Vandal, A C; Hodgins, D C; Battersby, M; Rodda, S N

    2017-01-01

    Introduction The primary purpose of this study is to evaluate the relative effectiveness of 2 of the best developed and most promising forms of therapy for problem gambling, namely face-to-face motivational interviewing (MI) combined with a self-instruction booklet (W) and follow-up telephone booster sessions (B; MI+W+B) and face-to-face cognitive–behavioural therapy (CBT). Methods and analysis This project is a single-blind pragmatic randomised clinical trial of 2 interventions, with and without the addition of relapse-prevention text messages. Trial assessments take place pretreatment, at 3 and 12 months. A total of 300 participants will be recruited through a community treatment agency that provides services across New Zealand and randomised to up to 10 face-to-face sessions of CBT or 1 face-to-face session of MI+W+up to 5 B. Participants will also be randomised to 9 months of postcare text messaging. Eligibility criteria include a self-perception of having a current gambling problem and a willingness to participate in all components of the study (eg, read workbook). The statistical analysis will use an intent-to-treat approach. Primary outcome measures are days spent gambling and amount of money spent per day gambling in the prior month. Secondary outcome measures include problem gambling severity, gambling urges, gambling cognitions, mood, alcohol, drug use, tobacco, psychological distress, quality of life, health status and direct and indirect costs associated with treatment. Ethics and dissemination The research methods to be used in this study have been approved by the Ministry of Health, Health and Disability Ethics Committees (HDEC) 15/CEN/99. The investigators will provide annual reports to the HDEC and report any adverse events to this committee. Amendments will also be submitted to this committee. The results of this trial will be submitted for publication in peer-reviewed journals and as a report to the funding body. Additionally, the results

  20. The influence of digital filter type, amplitude normalisation method, and co-contraction algorithm on clinically relevant surface electromyography data during clinical movement assessments.

    Science.gov (United States)

    Devaprakash, Daniel; Weir, Gillian J; Dunne, James J; Alderson, Jacqueline A; Donnelly, Cyril J

    2016-12-01

    There is a large and growing body of surface electromyography (sEMG) research using laboratory-specific signal processing procedures (i.e., digital filter type and amplitude normalisation protocols) and data analyses methods (i.e., co-contraction algorithms) to acquire practically meaningful information from these data. As a result, the ability to compare sEMG results between studies is, and continues to be challenging. The aim of this study was to determine if digital filter type, amplitude normalisation method, and co-contraction algorithm could influence the practical or clinical interpretation of processed sEMG data. Sixteen elite female athletes were recruited. During data collection, sEMG data was recorded from nine lower limb muscles while completing a series of calibration and clinical movement assessment trials (running and sidestepping). Three analyses were conducted: (1) signal processing with two different digital filter types (Butterworth or critically damped), (2) three amplitude normalisation methods, and (3) three co-contraction ratio algorithms. Results showed the choice of digital filter did not influence the clinical interpretation of sEMG; however, choice of amplitude normalisation method and co-contraction algorithm did influence the clinical interpretation of the running and sidestepping task. Care is recommended when choosing amplitude normalisation method and co-contraction algorithms if researchers/clinicians are interested in comparing sEMG data between studies.

  1. Assessing hospitals' clinical risk management: Development of a monitoring instrument

    Directory of Open Access Journals (Sweden)

    Pfeiffer Yvonne

    2010-12-01

    Full Text Available Abstract Background Clinical risk management (CRM plays a crucial role in enabling hospitals to identify, contain, and manage risks related to patient safety. So far, no instruments are available to measure and monitor the level of implementation of CRM. Therefore, our objective was to develop an instrument for assessing CRM in hospitals. Methods The instrument was developed based on a literature review, which identified key elements of CRM. These elements were then discussed with a panel of patient safety experts. A theoretical model was used to describe the level to which CRM elements have been implemented within the organization. Interviews with CRM practitioners and a pilot evaluation were conducted to revise the instrument. The first nationwide application of the instrument (138 participating Swiss hospitals was complemented by in-depth interviews with 25 CRM practitioners in selected hospitals, for validation purposes. Results The monitoring instrument consists of 28 main questions organized in three sections: 1 Implementation and organizational integration of CRM, 2 Strategic objectives and operational implementation of CRM at hospital level, and 3 Overview of CRM in different services. The instrument is available in four languages (English, German, French, and Italian. It allows hospitals to gather comprehensive and systematic data on their CRM practice and to identify areas for further improvement. Conclusions We have developed an instrument for assessing development stages of CRM in hospitals that should be feasible for a continuous monitoring of developments in this important area of patient safety.

  2. Impact of an Abbreviated Cardiac Enzyme Protocol to Aid Rapid Discharge of Patients with Cocaine-associated Chest Pain in the Clinical Decision Unit

    Directory of Open Access Journals (Sweden)

    Faheem W. Guirgis

    2014-03-01

    Full Text Available Introduction: In 2007 there were 64,000 visits to the emergency department (ED for possible myocardial infarction (MI related to cocaine use. Prior studies have demonstrated that low- to intermediate-risk patients with cocaine-associated chest pain can be safely discharged after 9-12 hours of observation. The goal of this study was to determine the safety of an 8-hour protocol for ruling out MI in patients who presented with cocaine-associated chest pain. Methods: We conducted a retrospective review of patients treated with an 8-hour cocaine chest pain protocol between May 1, 2011 and November 30, 2012 who were sent to the clinical decision unit (CDU for observation. The protocol included serial cardiac biomarker testing with Troponin-T, CK-MB (including delta CK-MB, and total CK at 0, 2, 4, and 8 hours after presentation with cardiac monitoring for the observation period. Patients were followed up for adverse cardiac events or death within 30 days of discharge. Results: There were 111 admissions to the CDU for cocaine chest pain during the study period. One patient had a delta CK-MB of 1.6 ng/ml, but had negative Troponin-T at all time points. No patient had a positive Troponin-T or CK-MB at 0, 2, 4 or 8 hours, and there were no MIs or deaths within 30 days of discharge. Most patients were discharged home (103 and there were 8 inpatient admissions from the CDU. Of the admitted patients, 2 had additional stress tests that were negative, 1 had additional cardiac biomarkers that were negative, and all 8 patients were discharged home. The estimated risk of missing MI using our protocol is, with 99% confidence, less than 5.1% and with 95% confidence, less than 3.6% (99% CI, 0-5.1%; 95% CI, 0-3.6%. Conclusion: Application of an abbreviated cardiac enzyme protocol resulted in the safe and rapid discharge of patients presenting to the ED with cocaine-associated chest pain. [West J Emerg Med. 2014;15(2:180–183.

  3. Drug delivery system innovation and Health Technology Assessment: Upgrading from Clinical to Technological Assessment.

    Science.gov (United States)

    Panzitta, Michele; Bruno, Giorgio; Giovagnoli, Stefano; Mendicino, Francesca R; Ricci, Maurizio

    2015-11-30

    Health Technology Assessment (HTA) is a multidisciplinary health political instrument that evaluates the consequences, mainly clinical and economical, of a health care technology; the HTA aim is to produce and spread information on scientific and technological innovation for health political decision making process. Drug delivery systems (DDS), such as nanocarriers, are technologically complex but they have pivotal relevance in therapeutic innovation. The HTA process, as commonly applied to conventional drug evaluation, should upgrade to a full pharmaceutical assessment, considering the DDS complexity. This is useful to study more in depth the clinical outcome and to broaden its critical assessment toward pharmaceutical issues affecting the patient and not measured by the current clinical evidence approach. We draw out the expertise necessary to perform the pharmaceutical assessment and we propose a format to evaluate the DDS technological topics such as formulation and mechanism of action, physicochemical characteristics, manufacturing process. We integrated the above-mentioned three points in the Evidence Based Medicine approach, which is data source for any HTA process. In this regard, the introduction of a Pharmaceutics Expert figure in the HTA could be fundamental to grant a more detailed evaluation of medicine product characteristics and performances and to help optimizing DDS features to overcome R&D drawbacks. Some aspects of product development, such as manufacturing processes, should be part of the HTA as innovative manufacturing processes allow new products to reach more effectively patient bedside. HTA so upgraded may encourage resource allocating payers to invest in innovative technologies and providers to focus on innovative material properties and manufacturing processes, thus contributing to bring more medicines in therapy in a sustainable manner.

  4. Selection and utilization of assessment instruments in substance abuse treatment trials: the National Drug Abuse Treatment Clinical Trials Network experience

    Directory of Open Access Journals (Sweden)

    Rosa C

    2012-07-01

    Full Text Available Carmen Rosa, Udi Ghitza, Betty TaiCenter for the Clinical Trials Network, National Institute on Drug Abuse, Bethesda, MD, USAAbstract: Based on recommendations from a US Institute of Medicine report, the National Institute on Drug Abuse established the National Drug Abuse Treatment Clinical Trials Network (CTN in 1999, to accelerate the translation of science-based addiction treatment research into community-based practice, and to improve the quality of addiction treatment, using science as the vehicle. One of the CTN's primary tasks is to serve as a platform to forge bi-directional communications and collaborations between providers and scientists, to enhance the relevance of research, which generates empirical results that impact practice. Among many obstacles in moving research into real-world settings, this commentary mainly describes challenges and iterative experiences in regard to how the CTN develops its research protocols, with focus on how the CTN study teams select and utilize assessment instruments, which can reasonably balance the interests of both research scientists and practicing providers when applied in CTN trials. This commentary also discusses the process by which the CTN further selects a core set of common assessment instruments that may be applied across all trials, to allow easier cross-study analyses of comparable data.Keywords: addiction, assessment, drug abuse treatment, drug dependence, NIDA Clinical Trials Network, substance use disorder

  5. Standardized Clinical Assessment And Management Plans (SCAMPs) Provide A Better Alternative To Clinical Practice Guidelines

    Science.gov (United States)

    Farias, Michael; Jenkins, Kathy; Lock, James; Rathod, Rahul; Newburger, Jane; Bates, David W.; Safran, Dana G.; Friedman, Kevin; Greenberg, Josh

    2014-01-01

    Variability in medical practice in the United States leads to higher costs without achieving better patient outcomes. Clinical practice guidelines, which are intended to reduce variation and improve care, have several drawbacks that limit the extent of buy-in by clinicians. In contrast, standardized clinical assessment and management plans (SCAMPs) offer a clinician-designed approach to promoting care standardization that accommodates patients’ individual differences, respects providers’ clinical acumen, and keeps pace with the rapid growth of medical knowledge. Since early 2009 more than 12,000 patients have been enrolled in forty-nine SCAMPs in nine states and Washington, D.C. In one example, a SCAMP was credited with increasing clinicians’ rate of compliance with a recommended specialist referral for children from 19.6 percent to 75 percent. In another example, SCAMPs were associated with an 11–51 percent decrease in total medical expenses for six conditions when compared with a historical cohort. Innovative tools such as SCAMPs should be carefully examined by policy makers searching for methods to promote the delivery of high-quality, cost-effective care. PMID:23650325

  6. Neutron dosimetry for low dose rate Cf-252 AT sources and adherence to recent clinical dosimetry protocol for brachytherapy

    Energy Technology Data Exchange (ETDEWEB)

    Rivard, M.J.; Wierzbicki, J.G.; Van den Heuvel, F. [Wayne State Univ., Detroit, MI (United States). Dept. of Radiation Oncology; Martin, R.C. [Oak Ridge National Lab., TN (United States). Chemical Technology Div.

