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Sample records for testing minimal clinically

  1. Responsiveness and minimal clinically important change

    DEFF Research Database (Denmark)

    Christiansen, David Høyrup; Frost, Poul; Falla, Deborah

    2015-01-01

    Study Design A prospective cohort study nested in a randomized controlled trial. Objectives To determine and compare responsiveness and minimal clinically important change of the modified Constant score (CS) and the Oxford Shoulder Score (OSS). Background The OSS and the CS are commonly used...

  2. Vestibular Neuritis With Minimal Canal Paresis: Characteristics and Clinical Implication.

    Science.gov (United States)

    Kim, Hyun Ji; Kim, Dae-Young; Hwang, Jun Ha; Kim, Kyu-Sung

    2017-06-01

    To analyze the clinical characteristics of vestibular neuritis patients with minimal canal paresis (canal paresis vestibular neuritis and treated at our institute (n=201) underwent otoneurological examination and vestibular function tests. Patients were categorized in terms of the results of caloric testing (canal paresisvestibular neuritis patients, but have faster recovery of symptoms and a higher incidence of recovery nystagmus. This finding support that the minimal canal paresis could be considered as a milder type of vestibular neuritis.

  3. Minimal supervision out-patient clinical teaching.

    Science.gov (United States)

    Figueiró-Filho, Ernesto Antonio; Amaral, Eliana; McKinley, Danette; Bezuidenhout, Juanita; Tekian, Ara

    2014-08-01

    Minimal faculty member supervision of students refers to a method of instruction in which the patient-student encounter is not directly supervised by a faculty member, and presents a feasible solution in clinical teaching. It is unclear, however, how such practices are perceived by patients and how they affect student learning. We aimed to assess patient and medical student perceptions of clinical teaching with minimal faculty member supervision. Questionnaires focusing on the perception of students' performance were administered to patients pre- and post-consultation. Students' self-perceptions on their performance were obtained using a questionnaire at the end of the consultation. Before encounters with students, 22 per cent of the 95 patients were not sure if they would feel comfortable or trust the students; after the consultation, almost all felt comfortable (97%) and relied on the students (99%). The 81 students surveyed agreed that instruction with minimal faculty member supervision encouraged their participation and engagement (86%). They expressed interest in knowing patients' opinions about their performance (94%), and they felt comfortable about being assessed by the patients (86%). The minimal faculty member supervision model was well accepted by patients. Responses from the final-year students support the use of assessments that incorporate feedback from patients in their overall clinical evaluations. © 2014 John Wiley & Sons Ltd.

  4. Locating Minimal Fault Interaction in Combinatorial Testing

    Directory of Open Access Journals (Sweden)

    Wei Zheng

    2016-01-01

    Full Text Available Combinatorial testing (CT technique could significantly reduce testing cost and increase software system quality. By using the test suite generated by CT as input to conduct black-box testing towards a system, we are able to detect interactions that trigger the system’s faults. Given a test case, there may be only part of all its parameters relevant to the defects in system and the interaction constructed by those partial parameters is key factor of triggering fault. If we can locate those parameters accurately, this will facilitate the software diagnosing and testing process. This paper proposes a novel algorithm named complete Fault Interaction Location (comFIL to locate those interactions that cause system’s failures and meanwhile obtains the minimal set of target interactions in test suite produced by CT. By applying this method, testers can analyze and locate the factors relevant to defects of system more precisely, thus making the process of software testing and debugging easier and more efficient. The results of our empirical study indicate that comFIL performs better compared with known fault location techniques in combinatorial testing because of its improved effectiveness and precision.

  5. Assessment of Minimal HE (with emphasis on computerized psychometric tests)

    OpenAIRE

    Kappus, Matthew R; Bajaj, Jasmohan S

    2012-01-01

    Minimal hepatic encephalopathy (MHE) is associated with a high risk of development of overt hepatic encephalopathy, impaired quality of life and driving accidents. The detection of MHE requires specialized testing since it cannot by definition, be diagnosed on standard clinical examination. Psychometric (paper-pencil or computerized or a combination) and neuro-physiological techniques are often used to test for MHE. Paper-pencil psychometric batteries like the Psychometric Hepatic Encephalopa...

  6. Assessment of Minimal HE (with emphasis on computerized psychometric tests)

    Science.gov (United States)

    Kappus, Matthew R; Bajaj, Jasmohan S

    2012-01-01

    Synopsis Minimal hepatic encephalopathy (MHE) is associated with a high risk of development of overt hepatic encephalopathy, impaired quality of life and driving accidents. The detection of MHE requires specialized testing since it cannot by definition, be diagnosed on standard clinical examination. Psychometric (paper-pencil or computerized or a combination) and neuro-physiological techniques are often used to test for MHE. Paper-pencil psychometric batteries like the Psychometric Hepatic Encephalopathy Score (PHES) have been validated in several countries but do not have US normative values. Computerized tests such as the inhibitory control test (ICT), cognitive drug research system and Scan test have proven useful to diagnose MHE and predict outcomes. The specificity and sensitivity of these tests are similar to the recommended gold standards. Neuro-physiological tests such as the EEG and its interpretations, evoked potentials and Critical Flicker Frequency (CFF) also provide useful information. The diagnosis of MHE is an important issue for clinicians and patients alike and the testing strategies depend on the normative data available, patient comfort and local expertise. PMID:22321464

  7. 7 CFR 983.53 - Testing of minimal quantities.

    Science.gov (United States)

    2010-01-01

    ... Agreements and Orders; Fruits, Vegetables, Nuts), DEPARTMENT OF AGRICULTURE PISTACHIOS GROWN IN CALIFORNIA, ARIZONA, AND NEW MEXICO Regulations § 983.53 Testing of minimal quantities. (a) Aflatoxin. Handlers who... following methods for testing for aflatoxin: (1) The handler may have an inspector sample and test his or...

  8. Minimalism

    CERN Document Server

    Obendorf, Hartmut

    2009-01-01

    The notion of Minimalism is proposed as a theoretical tool supporting a more differentiated understanding of reduction and thus forms a standpoint that allows definition of aspects of simplicity. This book traces the development of minimalism, defines the four types of minimalism in interaction design, and looks at how to apply it.

  9. Minimization of mixed waste in explosive testing operations

    International Nuclear Information System (INIS)

    Gonzalez, M.A.; Sator, F.E.; Simmons, L.F.

    1993-02-01

    In the 1970s and 1980s, efforts to manage mixed waste and reduce pollution focused largely on post-process measures. In the late 1980s, the approach to waste management and pollution control changed, focusing on minimization and prevention rather than abatement, treatment, and disposal. The new approach, and the formulated guidance from the US Department of Energy, was to take all necessary measures to minimize waste and prevent the release of pollutants to the environment. Two measures emphasized in particular were source reduction (reducing the volume and toxicity of the waste source) and recycling. In 1988, a waste minimization and pollution prevention program was initiated at Site 300, where the Lawrence Livermore National Laboratory (LLNL) conducts explosives testing. LLNL's Defense Systems/Nuclear Design (DS/ND) Program has adopted a variety of conservation techniques to minimize waste generation and cut disposal costs associated with ongoing operations. The techniques include minimizing the generation of depleted uranium and lead mixed waste through inventory control and material substitution measures and through developing a management system to recycle surplus explosives. The changes implemented have reduced annual mixed waste volumes by more than 95% and reduced overall radioactive waste generation (low-level and mixed) by more than 75%. The measures employed were cost-effective and easily implemented

  10. [Clinical importance and diagnostic methods of minimal hepatic encephalopathy].

    Science.gov (United States)

    Stawicka, Agnieszka; Zbrzeźniak, Justyna; Świderska, Aleksandra; Kilisińska, Natalia; Świderska, Magdalena; Jaroszewicz, Jerzy; Flisiak, Robert

    2016-02-01

    Minimal hepatic encephalopathy (MHE) encompasses a number of neuropsychological and neurophysiological disorders in patients suffering from liver cirrhosis, who do not display abnormalities during a medical interview or physical examination. A negative influence of MHE on the quality of life of patients suffering from liver cirrhosis was confirmed, which include retardation of ability of operating motor vehicles and disruption of multiple health-related areas, as well as functioning in the society. The data on frequency of traffic offences and accidents amongst patients diagnosed with MHE in comparison to patients diagnosed with liver cirrhosis without MHE, as well as healthy persons is alarming. Those patients are unaware of their disorder and retardation of their ability to operate vehicles, therefore it is of utmost importance to define this group. The term minimal hepatic encephalopathy (formerly "subclinical" encephalopathy) erroneously suggested the unnecessity of diagnostic and therapeutic procedures in patients with liver cirrhosis. Diagnosing MHE is an important predictive factor for occurrence of overt encephalopathy - more than 50% of patients with this diagnosis develop overt encephalopathy during a period of 30 months after. Early diagnosing MHE gives a chance to implement proper treatment which can be a prevention of overt encephalopathy. Due to continuing lack of clinical research there exist no commonly agreed-upon standards for definition, diagnostics, classification and treatment of hepatic encephalopathy. This article introduces the newest findings regarding the importance of MHE, scientific recommendations and provides detailed descriptions of the most valuable diagnostic methods. © 2016 MEDPRESS.

  11. Minimal residual disease in breast cancer. Clinical significance

    International Nuclear Information System (INIS)

    Kvalheim, G.

    2004-01-01

    Previously we have reported our results on minimal residual disease in breast cancer. Briefly, B M-aspirates were collected from 817 patients at primary surgery. Tumor cells in B M were detected by immunocytochemistry using anticytokeratin-antibodies (A E1/ A E3). Analyses of the primary tumor included histological grading, vascular invasion and immunohistochemical detection of cerbB2, cathepsin D, p53 and ER/PgRexpression. These analyses were compared to clinical outcome. Median follow-up was 49 months. ITC were detected in 13.2% of the patients. The detection rate rose with increasing tumor size (p=0.011) and lymph node involvement (p<0.001). Systemic relapse and death from breast cancer occurred in 31.7% and 26.9% of the B M-positive versus 13.7% and 10.9% of B M-negative patients, respectively (p<0.001). Analyzing node-positive and node-negative patients separately, ITC-positivity was associated with poor prognosis in the node-positive group and in node-negative patients not receiving adjuvant therapy (T1N0). In multivariate analysis, ITC in B M was an independent prognostic factor together with N-, T-, ER/Pg R-status, histological grade and vascular invasion. Combination of several independent prognostic factors can classify subgroups of patients into excellent and high-risk prognosis groups. Like other groups we have investigated the clinical role of monitoring minimal residual disease before and after adjuvant therapy in breast cancer. One hundred and eighteen high risk stage II breast cancer patients entering the Scandinavian Study Group multicenter trial were randomized to 9 cycles of dose escalated and tailored FEC (5-flurouracil, epirubicin, cyclophosphamide) or standard FEC followed by high dose chemotherapy. B M samples at diagnosis and 6 months after completion of chemotherapy were assessed for the presence of I CT. Median observation time for patients was 68 months. ITC positivity in bone marrow was evaluated as a prognostic and predictive marker and

  12. Assessment of minimal hepatic encephalopathy (with emphasis on computerized psychometric tests).

    Science.gov (United States)

    Kappus, Matthew R; Bajaj, Jasmohan S

    2012-02-01

    Minimal hepatic encephalopathy (MHE) is associated with a high risk of development of overt hepatic encephalopathy, impaired quality of life, and driving accidents. The detection of MHE requires specialized testing because it cannot, by definition, be diagnosed on standard clinical examination. Psychometric and neurophysiologic techniques are often used to test for MHE. Paper-pencil psychometric batteries and computerized tests have proved useful in diagnosing MHE and predicting its outcomes. Neurophysiologic tests also provide useful information. The diagnosis of MHE is an important issue for clinicians and patients alike. Testing strategies depend on the normative data available, patient comfort, and local expertise. Copyright © 2012 Elsevier Inc. All rights reserved.

  13. Minimal hepatic encephalopathy characterized by parallel use of the continuous reaction time and portosystemic encephalopathy tests

    DEFF Research Database (Denmark)

    Lauridsen, M M; Schaffalitzky de Muckadell, O B; Vilstrup, H

    2015-01-01

    based vs. paper and pencil). To compare results of the Continuous Reaction time (CRT) and the Portosystemic Encephalopathy (PSE) tests in a large unselected cohort of cirrhosis patients without clinically detectable brain impairment and to clinically characterize the patients according to their test...... results. The CRT method is a 10-minute computerized test of a patient's motor reaction time stability (CRTindex) to 150 auditory stimuli. The PSE test is a 20-minute paper-pencil test evaluating psychomotor speed. Both tests were performed at the same occasion in 129 patients. Both tests were normal......Minimal hepatic encephalopathy (MHE) is a frequent complication to liver cirrhosis that causes poor quality of life, a great burden to caregivers, and can be treated. For diagnosis and grading the international guidelines recommend the use of psychometric tests of different modalities (computer...

  14. OxMaR: open source free software for online minimization and randomization for clinical trials.

    Science.gov (United States)

    O'Callaghan, Christopher A

    2014-01-01

    Minimization is a valuable method for allocating participants between the control and experimental arms of clinical studies. The use of minimization reduces differences that might arise by chance between the study arms in the distribution of patient characteristics such as gender, ethnicity and age. However, unlike randomization, minimization requires real time assessment of each new participant with respect to the preceding distribution of relevant participant characteristics within the different arms of the study. For multi-site studies, this necessitates centralized computational analysis that is shared between all study locations. Unfortunately, there is no suitable freely available open source or free software that can be used for this purpose. OxMaR was developed to enable researchers in any location to use minimization for patient allocation and to access the minimization algorithm using any device that can connect to the internet such as a desktop computer, tablet or mobile phone. The software is complete in itself and requires no special packages or libraries to be installed. It is simple to set up and run over the internet using online facilities which are very low cost or even free to the user. Importantly, it provides real time information on allocation to the study lead or administrator and generates real time distributed backups with each allocation. OxMaR can readily be modified and customised and can also be used for standard randomization. It has been extensively tested and has been used successfully in a low budget multi-centre study. Hitherto, the logistical difficulties involved in minimization have precluded its use in many small studies and this software should allow more widespread use of minimization which should lead to studies with better matched control and experimental arms. OxMaR should be particularly valuable in low resource settings.

  15. Stable-label intravenous glucose tolerance test minimal model

    International Nuclear Information System (INIS)

    Avogaro, A.; Bristow, J.D.; Bier, D.M.; Cobelli, C.; Toffolo, G.

    1989-01-01

    The minimal model approach to estimating insulin sensitivity (Sl) and glucose effectiveness in promoting its own disposition at basal insulin (SG) is a powerful tool that has been underutilized given its potential applications. In part, this has been due to its inability to separate insulin and glucose effects on peripheral uptake from their effects on hepatic glucose inflow. Prior enhancements, with radiotracer labeling of the dosage, permit this separation but are unsuitable for use in pregnancy and childhood. In this study, we labeled the intravenous glucose tolerance test (IVGTT) dosage with [6,6- 2 H 2 ]glucose, [2- 2 H]glucose, or both stable isotopically labeled glucose tracers and modeled glucose kinetics in six postabsorptive, nonobese adults. As previously found with the radiotracer model, the tracer-estimated S*l derived from the stable-label IVGTT was greater than Sl in each case except one, and the tracer-estimated SG* was less than SG in each instance. More importantly, however, the stable-label IVGTT estimated each parameter with an average precision of +/- 5% (range 3-9%) compared to average precisions of +/- 74% (range 7-309%) for SG and +/- 22% (range 3-72%) for Sl. In addition, because of the different metabolic fates of the two deuterated tracers, there were minor differences in basal insulin-derived measures of glucose effectiveness, but these differences were negligible for parameters describing insulin-stimulated processes. In conclusion, the stable-label IVGTT is a simple, highly precise means of assessing insulin sensitivity and glucose effectiveness at basal insulin that can be used to measure these parameters in individuals of all ages, including children and pregnant women

  16. Clinical application of minimizing picture archiving and communication system

    International Nuclear Information System (INIS)

    Chen Lixin; Zhao Weijiang; Jin Qiongying; Gu Wenxiang; Yuan Quan

    2003-01-01

    Objective: To investigate the use of the minimizing picture archiving and communication system (mini-PACS) in practical work and to realize the advent of filmless radiology. Methods: A PC-based ethernet was set up. The medical imaging equipments including CT, MR, digital fluoroscopy, DSA, and a laser camera were combined with the ethernet, and the digital imaging network (DIN) was integrated with the medical diagnostic imaging system (MDIS). In this way, the radiology information system (RIS) was established. Through one of the PC workstations with a double network card, this RIS was connected to the hospital information system (HIS). Results: The mini-PACS has been repeatedly used for more than 2 years. The system in Radiology department has been established and improved. With the present digital imaging system, such functions as the acquiring, storing, transmitting, printing, and browsing of digital images have been put into practice, all in accordance with the manners of the digital imaging communication in medicine 3.0 (DICOM 3.0). Digital imaging and diagnostic reports were managed through Microsoft Access database. Images may be kept on line in different kinds of equipment for 3-6 months. All images have been recorded on CD-R disks, so as to be kept off line permanently. So far, over 32700 reports have been stored in the database. From mini-PACS HIS terminals images and diagnostic information may be acquired on a limited scale. Conclusion: mini-PACS needs only a low cost of investment and operation. Its maintenance is simple and its performance is efficient. The main functions of the PACS can mostly be achieved. There lies a bright prospect for its use in small and medium hospitals

  17. Responsiveness and Minimal Clinically Important Change of the Pain Disability Index in Patients With Chronic Back Pain

    NARCIS (Netherlands)

    Soer, Remko; Reneman, Michiel F.; Vroomen, Patrick C. A. J.; Stegeman, Patrick; Coppes, Maarten H.

    2012-01-01

    Study Design. Prospective cohort study. Objective. The objective of this study was to test the responsiveness and minimal clinically important change (MCIC) of the Pain Disability Index (PDI) in patients with chronic back pain (CBP). Summary of Background Data. Treatment of patients with CBP is

  18. Implications of the concept of minimal risk in research on informed choice in clinical practice.

    Science.gov (United States)

    Wada, Kyoko; Nisker, Jeff

    2015-10-01

    The concept of a minimal risk threshold in research, beneath which exception to informed consent and ethics review processes may occur, has been codified for over 30 years in many national research regulations and by the Council for International Organizations of Medical Sciences. Although minimal risk in research constitutes one of the criteria for allowing waiver of informed consent or modification to the consent process and a large body of literature exists, discussion of a minimal risk threshold in clinical practice has not occurred. One reason for lack of discussion may be that implicit consent is accepted for a wide range of routine clinical practices. Extending the role of minimal risk in research to clinical practice might assist clinicians in identifying circumstances for which implicit consent is indeed sufficient and circumstances in which it is not. Further, concepts from minimal risk in research might assist clinicians regarding when information provision in health promotion is required. We begin by reviewing concepts in both minimal risk in research and informed choice in clinical practice. We then explore how a clinical minimal risk concept may clarify recommendations for information provision in clinical practice and support the patient's informed choice regarding therapeutic and diagnostic procedures and also health promotion. Given that clinical practice involves a broad scope of health information, professional practice guidelines on information provision based on the application of the minimal risk threshold in research could be developed to guide clinicians in what information must be provided to their patients. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  19. Minimal Clinically Important Difference for Safe and Simple Novel Acute Ischemic Stroke Therapies.

    Science.gov (United States)

    Cranston, Jessica S; Kaplan, Brett D; Saver, Jeffrey L

    2017-11-01

    Determining the minimal clinically important difference (MCID) is essential for evaluating novel therapies. For acute ischemic stroke, expert surveys have yielded MCIDs that are substantially higher than the MCIDs observed in actual expert behavior in guideline writing and clinical practice, potentially because of anchoring bias. We administered a structured, internet-based survey to a cross-section of academic stroke neurologists in the United States. Survey responses assessed demographic and clinical experience, and expert judgment of the MCID of the absolute increase needed in the proportion of patients achieving functional independence at 3 months to consider a novel, safe neuroprotective agent as clinically worthwhile. To mitigate anchoring bias, the survey response framework used a base 1000 rather than base 100 patient framework. Survey responses were received from 122 of 333 academic stroke neurologists, there were 23% women, 72.8% had ≥6 years of practice experience, and neurovascular disease accounted for more than half of practice time in >70%. Responder-nonresponder and continuum of resistance tests indicated that responders were representative of the full expert population. Among respondents, the median MCID was 1.3% (interquartile range, 0.8% to >2%). Stroke expert responses to MCID surveys are affected by anchoring and centrality bias. When survey design takes these into account, the expert-derived MCID for a safe acute ischemic stroke treatment is 1.1% to 1.5%, in accord with actual physician behavior in guideline writing and clinical practice. This revised MCID value can guide clinical trial design and grant-funding and regulatory agency decisions. © 2017 American Heart Association, Inc.

  20. Clinical and radiological outcome of minimally invasive posterior lumbar interbody fusion in primary versus revision surgery

    NARCIS (Netherlands)

    Hentenaar, B.; Spoor, A. B.; Malefijt, J. de Waal; Diekerhof, C. H.; den Oudsten, B. L.

    2016-01-01

    Purpose The aim of this study is to compare the clinical and radiological outcome of minimally invasive posterior lumbar interbody fusion (MI-PLIF) in revision and primary cases. Methods In a retrospective study, we compared the clinical and radiological results of MI-PLIF for lytic

  1. Minimal clinically important difference on the Motor Examination part of MDS-UPDRS.

    Science.gov (United States)

    Horváth, Krisztina; Aschermann, Zsuzsanna; Ács, Péter; Deli, Gabriella; Janszky, József; Komoly, Sámuel; Balázs, Éva; Takács, Katalin; Karádi, Kázmér; Kovács, Norbert

    2015-12-01

    Recent studies increasingly utilize the Movement Disorders Society Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS). However, the minimal clinically important difference (MCID) has not been fully established for MDS-UPDRS yet. To assess the MCID thresholds for MDS-UPDRS Motor Examination (Part III). 728 paired investigations of 260 patients were included. At each visit both MDS-UPDRS and Clinician-reported Global Impression-Improvement (CGI-I) scales were assessed. MDS-UPDRS Motor Examination (ME) score changes associated with CGI-I score 4 (no change) were compared with MDS-UPDRS ME score changes associated with CGI-I score 3 (minimal improvement) and CGI-I score 5 (minimal worsening). Both anchor- and distribution-based techniques were utilized to determine the magnitude of MCID. The MCID estimates for MDS-UPDRS ME were asymmetric: -3.25 points for detecting minimal, but clinically pertinent, improvement and 4.63 points for observing minimal, but clinically pertinent, worsening. MCID is the smallest change of scores that are clinically meaningful to patients. These MCID estimates may allow the judgement of a numeric change in MDS-UPDRS ME on its clinical importance. Copyright © 2015 Elsevier Ltd. All rights reserved.

  2. Strategy to Minimize Energetics Contamination at Military Testing/Training Ranges

    National Research Council Canada - National Science Library

    Lamontagne, Colette; Mahannah, Janet; Jasinkiewicz, Kristin; Hogrelius, Kimberly

    2005-01-01

    The ARDEC is sponsoring the GAT Program. One important goal under the GAT program umbrella is to minimize the impacts of energetics contamination on military ranges resulting from testing and training activities...

  3. Minimal important difference in field walking tests in non-cystic fibrosis bronchiectasis following exercise training.

    Science.gov (United States)

    Lee, A L; Hill, C J; Cecins, N; Jenkins, S; McDonald, C F; Burge, A T; Rautela, L; Stirling, R G; Thompson, P J; Holland, A E

    2014-09-01

    The 6-min walk distance (6MWD) and incremental shuttle walk distance (ISWD) are clinically meaningful measures of exercise capacity in people with non-cystic fibrosis (CF) bronchiectasis, but the change in walking distance which constitutes clinical benefit is undefined. This study aimed to determine the minimal important difference for the 6MWD and ISWD in non-CF bronchiectasis. Thirty-seven participants with mean FEV1 70% predicted completed both field walking tests before and after an 8-week exercise program. The minimal important difference was calculated using a distribution-based and anchor-based method, with the global rating of change scale used. The mean change in 6MWD in participants who reported themselves to be unchanged was 10 m, compared to 36 m (small change) and 45 m (substantial change) (p = 0.01). For the ISWD, the mean change in participants who reported themselves to be unchanged was 33 m, compared to 54 m (small change) and 73 m (substantial change) (p = 0.04). The anchor-based method defined the minimal important difference for 6MWD as 24.5 m (AUC 0.76, 95% CI 0.61-0.91) and for ISWD as 35 m (AUC 0.88, 95% CI 0.73-0.99), based on participant's global rating of change. The distribution-based method indicated a value of 22.3 m for the 6MWD and 37 m for the ISWD. There was excellent agreement between the two methods for the 6MWD (kappa = 0.91) and the ISWD (kappa = 0.92). Small changes in 6MWD and ISWD may represent clinically important benefits in people with non-CF bronchiectasis. These data are likely to assist in the interpretation of change in exercise capacity following intervention. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. The continuous reaction time test for minimal hepatic encephalopathy validated by a randomized controlled multi-modal intervention

    DEFF Research Database (Denmark)

    Lauridsen, M. M.; Mikkelsen, S.; Svensson, T.

    2017-01-01

    Background: Minimal hepatic encephalopathy (MHE) is clinically undetectable and the diagnosis requires psychometric tests. However, a lack of clarity exists as to whether the tests are in fact able to detect changes in cognition. Aim: To examine if the continuous reaction time test (CRT) can detect...... in a double-blinded fashion. The CRT is a simple PC-based test and the test result, the CRT index (normal threshold > 1.9), describes the patient’s stability of alertness during the 10–minute test. Our study outcome was the change in CRT index in each group at study exit. The portosystemic encephalopathy (PSE......) test, a paper-and-pencil test battery (normal threshold above -5), was used as a comparator test according to international guidelines. Results: The patients with an abnormal CRT index who were randomized to receive the active intervention normalized or improved their CRT index (mean change 0.92 ± 0...

  5. Developing a provisional, international minimal dataset for Juvenile Dermatomyositis: for use in clinical practice to inform research.

    Science.gov (United States)

    McCann, Liza J; Arnold, Katie; Pilkington, Clarissa A; Huber, Adam M; Ravelli, Angelo; Beard, Laura; Beresford, Michael W; Wedderburn, Lucy R

    2014-01-01

    Juvenile dermatomyositis (JDM) is a rare but severe autoimmune inflammatory myositis of childhood. International collaboration is essential in order to undertake clinical trials, understand the disease and improve long-term outcome. The aim of this study was to propose from existing collaborative initiatives a preliminary minimal dataset for JDM. This will form the basis of the future development of an international consensus-approved minimum core dataset to be used both in clinical care and inform research, allowing integration of data between centres. A working group of internationally-representative JDM experts was formed to develop a provisional minimal dataset. Clinical and laboratory variables contained within current national and international collaborative databases of patients with idiopathic inflammatory myopathies were scrutinised. Judgements were informed by published literature and a more detailed analysis of the Juvenile Dermatomyositis Cohort Biomarker Study and Repository, UK and Ireland. A provisional minimal JDM dataset has been produced, with an associated glossary of definitions. The provisional minimal dataset will request information at time of patient diagnosis and during on-going prospective follow up. At time of patient diagnosis, information will be requested on patient demographics, diagnostic criteria and treatments given prior to diagnosis. During on-going prospective follow-up, variables will include the presence of active muscle or skin disease, major organ involvement or constitutional symptoms, investigations, treatment, physician global assessments and patient reported outcome measures. An internationally agreed minimal dataset has the potential to significantly enhance collaboration, allow effective communication between groups, provide a minimal standard of care and enable analysis of the largest possible number of JDM patients to provide a greater understanding of this disease. This preliminary dataset can now be developed into

  6. Test-Retest Reliability and Minimal Detectable Change of the D2 Test of Attention in Patients with Schizophrenia.

    Science.gov (United States)

    Lee, Posen; Lu, Wen-Shian; Liu, Chin-Hsuan; Lin, Hung-Yu; Hsieh, Ching-Lin

    2017-12-08

    The d2 Test of Attention (D2) is a commonly used measure of selective attention for patients with schizophrenia. However, its test-retest reliability and minimal detectable change (MDC) are unknown in patients with schizophrenia, limiting its utility in both clinical and research settings. The aim of the present study was to examine the test-retest reliability and MDC of the D2 in patients with schizophrenia. A rater administered the D2 on 108 patients with schizophrenia twice at a 1-month interval. Test-retest reliability was determined through the calculation of the intra-class correlation coefficient (ICC). We also carried out Bland-Altman analysis, which included a scatter plot of the differences between test and retest against their mean. Systematic biases were evaluated by use of a paired t-test. The ICCs for the D2 ranged from 0.78 to 0.94. The MDCs (MDC%) of the seven subscores were 102.3 (29.7), 19.4 (85.0), 7.2 (94.6), 21.0 (69.0), 104.0 (33.1), 105.0 (35.8), and 7.8 (47.8), which represented limited-to-acceptable random measurement error. Trends in the Bland-Altman plots of the omissions (E1), commissions (E2), and errors (E) were noted, presenting that the data had heteroscedasticity. According to the results, the D2 had good test-retest reliability, especially in the scores of TN, TN-E, and CP. For the further research, finding a way to improve the administration procedure to reduce random measurement error would be important for the E1, E2, E, and FR subscores.

  7. Clinical laboratory test reference (CLTR).

    Science.gov (United States)

    Grams, R R

    1993-04-01

    As the healthcare system undergoes a transformation in scope and funding, there remain many unfinished projects which will be essential for the next generation of automated medical support services. The most demanding and labor intensive tasks for this new frontier deal with the accumulation of knowledge which can be used as a clinical database to support supervisory functions in a physician operated interactive care delivery environment. These databases will contain the worlds accumulated knowledge in specialized areas. They will be organized by topic or clinical service, and have significant impact on the quality of care as well as medical malpractice exposure. This article will describe a clinical pathology database that has been adapted for medical practice. The database contains information about laboratory tests and their interpretation. The data is structured for rapid reading and has references where indicated. The database can be used in a stand alone program or integrated into an information system within an application program. The files are reviewed on a continuing basis and quarterly updates are made available to subscribers.

  8. Establishing the minimal clinically important difference of the Barthel Index in stroke patients.

    Science.gov (United States)

    Hsieh, Yu-Wei; Wang, Chun-Hou; Wu, Shwu-Chong; Chen, Pau-Chung; Sheu, Ching-Fan; Hsieh, Ching-Lin

    2007-01-01

    The interpretation of the change scores of the Barthel Index (BI) in follow-up or outcome studies has been hampered by the fact that its minimal clinically important difference (MCID) has not been determined. This article was written to establish the MCID of the BI in stroke patients. Both anchor-based and distribution-based methods were used to establish the MCID. In the anchor-based method, 43 stroke inpatients participated in a follow-up study designed to determine the MCID of the BI using patients' global ratings of the activities of daily living function on a 15-point Likert-type scale. The mean change scores on the 20-point scale of the BI of the MCID group, based on the patients' ratings on the Likert-type scale, served as the first estimate of the MCID. In the distribution-based method, 56 chronic stroke patients participated in the test-retest reliability study to determine the MCID of the BI. One standard error of measurement (SEM) served as the second estimate for the MCID. The larger MCID value of the 2 estimates was chosen as the MCID of the BI. In the anchor-based study, there were 20 patients in the MCID group, with a mean change score of 1.85 points (ie, the first MCID estimate). In the distribution-based study, the SEM based on test-retest agreement was 1.45 points (ie, the second MCID estimate). The MCID of the BI in stroke patients was estimated to be 1.85 points. The authors' results, within the limitations of their design, suggest that if the mean BI change score within a stroke group has reached 1.85 points in a study, the change score on the BI can be perceived by patients as important and beyond measurement error (ie, such a change score is clinically important).

  9. Minimally invasive (13)C-breath test to examine phenylalanine metabolism in children with phenylketonuria.

    Science.gov (United States)

    Turki, Abrar; Murthy, Gayathri; Ueda, Keiko; Cheng, Barbara; Giezen, Alette; Stockler-Ipsiroglu, Sylvia; Elango, Rajavel

    2015-01-01

    Phenylketonuria (PKU) is an autosomal recessive disorder caused by deficiency of hepatic phenylalanine hydroxylase (PAH) leading to increased levels of phenylalanine in the plasma. Phenylalanine levels and phenylalanine hydroxylase (PAH) activity monitoring are currently limited to conventional blood dot testing. 1-(13)C-phenylalanine, a stable isotope can be used to examine phenylalanine metabolism, as the conversion of phenylalanine to tyrosine occurs in vivo via PAH and subsequently releases the carboxyl labeled (13)C as (13)CO2 in breath. Our objective was to examine phenylalanine metabolism in children with PKU using a minimally-invasive 1-(13)C-phenylalanine breath test ((13)C-PBT). Nine children (7 M: 2 F, mean age 12.5 ± 2.87 y) with PKU participated in the study twice: once before and once after sapropterin supplementation. Children were provided 6 mg/kg oral dose of 1-(13)C-phenylalanine and breath samples were collected at 20 min intervals for a period of 2h. Rate of CO2 production was measured at 60 min post-oral dose using indirect calorimetry. The percentage of 1-(13)C-phenylalanine exhaled as (13)CO2 was measured over a 2h period. Prior to studying children with PKU, we tested the study protocol in healthy children (n = 6; 4M: 2F, mean age 10.2 ± 2.48 y) as proof of principle. Production of a peak enrichment (Cmax) of (13)CO2 (% of dose) in all healthy children occurred at 20 min ranging from 17-29% of dose, with a subsequent return to ~5% by the end of 2h. Production of (13)CO2 from 1-(13)C-phenylalanine in all children with PKU prior to sapropterin treatment remained low. Following sapropterin supplementation for a week, production of (13)CO2 significantly increased in five children with a subsequent decline in blood phenylalanine levels, suggesting improved PAH activity. Sapropterin treatment was not effective in three children whose (13)CO2 production remained unchanged, and did not show a reduction in blood phenylalanine levels and improvement

  10. Randomization in clinical trials: stratification or minimization? The HERMES free simulation software.

    Science.gov (United States)

    Fron Chabouis, Hélène; Chabouis, Francis; Gillaizeau, Florence; Durieux, Pierre; Chatellier, Gilles; Ruse, N Dorin; Attal, Jean-Pierre

    2014-01-01

    Operative clinical trials are often small and open-label. Randomization is therefore very important. Stratification and minimization are two randomization options in such trials. The first aim of this study was to compare stratification and minimization in terms of predictability and balance in order to help investigators choose the most appropriate allocation method. Our second aim was to evaluate the influence of various parameters on the performance of these techniques. The created software generated patients according to chosen trial parameters (e.g., number of important prognostic factors, number of operators or centers, etc.) and computed predictability and balance indicators for several stratification and minimization methods over a given number of simulations. Block size and proportion of random allocations could be chosen. A reference trial was chosen (50 patients, 1 prognostic factor, and 2 operators) and eight other trials derived from this reference trial were modeled. Predictability and balance indicators were calculated from 10,000 simulations per trial. Minimization performed better with complex trials (e.g., smaller sample size, increasing number of prognostic factors, and operators); stratification imbalance increased when the number of strata increased. An inverse correlation between imbalance and predictability was observed. A compromise between predictability and imbalance still has to be found by the investigator but our software (HERMES) gives concrete reasons for choosing between stratification and minimization; it can be downloaded free of charge. This software will help investigators choose the appropriate randomization method in future two-arm trials.