    1997-12-01

    In 1995, the American Association of Physicists in Medicine Task Group 43 (AAPM TG-43) published a protocol obsoleting all mixed-field radiation dosimetry for Cf-252. Recommendations for a new brachytherapy dosimetry formalism made by this Task Group favor quantification of source strength in terms of air kerma rather than apparent Curies or other radiation units. Additionally, representation of this dosimetry data in terms of radial dose functions, anisotropy functions, geometric factors, and dose rate constants are in an angular and radial (spherical) coordinate system as recommended, rather than the along-away dosimetry data (Cartesian coordinate system) currently available. This paper presents the initial results of calculated neutron dosimetry in a water phantom for a Cf-252 applicator tube (AT) type medical source soon available from Oak Ridge National Laboratory (ORNL).

  7. A clinical trial protocol for second line treatment of malignant brain tumors with BNCT at University of Tsukuba

    Energy Technology Data Exchange (ETDEWEB)

    Aiyama, H. [Department of Neurosurgery, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan); Nakai, K., E-mail: knakai@Neurosurg-tsukuba.com [Department of Neurosurgery, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan); Yamamoto, T. [Department of Neurosurgery, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan)] [Department of Radiation Oncology, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan); Nariai, T. [Department of Neurosurgery, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyouku (Japan); Kumada, H. [Department of Radiation Oncology, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan); Ishikawa, E. [Department of Neurosurgery, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan); Isobe, T. [Department of Radiation Oncology, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan); Endo, K.; Takada, T.; Yoshida, F.; Shibata, Y.; Matsumura, A. [Department of Neurosurgery, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan)

    2011-12-15

    We have evaluated the efficacy and safety of boron neutron capture therapy (BNCT) for recurrent glioma and malignant brain tumor using a new protocol. One of the two patients enrolled in this trial is a man with recurrent glioblastoma and the other is a woman with anaplastic meningioma. Both are still alive and no severe adverse events have been observed. Our findings suggest that NCT will be safe as a palliative therapy for malignant brain tumors. - Highlights: Black-Right-Pointing-Pointer Boron neutron capture therapy (BNCT) for recurrent glioma and malignant brain tumor. Black-Right-Pointing-Pointer Two cases with recurrent glioblastoma and anaplastic meningioma. Black-Right-Pointing-Pointer No severe adverse events have been observed using BNCT. Black-Right-Pointing-Pointer BNCT has a possibility of a safe palliative therapy for malignant brain tumors.

  8. Predictive validity of measurements of clinical competence using the team objective structured bedside assessment (TOSBA): assessing the clinical competence of final year medical students.

    LENUS (Irish Health Repository)

    Meagher, Frances M

    2009-11-01

    The importance of valid and reliable assessment of student competence and performance is gaining increased recognition. Provision of valid patient-based formative assessment is an increasing challenge for clinical teachers in a busy hospital setting. A formative assessment tool that reliably predicts performance in the summative setting would be of value to both students and teachers.

  9. The Seamless Transfer-of-Care Protocol: a randomized controlled trial assessing the efficacy of an electronic transfer-of-care communication tool

    Directory of Open Access Journals (Sweden)

    Okoniewska Barbara M

    2012-11-01

    evaluation will assess the cost per life saved, cost per readmission avoided and cost per QALY gained with the TOC communication tool compared to traditional dictation summaries. Discussion This paper outlines the study protocol for a randomized controlled trial evaluating an electronic transfer-of-care communication tool, with sufficient statistical power to assess the impact of the tool on the significant outcomes of post-discharge death or readmission. The study findings will inform health systems around the world on the potential benefits of such tools, and the value for money associated with their widespread implementation. Trial registration ClinicalTrials.gov NCT01402609.

  10. Demonstration of Model Assisted Reliability Assessment Protocol on a Proposed Low Frequency Vibration Based Damage Sensing Case

    Science.gov (United States)

    2011-09-01

    demonstration and broad use of the methodology and protocol. INTRODUCTION The successful deployment of systems for health monitoring of...based damage detection method. An ETrema brand Terfenol-D magnetostrictive actuator was used for band-limited pseudo-random excitation up to 1200 Hz

  11. The impact of topology on energy consumption for collection tree protocols : An experimental assessment through evolutionary computation

    NARCIS (Netherlands)

    Bucur, Doina; Iacca, Giovanni; Squillero, Giovanni; Tonda, Alberto

    2014-01-01

    Abstract The analysis of worst-case behavior in wireless sensor networks is an extremely difficult task, due to the complex interactions that characterize the dynamics of these systems. In this paper, we present a new methodology for analyzing the performance of routing protocols used in such networ

  12. Development and validation of a Clinical Assessment Tool for Nursing Education (CAT-NE).

    Science.gov (United States)

    Skúladóttir, Hafdís; Svavarsdóttir, Margrét Hrönn

    2016-09-01

    The aim of this study was to develop a valid assessment tool to guide clinical education and evaluate students' performance in clinical nursing education. The development of the Clinical Assessment Tool for Nursing Education (CAT-NE) was based on the theory of nursing as professional caring and the Bologna learning outcomes. Benson and Clark's four steps of instrument development and validation guided the development and assessment of the tool. A mixed-methods approach with individual structured cognitive interviewing and quantitative assessments was used to validate the tool. Supervisory teachers, a pedagogical consultant, clinical expert teachers, clinical teachers, and nursing students at the University of Akureyri in Iceland participated in the process. This assessment tool is valid to assess the clinical performance of nursing students; it consists of rubrics that list the criteria for the students' expected performance. According to the students and their clinical teachers, the assessment tool clarified learning objectives, enhanced the focus of the assessment process, and made evaluation more objective. Training clinical teachers on how to assess students' performances in clinical studies and use the tool enhanced the quality of clinical assessment in nursing education.

  13. Comprehensive small animal imaging strategies on a clinical 3 T dedicated head MR-scanner; adapted methods and sequence protocols in CNS pathologies.

    Directory of Open Access Journals (Sweden)

    Deepu R Pillai

    Full Text Available BACKGROUND: Small animal models of human diseases are an indispensable aspect of pre-clinical research. Being dynamic, most pathologies demand extensive longitudinal monitoring to understand disease mechanisms, drug efficacy and side effects. These considerations often demand the concomitant development of monitoring systems with sufficient temporal and spatial resolution. METHODOLOGY AND RESULTS: This study attempts to configure and optimize a clinical 3 Tesla magnetic resonance scanner to facilitate imaging of small animal central nervous system pathologies. The hardware of the scanner was complemented by a custom-built, 4-channel phased array coil system. Extensive modification of standard sequence protocols was carried out based on tissue relaxometric calculations. Proton density differences between the gray and white matter of the rodent spinal cord along with transverse relaxation due to magnetic susceptibility differences at the cortex and striatum of both rats and mice demonstrated statistically significant differences. The employed parallel imaging reconstruction algorithms had distinct properties dependent on the sequence type and in the presence of the contrast agent. The attempt to morphologically phenotype a normal healthy rat brain in multiple planes delineated a number of anatomical regions, and all the clinically relevant sequels following acute cerebral ischemia could be adequately characterized. Changes in blood-brain-barrier permeability following ischemia-reperfusion were also apparent at a later time. Typical characteristics of intra-cerebral haemorrhage at acute and chronic stages were also visualized up to one month. Two models of rodent spinal cord injury were adequately characterized and closely mimicked the results of histological studies. In the employed rodent animal handling system a mouse model of glioblastoma was also studied with unequivocal results. CONCLUSIONS: The implemented customizations including extensive

  14. Development of a clinically applicable tool for bone density assessment

    Energy Technology Data Exchange (ETDEWEB)

    Sun, Y. [Katholieke Universiteit Leuven, Oral Imaging Center, Faculty of Medicine, Leuven (Belgium); St John' s Hospital, Department of Oral and Maxillofacial Surgery, Genk (Belgium); Dobbelaer, B. de; Suetens, P. [Katholieke Universiteit Leuven, Medical Image Computing (PSI), Faculty of Engineering, Leuven (Belgium); Nackaerts, O.; Yan, B.; Jacobs, R. [Katholieke Universiteit Leuven, Oral Imaging Center, Faculty of Medicine, Leuven (Belgium); Loubele, M. [Katholieke Universiteit Leuven, Oral Imaging Center, Faculty of Medicine, Leuven (Belgium); Katholieke Universiteit Leuven, Medical Image Computing (PSI), Faculty of Engineering, Leuven (Belgium); Politis, C.; Vrielinck, L. [St John' s Hospital, Department of Oral and Maxillofacial Surgery, Genk (Belgium); Schepers, S. [St John' s Hospital, Department of Oral and Maxillofacial Surgery, Genk (Belgium); University of Gent, Department of Oral and Maxillofacial Surgery, Faculty of Medicine, Gent (Belgium); Lambrichts, I. [University of Hasselt, Department of Morphology, Diepenbeek (Belgium); Horner, K.; Devlin, H. [University of Manchester, School of Dentistry, Manchester (United Kingdom)

    2009-03-15

    To assess the accuracy and reliability of new software for radiodensitometric evaluations. A densitometric tool developed by MevisLab {sup registered} was used in conjunction with intraoral radiographs of the premolar region in both in vivo and laboratory settings. An aluminum step wedge was utilized for comparison of grey values. After computer-aided segmentation, the interproximal bone between the premolars was assessed in order to determine the mean grey value intensity of this region and convert it to a thickness in aluminum. Evaluation of the tool was determined using bone mineral density (BMD) values derived from decalcified human bone specimens as a reference standard. In vivo BMD data was collected from 35 patients as determined with dual X-ray absorptiometry (DXA). The intra and interobserver reliability of this method was assessed by Bland and Altman Plots to determine the precision of this tool. In the laboratory study, the threshold value for detection of bone loss was 6.5%. The densitometric data (mm Al eq.) was highly correlated with the jaw bone BMD, as determined using dual X-ray absorptiometry (r=0.96). For the in vivo study, the correlations between the mm Al equivalent of the average upper and lower jaw with the lumbar spine BMD, total hip BMD and femoral neck BMD were 0.489, 0.537 and 0.467, respectively (P<0.05). For the intraobserver reliability, a Bland and Altman plot showed that the mean difference {+-}1.96 SD were within {+-}0.15 mm Al eq. with the mean difference value small than 0.003 mm Al eq. For the interobserver reliability, the mean difference {+-}1.96 SD were within {+-}0.11 mm Al eq. with the mean difference of 0.008 mm Al eq. A densitometric software tool has been developed, that is reliable for bone density assessment. It now requires further investigation to evaluate its accuracy and clinical applicability in large scale studies. (orig.)

  15. Feasibility and limitations of the round robin test for assessment of in vitro chondrogenesis evaluation protocol in a tissue-engineered medical product.

    Science.gov (United States)

    Yokoi, Masako; Hattori, Koji; Narikawa, Koichi; Ohgushi, Hajime; Tadokoro, Mika; Hoshi, Kazuto; Takato, Tsuyoshi; Myoui, Akira; Nanno, Katsuhiko; Kato, Yukio; Kanawa, Masami; Sugawara, Katsura; Kobo, Tomoko; Ushida, Takashi

    2012-07-01

    Tissue-engineered medical products (TEMPs) should be evaluated before implantation. Therefore, it is indispensable to establish evaluation protocols in regenerative medicine. Whether or not such evaluation protocols are reasonable is generally verified through a 'round robin' test. However, the round robin test for TEMPs intrinsically includes a deficiency, because 'identical' specimens can not be prepared for TEMPs. The aim of the study was to assess the feasibility and limitations of the round robin test for TEMPs by using a prepared evaluation protocol. We adopted tissue-engineered cartilage constructs as delivered specimens and a protocol of measuring sGAG content as an evaluation protocol proposed to ISO TC150/SC7, which is an invasive, but usually applied, method, although non-invasive methods are keenly required in evaluating TEMPs. The results showed that: (a) the coefficient of variation (CV) of the measured sGAG contents in intralaboratory tests was ~5% at most; (b) the CV of sGAG content in the scheme where each participating laboratory measured different constructs was comparable with that in the scheme where each participating laboratory measured one half of a construct along with the organizing laboratory; (c) the CV caused by factors other than the specimen was ~15%, comparable to that in reproducible experiments in biomedical fields. Based on these results, the study concludes that a round robin test for a TEMP could be valuable, under the condition that the delivered TEMPs are sufficiently reproducible so that the CV of the measured values is < 5% in the organizing laboratory.

  16. SU-F-207-02: Use of Postmortem Subjects for Subjective Image Quality Assessment in Abdominal CT Protocols with Iterative Reconstruction

    Energy Technology Data Exchange (ETDEWEB)

    Mench, A [Salem Hospital, Salem, OR (United States); Lipnharski, I; Carranza, C; Lamoureux, R; Smajdor, L; Cormack, B; Mohammed, T; Rill, L; Arreola, M [University of Florida, Gainesville, FL (United States); Sinclair, L [Oregon Health & Science University, Portland, OR (United States)

    2015-06-15

    Purpose: New radiation dose reduction technologies are emerging constantly in the medical imaging field. The latest of these technologies, iterative reconstruction (IR) in CT, presents the ability to reduce dose significantly and hence provides great opportunity for CT protocol optimization. However, without effective analysis of image quality, the reduction in radiation exposure becomes irrelevant. This work explores the use of postmortem subjects as an image quality assessment medium for protocol optimizations in abdominal CT. Methods: Three female postmortem subjects were scanned using the Abdomen-Pelvis (AP) protocol at reduced minimum tube current and target noise index (SD) settings of 12.5, 17.5, 20.0, and 25.0. Images were reconstructed using two strengths of iterative reconstruction. Radiologists and radiology residents from several subspecialties were asked to evaluate 8 AP image sets including the current facility default scan protocol and 7 scans with the parameters varied as listed above. Images were viewed in the soft tissue window and scored on a 3-point scale as acceptable, borderline acceptable, and unacceptable for diagnosis. The facility default AP scan was identified to the reviewer while the 7 remaining AP scans were randomized and de-identified of acquisition and reconstruction details. The observers were also asked to comment on the subjective image quality criteria they used for scoring images. This included visibility of specific anatomical structures and tissue textures. Results: Radiologists scored images as acceptable or borderline acceptable for target noise index settings of up to 20. Due to the postmortem subjects’ close representation of living human anatomy, readers were able to evaluate images as they would those of actual patients. Conclusion: Postmortem subjects have already been proven useful for direct CT organ dose measurements. This work illustrates the validity of their use for the crucial evaluation of image quality

  17. Assessment of prescription profile of pregnant women visiting antenatal clinics.

    Directory of Open Access Journals (Sweden)

    Eze UI

    2007-09-01

    Full Text Available Managing medical complications in pregnancy is a challenge to clinicians. Objectives: This study profiled some disease and prescription patterns for pregnant women attending antenatal clinics (ANCs in Nigeria. A risk classification of the medicines was also determined. Methods: Medical case files of 1,200 pregnant women attending antenatal clinics of 3 health facilities in Benin City, Nigeria were investigated. Disease pattern was determined from their diagnoses. The prescription pattern was assessed using WHO indicators, and the United States Food and Drug Administration classification of medicines according to risk to the foetus. Results: A total of 1,897 prescriptions of the 1,200 pregnant women attendees during the period under review were evaluated. Results indicated that malaria 554 (38% was the most prevalent disease, followed by upper respiratory tract infections (URTIs, 13% and gastrointestinal disturbances (GIT, 12%. The average number of drugs prescribed per encounter was found to be 3.0, and 2,434 (43% of medicines were prescribed by generic name. Minerals/ Vitamins 2,396 (42% were the most frequently prescribed medicines, and antibiotics occurred in 502 (8.8% of the total medicines. Of all medicines prescribed, 984 (17% were included in the foetal risk category C and 286 (5% in category D. Conclusion: The study concluded that malaria fever occurred most frequently followed by URTIs and GIT disturbances among the pregnant women. Minerals, vitamins and to a less extent anti-malarials topped the list of the prescribed medicines. The average number of medicines per encounter was much higher than WHO standards. The occurrence of contraindicated medicines was low.

  18. Lymphoplasmacytic sclerosing cholangitis: assessment of clinical, CT, and pathological findings

    Energy Technology Data Exchange (ETDEWEB)

    Itoh, S., E-mail: shigekimiyo@luck.ocn.ne.j [Department of Technical Radiology, Nagoya University School of Health Sciences, Nagoya (Japan); Nagasaka, T. [Department of Pathology, Nagoya University Graduate School of Medicine, Nagoya (Japan); Suzuki, K.; Satake, H.; Ota, T.; Naganawa, S. [Department of Radiology, Nagoya University Graduate School of Medicine, Nagoya (Japan)

    2009-11-15

    Aim: To assess the clinical, computed tomography (CT), and pathological findings in patients with lymphoplasmacytic sclerosing cholangitis. Materials and methods: Fifteen consecutive patients (four women and 11 men, mean age 71 years) with lymphoplasmacytic sclerosing cholangitis and without the characteristic features of underlying disorders causing benign biliary strictures were retrospectively recruited. Two radiologists evaluated multiphase contrast-enhanced CT images acquired with 0.5 or 1-mm collimation. One pathologist performed all histological examinations, including IgG4 immunostaining. Results: The intrahepatic biliary ducts showed dilatation in all 15 patients, but only seven presented with jaundice. Although laboratory data were not available in all patients, serum gammaglobulin and IgG levels were elevated in five of six patients and six of eight patients, respectively. Anti-nuclear antibody was detected in three of six patients. The involved biliary ducts showed the following CT findings: involvement of the hilar biliary duct (14/15), a mean wall thickness of 4.9 mm, a smooth margin (10/15), a narrow but visible lumen (6/15), hyper-attenuation during the late arterial phase (9/15), homogeneous hyper-attenuation during the delayed phase (11/11), and no vascular invasion (14/15). Abnormal findings in the pancreas and urinary tract were detected in eight of 15 patients. In 13 patients with adequate specimens, moderate to severe lymphoplasmacytic infiltration associated with dense fibrosis was observed. Infiltration of IgG4-positive plasma cells was moderate or severe in nine patients and minimal or absent in four patients. Conclusion: Lymphoplasmacytic sclerosing cholangitis exhibits relatively characteristic clinical and CT findings, although they are not sufficiently specific for differentiation from other biliary diseases.

  19. Designing intervention protocols for nursing clinical trials%护理临床研究中干预方案的制定

    Institute of Scientific and Technical Information of China (English)

    王少玲; 黄金月; 周家仪

    2014-01-01

    Intervention design is a key link in an experimental research and may directly affect the quality and outcomes of care and research. Effective nursing interventions are developed through a systematic and rigorous process. With authors own experience in designing nursing interventions, this article recommends three main steps for developing intervention protocols in nursing clinical trials. They are: ①to establish a conceptual framework for interventions with the regard to the indentiifed research problem;②to develop evidence-based intervention protocols along with careful consideration of the intervention target, delivery methods, intervention property, intervention dose (including components, amount, frequency and duration of nursing care), interventionists and intervention management;③to validate and take pilot test of the protocols before their actual usage in the main study.%干预方案的设计是实验性研究中的一个重要环节,直接影响护理和研究的质量和结局。有效护理干预方案的制定须经历一个严谨的过程。本文借助笔者的设计经验提出护理临床研究中干预方案的制定的三个重要步骤:①围绕研究主题建立干预的概念框架;②建立以循证为基础的干预方案,包含目标群体、实施方法、干预特性、护理剂量(成分、数量、频次和周期)、干预者和干预管理;③实施前对干预方案进行审核和测试。

  20. A computer-assisted protocol for endovascular target interventions using a clinical MRI system for controlling untethered microdevices and future nanorobots.

    Science.gov (United States)

    Martel, Sylvain; Mathieu, Jean-Baptiste; Felfoul, Ouajdi; Chanu, Arnaud; Aboussouan, Eric; Tamaz, Samer; Pouponneau, Pierre; Yahia, L'Hocine; Beaudoin, Gilles; Soulez, Gilles; Mankiewicz, Martin

    2008-11-01

    The possibility of automatically navigating untethered microdevices or future nanorobots to conduct target endovascular interventions has been demonstrated by our group with the computer-controlled displacement of a magnetic sphere along a pre-planned path inside the carotid artery of a living swine. However, although the feasibility of propelling, tracking and performing real-time closed-loop control of an untethered ferromagnetic object inside a living animal model with a relatively close similarity to human anatomical conditions has been validated using a standard clinical Magnetic Resonance Imaging (MRI) system, little information has been published so far concerning the medical and technical protocol used. In fact, such a protocol developed within technological and physiological constraints was a key element in the success of the experiment. More precisely, special software modules were developed within the MRI software environment to offer an effective tool for experimenters interested in conducting such novel interventions. These additional software modules were also designed to assist an interventional radiologist in all critical real-time aspects that are executed at a speed beyond human capability, and include tracking, propulsion, event timing and closed-loop position control. These real-time tasks were necessary to avoid a loss of navigation control that could result in serious injury to the patient. Here, additional simulation and experimental results for microdevices designed to be targeted more towards the microvasculature have also been considered in the identification, validation and description of a specific sequence of events defining a new computer-assisted interventional protocol that provides the framework for future target interventions conducted in humans.

  1. SPECT/CT workflow and imaging protocols

    Energy Technology Data Exchange (ETDEWEB)

    Beckers, Catherine [University Hospital of Liege, Division of Nuclear Medicine and Oncological Imaging, Department of Medical Physics, Liege (Belgium); Hustinx, Roland [University Hospital of Liege, Division of Nuclear Medicine and Oncological Imaging, Department of Medical Physics, Liege (Belgium); Domaine Universitaire du Sart Tilman, Service de Medecine Nucleaire et Imagerie Oncologique, CHU de Liege, Liege (Belgium)

    2014-05-15

    Introducing a hybrid imaging method such as single photon emission computed tomography (SPECT)/CT greatly alters the routine in the nuclear medicine department. It requires designing new workflow processes and the revision of original scheduling process and imaging protocols. In addition, the imaging protocol should be adapted for each individual patient, so that performing CT is fully justified and the CT procedure is fully tailored to address the clinical issue. Such refinements often occur before the procedure is started but may be required at some intermediate stage of the procedure. Furthermore, SPECT/CT leads in many instances to a new partnership with the radiology department. This article presents practical advice and highlights the key clinical elements which need to be considered to help understand the workflow process of SPECT/CT and optimise imaging protocols. The workflow process using SPECT/CT is complex in particular because of its bimodal character, the large spectrum of stakeholders, the multiplicity of their activities at various time points and the need for real-time decision-making. With help from analytical tools developed for quality assessment, the workflow process using SPECT/CT may be separated into related, but independent steps, each with its specific human and material resources to use as inputs or outputs. This helps identify factors that could contribute to failure in routine clinical practice. At each step of the process, practical aspects to optimise imaging procedure and protocols are developed. A decision-making algorithm for justifying each CT indication as well as the appropriateness of each CT protocol is the cornerstone of routine clinical practice using SPECT/CT. In conclusion, implementing hybrid SPECT/CT imaging requires new ways of working. It is highly rewarding from a clinical perspective, but it also proves to be a daily challenge in terms of management. (orig.)