  11. Considerations in the evaluation and determination of minimal risk in pragmatic clinical trials.

    Science.gov (United States)

    Lantos, John D; Wendler, David; Septimus, Edward; Wahba, Sarita; Madigan, Rosemary; Bliss, Geraldine

    2015-10-01

    Institutional review boards, which are charged with overseeing research, must classify the riskiness of proposed research according to a federal regulation known as the Common Rule (45 CFR 46, Subpart A) and by regulations governing the US Food and Drug Administration codified in 21 CFR 50. If an institutional review board determines that a clinical trial constitutes "minimal risk," there are important practical implications: the institutional review board may then allow a waiver or alteration of the informed consent process; the study may be carried out in certain vulnerable populations; or the study may be reviewed by institutional review boards using an expedited process. However, it is unclear how institutional review boards should assess the risk levels of pragmatic clinical trials. Such trials typically compare existing, widely used medical therapies or interventions in the setting of routine clinical practice. Some of the therapies may be considered risky of themselves but the study comparing them may or may not add to that pre-existing level of risk. In this article, we examine the common interpretations of research regulations regarding minimal-risk classifications and suggest that they are marked by a high degree of variability and confusion, which in turn may ultimately harm patients by delaying or hindering potentially beneficial research. We advocate for a clear differentiation between the risks associated with a given therapy and the incremental risk incurred during research evaluating those therapies as a basic principle for evaluating the risk of a pragmatic clinical trial. We then examine two pragmatic clinical trials and consider how various factors including clinical equipoise, practice variation, research methods such as cluster randomization, and patients' perspectives may contribute to current and evolving concepts of minimal-risk determinations, and how this understanding in turn affects the design and conduct of pragmatic clinical trials.

  12. Stroop Test Validation to Screen for Minimal Hepatic Encephalopathy in Pediatric Extrahepatic Portal Venous Obstruction.

    Science.gov (United States)

    Suresh, Meera Vyshni; Jagadisan, Barath; Kandasamy, Preeti; Senthilkumar, Gandhipuram Periyasamy

    2018-01-25

    Minimal Hepatic encephalopathy (MHE) has been reported in children with extra hepatic portal vein obstruction (EHPVO). MHE assessment is restricted to research situations as neuropsychiatric tests are time-intensive. Computerised Stroop Test (CST) has been used in cirrhotic adults for MHE screening. The study aims to assess MHE frequency in young Indian children with EHPVO and validate CST for MHE screening in pediatric EHPVO METHODS:: 37 children with EHPVO between 7-12 years of age and 37 age and gender matched controls were enrolled. Fasting plasma ammonia was measured. MHE was diagnosed by Revised Amsterdamse Kinder Intelligentie Test (RAKIT). The performance of a Tamil language version of CST in MHE screening was assessed. MHE was diagnosed in 18.9% (7/37) of EHPVO (EHPVO-MHE). Plasma ammonia levels were higher in EHPVO-MHE compared to EHPVO without MHE (EHPVO-No-MHE) but abnormal plasma ammonia levels are unsuitable for MHE screening. CST was administered in 35 EHPVO and 37 controls. EHPVO-MHE, compared to EHPVO-No-MHE, had longer "on time", "off time", "(on+off) time" and "(on-off) time". For MHE diagnosis, specificity and sensitivity of '(on+off) time' were 100% and 89.6% for a cut-off of >180.4 s (AUROC=0.97). In the absence of other risk factors for neurological insult or patent surgical shunts, MHE frequency in young Indian children with EHPVO, determined by RAKIT, was lesser than in earlier studies. CST is suitable for MHE screening in clinical practice to select patients for neuropsychiatric evaluation.

  13. Screening test recommendations for methicillin-resistant Staphylococcus aureus surveillance practices: A cost-minimization analysis.

    Science.gov (United States)

    Whittington, Melanie D; Curtis, Donna J; Atherly, Adam J; Bradley, Cathy J; Lindrooth, Richard C; Campbell, Jonathan D

    2017-07-01

    To mitigate methicillin-resistant Staphylococcus aureus (MRSA) infections, intensive care units (ICUs) conduct surveillance through screening patients upon admission followed by adhering to isolation precautions. Two surveillance approaches commonly implemented are universal preemptive isolation and targeted isolation of only MRSA-positive patients. Decision analysis was used to calculate the total cost of universal preemptive isolation and targeted isolation. The screening test used as part of the surveillance practice was varied to identify which screening test minimized inappropriate and total costs. A probabilistic sensitivity analysis was conducted to evaluate the range of total costs resulting from variation in inputs. The total cost of the universal preemptive isolation surveillance practice was minimized when a polymerase chain reaction screening test was used ($82.51 per patient). Costs were $207.60 more per patient when a conventional culture was used due to the longer turnaround time and thus higher isolation costs. The total cost of the targeted isolation surveillance practice was minimized when chromogenic agar 24-hour testing was used ($8.54 per patient). Costs were $22.41 more per patient when polymerase chain reaction was used. For ICUs that preemptively isolate all patients, the use of a polymerase chain reaction screening test is recommended because it can minimize total costs by reducing inappropriate isolation costs. For ICUs that only isolate MRSA-positive patients, the use of chromogenic agar 24-hour testing is recommended to minimize total costs. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  14. Good agreement between minimal erythema dose test reactions and objective measurements

    DEFF Research Database (Denmark)

    Bodekær, Mette; Philipsen, Peter Alshede; Karlsmark, Tonny

    2013-01-01

    The erythema resulting from the minimal erythema dose (MED) test is subjectively assessed. The evaluator visually grades erythema on an ordinal scale. Both intra- and interobserver variation have been found for this erythema assessment. We wanted to examine if objective measurements could be used...

  15. Approaches for estimating minimal clinically important differences in systemic lupus erythematosus.

    Science.gov (United States)

    Rai, Sharan K; Yazdany, Jinoos; Fortin, Paul R; Aviña-Zubieta, J Antonio

    2015-06-03

    A minimal clinically important difference (MCID) is an important concept used to determine whether a medical intervention improves perceived outcomes in patients. Prior to the introduction of the concept in 1989, studies focused primarily on statistical significance. As most recent clinical trials in systemic lupus erythematosus (SLE) have failed to show significant effects, determining a clinically relevant threshold for outcome scores (that is, the MCID) of existing instruments may be critical for conducting and interpreting meaningful clinical trials as well as for facilitating the establishment of treatment recommendations for patients. To that effect, methods to determine the MCID can be divided into two well-defined categories: distribution-based and anchor-based approaches. Distribution-based approaches are based on statistical characteristics of the obtained samples. There are various methods within the distribution-based approach, including the standard error of measurement, the standard deviation, the effect size, the minimal detectable change, the reliable change index, and the standardized response mean. Anchor-based approaches compare the change in a patient-reported outcome to a second, external measure of change (that is, one that is more clearly understood, such as a global assessment), which serves as the anchor. Finally, the Delphi technique can be applied as an adjunct to defining a clinically important difference. Despite an abundance of methods reported in the literature, little work in MCID estimation has been done in the context of SLE. As the MCID can help determine the effect of a given therapy on a patient and add meaning to statistical inferences made in clinical research, we believe there ought to be renewed focus on this area. Here, we provide an update on the use of MCIDs in clinical research, review some of the work done in this area in SLE, and propose an agenda for future research.

  16. Minimal Clinically Important Difference of Patient Reported Outcome Measures of Lower Extremity Injuries in Orthopedics

    Science.gov (United States)

    Çelik, Derya; Çoban, Özge; Kılıçoğlu, Önder

    2017-01-01

    Purpose: MCID scores for outcome measures are frequently used evidence-based guides to gage meaningful changes. To conduct a systematic review of the quality and content of the the minimal clinically important difference (MCID) relating to 16 patient-rated outcome measures (PROM) used in lower extremity. Methods: We conducted a systematic literature review on articles reporting MCID in lower extremity outcome measures and orthopedics from January 1, 1980, to May 10, 2016. We evaluated MCID of the 16 patient reported outcome measures (PROM) which were Harris Hip Score (HHS), Oxford Hip Score (OHS), Hip Outcome Score (HOS), Hip Disability and Osteoarthritis Outcome Score (HOOS), The International Knee Documentation Committee Subjective Knee Form (IKDC), The Lysholm Scale, The Western Ontario Meniscal Evaluation Tool (WOMET), The Anterior Cruciate Ligament Quality of Life Questionnaire (ACL-QOL), The Lower Extremity Functional Scale (LEFS), The Western Ontario and Mcmaster Universities Index (WOMAC), Knee İnjury And Osteoarthritis Outcome Score (KOOS), Oxford Knee Score (OKS), Kujala Anterior Knee Pain Scale, The Victorian Institute of Sports Assessment Patellar Tendinosis (Jumper’s Knee) (VİSA-P), Tegner Activity Rating Scale, Marx Activity Rating Scale, Foot And Ankle Outcome Score (FAOS), The Foot Function Index (FFI), Foot And Ankle Ability Measure (FAAM), The Foot And Ankle Disability Index Score and Sports Module, Achill Tendon Total Rupture Score(ATRS), The Victorian İnstitute Of Sports Assesment Achilles Questionnaire(VİSA-A), American Orthopaedic Foot and Ankle Society (AOFAS). A search of the PubMed/MEDLINE, PEDro and Cochrane Cen¬tral Register of Controlled Trials and Web of Science databases from the date of inception to May 1, 2016 was conducted. The terms “minimal clinically important difference,” “minimal clinically important change”, “minimal clinically important improvement” “were combined with one of the PROM as mentioned above

  17. Proposed tests for minimal SU(5) supergravity at Fermilab, Gran Sasso, SuperKamiokande, and LEP

    CERN Document Server

    López, J L; Pois, H; Zichichi, Antonino

    1993-01-01

    A series of predictions are worked out in order to put the minimal $SU(5)$ supergravity model under experimental test. Using the two-loop gauge coupling renormalization group equations, with the inclusion of supersymmetric threshold corrections, we calculate a new value for the proton decay rate in this model and find that SuperKamiokande and Gran Sasso should see the proton decay mode $p\\to\\bar\

  18. Validation of a Paper and Pencil Test Battery for the Diagnosis of Minimal Hepatic Encephalopathy in Korea.

    Science.gov (United States)

    Jeong, Jae Yoon; Jun, Dae Won; Bai, Daiseg; Kim, Ji Yean; Sohn, Joo Hyun; Ahn, Sang Bong; Kim, Sang Gyune; Kim, Tae Yeob; Kim, Hyoung Su; Jeong, Soung Won; Cho, Yong Kyun; Song, Do Seon; Kim, Hee Yeon; Jung, Young Kul; Yoon, Eileen L

    2017-09-01

    The aim of this study was to validate a new paper and pencil test battery to diagnose minimal hepatic encephalopathy (MHE) in Korea. A new paper and pencil test battery was composed of number connection test-A (NCT-A), number connection test-B (NCT-B), digit span test (DST), and symbol digit modality test (SDMT). The norm of the new test was based on 315 healthy individuals between the ages of 20 and 70 years old. Another 63 healthy subjects (n = 31) and cirrhosis patients (n = 32) were included as a validation cohort. All participants completed the new paper and pencil test, a critical flicker frequency (CFF) test and computerized cognitive function test (visual continuous performance test [CPT]). The scores on the NCT-A and NCT-B increased but those of DST and SDMT decreased according to age. Twelve of the cirrhotic patients (37.5%) were diagnosed with MHE based on the new paper and pencil test battery. The total score of the paper and pencil test battery showed good positive correlation with the CFF (r = 0.551, P computer base cognitive test decreased significantly in patients with MHE compared to those without MHE. Test-retest reliability was comparable. In conclusion, the new paper and pencil test battery including NCT-A, NCT-B, DST, and SDMT showed good correlation with neuropsychological tests. This new paper and pencil test battery could help to discriminate patients with impaired cognitive function in cirrhosis (registered at Clinical Research Information Service [CRIS], https://cris.nih.go.kr/cris, KCT0000955). © 2017 The Korean Academy of Medical Sciences.

  19. Clinical effect of minimally invasive intracranial hematoma in treating hypertensive cerebral hemorrhage.

    Science.gov (United States)

    Yang, Gang; Shao, Gaofeng

    2016-01-01

    To evaluate the clinical effect of minimally invasive intracranial hematoma in treating hypertensive cerebral hemorrhage. One hundred and fifty-six patients with hypertensive cerebral hemorrhage were selected. They were randomly divided into the control group (78 cases) and observation group (78 cases). The control group was treated with conventional craniotomy evacuation of hematoma, while the observation group was treated with minimally invasive intracranial hematoma. Neurological impairment score, treatment efficacy and Barthel index were compared between two groups. Comparison results and clinical data of these patients were retrospectively analyzed. Neurological impairment score in observation group had a significantly obvious decrease compared to control group (p hematoma cleared for the first time in control group (75.40±10.20 (%)) was more than observation group (45.10±8.70 (%)). Hematoma in observation group (3.90±0.80 days) disappeared faster than control group (5.80±0.90 days). Differences of the above indexes between two groups were all significant (p intracranial hematoma is remarkably effective. It should be promoted and practiced extensively.

  20. Test-retest reliability and minimal detectable change of three-dimensional gait analysis in chronic low back pain patients.

    Science.gov (United States)

    Fernandes, Rita; Armada-da-Silva, Paulo; Pool-Goudzwaard, Annelies L; Moniz-Pereira, Vera; Veloso, António P

    2015-10-01

    Three-dimensional gait analysis (3DGA) can provide detailed data on gait impairment in chronic low back pain (CLBP) patients. However, data about reliability and measurement error of 3DGA in this population is lacking. The aim of this study is to investigate test-retest reliability and minimal detectable change of 3DGA in a sample of CLBP patients. A test-retest study was conducted with a sample of 14 CLBP patients that underwent two biomechanical gait assessments with an interval of 7.6 ± 1.8 days. Anthropometric and time-distance parameters, as well as peak values for lower limb and trunk joint angles and moments, were computed. Intraclass Correlation Coefficient (ICC3,k) and their 95% confidence intervals were calculated. Standard error of measurement (SEM), minimal detectable change (MDC) and limits of agreement (LOA) were also estimated. The obtained ICC values demonstrate high test-retest reliability for most joint angles, with low SEM ( 0.86). The results of this study show high test-retest reliability for lower limb and trunk joint angles, and time-distance parameters during gait in CLBP individuals, together with a low measurement error. These results also support the use of this method in clinical assessments of CLBP patients' gait patterns. Copyright © 2015 Elsevier B.V. All rights reserved.

  1. Assessing Minimal Detectable Changes and Test-Retest Reliability of the Timed Up and Go Test and the 2-Minute Walk Test in Patients With Total Knee Arthroplasty.

    Science.gov (United States)

    Yuksel, Ertugrul; Kalkan, Serpil; Cekmece, Senol; Unver, Bayram; Karatosun, Vasfi

    2017-02-01

    Two-minute walk test (2MWT) and the Timed Up and Go test (TUG) are simple, quick, and can be applied in a short time as part of the routine medical examination. They were shown to be reliable and valid tests in many patient groups. The aims of the present study were: (1) to determine test-retest reliability of data for the TUG and 2MWT and (2) to determine minimal detectable change (MDC) scores for the TUG and 2MWT in patients with TKA. Forty-eight patients with total knee arthroplasty, operated by the same surgeon, were included in this study. Patients performed trials for TUG and 2MWT twice on the same day. Between the first and second trials, patients waited for an hour on sitting position to prevent fatigue. The TUG and 2MWT showed an excellent test-retest reliability in this study. Intraclass correlation coefficient [ICC(2,1)] for TUG and 2MWT were 0.98 and 0.97, respectively. Standard error of measurement and MDC 95 for TUG were 0.82 and 2.27, respectively. Standard error of measurement and MDC 95 for 2MWT were 5.40 and 14.96, respectively. The TUG and 2MWT have an excellent test-retest reliability in patients with TKA. Clinicians and researchers can be confident that changes in TUG time above 2.27 seconds and changes in 2MWT distances above 14.96 meters, represent a "real" clinical change in an individual patient with TKA. We, therefore, recommend the use of these 2 tests as complementary outcome measures for functional evaluation in patients TKA. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Genetic testing in clinical practice.

    Science.gov (United States)

    Lamberts, Steven W J; Uitterlinden, André G

    2009-01-01

    In the practice of internal medicine, the value of genetic testing in common (mono)genetic diseases such as familial hemochromatosis, hypercholesterolemia, Mediterranean fever, and thrombophilia is limited. The genotype insufficiently predicts the phenotype because of the powerful effects of other modifying genes, environmental influences, and lifestyle factors. Many common diseases, including diabetes mellitus, osteoporosis, and cardiovascular disease, have strong genetic influences but are called complex genetic traits. The underlying genetic factors are currently investigated using new molecular tools such as genome-wide association studies, analyzing up to 500,000 markers in huge numbers of patients. Many new (often unexpected) markers have been identified, and in many instances their functional significance is unknown. Genomic profiles play a rapidly growing role in the field of pharmacogenomics. A number of recently identified pharmacogenomic biomarkers are helpful to predict drug-related toxic effects.

  3. Minimum detectable and minimal clinically important changes for pain in patients with nonspecific neck pain

    Directory of Open Access Journals (Sweden)

    Zamora Javier

    2008-04-01

    Full Text Available Abstract Background The minimal detectable change (MDC and the minimal clinically important changes (MCIC have been explored for nonspecific low back pain patients and are similar across different cultural settings. No data on MDC and MCIC for pain severity are available for neck pain patients. The objectives of this study were to estimate MDC and MCIC for pain severity in subacute and chronic neck pain (NP patients, to assess if MDC and MCIC values are influenced by baseline values and to explore if they are different in the subset of patients reporting referred pain, and in subacute versus chronic patients. Methods Subacute and chronic patients treated in routine clinical practice of the Spanish National Health Service for neck pain, with or without pain referred to the arm, and a pain severity ≥ 3 points on a pain intensity number rating scale (PI-NRS, were included in this study. Patients' own "global perceived effect" over a 3 month period was used as the external criterion. The minimal detectable change (MDC was estimated by means of the standard error of measurement in patients who self-assess as unchanged. MCIC were estimated by the mean value of change score in patients who self-assess as improved (mean change score, MCS, and by the optimal cutoff point in receiver operating characteristics curves (ROC. The effect on MDC and MCIC of initial scores, duration of pain, and existence of referred pain were assessed. Results 658 patients were included, 487 of them with referred pain. MDC was 4.0 PI-NRS points for neck pain in the entire sample, 4.2 for neck pain in patients who also had referred pain, and 6.2 for referred pain. MCS was 4.1 and ROC was 1.5 for referred and for neck pain, both in the entire sample and in patients who also complained of referred pain. ROC was lower (0.5 PI-NRS points for subacute than for chronic patients (1.5 points. MCS was higher for patients with more intense baseline pain, ranging from 2.4 to 4.9 PI

  4. [More efficient testing policy at STI clinics].

    Science.gov (United States)

    Suijkerbuijk, Anita W M; Over, Eelco A B; Koedijk, Femke D H; van Benthem, Birgit H B; van der Sande, Marianne A B; Lugnér, Anna K

    2014-01-01

    To assess the efficiency of the testing policy change in 2012 in sexually transmitted infection (STI) outpatient clinics: persons who attend the clinic and are aged STI testing policy were explored. Explorative study. To test the new policy, data from STI outpatient clinics from 2011 were used for the risk group "young people under 25 years of age without other STI risks". Other groups who visited STI outpatient clinic were selected from the data from the STI outpatient clinics from 2012. Test cost savings and missed STIs were calculated if STI outpatient clinic attendees from these risk groups first received only a chlamydia or a combination test (chlamydia and gonorrhoea). Test cost savings were divided by the number of missed STIs as a measure of efficiency. The policy change led to an annual test cost saving of € 1.1 million but missed 31 gonorrhoea infections (€ 36,200 at the cost of one missed gonorrhoea infection). Using a combination test for chlamydia and gonorrhoea in heterosexual individuals visiting the clinic aged STI-endemic country could lead to test costs savings of € 3.8 million. Savings at the cost of one missed STI would be about € 350,000; 4 HIV and 7 syphilis infections would have been missed. The national policy change has led to a substantial reduction in test costs. The policy measure would be even more efficient if a combination test for chlamydia and gonorrhoea were applied. Testing using a combination test in all heterosexual individuals who attend the clinic and are aged STI-endemic country would lead to additional savings.

  5. 3D quantification of clinical marginal and internal gap of porcelain laminate veneers with minimal and without tooth preparation and 2-year clinical evaluation.

    Science.gov (United States)

    Karagözoğlu, İrem; Toksavul, Suna; Toman, Muhittin

    2016-01-01

    The aims of this clinical study were to compare internal three-dimensional (3D) adaptation of porcelain laminate veneers (PLV) with minimal tooth preparation and without tooth preparation (prepless) and to evaluate the clinical outcomes at baseline and following 6, 12, and 24 months after luting. Thirty-one prepless PLV and 31 PLV with minimal tooth preparation were fabricated using lithium disilicate glass-ceramic material and placed in 12 patients (8 women, 4 men; 18 to 40 years old). All PLV were luted with an adhesive luting system (Variolink veneer). A silicone replica was obtained to measure internal adaptation of each PLV using a low viscosity polyvinyl siloxane impression material just before luting. Silicone replicas were scanned in x-ray micro computerized tomography (micro CT). Clinical evaluations took place at baseline (2 days after luting) and following 6, 12, and 24 months after luting. Marginal integrity, marginal discoloration, secondary caries, tooth sensitivity, and fracture were evaluated following FDI criteria. Replica scores were analyzed using Mann-Whitney U and Student's t test (α = .05). Kaplan-Meier statistical analysis was done for the survival rate of PLV. FDI criteria scores were analyzed using Pearson's chi-square test (α = .05). The median marginal gaps for PLV-without-tooth-preparation and PLV-with-minimal-tooth-preparation groups were 100 μm and 140 μm respectively. There was a statistically significant difference between the two groups with respect to marginal gap (P = .04). The mean internal adaptation for the PLV-without-tooth-preparation group was 217.17 ± 54.72 μm, and was 170.67 ± 46.54 μm for the PLV-with-minimaltooth- preparation group. There was a statistically significant difference between the two groups (P = .001). Based on FDI criteria, 100% of the PLV were rated satisfactory during the 2-year period. In this in-vivo study, mean and median values of marginal gap and internal adaptation for PLV with minimal tooth

  6. Towards Clinically Optimized MRI-guided Surgical Manipulator for Minimally Invasive Prostate Percutaneous Interventions: Constructive Design*

    Science.gov (United States)

    Eslami, Sohrab; Fischer, Gregory S.; Song, Sang-Eun; Tokuda, Junichi; Hata, Nobuhiko; Tempany, Clare M.; Iordachita, Iulian

    2013-01-01

    This paper undertakes the modular design and development of a minimally invasive surgical manipulator for MRI-guided transperineal prostate interventions. Severe constraints for the MRI-compatibility to hold the minimum artifact on the image quality and dimensions restraint of the bore scanner shadow the design procedure. Regarding the constructive design, the manipulator kinematics has been optimized and the effective analytical needle workspace is developed and followed by proposing the workflow for the manual needle insertion. A study of the finite element analysis is established and utilized to improve the mechanism weaknesses under some inevitable external forces to ensure the minimum structure deformation. The procedure for attaching a sterile plastic drape on the robot manipulator is discussed. The introduced robotic manipulator herein is aimed for the clinically prostate biopsy and brachytherapy applications. PMID:24683502

  7. Establishing the minimal clinically important difference for the Questionnaire of Olfactory Disorders.

    Science.gov (United States)

    Mattos, Jose L; Schlosser, Rodney J; Mace, Jess C; Smith, Timothy L; Soler, Zachary M

    2018-05-02

    Olfactory-specific quality of life (QOL) can be measured using the Questionnaire of Olfactory Disorders Negative Statements (QOD-NS). Changes in the QOD-NS after treatment can be difficult to interpret since there is no standardized definition of clinically meaningful improvement. Patients with chronic rhinosinusitis (CRS) completed the QOD-NS. Four distribution-based methods were used to calculate the minimal clinically important difference (MCID): (1) one-half standard deviation (SD); (2) standard error of the mean (SEM); (3) Cohen's effect size (d) of the smallest unit of change; and (4) minimal detectable change (MDC). We also averaged all 4 of the scores together. Finally, the likelihood of achieving a MCID after sinus surgery using these methods, as well as average QOD-NS scores, was stratified by normal vs abnormal baseline QOD-NS scores. Outcomes were examined on 128 patients. The mean ± SD improvement in QOD-NS score after surgery was 4.3 ± 11.0 for the entire cohort and 9.6 ± 12.9 for those with abnormal baseline scores (p < 0.001). The MCID values using the different techniques were: (1) SD = 6.5; (2) SEM = 3.1; (3) d = 2.6; and (4) MDC = 8.6. The MCID score was 5.2 on average. For the total cohort analysis, the likelihood of reporting a MCID ranged from 26% to 51%, and 49% to 70% for patients reporting preoperative abnormal olfaction. Distribution-based MCID values of the QOD-NS range between 2.6 and 8.6 points, with an average of 5.2. When stratified by preoperative QOD-NS scores the majority of patients reporting abnormal preoperative QOD-NS scores achieved a MCID. © 2018 ARS-AAOA, LLC.

  8. Development and testing of a compact endoscope manipulator for minimally invasive surgery.

    Science.gov (United States)

    Berkelman, Peter; Cinquin, Philippe; Boidard, Eric; Troccaz, Jocelyne; Létoublon, Christian; Long, Jean-Alexandre

    2005-01-01

    This report describes the design, development, and testing of a novel compact surgical assistant robot to control the orientation and insertion depth of a laparoscopic endoscope during minimally invasive abdominal surgery. In contrast to typical endoscope manipulators, the described robot is particularly compact and lightweight, is simple to set up and use, occupies no floor or operating table space, and does not limit access to the patient in any way. The sterilizable endoscope manipulator is sufficiently small and lightweight at 625 g and 110 mm in diameter that it can be placed directly on the abdomen of the patient without interfering with other handheld instruments during minimally invasive surgery. It consists of an annular base, a clamp to hold an endoscope trocar, and two joints which enable azimuth rotation and inclination of the endoscope about a pivot point at the incision. The endoscope insertion depth is controlled by a cable winding acting against a compression spring on the endoscope shaft. Voice recognition and miniature keypad user command interfaces are provided, and the manipulator motors are backdriveable for manual repositioning. Endoscope camera trajectory-following accuracy and response-time results were measured using an optical localizer. Experimental results are given comparing the current prototype with the previous cable-driven prototype. The endoscope manipulator and its user interface were tested and evaluated by several surgeons during a series of minimally invasive surgical training procedures on cadavers and animals. The endoscope manipulator described has been shown to be a viable, practical device with performance and functionality equivalent to those of commercially available models, yet with greatly reduced size, weight, and cost.

  9. Comparison of clinical outcomes following minimally invasive lateral interbody fusion stratified by preoperative diagnosis.

    Science.gov (United States)

    Khajavi, Kaveh; Shen, Alessandria; Lagina, Madeline; Hutchison, Anthony

    2015-04-01

    Lumbar fusion has been shown to be effective in treating a variety of degenerative spinal conditions, though significant differences exist in the magnitude of clinical improvement across different surgical diagnoses. With modern, minimally disruptive approaches for fusion, diagnosis-specific differences in clinical improvement may be reduced. The purpose of this study is to report and compare interim clinical improvements in patients treated with XLIF for various degenerative lumbar conditions. 160 patients underwent XLIF for either degenerative spondylolisthesis (n = 68), degenerative disc disease (n = 20), adjacent segment disease (n = 26), or post-laminectomy syndrome (n = 46). Average age was 61 years and 66 % were female. Mean BMI was 28.9 kg/m(2). 37 % were smokers, 23 % had diabetes mellitus, 22 % had depression. Mean age was highest for ASD patients (66 years) and lowest for DDD patients (48 years) (p < 0.001). There were no other baseline demographic differences between groups. Patient-reported clinical outcomes measures were collected at baseline and prospectively at standard intervals. Interim results at an average of 19 months follow-up are reported here. In total, 197 levels were treated with XLIF (mean 1.2 per patient). There were no cases of symptomatic pseudoarthrosis or implant/instrument failure. Overall, 1 patient (0.6 %) had a major complication and 12 % had a minor complication. Approach-related anterolateral thigh/groin sensory changes were present in 14 % and hip flexion weakness in 9 %. At last follow-up, overall ODI decreased 47 % (44.1-23.5), VAS LBP decreased 59 % (6.9-2.8), VAS LP decreased 56 % (7.1-3.1), and SF-36 PCS improved 40 % (30.9-43.2) (all p < 0.001). Baseline ODI was significantly lower for DDD patients (p = 0.052). At last follow-up, mean percent improvements on all outcomes were highest for DSP group, though not all differences were significant. Improvements between diagnostic groups were statistically different for LBP (p

  10. Pronounced Structural and Functional Damage in Early Adult Pediatric-Onset Multiple Sclerosis with No or Minimal Clinical Disability

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    Antonio Giorgio

    2017-11-01

    Full Text Available Pediatric-onset multiple sclerosis (POMS may represent a model of vulnerability to damage occurring during a period of active maturation of the human brain. Whereas adaptive mechanisms seem to take place in the POMS brain in the short-medium term, natural history studies have shown that these patients reach irreversible disability, despite slower progression, at a significantly younger age than adult-onset MS (AOMS patients. We tested for the first time whether significant brain alterations already occurred in POMS patients in their early adulthood and with no or minimal disability (n = 15 in comparison with age- and disability-matched AOMS patients (n = 14 and to normal controls (NC, n = 20. We used a multimodal MRI approach by modeling, using FSL, voxelwise measures of microstructural integrity of white matter tracts and gray matter volumes with those of intra- and internetwork functional connectivity (FC (analysis of variance, p ≤ 0.01, corrected for multiple comparisons across space. POMS patients showed, when compared with both NC and AOMS patients, altered measures of diffusion tensor imaging (reduced fractional anisotropy and/or increased diffusivities and higher probability of lesion occurrence in a clinically eloquent region for physical disability such as the posterior corona radiata. In addition, POMS patients showed, compared with the other two groups, reduced long-range FC, assessed from resting functional MRI, between default mode network and secondary visual network, whose interaction subserves important cognitive functions such as spatial attention and visual learning. Overall, this pattern of structural damage and brain connectivity disruption in early adult POMS patients with no or minimal clinical disability might explain their unfavorable clinical outcome in the long term.

  11. Clinical outcomes of two minimally invasive transforaminal lumbar interbody fusion (TLIF) for lumbar degenerative diseases.

    Science.gov (United States)

    Tian, Yonghao; Liu, Xinyu

    2016-10-01

    There are two modified TLIF, including MIS-TLIF and TLIF through Wiltse approach (W-TLIF). Although both of the two minimally invasive surgical procedures can be effective in the treatment for lumbar degenerative diseases, no comparative analysis has been made so far regarding their clinical outcomes. To compare the clinical outcomes of MIS-TLIF and W-TLIF for the treatment for single-segment degenerative lumbar diseases. Ninety-seven patients with single-segment degenerative lumbar disorders were included in this study. Forty-seven underwent MIS-TLIF surgery (group A). For group B, fifty patients underwent W-TLIF. The Japanese Orthopedic Association (JOA) score, the visual analog scale (VAS) of low back pain (LBP) and leg pain, MRI score and atrophy rate of CSA, interbody fusion rate were assessed during the postoperative follow-up. Incision length, blood loss, operative time, CPK, and postoperative incision pain VAS were better in group A (P degenerative disease. MIS-TLIF has less blood loss, shorter surgical incision, and less lower postoperative back pain, while W-TLIF is less expensive for hospital stay with lower exposure to X-rays.

  12. Transtemporal amygdalohippocampectomy: a novel minimally-invasive technique with optimal clinical results and low cost

    Directory of Open Access Journals (Sweden)

    Juan Antonio Castro Flores

    Full Text Available ABSTRACT Mesial temporal sclerosis creates a focal epileptic syndrome that usually requires surgical resection of mesial temporal structures. Objective: To describe a novel operative technique for treatment of temporal lobe epilepsy and its clinical results. Methods: Prospective case-series at a single institution, performed by a single surgeon, from 2006 to 2012. A total of 120 patients were submitted to minimally-invasive keyhole transtemporal amygdalohippocampectomy. Results: Of the patients, 55% were male, and 85% had a right-sided disease. The first 70 surgeries had a mean surgical time of 2.51 hours, and the last 50 surgeries had a mean surgical time of 1.62 hours. There was 3.3% morbidity, and 5% mild temporal muscle atrophy. There was no visual field impairment. On the Engel Outcome Scale at the two-year follow-up, 71% of the patients were Class I, 21% were Class II, and 6% were Class III. Conclusion: This novel technique is feasible and reproducible, with optimal clinical results.

  13. Clinical Trial Designs to Support Clinical Utility of Pharmacogenomic Testing.

    Science.gov (United States)

    Drozda, Katarzyna; Pacanowski, Michael A

    2017-09-01

    Advancing the use of biomarkers and pharmacogenomics has been a key priority area for the U.S. Food and Drug Administration (FDA). The FDA offers prescribing recommendations to manage ~100 gene-drug interactions, and multiple institutions around the United States and abroad have incorporated genomic testing into patient care. However, the penetration of pharmacogenomic testing remains incomplete. In this perspective, we summarize the evidence streams to support the clinical utility of pharmacogenomic testing and its transition into clinical practice. © 2017 Pharmacotherapy Publications, Inc.

  14. Non invasive blood flow measurement in cerebellum detects minimal hepatic encephalopathy earlier than psychometric tests.

    Science.gov (United States)

    Felipo, Vicente; Urios, Amparo; Giménez-Garzó, Carla; Cauli, Omar; Andrés-Costa, Maria-Jesús; González, Olga; Serra, Miguel A; Sánchez-González, Javier; Aliaga, Roberto; Giner-Durán, Remedios; Belloch, Vicente; Montoliu, Carmina

    2014-09-07

    To assess whether non invasive blood flow measurement by arterial spin labeling in several brain regions detects minimal hepatic encephalopathy. Blood flow (BF) was analyzed by arterial spin labeling (ASL) in different brain areas of 14 controls, 24 cirrhotic patients without and 16 cirrhotic patients with minimal hepatic encephalopathy (MHE). Images were collected using a 3 Tesla MR scanner (Achieva 3T-TX, Philips, Netherlands). Pulsed ASL was performed. Patients showing MHE were detected using the battery Psychometric Hepatic Encephalopathy Score (PHES) consisting of five tests. Different cognitive and motor functions were also assessed: alterations in selective attention were evaluated using the Stroop test. Patients and controls also performed visuo-motor and bimanual coordination tests. Several biochemical parameters were measured: serum pro-inflammatory interleukins (IL-6 and IL-18), 3-nitrotyrosine, cGMP and nitrates+nitrites in plasma, and blood ammonia. Bivariate correlations were evaluated. In patients with MHE, BF was increased in cerebellar hemisphere (P = 0.03) and vermis (P = 0.012) and reduced in occipital lobe (P = 0.017). BF in cerebellar hemisphere was also increased in patients without MHE (P = 0.02). Bimanual coordination was impaired in patients without MHE (P = 0.05) and much more in patients with MHE (P battery and with CFF. BF in cerebellar hemisphere correlates with plasma cGMP and nitric oxide (NO) metabolites. BF in vermis cerebellar also correlates with NO metabolites and with 3-nitrotyrosine. IL-18 in plasma correlates with BF in thalamus and occipital lobe. Non invasive BF determination in cerebellum using ASL may detect MHE earlier than the PHES. Altered NO-cGMP pathway seems to be associated to altered BF in cerebellum.

  15. The clinical value of breath hydrogen testing.

    Science.gov (United States)

    Yao, Chu K; Tuck, Caroline J

    2017-03-01

    Breath hydrogen testing for assessing the presence of carbohydrate malabsorption is frequently applied to refine dietary restrictions on a low fermentable carbohydrate (FODMAP) diet. Its application has also been extended for the detection of small intestinal bacterial overgrowth. Recently, several caveats of its methodology and interpretation have emerged. A review of the evidence surrounding its application in the management of patients with a functional bowel disorder was performed. Studies were examined to assess limitations of testing methodology, interpretation of results, reproducibility, and how this relates to clinical symptoms. A wide heterogeneity in testing parameters, definition of positive/negative response, and the use of clinically irrelevant doses of test carbohydrate were common methodological limitations. These factors can subsequently impact the sensitivity, specificity, and false positive or negative detection rates. Evidence is also increasing on the poor intra-individual reproducibility in breath responses with repeated testing for fructose and lactulose. On the basis of these limitations, it is not surprising that the diagnosis of small intestinal bacterial overgrowth based on a lactulose breath test yields a wide prevalence rate and is unreliable. Finally, symptom induction during a breath test has been found to correlate poorly with the presence of carbohydrate malabsorption. The evidence suggests that breath hydrogen tests have limited clinical value in guiding clinical decision for the patient with a functional bowel disorder. © 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

  16. The minimal clinically important difference for Knee Society Clinical Rating System after total knee arthroplasty for primary osteoarthritis.