  2. Can a management pathway for chronic cough in children improve clinical outcomes: protocol for a multicentre evaluation

    Directory of Open Access Journals (Sweden)

    Masters IB

    2010-11-01

    Full Text Available Abstract Background Chronic cough is common and is associated with significant economic and human costs. While cough can be a problematic symptom without serious consequences, it could also reflect a serious underlying illness. Evidence shows that the management of chronic cough in children needs to be improved. Our study tests the hypothesis that the management of chronic cough in children with an evidence-based management pathway is feasible and reliable, and improves clinical outcomes. Methods/Design We are conducting a multicentre randomised controlled trial based in respiratory clinics in 5 major Australian cities. Children (n = 250 fulfilling inclusion criteria (new patients with chronic cough are randomised (allocation concealed to the standardised clinical management pathway (specialist starts clinical pathway within 2 weeks or usual care (existing care until review by specialist at 6 weeks. Cough diary, cough-specific quality of life (QOL and generic QOL are collected at baseline and at 6, 10, 14, 26, and 52 weeks. Children are followed-up for 6 months after diagnosis and cough resolution (with at least monthly contact from study nurses. A random sample from each site will be independently examined to determine adherence to the pathway. Primary outcomes are group differences in QOL and proportion of children that are cough free at week 6. Discussion The clinical management pathway is based on data from Cochrane Reviews combined with collective clinical experience (250 doctor years. This study will provide additional evidence on the optimal management of chronic cough in children. Trial registration ACTRN12607000526471

  3. Assessment of first-year veterinary students' clinical skills using objective structured clinical examinations.

    Science.gov (United States)

    Hecker, Kent; Read, Emma K; Vallevand, Andrea; Krebs, Gord; Donszelmann, Darlene; Muelling, Christoph K W; Freeman, Sarah L

    2010-01-01

    The DVM program at the University of Calgary offers a Clinical Skills course each year for the first three years. The course is designed to teach students the procedural skills required for entry-level general veterinary practice. Objective Structured Clinical Examinations (OSCEs) were used to assess students' performance on these procedural skills. A series of three OSCEs were developed for the first year. Content was determined by an exam blueprint, exam scoring sheets were created, rater training was provided, a mock OSCE was performed with faculty and staff, and the criterion-referencing Ebel method was used to set cut scores for each station using two content experts. Each station and the overall exam were graded as pass or fail. Thirty first-year DVM students were assessed. Content validity was ensured by the exam blueprint and expert review. Reliability (coefficient α) of the stations from the three OSCE exams ranged from 0.0 to 0.71. The three exam reliabilities (Generalizability Theory) were, for OSCE 1, G=0.56; OSCE 2, G=0.37; and OSCE 3, G=0.32. Preliminary analysis has suggested that the OSCEs demonstrate face and content validity, and certain stations demonstrated adequate reliability. Overall exam reliability was low, which reflects issues with first-time exam delivery. Because this year was the first that this course was taught and this exam format was used, work continues in the program on the teaching of the procedural skills and the development and revision of OSCE stations and scoring checklists.

  4. Expanding the Aperture of Psychological Assessment: Introduction to the Special Section on Innovative Clinical Assessment Technologies and Methods

    Science.gov (United States)

    Trull, Timothy J.

    2007-01-01

    Contemporary psychological assessment is dominated by tried-and-true methods like clinical interviewing, self-report questionnaires, intellectual assessment, and behavioral observation. These approaches have served as the mainstays of psychological assessment for decades. To be sure, these methods have survived over the years because clinicians…

  5. Validation of NINDS-VCI Neuropsychology Protocols for Vascular Cognitive Impairment in Taiwan.

    Directory of Open Access Journals (Sweden)

    Hsiu-Fen Lin

    Full Text Available To validate the three time-difference neuropsychological protocols developed by the National Institute of Health/National Institute of Neurological Disorders and Stroke (NINDS and the Canadian Stroke Network for assessment of vascular cognitive impairment (VCI in Mandarin-speaking subjects and to investigate the clinical application of the shortest form.Patients aged 50 years or older who had a stroke were invited to participate in the study. Clinical diagnosis of VCI was made. The NINDS-VCI Neuropsychology Protocols, 60-, 30-, and two 5-minute protocols, were administered. The criteria validities of the cognitive protocols against the diagnoses of stroke and VCI were determined via Receiver Operating Characteristic (ROC analysis. The optimal cut-off point for the 5-minute protocols total score was estimated for clinical use in screening.Eighty-three patients and 53 controls were recruited during the study period. Patients with stroke performed more poorly than the control group in the three neuropsychological protocols. Forty-two patients with stroke were diagnosed with VCI. VCI was used as the standard to estimate the criteria validities. The area under the ROC curve was 0.78, 0.80, 0.75, and 0.73 for the 60-, 30-, 5-mintue protocol-A and 5-minute protocol-B, respectively.These modified neuropsychological protocols can be used as valid instruments when performing comprehensive cognitive assessment or for screening of VCI in Taiwan.

  6. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    Directory of Open Access Journals (Sweden)

    Krämer Jürgen

    2004-03-01

    Full Text Available Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial. Discussion A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers.

  7. Reliable Multihop Broadcast Protocol with a Low-Overhead Link Quality Assessment for ITS Based on VANETs in Highway Scenarios

    Directory of Open Access Journals (Sweden)

    Alejandro Galaviz-Mosqueda

    2014-01-01

    Full Text Available Vehicular ad hoc networks (VANETs have been identified as a key technology to enable intelligent transport systems (ITS, which are aimed to radically improve the safety, comfort, and greenness of the vehicles in the road. However, in order to fully exploit VANETs potential, several issues must be addressed. Because of the high dynamic of VANETs and the impairments in the wireless channel, one key issue arising when working with VANETs is the multihop dissemination of broadcast packets for safety and infotainment applications. In this paper a reliable low-overhead multihop broadcast (RLMB protocol is proposed to address the well-known broadcast storm problem. The proposed RLMB takes advantage of the hello messages exchanged between the vehicles and it processes such information to intelligently select a relay set and reduce the redundant broadcast. Additionally, to reduce the hello messages rate dependency, RLMB uses a point-to-zone link evaluation approach. RLMB performance is compared with one of the leading multihop broadcast protocols existing to date. Performance metrics show that our RLMB solution outperforms the leading protocol in terms of important metrics such as packet dissemination ratio, overhead, and delay.

  8. The Assessment of Patient Clinical Outcome: Advantages, Models, Features of an Ideal Model

    Directory of Open Access Journals (Sweden)

    Mou’ath Hourani

    2016-06-01

    Full Text Available Background: The assessment of patient clinical outcome focuses on measuring various aspects of the health status of a patient who is under healthcare intervention. Patient clinical outcome assessment is a very significant process in the clinical field as it allows health care professionals to better understand the effectiveness of their health care programs and thus for enhancing the health care quality in general. It is thus vital that a high quality, informative review of current issues regarding the assessment of patient clinical outcome should be conducted. Aims & Objectives: 1 Summarizes the advantages of the assessment of patient clinical outcome; 2 reviews some of the existing patient clinical outcome assessment models namely: Simulation, Markov, Bayesian belief networks, Bayesian statistics and Conventional statistics, and Kaplan-Meier analysis models; and 3 demonstrates the desired features that should be fulfilled by a well-established ideal patient clinical outcome assessment model. Material & Methods: An integrative review of the literature has been performed using the Google Scholar to explore the field of patient clinical outcome assessment. Conclusion: This paper will directly support researchers, clinicians and health care professionals in their understanding of developments in the domain of the assessment of patient clinical outcome, thus enabling them to propose ideal assessment models.

  9. Telephone follow-up by nurse following total knee arthroplasty - protocol for a randomized clinical trial (NCT01771315)

    DEFF Research Database (Denmark)

    Szöts, Kirsten; Konradsen, Hanne; Solgaard, Søren

    2014-01-01

    BACKGROUND: Due to shorter hospitalization, patients have to take responsibility for their rehabilitation period at a very early stage. The objective of this trial is to study the effects of two treatment schemes following total knee arthroplasty: conventional treatment following discharge from...... to the orthopaedic outpatient clinic during the rehabilitation period. METHOD/DESIGN: The design is a randomized un-blinded parallel group clinical trial conducted at the Department of Orthopaedic Surgery, Gentofte Hospital, the Capital Region of Denmark. In total, 116 patients will be allocated by an external...... randomization program to 2 groups: an intervention group following usual treatment after discharge supplemented by a nurse managed structured follow-up consultation conducted by telephone 4 and 14 days after discharge from hospital and a control group following treatment as usual. The consultations...

  10. A simple MRI protocol in patients with clinically suspected appendicitis: results in 138 patients and effect on outcome of appendectomy

    Energy Technology Data Exchange (ETDEWEB)

    Cobben, Lodewijk [Medisch Centrum Haaglanden, Department of Radiology, Leidschendam (Netherlands); Groot, Ingrid [Medisch Centrum Haaglanden, Department of Surgery, Leidschendam (Netherlands); Kingma, Lucas; Coerkamp, Emile; Puylaert, Julien [Medisch Centrum Haaglanden, Department of Radiology, Den Haag (Netherlands); Blickman, Johan [Universitair Medisch Centrum St Radboud, Department of Radiology, Geert Grooteplein 10, GA, Nijmegen (Netherlands)

    2009-05-15

    To establish the value of breathhold magnetic resonance imaging (MRI) in the diagnosis of acute appendicitis. Over a 14-month period, 138 patients clinically suspected of having appendicitis were evaluated prospectively with MRI and comprised the study group. Fast turbo spin-echo breathhold T1, T2 and T2 fat suppression sequences were used in coronal and axial planes. The imaging results were recorded separately and subsequently correlated with clinical, radiological and histopathological follow-up. The effect of imaging strategies in patients suspected of appendicitis on hospital resources was calculated. Sixty-two of the 138 patients had a histopathologically proven appendicitis. MRI determined appendicitis in 63 patients, with one examination being false positive. The resulting sensitivity and specificity were 100% and 99%, respectively. MRI showed an alternative diagnosis in 41 of the 75 remaining patients. In 22 of the remaining 34 patients, a normal appendix was depicted with MRI. In two patients, where MRI showed no appendicitis, an alternative diagnosis or normal appendix, an unnecessary appendectomy was performed. The overall effect of using MRI in patients suspected of appendicitis on the use of hospital resources could have been a net saving between EUR 55,746 and EUR 72,534. MRI has a high accuracy in detecting and excluding appendicitis, an alternative diagnosis or showing the normal appendix, and can be a valuable and cost-effective tool in the workup of patients clinically suspected of having appendicitis. (orig.)

  11. Objective Structured Clinical Examinations Provide Valid Clinical Skills Assessment in Emergency Medicine Education

    Directory of Open Access Journals (Sweden)

    Wallenstein, Joshua

    2014-12-01

    Full Text Available Introduction: Evaluation of emergency medicine (EM learners based on observed performance in the emergency department (ED is limited by factors such as reproducibility and patient safety. EM educators depend on standardized and reproducible assessments such as the objective structured clinical examination (OSCE. The validity of the OSCE as an evaluation tool in EM education has not been previously studied. The objective was to assess the validity of a novel management-focused OSCE as an evaluation instrument in EM education through demonstration of performance correlation with established assessment methods and case item analysis. Methods: We conducted a prospective cohort study of fourth-year medical students enrolled in a required EM clerkship. Students enrolled in the clerkship completed a five-station EM OSCE. We used Pearson’s coefficient to correlate OSCE performance with performance in the ED based on completed faculty evaluations. Indices of difficulty and discrimination were computed for each scoring item. Results: We found a moderate and statistically-significant correlation between OSCE score and ED performance score [r(239 =0.40, p<0.001]. Of the 34 OSCE testing items the mean index of difficulty was 63.0 (SD =23.0 and the mean index of discrimination was 0.52 (SD =0.21. Conclusion: Student performance on the OSCE correlated with their observed performance in the ED, and indices of difficulty and differentiation demonstrated alignment with published best-practice testing standards. This evidence, along with other attributes of the OSCE, attest to its validity. Our OSCE can be further improved by modifying testing items that performed poorly and by examining and maximizing the inter-rater reliability of our evaluation instrument. [West J Emerg Med. 2015;16(1:121–126.

  12. Shoulder muscle endurance: the development of a standardized and reliable protocol

    Directory of Open Access Journals (Sweden)

    Roy Jean-Sébastien

    2011-01-01

    Full Text Available Abstract Background Shoulder muscle fatigue has been proposed as a possible link to explain the association between repetitive arm use and the development of rotator cuff disorders. To our knowledge, no standardized clinical endurance protocol has been developed to evaluate the effects of muscle fatigue on shoulder function. Such a test could improve clinical examination of individuals with shoulder disorders. Therefore, the purpose of this study was to establish a reliable protocol for objective assessment of shoulder muscle endurance. Methods An endurance protocol was developed on a stationary dynamometer (Biodex System 3. The endurance protocol was performed in isotonic mode with the resistance set at 50% of each subject's peak torque as measured for shoulder external (ER and internal rotation (IR. Each subject performed 60 continuous repetitions of IR/ER rotation. The endurance protocol was performed by 36 healthy individuals on two separate occasions at least two days apart. Maximal isometric shoulder strength tests were performed before and after the fatigue protocol to evaluate the effects of the endurance protocol and its reliability. Paired t-tests were used to evaluate the reduction in shoulder strength due to the protocol, while intraclass correlation coefficients (ICC and minimal detectable change (MDC were used to evaluate its reliability. Results Maximal isometric strength was significantly decreased after the endurance protocol (P 0.84. Conclusions Changes in muscular performance observed during and after the muscular endurance protocol suggests that the protocol did result in muscular fatigue. Furthermore, this study established that the resultant effects of fatigue of the proposed isotonic protocol were reproducible over time. The protocol was performed without difficulty by all volunteers and took less than 10 minutes to perform, suggesting that it might be feasible for clinical practice. This protocol could be used to induce

  13. Hypnosis for hot flashes among postmenopausal women study: A study protocol of an ongoing randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Johnson Aimee K

    2011-10-01

    Full Text Available Abstract Background Hot flashes are a highly prevalent problem associated with menopause and breast cancer treatments. The recent findings from the Women's Health Initiative have important implications for the significance of a non-hormonal, mind-body intervention for hot flashes in breast cancer survivors. Women who take hormone therapy long-term may have a 1.2 to 2.0 fold increased risk of developing breast cancer. In addition, it is now known that hormone therapy with estrogen and progestin is associated with increased risk of cardiovascular disease and stroke. Currently there are limited options to hormone replacement therapy as non-hormonal pharmacological agents are associated with only modest activity and many adverse side effects. Because of this there is a need for more alternative, non-hormonal therapies. Hypnosis is a mind-body intervention that has been shown to reduce self-reported hot flashes by up to 68% among breast cancer survivors, however, the use of hypnosis for hot flashes among post-menopausal women has not been adequately explored and the efficacy of hypnosis in reducing physiologically measured hot flashes has not yet been determined. Methods/design A sample of 180 post-menopausal women will be randomly assigned to either a 5-session Hypnosis Intervention or 5-session structured-attention control with 12 week follow-up. The present study will compare hypnosis to a structured-attention control in reducing hot flashes (perceived and physiologically monitored in post-menopausal women in a randomized clinical trial. Outcomes will be hot flashes (self-report daily diaries; physiological monitoring; Hot Flash Related Daily Interference Scale, anxiety (State-Trait Anxiety Inventory; Hospital Anxiety and Depression Scale (HADS; anxiety visual analog scale (VAS rating; depression (Center for Epidemiologic Studies Depression Scale, sexual functioning (Sexual Activity Questionnaire, sleep quality (Pittsburgh Sleep Quality Index and

  14. Clinical research training of Peruvian neurologists: a baseline assessment

    Directory of Open Access Journals (Sweden)

    Gian Carlos Navarro-Chumbes

    2010-05-01

    Full Text Available In Peru, despite a strong clinical research infrastructure in Lima, and Masters degree programs in epidemiology at three universities, few neurologists participate in clinical research. It was our objective to identify perceived needs and opportunities for increasing clinical research capacity and training opportunities for Peruvian neurologists. We conducted a descriptive, cross-sectional survey of Peruvian neurologists in Lima and Arequipa, Peru. Forty-eight neurologists completed written surveys and oral interviews. All neurologists reported interest in clinical research, but noted that lack of time and financial resources limited their ability to participate. Although most neurologists had received some training in epidemiology and research design as medical students or residents, the majority felt these topics were not adequately covered. Neurologists in Arequipa noted international funding for clinical research was uncommon outside the capital city of Lima. We concluded that clinical research is important to Peruvian neurologists. The three main barriers to increased participation in clinical research identified by neurologists were insufficient training in clinical research methodology, meager funding opportunities, and lack of dedicated time to participate in clinical research. Distance learning holds promise as a method for providing additional training in clinical research methodology, especially for neurologists who may have difficulty traveling to larger cities for additional training.

  15. Clinical research training of Peruvian neurologists: a baseline assessment.

    Science.gov (United States)

    Navarro-Chumbes, Gian Carlos; Montano-Torres, Silvia Margarita; Díaz-Vásquez, Alberto; Zunt, Joseph Raymond

    2010-06-21

    In Peru, despite a strong clinical research infrastructure in Lima, and Masters degree programs in epidemiology at three universities, few neurologists participate in clinical research. It was our objective to identify perceived needs and opportunities for increasing clinical research capacity and training opportunities for Peruvian neurologists. We conducted a descriptive, cross-sectional survey of Peruvian neurologists in Lima and Arequipa, Peru. Forty-eight neurologists completed written surveys and oral interviews. All neurologists reported interest in clinical research, but noted that lack of time and financial resources limited their ability to participate. Although most neurologists had received some training in epidemiology and research design as medical students or residents, the majority felt these topics were not adequately covered. Neurologists in Arequipa noted international funding for clinical research was uncommon outside the capital city of Lima. We concluded that clinical research is important to Peruvian neurologists. The three main barriers to increased participation in clinical research identified by neurologists were insufficient training in clinical research methodology, meager funding opportunities, and lack of dedicated time to participate in clinical research. Distance learning holds promise as a method for providing additional training in clinical research methodology, especially for neurologists who may have difficulty traveling to larger cities for additional training.

  16. Translating stem cell research to the clinic: a primer on translational considerations for your first stem cell protocol.

    Science.gov (United States)

    O'Brien, Timothy; Creane, Michael; Windebank, Anthony J; Terzic, Andre; Dietz, Allan B

    2015-08-22

    Over the last two decades, a new therapeutic paradigm has emerged which has changed the way debilitating diseases may be treated in the future. Instead of using small-molecule drugs and devices to ameliorate the symptoms of disease, clinicians may harness the therapeutic power of cells to regenerate and cure diseases which currently represent a major unmet medical need. Advancements in the scientific knowledge of stem cell biology, along with highly encouraging preclinical proof-of-concept studies, in the last several years have served as a launch pad for testing such therapeutics in humans with life-threatening diseases. However, translating basic research findings into human therapy has not been straightforward and has presented many scientific, clinical, and regulatory challenges for scientists and clinicians. In this article, we provide a guidance framework for investigators for the design of early-phase clinical studies using stem cell-based therapeutics. Furthermore, important trial parameters and design features which must be considered before regulatory submission of such studies are highlighted.

  17. Organisation and management of the first clinical trial of BNCT in Europe (EORTC protocol 11961).EORTC BNCT study group.

    Science.gov (United States)

    Sauerwein, W; Moss, R; Rassow, J; Stecher-Rasmussen, F; Hideghéty, K; Wolbers, J G; Sack, H

    1999-06-01

    Boron Neutron Capture Therapy is based on the ability of the isotope 10B to capture thermal neutrons and to disintegrate instantaneously producing high LET particles. The only neutron beam available in Europe for such a treatment is based at the European High Flux Reactor HFR at Petten (The Netherlands). The European Commission, owners of the reactor, decided that the potential benefit of the facility should be opened to all European citizens and therefore insisted on a multinational approach to perform the first clinical trial in Europe on BNCT. This precondition had to be respected as well as the national laws and regulations. Together with the Dutch authorities actions were undertaken to overcome the obvious legal problems. Furthermore, the clinical trial at Petten takes place in a nuclear research reactor, which apart from being conducted in a non-hospital environment, is per se known to be dangerous. It was therefore of the utmost importance that special attention is given to safety, beyond normal rules, and to the training of staff. In itself, the trial is an unusual Phase I study, introducing a new drug with a new irradiation modality, with really an unknown dose-effect relationship. This trial must follow optimal procedures, which underscore the quality and qualified manner of performance.

  18. Correction of vitamin D deficiency in critically ill patients - VITdAL@ICU study protocol of a double-blind, placebo-controlled randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Amrein Karin

    2012-11-01

    Full Text Available Abstract Background Vitamin D deficiency is associated with multiple adverse health outcomes including increased morbidity and mortality in the general population and in critically ill patients. However, no randomized controlled trial has evaluated so far whether treatment with sufficiently large doses of vitamin D can improve clinical outcome of patients in an intensive care setting. Methods/design The VITdAL@ICU trial is an investigator-initiated, non-commercial, double-blind, placebo-controlled randomized clinical trial. This study compares high-dose oral cholecalciferol (vitamin D3 versus placebo treatment in a mixed population of 480 critically ill patients with low 25-hydroxyvitamin-D levels at study enrollment (≤ 20ng/ml. Following an initial loading dose of 540,000 IU of vitamin D3, patients receive 90,000 IU of vitamin D3 on a monthly basis for 5 months. The study is designed to compare clinical outcome in the two study arms with the primary endpoint being length of hospital stay. Secondary endpoints include among others length of ICU stay, the percentage of patients with 25(OHD levels > 30 ng/ml at day 7, ICU and hospital mortality and duration of mechanical ventilation. We describe here the VITdAL@ICU study protocol for the primary report. Discussion This trial is designed to evaluate whether high-dose vitamin D3 is able to improve morbidity and mortality in a mixed population of adult critically ill patients and correct vitamin D deficiency safely. Trial registration ClinicalTrials: NCT01130181

  19. A protocol for generation of clinical grade mRNA-transfected monocyte-derived dendritic cells for cancer vaccines.

    Science.gov (United States)

    Mu, L J; Gaudernack, G; Saebøe-Larssen, S; Hammerstad, H; Tierens, A; Kvalheim, G

    2003-11-01

    With the aim of producing large quantities of mRNA-transfected monocyte-derived dendritic cells (DCs) to be used as cancer vaccines, a new clinical grade procedure has been developed. Peripheral blood mononuclear cells (PBMCs) obtained by leukapheresis were enriched for monocytes by immunomagnetic depletion of CD19+ B cells and CD2+ T cells employing the ISOLEX 300i device. After 5 days of culture of enriched monocytes in gas permeable Teflon bags, using serum-free medium supplemented with granulocyte/macrophage-colony stimulating factor and interleukin-4 (IL-4), immature DCs were generated. Following transfection with mRNA from three human prostate cancer cell lines (DU145, LNCaP and PC-3), employing a newly developed square wave electroporation procedure, the immature DCs were immediately transferred to Teflon bags and matured for 48 h, using serum-free medium supplemented with IL-1alpha, IL-6, tumour necrosis factor-alpha and PGE2. The electroporation procedure efficiently transferred mRNA into the DCs with minor effect on the viability of the cells. The generated matured transfected DCs show high expression of the antigens CD83, CD80, CD86 and human leucocyte antigen-DR. Freezing and thawing of the transfected matured DCs had minor effect on cell viability and the phenotype. From 4 x 109 PBMCs, about 1 x 108 transfected matured DCs are produced. The thawed transfected DCs were able to elicit primary T-cell responses in vitro against antigens encoded by the prostate cancer mRNA as shown by enzyme-linked immunospot assay using mock-transfected DCs as control. Based on these results, clinical trials in cancer patients have been initiated.