    Science.gov (United States)

    Lee, Wu Chean; Kwan, Yu Heng; Chong, Hwei Chi; Yeo, Seng Jin

    2017-11-01

    The Knee Society Clinical Rating System (KS) is one of the most popular tools used to assess patient outcome after total knee arthroplasty (TKA), but its minimal clinically important difference (MCID) has not been identified. This study aims to identify the MCID of KS function score (KS-FS) and knee score (KS-KS) after TKA in patients with primary knee osteoarthritis. The authors retrospectively analysed patients who underwent TKA for primary knee osteoarthritis between 2005 and 2015 in a single institution. KS-FS, KS-KS, and Oxford Knee Score (OKS) were collected pre-operatively and 2 years post-operatively. Patient satisfaction with TKA at 2 years was also collected. Anchor-based approach with 2 external indicators was used. The MCID for KS-FS and KS-KS was determined using simple linear regression according to patient satisfaction with TKA and the MCID of OKS. The mean age of the 550 subjects studied was 66 ± 8 years. There were 373 (67.8 %) female subjects. The KS-FS improved by 22.8 (95 % CI 20.9-24.6) points, and the KS-KS improved by 44.4 (95 % CI 42.6-46.3) points. The MCID identified for KS-FS is between 6.1 (95 % CI 5.1-7.1) and 6.4 (95 % CI 4.4-8.4) and between 5.3 (95 % CI 4.3-6.3) and 5.9 (95 % CI 3.9-7.8) for KS-KS. This is the first study, to the knowledge of the authors, to identify the MCID of KS. This will allow future trials to have an accurate prediction of sample size. Clinically, physicians will be able to better interpret outcomes of TKA studies to guide a treatment option. IV.

  17. Validation of the minimal citrate tube fill volume for routine coagulation tests on ACL TOP 500 CTS®.

    Science.gov (United States)

    Ver Elst, K; Vermeiren, S; Schouwers, S; Callebaut, V; Thomson, W; Weekx, S

    2013-12-01

    CLSI recommends a minimal citrate tube fill volume of 90%. A validation protocol with clinical and analytical components was set up to determine the tube fill threshold for international normalized ratio of prothrombin time (PT-INR), activated partial thromboplastin time (aPTT) and fibrinogen. Citrated coagulation samples from 16 healthy donors and eight patients receiving vitamin K antagonists (VKA) were evaluated. Eighty-nine tubes were filled to varying volumes of >50%. Coagulation tests were performed on ACL TOP 500 CTS(®) . Receiver Operating Characteristic (ROC) plot, with Total error (TE) and critical difference (CD) as possible acceptance criteria, was used to determine the fill threshold. Receiving Operating Characteristic was the most accurate with CD for PT-INR and TE for aPTT resulting in thresholds of 63% for PT and 80% for aPTT. By adapted ROC, based on threshold setting at a point of 100% sensitivity at a maximum specificity, CD was best for PT and TE for aPTT resulting in thresholds of 73% for PT and 90% for aPTT. For fibrinogen, the method was only valid with the TE criterion at a 63% fill volume. In our study, we validated the minimal citrate tube fill volumes of 73%, 90% and 63% for PT-INR, aPTT and fibrinogen, respectively. © 2013 John Wiley & Sons Ltd.

  18. Evaluating clinically meaningful change on the ITP-PAQ: preliminary estimates of minimal important differences.

    Science.gov (United States)

    Mathias, Susan D; Gao, Sue K; Rutstein, Mark; Snyder, Claire F; Wu, Albert W; Cella, David

    2009-02-01

    Interpretation of data from health-related quality of life (HRQoL) questionnaires can be enhanced with the availability of minimally important difference (MID) estimates. This information will aid clinicians in interpreting HRQoL differences within patients over time and between treatment groups. The Immune Thrombocytopenic Purpura (ITP)-Patient Assessment Questionnaire (PAQ) is the only comprehensive HRQoL questionnaire available for adults with ITP. Forty centers from within the US and Europe enrolled ITP patients into one of two multicenter, randomized, placebo-controlled, double-blind, 6-month, phase III clinical trials of romiplostim. Patients enrolled in these studies self-administered the ITP-PAQ and two items assessing global change (anchors) at baseline and weeks 4, 12, and 24. Using data from the ITP-PAQ and these two anchors, an anchor-based estimate was computed and combined with the standard error of measurement and standard deviation to compute a distribution-based estimate in order to provide an MID range for each of the 11 scales of the ITP-PAQ. A total of 125 patients participated in these clinical trials and provided data for use in these analyses. Combining results from anchor- and distribution-based approaches, MID values were computed for 9 of the 11 scales. MIDs ranged from 8 to 12 points for Symptoms, Bother, Psychological, Overall QOL, Social Activity, Menstrual Symptoms, and Fertility, while the range was 10 to 15 points for the Fatigue and Activity scales of the ITP-PAQ. These estimates, while slightly higher than other published MID estimates, were consistent with moderate effect sizes. These MID estimates will serve as a useful tool to researchers and clinicians using the ITP-PAQ, providing guidance for interpretation of baseline scores as well as changes in ITP-PAQ scores over time. Additional work should be done to finalize these initial estimates using more appropriate anchors that correlate more highly with the ITP-PAQ scales.

  19. Toxicity minimization of pipelines hydrostatic tests fluids, stage I: laboratory essays

    Energy Technology Data Exchange (ETDEWEB)

    Lacerda, Jorge A.S.; Penna, Monica de O.; Portela, Daniele B.; Christino, Fernando P.; Silva, Joao L.B. da; Geraldo, Lucia M.L. [Petroleo do Brasileiro S.A. (PETROBRAS), Rio de Janeiro, RJ (Brazil); Mota, Vanessa V.C. [Fundacao Gorceix, Ouro Preto, MG (Brazil); Cravo Junior, Walter [Pontificia Univ. Catolica do Rio de Janeiro (PUC-Rio), RJ (Brazil)

    2009-07-01

    This paper presents the results of the laboratory essays stage of the project for toxicity minimization of pipelines hydrostatic tests fluids. The hydrostatic-hibernation fluid composition most used by PETROBRAS in offshore operations is seawater added with sodium bis sulfite, fluorescein, alquildimetilbenzilamonium chloride, and tetrakis-hydroxymethyl-phosphonium sulfate (THPS). In order to reduce the toxicity of the fluid used in hydrostatic tests, the use of lesser concentrations of THPS was attempted with UV radiation application as a disinfection technique prior to the adding of the fluid's components. The compositions were evaluated in different conditions of temperature use of UV radiation or not and oxygen scavenger adding (presence and absence). The fluids were kept hibernating for 120 days. All the parameters tested after hibernation were compared to fresh from preparation samples (zero time samples). The fluid's characteristics were evaluated by microbiological control and toxicity as well as the THPS residual. Results showed that the UV treatment was more effective in the absence of oxygen scavenger. The temperature acts as a microbial growth control agent, as expected. To large scale operations, a water quality monitoring must be performed previously to any field operations, in order to determinate the best treatment to be used in each case. (author)

  20. Mismatch repair deficiency testing in clinical practice.

    Science.gov (United States)

    Buza, Natalia; Ziai, James; Hui, Pei

    2016-01-01

    Lynch syndrome, an autosomal dominant inherited disorder, is caused by inactivating mutations involving DNA mismatch repair (MMR) genes. This leads to profound genetic instability, including microsatellite instability (MSI) and increased risk for cancer development, particularly colon and endometrial malignancies. Clinical testing of tumor tissues for the presence of MMR gene deficiency is standard practice in clinical oncology, with immunohistochemistry and PCR-based microsatellite instability analysis used as screening tests to identify potential Lynch syndrome families. The ultimate diagnosis of Lynch syndrome requires documentation of mutation within one of the four MMR genes (MLH1, PMS2, MSH2 and MSH6) or EPCAM, currently achieved by comprehensive sequencing analysis of germline DNA. In this review, the genetic basis of Lynch syndrome, methodologies of MMR deficiency testing, and current diagnostic algorithms in the clinical management of Lynch syndrome, are discussed.

  1. The Candy Smell Test in clinical routine.

    Science.gov (United States)

    Haxel, Boris R; Bertz-Duffy, Shannon; Faldum, Andreas; Trellakis, Sokrates; Stein, Bernhard; Renner, Bertold; Kobal, Gerd; Letzel, Stephan; Mann, Wolf J; Muttray, Axel

    2011-01-01

    The "Candy Smell Test" (CST) has been introduced as a new testing method for the evaluation of the human sense of smell. In contrast to other established orthonasal smell tests, the CST addresses the retronasal application of odors, typical for food aroma effects during mastication and swallowing. The aim of this study was to evaluate the CST in a clinical setting in patients with olfactory dysfunction and normal controls against the Sniffin' Sticks test. Furthermore, cutoff points for normal and pathological results in the CST should be determined. The olfactory performance of 96 patients presenting with olfactory disorders and 71 healthy controls was evaluated with the CST-comprised of 23 different aromatized smell candies and the extended Sniffin' Sticks test (threshold, discrimination, and identification). The control group was gender matched but included also younger persons. The tested subjects could easily understand the procedures and were motivated to participate. The CST correlated well with the Sniffin' Sticks for all tested subjects and for patients (n = 96) and controls (n = 71). The proposed cutoff value to differentiate normosmia from hyposmia in the CST was a score of <16 (i.e., 16 correctly identified odors) of 23. A score below 13 in the CST was the cutoff value for anosmia. The CST is an easy-to-handle reliable tool to investigate retronasal olfaction suited for clinical determination of normosmia, hyposmia, and ansomia. In addition, it can be used for investigation where self-application is necessary such as in large survey studies.

  2. Minimal Clinically Important Differences for American Orthopaedic Foot & Ankle Society Score in Hallux Valgus Surgery.

    Science.gov (United States)

    Chan, Hiok Yang; Chen, Jerry Yongqiang; Zainul-Abidin, Suraya; Ying, Hao; Koo, Kevin; Rikhraj, Inderjeet Singh

    2017-05-01

    The American Orthopaedic Foot & Ankle Society (AOFAS) score is one of the most common and adapted outcome scales in hallux valgus surgery. However, AOFAS is predominantly physician based and not patient based. Although it may be straightforward to derive statistical significance, it may not equate to the true subjective benefit of the patient's experience. There is a paucity of literature defining MCID for AOFAS in hallux valgus surgery although it could have a great impact on the accuracy of analyzing surgical outcomes. Hence, the primary aim of this study was to define the Minimal Clinically Important Difference (MCID) for the AOFAS score in these patients, and the secondary aim was to correlate patients' demographics to the MCID. We conducted a retrospective cross-sectional study. A total of 446 patients were reviewed preoperatively and followed up for 2 years. An anchor question was asked 2 years postoperation: "How would you rate the overall results of your treatment for your foot and ankle condition?" (excellent, very good, good, fair, poor, terrible). The MCID was derived using 4 methods, 3 from an anchor-based approach and 1 from a distribution-based approach. Anchor-based approaches were (1) mean difference in 2-year AOFAS scores of patients who answered "good" versus "fair" based on the anchor question; (2) mean change of AOFAS score preoperatively and at 2-year follow-up in patients who answered good; (3) receiver operating characteristic (ROC) curves method, where the area under the curve (AUC) represented the likelihood that the scoring system would accurately discriminate these 2 groups of patients. The distribution-based approach used to calculate MCID was the effect size method. There were 405 (90.8%) females and 41 (9.2%) males. Mean age was 51.2 (standard deviation [SD] = 13) years, mean preoperative BMI was 24.2 (SD = 4.1). Mean preoperative AOFAS score was 55.6 (SD = 16.8), with significant improvement to 85.7 (SD = 14.4) in 2 years ( P value

  3. Minimal important difference and responsiveness of 2-minute walk test performance in people with COPD undergoing pulmonary rehabilitation

    Directory of Open Access Journals (Sweden)

    Johnston KN

    2017-10-01

    Full Text Available Kylie Nicole Johnston, Adrian James Potter, Anna Caroline Phillips School of Health Sciences, Sansom Institute for Health Research, University of South Australia, Adelaide, SA, Australia Background and objectives: Field exercise tests (eg, 6-minute walk test [6MWT] are important measures of functional exercise capacity in people with COPD. Shorter tests such as the 2-minute walk test (2MWT may offer advantages in some populations but lack information about responsiveness to change. This study examined responsiveness, minimal important difference (MID, test–retest reliability, and construct validity of the 2MWT in people with stable COPD attending outpatient pulmonary rehabilitation (PR.Methods: At pre-PR assessment, study participants completed a 2MWT twice in addition to usual measures (6MWT and Chronic Respiratory Questionnaire. At post-PR assessment following a standard PR program, measures were repeated and global rating of change scores obtained (patient and therapist. Pre–post program change scores were examined for correlations with change in 2-minute walk distance (2MWD and used (where r≥0.3 to estimate the MID through anchor-based methods. Distribution-based estimates based on standard error of measurement were examined. Test–retest reliability (intraclass correlation coefficient [ICC] and Bland–Altman agreement and validity (Pearson correlation with 6-minute walk distance [6MWD] were reported.Results: Fifty-nine people (28 men with stable COPD, mean age 68 years (SD 10 years, and percentage predicted forced expiratory volume in 1 second 48% (SD 20% attended pre-PR assessment. Test–retest ICC for same-session 2MWD was 0.985. A mean difference of 2.4 m (95% confidence interval [CI] 0.7–4.0 m, P=0.006 occurred between the first and second trials. 2MWD and 6MWD were highly correlated (r=0.87, P<0.001. Forty-one participants completed PR and were included in responsiveness and MID analysis. Mean 2MWD improved significantly

  4. Feline genetics: clinical applications and genetic testing.

    Science.gov (United States)

    Lyons, Leslie A

    2010-11-01

    DNA testing for domestic cat diseases and appearance traits is a rapidly growing asset for veterinary medicine. Approximately 33 genes contain 50 mutations that cause feline health problems or alterations in the cat's appearance. A variety of commercial laboratories can now perform cat genetic diagnostics, allowing both the veterinary clinician and the private owner to obtain DNA test results. DNA is easily obtained from a cat via a buccal swab with a standard cotton bud or cytological brush, allowing DNA samples to be easily sent to any laboratory in the world. The DNA test results identify carriers of the traits, predict the incidence of traits from breeding programs, and influence medical prognoses and treatments. An overall goal of identifying these genetic mutations is the correction of the defect via gene therapies and designer drug therapies. Thus, genetic testing is an effective preventative medicine and a potential ultimate cure. However, genetic diagnostic tests may still be novel for many veterinary practitioners and their application in the clinical setting needs to have the same scrutiny as any other diagnostic procedure. This article will review the genetic tests for the domestic cat, potential sources of error for genetic testing, and the pros and cons of DNA results in veterinary medicine. Highlighted are genetic tests specific to the individual cat, which are a part of the cat's internal genome. Copyright © 2010 Elsevier Inc. All rights reserved.

  5. Clinical investigation of radioallergosorbent test (RAST)

    International Nuclear Information System (INIS)

    Okuda, Minoru; Usami, Atsushi

    1974-01-01

    Relationship of radioallergosorbent test (RAST), intracutaneous reaction, serum IgE determination and RMCD (Rat Mast Cell Degranulation Test) in subjects with tick allergy was compared in order to investigate clinical application for nasal allergy. 1. RAST is suitable for clinical examinations as determination of IgE. Because it is simple in technique, a technical expert can treat many subjects within a short time, and the result can be decleared within 2 days. 2. RAST was high in specificity and was consistent with clinical findings. RAST positive was thought to be allergy by the antigen, but RAST negative could not deny allergy by the antigen. 3. Correlation of some degree was found to exist between RAST and intracutaneous reaction or degree of induced reaction or threshold value of antigen intracutaneous reaction. But degree of intracutaneous reaction and induced reaction and threshold value of intracutaneous reaction could not be determined from the result of RAST. 4. Determination of IgE antibody by RAST was more useful in clinical study than that of IgE or IgE antibody by RMCD. (Oyama, S.)

  6. Management of Animal Botulism Outbreaks: From Clinical Suspicion to Practical Countermeasures to Prevent or Minimize Outbreaks

    DEFF Research Database (Denmark)

    Anniballi, Fabrizio; Fiore, Alfonsina; Löfström, Charlotta

    2013-01-01

    and supportive therapies are used to treat sick animals. Once the diagnosis has been made, euthanasia is frequently advisable. Vaccine administration is subject to health authorities' permission, and it is restricted to a small number of animal species. Several measures can be adopted to prevent or minimize...

  7. Minimally invasive posterior cervical discectomy for cervical radiculopathy: technique and clinical results.

    Science.gov (United States)

    Lidar, Zvi; Salame, Khalil

    2011-12-01

    Retrospective analysis of data of all patients treated by minimally invasive posterior discectomy for cervical radiculopathy between January 2004 and February 2008. To describe our technique and report the outcome of minimally invasive posterior cervical discectomy using the MetRx tubular retractor system and surgical microscope. Although several studies have been published on posterior minimally invasive approaches to cervical radiculopathy, most have focused on decompression of the nerve root by laminoforaminotomy only without the removal of the offending disc. The hospital charts, magnetic resonance imaging studies, and follow-up records of all the patients were reviewed. Outcome was assessed by neurological status, visual analog scale (VAS) for neck and arm pain, and by the short form-36 health survey questionnaire. Thirty-two patients were included in this study. The follow-up time was 20 to 67 months (mean, 39 mo). Muscle weakness improved in all patients; sensory deficits resolved in 21 patients and improved in 7 patients. Analysis of the mean VAS for radicular pain, VAS for neck pain, and all 8 domains of the short form-36 health survey questionnaire showed significant improvement. Complications included 1 case of incidental dural tear without postoperative cerebrospinal fluid leakage and 1 case of longstanding neck pain. Minimally invasive posterior cervical discectomy is safe and effective in the management of lateral cervical disc herniation manifested by radiculopathy. In addition to eliminating some of the disadvantages of open surgical approaches, it may also have swifter symptoms resolution compared with laminoforaminotomy without discectomy.

  8. [Clinical outcomes of single-level lumbar spondylolisthesis by minimally invasive transforaminal lumbar interbody fusion with bilateral tubular channels].

    Science.gov (United States)

    Zeng, Z L; Jia, L; Yu, Y; Xu, W; Hu, X; Zhan, X H; Jia, Y W; Wang, J J; Cheng, L M

    2017-04-01

    Objective: To evaluate the clinical effectiveness of minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) for single-level lumbar spondylolisthesis treatment with bilateral Spotlight tubular channels. Methods: A total of 21 patients with lumbar spondylolisthesis whom underwent MIS-TLIF via bilateral Spotlight tubular channels were retrospectively analyzed from October 2014 to November 2015. The 21 patients included 11 males and 10 females ranged from 35 to 82 years (average aged 60.7 years). In term of spondylolisthesis category, there were 18 cases of degenerative spondylolisthesis and 3 cases of isthmic spondylolisthesis. With respect to spondylolisthesis degree, 17 cases were grade Ⅰ° and 4 cases were grade Ⅱ°. Besides, 17 cases at L(4-5) and 4 cases at L(5)-S(1)were categorized by spondylolisthesis levels. Operation duration, blood loss, postoperative drainage and intraoperative exposure time were recorded, functional improvement was defined as an improvement in the Oswestry Disability Index (ODI), Visual Analog Scale (VAS) was also employed at pre and post-operation (3 months and the last follow-up), to evaluate low back and leg pain. Furthermore, to evaluate the recovery of the intervertebral foramen and of lumbar sagittal curvature, average height of intervertebral space, Cobb angles of lumbar vertebrae and operative segments, spondylolisthesis index were measured. At the last follow-up, intervertebral fusion was assessed using Siepe evaluation criteria and the clinical outcome was assessed using the MacNab scale. Radiographic and functional outcomes were compared pre- and post-operation using the paired T test to determine the effectiveness of MIS-TLIF. Statistical significance was defined as P spondylolisthesis incidence ( t =17.1, P spondylolisthesis incidence ( t =18.6, P spondylolisthesis vertebrae were restored completely. Lastly, at the last follow-up, 12 cases of grade 1 and 7 cases of grade 2 fusion were present as determined

  9. Cavity disinfection in minimally invasive dentistry - comparative evaluation of Aloe vera and propolis: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    A R Prabhakar

    2015-01-01

    Full Text Available Context: The survival of atraumatic restorative treatment (ART restorations would probably increase if near total elimination of cariogenic microorganisms could be done in the process of cavity cleaning before going ahead with the restoration. Thus, use of naturally occurring disinfecting agents for achieving this goal could herald a new beginning in the field of contemporary minimum intervention dentistry. Aims: To evaluate the efficacy of hand instruments in excavating dental caries and comparatively evaluate the roles of Aloe vera and propolis as potential cavity disinfecting agents after minimally invasive hand excavation of dental caries. Settings and Designs: Experimental, in vivo intergroup split mouth, randomized clinical trial. Subjects and Methods: The study included Group I (Control, Group II (A. vera and Group III (propolis. Ten patients with three teeth each have occlusal/occlusoproximal lesions suitable for ART were selected. Dentinal samples were collected three times from each tooth viz., preexcavation, postexcavation and postdisinfection of the cavities. These dentinal samples were subjected to microbiological analyses for total viable count. Statistical Analysis Used: Repeated measures of analysis of variance (ANOVA with Bonferroni post-hoc test and one-way ANOVA with Tukey post-hoc test. Results: In all the three groups, significant amount of bacteria were left behind after hand excavation. Group II and Group III, in which cavities were treated with A. vera and propolis extracts respectively, showed a significant reduction in the bacterial counts when compared to control the group. Conclusions: Hand excavation alone does not completely eliminate bacteria, which may predispose treated teeth to secondary caries. Both propolis and A. vera extracts can be used as potential natural disinfecting agents, thereby embracing the concept of phytotherapy in minimum intervention dentistry.

  10. Vegetative and minimally conscious state(s) survey: attitudes of clinical neuropsychologists and speech and language therapists.

    Science.gov (United States)

    Wilson, F Colin; Harpur, Jocelyn; McConnell, Nigel

    2007-11-30

    To gauge the understanding and opinions of clinical neuropsychologists and speech and language therapists (SLT) in relation to vegetative (VS) and minimally conscious (MCS) patients relative to available practice guidelines. Semi-structured questionnaires were sent to all UK Practitioner Full Members of the BPS Division of Neuropsychology (307) and SLT managers (371) in March to April 2002 examining post qualification clinical practice, professional-family involvement and views on neuro-rehabilitation access. Difference(s) in clinical practice among clinical neuropsychologists and SLTs were observed. Some 27% returned questionnaires (n=184). Despite significant working experience, most respondents poorly defined both VS and MCS. Among clinical neuropsychologists and speech and language therapists not working with these patients, less positive attitudes regarding the value of neuro-rehabilitation were endorsed. Despite the development of SMART training for VS, there is a dearth of specific training in MCS assessment and management. The need to improve professional understanding among these staff groups is highlighted.

  11. Minimally Invasive Transforaminal Lumbar Interbody Fusion: A Perspective on Current Evidence and Clinical Knowledge

    Directory of Open Access Journals (Sweden)

    Ali Habib

    2012-01-01

    Full Text Available This paper reviews the current published data regarding open transforaminal lumbar interbody fusion (TLIF in relation to minimally invasive transforaminal lumbar interbody fusion (MI-TLIF. Introduction. MI-TLIF, a modern method for lumbar interbody arthrodesis, has allowed for a minimally invasive method to treat degenerative spinal pathologies. Currently, there is limited literature that compares TLIF directly to MI-TLIF. Thus, we seek to discuss the current literature on these techniques. Methods. Using a PubMed search, we reviewed recent publications of open and MI-TLIF, dating from 2002 to 2012. We discussed these studies and their findings in this paper, focusing on patient-reported outcomes as well as complications. Results. Data found in 14 articles of the literature was analyzed. Using these reports, we found mean follow-up was 20 months. The mean patient study size was 52. Seven of the articles directly compared outcomes of open TLIF with MI-TLIF, such as mean duration of surgery, length of post-operative stay, blood loss, and complications. Conclusion. Although high-class data comparing these two techniques is lacking, the current evidence supports MI-TLIF with outcomes comparable to that of the traditional, open technique. Further prospective, randomized studies will help to further our understanding of this minimally invasive technique.

  12. Minimally Invasive Transforaminal Lumbar Interbody Fusion: A Perspective on Current Evidence and Clinical Knowledge

    Science.gov (United States)

    Habib, Ali; Smith, Zachary A.; Lawton, Cort D.; Fessler, Richard G.

    2012-01-01

    This paper reviews the current published data regarding open transforaminal lumbar interbody fusion (TLIF) in relation to minimally invasive transforaminal lumbar interbody fusion (MI-TLIF). Introduction. MI-TLIF, a modern method for lumbar interbody arthrodesis, has allowed for a minimally invasive method to treat degenerative spinal pathologies. Currently, there is limited literature that compares TLIF directly to MI-TLIF. Thus, we seek to discuss the current literature on these techniques. Methods. Using a PubMed search, we reviewed recent publications of open and MI-TLIF, dating from 2002 to 2012. We discussed these studies and their findings in this paper, focusing on patient-reported outcomes as well as complications. Results. Data found in 14 articles of the literature was analyzed. Using these reports, we found mean follow-up was 20 months. The mean patient study size was 52. Seven of the articles directly compared outcomes of open TLIF with MI-TLIF, such as mean duration of surgery, length of post-operative stay, blood loss, and complications. Conclusion. Although high-class data comparing these two techniques is lacking, the current evidence supports MI-TLIF with outcomes comparable to that of the traditional, open technique. Further prospective, randomized studies will help to further our understanding of this minimally invasive technique. PMID:22928099

  13. Surgical Treatment of Carpal Tunnel Syndrome through a Minimal Incision on the Distal Wrist Crease: An Anatomical and Clinical Study

    Directory of Open Access Journals (Sweden)

    Hye Mi Yoo

    2015-05-01

    Full Text Available BackgroundAn anatomical analysis of the transverse carpal ligament (TCL and the surrounding structures might help in identifying effective measures to minimize complications. Here, we present a surgical technique based on an anatomical study that was successfully applied in clinical settings.MethodsUsing 13 hands from 8 formalin-fixed cadavers, we measured the TCL length and thickness, correlation between the distal wrist crease and the proximal end of the TCL, and distance between the distal end of the TCL and the palmar arch; the TCL cross sections and the thickest parts were also examined. Clinically, fasciotomy was performed on the relevant parts of 15 hands from 13 patients by making a minimally invasive incision on the distal wrist crease. Postoperatively, a two-point discrimination check was conducted in which the sensations of the first, second, and third fingertips and the palmar cutaneous branch injuries were monitored (average duration, 7 months.ResultsIn the 13 cadaveric hands, the distal wrist crease and the proximal end of the TCL were placed in the same location. The average length of the TCL and the distance from the distal TCL to the superficial palmar arch were 35.30±2.59 mm and 9.50±2.13 mm, respectively. The thickest part of the TCL was a region 25 mm distal to the distal wrist crease (average thickness, 4.00±0.57 mm. The 13 surgeries performed in the clinical settings yielded satisfactory results.ConclusionsThis peri-TCL anatomical study confirmed the safety of fasciotomy with a minimally invasive incision of the distal wrist crease. The clinical application of the technique indicated that the minimally invasive incision of the distal wrist crease was efficacious in the treatment of the carpal tunnel syndrome.

  14. Minimizing liability risks under the ACMG recommendations for reporting incidental findings in clinical exome and genome sequencing.

    Science.gov (United States)

    Evans, Barbara J

    2013-12-01

    Recent recommendations by the American College of Medical Genetics and Genomics (ACMG) for reporting incidental findings present novel ethical and legal issues. This article expresses no views on the ethical aspects of these recommendations and focuses strictly on liability risks and how to minimize them. The recommendations place labs and clinicians in a new liability environment that exposes them to intentional tort lawsuits as well to traditional suits for negligence. Intentional tort suits are especially troubling because of their potential to inflict ruinous personal financial losses on individual clinicians and laboratory personnel. This article surveys this new liability landscape and describes analytical approaches for minimizing tort liabilities. To a considerable degree, liability risks can be controlled by structuring activities in ways that make future lawsuits nonviable before the suits ever arise. Proactive liability analysis is an effective tool for minimizing tort liabilities in connection with the testing and reporting activities that the ACMG recommends.

  15. Minimally invasive laminectomy for lumbar spinal stenosis in patients with and without preoperative spondylolisthesis: clinical outcome and reoperation rates.

    Science.gov (United States)

    Alimi, Marjan; Hofstetter, Christoph P; Pyo, Se Young; Paulo, Danika; Härtl, Roger

    2015-04-01

    Surgical decompression is the intervention of choice for lumbar spinal stenosis (LSS) when nonoperative treatment has failed. Standard open laminectomy is an effective procedure, but minimally invasive laminectomy through tubular retractors is an alternative. The aim of this retrospective case series was to evaluate the clinical and radiographic outcomes of this procedure in patients who underwent LSS and to compare outcomes in patients with and without preoperative spondylolisthesis. Patients with LSS without spondylolisthesis and with stable Grade I spondylolisthesis who had undergone minimally invasive tubular laminectomy between 2004 and 2011 were included in this analysis. Demographic, perioperative, and radiographic data were collected. Clinical outcome was evaluated using the Oswestry Disability Index (ODI) and visual analog scale (VAS) scores, as well as Macnab's criteria. Among 110 patients, preoperative spondylolisthesis at the level of spinal stenosis was present in 52.5%. At a mean follow-up of 28.8 months, scoring revealed a median improvement of 16% on the ODI, 2.75 on the VAS back, and 3 on the VAS leg, compared with the preoperative baseline (p spondylolisthesis had no significant differences in their clinical outcome or reoperation rate. Minimally invasive laminectomy is an effective procedure for the treatment of LSS. Reoperation rates for instability are lower than those reported after open laminectomy. Functional improvement is similar in patients with and without preoperative spondylolisthesis. This procedure can be an alternative to open laminectomy. Routine fusion may not be indicated in all patients with LSS and spondylolisthesis.

  16. Clinical comparison of bur- and laser-prepared minimally invasive occlusal resin composite restorations: two-year follow-up.

    Science.gov (United States)

    Yazici, A Rüya; Baseren, Meserret; Gorucu, Jale

    2010-01-01

    This study evaluated the two-year clinical performance of two minimally invasive cavity preparation techniques, bur and laser, in Class I occlusal resin composite restorations. Twenty-seven patients, each having at least one pair of occlusal caries, were enrolled in this study. For each patient, one of the cavities was prepared with a diamond bur, and the other was prepared with Er, Cr:YSGG laser. The cavities were restored with a nanofilled flowable resin composite, Grandio Flow, using an etch-and-rinse adhesive, Solobond M. A total of 108 restorations were placed in molars by a single operator. The restorations were evaluated according to modified Cvar/Ryge criteria. The evaluations were performed at baseline, 6, 12, 18 and 24 months after initial placement by two calibrated operators. The Chi-square and Fisher's exact test were used for statistical analysis. All the patients were available during all evaluated periods, resulting in a recall rate of 100%. The retention rates of the restorations at 24 months were 98.1% for bur and 100% for the laser-prepared group. After 24 months, 5.6% of the bur-prepared and 7.4% of the laser-prepared restorations were rated Bravo in marginal discoloration (p > 0.05). Bur-prepared (9.3%) and laser-prepared (13%) restorations were rated Bravo in marginal adaptation (p > 0.05). There were no significant differences between the two cavity preparation techniques regarding the evaluated parameters (p > 0.05). Both cavity preparation techniques performed equally, with excellent outcomes after a 24-month period.

  17. Test-retest reliability and minimal detectable change scores for sit-to-stand-to-sit tests, the six-minute walk test, the one-leg heel-rise test, and handgrip strength in people undergoing hemodialysis.

    Science.gov (United States)

    Segura-Ortí, Eva; Martínez-Olmos, Francisco José

    2011-08-01

    Determining the relative and absolute reliability of outcomes of physical performance tests for people undergoing hemodialysis is necessary to discriminate between the true effects of exercise interventions and the inherent variability of this cohort. The aims of this study were to assess the relative reliability of sit-to-stand-to-sit tests (the STS-10, which measures the time [in seconds] required to complete 10 full stands from a sitting position, and the STS-60, which measures the number of repetitions achieved in 60 seconds), the Six-Minute Walk Test (6MWT), the one-leg heel-rise test, and the handgrip strength test and to calculate minimal detectable change (MDC) scores in people undergoing hemodialysis. This study was a prospective, nonexperimental investigation. Thirty-nine people undergoing hemodialysis at 2 clinics in Spain were contacted. Study participants performed the STS-10 (n=37), the STS-60 (n=37), and the 6MWT (n=36). At one of the settings, the participants also performed the one-leg heel-rise test (n=21) and the handgrip strength test (n=12) on both the right and the left sides. Participants attended 2 testing sessions 1 to 2 weeks apart. High intraclass correlation coefficients (≥.88) were found for all tests, suggesting good relative reliability. The MDC scores at 90% confidence intervals were as follows: 8.4 seconds for the STS-10, 4 repetitions for the STS-60, 66.3 m for the 6MWT, 3.4 kg for handgrip strength (force-generating capacity), 3.7 repetitions for the one-leg heel-rise test with the right leg, and 5.2 repetitions for the one-leg heel-rise test with the left leg. Limitations A limited sample of patients was used in this study. The STS-16, STS-60, 6MWT, one-leg heel rise test, and handgrip strength test are reliable outcome measures. The MDC scores at 90% confidence intervals for these tests will help to determine whether a change is due to error or to an intervention.

  18. Testing the minimal supersymmetric standard model with the mass of the W boson

    International Nuclear Information System (INIS)

    Heinemeyer, S.; Hollik, W.; Weber, A.M.; Stoeckinger, D.; Weiglein, G.

    2007-01-01

    We review the currently most accurate evaluation of the W boson mass, Mw, in the minimal supersymmetric standard model (MSSM). It consists of a full one-loop calculation, including the complex phase dependence, all available MSSM two-loop corrections as well as the full standard model result. We analyse the impact of the phases in the scalar quark sector on Mw and compare the prediction for Mw based on all known higher-order contributions with the experimental results. (author)

  19. A Coons Patch Spanning a Finite Number of Curves Tested for Variationally Minimizing Its Area

    Directory of Open Access Journals (Sweden)

    Daud Ahmad

    2013-01-01

    Full Text Available In surface modeling a surface frequently encountered is a Coons patch that is defined only for a boundary composed of four analytical curves. In this paper we extend the range of applicability of a Coons patch by telling how to write it for a boundary composed of an arbitrary number of boundary curves. We partition the curves in a clear and natural way into four groups and then join all the curves in each group into one analytic curve by using representations of the unit step function including one that is fully analytic. Having a well-parameterized surface, we do some calculations on it that are motivated by differential geometry but give a better optimized and possibly more smooth surface. For this, we use an ansatz consisting of the original surface plus a variational parameter multiplying the numerator part of its mean curvature function and minimize with the respect to it the rms mean curvature and decrease the area of the surface we generate. We do a complete numerical implementation for a boundary composed of five straight lines, that can model a string breaking, and get about 0.82 percent decrease of the area. Given the demonstrated ability of our optimization algorithm to reduce area by as much as 23 percent for a spanning surface not close of being a minimal surface, this much smaller fractional decrease suggests that the Coons patch we have been able to write is already close of being a minimal surface.

  20. Sensitivity and specificity of the minimal chair height standing ability test: a simple and affordable fall-risk screening instrument.