  20. Clinical Implementation of an Online Adaptive Plan-of-the-Day Protocol for Nonrigid Motion Management in Locally Advanced Cervical Cancer IMRT

    Energy Technology Data Exchange (ETDEWEB)

    Heijkoop, Sabrina T., E-mail: s.heijkoop@erasmusmc.nl; Langerak, Thomas R.; Quint, Sandra; Bondar, Luiza; Mens, Jan Willem M.; Heijmen, Ben J.M.; Hoogeman, Mischa S.

    2014-11-01

    Purpose: To evaluate the clinical implementation of an online adaptive plan-of-the-day protocol for nonrigid target motion management in locally advanced cervical cancer intensity modulated radiation therapy (IMRT). Methods and Materials: Each of the 64 patients had four markers implanted in the vaginal fornix to verify the position of the cervix during treatment. Full and empty bladder computed tomography (CT) scans were acquired prior to treatment to build a bladder volume-dependent cervix-uterus motion model for establishment of the plan library. In the first phase of clinical implementation, the library consisted of one IMRT plan based on a single model-predicted internal target volume (mpITV), covering the target for the whole pretreatment observed bladder volume range, and a 3D conformal radiation therapy (3DCRT) motion-robust backup plan based on the same mpITV. The planning target volume (PTV) combined the ITV and nodal clinical target volume (CTV), expanded with a 1-cm margin. In the second phase, for patients showing >2.5-cm bladder-induced cervix-uterus motion during planning, two IMRT plans were constructed, based on mpITVs for empty-to-half-full and half-full-to-full bladder. In both phases, a daily cone beam CT (CBCT) scan was acquired to first position the patient based on bony anatomy and nodal targets and then select the appropriate plan. Daily post-treatment CBCT was used to verify plan selection. Results: Twenty-four and 40 patients were included in the first and second phase, respectively. In the second phase, 11 patients had two IMRT plans. Overall, an IMRT plan was used in 82.4% of fractions. The main reasons for selecting the motion-robust backup plan were uterus outside the PTV (27.5%) and markers outside their margin (21.3%). In patients with two IMRT plans, the half-full-to-full bladder plan was selected on average in 45% of the first 12 fractions, which was reduced to 35% in the last treatment fractions. Conclusions: The implemented

  1. Protocol: Personality assessment as a support for referral and case-work in treatment for substance use disorders (PASRC-study

    Directory of Open Access Journals (Sweden)

    Pedersen Mads K

    2008-04-01

    Full Text Available Abstract Background Assessment of co-morbid personality disorders in substance use disorders may lead to important insights concerning individual patients. However, little is known about the potential value of routine personality disorder assessment in a clinical context. Methods Patients are adults with past-year substance dependence seeking treatment at a centralized intake unit for substance abusers in the City of Copenhagen. A randomized controlled trial of assessment of personality disorders and individual feedback vs. a general life situation interview. Patients are followed at 3 and 6 months post-treatment Discussion If routine personality assessment improves outcomes of substance abuse treatment, the clinical implication is to increase the use of personality disorder assessment in substance abuse treatment settings. Trial registration Current controlled trials ISRCTN39851689

  2. A clinical assessment tool for ultrasound-guided axillary brachial plexus block.

    LENUS (Irish Health Repository)

    Sultan, S F

    2012-05-01

    Competency in anesthesia traditionally has been determined subjectively in practice. Optimal training in procedural skills requires valid and reliable forms of assessment. The objective was to examine a procedure-specific clinical assessment tool for ultrasound-guided axillary brachial plexus block for inter-rater reliability and construct validity in a clinical setting.

  3. Assessment of Clinical Skills in Midwifery: Some Ethical and Practical Problems.

    Science.gov (United States)

    Somers-Smith, M. J.; Race, Angela J.

    1997-01-01

    Increased academic standards in midwifery education are causing conflict between research-based and traditional knowledge used in clinical assessments. Training of evaluators, frequent changes in clinical placements, and lack of contact between students and evaluators also impinge on the validity and reliability of assessments. (SK)

  4. Survey protocol for invasive species

    OpenAIRE

    Menza, Charles

    2009-01-01

    This protocol was developed by the Biogeography Branch of NOAA’s Center for Coastal Monitoring and Assessment to support invasive species research by the Papahānaumokuākea Marine National Monument. The protocol’s objective is to detect Carijoa riisei and Hypnea musciformis in deepwater habitats using visual surveys by technical divers. Note: This protocol is designed to detect the presence or absence of invasive species. A distinct protocol is required to collect information on abundance ...

  5. Reliability of an occlusal and nonocclusal tooth wear grading system: clinical use versus dental cast assessment.

    Science.gov (United States)

    Wetselaar, Peter; Lobbezoo, Frank; Koutris, Michail; Visscher, Corine M; Naeije, Machiel

    2009-01-01

    The reliability of a newly developed tooth wear grading system was assessed both clinically and on dental casts by two observers using 20 participants. The reliability of clinical occlusal/incisal tooth wear grading was fair-to-good to excellent, while that of most of the clinical nonocclusal/nonincisal grades was at least fair-to-good. Dental cast assessment frequently yielded poor reliabilities, especially for nonocclusal/nonincisal surfaces. Hence, occlusal/incisal wear could be graded more reliably than nonocclusal/nonincisal wear, while the clinical assessment of tooth wear was more reliable than the grading of dental casts.

  6. Clinical, Radiographic and Microbiological Evaluation of High Level Laser Therapy, a New Photodynamic Therapy Protocol, in Peri-Implantitis Treatment; a Pilot Experience

    Directory of Open Access Journals (Sweden)

    Gianluigi Caccianiga

    2016-01-01

    Full Text Available Aim. Endosseous implants are widely used to replace missing teeth but mucositis and peri-implantitis are the most frequent long-term complications related with dental implants. Removing all bacterial deposits on contaminated implant surface is very difficult due to implant surface morphology. The aim of this study was to evaluate the bactericidal potential of photodynamic therapy by using a new high level laser irradiation protocol associated with hydrogen peroxide in peri-implantitis. Materials and Methods. 10 patients affected by peri-implantitis were selected for this study. Medical history, photographic documentation, periodontal examination, and periapical radiographs were collected at baseline and 6 months after surgery. Microbiological analysis was performed with PCR Real Time. Each patient underwent nonsurgical periodontal therapy and surgery combined with photodynamic therapy according to High Level Laser Therapy protocol. Results. All peri-implant pockets were treated successfully, without having any complication and not showing significant differences in results. All clinical parameters showed an improvement, with a decrease of Plaque Index (average decrease of 65%, range 23–86%, bleeding on probing (average decrease of 66%, range 26–80%, and probing depth (average decrease of 1,6 mm, range 0,46–2,6 mm. Periapical radiographs at 6 months after surgery showed a complete radiographic filling of peri-implant defect around implants treated. Results showed a decrease of total bacterial count and of all bacterial species, except for Eikenella corrodens, 6 months after surgery. Conclusion. Photodynamic therapy using HLLT appears to be a good adjunct to surgical treatment of peri-implantitis.

  7. Technetium-99m tetrofosmin rest/stress myocardial SPET with a same-day 2-hour protocol: comparison with coronary angiography. A Spanish-Portuguese multicentre clinical trial

    Energy Technology Data Exchange (ETDEWEB)

    Montz, R. [Univ. Complutense, Madrid (Spain); Perez-Castejon, M.J. [Univ. Complutense, Madrid (Spain); Jurado, J.A. [Inst. de Cardiologia, Madrid (Spain); Martin-Comin, J. [Hospital de Bellvitge, Hospitalet de Ll./Barcelona (Spain); Esplugues, E. [Hospital de Bellvitge, Hospitalet de Ll./Barcelona (Spain); Salgado, L. [Hospital de Santa Cruz, Carnaxide (Portugal); Ventosa, A. [Hospital de Santa Cruz, Carnaxide (Portugal); Cantinho, G. [Facultad de Medicina, Hospital Santa Maria, Lisbon (Portugal); Sa, E.P. [Facultad de Medicina, Hospital Santa Maria, Lisbon (Portugal); Fonseca, A.T. [Inst. Portugues de Oncologia (IPOFG), Lisbon (Portugal); Vieira, M.R. [Inst. Portugues de Oncologia (IPOFG), Lisbon (Portugal); Ortiz-Berrocal, J. [Universidad Autonoma de Madrid (Spain). Clinica Puerta de Hierro; Tabuenca, M.J. [Universidad Autonoma de Madrid (Spain). Clinica Puerta de Hierro; Garcia, A. [Hospital Clinico y Provincial, Barcelona (Spain); Magrina, J. [Hospital Clinico y Provincial, Barcelona (Spain); Ortega, D. [Hospital Valle de Hebron, Barcelona (Spain); Puente, C. [Hospital Regional Carlos Haya, Malaga (Spain); Ferrer, A.I. [Hospitals da Universidade, Coimbra (Portugal); Pedrosa, J. [Hospitals da Universidade, Coimbra (Portugal); Latre, J.M. [Hospital Reina Sofia, Cordoba (Spain); Carreras, J.L. [Univ. Complutense, Madrid (Spain)

    1996-06-01

    Technetium-99m tetrofosmin (Myoview) has unique properties for myocardial perfusion imaging very early after injection of the tracer. We used a very short same-day rest/stress protocol, to be performed within 2 h and evaluated its diagnostic accuracy. The study included 144 patients from seven Spanish and four Portuguese centres with a diagnosis of uncomplicated coronary artery disease (CAD); 78 patients (54%) had no history of prior myocardial infarction. Patients were injected with {<=}300 MBq {sup 99m}Tc-tetrofosmin at rest and {<=}900 MBq approximately 1 h later at peak exercise. Single-photon emission tomographic (SPET) acquisitions were initiated within 5-30 min post injection. The results were compared with those of coronary angiography (CA). The data of 142 patients were completely evaluable (two with non-evaluable images were excluded). The quality of rest images was excellent or good in 86%, regionally problematic in 7%, poor but well interpretable in 5% and non-evaluable in 2%. The overall sensitivity for the detection of CAD was 93%, the specificity 38% and the accuracy 85%. The localization of defects by SPET in relation the perfusion territories of stenosed vessels ({>=}=50%) was achieved with a sensitivity of 64% for the left anterior descending artery, 49% for the left circumflex artery and 86% for the right coronary artery, and an accuracy of 71%, 72% and 73% respectively. Concordance of SPET and CA was 62% for single-vessel disease and 68% for multivessel disease. In conclusion, this Spanish-Portuguese multicentre clinical trial confirmed, in a considerable number of patients who underwent coronary angiography, the feasibility of {sup 99m}Tc terofosmin (Myoview) rest/stress myocardial SPET using a very short protocol (2 h). (orig.)