    Science.gov (United States)

    Reider, Nadia C; Naylor, Patti-Jean; Gaul, Catherine

    2015-01-01

    Fall-risk screening instruments have been underutilized in clinical settings because of their lengthy administration time, need of cumbersome equipment, and lack of validation. The primary objective of this study was to assess the validity (sensitivity and specificity) of the Minimal Chair Height Standing Ability Test (MCHSAT). The secondary objective was to develop guidelines to provide physical therapists with best-practice recommendations that can easily be implemented in clinical practice. A retrospective cohort study design was used in which falling history, major medical conditions, cognitive status (Mini-Mental State Examination), and level of independence (Independent Activities of Daily Living) were obtained for 167 community-dwelling older adults (mean age = 83.6 ± 7.3 years), residents of British Columbia, Canada. Participants MCHSAT performance was assessed using a chair whose seat height was modifiable by increments of 5 cm, starting at 47 cm and lowering after each successful attempt. Sensitivity and specificity of the MCHSAT at each chair height were calculated and plotted as a receiver operating characteristic curve. A model to identify participants with history of falls was developed using a forward logistic regression (Wald). Mean MCHSAT performance (cm) was significantly better for participants without history of falls (30.3 cm, 95% CI: 28.1-32.5 cm) than for those with history of falls (37.7 cm, 95% CI: 35.5-40.0 cm) and was the single risk factor associated with fall status (β= 1.087, P falls was 34 cm (AUC = 0.72, 95% CI: 0.63-0.82). At this threshold, sensitivity and specificity values were 75% and 62%, respectively. Using 34 cm as the optimal performance, the MCHSAT correctly identified 75% of participants with history of falls and 62% of participants without history of falls. This provides evidence that the MCHSAT is a valid screening tool for use with an older Canadian population. As a simple and inexpensive testing instrument, the

  1. Early Clinical and Radiographic Results of Minimally Invasive Anterior Approach Hip Arthroplasty

    Directory of Open Access Journals (Sweden)

    Tamara Alexandrov

    2014-01-01

    consecutive patients with 43 total hip arthroplasties performed through an anterior muscle sparing minimally invasive approach. We found the early complication rates and radiographic outcomes comparable to those reported from arthroplasties performed via traditional approaches. Complications included dislocation (2%, femur fracture (2%, greater trochanteric fracture (12%, postoperative periprosthetic intertrochanteric fracture (2%, femoral nerve palsy (5%, hematoma (2%, and postoperative iliopsoas avulsion (2%. Radiographic analysis revealed average cup anteversion of 19.6°±6.6, average cup abduction angle of 48.4°±7, stem varus of 0.9°±2, and a mean leg length discrepancy of 0.7 mm. The anterior approach to the hip is an attractive alternative to the more traditional approaches. Acceptable component placement with comparable complication rates is possible using a muscle sparing technique which may lead to faster overall recovery.

  2. Inadvertent adverse consequences of clinical and forensic hypnosis: minimizing the risks.

    Science.gov (United States)

    Eimer, Bruce N

    2012-07-01

    Hypnosis is a psychological intervention tool that can make a gamut of psychological, medical, and dental treatments work more rapidly and effectively. It can also be used profitably with some witnesses, victims, and defendants in forensic and investigative contexts as a data gathering tool. As with any other power tool, its use entails some risks. Since risks cannot be totally avoided, this article examines some ways to minimize the risks of inadvertent adverse or negative consequences as a result of the use of the hypnosis tool. Fundamentals of hypnosis risk management are covered as a foundation for beginners and as a review for experienced practitioners. Various straightforward safeguards that should be heeded by all practitioners are discussed.

  3. Two-stage classifiers that minimize PCA3 and the PSA proteolytic activity testing in the prediction of prostate cancer recurrence after radical prostatectomy.

    Science.gov (United States)

    Jeske, Daniel R; Linehan, Jenifer A; Wilson, Timothy G; Kawachi, Mark H; Wittig, Kristina; Lamparska, Katarzya; Amparo, Camille; Mejia, Rosa; Lai, Fang; Georganopoulou, Dimitra; Smith, Steven S

    2017-12-01

    Early biochemical recurrence after prostate cancer surgery is associated with higher risk of aggressive disease and cancer specific death. Many new tests are being developed that will predict the presence of indicators of aggressive disease like early biochemical recurrence. Since recurrence occurs in less than 10% of patients treated for prostate cancer, validation of such tests will require expensive testing on large patient groups. Moreover, clinical application of the validated test requires that each new patient be tested. In this report we introduce a two-stage classifier system that minimizes the number of patients that must be tested in both the validation and clinical application of any new test for recurrence. Expressed prostatic secretion specimens were prospectively collected from 450 patients prior to robot-assisted radical prostatectomy for prostate cancer. Patients were followed for 2.5 years for evidence of biochemical recurrence. Standard clinical parameters, the levels proteolytic activity of prostate specific antigen (PSA) and the levels of PCA3 RNA, PSA RNA and TMPRSS2:ERG fusion RNA were determined in each prospective patient specimen for subsequent correlation with biochemical recurrence. While levels of PCA3 and PSA proteolytic activity (PPA) in prostatic secretions provided an effective pre-surgical predictor of early biochemical recurrence in prostate cancer, application of the two-stage classifier shows that only 60% of the patients need these tests. Two-stage classifiers can provide a parsimonious approach to both the validation and clinical application of biomarker-based tests. Adoption of the two-stage neutral zone classifier can reduce unnecessary testing in prostate cancer treatment.

  4. Realizing the clinical potential of cancer nanotechnology by minimizing toxicologic and targeted delivery concerns.

    Science.gov (United States)

    Singh, Sanjay; Sharma, Arati; Robertson, Gavin P

    2012-11-15

    Nanotechnology has the potential to make smart drugs that would be capable of targeting cancer but not normal cells and to load combinations of cooperating agents into a single nanosized particle to more effectively treat this disease. However, to realize the full potential of this technology, the negative aspects associated with these nanoparticles need to be overcome. This review discusses concerns in the field limiting realization of the full clinical potential of this technology, which are toxicity and targeted delivery. Strategies to overcome these hurdles are also reviewed, which could lead to attainment of the full clinical potential of this exciting technology. ©2012 AACR.

  5. Realizing the Clinical Potential of Cancer Nanotechnology by Minimizing Toxicological and Targeted Delivery Concerns

    Science.gov (United States)

    Singh, Sanjay; Sharma, Arati; Robertson, Gavin P.

    2013-01-01

    Nanotechnology has the potential to make smart drugs that would be capable of targeting cancer but not normal cells and loading combinations of cooperating agents into a single nano-sized particle to more effectively treat this disease. However, to realize the full potential of this technology the negative aspects associated with these nanoparticles needs to be overcome. This review discusses concerns in the field limiting realization of the full clinical potential of this technology, which are toxicity and targeted delivery. Strategies to overcome these hurdles are also reviewed which could lead to attainment of the full clinical potential of this exciting technology. PMID:23139207

  6. Solar system tests for realistic f(T) models with non-minimal torsion-matter coupling

    Energy Technology Data Exchange (ETDEWEB)

    Lin, Rui-Hui; Zhai, Xiang-Hua; Li, Xin-Zhou [Shanghai Normal University, Shanghai United Center for Astrophysics (SUCA), Shanghai (China)

    2017-08-15

    In the previous paper, we have constructed two f(T) models with non-minimal torsion-matter coupling extension, which are successful in describing the evolution history of the Universe including the radiation-dominated era, the matter-dominated era, and the present accelerating expansion. Meantime, the significant advantage of these models is that they could avoid the cosmological constant problem of ΛCDM. However, the non-minimal coupling between matter and torsion will affect the tests of the Solar system. In this paper, we study the effects of the Solar system in these models, including the gravitation redshift, geodetic effect and perihelion precession. We find that Model I can pass all three of the Solar system tests. For Model II, the parameter is constrained by the uncertainties of the planets' estimated perihelion precessions. (orig.)

  7. Clinical Effectiveness of Modified Laparoscopic Fimbrioplasty for the Treatment of Minimal Endometriosis and Unexplained Infertility

    Directory of Open Access Journals (Sweden)

    Sarah E. Franjoine

    2015-01-01

    Full Text Available Objective. To study the reproductive outcomes of modified laparoscopic fimbrioplasty (MLF, a surgical technique designed to increase the working surface area of the fimbriated end of the fallopian tube. We postulated that an improvement in fimbrial function through MLF will improve reproductive outcomes. Design. Retrospective cohort study. Setting. Academic tertiary-care medical center. Patients. Women with minimal endometriosis or unexplained infertility, who underwent MLF during diagnostic laparoscopy (n=50 or diagnostic laparoscopy alone (n=87. Intervention. MLF involved gentle, circumferential dilatation of the fimbria and lysis of fimbrial adhesions bridging the fimbrial folds. Main Outcome Measures. The primary outcome was pregnancy rate and the secondary outcome was time to pregnancy. Results. The pregnancy rate for the MLF group was 40.0%, compared to 28.7% for the control group. The average time to pregnancy for the MLF group was 13 weeks, compared to 18 weeks for the control group. The pregnancy rate in the MLF group was significantly higher for patients ≤35 ys (51.5% versus 28.8%, but not for those >35 ys (17.6% versus 28.6%. Conclusion. MLF was associated with a significant increase in pregnancy rate for patients ≤35 ys.

  8. Test-retest reliability and minimal detectable change scores for fitness assessment in older adults with type 2 diabetes.

    Science.gov (United States)

    Alfonso-Rosa, Rosa M; Del Pozo-Cruz, Borja; Del Pozo-Cruz, Jesus; Sañudo, Borja; Rogers, Michael E

    2014-01-01

    To assess the intraclass correlation coefficients (ICCs) and to determine the minimal detectable change (MDC95 ) scores of the data for the Hand Grip Strength Test, the Chair Sit and Reach Test (CSRT), the Timed "Up and Go" (TUG) test, the 6-Minute Walk Test (6MWT) and 30 seconds Sit to Stand Test (30s-STS) test in older adults with type 2 NIDDM. Test-retest reliability. Eighteen subject participated in two sessions (1 week apart), which included the different tests. High ICCs (≥ 0.92) were found for all tests. The MDC₉₅ scores were as follows: 4.0 kg for Hand Grip Strength Tests, 7.5 cm for the right leg-CSRT, 9.0 cm for the left leg-CSRT, 1.0 second for the TUG test, 27 m for the 6MWT, and 3.3 repetitions for the 30s-STS test. All tests evaluated are reliable outcome measures for type 2 NIDDM patients. This study has generated novel MCD₉₅ data, which will assist nursing practitioners in both prescribing the most beneficial exercise and interpreting posttreatment changes after rehabilitation in patients with T2DM. © 2013 Association of Rehabilitation Nurses.

  9. Clinical tests with improved disposable diapers.

    Science.gov (United States)

    Campbell, R L

    1987-01-01

    Etiologic factors in the development of episodic diaper dermatitis include skin wetness and skin damage from fecal enzymes. In addition, when urine and feces mix, the activities of fecal enzymes increase as the pH rises from production of ammonia. An improved disposable diaper has been developed to provide better control of these factors by improved wetness and pH control. The improved diaper contains absorbent gelling materials (AGMs) blended into the diaper's cellulose core. AGMs are nontoxic, cross-linked polyacrylate polymers. They bind water tightly, give pH control by providing a buffering capacity, and in a diaper help to segregate urine and feces, thereby reducing the potential for increases in pH from ammonia production. To assess the effectiveness of this diaper, four 16-week clinical home-use tests were conducted with the AGM disposable versus conventional cellulose core disposable and home-laundered cloth diapers. Rigid group randomized stratification of infant maturity, diet, and initial level of diaper dermatitis provided control of factors other than the diaper that impact on development of diaper dermatitis. Skin wetness as measured by transepidermal water loss immediately after diaper removal, skin pH, and blinded visual evaluation of diaper dermatitis were used as skin condition measures. The use of AGM disposable diapers was associated with significantly reduced skin wetness and closer to normal skin pH as compared with the use of conventional disposable or home-laundered cloth diapers. Considered as an aggregate, the four clinical studies showed that AGM disposable diapers provide a better diaper environment and are associated with significantly lower degrees of diaper dermatitis than conventional disposable and home-laundered cloth diapers.

  10. Minimal care--a new concept for the management of urinary incontinence in an open access, interdisciplinary incontinence clinic. The way ahead?

    DEFF Research Database (Denmark)

    Andersen, J T; Sander, P

    1996-01-01

    A new concept for assessment and treatment of urinary incontinence in an open access, interdisciplinary clinic is evaluated prospectively. Based on the patients needs and expectations, a minimal relevant investigative programme was planned. The patients were primarily offered conservative, non...... of the patients were managed by conservative treatment modalities whereas only 10% of the patients were referred to in-hospital treatment with invasive treatment modalities, mainly surgical procedures for urinary incontinence. Subjectively, 68% felt cured or very much improved, 23% experienced improvement and 9......% did not report benefit of the treatment. Objectively, significantly diminished leakage of urine could be demonstrated in 71% of the patients by the pad weighing test. Our results demonstrate that an open access, interdisciplinary clinic is well accepted by the patients and effective for the evaluation...

  11. Establishing Minimal Clinically Important Difference of Spinal Cord Stimulation Therapy in Post-Laminectomy Syndrome.

    Science.gov (United States)

    Paul, Alexandra R; Kumar, Vignessh; Roth, Steven; Gooch, M Reid; Pilitsis, Julie G

    2017-12-01

    The concept of minimum clinically important difference (MCID) has been shown to be effective in spine surgery to differentiate between clinically insignificant and significant improvements as determined by the patient. The MCID for spinal cord stimulation (SCS) to date has not been established. We sought to determine the MCID for SCS therapy for failed laminectomy syndromes. Preoperative and 6-mo outcomes were assessed prospectively, including the Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), and McGill and Visual Analog Survey questionnaires. Patients were asked: (1) are you satisfied with SCS therapy and (2) would you have the surgery again. Four methods of calculating the MCID were utilized. Forty-eight patients who underwent placement of an SCS between 2012 and 2014 were reviewed. The 4 calculation methods yielded a range of outcome scores (ODI 8.2-13.3, BDI 3.2-7, McGill 0.3-1.3, and Visual Analog Scale [VAS] 1.2-3.7). The maximum area under the curve was observed for the ODI, BDI, and VAS (0.73, 0.81, and 0.89, respectively), which signifies acceptable accuracy in distinguishing responders from nonresponders with the receiver operating characteristic method and suggests that VAS may be the most sensitive in determining meaningful change for the patient. The MCID for SCS placement was calculated using 4 different methods. The results are similar to calculations for the MCID for many lumbar and cervical procedures done for pain. Our results suggest that an improvement of 1.2 to 3.7 points on the VAS scale and 8.2 to 13.3 points on the ODI is clinically meaningful to the patient. Further defining the MCID for SCS therapy will remain of utmost importance in order to justify the cost of the procedure. Copyright © 2017 by the Congress of Neurological Surgeons

  12. Minimally invasive total knee arthroplasty: comparison of jig-based technique versus computer navigation for clinical and alignment outcome.

    Science.gov (United States)

    Hasegawa, Masahiro; Yoshida, Kakunoshin; Wakabayashi, Hiroki; Sudo, Akihiro

    2011-06-01

    Correct alignment of the leg and positioning of the components are important factors in good long-term outcome of total knee arthroplasty (TKA). Computer-assisted navigation systems were introduced to improve component alignment accuracies. The three main hypotheses of this study were that the navigated compared to jig-based patient will show the following: (1) No difference in clinical outcomes. (2) Better alignment in the frontal and sagittal plane. (3) Better rotational positioning of components. The authors evaluated 100 patients who had minimally invasive TKA using either an image-free computer-assisted navigation system (n=50) or a jig-based technique (n=50). Six months postoperatively, clinical and radiological evaluations were performed using full-length standing anteroposterior and lateral radiographs and CT scans of the knee. Knee Society knee score, function score, and range of motion were comparable in the two groups after surgery. The percentage of patients with a frontal tibiofemoral angle within ±3° of the ideal was significantly higher in the navigated group than in the jig-based group (94% vs. 78%, respectively; P=0.041). No significant differences were found between groups in terms of the frontal and sagittal planes as well as rotational alignment of the femoral or tibial components. Computer-assisted TKA gives a better correction of alignment of the leg compared with jig-based TKA when combined with a minimally invasive surgical approach.

  13. Testing Mean Differences among Groups: Multivariate and Repeated Measures Analysis with Minimal Assumptions.

    Science.gov (United States)

    Bathke, Arne C; Friedrich, Sarah; Pauly, Markus; Konietschke, Frank; Staffen, Wolfgang; Strobl, Nicolas; Höller, Yvonne

    2018-03-22

    To date, there is a lack of satisfactory inferential techniques for the analysis of multivariate data in factorial designs, when only minimal assumptions on the data can be made. Presently available methods are limited to very particular study designs or assume either multivariate normality or equal covariance matrices across groups, or they do not allow for an assessment of the interaction effects across within-subjects and between-subjects variables. We propose and methodologically validate a parametric bootstrap approach that does not suffer from any of the above limitations, and thus provides a rather general and comprehensive methodological route to inference for multivariate and repeated measures data. As an example application, we consider data from two different Alzheimer's disease (AD) examination modalities that may be used for precise and early diagnosis, namely, single-photon emission computed tomography (SPECT) and electroencephalogram (EEG). These data violate the assumptions of classical multivariate methods, and indeed classical methods would not have yielded the same conclusions with regards to some of the factors involved.

  14. Minimal-invasive core needle biopsy of head and neck malignancies: Clinical evaluation for radiation oncology

    International Nuclear Information System (INIS)

    Pfeiffer, Jens; Kayser, Lis; Ridder, Gerd J.

    2009-01-01

    Background and purpose: Neck masses are common presentations of cancer and require tissue sampling to establish a diagnosis prior to the institution of adequate therapy. The purpose of this study was to evaluate the specific use and potential advantages of core needle biopsy (CNB) for radiation oncology in the head and neck. Materials and methods: We performed a retrospective analysis of 346 CNB procedures implemented in 165 patients with cervicofacial masses over a period of 56 months. Seventy-three patients had a history of malignancy, 43 had previously received radiation. Results: High-quality tissue cores were obtained from all patients. The target lesion was correctly sampled in 92.1% of patients. Final diagnosis was malignant in 115 patients, of whom 78 received radiotherapy. One biopsy result was false-negative. CNB was equally successful in the pre-irradiated patients and enabled institution of therapy in 92.3% of lymphoma patients. Conclusions: CNB is an efficient tool for tissue sampling of head and neck masses. The potential advantages of CNB for radiation oncology over fine needle aspiration and open surgical biopsy are discussed. CNB enables clinicians to make optimal therapeutic strategies and facilitates prompt referral to the relevant clinical team, both at initial presentation and during follow-up

  15. Randomized clinical trial on percutaneous minimally invasive osteosynthesis of fractures of the distal extremity of the radius,

    Directory of Open Access Journals (Sweden)

    Marcio Aurélio Aita

    2014-06-01

    Full Text Available OBJECTIVES: the purpose of this study was to compare the postoperative radiological and clinical outcomes with minimally invasive percutaneous osteosynthesis using three implants: volar locking plate, intramedullary nail system and nonbridging external fixator for distal radius fractures.METHODS: forty-eight patients (A group, 16; B group 16; C group 16 underwent minimally invasive percutaneous osteosynthesis of reductible and unstable displaced (Type IIB by Rayhack Classification distal radius fractures. In B group intramedullary nail system was used, in A group the patients were treated with volar locking plate and in C group the patients were treated by nonbridging external fixator from January 2011 to December 2012. The mean follow-up period was 12 months. Radiologic parameters, range of motion, grip strength, and disability of the arm, shoulder, and hand score were evaluated at each examination (3rd and 6th week, and 12th months. The visual analog scale of wrist pain and complications were assessed at the final follow-up.RESULTS: the groups did not differ significantly in radiological outcomes after 12 months, but the clinical results, VAS scale and dash score in group A (volar locking plate and B (nail intramedullary were statistically significantly better than that of C group (nonbridging external fixator. One patient underwent an osteosynthesis with nail intramedullary and another with external fixator (C group developed persistent pain near the site of the superficial radial nerve because of the distal's screw and pins, respectively.CONCLUSION: in clinical parameters, significant differences in outcomes were found between groups A and B after six weeks versus C group.

  16. Effects of common chronic medical conditions on psychometric tests used to diagnose minimal hepatic encephalopathy

    DEFF Research Database (Denmark)

    Lauridsen, M M; Poulsen, L; Rasmussen, C K

    2016-01-01

    Many chronic medical conditions are accompanied by cognitive disturbances but these have only to a very limited extent been psychometrically quantified. An exception is liver cirrhosis where hepatic encephalopathy is an inherent risk and mild forms are diagnosed by psychometric tests. The preferred...

  17. A novel flapless approach versus minimally invasive surgery in periodontal regeneration with enamel matrix derivative proteins: a 24-month randomized controlled clinical trial.

    Science.gov (United States)

    Aimetti, Mario; Ferrarotti, Francesco; Mariani, Giulia Maria; Romano, Federica

    2017-01-01

    This investigation was designed to compare the effectiveness of enamel matrix derivative (EMD) proteins in combination with flapless or flap procedure in periodontal regeneration of deep intrabony defects. Thirty chronic periodontitis patients who had at least one residual periodontal defect with an intrabony component of ≥3 mm were consecutively enrolled. Defects were randomly assigned to test or control treatments which both consisted of the use of EMD to reach periodontal regeneration. Test sites (n = 15) were treated according to a novel flapless approach, whereas control sites (n = 15) by means of minimally invasive surgery (MIST). Clinical and radiographic parameters were recorded at baseline, 12 and 24 months post-operatively. Both therapeutic modalities yielded similar probing depth (PD) reduction and clinical attachment level (CAL) gain at 24 months. In flapless-treated sites, a mean PD reduction of 3.6 ± 1.0 mm and a CAL gain of 3.2 ± 1.1 mm were observed. In the MIST group, they were 3.7 ± 0.6 and 3.6 ± 0.9 mm. The operative chair time was twice as long in the MIST compared to the flapless group, whereas comparable patient-oriented outcomes were observed. The flapless procedure may be successfully applied in the regenerative treatment of deep intrabony defects reaching clinical outcomes comparable with those of minimally invasive surgical approaches and may present important advantages in terms of reduction of operative chair time. The use of EMD as an adjunct to non-surgical periodontal treatment may be considered a suitable option to treat defects mainly in the anterior sextants.

  18. Clinical efficacy of buprenorphine to minimize distress in MRL/lpr mice

    Science.gov (United States)

    Swenson, Julie; Olgun, Selen; Radjavi, Ali; Kaur, Taranjit; Reilly, Christopher M.

    2007-01-01

    MRL/MpJ-Faslpr (MRL/lpr) mice are an accepted animal model to study human systemic lupus erythematosus. We tested if a commonly used analgesic (buprenorphine hydrochloride) would reduce pain and distress in these mice without impacting the progression of autoimmune disease. Female MRL/lpr mice were randomly separated into four groups. Experimental groups received cyclophosphamide (25 mg/kg i.p. weekly), buprenorphine (0.09 mg/kg/mouse/day via drinking water), or cyclophosphamide + buprenorphine from 11 - 21 weeks of age. Controls received no treatments. Mice were monitored daily by a licensed veterinarian (blinded observer) and assigned a score weekly on parameters associated with pain and distress as well as progression of disease. Proteinuria was measured weekly, and serum anti-dsDNA antibody levels were determined at 11, 15, and 18 weeks of age. At 21 weeks of age, the animals were euthanized and the kidneys and spleens were removed for evaluation. Regardless of the parameter observed, buprenorphine did not significantly decrease distress when compared to the controls. Buprenorphine did not alter the progression of autoimmune disease, based on characteristics of splenic architecture and splenocyte cell profiles, development of lymphadenopathy, or kidney histology as compared to controls. This study indicates that buprenorphine at this dose and route of administration was ineffective in reducing distress associated with disease progression in the MRL/lpr strain. More studies are needed to determine if, at a different dose or route, buprenorphine would be useful as adjunctive therapy in reducing distress in MRL/lpr mice. PMID:17490635

  19. Wedge-Splitting Test – Determination of Minimal Starting Notch Length for Various Cement Based Composites

    Czech Academy of Sciences Publication Activity Database

    Seitl, Stanislav; Klusák, Jan; Veselý, V.; Řoutil, L.

    452-453, - (2011), s. 81-84 ISSN 1013-9826 R&D Projects: GA AV ČR KJB200410901; GA ČR GA103/08/0963 Institutional research plan: CEZ:AV0Z20410507 Keywords : wedge-splitting test, cementitious composites, quasi-brittle fracture, brittle fracture Subject RIV: JL - Materials Fatigue, Friction Mechanics www.scientific.net

  20. Errors in the Total Testing Process in the Clinical Chemistry ...

    African Journals Online (AJOL)

    2018-03-01

    Mar 1, 2018 ... and post-analytical errors that undermine laboratory quality status helps to put a new strategy to minimize and control errors, and improve processes. Therefore, the aim of this study was to assess errors in TTP in the Clinical. Chemistry laboratory of UOG Hospital. METHODS AND MATERIALS. Study area: ...

  1. Interrater and Test-Retest Reliability and Minimal Detectable Change of the Balance Evaluation Systems Test (BESTest) and Subsystems With Community-Dwelling Older Adults.

    Science.gov (United States)

    Wang-Hsu, Elizabeth; Smith, Susan S

    2017-01-10

    Falls are a common cause of injuries and hospital admissions in older adults. Balance limitation is a potentially modifiable factor contributing to falls. The Balance Evaluation Systems Test (BESTest), a clinical balance measure, categorizes balance into 6 underlying subsystems. Each of the subsystems is scored individually and summed to obtain a total score. The reliability of the BESTest and its individual subsystems has been reported in patients with various neurological disorders and cancer survivors. However, the reliability and minimal detectable change (MDC) of the BESTest with community-dwelling older adults have not been reported. The purposes of our study were to (1) determine the interrater and test-retest reliability of the BESTest total and subsystem scores; and (2) estimate the MDC of the BESTest and its individual subsystem scores with community-dwelling older adults. We used a prospective cohort methodological design. Community-dwelling older adults (N = 70; aged 70-94 years; mean = 85.0 [5.5] years) were recruited from a senior independent living community. Trained testers (N = 3) administered the BESTest. All participants were tested with the BESTest by the same tester initially and then retested 7 to 14 days later. With 32 of the participants, a second tester concurrently scored the retest for interrater reliability. Testers were blinded to each other's scores. Intraclass correlation coefficients [ICC(2,1)] were used to determine the interrater and test-retest reliability. Test-retest reliability was also analyzed using method error and the associated coefficients of variation (CVME). MDC was calculated using standard error of measurement. Interrater reliability (N = 32) of the BESTest total score was ICC(2, 1) = 0.97 (95% confidence interval [CI], 0.94-0.99). The ICCs for the individual subsystem scores ranged from 0.85 to 0.94. Test-retest reliability (N = 70) of the BESTest total score was ICC(2,1) = 0.93 (95% CI, 0.89-0.96). ICCs for the

  2. Clinical test for Attention Enhancement System.

    Science.gov (United States)

    Cho, Baek-Hwan; Ku, Jeonghun; Jang, Dongpyo; Lee, Jaemin; Oh, Myungjin; Kim, Hun; Lee, Janghan; Kim, Jaeseok; Kim, Inyoung; Kim, Sunill

    2002-01-01

    Attention Deficit Hyperactivity Disorder (ADHD) is a childhood syndrome characterized by short attention span, impulsiveness, and hyperactivity, which often leads to learning disabilities and various behavioral problems. The prevalence rates for ADHD varied from a low of 2.0% to a high of 6.3% in 1992 statistics, and it may be higher now. Using Virtual Environments and Neurofeedback, we have developed an Attention Enhancement System for treating ADHD. And we made a clinical test. Classroom-based virtual environments are constructed for intimacy and intensive attention enhancement. In this basic virtual environment, subjects performed some training sessions. There are two kinds of training sessions. One is Virtual Reality Cognitive Training (VRCT) and the other is Virtual Reality Neurofeedback Training (VRNT). In VRNT, we made a change in the virtual environment by Neurofeedback. Namely, if the Beta ratio is greater than the specified threshold level, the change as positive reinforce is created in the virtual environment. 50 subjects, aged 14 to 18, who had committed crimes and had been isolated in a reformatory took part in this study. They were randomly assigned to one of five 10-subject groups: a control Group, two placebo groups, and two experimental groups. The experimental groups and the placebo groups underwent 10 sessions over two weeks. The control group underwent no training session during the same period of time. While the experimental groups used HMD and Head Tracker in each session, the placebo groups used only a computer monitor. Consequently, only the experimental Groups could look around the virtual classroom. Besides that, Placebo Group 1 and Experimental Group 1 performed the same task(Neurofeedback Training), and Placebo Group 2 and Experimental Group 2 also performed the same task(Cognitive Training). All subjects Continuous Performance Task(CPT) before and after all training sessions. In the number of correct answers, omission errors and signal

  3. Minimal Hepatic Encephalopathy

    Directory of Open Access Journals (Sweden)

    Laura M Stinton

    2013-01-01

    Full Text Available Minimal hepatic encephalopathy (MHE is the earliest form of hepatic encephalopathy and can affect up to 80% of cirrhotic patients. By definition, it has no obvious clinical manifestation and is characterized by neurocognitive impairment in attention, vigilance and integrative function. Although often not considered to be clinically relevant and, therefore, not diagnosed or treated, MHE has been shown to affect daily functioning, quality of life, driving and overall mortality. The diagnosis of MHE has traditionally been achieved through neuropsychological examination, psychometric tests or the newer critical flicker frequency test. A new smartphone application (EncephalApp Stroop Test may serve to function as a screening tool for patients requiring further testing. In addition to physician reporting and driving restrictions, medical treatment for MHE includes non-absorbable disaccharides (eg, lactulose, probiotics or rifaximin. Liver transplantation may not result in reversal of the cognitive deficits associated with MHE.

  4. Minimal hepatic encephalopathy.

    Science.gov (United States)

    Stinton, Laura M; Jayakumar, Saumya

    2013-10-01

    Minimal hepatic encephalopathy (MHE) is the earliest form of hepatic encephalopathy and can affect up to 80% of cirrhotic patients. By definition, it has no obvious clinical manifestation and is characterized by neurocognitive impairment in attention, vigilance and integrative function. Although often not considered to be clinically relevant and, therefore, not diagnosed or treated, MHE has been shown to affect daily functioning, quality of life, driving and overall mortality. The diagnosis of MHE has traditionally been achieved through neuropsychological examination, psychometric tests or the newer critical flicker frequency test. A new smartphone application (EncephalApp Stroop Test) may serve to function as a screening tool for patients requiring further testing. In addition to physician reporting and driving restrictions, medical treatment for MHE includes non-absorbable disaccharides (eg, lactulose), probiotics or rifaximin. Liver transplantation may not result in reversal of the cognitive deficits associated with MHE.

  5. Towards reporting standards for neuropsychological study results: A proposal to minimize communication errors with standardized qualitative descriptors for normalized test scores.

    Science.gov (United States)

    Schoenberg, Mike R; Rum, Ruba S

    2017-11-01

    Rapid, clear and efficient communication of neuropsychological results is essential to benefit patient care. Errors in communication are a lead cause of medical errors; nevertheless, there remains a lack of consistency in how neuropsychological scores are communicated. A major limitation in the communication of neuropsychological results is the inconsistent use of qualitative descriptors for standardized test scores and the use of vague terminology. PubMed search from 1 Jan 2007 to 1 Aug 2016 to identify guidelines or consensus statements for the description and reporting of qualitative terms to communicate neuropsychological test scores was conducted. The review found the use of confusing and overlapping terms to describe various ranges of percentile standardized test scores. In response, we propose a simplified set of qualitative descriptors for normalized test scores (Q-Simple) as a means to reduce errors in communicating test results. The Q-Simple qualitative terms are: 'very superior', 'superior', 'high average', 'average', 'low average', 'borderline' and 'abnormal/impaired'. A case example illustrates the proposed Q-Simple qualitative classification system to communicate neuropsychological results for neurosurgical planning. The Q-Simple qualitative descriptor system is aimed as a means to improve and standardize communication of standardized neuropsychological test scores. Research are needed to further evaluate neuropsychological communication errors. Conveying the clinical implications of neuropsychological results in a manner that minimizes risk for communication errors is a quintessential component of evidence-based practice. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. General cognition predicts post-stroke recovery defined through minimal clinically important difference (MCID): a cohort study in an Italian rehabilitation clinic.

    Science.gov (United States)

    Ginex, V; Vanacore, N; Lacorte, E; Sozzi, M; Pisani, L; Corbo, M; Clerici, F

    2015-10-01

    In the field of rehabilitation it is crucial to define if changes in functional scores correspond to relevant clinical improvements. To assess whether cognition affects motor recovery in post-stroke patients using a clinical meaningful criterion: the minimal clinically important difference (MCID). Retrospective cohort study. Inpatient rehabilitation clinic Two hundred nine first-ever stroke patients undergoing a post-acute inpatient rehabilitation. Cognitive status was assessed with the cognitive FIM and the Mini-Mental State Examination (MMSE). The response to the rehabilitation was defined as the achievement of the MCID between admission and discharge in the motor FIM (responder) and both in the motor and in the cognitive FIM (best-responder). Subjects with a baseline higher MMSE>24.9 had a near four-fold higher probability of being responder (OR 3.91; 95% CI 1.72-8.89) and a two-fold higher probability of being best-responder (OR 2.69; 95% CI 1.24-5.84) on motor FIM as compared to those with a MMSE≤24.9. A duration of the rehabilitation of 55-61 days implies a three-fold higher probability (OR 3.17; 95% CI 1.15-8.72) to be responder as compared to shorter period of treatment; a treatment >61 days does not involve a greater probability of response. This is the first study that examined post-stroke motor recovery mainly in terms of clinical relevance (MCID). Subjects with a higher cognitive level are more likely to achieve a clinically meaningful recovery. MCID can be applied extensively to post-stroke patients undergoing to an inpatient rehabilitation in order to have a clinically useful instrument that assess the recovery.

  7. Minimally invasive decompression surgery for lumbar spinal stenosis with degenerative scoliosis: Predictive factors of radiographic and clinical outcomes.

    Science.gov (United States)

    Minamide, Akihito; Yoshida, Munehito; Iwahashi, Hiroki; Simpson, Andrew K; Yamada, Hiroshi; Hashizume, Hiroshi; Nakagawa, Yukihiro; Iwasaki, Hiroshi; Tsutsui, Shunji; Kagotani, Ryohei; Sonekatsu, Mayumi; Sasaki, Takahide; Shinto, Kazunori; Deguchi, Tsuyoshi

    2017-05-01

    There is ongoing controversy regarding the most appropriate surgical treatment for lumbar spinal stenosis (LSS) with concurrent degenerative lumbar scoliosis (DLS): decompression alone, decompression with limited spinal fusion, or long spinal fusion for deformity correction. The coexistence of degenerative stenosis and deformity is a common scenario; Nonetheless, selecting the appropriate surgical intervention requires thorough understanding of the patients clinical symptomatology as well as radiographic parameters. Minimally invasive (MIS) decompression surgery was performed for LSS patients with DLS. The aims of this study were (1) to investigate the clinical outcomes of MIS decompression surgery in LSS patients with DLS, and (2) to identify the predictive factors for both radiographic and clinical outcomes after MIS surgery. 438 consecutive patients were enrolled in this study. Inclusion criteria was evidence of LSS and DLS with coronal curvature measuring greater than 10°. The Japanese Orthopaedic Association (JOA) score, JOA recovery rate, low back pain (LBP), and radiographic features were evaluated preoperatively and at over 2 years postoperatively. Of the 438 patients, 122 were included in final analysis, with a mean follow-up of 2.4 years. The JOA recovery rate was 47.6%. LBP was significantly improved at final follow-up. Cobb angle was maintained for 2 years postoperatively (p = 0.159). Clinical outcomes in foraminal stenosis patients were significantly related to sex, preoperative high Cobb angle and progression of scoliosis (p = 0.008). In the severe scoliosis patients, the JOA recovery was 44%, and was significantly depended on progression of scoliosis (Cobb angle: preoperation 29.6°, 2-years follow-up 36.9°) and mismatch between the pelvic incidence (PI) and the lumbar lordosis (LL) (preoperative PI-LL 35.5 ± 21.2°) (p = 0.028). This study investigated clinical outcomes of MIS decompression surgery in LSS patients with DLS. The predictive

  8. Evaluation of a simple, non-surgical concept for management of urinary incontinence (minimal care) in an open-access, interdisciplinary incontinence clinic

    DEFF Research Database (Denmark)

    Sander, P; Mouritsen, L; Andersen, J T

    2000-01-01

    Our objective was to evaluate a new concept for assessment and treatment of urinary incontinence in an open-access, interdisciplinary incontinence clinic. A standardized program for investigation and treatment of incontinence was based on minimal relevant investigations, primarily non-surgical tr......Our objective was to evaluate a new concept for assessment and treatment of urinary incontinence in an open-access, interdisciplinary incontinence clinic. A standardized program for investigation and treatment of incontinence was based on minimal relevant investigations, primarily non....... The minimal care program and interdisciplinary structure in the incontinence clinic offer effective and low cost treatment for urinary incontinence. The open-access, interdisciplinary incontinence clinic model is recommended. Neurourol. Urodynam. 18:9-17, 2000....