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

    Science.gov (United States)

    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…

  9. Reliability of an occlusal and nonocclusal tooth wear grading system: clinical use versus dental cast assessment

    NARCIS (Netherlands)

    Wetselaar, P.; Lobbezoo, F.; Koutris, M.; Visscher, C.M.; Naeije, M.

    2009-01-01

    The reliability of a newly developed tooth wear grading system was assessed both clinically and on dental casts by two observers using 20 participants. The reliability of clinical occlusal/incisal tooth wear grading was fair-to-good to excellent, while that of most of the clinical nonocclusal/noninc

  10. Quality assessment of reports on clinical trials in the Journal of Hepatology

    DEFF Research Database (Denmark)

    Gluud, C; Nikolova, D

    1998-01-01

    Electronic searches on databases for randomised clinical trials and controlled clinical trials do not identify as many trials as handsearches, and trial reporting may be flawed. The aims were to identify all fully reported randomised clinical trials in the Journal of Hepatology and to make a qual...... a qualitative assessment of the reporting....

  11. A quantitative comparison of two kinematic protocols for lumbar segment motion during gait.

    Science.gov (United States)

    Kiernan, D; Malone, A; O'Brien, T; Simms, C K

    2015-02-01

    During gait analysis, motion of the lumbar region is tracked either by means of a 2-dimensional assessment with markers placed along the spine or a 3-dimensional assessment treating the lumbar region as a rigid segment. The rigid segment assumption is necessary for inverse dynamic calculations further up the kinematic chain. In the absence of a reference standard, the choice of model is mostly based on clinical experience. However, the potential exists for large differences in kinematic output if different protocols are used. The aim of this study was to determine the influence of using two 3-dimensional lumbar segment protocols on the resultant kinematic output during gait. The first protocol was a skin surface rigid protocol with markers placed across the lumbar region while the second consisted of a rigid cluster utilizing active markers applied over the 3rd lumbar vertebra. Data from both protocols were compared through simultaneous recording during gait. Overall variability was lower in 4 out of 6 measures for the skin surface protocol. Ensemble average graphs demonstrated similar mean profiles between protocols. However, Functional Limits of Agreement demonstrated only a poor to moderate agreement. This trend was confirmed with a poor to moderate waveform similarity (CMC range 0.29-0.71). This study demonstrates that the protocol used to track lumbar segment kinematics is an important consideration for clinical and research purposes. Greater variability recorded by the rigid cluster during lumbar rotation suggests the skin surface protocol may be more suited to studies where axial rotation is a consideration.

  12. Assessing uncertainty in outsourcing clinical services at tertiary health centers.

    Science.gov (United States)

    Billi, John E; Pai, Chih-Wen; Spahlinger, David A

    2007-01-01

    When tertiary health centers face capacity constraint, one feasible strategy to meet service demand is outsourcing clinical services to qualified community providers. Clinical outsourcing enables tertiary health centers to meet the expectations of service timeliness and provides good opportunities to collaborate with other health care providers. However, outsourcing may result in dependence and loss of control for the tertiary health centers. Other parties involved in clinical outsourcing such as local partners, patients, and payers may also encounter potential risks as well as enjoy benefits in an outsourcing arrangement. Recommendations on selecting potential outsourcing partners are given to minimize the risks associated with an outsourcing contract.

  13. Protocols for assessing radiofrequency interactions with gold nanoparticles and biological systems for non-invasive hyperthermia cancer therapy.

    Science.gov (United States)

    Corr, Stuart J; Cisneros, Brandon T; Green, Leila; Raoof, Mustafa; Curley, Steven A

    2013-08-28

    Cancer therapies which are less toxic and invasive than their existing counterparts are highly desirable. The use of RF electric-fields that penetrate deep into the body, causing minimal toxicity, are currently being studied as a viable means of non-invasive cancer therapy. It is envisioned that the interactions of RF energy with internalized nanoparticles (NPs) can liberate heat which can then cause overheating (hyperthermia) of the cell, ultimately ending in cell necrosis. In the case of non-biological systems, we present detailed protocols relating to quantifying the heat liberated by highly-concentrated NP colloids. For biological systems, in the case of in vitro experiments, we describe the techniques and conditions which must be adhered to in order to effectively expose cancer cells to RF energy without bulk media heating artifacts significantly obscuring the data. Finally, we give a detailed methodology for in vivo mouse models with ectopic hepatic cancer tumors.

  14. The fitness for the Ageing Brain Study II (FABS II: protocol for a randomized controlled clinical trial evaluating the effect of physical activity on cognitive function in patients with Alzheimer's disease

    Directory of Open Access Journals (Sweden)

    Ames David

    2010-12-01

    Full Text Available Abstract Background Observational studies have documented a potential protective effect of physical exercise in older adults who are at risk for developing Alzheimer's disease. The Fitness for the Ageing Brain II (FABS II study is a multicentre randomized controlled clinical trial (RCT aiming to determine whether physical activity reduces the rate of cognitive decline among individuals with Alzheimer's disease. This paper describes the background, objectives of the study, and an overview of the protocol including design, organization and data collection methods. Methods/Design The study will recruit 230 community-dwelling participants diagnosed with Alzheimer's disease. Participants will be randomly allocated to two treatment groups: usual care group or 24-week home-based program consisting of 150 minutes per week of tailored moderate physical activity. The primary outcome measure of the study is cognitive decline as measured by the change from baseline in the total score on the Alzheimer's disease Assessment Scale-Cognitive section. Secondary outcomes of interest include behavioral and psychological symptoms, quality of life, functional level, carer burden and physical function (strength, balance, endurance, physical activity. Primary endpoints will be measured at six and twelve months following the baseline assessment. Discussion This RCT will contribute evidence regarding the potential benefits of a systematic program of physical activity as an affordable and safe intervention for people with Alzheimer's disease. Further, if successful, physical activity in combination with usual care has the potential to alleviate the symptoms of Alzheimer's disease and improve its management and the quality of life of patients and their carers. Trial Registration Australia New Zealand Clinical Trials Registry ACTRN12609000755235

  15. Prolonged-release melatonin versus placebo for benzodiazepine discontinuation in patients with schizophrenia: a randomized clinical trial - the SMART trial protocol

    DEFF Research Database (Denmark)

    Baandrup, Lone; Fagerlund, Birgitte; Jennum, Poul

    2011-01-01

    Treatment of schizophrenia frequently includes prolonged benzodiazepine administration despite a lack of evidence of its use. It is often difficult to discontinue benzodiazepines because of the development of dependence. We aim to assess if melatonin can facilitate the withdrawal of prolonged...... benzodiazepine administration in patients with schizophrenia. Furthermore, we aim to investigate the association of benzodiazepine dose reduction with the following clinically important variables: sleep, psychophysiology, cognition, social function, and quality of life....

  16. Protocol for assessing brain function in fish and the effectiveness of methods used to stun and kill them

    NARCIS (Netherlands)

    Kestin, S.C.; Vis, van de J.W.; Robb, D.H.F.

    2002-01-01

    A method for the evaluation of brain function in fish has been developed which is based on assessments of self-initiated behaviours, responses to stimulation, and reflexes. These assessments were validated in several freshwater and marine species and applied to evaluate the brain function of fish wh

  17. Treatment of atrial fibrillation with a dual defibrillator in heart failure patients (TRADE HF: protocol for a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Grandinetti Giuseppe

    2011-02-01

    Full Text Available Abstract Background Heart failure(HF and atrial fibrillation(AF frequently coexist in the same patient and are associated with increased mortality and frequent hospitalizations. As the concomitance of AF and HF is often associated with a poor prognosis, the prompt treatment of AF in HF patients may significantly improve outcome. Methods/design Recent implantable cardiac resynchronization (CRT devices allow electrical therapies to treat AF automatically. TRADE-HF (trial registration: NCT00345592; http://www.clinicaltrials.gov is a prospective, randomized, double arm study aimed at demonstrating the efficacy of an automatic, device-based therapy for treatment of atrial tachycardia and fibrillation(AT/AF in patients indicated for CRT. The study compares automatic electrical therapy to a traditional more usual treatment of AT/AF: the goal is to demonstrate a reduction in a combined endpoint of unplanned hospitalizations for cardiac reasons, death from cardiovascular causes or permanent AF when using automatic atrial therapy as compared to the traditional approach involving hospitalization for symptoms and in-hospital treatment of AT/AF. Discussion CRT pacemaker with the additional ability to convert AF as well as ventricular arrhythmias may play a simultaneous role in rhythm control and HF treatment. The value of the systematic implantation of CRT ICDs with the capacity to deliver atrial therapy in HF patients at risk of AF has not yet been explored. The TRADE-HF study will assess in CRT patients whether a strategy based on automatic management of atrial arrhythmias might be a valuable option to reduce the number of hospital admission and to reduce the progression the arrhythmia to a permanent form. Trial registration NCT00345592

  18. Objective Assessment of Joint Stiffness: A Clinically Oriented Hardware and Software Device with an Application to the Shoulder Joint.

    Science.gov (United States)

    McQuade, Kevin; Price, Robert; Liu, Nelson; Ciol, Marcia A

    2012-08-30

    Examination of articular joints is largely based on subjective assessment of the "end-feel" of the joint in response to manually applied forces at different joint orientations. This technical report aims to describe the development of an objective method to examine joints in general, with specific application to the shoulder, and suitable for clinical use. We adapted existing hardware and developed laptop-based software to objectively record the force/displacement behavior of the glenohumeral joint during three common manual joint examination tests with the arm in six positions. An electromagnetic tracking system recorded three-dimensional positions of sensors attached to a clinician examiner and a patient. A hand-held force transducer recorded manually applied translational forces. The force and joint displacement were time-synchronized and the joint stiffness was calculated as a quantitative representation of the joint "end-feel." A methodology and specific system checks were developed to enhance clinical testing reproducibility and precision. The device and testing protocol were tested on 31 subjects (15 with healthy shoulders, and 16 with a variety of shoulder impairments). Results describe the stiffness responses, and demonstrate the feasibility of using the device and methods in clinical settings.

  19. Assessing the Clinical Skills of Dental Students: A Review of the Literature

    Science.gov (United States)

    Taylor, Carly L.; Grey, Nick; Satterthwaite, Julian D.

    2013-01-01

    Education, from a student perspective, is largely driven by assessment. An effective assessment tool should be both valid and reliable, yet this is often not achieved. The aim of this literature review is to identify and appraise the evidence base for assessment tools used primarily in evaluating clinical skills of dental students. Methods:…

  20. Validation of the tool assessment of clinical education (AssCE): A study using Delphi method and clinical experts.

    Science.gov (United States)

    Löfmark, Anna; Mårtensson, Gunilla

    2017-03-01

    The aim of the present study was to establish the validity of the tool Assessment of Clinical Education (AssCE). The tool is widely used in Sweden and some Nordic countries for assessing nursing students' performance in clinical education. It is important that the tools in use be subjected to regular audit and critical reviews. The validation process, performed in two stages, was concluded with a high level of congruence. In the first stage, Delphi technique was used to elaborate the AssCE tool using a group of 35 clinical nurse lecturers. After three rounds, we reached consensus. In the second stage, a group of 46 clinical nurse lecturers representing 12 universities in Sweden and Norway audited the revised version of the AssCE in relation to learning outcomes from the last clinical course at their respective institutions. Validation of the revised AssCE was established with high congruence between the factors in the AssCE and examined learning outcomes. The revised AssCE tool seems to meet its objective to be a validated assessment tool for use in clinical nursing education.