  9. Minimal Clinically Important Difference (MCID) in Allergic Rhinitis: Agency for Healthcare Research and Quality or Anchor-Based Thresholds?

    Science.gov (United States)

    Meltzer, Eli O; Wallace, Dana; Dykewicz, Mark; Shneyer, Lucy

    2016-01-01

    In 2013, the Agency for Healthcare Research and Quality (AHRQ) recommended that allergic rhinitis (AR) studies calculate a minimal clinically important difference (MCID) based on an estimated threshold equal to 30% of the maximum total nasal symptom score. Applying this threshold, their data showed no differences between well-established treatments, and a subsequent analysis using prescribing information found no differences between active treatments and placebo controls. The objective of this study was to demonstrate the application of an evidence-based model to determine MCIDs for AR studies, with an absolute value for an anchor-based threshold and validated methods for calculating distribution-based thresholds. Using the same studies as the AHRQ report, anchor- and distribution-based MCID thresholds were determined for 3 clinical comparisons identified by the AHRQ: (1) oral antihistamine+intranasal corticosteroid (INCS) versus INCS, (2) montelukast versus INCS, and (3) intranasal antihistamine+INCS in a single device versus the monotherapies. The outcomes were compared with those reported using the AHRQ threshold. No treatment comparison met the AHRQ-defined MCID threshold; all treatments were determined to be equivalent for all 3 queries. In contrast, the evidence-based model revealed some differences between treatments: INCS > montelukast; intranasal antihistamine+INCS > either monotherapy. No clinically relevant benefit was observed for adding an oral antihistamine to INCS, but some studies were not optimal choices for quantitative determination of MCIDs. Updating the literature search revealed no additional studies that met the AHRQ inclusion criteria. The evidence-based threshold for MCID determination for AR studies should supersede the threshold recommended in the AHRQ report. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  10. A New Agility Test for Adults: Its Test-Retest Reliability and Minimal Detectable Change in Untrained Women and Men Aged 28-55.

    Science.gov (United States)

    Manderoos, Sirpa A; Vaara, Mariitta E; Mäki, P Juhani; Mälkiä, Esko A; Aunola, Sirkka K; Karppi, Sirkka-Liisa

    2016-08-01

    Manderoos, SA, Vaara, ME, Mäki, PJ, Mälkiä, EA, Aunola, SK, and Karppi, S-L. A new agility test for adults: its test-retest reliability and minimal detectable change in untrained women and men aged 28-55. J Strength Cond Res 30(8): 2226-2234, 2016-The aims of this study were to present a new Agility Test for Adults (ATA), to investigate its test-retest reliability and to quantify minimal detectable change at the 95% confidence interval (MDC95). Both the relative and absolute reliabilities were evaluated. Altogether 52 healthy untrained volunteers (25 women: age 43.3 ± 6.6 years; 27 men: age 42.8 ± 7.2 years) were recruited into the study. The subjects performed 3 ATA tests repeated after 2 different intervals: the first test session was baseline, session 2 was a week later, and session 3 was half an hour after session 2. The intraclass correlation coefficient and the SEM of the performance time of ATA were 0.91 and 0.27 seconds (same day), 0.94 and 0.20 seconds (1 week) for women, and 0.95, 0.13 seconds, and 0.94, 0.19 seconds for men, respectively. MDC95 was 0.76 seconds (same day) and 0.56 seconds (1 week) for women, and respectively 0.37 and 0.51 seconds for men. The results showed that ATA is stable and reliable when evaluating agility characteristics in untrained adults. The properties of ATA make it appropriate for screening people to find early signs of declined agility and allow possibility to clinicians and physical trainers to monitor true changes in performance time at agility test by applying the knowledge of MDC95 coefficient. Furthermore, ATA can give tips for planning appropriate exercise programes to prevent clumsiness and falls with more serious consequences among aging people.

  11. Genetic testing for clinically suspected spinocerebellar ataxias ...

    Indian Academy of Sciences (India)

    Mahesh

    Key words: SCA, Genotyping, CAG repeats, India. Introduction. The ataxia .... 2014), we also identified one SCA 12 positive case from southern India (Table 2). Out of the patients that tested positive for FRDA, 75% (N=15) were from southern India and 25% (N=5) from northern and eastern India. FRDA has been reported to ...

  12. Clinical Applications of CO2 and H2 Breath Test

    Directory of Open Access Journals (Sweden)

    ZHAO Si-qian;CHEN Bao-jun;LUO Zhi-fu

    2016-08-01

    Full Text Available Breath test is non-invasive, high sensitivity and high specificity. In this article, CO2 breath test, H2 breath test and their clinical applications were elaborated. The main applications of CO2 breath test include helicobacter pylori test, liver function detection, gastric emptying test, insulin resistance test, pancreatic exocrine secretion test, etc. H2 breath test can be applied in the diagnosis of lactose malabsorption and detecting small intestinal bacterial overgrowth. With further research, the breath test is expected to be applied in more diseases diagnosis.

  13. The clinical value of 14C-urea breath test for diagnosis of helicobacter pylori infection

    International Nuclear Information System (INIS)

    Zhang Shuwen; Zhang Yongxian; Zhang Jinming; Ding Yong; Shao Mingzhe; Liu Zilai; Tian Jiahe

    2003-01-01

    The purpose of this study is to evaluate a rapid microdose 14 C-urea breath test ( 14 C-UBT) with a simplified protocol for detecting the infection of helicobacter pylori (HP). 244 fasting patients with upper gastrointestinal symptoms undergo the 14 C-UBT and 124 cases appear positive. 89 patients of those undergo upper gastrointestinal endoscopy and confirmed as HP infection. The sensitivity and specificity of the 14 C-UBT is 100% when compared with the endoscopy. The test has good diagnostic accuracy with minimal radiation exposure and low cost. Thus, the test is reliable, safe, convenient and cost-effective to clinical use

  14. Sensitivity and Specificity of Clinical and Laboratory Otolith Function Tests.

    Science.gov (United States)

    Kumar, Lokesh; Thakar, Alok; Thakur, Bhaskar; Sikka, Kapil

    2017-10-01

    To evaluate clinic based and laboratory tests of otolith function for their sensitivity and specificity in demarcating unilateral compensated complete vestibular deficit from normal. Prospective cross-sectional study. Tertiary care hospital vestibular physiology laboratory. Control group-30 healthy adults, 20-45 years age; Case group-15 subjects post vestibular shwannoma excision or post-labyrinthectomy with compensated unilateral complete audio-vestibular loss. Otolith function evaluation by precise clinical testing (head tilt test-HTT; subjective visual vertical-SVV) and laboratory testing (headroll-eye counterroll-HR-ECR; vesibular evoked myogenic potentials-cVEMP). Sensitivity and specificity of clinical and laboratory tests in differentiating case and control subjects. Measurable test results were universally obtained with clinical otolith tests (SVV; HTT) but not with laboratory tests. The HR-ECR test did not indicate any definitive wave forms in 10% controls and 26% cases. cVEMP responses were absent in 10% controls.HTT test with normative cutoff at 2 degrees deviations from vertical noted as 93.33% sensitive and 100% specific. SVV test with normative cutoff at 1.3 degrees noted as 100% sensitive and 100% specific. Laboratory tests demonstrated poorer specificities owing primarily to significant unresponsiveness in normal controls. Clinical otolith function tests, if conducted with precision, demonstrate greater ability than laboratory testing in discriminating normal controls from cases with unilateral complete compensated vestibular dysfunction.

  15. Phase I Clinical Testing Antimalarial Drugs.

    Science.gov (United States)

    1977-10-01

    The 52-week, safety and tolerance test administration of 500 mg mefloquine weekly continues. Four of the 5 groups (10 each) have compelted the drug...in 2 subjects receiving drug. Three additional acute studies involving oral mefloquine administration were completed and reports submitted. These...formulation B-512, transient nausea and diarrhea occurred in some subjects receiving 1000 mg and all subjects receiving 1500 mg mefloquine . No other

  16. Clinical Management of Pediatric Genomic Testing.

    Science.gov (United States)

    Holm, Ingrid A

    2014-12-01

    As sequencing becomes integrated into clinical medicine, many complex ethical questions arise regarding the return of genomic information, especially in pediatrics. Issues center on the best interests of the child, particularly in return of information about adult-onset conditions. These include the child's future autonomous decision-making and access to knowledge about treatable conditions, the child in the family unit, and benefit to family members of learning information which could impact them personally. This article first discusses the framework for returning genomic information, and then ethical issues regarding return of results. Finally it discusses potential harms and benefits, while recognizing that little is known about what these actually are. A new era of genomic information is in its infancy; handling genomic information in a way that provides patients and their families with knowledge that is helpful without causing distress is the greatest challenge.

  17. Simple Approaches to Minimally-Instrumented, Microfluidic-Based Point-of-Care Nucleic Acid Amplification Tests

    Science.gov (United States)

    Mauk, Michael G.; Song, Jinzhao; Liu, Changchun; Bau, Haim H.

    2018-01-01

    Designs and applications of microfluidics-based devices for molecular diagnostics (Nucleic Acid Amplification Tests, NAATs) in infectious disease testing are reviewed, with emphasis on minimally instrumented, point-of-care (POC) tests for resource-limited settings. Microfluidic cartridges (‘chips’) that combine solid-phase nucleic acid extraction; isothermal enzymatic nucleic acid amplification; pre-stored, paraffin-encapsulated lyophilized reagents; and real-time or endpoint optical detection are described. These chips can be used with a companion module for separating plasma from blood through a combined sedimentation-filtration effect. Three reporter types: Fluorescence, colorimetric dyes, and bioluminescence; and a new paradigm for end-point detection based on a diffusion-reaction column are compared. Multiplexing (parallel amplification and detection of multiple targets) is demonstrated. Low-cost detection and added functionality (data analysis, control, communication) can be realized using a cellphone platform with the chip. Some related and similar-purposed approaches by others are surveyed. PMID:29495424

  18. Errors in the Total Testing Process in the Clinical Chemistry ...

    African Journals Online (AJOL)

    2018-03-01

    Mar 1, 2018 ... Chemistry tests taking into account venous blood .... on routinely submitted test request forms in Clinical Chemistry laboratory at UOG. Hospital from February to March 2016, Northwest Ethiopia. Data type ... Table 3: Type and frequency of reason for sample rejected in Clinical Chemistry laboratory at UOG.

  19. Testing for homocysteine in clinical practice.

    Science.gov (United States)

    Nichols, John

    2017-03-01

    The theory that raised blood homocysteine is a major factor in the development of cardiovascular disease was initially rejected by the medical establishment. Trials of a treatment to lower homocysteine in moderately advanced disease have failed to show benefits (except in those not treated with anti-platelet drug), but there is mounting evidence for a role in treatment of very early disease and as a preventive strategy. Recent evidence has shown that lowering of high blood homocysteine significantly slows cognitive decline and the brain shrinkage associated with Alzheimer's disease. This is a test that should be done more frequently by National Health Service (NHS) general practitioners and private practitioners.

  20. Minimal Clinically Important Difference in Parkinson’s Disease as Assessed in Pivotal Trials of Pramipexole Extended Release

    Directory of Open Access Journals (Sweden)

    Robert A. Hauser

    2014-01-01

    Full Text Available Background. The minimal clinically important difference (MCID is the smallest change in an outcome measure that is meaningful for patients. Objectives. To calculate the MCID for Unified Parkinson’s Disease Rating Scale (UPDRS scores in early Parkinson’s disease (EPD and for UPDRS scores and “OFF” time in advanced Parkinson’s disease (APD. Methods. We analyzed data from two pivotal, double-blind, parallel-group trials of pramipexole ER that included pramipexole immediate release (IR as an active comparator. We calculated MCID as the mean change in subjects who received active treatment and rated themselves “a little better” on patient global impression of improvement (PGI-I minus the mean change in subjects who received placebo and rated themselves unchanged. Results. MCIDs in EPD (pramipexole ER, pramipexole IR for UPDRS II were −1.8 and −2.0, for UPDRS III −6.2 and −6.1, and for UPDRS II + III −8.0 and −8.1. MCIDs in APD for UPDRS II were −1.8 and −2.3, for UPDRS III −5.2 and −6.5, and for UPDRS II + III −7.1 and −8.8. MCID for “OFF” time (pramipexole ER, pramipexole IR was −1.0 and −1.3 hours. Conclusions. A range of MCIDs is emerging in the PD literature that provides the basis for power calculations and interpretation of clinical trials.

  1. Minimally Invasive Sacroiliac Joint Fusion: 2-Year Radiographic and Clinical Outcomes with a Principles-Based SIJ Fusion System.

    Science.gov (United States)

    Cross, William W; Delbridge, Arnold; Hales, Donald; Fielding, Louis C

    2018-01-01

    Sacroiliac joint (SIJ) degeneration is a common source of low back pain (LBP). Minimally invasive (MI) SIJ fusion procedures have demonstrated meaningful clinical improvement. A recently developed MI SIJ fusion system incorporates decortication, placement of bone graft and fixation with threaded implants (DC/BG/TF). Nineteen patients who had MI SIJ fusion with DC/BG/TF were enrolled at three centers. Fusion was assessed in CT images obtained 12 and 24 months postoperatively by an independent radiographic core laboratory. LBP was assessed using a 0-10 numerical pain scale (NPS) preoperatively and at 12 and 24 months postoperatively. At 12 months, 15/19 patients (79%) had bridging bone across the SIJ, and at 24 months 17/18 patients (94%) available for follow-up had SIJ fusion. Of the patients with bridging bone 88% had fusion within the decorticated area, with solid fusion in 83%. A significant reduction in NPS scores was demonstrated, representing a 73% reduction in average low back pain. The patients in this series demonstrated significant improvement in LBP. Fusion rates at 24 months demonstrate promise for this system, which utilizes the established orthopedic principles of DC/BG/TF to achieve arthrodesis. Further study is warranted to demonstrate comparative fusion rates for different implant systems.

  2. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data.

    Science.gov (United States)

    Basra, M K A; Salek, M S; Camilleri, L; Sturkey, R; Finlay, A Y

    2015-01-01

    To determine the minimal clinically important difference (MCID) of the Dermatology Life Quality Index (DLQI) and its responsiveness to change in inflammatory skin diseases. A longitudinal study: at stage 1, patients completed the DLQI and a disease severity global question; at stage 2, a global rating of change in quality of life (QoL; Global Rating of Change Questionnaire, GRCQ) was added and used as an anchor to measure the MCID of the DLQI. 192 patients completed stage 1 and 107 completed stage 2. The mean DLQI score at stage 1 was 9.8 and 7.4 at stage 2 with a mean change of 2.4 (p < 0.0001). 31 patients experienced a 'small change' in their QoL (±3 and ±2) on the GRCQ. The mean corresponding change in DLQI scores was 3.3, which is regarded as the approximate MCID. Previous estimates of the MCID of the DLQI have varied from 3 to 5. Although this study demonstrated a MCID of 3.3, we recommend that the MCID in inflammatory skin diseases should be 4. © 2015 S. Karger AG, Basel.

  3. Clinical Studies of Nonpharmacological Methods to Minimize Salivary Gland Damage after Radioiodine Therapy of Differentiated Thyroid Carcinoma: Systematic Review

    Directory of Open Access Journals (Sweden)

    Andri Christou

    2016-01-01

    Full Text Available Purpose. To systematically review clinical studies examining the effectiveness of nonpharmacological methods to prevent/minimize salivary gland damage due to radioiodine treatment of differentiated thyroid carcinoma (DTC. Methods. Reports on relevant trials were identified by searching the PubMed, CINHAL, Cochrane, and Scopus electronic databases covering the period 01/2000–10/2015. Inclusion/exclusion criteria were prespecified. Search yielded eight studies that were reviewed by four of the present authors. Results. Nonpharmacological methods used in trials may reduce salivary gland damage induced by radioiodine. Sialogogues such as lemon candy, vitamin E, lemon juice, and lemon slice reduced such damage significantly (p<0.0001, p<0.05, p<0.10, and p<0.05, resp.. Parotid gland massage also reduced the salivary damage significantly (p<0.001. Additionally, vitamin C had some limited effect (p=0.37, whereas no effect was present in the case of chewing gum (p=0.99. Conclusion. The review showed that, among nonpharmacological interventions, sialogogues and parotid gland massage had the greatest impact on reducing salivary damage induced by radioiodine therapy of DTC. However, the studies retrieved were limited in number, sample size, strength of evidence, and generalizability. More randomized controlled trials of these methods with multicenter scope and larger sample sizes will provide more systematic and reliable results allowing more definitive conclusions.

  4. Different minimally important clinical difference (MCID) scores lead to different clinical prediction rules for the Oswestry disability index for the same sample of patients.

    Science.gov (United States)

    Schwind, Julie; Learman, Kenneth; O'Halloran, Bryan; Showalter, Christopher; Cook, Chad

    2013-05-01

    Minimal clinically important difference (MCID) scores for outcome measures are frequently used evidence-based guides to gage meaningful changes. There are numerous outcome instruments used for analyzing pain, disability, and dysfunction of the low back; perhaps the most common of these is the Oswestry disability index (ODI). A single agreed-upon MCID score for the ODI has yet to be established. What is also unknown is whether selected baseline variables will be universal predictors regardless of the MCID used for a particular outcome measure. To explore the relationship between predictive models and the MCID cutpoint on the ODI. Data were collected from 16 outpatient physical therapy clinics in 10 states. Secondary database analysis using backward stepwise deletion logistic regression of data from a randomized controlled trial (RCT) to create prognostic clinical prediction rules (CPR). One hundred and forty-nine patients with low back pain (LBP) were enrolled in the RCT. All were treated with manual therapy, with a majority also receiving spine-strengthening exercises. The resultant predictive models were dependent upon the MCID used and baseline sample characteristics. All CPR were statistically significant (P < 001). All six MCID cutpoints used resulted in completely different significant predictor variables with no predictor significant across all models. The primary limitations include sub-optimal sample size and study design. There is extreme variability among predictive models created using different MCIDs on the ODI within the same patient population. Our findings highlight the instability of predictive modeling, as these models are significantly affected by population baseline characteristics along with the MCID used. Clinicians must be aware of the fragility of CPR prior to applying each in clinical practice.

  5. 21 CFR 50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct...

    Science.gov (United States)

    2010-04-01

    ... minimal risk but presenting the prospect of direct benefit to individual subjects. 50.52 Section 50.52... investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual... contribute to the subject's well-being, may involve children as subjects only if the IRB finds and documents...

  6. Minimally invasive video-assisted thyroidectomy versus conventional thyroidectomy: A single-blinded, randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    El-Labban Gouda

    2009-01-01

    Full Text Available We aimed to test the hypothesis that Minimally Invasive Video-assisted Thyroidectomy (MIVAT affords comparable safety and efficacy as to the open conventional surgery, when dealing with patients with unilateral thyroid nodules or follicular lesions, in terms of cosmetic results, intraoperative and postoperative complications, postoperative pain and hospital stay. Materials And Methods: This was a single-blinded randomised controlled trial comparing the MIVAT with conventional thyroidectomy. The primary endpoints of the study were measurement of postoperative pain after 24 and 48 hours from operation and self-rated patient satisfaction with cosmetic outcome three months postoperatively. The secondary outcome measures were operative time, incidence of temporary and permanent recurrent laryngeal nerve injury, postoperative haematoma formation, length of incision, and duration of hospital stay. Results: Operative time was significantly less with open thyroidectomy than with MIVAT, while MIVAT was associated with less pain 24 hours postoperatively. Blood loss did not reach significance between procedures. Comparisons between the two procedures with regard to pain scores after 24 and 48 hours, respectively, depicted statistically significant differences in favour of the MIVAT after 24 hours. MIVAT was associated with less scarring and more satisfactory cosmetic results. There were statistically no significant differences between both procedures for the presence of transient recurrent laryngeal nerve palsy and hypoparathyroidism. Conclusions: MIVAT is a safe procedure that produces outcomes, in view of short-term adverse events, similar to those of open thyroidectomy, and is superior in terms of immediate postoperative pain and cosmetic results.

  7. Pharmacogenetic tests for antipsychotic medications: clinical implications and considerations

    Science.gov (United States)

    Eum, Seenae; Lee, Adam M.; Bishop, Jeffrey R.

    2016-01-01

    Optimizing antipsychotic pharmacotherapy is often challenging due to significant variability in effectiveness and tolerability. Genetic factors influencing pharmacokinetics and pharmacodynamics may contribute to some of this variability. Research studies have characterized these pharmacogenetic relationships, and some genetic markers are now available as clinical tests. These advances in pharmacogenetics research and test availability have great potential to improve clinical outcomes and quality of life in psychiatric patients. For clinicians considering using pharmacogenetics, it is important to understand the clinical implications and also the limitations of markers included in currently available tests. This review focuses on pharmacokinetic and pharmacodynamic gene variants that are currently available in commercial genetic testing panels. Associations of these variants with clinical efficacy and adverse effects, as well as other clinical implications, in antipsychotic pharmacotherapy are discussed. PMID:27757066

  8. [Discussion on the standard of clinical genetic testing report and the consensus of gene testing industry].

    Science.gov (United States)

    Huang, Hui; Shen, Yiping; Gu, Weihong; Wang, Wei; Wang, Yiming; Qi, Ming; Shen, Jun; Qiu, Zhengqing; Yu, Shihui; Zhou, Zaiwei; Chen, Baixue; Chen, Lei; Chen, Yundi; Cui, Huanhuan; Du, Juan; Gao, Yong; Guo, Yiran; Hu, Chanjuan; Hu, Liang; Huang, Yi; Li, Peipei; Li, Xiaorong; Li, Xiurong; Liu, Yaping; Lu, Jie; Ma, Duan; Ma, Yongyi; Peng, Mei; Song, Fang; Sun, Hongye; Wang, Liang; Wang, Dawei; Wang, Jingmin; Wang, Ling; Wang, Zhengyuan; Wang, Zhinong; Wu, Jihong; Wu, Jing; Wu, Jian; Xu, Yimin; Yao, Hong; Yang, Dongsheng; Yang, Xu; Yang, Yanling; Zhang, Ying; Zhou, Yulin; Zhu, Baosheng; Zeng, Sicong; Peng, Zhiyu; Huang, Shangzhi

    2018-02-10

    The widespread application of next generation sequencing (NGS) in clinical settings has enabled testing, diagnosis, treatment and prevention of genetic diseases. However, many issues have arisen in the meanwhile. One of the most pressing issues is the lack of standards for reporting genetic test results across different service providers. The First Forum on Standards and Specifications for Clinical Genetic Testing was held to address the issue in Shenzhen, China, on October 28, 2017. Participants, including geneticists, clinicians, and representatives of genetic testing service providers, discussed problems of clinical genetic testing services across in China and shared opinions on principles, challenges, and standards for reporting clinical genetic test results. Here we summarize expert opinions presented at the seminar and report the consensus, which will serve as a basis for the development of standards and guidelines for reporting of clinical genetic testing results, in order to promote the standardization and regulation of genetic testing services in China.

  9. Test-Retest Reliability and Minimal Detectable Change of the Test of Visual Perceptual Skills-Third Edition in Patients With Stroke.

    Science.gov (United States)

    Chiu, En-Chi; Wu, Wen-Chi; Chou, Chiung-Xia; Yu, Min-Yuan; Hung, Jen-Wen

    2016-11-01

    To examine the test-retest reliability, calculate minimal detectable change (MDC), and report internal consistency of the Test of Visual Perceptual Skills-Third Edition (TVPS-3) in patients with stroke. Repeated-measures design (at an interval of 2wk). Medical center. Patients (N=50) with chronic stroke who completed the TVPS-3. Not applicable. TVPS-3 that contains 7 subscales, namely, visual discrimination, visual memory, spatial relations, form constancy, sequential memory, visual figure-ground, and visual closure. The intraclass correlation coefficient value of the overall scale was .92 and those of the 7 subscales were .53 to .82. The MDC values of the overall scale and the subscales were 18.1 and 5.4 to 7.1, respectively. The MDC% value of the overall scale was 16.2% (30%), indicating substantial random measurement errors. The Cronbach α of the 7 subscales were .71 to .89, indicating good internal consistency. Our results showed that the overall scale of the TVPS-3 had satisfactory test-retest reliability. However, the subscales demonstrated insufficient test-retest reliability. Therefore, the subscales should be used cautiously to explain the test results over repeated assessments in patients with stroke. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  10. Management of adults with acute streptococcal pharyngitis: minimal value for backup strep testing and overuse of antibiotics.

    Science.gov (United States)

    Nakhoul, Georges N; Hickner, John

    2013-06-01

    Rapid antigen detection tests (RADT) are commonly used to guide appropriate antibiotic treatment of group A beta-hemolytic streptococcal (GABHS) pharyngitis. In adults, there is controversy about the need for routine backup testing of negative RADT. Estimate the costs and benefits in adults of routine backup testing by DNA Gen-probe of negative RADT (Acceava). Observational follow-up study. All patients aged 18 years and older visiting a Cleveland Clinic generalist physician in 2009 and 2010 with a visit diagnosis of acute pharyngitis (ICD codes 462, 034.0). The patients were identified using the Cleveland Clinic Epic Clarity database. We determined the proportion of false negative RADT, antibiotic prescription patterns and rate of serious suppurative complications within 30 days of the office visit. Of 25,130 patients with acute pharyngitis, 19% had no testing and 81% were tested. Of the 15,555 patients that had a negative RADT and follow-up DNA probe, 6% had a positive DNA probe. Of the 953 patients who had a negative RADT and a positive DNA strep probe, 48% received an antibiotic prescription at the time of the visit and 51% received an antibiotic prescription after an average of 2.3 days. Only one patient with a negative RADT and no follow-up DNA probe developed a peritonsillar abscess. Overall, of the 15,555 DNA probes performed, management was altered in only 3% of the patients at a total cost of $1,757,715. Fifty-six percent received an antibiotic while only 19.5% had a confirmed strep throat diagnosis. The false negative rate of Acceava RADT for the diagnosis of GABHS pharyngitis was 6%. We question the benefit of routine DNA probe backup testing in adults because of its substantial cost, an average delay in antibiotic prescribing of over 2 days, and because suppurative complications are very uncommon. We found a high rate of inappropriate antibiotic prescribing.

  11. The Angioedema Quality of Life Questionnaire (AE-QoL) - assessment of sensitivity to change and minimal clinically important difference.

    Science.gov (United States)

    Weller, K; Magerl, M; Peveling-Oberhag, A; Martus, P; Staubach, P; Maurer, M

    2016-08-01

    The Angioedema Quality of Life Questionnaire (AE-QoL) has recently been developed and validated as the first specific patient-reported outcome tool to assess quality of life (QoL) impairment in recurrent angioedema patients. As of yet, its sensitivity to change and minimal clinically important difference (MCID) have not been established. Recurrent angioedema patients with chronic spontaneous urticaria or hereditary angioedema were repeatedly asked to complete the AE-QoL along with the SF-12 and other anchors for QoL impairment and disease activity during routine care visits. The sensitivity to change of AE-QoL was determined by correlating changes in its scores over time with changes in the applied anchors. In addition, the MCID was determined using anchor-based and distributional criterion-based approaches. Two hundred and seventy-eight patients contributed data sets for analysis. Baseline AE-QoL values were found to correlate well with SF-12 results as well as all other applied anchors for angioedema-related QoL impairment and disease activity. In addition, AE-QoL score changes over time correlated significantly with changes in the above anchors, thus demonstrating its sensitivity to change. The MCID of the AE-QoL total score was found to be six points. The AE-QoL is a valuable tool to assess changes of QoL impairment in recurrent angioedema patients over time, including changes due to treatment. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  12. Early post-operative pulmonary function tests after mitral valve replacement: Minimally invasive versus conventional approach. Which is better?

    Directory of Open Access Journals (Sweden)

    Magdy Gomaa

    2016-12-01

    Conclusion: Minimally invasive right anterolateral mini-thoracotomy is as safe as median sternotomy for mitral valve surgery, with fewer complications and postoperative pain, less ICU and hospital stay, fast recovery to work with no movement restriction after surgery. There was a highly significant difference denoting better post operative pulmonary function of the minimally invasive approach.

  13. Clinically relevant mechanical testing of hernia graft constructs.

    Science.gov (United States)

    Sahoo, Sambit; DeLozier, Katherine R; Erdemir, Ahmet; Derwin, Kathleen A

    2015-01-01

    To understand the mechanical behavior of grafts in the context of hernia repair, there is a need to develop and adopt methods for mechanical testing of grafts in a clinically-relevant manner with clinically-relevant outcomes. Ball-burst and planar-biaxial methods were used to test three commercially-available hernia grafts (DermaMatrix, Biodesign, VitaMesh Blue). Both load-to-failure and cyclic fatigue tests were performed (n=6-11/group/test). Grafts were tested as sutured constructs in patch geometry. Dilatational strain analysis was performed considering the construct (both test methods) or the graft (planar-biaxial only) as the area of interest. DermaMatrix, Biodesign, and VitaMesh grafts showed differences in mechanical properties at the point of construct failure (load, in-plane load-per-suture and membrane tension) in ball-burst tests and differences in sub-failure properties (stiffness, dilatational strain at 16N/cm and cyclic mechanical properties) in planar-biaxial tests. In both load-to-failure and cyclic fatigue tests, each graft construct tended to be stiffer in planar-biaxial than ball-burst testing. In biaxial testing, the strain analysis method influenced the mechanical properties with the construct being more compliant than the graft. This study demonstrates that graft-fixation method, test mode and analysis method are important considerations for mechanical characterization of hernia grafts. Ball-burst tests can only estimate construct or material properties, whereas planar-biaxial tests capture anisotropy and can estimate construct, graft and material properties of the same test specimen. When the clinical performance of a graft in the context of hernia repair is of interest, testing a sutured construct and performing construct strain analysis arguably provides the most clinically-relevant assessment method. Copyright © 2014 Elsevier Ltd. All rights reserved.

  14. Minimal surfaces

    CERN Document Server

    Dierkes, Ulrich; Sauvigny, Friedrich; Jakob, Ruben; Kuster, Albrecht

    2010-01-01

    Minimal Surfaces is the first volume of a three volume treatise on minimal surfaces (Grundlehren Nr. 339-341). Each volume can be read and studied independently of the others. The central theme is boundary value problems for minimal surfaces. The treatise is a substantially revised and extended version of the monograph Minimal Surfaces I, II (Grundlehren Nr. 295 & 296). The first volume begins with an exposition of basic ideas of the theory of surfaces in three-dimensional Euclidean space, followed by an introduction of minimal surfaces as stationary points of area, or equivalently

  15. The challenge of producing skin test antigens with minimal resources suitable for human application against a neglected tropical disease; leprosy.

    Directory of Open Access Journals (Sweden)

    Becky L Rivoire

    Full Text Available True incidence of leprosy and its impact on transmission will not be understood until a tool is available to measure pre-symptomatic infection. Diagnosis of leprosy disease is currently based on clinical symptoms, which on average take 3-10 years to manifest. The fact that incidence, as defined by new case detection, equates with prevalence, i.e., registered cases, suggests that the cycle of transmission has not been fully intercepted by implementation of multiple drug therapy. This is supported by a high incidence of childhood leprosy. Epidemiological screening for pre-symptomatic leprosy in large endemic populations is required to facilitate targeted chemoprophylactic interventions. Such a test must be sensitive, specific, simple to administer, cost-effective, and easy to interpret. The intradermal skin test method that measures cell-mediated immunity was explored as the best option. Prior knowledge on skin testing of healthy subjects and leprosy patients with whole or partially fractionated Mycobacterium leprae bacilli, such as Lepromin or the Rees' or Convit' antigens, has established an acceptable safety and potency profile of these antigens. These data, along with immunoreactivity data, laid the foundation for two new leprosy skin test antigens, MLSA-LAM (M. leprae soluble antigen devoid of mycobacterial lipoglycans, primarily lipoarabinomannan and MLCwA (M. leprae cell wall antigens. In the absence of commercial interest, the challenge was to develop these antigens under current good manufacturing practices in an acceptable local pilot facility and submit an Investigational New Drug to the Food and Drug Administration to allow a first-in-human phase I clinical trial.

  16. Clinical outcomes of modified minimally invasive approach and de-rotation of symptomatic chronic gastric volvulus – A tertiary centre experience

    Directory of Open Access Journals (Sweden)

    Bin Chet Toh

    Full Text Available Introduction: Gastric volvulus is a surgical condition that should be recognised promptly to prevent life-threatening gastric ischaemia and perforation in acute setting. There are two peak age group of incidence with children less than one year old and at fifth decade.1 The mortality rates for acute gastric volvulus remain high with reported range from 30% to 50% signifying the need of early diagnosis and treatment.2 These case series reported modified minimal invasive approach for symptomatic chronic gastric volvulus in a tertiary upper gastrointestinal unit in Singapore. Methods: Retrospective case series reviewed in single centre from 1st May 2016 to 1st May 2017 of clinical outcomes of modified minimally invasive approach and de-rotation of symptomatic chronic gastric volvulus. Results: Three symptomatic patients with evidence of gastric volvulus on CT-scan underwent minimally invasive repair with the aids of GastriSail™ Gastric positioning system. GastriSail™ was used for gastric volvulus de-rotation prior to repair definitely. Two patients had fundoplication done and one patient had gastropexy performed successfully. All patients started on blended diet post-operative day 1 and discharged well. Patient remained asymptomatic and nil recurrence at 3 months follow-up post-operation. Conclusion: Based on our experience, we advocate modified minimally invasive repair of chronic gastric volvulus as an alternative to traditional open surgical technique with acceptable good clinical outcomes. Keywords: Chronic gastric volvulus, Minimal invasive surgery, Upper gastrointestinal tract

  17. Superior Facet Joint Violations during Single Level Minimally Invasive Transforaminal Lumbar Interbody Fusion: A Preliminary Retrospective Clinical Study

    Directory of Open Access Journals (Sweden)

    Long Jia

    2018-01-01

    Full Text Available Background. Facet joint violation (FV was reported as variable iatrogenic damage that can be a crucial risk factor leading to the adjacent segment degeneration (ASD. “Blind” screw placement technique in minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF contributes to the increasing incidence of FV that can be influenced by several potential factors. Many controversies about these factors and clinical outcomes of different types of FV patients exist, yet they have not been analyzed. Methods. 99 cases undergoing single-segment MIS-TLIF from July 2013 to December 2015 were retrospectively analyzed. Computed tomography (CT was applied to determine the incidence of FV, and then the correlation between FV and relevant factors, including gender, age, body mass index (BMI, top-screw level, and decompression, was analyzed. A total of 53 cases were followed up after one year, 31 cases in noninjury (A group and 22 patients in FV injury (B group. Results. The incidence of FV was 39. 39% (39/99 in the patients and 23.23% (46/198 in the screws. Logistic regression analysis showed that screw at L5 in patients with BMI > 30 kg/m2 was vulnerable to FV (P<0.05. Moreover, postoperative average intervertebral disc height (AIDH of fusion segment, visual analog scale (VAS, and Oswestry disability index (ODI scores improved significantly in group A and B when compared with preoperative data (P<0.05. Adjacent superior average intervertebral disc height (ASAIDH presented decrease, but adjacent superior intervertebral disc Cobb angle (ASIDCA appeared to increase in the two groups at the final follow-up compared with postoperative 3 days (P<0.05. Low back VAS and ODI scores in group A (31 cases were lower than those in group B (22 cases in the final follow-up (P<0.05. Conclusion. MIS-TLIF is an effective treatment for lumbar degenerative disease, but FV occurred at a higher incidence. Facet joints should be protected in MIS-TLIF to avoid FV.

  18. Histoplasmosis in a Brazilian center: clinical forms and laboratory tests.

    Science.gov (United States)

    Leimann, Beatriz Consuelo Quinet; Pizzini, Cláudia Vera; Muniz, Mauro Medeiros; Albuquerque, Priscila Carvalho; Monteiro, Paulo Cezar Fialho; Reis, Rosani Santos; Almeida-Paes, Rodrigo; Lazera, Márcia Santos; Wanke, Bodo; Pérez, Maurício Andrade; Zancopé-Oliveira, Rosely Maria

    2005-09-01

    Histoplasmosis, caused by the dimorphic fungus Histoplasma capsulatum, is endemic in many regions of the Americas, Asia and Africa. It has a wide spectrum of clinical manifestations, from asymptomatic infection to severe disseminated disease. A retrospective study was carried out to describe the clinical forms and assess the clinical significance of the laboratory diagnostic tests of patients with histoplasmosis during the period of July 1987 to December 2003 at Instituto de Pesquisa Clínica Evandro Chagas/ FIOCRUZ, RJ, Brazil. Seventy-four patients were included. Forty-nine percent of the cases (n = 36) occurred in HIV positive patients who presented with disseminated disease. The remaining 38 cases were classified in different clinical forms. Histoplasma capsulatum was isolated from 69.5% of the clinical specimens sent to culture. Immunodiffusion and immunoblot were positive in 72.6% and 100% of the performed tests, respectively. Histopathologic findings suggestive of H. capsulatum were found in 63.2% of the performed exams. Serology had a lower proportion of positivity amongst AIDS patients, when compared with HIV negative patients (X2 = 6.65; p lower than 0.008). Statistical differences between AIDS and non-AIDS patients were not observed with culture and histopathology. The specific role of each test varies according to the clinical form. Physicians need to know the value and limitations of the available diagnostic tests, but before that, they have to think about histoplasmosis and consider this clinical entity in their differential diagnosis.

  19. Core stability: inter- and intraobserver reliability of 6 clinical tests

    NARCIS (Netherlands)

    Weir, Adam; Darby, Jennifer; Inklaar, Han; Koes, Bart; Bakker, Erik; Tol, Johannes L.

    2010-01-01

    Core stability is a complex concept within sports medicine and is thought to play a role in sports injuries. There is a lack of reliable and valid clinical tests for core stability. The inter- and intraobserver reliability of 6 tests commonly used to assess core stability was determined. A video of

  20. Routine Patch Testing In A Dermatology Clinic Of A Teaching ...

    African Journals Online (AJOL)

    Introduction: Allergic Contact Dermatitis (ACD) poses a great diagnostic challenge to the dermatologist as it mimics many common dermatoses. Patch test (PT) is used to establish the diagnosis of ACD and to exclude suspected allergens. Aim: This study reviewed the clinical presentations and patch test results of ...

  1. Genetic Testing for Dilated Cardiomyopathy in Clinical Practice

    Science.gov (United States)

    Lakdawala, Neal K.; Funke, Birgit H.; Baxter, Samantha; Cirino, Allison L.; Roberts, Amy E.; Judge, Daniel P.; Johnson, Nicole; Mendelsohn, Nancy J.; Morel, Chantal; Care, Melanie; Chung, Wendy K.; Jones, Carolyn; Psychogios, Apostolos; Duffy, Elizabeth; Rehm, Heidi L.; White, Emily; Seidman, J.G.; Seidman, Christine E.; Ho, Carolyn Y.

    2013-01-01

    Background Familial involvement is common in dilated cardiomyopathy (DCM) and >40 genes have been implicated in causing disease. However, the role of genetic testing in clinical practice is not well defined. We examined the experience of clinical genetic testing in a diverse DCM population to characterize the prevalence and predictors of gene mutations. Methods and Results We studied 264 unrelated adult and pediatric DCM index patients referred to 1 reference lab for clinical genetic testing. Up to 10 genes were analyzed (MYH7, TNNT2, TNNI3, TPM1, MYBPC3, ACTC, LMNA, PLN, TAZ, and LDB3), and 70% of patients were tested for all genes. The mean age was 26.6 ± 21.3 years, and 52% had a family history of DCM. Rigorous criteria were used to classify DNA variants as clinically relevant (mutations), variants of unknown clinical significance (VUS), or presumed benign. Mutations were found in 17.4% of patients, commonly involving MYH7, LMNA, or TNNT2 (78%). An additional 10.6% of patients had VUS. Genetic testing was rarely positive in older patients without a family history of DCM. Conversely in pediatric patients, family history did not increase the sensitivity of genetic testing. Conclusions Using rigorous criteria for classifying DNA variants, mutations were identified in 17% of a diverse group of DCM index patients referred for clinical genetic testing. The low sensitivity of genetic testing in DCM reflects limitations in both current methodology and knowledge of DCM-associated genes. However, if mutations are identified, genetic testing can help guide family management. PMID:22464770

  2. Spinal Anesthesia and Minimal Invasive Laminotomy for Paddle Electrode Placement in Spinal Cord Stimulation: Technical Report and Clinical Results at Long-Term Followup

    Directory of Open Access Journals (Sweden)

    S. Sarubbo

    2012-01-01

    Full Text Available Object. We arranged a mini-invasive surgical approach for implantation of paddle electrodes for SCS under spinal anesthesia obtaining the best paddle electrode placement and minimizing patients’ discomfort. We describe our technique supported by neurophysiological intraoperative monitoring and clinical results. Methods. 16 patients, affected by neuropathic pain underwent the implantation of paddle electrodes for spinal cord stimulation in lateral decubitus under spinal anesthesia. The paddle was introduced after flavectomy and each patient confirmed the correct distribution of paresthesias induced by intraoperative test stimulation. VAS and patients’ satisfaction rate were recorded during the followup and compared to preoperative values. Results. No patients reported discomfort during the procedure. In all cases, paresthesias coverage of the total painful region was achieved, allowing the best final electrode positioning. At the last followup (mean 36.7 months, 87.5% of the implanted patients had a good rate of satisfaction with a mean VAS score improvement of 70.5%. Conclusions. Spinal cord stimulation under spinal anesthesia allows an optimal positioning of the paddle electrodes without any discomfort for patients or neurosurgeons. The best intraoperative positioning allows a better postoperative control of pain, avoiding the risk of blind placements of the paddle or further surgery for their replacement.

  3. Interference by pralidoxime (PAM) salts in clinical laboratory tests.

    Science.gov (United States)

    Nagase, Sumika; Kohguchi, Katsunori; Tohyama, Kaoru; Watanabe, Mikio; Iwatani, Yoshinori

    2013-02-01

    Drugs sometimes alter the results of clinical laboratory tests. We examined the effects of pralidoxime (PAM) salts, a medicine used to treat organophosphorus poisoning, on clinical laboratory test results for the first time. The effects of PAM salts on glucose (GLU) measurements were examined using a point-of-care testing (POCT) meter, four self-monitoring of blood glucose (SMBG) meters, and two biochemical autoanalyzers. The effects of PAM salts on other clinical tests were also evaluated. The addition of PAM iodide or potassium iodide, but not of PAM chloride or potassium chloride, to blood samples increased the GLU values measured by one POCT meter and 4 SMBG meters using the enzyme electrode (hydrogen peroxidase or oxygen electrode) method. On the other hand, PAM iodide or PAM chloride, but not KI or KCl, affected the values measured at 340 nm by an autoanalyzer using absorption spectrophotometry in 8 of 14 clinical laboratory tests. The absorption spectrum of PAM changed from 294 to 338 nm due to the reaction between PAM and the alkaline buffer, a component of the measuring reagents. PAM iodide increases the GLU values measured by the enzyme electrode method, and PAM salts affected the values measured at 340 nm by absorption spectrophotometry in many other clinical test items. Copyright © 2012 Elsevier B.V. All rights reserved.

  4. Validity, reliability and minimal detectable change of the balance evaluation systems test (BESTest), mini-BESTest and brief-BESTest in patients with end-stage renal disease.

    Science.gov (United States)

    Jácome, Cristina; Flores, Inês; Martins, Filipa; Castro, Conceição; McPhee, Charlotte C; Shepherd, Ellen; Demain, Sara; Figueiredo, Daniela; Marques, Alda

    2017-09-08

    This study determined the validity, test-retest reliability and minimal detectable change of the balance evaluation systems test (BESTest), mini-balance evaluation systems test (Mini-BESTest) and brief-balance evaluation systems test (Brief-BESTest) in patients with end-stage renal disease. A cross-sectional study with 74 patients with end-stage renal disease (male 66.2%; 63.9 ± 15.1 years old) was conducted. Participants were asked to report the number of falls during the previous 12 months and to complete the activity-specific balance confidence (ABC) scale. The BESTest was administered, and the Mini-BESTest and Brief-BESTest scores were computed based on the BESTest performance. Validity was assessed by correlating balance tests with each other and with the ABC scale. Test-retest relative reliability and agreement were explored with the intraclass correlation coefficient (ICC) equation (2,1) and the Bland and Altman method. Minimal detectable changes at the 95% confidence level were established. Balance test scores were significantly correlated with each other (spearman's correlation = 0.89-0.92) and with the ABC scale (spearman's correlation = 0.49-0.59). Balance tests presented high test-retest reliability (ICC = 0.84-0.94), with no evidence of bias. Minimal detectable change values were 10.8 (expressed as a percentage 13.5%), 5.3 (23.7%) and 5.6 (34%) points for the BESTest, Mini-BESTest and Brief-BESTest, respectively. All tests are valid and reliable to assess balance in patients with end-stage renal disease. Nevertheless, based on the minimal detectable changes found, BESTest and Mini-BESTest may be the most recommended tests for this specific population. Implications for Rehabilitation Balance evaluation systems test (BESTest), mini-balance evaluation systems test (Mini-BESTest) and brief-balance evaluation systems test (Brief-BESTest) are reliable and valid in patients with end stage renal disease (ESRD). The minimal detectable

  5. Duplicate Type and Screen Testing: Waste in the Clinical Laboratory.

    Science.gov (United States)

    Compton, Margaret L; Szklarski, Penny C; Booth, Garrett S

    2018-03-01

    - In the United States, approximately $65 billion dollars is spent per year on clinical laboratory testing, of which 20% to 30% of all testing is deemed inappropriate. There have been multiple studies in the field of transfusion medicine regarding evidence-based transfusion practices, but limited data exist regarding inappropriate pretransfusion testing and its financial and clinical implications. - To assess duplicative testing practices in the transfusion medicine service. - A 24-month retrospective review was performed at a 1025-bed tertiary care center, identifying all duplicate type and screen (TS) tests performed within 72 hours of the previous TS. Duplicative testing was classified as appropriate or inappropriate by predetermined criteria. The level of underordering was analyzed through a query of the electronic event reporting system. A cost analysis was performed to determine the financial impact of inappropriate duplicative TS. - The mean rate of inappropriate, duplicative TS orders was 4.13% (standard deviation ± 4.09%). Rates of inappropriate ordering ranged from 0.01% to 15.5% depending on the clinical service and did not correlate with volume of tests ordered. There were 8 reported cases of delayed blood delivery due to lack of a valid TS during the study period, demonstrating that underordering is also a harmful practice. The laboratory cost of inappropriate testing for the study period was $80,434, and phlebotomy costs were $45,469. - Our study demonstrates that inappropriate TS ordering is costly, both financially and clinically. By evaluating the percentage of inappropriate TS tests by clinical services, we have identified services that may benefit from additional education and technologic intervention.

  6. Erythema-index of clinical patch test reactions

    DEFF Research Database (Denmark)

    Jemec, G B; Johansen, J D

    1995-01-01

    : The erythema index of 56 patch test reactions ranging from +? to +++, was compared to regional controls and negative patch tests (189). The effects of intrumental application pressure was studied in 5 volunteers. Statistical analysis was carried out using Mann-Whitney and Jonckheere-Terpstra tests. RESULTS......: The erythema-index was significantly higher in all degrees of patch test reactions than in uninvolved regional skin or negative patch tests. It also showed a significant positive trend for higher values in +, ++ and +++ reactions (P... that the method could be used for the grading of eczematous reactions in a clinical setting as well. OBJECTIVE: To assess the usefulness of the erythema index for the quantification of eczematous reactions using the Derma-Spectrometer (Cortex technology, Hadsund, Denmark) in a clinical setting. METHOD...

  7. Clinical study on minimally invasive transforaminal lumbar interbody fusion combined with percutaneous pedicle screw fixation for degenerative lumbar scoliosis

    Directory of Open Access Journals (Sweden)

    Hao WU

    2016-04-01

    Full Text Available Objective To discuss the operative essentials and therapeutic effects of minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF combined with percutaneous pedicle screw fixation for degenerative lumbar scoliosis (DLS.  Methods A total of 17 DLS patients without prior spinal diseases were treated by MIS-TLIF and percutaneous pedicle screw fixation from January 2013 to September 2015 in Xuanwu Hospital, Capital Medical University. The operation time, intraoperative blood loss, hospital stay, and postoperative complication were recorded in each patient. Visual Analogue Scale (VAS and Oswestry Disability Index (ODI were used to evaluate postoperative improvement of low back and leg pain, and clinical effects were assessed according to Medical Outcome Study 36-Item Short-Form Health Survey (SF-36. Coronal Cobb angle, sagittal lordosis angle and spinal deviation distances on coronal and sagittal plane were measured before operation, one week, 3 months after operation and in the last follow-up in spinal full-length X-ray examination. Fusion rate was calculated according to X-ray or CT scan, and the degree of decompression was evaluated by MRI.  Results Decompression and fusion levels ranged from T12-S1 vertebrae, and interbody fusion was performed in 17 patients and 56 levels were fused. Average operation time was 200 min (180-300 min, intraoperative blood loss was 320 ml (200-1000 ml and hospital stay was 8.21 d (5-12 d. All patients were followed-up for 12.13 months (5-24 months. Compared with preoperation, VAS (P = 0.000, for all and ODI scores (P = 0.000, for all decreased significantly, SF-36 score increased (P = 0.000, for all, coronal Cobb angle (P = 0.000, for all, sagittal lordosis angle (P = 0.000, for all, coronal and sagittal deviation (P = 0.000, for all decreased significantly one week and 3 months after operation and in the last follow-up. The improvement rate of ODI was (86.51 ± 6.02%, fusion rate of vertebral bodies

  8. A Functional Neuroimaging Analysis of the Trail Making Test-B: Implications for Clinical Application

    Directory of Open Access Journals (Sweden)

    Mark D. Allen

    2011-01-01

    Full Text Available Recent progress has been made using fMRI as a clinical assessment tool, often employing analogues of traditional “paper and pencil” tests. The Trail Making Test (TMT, popular for years as a neuropsychological exam, has been largely ignored in the realm of neuroimaging, most likely because its physical format and administration does not lend itself to straightforward adaptation as an fMRI paradigm. Likewise, there is relatively more ambiguity about the neural systems associated with this test than many other tests of comparable clinical use. In this study, we describe an fMRI version of Trail Making Test-B (TMTB that maintains the core functionality of the TMT while optimizing its use for both research and clinical settings. Subjects (N = 32 were administered the Functional Trail Making Test-B (f-TMTB. Brain region activations elicited by the f-TMTB were consistent with expectations given by prior TMT neurophysiological studies, including significant activations in the ventral and dorsal visual pathways and the medial pre-supplementary motor area. The f-TMTB was further evaluated for concurrent validity with the traditional TMTB using an additional sample of control subjects (N = 100. Together, these results support the f-TMTB as a viable neuroimaging adaptation of the TMT that is optimized to evoke maximally robust fMRI activation with minimal time and equipment requirements.

  9. Pre-clinical biocompatibility testing of peritoneal dialysis solutions.

    Science.gov (United States)

    Holmes, C J

    2000-01-01

    Pre-clinical biocompatibility testing of peritoneal dialysis (PD) solutions has become an integral part of new solution development. The construction of a pre-clinical screening program for solution biocompatibility should take a hierarchical approach, starting with in vitro cell viability and function assays. The selection of cell types and assay systems for the in vitro studies should be broad enough to permit a balanced interpretation. Whenever possible, animal models are recommended for the next hierarchical level of testing, followed by human ex vivo study designs. Designs of the latter sort provide evidence that a new solution formulation is exerting an altered biological response in vivo; the response is not purely an in vitro artifact or restricted to a given animal species. This article discusses the various approaches available for biocompatibility testing during the pre-clinical phase of solution development, with an emphasis on the advantages and drawbacks of each method.

  10. 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.

  11. 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.

  12. Sportsmen's Groin-Diagnostic Approach and Treatment With the Minimal Repair Technique: A Single-Center Uncontrolled Clinical Review.

    Science.gov (United States)

    Muschaweck, Ulrike; Berger, Luise Masami

    2010-05-01

    Sportsmen's groin, also called sports hernia and Gilmore groin, is one of the most frequent sports injuries in athletes and may place an athletic career at risk. It presents with acute or chronic groin pain exacerbated with physical activity. So far, there is little consensus regarding pathogenesis, diagnostic criteria, or treatment. There have been various attempts to explain the cause of the groin pain. The assumption is that a circumscribed weakness in the posterior wall of the inguinal canal, which leads to a localized bulge, induces a compression of the genital branch of the genitofemoral nerve, considered responsible for the symptoms. The authors developed an innovative open suture repair-the Minimal Repair technique-to fit the needs of professional athletes. With this technique, the circumscribed weakness of the posterior wall of the inguinal canal is repaired by an elastic suture; the compression on the nerve is abolished, and the cause of the pain is removed. In contrast with that of common open suture repairs, the defect of the posterior wall is not enlarged, the suture is nearly tension free, and the patient can return to full training and athletic activity within a shorter time. The outcome of patients undergoing operations with the Minimal Repair technique was compared with that of commonly used surgical procedures. THE FOLLOWING ADVANTAGES OF THE MINIMAL REPAIR TECHNIQUE WERE FOUND: no insertion of prosthetic mesh, no general anesthesia required, less traumatization, and lower risk of severe complications with equal or even faster convalescence. In 2009, a prospective cohort of 129 patients resumed training in 7 days and experienced complete pain relief in an average of 14 days. Professional athletes (67%) returned to full activity in 14 days (median). The Minimal Repair technique is an effective and safe way to treat sportsmen's groin.

  13. Assessment of Mobility in Older People Hospitalized for Medical Illness Using de Morton Mobility Index and Cumulated Ambulation Score-Validity and Minimal Clinical Important Difference

    DEFF Research Database (Denmark)

    Trøstrup, Jeanette; Andersen, Helle; Kam, Charlotte Agger Meiner

    2017-01-01

    and carrying out targeted interventions that ensure mobilization during hospital admission. The aim of this study was to determine convergent validity, known group validity, floor and ceiling effects, and anchor-based minimal clinically important difference (MCID) of the more time-consuming de Morton Mobility...... = 0.60, P nursing home were associated with significantly lower DEMMI and CAS scores. No floor or ceiling effects were present in the DEMMI, while a ceiling effect was present in the CAS. The MCID scores...

  14. Definition of Nonresponse to Analgesic Treatment of Arthritic Pain: An Analytical Literature Review of the Smallest Detectable Difference, the Minimal Detectable Change, and the Minimal Clinically Important Difference on the Pain Visual Analog Scale

    Directory of Open Access Journals (Sweden)

    Melissa E. Stauffer

    2011-01-01

    Full Text Available Our objective was to develop a working definition of nonresponse to analgesic treatment of arthritis, focusing on the measurement of pain on the 0–100 mm pain visual analog scale (VAS. We reviewed the literature to assess the smallest detectable difference (SDD, the minimal detectable change (MDC, and the minimal clinically important difference (MCID. The SDD for improvement reported in three studies of rheumatoid arthritis was 18.6, 19.0, and 20.0. The median MDC was 25.4 for 7 studies of osteoarthritis and 5 studies of rheumatoid arthritis (calculated for a reliability coefficient of 0.85. The MCID increased with increasing baseline pain score. For baseline VAS tertiles defined by scores of 30–49, 50–65, and >65, the MCID for improvement was, respectively, 7–11 units, 19–27 units, and 29–37 units. Nonresponse can thus be defined in terms of the MDC for low baseline pain scores and in terms of the MCID for high baseline scores.

  15. Testing the effectiveness of certainty scales, cheap talk, and dissonance-minimization in reducing hypothetical bias in contingent valuation studies

    Science.gov (United States)

    Mark Morrison; Thomas C. Brown

    2009-01-01

    Stated preference methods such as contingent valuation and choice modeling are subject to various biases that may lead to differences between actual and hypothetical willingness to pay. Cheap talk, follow-up certainty scales, and dissonance minimization are three techniques for reducing this hypothetical bias. Cheap talk and certainty scales have received considerable...

  16. Post Hoc Analysis of Data from Two Clinical Trials Evaluating the Minimal Clinically Important Change in International Restless Legs Syndrome Sum Score in Patients with Restless Legs Syndrome (Willis-Ekbom Disease).

    Science.gov (United States)

    Ondo, William G; Grieger, Frank; Moran, Kimberly; Kohnen, Ralf; Roth, Thomas

    2016-01-01

    Determine the minimal clinically important change (MCIC), a measure determining the minimum change in scale score perceived as clinically beneficial, for the international restless legs syndrome (IRLS) and restless legs syndrome 6-item questionnaire (RLS-6) in patients with moderate to severe restless legs syndrome (RLS/Willis-Ekbom disease) treated with the rotigotine transdermal system. This post hoc analysis analyzed data from two 6-mo randomized, double-blind, placebo-controlled studies (SP790 [NCT00136045]; SP792 [NCT00135993]) individually and as a pooled analysis in rotigotine-treated patients, with baseline and end of maintenance IRLS and Clinical Global Impressions of change (CGI Item 2) scores available for analysis. An anchor-based approach and receiver operating characteristic (ROC) curves were used to determine the MCIC for the IRLS and RLS-6. We specifically compared "much improved vs minimally improved," "much improved/very much improved vs minimally improved or worse," and "minimally improved or better vs no change or worse" on the CGI-2 using the full analysis set (data as observed). The MCIC IRLS cut-off scores for SP790 and SP792 were similar. Using the pooled SP790+SP792 analysis, the MCIC total IRLS cut-off score (sensitivity, specificity) for "much improved vs minimally improved" was -9 (0.69, 0.66), for "much improved/very much improved vs minimally improved or worse" was -11 (0.81, 0.84), and for "minimally improved or better vs no change or worse" was -9 (0.79, 0.88). MCIC ROC cut-offs were also calculated for each RLS-6 item. In patients with RLS, the MCIC values derived in the current analysis provide a basis for defining meaningful clinical improvement based on changes in the IRLS and RLS-6 following treatment with rotigotine. © 2016 American Academy of Sleep Medicine.

  17. Clinically relevant fracture testing of all-ceramic crowns.

    Science.gov (United States)

    Øilo, Marit; Kvam, Ketil; Tibballs, John E; Gjerdet, Nils Roar

    2013-08-01

    Fracture strength measured in vitro indicates that most all-ceramic crowns should be able to withstand mastication forces. Nevertheless, fractures are one of the major clinical problems with all-ceramic restorations. Furthermore, the fracture mode of all-ceramic crowns observed in clinical use differs from that found in conventional fracture strength tests. The aim of the present study was to develop and investigate a method that simulates clinical fracture behavior in vitro. 30 crowns with alumina cores were made to fit a cylindrical model with a molar-like preparation design. These crowns were randomly allocated to 3 tests groups (n=10). The crowns in group 1 were cemented to abutment models of epoxy and subsequently fractured by occlusal loading without contact damage. The crowns in group 2 were fractured by cementation with expanding cement. The crowns in group 3 were cemented on an abutment model of epoxy split almost in two and fractured by increasing the diameter of the model in the bucco-lingual direction. The fractured crowns were analyzed by fractographic methods and compared to a reference group of 10 crowns fractured in clinical use. The fracture modes of all the in vitro crowns were similar to clinical fracture modes. The fracture modes in group 1 were most closely matched to the clinical fractures. These crowns also fractured at clinically relevant loads. Laboratory tests that induce a distortion of the abutment model during occlusal loading without occlusal contact damage can simulate clinical fractures of all-ceramic crowns. Copyright © 2013 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

  18. Clinical utility of celiac disease associated HLA testing

    Science.gov (United States)

    Pallav, Kumar; Kabbani, Toufic; Tariq, Sohaib; Vanga, Rohini; Kelly, Ciaran P.; Leffler, Daniel A.

    2014-01-01

    Background Negative predictive value (NPV) of Celiac Disease (CD) related human leukocyte antigens (HLA) DQ2 and DQ8 approaches 100% in individual patients. However, studies evaluating its exclusionary utility in patient groups are lacking. Aim We aim to assess the performance of HLA testing when applied to patient groups with varying characteristics and propose evidence-based recommendations for its clinical use. Methods Demographic and clinical information was recorded in patients undergoing HLA testing. Using predetermined criteria, patients were classified as CD, Non CD or indeterminate. Diagnostic yield of HLA testing was defined as the percentage of patients in whom CD could be excluded based on negative HLA test. Results 256 patients underwent testing for CD related HLA DQ2 and DQ8. 102 (100 Non CD, 2 CD) patients tested HLA negative for a 98% NPV and 39% diagnostic yield. Diagnostic yield was highest (60%) in patients with intraepithelial lymphocytosis plus normal IgA tissue transglutaminase antibody (IgA-tTG) and lowest in patients with positive IgA-tTG plus villous atrophy (0%). CD was diagnosed in 2 HLA negative patients, who carried half of DQ2.5 trans genotype. Conclusions Diagnostic yield of CD related HLA testing varies widely depending on clinical indication. HLA testing is a practical and valuable test for most patients in whom initial evaluation for CD is inconclusive. A negative HLA result usually obviates the need for further celiac testing including endoscopy and gluten challenge. Rarely, in patients reported as HLA negative, half of HLA DQ2.5 (cis or trans) is sufficient for development of CD. PMID:24705698

  19. The role of neuro-electrophysiological diagnostic tests in clinical ...

    African Journals Online (AJOL)

    Objective: To summarise and discuss the role of neuro-electrophysiological diagnostic tests in clinical medicine. Data Sources: Published original research and reviews to date. Study Selection: The review was with emphasis on diagnosis of peripheral neuropathic and neuromuscular disorders. Data extraction and ...

  20. Clinical value of single versus composite provocative clinical tests in the assessment of painful shoulder.

    Science.gov (United States)

    Salaffi, Fausto; Ciapetti, Alessandro; Carotti, Marina; Gasparini, Stefania; Filippucci, Emilio; Grassi, Walter

    2010-04-01

    The aims of the present study were to investigate the clinical value of the provocative clinical tests and propose a composite index for the assessment of painful shoulder, using ultrasonography (US) as reference method. Two hundred three patients with painful shoulder underwent both clinical and US evaluations. The physical examination was carried out performing the Hawkins, Jobe, Patte, Gerber, and Speed tests. Each test was included in a composite index namely, SNAPSHOT (Simple Numeric Assessment of Pain by SHOulder Tests). The US examination was performed by a rheumatologist experienced in US and blinded to clinical findings. Sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratio of each clinical test were calculated. The receiver operating characteristic (ROC) curve analysis was used to assess the performance of the composite SNAPSHOT index. Sensitivity was low for the clinical diagnosis of all shoulder abnormalities. The highest sensitivity and smallest negative likelihood ratio were found for the Hawkins (63.88% and 0.50%) and Patte (62.21% and 0.52%) tests. Specificity was good for Speed (76.33%), Gerber (75.42%), and Patte (74.20%) tests. Patte and Speed tests were the most accurate (71.12% and 66.41%, respectively). The calculated area under the ROC curve related to the SNAPSHOT composite index was 0.881 +/- 0.026. With an optimal cut-off point of 3, the sensitivity and specificity were 75.8% and 87.5%, respectively. The results of the present study showed that SNAPSHOT is a feasible, informative and quantitative composite index for the assessment of painful shoulder in the clinical setting.

  1. Clinical comparison of robotic minimally invasive surgery and transcatheter interventional occlusion for adult secundum atrial septal defect

    Directory of Open Access Journals (Sweden)

    Cheng WANG

    2016-06-01

    Full Text Available Objective  To assess the safety and efficiency of robotic minimally invasive surgery and transcatheter interventional occlusion for treatment of adult secundum atrial septal defect (ASD by comparing the early and recent postoperative follow-up results of the two minimally invasive surgery. Methods  Thirty adult patients with secundum ASD, who admitted to the General Hospital of PLA from Jan. 2008 to Dec. 2014 and received treatment of da Vinci Surgical System, were recruited as TEASD-R group, meanwhile, another 30 adult patients who received transcatheter interventional occlusion were recruited under the strict 1:1 criterion as TIASD-O group. The early postoperative complications, in-hospital conditions, recent postoperative follow-up results and the quality of life 30d and 6 months after operation were compared and retrospectively analyzed between the two groups. Results  The success rates of surgery were 100% in the both groups, no early and recent postoperative complications (residual shunt, pericardial effusion, cerebral infarction, peripheral vascular embolism, new arrhythmia, etc. were found in TEASD-R group. While some of corresponding complications existed in TISAD-O group, and the differences were of statistical significance (P<0.05 between the two groups in the incidence of postoperative new arrhythmia, tricuspid incompetence and pulmonary hypertension, as well as in the early size of right atrium and in-hospital time. SF-36 quality of life questionnaire showed that the difference of somatic pain 30d after operation was of statistical significance (P<0.05 between the two groups, but the difference disappeared 6 months after operation. Conclusion  Robotic minimally invasive surgery for adult secundum ASD is feasible, safe and efficacious since no postoperative complications occurred such as tricuspid incompetence and pulmonary hypertension, but the longer operative and inhosptial time are the shortages of the operation. DOI: 10

  2. Cardiac autonomic testing and treating heart disease. 'A clinical perspective'

    Directory of Open Access Journals (Sweden)

    Nicholas L. DePace

    2014-12-01

    Full Text Available Background Coronary heart disease (CHD is a major health concern, affecting nearly half the middle-age population and responsible for nearly one-third of all deaths. Clinicians have several major responsibilities beyond diagnosing CHD, such as risk stratification of patients for major adverse cardiac events (MACE and treating risks, as well as the patient. This second of a two-part review series discusses treating risk factors, including autonomic dysfunction, and expected outcomes. Methods Therapies for treating cardiac mortality risks including cardiovascular autonomic neuropathy (CAN, are discussed. Results While risk factors effectively target high-risk patients, a large number of individuals who will develop complications from heart disease are not identified by current scoring systems. Many patients with heart conditions, who appear to be well-managed by traditional therapies, experience MACE. Parasympathetic and Sympathetic (P&S function testing provides more information and has the potential to further aid doctors in individualizing and titrating therapy to minimize risk. Advanced autonomic dysfunction (AAD and its more severe form cardiovascular autonomic neuropathy have been strongly associated with an elevated risk of cardiac mortality and are diagnosable through autonomic testing. This additional information includes patient-specific physiologic measures, such as sympathovagal balance (SB. Studies have shown that establishing and maintaining proper SB minimizes morbidity and mortality risk. Conclusions P&S testing promotes primary prevention, treating subclinical disease states, as well as secondary prevention, thereby improving patient outcomes through (1 maintaining wellness, (2 preventing symptoms and disorder and (3 treating subclinical manifestations (autonomic dysfunction, as well as (4 disease and symptoms (autonomic neuropathy.

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

    Science.gov (United States)

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

    2004-03-01

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

  4. The Stice model of overeating: Tests in clinical and non-clinical samples

    NARCIS (Netherlands)

    Strien, T. van; Engels, R.C.M.E.; Leeuwe, J.F.J. van; Snoek, H.M.

    2005-01-01

    The present study tested the dual pathway model of Stice [Stice, E (1994). A review of the evidence for a sociocultural model of bulimia nervosa and an exploration of the mechanisms of action. Clinical Psychology Review, 14, 633-661 and Stice, E. (2001). A prospective test of the dual-pathway model

  5. Skin signs in Ehlers-Danlos syndrome: clinical tests and para-clinical methods

    DEFF Research Database (Denmark)

    Remvig, L; Duhn, Ph; Ullman, S

    2010-01-01

    extensibility. The present study aimed to assess skin signs by means of clinical and para-clinical methods. Methods: A total of 31 EDS patients and 28 healthy controls were examined blinded and in random order. Inter-examiner analysis of clinical tests for skin extensibility, consistency, scarring, and bruising...... measurements. We suggest that skin consistency is withdrawn as a diagnostic criterion. The upper level for normal skin extensibility should be 3 cm. SC and STSM are promising para-clinical methods, but their diagnostic sensitivity and specificity need to be determined....... was performed, followed by analyses of extensibility with the suction cup (SC), consistency with a soft tissue stiffness meter (STSM), and thickness with ultrasonography (US). Semi-quantitative assessment of skin extensibility in healthy controls was incorporated in the tests. Results: The clinical analyses...

  6. Clinical laboratory test prices in Zimbabwe: A case of profiteering?

    Science.gov (United States)

    Musarurwa, C; Nyamayaro, T; Mujaji, W B; Matarira, H T; Gomo, Z A R

    2012-01-01

    To compare the prices charged for clinical laboratory tests in Zimbabwean institutions with those of similar institutions abroad. An online analytical cross sectional study was conducted. An online survey. We did an online survey of clinical laboratories that published prices of the tests offered on their websites. We also extracted price information from documents published by fees regulatory authorities. Laboratory test prices for independent institutions, Laboratory test prices for State institutions. Overally for all countries, laboratory test prices were lower in state laboratories compared to the independent laboratories. In Zimbabwe, state laboratories generally charged about 50% of the independent laboratory tariff for most tests. However prices from both Zimbabwean institutions were generally much higher than those of the comparison countries (United Kingdom, South Africa, India, United States of America and New Zealand). Prices of laboratory tests are indeed higher in Zimbabwean institutions compared to other centres abroad. These higher prices could be attributed to challenges in consumable procurement logistics. We also present measures that could be put in place to reduce the costs and therefore prices.

  7. Overview of a gay men's STI/HIV testing clinic in Ottawa: clinical operations and outcomes.

    Science.gov (United States)

    O'Byrne, Patrick; MacPherson, Paul; Ember, Andrew; Grayson, Marie-Odile; Bourgault, Andree

    2014-09-15

    To 1) create a space where men who have sex with men (MSM) feel comfortable accessing sexually transmitted infection/human immunodeficiency virus (STI/HIV) testing, and 2) reduce STI/HIV incidence. Gay men in Ottawa and its surrounding regions. A preponderance of diagnoses of sexually transmitted infections and HIV continue to occur among MSM. Meanwhile, other literature identifies that many MSM are reluctant to access STI/HIV testing services or to disclose their sexual practices to primary care practitioners. In Ottawa, in an effort to surmount these issues and decrease STI/HIV incidence among MSM, the local public health unit in collaboration with community partners created "GayZone", a three-hour-per-week STI/HIV testing and STI treatment clinic for gay men. In this paper, we report on the uptake and STI/HIV diagnosis outcomes for this clinic from January 2010 through December 2013. GayZone is a well-utilized clinic that yields a number of STI/HIV diagnoses per year. Overall, the positivity rates of the STI/HIV tests at this clinic are above-average, although lower than what might be expected by local epidemiological data. While the results of this clinic validate anonymous HIV testing, they bring into question the utility of pharyngeal swabs to test for gonorrhea and chlamydia. The results of our study demonstrate the utility of a gay men's STI/HIV testing clinic and highlight some areas for improvement. Public health practitioners, frontline clinicians, and community workers in other regions who wish to implement such an STI/HIV clinic would do well to consider our results beforehand.