  1. Neuromuscular function in patients with Subacromial Impingement Syndrome and clinical assessment of scapular kinematics

    DEFF Research Database (Denmark)

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

    2014-01-01

    patient sample with SIS, and to assess the clinimetric properties of clinical assessment methods of scapular kinematics as important aspects for optimising effect measures of treatment in order to improve clinical guidelines in this area. METHODS: Scapular muscle activity was examined, 1) during......Neuromuscular function in patients with Subacromial Impingement Syndrome and clinical assessment of scapular kinematics Larsen CM1, Juul-Kristensen B1,2 Holtermann A3, Lund H1,2, Søgaard K1 1University of Southern Denmark, Institute of Sports Science and Clinical Biomechanics, DK 2Institute...... a voluntary arm movement task and 2) selective activation tasks during sessions with and without on-line biofeedback, in a general population consisting of 16 SIS patients and 15 controls (No-SIS). Furthermore, 3) a systematic review was conducted of all available clinical scapular assessment methods...

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

    Science.gov (United States)

    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 education program.

  3. Assessment of enthesitis in patients with psoriatic arthritis using clinical examination and ultrasound

    Science.gov (United States)

    Kristensen, Salome; Christensen, Jeppe Hagstrup; Schmidt, Erik Berg; Olesen, Jens Lykkegaard; Johansen, Martin Berg; Arvesen, Kristian Bakke; Schlemmer, Annette

    2016-01-01

    Summary Background Enthesitis is a major feature of psoriatic arthritis. However, clinical assessment of enthesitis is known to lack accuracy and have poor interobserver reliability. Objective To determine effect of training on clinical assessment of enthesitis and to compare ultrasonography with clinical examination for the detection of entheseal abnormalities. Methods 20 rheumatologists performed repeated assessment of enthesitis in patients with established psoriatic arthritis before and after a 2-hour training session in standardised enthesitis count according to Leeds Enthesitis Index (LEI) and Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC). Moreover, 20 patients underwent clinical and ultrasonographic examination of entheses to evaluate consensus-based elementary lesions of enthesitis. Results Training significantly increased Intra-class Correlation Coefficient for LEI from 0.18 to 0.82 and for SPARCC from 0.38 to 0.67. Ultrasound examination showed high associations between hypoechogenicity and increased thickness of the entheses and clinical examination. There was no correlation between erosions and enthesophytes found by ultrasound and clinical assessments. Conclusion Training in standardised enthesitis scoring systems significantly improved clinical assessments of enthesitis and should be performed before use in daily clinical practice. Ultrasound revealed more advanced stages of enthesitis, such as enthesophytes and erosions, which were not detected with clinical examination. PMID:27900299

  4. Platelet function testing: methods of assessment and clinical utility.

    LENUS (Irish Health Repository)

    Mylotte, Darren

    2011-01-01

    Platelets play a central role in the regulation of both thrombosis and haemostasis yet tests of platelet function have, until recently, been exclusively used in the diagnosis and management of bleeding disorders. Recent advances have demonstrated the clinical utility of platelet function testing in patients with cardiovascular disease. The ex vivo measurement of response to antiplatelet therapies (aspirin and clopidogrel), by an ever-increasing array of platelet function tests, is with some assays, predictive of adverse clinical events and thus, represents an emerging area of interest for both the clinician and basic scientist. This review article will describe the advantages and disadvantages of the currently available methods of measuring platelet function and discuss both the limitations and emerging data supporting the role of platelet function studies in clinical practice.

  5. Platelet function testing: methods of assessment and clinical utility.

    LENUS (Irish Health Repository)

    Mylotte, Darren

    2012-02-01

    Platelets play a central role in the regulation of both thrombosis and haemostasis yet tests of platelet function have, until recently, been exclusively used in the diagnosis and management of bleeding disorders. Recent advances have demonstrated the clinical utility of platelet function testing in patients with cardiovascular disease. The ex vivo measurement of response to antiplatelet therapies (aspirin and clopidogrel), by an ever-increasing array of platelet function tests, is with some assays, predictive of adverse clinical events and thus, represents an emerging area of interest for both the clinician and basic scientist. This review article will describe the advantages and disadvantages of the currently available methods of measuring platelet function and discuss both the limitations and emerging data supporting the role of platelet function studies in clinical practice.

  6. Clinical Reasoning in School Psychology: From Assessment to Intervention

    Science.gov (United States)

    Andrews, Jac J. W.; Syeda, Maisha M.

    2017-01-01

    School psychologists typically conduct psychological and psychoeducational assessments, provide prevention and intervention services, and consult and collaborate with allied professionals (e.g., teachers, physicians, psychiatrists, physiotherapists, occupational therapists, social workers, and nurses) and parents toward better understanding and…

  7. Do pressure ulcer risk assessment scales improve clinical practice?

    OpenAIRE

    Jan Kottner; Katrin Balzer

    2010-01-01

    Jan Kottner1, Katrin Balzer21Department of Nursing Science, Charité-Universitätsmedizin Berlin, Germany; 2Nursing Research Group, Institute for Social Medicine, Universitätsklinikum Schleswig-Holstein, Lübeck, GermanyAbstract: Standardized assessment instruments are deemed important for estimating pressure ulcer risk. Today, more than 40 so-called pressure ulcer risk assessment scales are available but still there is an ongoing debate about their usefulne...

  8. Clinical and imaging assessment of cognitive dysfunction in multiple sclerosis

    DEFF Research Database (Denmark)

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

    2015-01-01

    In patients with multiple sclerosis (MS), grey matter damage is widespread and might underlie many of the clinical symptoms, especially cognitive impairment. This relation between grey matter damage and cognitive impairment has been lent support by findings from clinical and MRI studies. However...... with MS than exists at present. Imaging measures of the grey matter are necessary, but not sufficient to fully characterise cognitive decline in MS. Imaging measures of both lesioned and normal-appearing white matter lend support to the hypothesis of the existence of an underlying disconnection syndrome...

  9. Skills in clinical communication: Are we correctly assessing them at undergraduate level?

    Directory of Open Access Journals (Sweden)

    Alberto Zamora Cervantes

    2014-07-01

    Full Text Available Communicating with the patient in clinical practice refers to the way in which the doctor and the patient interact both verbally and nonverbally, in order to achieve a shared understanding of problems and solutions. Traditional learning and assessment systems are overwhelmed when it comes to addressing the complex and multi-dimensional problems of professional practice. Problem Based Learning (PBL has been put forward as an alternative to the mere reproduction of knowledge and pre-established patterns, enabling students to develop their own learning strategies to overcome problems in their future professional practice. The challenge is to determine how to assess the acquisition of clinical communication skills. The authors have recommended a summative assessment of clinical communication skills based on the combination of different methods. It highlights the importance of feedback-based formative assessment. This raises the need to develop and validate assessment scales in clinical communication at an undergraduate level. Based on this work, the authors put forward a "fanned out" assessment in terms of clinical communication skills in Medicine degrees, with the use of different instruments in a "spiraled" manner, where the greater the contact with clinical practice in the various degree and integral courses, the greater difficulty experienced, with the participation of all the stakeholders involved (self, hetero and peer assessment without precluding the involvement of patients (real or simulated in the design of assessment instruments.

  10. Instructor and Dental Student Perceptions of Clinical Communication Skills via Structured Assessments.

    Science.gov (United States)

    McKenzie, Carly T

    2016-05-01

    The aim of this study was to use structured assessments to assess dental students' clinical communication skills exhibited during patient appointments. Fourth-year dental students (n=55) at the University of Alabama at Birmingham evaluated their own interpersonal skills in a clinical setting utilizing the Four Habits Coding Scheme. An instructor also assessed student-patient clinical communication. These assessments were used to identify perceived strengths and weaknesses in students' clinical communication. Both instructor assessments and student self-assessments pinpointed the following clinical communication skills as effective the most often: patient greeting, avoidance of jargon, and non-verbal behavior. There was also relative agreement between instructor assessments and student self-assessments regarding clinical communication skills that were rated as not effective most frequently: ensuring patient comprehension, identification of patient feelings, and exploration of barriers to treatment. These resulted pointed to strengths and weaknesses in the portion of the curriculum designed to prepare students for effective provider-patient communication. These results may suggest a need for the school's current behavioral science curriculum to better address discussion of potential treatment barriers and patient feelings as well as techniques to ensure patient comprehension.

  11. Systematic protocol for assessment of the validity of BOLD MRI in a rabbit model of inflammatory arthritis at 1.5 tesla

    Energy Technology Data Exchange (ETDEWEB)

    Chan, Michael W.; Nathanael, George; Kis, Antonella; Amirabadi, Afsaneh; Zhong, Anguo; Rayner, Tammy; Weiss, Ruth; Detzler, Garry; Gahunia, Harpal [The Hospital for Sick Children, Department of Diagnostic Imaging, Toronto (Canada); Jong, Roland [Mount Sinai Hospital, Department of Pathology and Laboratory Medicine, Toronto (Canada); Moineddin, Rahim [Family and Community Medicine, Department of Public Health, Toronto (Canada); Crawley, Adrian [University of Toronto, Department of Medical Imaging, Toronto (Canada); Toronto Western Hospital, Department of Medical Imaging, Toronto (Canada); Doria, Andrea S. [The Hospital for Sick Children, Department of Diagnostic Imaging, Toronto (Canada); University of Toronto, Department of Medical Imaging, Toronto (Canada)

    2014-05-15

    Blood-oxygen-level-dependent (BOLD) MRI has the potential to identify regions of early hypoxic and vascular joint changes in inflammatory arthritis. There is no standard protocol for analysis of BOLD MRI measurements in musculoskeletal disorders. To optimize the following BOLD MRI reading parameters: (1) statistical threshold values (low, r > 0.01 versus high, r > 0.2); (2) summary measures of BOLD contrast (percentage of activated voxels [PT%] versus percentage signal difference between on-and-off signal intensities [diff{sub o}n{sub o}ff]); and (3) direction of BOLD response (positive, negative and positive + negative). Using BOLD MRI protocols at 1.5 T, arthritic (n = 21) and contralateral (n = 21) knees of 21 juvenile rabbits were imaged at baseline and on days 1, 14 and 28 after a unilateral intra-articular injection of carrageenan. Nine non-injected rabbits served as external control knees (n = 18). By comparing arthritic to contralateral knees, receiver operating characteristic curves were used to determine diagnostic accuracy. Using diff{sub o}n{sub o}ff and positive + negative responses, a threshold of r > 0.01 was more accurate than r > 0.2 (P = 0.03 at day 28). Comparison of summary measures yielded no statistically significant difference (P > 0.05). Although positive + negative (AUC = 0.86 at day 28) and negative responses (AUC = 0.90 at day 28) for PT% were the most diagnostically accurate, positive + negative responses for diff{sub o}n{sub o}ff (AUC = 0.78 at day 28) also had acceptable accuracy. The most clinically relevant reading parameters included a lower threshold of r > 0.01 and a positive + negative BOLD response. We propose that diff{sub o}n{sub o}ff is a more clinically relevant summary measure of BOLD MRI, wh