  8. Reliability, validity, and minimal detectable change of the push-off test scores in assessing upper extremity weight-bearing ability.

    Science.gov (United States)

    Mehta, Saurabh P; George, Hannah R; Goering, Christian A; Shafer, Danielle R; Koester, Alan; Novotny, Steven

    2017-11-01

    Clinical measurement study. The push-off test (POT) was recently conceived and found to be reliable and valid for assessing weight bearing through injured wrist or elbow. However, further research with larger sample can lend credence to the preliminary findings supporting the use of the POT. This study examined the interrater reliability, construct validity, and measurement error for the POT in patients with wrist conditions. Participants with musculoskeletal (MSK) wrist conditions were recruited. The performance on the POT, grip isometric strength of wrist extensors was assessed. The shortened version of the Disabilities of the Arm, Shoulder and Hand and numeric pain rating scale were completed. The intraclass correlation coefficient assessed interrater reliability of the POT. Pearson correlation coefficients (r) examined the concurrent relationships between the POT and other measures. The standard error of measurement and the minimal detectable change at 90% confidence interval were assessed as measurement error and index of true change for the POT. A total of 50 participants with different elbow or wrist conditions (age: 48.1 ± 16.6 years) were included in this study. The results of this study strongly supported the interrater reliability (intraclass correlation coefficient: 0.96 and 0.93 for the affected and unaffected sides, respectively) of the POT in patients with wrist MSK conditions. The POT showed convergent relationships with the grip strength on the injured side (r = 0.89) and the wrist extensor strength (r = 0.7). The POT showed smaller standard error of measurement (1.9 kg). The minimal detectable change at 90% confidence interval for the POT was 4.4 kg for the sample. This study provides additional evidence to support the reliability and validity of the POT. This is the first study that provides the values for the measurement error and true change on the POT scores in patients with wrist MSK conditions. Further research should examine the

  9. Dermatotoxicologic clinical solutions: textile dye dermatitis patch testing.

    Science.gov (United States)

    Coman, Garrett; Blickenstaff, Nicholas; Edwards, Ashley; Maibach, Howard

    2015-03-01

    The authors provide a framework for working up and counseling a patient with suspected textile dermatitis, focusing on identifying which textile materials are most likely to be the cause of the eczematous lesions, the current clinical guidelines, the utility and appropriateness of patch testing, the limitations of these guidelines, and our pro tempore recommendations. While there are many challenges to correctly identify and counsel patients on how to avoid the offending textile products in a patient with suspected textile dye dermatitis, there is value in following the guidelines set forth to help identify the causative textile(s). Although patch tests can be useful, dermatologists should understand the limitations of standardized patch testing for patients with suspected textile dye-induced dermatitis. These guidelines are expected to increase the likelihood of identifying the causative textile(s), so that patch testing can be supplemented with swatch testing and chemical dye extraction to help discover the allergenic dye.

  10. Resampling the bioconcentration factors data from Japan's chemical substances control law database to simulate and evaluate the bioconcentration factors derived from minimized aqueous exposure tests.

    Science.gov (United States)

    Hashizume, Naoki; Inoue, Yoshiyuki; Murakami, Hidekazu; Ozaki, Hiromichi; Tanabe, Aiko; Suzuki, Yasuyuki; Yoshida, Tomohiko; Kikushima, Erina; Tsuji, Toshiaki

    2013-02-01

    Existing standard bioconcentration tests (e.g., the Organization for Economic Cooperation and Development [OECD] test guideline 305) require large numbers of test animals and resources. The minimized aqueous exposure test is a new approach based on the standard bioconcentration test but allows estimation of bioconcentration factor (BCF) by minimized sampling of the test fish. The authors collected BCF data (298 curves from 155 chemicals, using common carp as test species) from Japan's Chemical Substances Control Law database and resampled the data to simulate the calculation of BCF that would be obtained if studies had been designed to obtain kinetic BCF derived from minimized aqueous exposure tests (BCF(km)). The correlation was high (r(2)  = 0.967) between BCF derived from standard bioconcentration tests (BCF(full)) and BCF(km). The average value of the BCF(full) to BCF(km) ratio (BCF(full):BCF(km)) was 1.04 and ranged from 0.54 to 1.93, the 5th and 95th percentiles being 0.74 and 1.45, respectively. The results based on the 5th and 95th percentiles of the BCF(full):BCF(km) ratio suggest that BCF(full) 2,000 corresponds to BCF(km) 1,400 to 2,700, whereas BCF(full) 5,000 corresponds to BCF(km) 3,400 to 6,800. The authors also emphasize that the standard bioconcentration test should be performed when the resulting BCF(km) is in the region of regulatory concern. Copyright © 2012 SETAC.

  11. Evaluation of gingival blood as a minimally invasive screening tool for diabetes mellitus among 40-59-year-old adults in dental clinics: A cross-sectional study.

    Science.gov (United States)

    Partheeban, Indumathi K; Chaly, Preetha; Priyadarshni, Indra; Junaid, Mohammed; Nijesh, J E; Vaishnavi, S

    2017-01-01

    To evaluate a quick, safe, and minimally invasive method to screen for diabetes using gingival blood with the help of self-monitoring glucometer during periodontal examination. A hospital-based, cross-sectional comparative study was conducted among 40-59-year-old diabetic and nondiabetic population who had come for their master health examination to a private tertiary care hospital (Global Hospital and Health City) in Chennai. Among them, those who fulfilled the inclusion criteria were selected for the study. Thirty diabetic and thirty nondiabetic patients with moderate to severe gingivitis were enrolled and subjected to routine clinical periodontal examination. Blood samples of two sites were analyzed using a glucose self-monitoring device (Accu-Check). Patients were tested for venous fasting blood sugar (VFBS), venous postprandial blood sugar (VPPS), gingival fasting blood sugar (GFBS) level, gingival postprandial blood sugar (GPPS) level, peripheral fingerstick fasting blood sugar (PFBS) level, and peripheral fingerstick postprandial sugar (PPPS) level. Data obtained were statistically analyzed using Student's t-test, ANOVA, and Pearson's correlation test. A significant positive correlation was found between GFBS and VFBS, GFBS and PFBS, GPPS and VPPS, and GPPS and PPPS (P diabetic and nondiabetic patients correlation. Using venous blood glucose level as a gold standard, the sensitivity and specificity of GFBS was 93% and 100%, respectively, whereas in GPPS, the sensitivity and specificity was 80% and 96%, respectively. Gingival blood glucometry can be used as a minimally invasive screening tool for diabetes mellitus in dental clinics.

  12. Society of Family Planning clinical guidelines pain control in surgical abortion part 1 - local anesthesia and minimal sedation.

    Science.gov (United States)

    Allen, Rebecca H; Singh, Rameet

    2018-01-31

    Satisfactory pain control for women undergoing surgical abortion is important for patient comfort and satisfaction. Clinicians ought to be aware of the safety and efficacy of different pain control regimens. This document will focus on nonpharmacologic modalities to reduce pain and pharmacologic interventions up to the level of minimal sedation. For surgical abortion without intravenous medications, a multimodal approach to pain control may combine a dedicated emotional-support person, visual or auditory distraction, administration of local anesthesia to the cervix with buffered lidocaine and a preoperative nonsteroidal anti-inflammatory drug. Oral opioids do not decrease procedural pain. Oral anxiolytics decrease anxiety but not the experience of pain. Further research is needed on alternative options to control pain short of moderate or deep sedation. Copyright © 2018 Elsevier Inc. All rights reserved.

  13. Are traditional cognitive tests useful in predicting clinical success?

    Science.gov (United States)

    Gray, Sarah A; Deem, Lisa P; Straja, Sorin R

    2002-11-01

    The purpose of this research was to determine the predictive value of the Dental Admission Test (DAT) for clinical success using Ackerman's theory of ability determinants of skilled performance. The Ackerman theory is a valid, reliable schema in the applied psychology literature used to predict complex skill acquisition. Inconsistent stimulus-response skill acquisition depends primarily on determinants of cognitive ability. Consistent information-processing tasks have been described as "automatic," in which stimuli and responses are mapped in a manner that allows for complete certainty once the relationships have been learned. It is theorized that the skills necessary for success in the clinical component of dental schools involve a significant amount of automatic processing demands and, as such, student performance in the clinics should begin to converge as task practice is realized and tasks become more consistent. Subtest scores of the DAT of four classes were correlated with final grades in nine clinical courses. Results showed that the DAT subtest scores played virtually no role with regard to the final clinical grades. Based on this information, the DAT scores were determined to be of no predictive value in clinical achievement.

  14. Volume CT with a flat-panel detector on a mobile, isocentric C-arm: pre-clinical investigation in guidance of minimally invasive surgery.

    Science.gov (United States)

    Siewerdsen, J H; Moseley, D J; Burch, S; Bisland, S K; Bogaards, A; Wilson, B C; Jaffray, D A

    2005-01-01

    A mobile isocentric C-arm (Siemens PowerMobil) has been modified in our laboratory to include a large area flat-panel detector (in place of the x-ray image intensifier), providing multi-mode fluoroscopy and cone-beam computed tomography (CT) imaging capability. This platform represents a promising technology for minimally invasive, image-guided surgical procedures where precision in the placement of interventional tools with respect to bony and soft-tissue structures is critical. The image quality and performance in surgical guidance was investigated in pre-clinical evaluation in image-guided spinal surgery. The control, acquisition, and reconstruction system are described. The reproducibility of geometric calibration, essential to achieving high three-dimensional (3D) image quality, is tested over extended time scales (7 months) and across a broad range in C-arm angulation (up to 45 degrees), quantifying the effect of improper calibration on spatial resolution, soft-tissue visibility, and image artifacts. Phantom studies were performed to investigate the precision of 3D localization (viz., fiber optic probes within a vertebral body) and effect of lateral projection truncation (limited field of view) on soft-tissue detectability in image reconstructions. Pre-clinical investigation was undertaken in a specific spinal procedure (photodynamic therapy of spinal metastases) in five animal subjects (pigs). In each procedure, placement of fiber optic catheters in two vertebrae (L1 and L2) was guided by fluoroscopy and cone-beam CT. Experience across five procedures is reported, focusing on 3D image quality, the effects of respiratory motion, limited field of view, reconstruction filter, and imaging dose. Overall, the intraoperative cone-beam CT images were sufficient for guidance of needles and catheters with respect to bony anatomy and improved surgical performance and confidence through 3D visualization and verification of transpedicular trajectories and tool placement

  15. Minimal duality breaking in the Kallen-Lehman approach to 3D Ising model: A numerical test

    International Nuclear Information System (INIS)

    Astorino, Marco; Canfora, Fabrizio; Martinez, Cristian; Parisi, Luca

    2008-01-01

    A Kallen-Lehman approach to 3D Ising model is analyzed numerically both at low and high temperatures. It is shown that, even assuming a minimal duality breaking, one can fix three parameters of the model to get a very good agreement with the Monte Carlo results at high temperatures. With the same parameters the agreement is satisfactory both at low and near critical temperatures. How to improve the agreement with Monte Carlo results by introducing a more general duality breaking is shortly discussed

  16. Evaluation of a minimally invasive system for measuring glucose area under the curve during oral glucose tolerance tests: usefulness of sweat monitoring for precise measurement.

    Science.gov (United States)

    Sakaguchi, Kazuhiko; Hirota, Yushi; Hashimoto, Naoko; Ogawa, Wataru; Hamaguchi, Tomoya; Matsuo, Toshihiro; Miyagawa, Jun-ichiro; Namba, Mitsuyoshi; Sato, Toshiyuki; Okada, Seiki; Tomita, Koji; Matsuhisa, Munehide; Kaneto, Hideaki; Kosugi, Keisuke; Maegawa, Hiroshi; Nakajima, Hiromu; Kashiwagi, Atsunori

    2013-05-01

    We developed a system for measuring glucose area under the curve (AUC) using minimally invasive interstitial fluid extraction technology (MIET). Sweat contamination during interstitial fluid glucose (IG) extraction affects the accuracy of glucose AUC measurement, because this technology uses extracted sodium ion levels as an internal standard. Therefore, we developed a sweat monitoring patch to reduce this effect and investigated its efficacy in volunteers undergoing oral glucose tolerance tests (OGTTs). Fifty diabetes mellitus inpatients and 10 healthy subjects undergoing the 75 g OGTT were included. Two sites on the forearm were pretreated with microneedle arrays, then hydrogels for interstitial fluid extraction were placed on the treated sites. Simultaneously, hydrogels for sweat monitoring were placed on untreated sites near the treated sites. Plasma glucose (PG) levels were measured every 30 min for 2 h to calculate reference AUC values. Using MIET, IG AUC was calculated from extracted glucose and sodium ion levels after attachment of the hydrogel for 2 h. Good correlation between IG AUC measurements using MIET and reference AUCs measured using PG levels was confirmed over a wide AUC range (202-610 mg/h/dl) after correction for the sweat-induced error detected by the hydrogel patches on the nonpretreated skin. Strong correlation between IG AUC and peak glucose levels indicates that glucose spikes can be easily detected by this system. We confirmed the effectiveness of a sweat monitoring patch for precise AUC measurement using MIET. This novel, easy-to-use system has potential for glucose excursion evaluation in daily clinical practice. © 2013 Diabetes Technology Society.

  17. On mixed reality environments for minimally invasive therapy guidance: Systems architecture, successes and challenges in their implementation from laboratory to clinic

    Science.gov (United States)

    Linte, Cristian A.; Davenport, Katherine P.; Cleary, Kevin; Peters, Craig; Vosburgh, Kirby G.; Navab, Nassir; Edwards, Philip “Eddie”; Jannin, Pierre; Peters, Terry M.; Holmes, David R.; Robb, Richard A.

    2013-01-01

    Mixed reality environments for medical applications have been explored and developed over the past three decades in an effort to enhance the clinician’s view of anatomy and facilitate the performance of minimally invasive procedures. These environments must faithfully represent the real surgical field and require seamless integration of pre- and intra-operative imaging, surgical instrument tracking, and display technology into a common framework centered around and registered to the patient. However, in spite of their reported benefits, few mixed reality environments have been successfully translated into clinical use. Several challenges that contribute to the difficulty in integrating such environments into clinical practice are presented here and discussed in terms of both technical and clinical limitations. This article should raise awareness among both developers and end-users toward facilitating a greater application of such environments in the surgical practice of the future. PMID:23632059

  18. Platelet Function Tests: A Review of Progresses in Clinical Application

    Directory of Open Access Journals (Sweden)

    Jae-Lim Choi

    2014-01-01

    Full Text Available The major goal of traditional platelet function tests has been to screen and diagnose patients who present with bleeding problems. However, as the central role of platelets implicated in the etiology of arterial thrombotic diseases such as myocardial infarction and stroke became widely known, platelet function tests are now being promoted to monitor the efficacy of antiplatelet drugs and also to potentially identify patients at increased risk of thrombosis. Beyond hemostasis and thrombosis, an increasing number of studies indicate that platelets play an integral role in intercellular communication, are mediators of inflammation, and have immunomodulatory activity. As new potential biomarkers and technologies arrive at the horizon, platelet functions testing appears to take on a new aspect. This review article discusses currently available clinical application of platelet function tests, placing emphasis on essential characteristics.

  19. Clinical tests in aquatic toxicology: state of the art.

    Science.gov (United States)

    Mehrle, P M; Mayer, F L

    1980-02-01

    Hazard assessment of chemicals to aquatic organisms involves the use of many toxicity tests. Acute toxicity tests, embryo-larval toxicity tests, and chronic toxicity tests that measure survival, growth, and reproductive effects now provide the most relative utility for evaluation of potential chemical hazards to aquatic life. Physiological, biochemical, and histological measurements have a low relative utility as diagnostic tests in aquatic toxicology because it is not yet possible to relate changes in these sublethal responses to adverse environmental impacts. The problem of interpreting the toxicological significance of chemical-induced changes in biochemical and physiological mechanisms is twofold: (1) the understanding of physiological and biochemical regulatory mechanisms in fish is limited; and (2) parallel changes in these mechanisms are difficult to correlate with toxicant exposure and impaired ability of fish to survive. To overcome this problem, more physiological and biochemical research must be conducted in conjunction with toxicity studies that measure important whole-animal responses. Toxicant-induced biochemical and physiological responses must be correlated unequivocally with responses related to reproduction, growth and development, survival, or fish health if pertinent diagnostic tests are to be developed for use in aquatic toxicology. The use of diagnostic tests in hazard assessment procedures can decrease the time required for safety evaluation of chemicals, define no-effect exposure concentrations more adequately, and provide a better understanding of the mode of action of chemicals. Considerations for improving the status of the "state of the art" of diagnostic or clinical tests in aquatic toxicology are discussed.

  20. Young Mania Rating Scale: how to interpret the numbers? Determination of a severity threshold and of the minimal clinically significant difference in the EMBLEM cohort.

    Science.gov (United States)

    Lukasiewicz, Michael; Gerard, Stephanie; Besnard, Adeline; Falissard, Bruno; Perrin, Elena; Sapin, Helene; Tohen, Mauricio; Reed, Catherine; Azorin, Jean-Michel

    2013-03-01

    The aim of this analysis was to identify Young Mania Rating Scale (YMRS) meaningful benchmarks for clinicians (severity threshold, minimal clinically significant difference [MCSD]) using the Clinical Global Impressions Bipolar (CGI-BP) mania scale, to provide a clinical perspective to randomized clinical trials (RCTs) results. We used the cohort of patients with acute manic/mixed state of bipolar disorders (N = 3459) included in the European Mania in Bipolar Longitudinal Evaluation of Medication (EMBLEM) study. A receiver-operating characteristic analysis was performed on randomly selected patients to determine the YMRS optimal severity threshold with CGI-BP mania score ≥ "Markedly ill" defining severity. The MCSD (clinically meaningful change in score relative to one point difference in CGI-BP mania for outcome measures) of YMRS, was assessed with a linear regression on baseline data. At baseline, YMRS mean score was 26.4 (±9.9), CGI-BP mania mean score was 4.8 (±1.0) and 61.7% of patients had a score ≥ 5. The optimal YMRS severity threshold of 25 (positive predictive value [PPV] = 83.0%; negative predictive value [NPV] = 66.0%) was determined. In this cohort, a YMRS score of 20 (typical cutoff for RCTs inclusion criteria) corresponds to a PPV of 74.6% and to a NPV of 77.6%, meaning that the majority of patients included would be classified as severely ill. The YMRS minimal clinically significant difference was 6.6 points. Copyright © 2013 John Wiley & Sons, Ltd.

  1. Clinical balance tests, proprioceptive system and adolescent idiopathic scoliosis.

    Science.gov (United States)

    Le Berre, Morgane; Guyot, Marc-Alexandre; Agnani, Olivier; Bourdeauducq, Isabelle; Versyp, Marie-Christine; Donze, Cécile; Thévenon, André; Catanzariti, Jean-Francois

    2017-06-01

    Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spinal column of unknown etiology. Multiple factors could be involved, including neurosensory pathways and, potentially, an elective disorder of dynamic proprioception. The purpose of this study was to determine whether routine balance tests could be used to demonstrate an elective alteration of dynamic proprioception in AIS. This was a multicentre case-control study based on prospectively collected clinical data, in three hospitals pediatric, with spine consultation, from January 2013 through April 2015. From an original population of 547 adolescents, inclusion and non-inclusion criteria indentified 114 adolescents with right thoracic AIS (mean age 14.5 ± 1.9 years, Cobb angle 35.7 ± 15.3°) and 81 matched adolescents without scoliosis (mean age 14.1 ± 1.9 years). Participants performed three routine clinical balance tests to assess the static and dynamic proprioception: the Fukuda-Utenberger stepping test (angle of rotation in degrees and distance of displacement in cm) to assess dynamic balance; the sharpened Romberg test and the unipedal stance test (eyes closed) to assess static balance. There was no significant difference between AIS subjects and controls for the static tests, but there was a significant difference for the dynamic test for both measures: distance of displacement (p < 0.01) and angle of rotation (p < 0.0001). This result confirms our initial these: the dynamic proprioception is altered electively in AIS. These findings confirm recent AIS studies. Our results might be related to immature central integration of dynamic proprioceptive input leading to a poorly adapted motor response, particularly for postural control of the, in AIS. These balance tests can be performed in routine practice. Their validity as a biomarker for screening and monitoring purposes should be assessed.

  2. Responsiveness of clinical tests for people with neck pain

    DEFF Research Database (Denmark)

    Jørgensen, René; Ris, Inge; Juhl, Carsten

    2017-01-01

    , positive and negative predictive values, in addition to positive and negative likelihood ratios were calculated. RESULTS: In total, 164 participants completed the 4 month follow up. One-hundred forty four participants were classified as unchanged whereas 20 patients were considered to be improved. Twenty...... with sensitivity ranging from 20 to 60%, and specificity from 54 to 86%. LR+ (0.8-2.07) and LR- (0.7-1.1) showed low diagnostic value for all variables, with PPV ranging from 12.1 to 26.1 and NPV ranging from 84.7 to 89.2. CONCLUSION: Responsiveness of the included clinical tests was generally low when using...... change in NDI score as the anchor from baseline to the 4-month follow up. Further investigations of responsiveness are warranted, possibly using other anchors, which to a higher degree resemble similar dimensions as the clinical tests....

  3. Clinical Validation of a Test for the Diagnosis of Vaginitis.

    Science.gov (United States)

    Gaydos, Charlotte A; Beqaj, Sajo; Schwebke, Jane R; Lebed, Joel; Smith, Bonnie; Davis, Thomas E; Fife, Kenneth H; Nyirjesy, Paul; Spurrell, Timothy; Furgerson, Dorothy; Coleman, Jenell; Paradis, Sonia; Cooper, Charles K

    2017-07-01

    Vaginitis may be diagnosed as bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis, or coinfection. A new molecular test assays the vaginal microbiome and organisms that cause three common infections. The objective of the trial was to evaluate the clinical accuracy of the investigational test for vaginal swabs collected by patients (self) or clinicians. The primary and secondary outcomes were to compare the investigational test with reference methods for the three most common causes of vaginitis and compare clinician-collected with self-collected swabs. We conducted a cross-sectional study in which women with symptoms of vaginitis were recruited at ten clinical centers and consented to the investigation between May and September 2015. The woman collected a vaginal swab, sheathed, and then handed it to the clinician. These swabs were to evaluate how self-collected swabs compared with clinician-collected swabs. The clinician collected an investigational test swab and reference test swabs. From 1,740 symptomatic patients, clinician-collected and self-collected vaginal swabs were evaluated by the molecular test and six tests. The reference methods for bacterial vaginosis were Nugent's score and Amsel's criteria for intermediate Nugent results. The reference methods for Candida infection were isolation of any potential Candida microorganisms from inoculation of two culture media: chromogenic and Sabouraud agar and sequencing. The reference methods for trichomoniasis were wet mount and culture. For clinician-collected swabs, by reference methods, bacterial vaginosis was diagnosed in 56.5%, vaginal candidiasis in 32.8%, trichomoniasis in 8%, and none of the three infections in 24% with a coinfection rate of 20%. The investigational test sensitivity was 90.5% (95% confidence interval [CI] 88.3-92.2%) and specificity was 85.8% (95% CI 83.0-88.3%) for bacterial vaginosis. The investigational test sensitivity was 90.9% (95% CI 88.1-93.1%) and specificity was 94

  4. Minimal morphological criteria for defining bone marrow dysplasia: a basis for clinical implementation of WHO classification of myelodysplastic syndromes.

    Science.gov (United States)

    Della Porta, M G; Travaglino, E; Boveri, E; Ponzoni, M; Malcovati, L; Papaemmanuil, E; Rigolin, G M; Pascutto, C; Croci, G; Gianelli, U; Milani, R; Ambaglio, I; Elena, C; Ubezio, M; Da Via', M C; Bono, E; Pietra, D; Quaglia, F; Bastia, R; Ferretti, V; Cuneo, A; Morra, E; Campbell, P J; Orazi, A; Invernizzi, R; Cazzola, M

    2015-01-01

    The World Health Organization classification of myelodysplastic syndromes (MDS) is based on morphological evaluation of marrow dysplasia. We performed a systematic review of cytological and histological data from 1150 patients with peripheral blood cytopenia. We analyzed the frequency and discriminant power of single morphological abnormalities. A score to define minimal morphological criteria associated to the presence of marrow dysplasia was developed. This score showed high sensitivity/specificity (>90%), acceptable reproducibility and was independently validated. The severity of granulocytic and megakaryocytic dysplasia significantly affected survival. A close association was found between ring sideroblasts and SF3B1 mutations, and between severe granulocytic dysplasia and mutation of ASXL1, RUNX1, TP53 and SRSF2 genes. In myeloid neoplasms with fibrosis, multilineage dysplasia, hypolobulated/multinucleated megakaryocytes and increased CD34+ progenitors in the absence of JAK2, MPL and CALR gene mutations were significantly associated with a myelodysplastic phenotype. In myeloid disorders with marrow hypoplasia, granulocytic and/or megakaryocytic dysplasia, increased CD34+ progenitors and chromosomal abnormalities are consistent with a diagnosis of MDS. The proposed morphological score may be useful to evaluate the presence of dysplasia in cases without a clearly objective myelodysplastic phenotype. The integration of cytological and histological parameters improves the identification of MDS cases among myeloid disorders with fibrosis and hypocellularity.

  5. A critique of statistical hypothesis testing in clinical research

    Directory of Open Access Journals (Sweden)

    Somik Raha

    2011-01-01

    Full Text Available Many have documented the difficulty of using the current paradigm of Randomized Controlled Trials (RCTs to test and validate the effectiveness of alternative medical systems such as Ayurveda. This paper critiques the applicability of RCTs for all clinical knowledge-seeking endeavors, of which Ayurveda research is a part. This is done by examining statistical hypothesis testing, the underlying foundation of RCTs, from a practical and philosophical perspective. In the philosophical critique, the two main worldviews of probability are that of the Bayesian and the frequentist. The frequentist worldview is a special case of the Bayesian worldview requiring the unrealistic assumptions of knowing nothing about the universe and believing that all observations are unrelated to each other. Many have claimed that the first belief is necessary for science, and this claim is debunked by comparing variations in learning with different prior beliefs. Moving beyond the Bayesian and frequentist worldviews, the notion of hypothesis testing itself is challenged on the grounds that a hypothesis is an unclear distinction, and assigning a probability on an unclear distinction is an exercise that does not lead to clarity of action. This critique is of the theory itself and not any particular application of statistical hypothesis testing. A decision-making frame is proposed as a way of both addressing this critique and transcending ideological debates on probability. An example of a Bayesian decision-making approach is shown as an alternative to statistical hypothesis testing, utilizing data from a past clinical trial that studied the effect of Aspirin on heart attacks in a sample population of doctors. As a big reason for the prevalence of RCTs in academia is legislation requiring it, the ethics of legislating the use of statistical methods for clinical research is also examined.

  6. Evaluation of dental pulp sensibility tests in a clinical setting.

    Science.gov (United States)

    Jespersen, James J; Hellstein, John; Williamson, Anne; Johnson, William T; Qian, Fang

    2014-03-01

    The goal of this project was to evaluate the performance of dental pulp sensibility testing with Endo Ice (1,1,1,2-tetrafluoroethane) and an electric pulp tester (EPT) and to determine the effect of several variables on the reliability of these tests. Data were collected from 656 patients seen in the University of Iowa College of Dentistry Endodontic graduate clinic. The results of pulpal sensibility tests, along with the tooth number, age, sex, number of restored surfaces, presence or absence of clinical or radiographic caries, and reported recent use of analgesic medications, were recorded. The presence of vital tissue within the pulp chamber was used to verify the diagnosis. The Endo Ice results showed accuracy, 0.904; sensitivity, 0.916; specificity, 0.896; positive predictive value, 0.862; and negative predictive value, 0.937. The EPT results showed accuracy, 0.75; sensitivity, 0.84; specificity, 0.74; positive predictive value, 0.58; and negative predictive value, 0.90. Patients aged 21-50 years exhibited a more accurate response to cold testing (P = .0043). Vital teeth with caries responded more accurately to cold testing (P = .0077). There was no statistically significant difference noted with any other variable examined. Pulpal sensibility testing with Endo Ice and EPT are accurate and reliable methods of determining pulpal vitality. Patients aged 21-50 exhibited a more accurate response to cold. Sex, tooth type, number of restored surfaces, presence of caries, and recent analgesic use did not significantly alter the results of pulpal sensibility testing in this study. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  7. Minimal care--a new concept for the management of urinary incontinence in an open access, interdisciplinary incontinence clinic. The way ahead?

    DEFF Research Database (Denmark)

    Andersen, J T; Sander, P

    1996-01-01

    A new concept for assessment and treatment of urinary incontinence in an open access, interdisciplinary clinic is evaluated prospectively. Based on the patients needs and expectations, a minimal relevant investigative programme was planned. The patients were primarily offered conservative, non...... of the patients were managed by conservative treatment modalities whereas only 10% of the patients were referred to in-hospital treatment with invasive treatment modalities, mainly surgical procedures for urinary incontinence. Subjectively, 68% felt cured or very much improved, 23% experienced improvement and 9...... and treatment of urinary incontinence....

  8. Estimation of minimal clinically important change of the Japanese version of EQ-5D in patients with chronic noncancer pain: a retrospective research using real-world data

    OpenAIRE

    Yoshizawa, Kazutake; Kobayashi, Hisanori; Fujie, Motoko; Ogawa, Yoshimasa; Yajima, Tsutomu; Kawai, Koji

    2016-01-01

    Background Quality of life (QoL) is routinely assessed and evaluated in medical research. However, in Japan, there is a lack of solid cutoff criteria for evaluating QoL improvement in chronic noncancer pain management. The present study was conducted to identify the minimal clinically important change (MCIC) of the Japanese version of EuroQol-5D 3L(EQ-5D) utility score and numeric rating scale (NRS) with an emphasis on chronic noncancer pain. Methods The data source for this post hoc research...

  9. Clinical utility of antinuclear antibody tests in children

    Directory of Open Access Journals (Sweden)

    Kickingbird Lauren M

    2004-07-01

    Full Text Available Abstract Background Antinuclear antibody (ANA tests are frequently used to screen children for chronic inflammatory diseases such as systemic lupus erythematosus (SLE. However, the diagnostic utility of this test is limited because of the large number of healthy children who have low-titer positive tests. We sought to determine the clinical utility of ANA tests in screening children for rheumatic disease and to determine whether there are specific signs or symptoms that enhance the clinical utility of ANA tests in children. Methods We undertook a retrospective analysis of 509 new patient referrals. Charts of patients referred because of results of ANA testing were selected for further analysis. Children with JRA, SLE, and other conditions were compared using demographic data, chief complaints at the time of presentation, and ANA titers. Results One hundred ten patients were referred because of an ANA test interpreted as positive. Ten patients were subsequently diagnosed with SLE. In addition, we identified one patient with mixed connective tissue disease, and an additional child with idiopathic Raynaud's phenomenon. Eighteen children of the children referred for a positive ANA test had juvenile rheumatoid arthritis (JRA. Another 80 children with positive ANA tests were identified, the majority of whom (n = 39, 49% had musculoskeletal pain syndromes. Neither the presence nor the titer of ANA served to distinguish children with JRA from children with other musculoskeletal conditions. Children with JRA were readily identified on the basis of the history and physical examination. Children with SLE were therefore compared with children with positive ANA tests who did not have JRA, designated the "comparison group." Non-urticarial rash was more common in children with SLE than in children without chronic inflammatory disease (p = 0.007. Children with SLE were also older (mean ± sd = 14.2 ± 2.5 years than the comparison group (11.0 ± 3.6 years; p

  10. Evaluating clinical significance: incorporating robust statistics with normative comparison tests.

    Science.gov (United States)

    van Wieringen, Katrina; Cribbie, Robert A

    2014-05-01

    The purpose of this study was to evaluate a modified test of equivalence for conducting normative comparisons when distribution shapes are non-normal and variances are unequal. A Monte Carlo study was used to compare the empirical Type I error rates and power of the proposed Schuirmann-Yuen test of equivalence, which utilizes trimmed means, with that of the previously recommended Schuirmann and Schuirmann-Welch tests of equivalence when the assumptions of normality and variance homogeneity are satisfied, as well as when they are not satisfied. The empirical Type I error rates of the Schuirmann-Yuen were much closer to the nominal α level than those of the Schuirmann or Schuirmann-Welch tests, and the power of the Schuirmann-Yuen was substantially greater than that of the Schuirmann or Schuirmann-Welch tests when distributions were skewed or outliers were present. The Schuirmann-Yuen test is recommended for assessing clinical significance with normative comparisons. © 2013 The British Psychological Society.

  11. Taxonomic minimalism.

    Science.gov (United States)

    Beattle, A J; Oliver, I

    1994-12-01

    Biological surveys are in increasing demand while taxonomic resources continue to decline. How much formal taxonomy is required to get the job done? The answer depends on the kind of job but it is possible that taxonomic minimalism, especially (1) the use of higher taxonomic ranks, (2) the use of morphospecies rather than species (as identified by Latin binomials), and (3) the involvement of taxonomic specialists only for training and verification, may offer advantages for biodiversity assessment, environmental monitoring and ecological research. As such, formal taxonomy remains central to the process of biological inventory and survey but resources may be allocated more efficiently. For example, if formal Identification is not required, resources may be concentrated on replication and increasing sample sizes. Taxonomic minimalism may also facilitate the inclusion in these activities of important but neglected groups, especially among the invertebrates, and perhaps even microorganisms. Copyright © 1994. Published by Elsevier Ltd.

  12. [Innovative Prenatal Testing: Clinical Applications and Ethical Considerations].

    Science.gov (United States)

    Huang, Mei-Chih; Lin, Shio-Jean; Chen, Chih-Ling; Huang, Tzu-Jung

    2017-10-01

    The biomedical technology related to prenatal screen/diagnosis has developed rapidly in recent decades. Many prenatal genetic examinations are now available to assist pregnant women to better understand the status and development of their fetus. Moreover, many commercial advertisements for innovative prenatal examinations are now shown in the media. Cell-free DNA Screening (cfDNA screening), a non-invasive prenatal testing (NIPT) procedure, is a safe and high accuracy test that may be done at an earlier gestational age to screen for fetal aneuploidy. The following questions should be considered when applying cfDNA screening in clinical practice: 1. what is cfDNA screening, 2. who are its potential users, and 3. what ethical and policy considerations are associated with this examination? This article provides relevant information, clinical practice guidelines, and ethical / policy considerations related to cfDNA screening. Discussing cases involving different clinical situations helps promote understanding of cfDNA screening and maternal-care quality.

  13. Genetic testing in congenital heart disease: A clinical approach

    Science.gov (United States)

    Chaix, Marie A; Andelfinger, Gregor; Khairy, Paul

    2016-01-01

    Congenital heart disease (CHD) is the most common type of birth defect. Traditionally, a polygenic model defined by the interaction of multiple genes and environmental factors was hypothesized to account for different forms of CHD. It is now understood that the contribution of genetics to CHD extends beyond a single unified paradigm. For example, monogenic models and chromosomal abnormalities have been associated with various syndromic and non-syndromic forms of CHD. In such instances, genetic investigation and testing may potentially play an important role in clinical care. A family tree with a detailed phenotypic description serves as the initial screening tool to identify potentially inherited defects and to guide further genetic investigation. The selection of a genetic test is contingent upon the particular diagnostic hypothesis generated by clinical examination. Genetic investigation in CHD may carry the potential to improve prognosis by yielding valuable information with regards to personalized medical care, confidence in the clinical diagnosis, and/or targeted patient follow-up. Moreover, genetic assessment may serve as a tool to predict recurrence risk, define the pattern of inheritance within a family, and evaluate the need for further family screening. In some circumstances, prenatal or preimplantation genetic screening could identify fetuses or embryos at high risk for CHD. Although genetics may appear to constitute a highly specialized sector of cardiology, basic knowledge regarding inheritance patterns, recurrence risks, and available screening and diagnostic tools, including their strengths and limitations, could assist the treating physician in providing sound counsel. PMID:26981213

  14. Clinical relevance of small copy-number variants in chromosomal microarray clinical testing.

    Science.gov (United States)

    Hollenbeck, Dana; Williams, Crescenda L; Drazba, Kathryn; Descartes, Maria; Korf, Bruce R; Rutledge, S Lane; Lose, Edward J; Robin, Nathaniel H; Carroll, Andrew J; Mikhail, Fady M

    2017-04-01

    The 2010 consensus statement on diagnostic chromosomal microarray (CMA) testing recommended an array resolution ≥400 kb throughout the genome as a balance of analytical and clinical sensitivity. In spite of the clear evidence for pathogenicity of large copy-number variants (CNVs) in neurodevelopmental disorders and/or congenital anomalies, the significance of small, nonrecurrent CNVs (<500 kb) has not been well established in a clinical setting. We investigated the clinical significance of all nonpolymorphic small, nonrecurrent CNVs (<500 kb) in patients referred for CMA clinical testing over a period of 6 years, from 2009 to 2014 (a total of 4,417 patients). We excluded from our study patients with benign or likely benign CNVs and patients with only recurrent microdeletions/microduplications <500 kb. In total, 383 patients (8.67%) were found to carry at least one small, nonrecurrent CNV, of whom 176 patients (3.98%) had one small CNV classified as a variant of uncertain significance (VUS), 45 (1.02%) had two or more small VUS CNVs, 20 (0.45%) had one small VUS CNV and a recurrent CNV, 113 (2.56%) had one small pathogenic or likely pathogenic CNV, 17 (0.38%) had two or more small pathogenic or likely pathogenic CNVs, and 12 (0.27%) had one small pathogenic or likely pathogenic CNV and a recurrent CNV. Within the pathogenic group, 80 of 142 patients (56% of all small pathogenic CNV cases) were found to have a single whole-gene or exonic deletion. The themes that emerged from our study are presented in the Discussion section. Our study demonstrates the diagnostic clinical relevance of small, nonrecurrent CNVs <500 kb during CMA clinical testing and underscores the need for careful clinical interpretation of these CNVs.Genet Med 19 4, 377-385.

  15. The Clinical Course of Minimal Change Nephrotic Syndrome With Onset in Adulthood or Late Adolescence: A Case Series.

    Science.gov (United States)

    Maas, Rutger J; Deegens, Jeroen K; Beukhof, Johan R; Reichert, Louis J; Ten Dam, Marc A; Beutler, Jaap J; van den Wall Bake, A Warmold L; Rensma, Pieter L; Konings, Constantijn J; Geerse, Daniel A; Feith, Geert W; Van Kuijk, Willi H; Wetzels, Jack F

    2017-05-01

    Few studies have examined the treatment and outcome of adult-onset minimal change nephrotic syndrome (MCNS). We retrospectively studied 125 patients who had MCNS with onset in either adulthood or late adolescence. Presenting characteristics, duration of initial treatment and response to treatment, relapse patterns, complications, and long-term outcome were studied. Case series. Patients with new-onset nephrotic syndrome 16 years or older and a histologic diagnosis of MCNS in 1985 to 2011 were identified from pathology records of 10 participating centers. Partial and complete remission, treatment resistance, relapse, complications, renal survival. Corticosteroids were given as initial treatment in 105 (84%) patients. After 16 weeks of corticosteroid treatment, 92 (88%) of these patients had reached remission. Median time to remission was 4 (IQR, 2-7) weeks. 7 (6%) patients initially received cyclophosphamide with or without corticosteroids, and all attained remission after a median of 4 (IQR, 3-11) weeks. 13 (10%) patients reached remission without immunosuppressive treatment. One or more relapses were observed in 57 (54%) patients who received initial corticosteroid treatment. Second-line cyclophosphamide resulted in stable remission in 57% of patients with relapsing MCNS. Acute kidney injury was observed in 50 (40%) patients. Recovery of kidney function occurred almost without exception. Arterial or venous thrombosis occurred in 11 (9%) patients. At the last follow-up, 113 (90%) patients were in remission and had preserved kidney function. 3 patients with steroid-resistant MCNS progressed to end-stage renal disease, which was associated with focal segmental glomerulosclerosis lesions on repeat biopsy. Retrospective design, variable treatment protocols. The large majority of patients who had MCNS with onset in adulthood or late adolescence were treated with corticosteroids and reached remission, but many had relapses. Cyclophosphamide resulted in stable remission

  16. When ethics constrains clinical research: trial design of control arms in "greater than minimal risk" pediatric trials.

    Science.gov (United States)

    de Melo-Martín, Inmaculada; Sondhi, Dolan; Crystal, Ronald G

    2011-09-01

    For more than three decades clinical research in the United States has been explicitly guided by the idea that ethical considerations must be central to research design and practice. In spite of the centrality of this idea, attempting to balance the sometimes conflicting values of advancing scientific knowledge and protecting human subjects continues to pose challenges. Possible conflicts between the standards of scientific research and those of ethics are particularly salient in relation to trial design. Specifically, the choice of a control arm is an aspect of trial design in which ethical and scientific issues are deeply entwined. Although ethical quandaries related to the choice of control arms may arise when conducting any type of clinical trials, they are conspicuous in early phase gene transfer trials that involve highly novel approaches and surgical procedures and have children as the research subjects. Because of children's and their parents' vulnerabilities, in trials that investigate therapies for fatal, rare diseases affecting minors, the scientific and ethical concerns related to choosing appropriate controls are particularly significant. In this paper we use direct gene transfer to the central nervous system to treat late infantile neuronal ceroid lipofuscinosis to illustrate some of these ethical issues and explore possible solutions to real and apparent conflicts between scientific and ethical considerations.

  17. Common errors and clinical guidelines for manual muscle testing: "the arm test" and other inaccurate procedures

    Directory of Open Access Journals (Sweden)

    Cuthbert Scott C

    2008-12-01

    Full Text Available Abstract Background The manual muscle test (MMT has been offered as a chiropractic assessment tool that may help diagnose neuromusculoskeletal dysfunction. We contend that due to the number of manipulative practitioners using this test as part of the assessment of patients, clinical guidelines for the MMT are required to heighten the accuracy in the use of this tool. Objective To present essential operational definitions of the MMT for chiropractors and other clinicians that should improve the reliability of the MMT as a diagnostic test. Controversy about the usefulness and reliability of the MMT for chiropractic diagnosis is ongoing, and clinical guidelines about the MMT are needed to resolve confusion regarding the MMT as used in clinical practice as well as the evaluation of experimental evidence concerning its use. Discussion We expect that the resistance to accept the MMT as a reliable and valid diagnostic tool will continue within some portions of the manipulative professions if clinical guidelines for the use of MMT methods are not established and accepted. Unreliable assessments of this method of diagnosis will continue when non-standard MMT research papers are considered representative of the methods used by properly trained clinicians. Conclusion Practitioners who employ the MMT should use these clinical guidelines for improving their use of the MMT in their assessments of muscle dysfunction in patients with musculoskeletal pain.

  18. Routine pharmacogenetic testing in clinical practice: dream or reality?

    Science.gov (United States)

    Grossman, Iris

    2007-10-01

    Pharmacogenetics (PGx) has become progressively popular in recent years, thanks to growing anticipation among scientists, healthcare providers and the general public for the incorporation of genetic tests into the diagnostic arsenal at the physician's disposal. Indeed, much research has been dedicated to elucidation of genetic determinants underlying interindividual variability in pharmacokinetic parameters, as well as drug safety and efficacy. However, few PGx applications have thus far been realized in healthcare management. This review uses examples from PGx research of psychiatric drugs to illustrate why the current published findings are inadequate and insufficient for utilization as routine clinical predictors of treatment safety, efficacy or dosing. I therefore suggest the necessary steps to demonstrate the validity, utility and cost-effectiveness of PGx. These recommendations include a whole range of aspects, starting from standardization of criteria and assessment of the technical quality of genotyping assays, up to design of prospective PGx studies, providing the basis for reimbursement programs to be recognized in routine clinical practice.

  19. Ethical and clinical practice considerations for genetic counselors related to direct-to-consumer marketing of genetic tests.

    Science.gov (United States)

    Wade, Christopher H; Wilfond, Benjamin S

    2006-11-15

    Several companies utilize direct-to-consumer (DTC) advertising for genetic tests and some, but not all, bypass clinician involvement by offering DTC purchase of the tests. This article examines how DTC marketing strategies may affect genetic counselors, using available cardiovascular disease susceptibility tests as an illustration. The interpretation of these tests is complex and includes consideration of clinical validity and utility, and the further complications of gene-environment interactions and pleiotropy. Although it is unclear to what extent genetic counselors will encounter clients who have been exposed to DTC marketing strategies, these strategies may influence genetic counseling interactions if they produce directed interest in specific tests and unrealistic expectations for the tests' capacity to predict disease. Often, a client's concern about risk for cardiovascular diseases is best addressed by established clinical tests and a family history assessment. Ethical dilemmas may arise for genetic counselors who consider whether to accept clients who request test interpretation or to order DTC-advertised tests that require a clinician's authorization. Genetic counselors' obligations to care for clients extend to interpreting DTC tests, although this obligation may be fulfilled by referral or consultation with specialists. Genetic counselors do not have an obligation to order DTC-advertised tests that have minimal clinical validity and utility at a client's request. This can be a justified restriction on autonomy based on consideration of risks to the client, the costs, and the implications for society. Published 2006 Wiley-Liss, Inc.

  20. Distal tibial fracture treated by minimally invasive plate osteosynthesis after external fixation Retrospective clinical and radiographic assessment

    Directory of Open Access Journals (Sweden)

    Al. Șerban

    2014-02-01

    Full Text Available Fractures of the horizontal surface of the distal tibia are known commonly as pylon or plafond fractures, and represent 1-5% of lower extremity fractures, 7-10% of all tibial fractures. The protocol consisted of immediate (within eight to 24 hours open reduction and internal fixation of the fibula, using a fibular plate or one third tubular plate and application of an external fixator spanning the ankle joint. In the second stage, the treatment of proximal and distal tibial fractures with close reduction and MIPPO technique can preserve soft tissue, simplify operative procedure and decrease wound, obtain rigid internal fixation and guarantee early function exercises of ankle joint. In this study we evaluated 22 patients treated in Clinical Emergency Hospital Constanta between April 2012 - July 2013 diagnosed with multifragmentary fractures of the distal tibia. This study evaluates the treatment of complex fractures of distal tibia with locked plate after external fixation. There were 17 males and 5 females of mean age 51,7 years (31-68. The mean follow-up period was 14 weeks. (Ranging from 9-16 weeks. All patients were fully weight bearing at 16 weeks (ranging 9-16 weeks showing radiological union. There were no cases of failures of fixation, or rotational misalignment. No significant complication was observed in our patients. MIPO is an effective method of treatment for distal tibial fractures, reduce surgical trauma and maintain a more biologically favorable environment for fracture healing, reducing risks of infection and nonunion.

  1. Test-retest reliability and minimal detectable change of three-dimensional gait analysis in chronic low back pain patients

    NARCIS (Netherlands)

    Fernandes, R.; Armada-da-Silva, P.; Pool-Goudzwaard, A.; Moniz-Pereira, V.; Veloso, A.P.

    2015-01-01

    Background and aim: Three-dimensional gait analysis (3DGA) can provide detailed data on gait impairment in chronic low back pain (CLBP) patients. However, data about reliability and measurement error of 3DGA in this population is lacking. The aim of this study is to investigate test-retest

  2. Standard Practice for Minimizing Dosimetry Errors in Radiation Hardness Testing of Silicon Electronic Devices Using Co-60 Sources

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2010-01-01

    1.1 This practice covers recommended procedures for the use of dosimeters, such as thermoluminescent dosimeters (TLD's), to determine the absorbed dose in a region of interest within an electronic device irradiated using a Co-60 source. Co-60 sources are commonly used for the absorbed dose testing of silicon electronic devices. Note 1—This absorbed-dose testing is sometimes called “total dose testing” to distinguish it from “dose rate testing.” Note 2—The effects of ionizing radiation on some types of electronic devices may depend on both the absorbed dose and the absorbed dose rate; that is, the effects may be different if the device is irradiated to the same absorbed-dose level at different absorbed-dose rates. Absorbed-dose rate effects are not covered in this practice but should be considered in radiation hardness testing. 1.2 The principal potential error for the measurement of absorbed dose in electronic devices arises from non-equilibrium energy deposition effects in the vicinity o...

  3. Validation of a clinical critical thinking skills test in nursing

    Directory of Open Access Journals (Sweden)

    Sujin Shin

    2015-01-01

    Full Text Available Purpose: The purpose of this study was to develop a revised version of the clinical critical thinking skills test (CCTS and to subsequently validate its performance. Methods: This study is a secondary analysis of the CCTS. Data were obtained from a convenience sample of 284 college students in June 2011. Thirty items were analyzed using item response theory and test reliability was assessed. Test-retest reliability was measured using the results of 20 nursing college and graduate school students in July 2013. The content validity of the revised items was analyzed by calculating the degree of agreement between instrument developer intention in item development and the judgments of six experts. To analyze response process validity, qualitative data related to the response processes of nine nursing college students obtained through cognitive interviews were analyzed. Results: Out of initial 30 items, 11 items were excluded after the analysis of difficulty and discrimination parameter. When the 19 items of the revised version of the CCTS were analyzed, levels of item difficulty were found to be relatively low and levels of discrimination were found to be appropriate or high. The degree of agreement between item developer intention and expert judgments equaled or exceeded 50%. Conclusion: From above results, evidence of the response process validity was demonstrated, indicating that subjects respondeds as intended by the test developer. The revised 19-item CCTS was found to have sufficient reliability and validity and will therefore represents a more convenient measurement of critical thinking ability.

  4. Clinic and Emergency Room Evaluation and Testing of Headache.

    Science.gov (United States)

    Nye, Barbara L; Ward, Thomas N

    2015-10-01

    Evaluation of the headache patient in the outpatient clinic and emergency department (ED) has different focuses and goals. The focus of this paper is to review the evaluation of patients in both settings with mention of evaluation in the pediatric and pregnant patient population.  The patient's history should drive the practitioner's decision and evaluation choices. We review recommendations made by the American Board of Internal Medicine and American Headache Society through the Choosing Wisely Campaign, which has an emphasis on choosing the right imaging modality for the clinical situation and elimination/prevention of medication overuse headache, as well as the US Headache Consortium guidelines for migraine headache. We will also review focusing on ED evaluation of the pediatric patient and pregnant patient presenting with headache. At the end of the review we hope to have provided you with a framework to think about the headache patient and what is the appropriate test in the given clinical setting in order to ensure that the patient gets the right diagnosis and is set on a path to the appropriate management plan. © 2015 American Headache Society.

  5. Clinical testing of Belarusian aortic stent graft system

    Directory of Open Access Journals (Sweden)

    А. П. Шкет

    2016-12-01

    Full Text Available Aim. The study looks at the results of clinical testing of the first Belarusian aortic stent graft system developed and manufactured by a team of specialists from RSPC "Cardiology", Minsk, Belarus, and Belarusian Technical University.Methods. The original system of aortic stent graft includes a delivery system and an aortic stent graft itself. It is used in surgical treatment of complicated and common aneurysms of the thoracic aorta, as well as in cases of concomitant thoracic aneurysms and heart pathology to be treated under cardiopulmonary bypass. Clinical testing of the stent graft was carried out according to the requirements of Ministry of Health of the Republic of Belarus on the basis of three different cardiac hospitals of the country. Results. All the three hospitals treated one patient each. The first patient underwent implantation of the stent graft into the descending thoracic aorta, with the thoracic aorta aneurysm isolated and the aortic valve replaced with bioprosthesis. The second patient underwent ascending aorta and aortic valve replacement with a conduit and implantation of aortic stent graft into the descending thoracic aorta. In the third patient the domestic aortic stent graft was implanted into the descending thoracic aorta with isolation of the thoracic aneurysm; aortic valve and ascending aorta were replaced with ‘MedEng' conduit and the aortic arch was also replaced, with the brachiocephalic arteries re-implanted in place. All the patients were followed-up for both early and long-term outcomes for more than 1 year and were examined by using CT angiography in the early postoperative period and after 1 year. Uncomplicated postoperative course was observed in all the patients. There were no complications in the long-term follow-up as well. CT angiography data confirmed good positioning of the stent graft and good isolation of the aneurysm lumen. Preoperative and postoperative СТ data of one patient are presented in the

  6. Social inequality and HIV-testing: Comparing home- and clinic-based testing in rural Malawi

    Directory of Open Access Journals (Sweden)

    Alexander A. Weinreb

    2009-10-01

    Full Text Available The plan to increase HIV testing is a cornerstone of the international health strategy against the HIV/AIDS epidemic, particularly in sub-Saharan Africa. This paper highlights a problematic aspect of that plan: the reliance on clinic- rather than home-based testing. First, drawing on DHS data from across Africa, we demonstrate the substantial differences in socio-demographic and economic profiles between those who report having ever had an HIV test, and those who report never having had one. Then, using data from a random household survey in rural Malawi, we show that substituting home-based for clinic-based testing may eliminate this source of inequality between those tested and those not tested. This result, which is stable across modeling frameworks, has important implications for accurately and equitably addressing the counseling and treatment programs that comprise the international health strategy against AIDS, and that promise to shape the future trajectory of the epidemic in Africa and beyond.

  7. Non-invasive prenatal chromosomal aneuploidy testing--clinical experience: 100,000 clinical samples.

    Directory of Open Access Journals (Sweden)

    Ron M McCullough

    Full Text Available OBJECTIVE: As the first laboratory to offer massively parallel sequencing-based noninvasive prenatal testing (NIPT for fetal aneuploidies, Sequenom Laboratories has been able to collect the largest clinical population experience data to date, including >100,000 clinical samples from all 50 U.S. states and 13 other countries. The objective of this study is to give a robust clinical picture of the current laboratory performance of the MaterniT21 PLUS LDT. STUDY DESIGN: The study includes plasma samples collected from patients with high-risk pregnancies in our CLIA-licensed, CAP-accredited laboratory between August 2012 to June 2013. Samples were assessed for trisomies 13, 18, 21 and for the presence of chromosome Y-specific DNA. Sample data and ad hoc outcome information provided by the clinician was compiled and reviewed to determine the characteristics of this patient population, as well as estimate the assay performance in a clinical setting. RESULTS: NIPT patients most commonly undergo testing at an average of 15 weeks, 3 days gestation; and average 35.1 years of age. The average turnaround time is 4.54 business days and an overall 1.3% not reportable rate. The positivity rate for Trisomy 21 was 1.51%, followed by 0.45% and 0.21% rate for Trisomies 18 and 13, respectively. NIPT positivity rates are similar to previous large clinical studies of aneuploidy in women of maternal age ≥ 35 undergoing amniocentesis. In this population 3519 patients had multifetal gestations (3.5% with 2.61% yielding a positive NIPT result. CONCLUSION: NIPT has been commercially offered for just over 2 years and the clinical use by patients and clinicians has increased significantly. The risks associated with invasive testing have been substantially reduced by providing another assessment of aneuploidy status in high-risk patients. The accuracy and NIPT assay positivity rate are as predicted by clinical validations and the test demonstrates improvement in the

  8. Optimal insemination and replacement decisions to minimize the cost of pathogen-specific clinical mastitis in dairy cows.

    Science.gov (United States)

    Cha, E; Kristensen, A R; Hertl, J A; Schukken, Y H; Tauer, L W; Welcome, F L; Gröhn, Y T

    2014-01-01

    Mastitis is a serious production-limiting disease, with effects on milk yield, milk quality, and conception rate, and an increase in the risk of mortality and culling. The objective of this study was 2-fold: (1) to develop an economic optimization model that incorporates all the different types of pathogens that cause clinical mastitis (CM) categorized into 8 classes of culture results, and account for whether the CM was a first, second, or third case in the current lactation and whether the cow had a previous case or cases of CM in the preceding lactation; and (2) to develop this decision model to be versatile enough to add additional pathogens, diseases, or other cow characteristics as more information becomes available without significant alterations to the basic structure of the model. The model provides economically optimal decisions depending on the individual characteristics of the cow and the specific pathogen causing CM. The net returns for the basic herd scenario (with all CM included) were $507/cow per year, where the incidence of CM (cases per 100 cow-years) was 35.6, of which 91.8% of cases were recommended for treatment under an optimal replacement policy. The cost per case of CM was $216.11. The CM cases comprised (incidences, %) Staphylococcus spp. (1.6), Staphylococcus aureus (1.8), Streptococcus spp. (6.9), Escherichia coli (8.1), Klebsiella spp. (2.2), other treated cases (e.g., Pseudomonas; 1.1), other not treated cases (e.g., Trueperella pyogenes; 1.2), and negative culture cases (12.7). The average cost per case, even under optimal decisions, was greatest for Klebsiella spp. ($477), followed by E. coli ($361), other treated cases ($297), and other not treated cases ($280). This was followed by the gram-positive pathogens; among these, the greatest cost per case was due to Staph. aureus ($266), followed by Streptococcus spp. ($174) and Staphylococcus spp. ($135); negative culture had the lowest cost ($115). The model recommended treatment for

  9. Clinical experience with a single-nucleotide polymorphism-based non-invasive prenatal test for five clinically significant microdeletions.

    Science.gov (United States)

    Martin, K; Iyengar, S; Kalyan, A; Lan, C; Simon, A L; Stosic, M; Kobara, K; Ravi, H; Truong, T; Ryan, A; Demko, Z P; Benn, P

    2018-02-01

    Single-nucleotide polymorphism (SNP)-based non-invasive prenatal testing (NIPT) can currently predict a subset of submicroscopic abnormalities associated with severe clinical manifestations. We retrospectively analyzed the performance of SNP-based NIPT in 80 449 referrals for 22q11.2 deletion syndrome and 42 326 referrals for 1p36, cri-du-chat, Prader-Willi, and Angelman microdeletion syndromes over a 1-year period, and compared the original screening protocol with a revision that reflexively sequenced high-risk calls at a higher depth of read. The prevalence of these microdeletion syndromes was also estimated in the referral population. The positive predictive value of the original test was 15.7% for 22q11.2 deletion syndrome, and 5.2% for the other 4 disorders combined. With the revised protocol, these values increased to 44.2% for 22q11.2 and 31.7% for the others. The 0.33% false-positive rate (FPR) for 22q11.2 deletion syndrome decreased to 0.07% with the revised protocol. Similarly, the FPR for the other 4 disorders combined decreased from 0.56% to 0.07%. Minimal prevalences were estimated to be 1 in 1255 for 22q11.2 deletion syndrome and 1 in 1464 for 1p36, cri-du-chat, and Angelman syndromes combined. Our results show that these microdeletions are relatively common in the referral population, and that the performance of SNP-based NIPT is improved with high-depth resequencing. © 2017 The Authors. Clinical Genetics published by John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  10. Minimal hepatic encephalopathy

    OpenAIRE

    Stinton, Laura M; Jayakumar, Saumya

    2013-01-01

    Minimal hepatic encephalopathy (MHE) is the earliest form of hepatic encephalopathy and can affect up to 80% of cirrhotic patients. By definition, it has no obvious clinical manifestation and is characterized by neurocognitive impairment in attention, vigilance and integrative function. Although often not considered to be clinically relevant and, therefore, not diagnosed or treated, MHE has been shown to affect daily functioning, quality of life, driving and overall mortality. The diagnosis o...

  11. What do spinal cord injury patients think of their improvement? A study of the minimal clinically important difference of the Spinal Cord Independence Measure III.

    Science.gov (United States)

    Corallo, Viviana; Torre, Monica; Ferrara, Giovanna; Guerra, Federica; Nicosia, Gabriella; Romanelli, Ersilia; Lopopolo, Angela; Onesta, Maria P; Fiore, Pietro; Falcone, Roberta; Bonavita, Jacopo; Molinari, Marco; Scivoletto, Giorgio

    2017-08-01

    The Spinal Cord Independence Measure (SCIM III) is a scale of independence in the activities of daily life, specifically designed for spinal cord injury subjects. The aim of this study was to calculate the minimal clinically important difference (MCID) of the SCIM III according to distribution and anchor based approach. Prospective study. Four Spinal Cord Units in Italy. Patients with acute/subacute spinal cord injury/lesion. The scores of the total SCIM and of the four subscale was recorded at admission and discharge. Clinical significance was calculated according to anchor based methodology using a global rating of change questionnaire. The accuracy of MCID values in predicting a judgment of small improvement by the patients has been assessed by means of the area under the receiving operating curves (aROC). Total SCIM MCID values varied from 12 for patients with complete tetraplegia to 45.3 for those with incomplete thoracic lesions. The MCID of self-care varied from 3.3 to 8.5 and from 10 to 18 for respiration and sphincter management, depending on the level and severity of the lesion. With regard to mobility (room and toilet), the MCID varied from 1 to 3 and from 2.5 to 7.26 for mobility (indoors and outdoors). The aROC was between good and excellent for all these values. The results provide benchmarks for clinicians and researchers to interpret whether patients' change score on the SCIM III can be interpreted as true or clinically meaningful and to make clinical judgments about the patients' progress. Our data could be useful for both clinicians and researchers. At the beginning of rehabilitation clinicians may have an idea of the minimal improvement of the patient (based on his neurological status) that could have an impact on patient's life. At the end of rehabilitation process, it is possible to control if the patient achieved an improvement that is true and significant. Researchers could also use these criteria to evaluate the clinical significance of an

  12. In Vitro Susceptibility Test of Different Clinical Isolates against Ceftriaxone

    Directory of Open Access Journals (Sweden)

    Syed Hakim Masood

    2010-06-01

    Full Text Available Objectives: Because of the prevailing penicillin resistance in microorganisms, broad spectrum cephalosporins are used empirically specially in developing countries. The aim of this study is to determine the susceptibility pattern of different gram positive and gram negative pathogens against third generation cephalosporin-ceftriaxone to explore the existing effectiveness of this antibiotic.Methods: 180 clinical isolates of different gram positive and gram negative pathogens including P.mirabilis, S. typhi P.aeruginosa, E. coli, S. aureus and Klebsiella were collected from blood and urine samples of in-patients. 30 isolates of all species were tested against each of six brands of ceftriaxone using in vitro sensitivity tests by disc diffusion method (NCCLS criteria. The susceptibility limit was ≥21 mm zone of inhibition, while moderately susceptible was considered at 20-14 mm, and those isolates which showed >13 mm or no zone of inhibition were resistant to this antibacterial drug.Results: Ceftriaxone was found most effective against S. aureus. While 96.1% of the isolates showed susceptibility towards ceftriaxone, followed by E. coli (95%, P. aeruginosa (92.7%, K. pneumonia (89.4% and S. typhi (87.2%. P. mirabilis showed lowest susceptibility amongst all the test organisms (83.8%.Conclusion: Ceftriaxone can be used as a drug of choice in infections caused by S. aureus, E. coli, P. aurigenosa, K. pneumonia and S. typhi. However, it should be used with other antimicrobial agents in order to increase its effectiveness against P. mirabilis.

  13. Evaluation of gingival blood as a minimally invasive screening tool for diabetes mellitus among 40–59-year-old adults in dental clinics: A cross-sectional study

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    Indumathi K Partheeban

    2017-01-01

    Full Text Available Objective: To evaluate a quick, safe, and minimally invasive method to screen for diabetes using gingival blood with the help of self-monitoring glucometer during periodontal examination. Materials and Methods: A hospital–based, cross-sectional comparative study was conducted among 40–59-year-old diabetic and nondiabetic population who had come for their master health examination to a private tertiary care hospital (Global Hospital and Health City in Chennai. Among them, those who fulfilled the inclusion criteria were selected for the study. Thirty diabetic and thirty nondiabetic patients with moderate to severe gingivitis were enrolled and subjected to routine clinical periodontal examination. Blood samples of two sites were analyzed using a glucose self-monitoring device (Accu-Check. Patients were tested for venous fasting blood sugar (VFBS, venous postprandial blood sugar (VPPS, gingival fasting blood sugar (GFBS level, gingival postprandial blood sugar (GPPS level, peripheral fingerstick fasting blood sugar (PFBS level, and peripheral fingerstick postprandial sugar (PPPS level. Data obtained were statistically analyzed using Student's t-test, ANOVA, and Pearson's correlation test. Results: A significant positive correlation was found between GFBS and VFBS, GFBS and PFBS, GPPS and VPPS, and GPPS and PPPS (P < 0.01 in both diabetic and nondiabetic patients correlation. Using venous blood glucose level as a gold standard, the sensitivity and specificity of GFBS was 93% and 100%, respectively, whereas in GPPS, the sensitivity and specificity was 80% and 96%, respectively. Conclusion: Gingival blood glucometry can be used as a minimally invasive screening tool for diabetes mellitus in dental clinics.

  14. Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials

    Directory of Open Access Journals (Sweden)

    Schmitz Heinz

    2010-11-01

    Full Text Available Abstract Background When comparing active treatments, a non-inferiority (or one-sided equivalence study design is often used. This design requires the definition of a non-inferiority margin, the threshold value of clinical relevance. In recent studies, a non-inferiority margin of 15 mm has been used for the change in endometriosis-associated pelvic pain (EAPP on a visual analog scale (VAS. However, this value was derived from other chronic painful conditions and its validation in EAPP was lacking. Methods Data were analyzed from two placebo-controlled studies of active treatments in endometriosis, including 281 patients with laparoscopically-confirmed endometriosis and moderate-to-severe EAPP. Patients recorded EAPP on a VAS at baseline and the end of treatment. Patients also assessed their satisfaction with treatment on a modified Clinical Global Impression scale. Changes in VAS score were compared with patients' self-assessments to derive an empirically validated non-inferiority margin. This anchor-based value was compared to a non-inferiority margin derived using the conventional half standard deviation rule for minimal clinically important difference (MCID in patient-reported outcomes. Results Anchor-based and distribution-based MCIDs were-7.8 mm and-8.6 mm, respectively. Conclusions An empirically validated non-inferiority margin of 10 mm for EAPP measured on a VAS is appropriate to compare treatments in endometriosis.

  15. The detection of sensitivity of proprioception by a new clinical test: the dual joint position test.

    Science.gov (United States)

    Beckmann, Yesim Yetimalar; Çiftçi, Yeliz; Ertekin, Cumhur

    2013-07-01

    To date, very few studies have paid attention to the joint sense (proprioception) of toes other than the big toe. We evaluated the sensitivity of joint position sense at the joint of the great toe in comparison to other digits, and with that determined by the dual digit stimulation test, in a sample of healthy normal controls and patients with clinical diagnosis of the lemniscal system dysfunction. Seventy-two patients with lemniscal system dysfunction (55 clinically definitive multiple sclerosis, 17 vasculitis) and 110 healthy volunteers participated in the study. All subjects underwent the joint position sense test of all digits of upper and lower extremities. The position sense resulting from the combined operation of the joints of the second and the fourth digits (simultaneous two digits position sense) was also measured and subsequently compared with the results of the great toe position sense. Upper extremities: no difference was found in recognition of the position sense in the single digits of the upper extremities between patients and healthy volunteers. There was a significant difference in the dual joint position test of the right upper extremity between patients and the case group (pproprioception of the great toe neither in the right and nor in the left side between patients and normal subjects. However, the joint position sense of other single digits was deteriorated in the patients, a difference that was significant compared to normal controls (pproprioception of simultaneous dual digits is diminished in patients when compared to a single digit position sense. Moreover, the great toe proprioception is less sensitive than other digits. Taken together, these observations lend evidence for a new clinical method which we named as dual joint position test. We suggest this novel method offers clinical utility to demonstrate lemniscal system dysfunction. Copyright © 2012 Elsevier B.V. All rights reserved.

  16. 42 CFR 414.508 - Payment for a new clinical diagnostic laboratory test.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Payment for a new clinical diagnostic laboratory... SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.508 Payment for a new clinical diagnostic laboratory test. For a new clinical diagnostic laboratory test that is assigned a new or...

  17. Novel applications for serum procalcitonin testing in clinical practice.

    Science.gov (United States)

    Choi, Justin J; McCarthy, Matthew W

    2018-01-01

    Procalcitonin has emerged as a reliable marker of acute bacterial infection in hospitalized patients and the assay has recently been incorporated into several clinical algorithms to reduce antimicrobial overuse, but its use in patients with end-organ dysfunction is controversial. Areas covered: In this review, the authors examine what is known about procalcitonin testing in patients with organ dysfunction, including those with end-stage renal disease, congestive heart failure, chronic obstructive pulmonary disease, and cirrhosis, and explore how the assay is now being used in the management of non-infectious diseases. Expert commentary: Procalcitonin holds tremendous promise to identify a diverse set of medical conditions beyond those associated with acute bacterial infection, including post-surgical anastomotic leaks, acute kidney injury, and complications after intracerebral hemorrhage. The authors review recent studies examining procalcitonin in these areas and explore how the assay might be used to guide diagnosis and prognosis of non-infectious diseases in the near future.

  18. Abnormalities of laboratory coagulation tests versus clinically evident coagulopathic bleeding

    DEFF Research Database (Denmark)

    Chang, Ronald; Fox, Erin E; Greene, Thomas J

    2018-01-01

    BACKGROUND: Laboratory-based evidence of coagulopathy (LC) is observed in 25-35% of trauma patients, but clinically-evident coagulopathy (CC) is not well described. METHODS: Prospective observational study of adult trauma patients transported by helicopter from the scene to nine Level 1 trauma...... centers in 2015. Patients meeting predefined highest-risk criteria were divided into CC+ (predefined as surgeon-confirmed bleeding from uninjured sites or injured sites not controllable by sutures) or CC-. We used a mixed-effects, Poisson regression with robust error variance to test the hypothesis...... that abnormalities on rapid thrombelastography (r-TEG) and international normalized ratio (INR) were independently associated with CC+. RESULTS: Of 1,019 highest-risk patients, CC+ (n=41, 4%) were more severely injured (median ISS 32 vs 17), had evidence of LC on r-TEG and INR, received more transfused blood...

  19. Minimal detectable changes of the Berg Balance Scale, Fugl-Meyer Assessment Scale, Timed "Up & Go" Test, gait speeds, and 2-minute walk test in individuals with chronic stroke with different degrees of ankle plantarflexor tone.

    Science.gov (United States)

    Hiengkaew, Vimonwan; Jitaree, Khanitha; Chaiyawat, Pakaratee

    2012-07-01

    To determine test-retest reliability and absolute and relative minimal detectable changes at the 95% confidence level (MDC(95)) of measures to detect postural balance and lower limb movements in individuals with chronic stroke who were able to walk and had differences in ankle plantarflexor tone. Test-retest study. Data were collected on 2 occasions, about 6 days apart. Outpatient physical therapy clinics. Volunteers (N=61) with chronic stroke who were able to walk and had differences in ankle plantarflexor tone: no increase in ankle plantarflexor tone (n=12), a slight increase in ankle plantarflexor tone (n=32), and a marked increase in ankle plantarflexor tone (n=17). Not applicable. Reliability and absolute and relative MDC(95) of the Berg Balance Scale (BBS), the lower limb subscale of Fugl-Meyer Assessment (FMA-LE), the Timed "Up & Go" test (TUG), the comfortable gait speed (CGS), the fast gait speed (FGS), and the 2-minute walk test (2MWT). Excellent reliability of the BBS, FMA-LE, TUG, CGS, FGS, and 2MWT for all the participants combined and for the subgroups was shown. All the participants combined showed the absolute and relative MDC(95) in the BBS of 5 points and 10%, FMA-LE of 4 points and 16%, TUG of 8 seconds and 28%, CGS of 0.2m/s and 34%, FGS of 0.1m/s and 21%, and 2MWT of 13m and 23%. The absolute and relative MDC(95) of the subgroups were varied based on ankle plantarflexor tone. The BBS, FMA-LE, TUG, CGS, FGS, and 2MWT are reliable measures to detect postural balance and lower limb movements in individuals with chronic stroke who have differences in ankle plantarflexor tone. The absolute and relative MDC(95) of each measure are dissimilar in those with differences in ankle plantarflexor tone. The relative MDC(95) seems more useful than the absolute MDC(95) because the relative value can be used for a single individual. Copyright © 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  20. Clinical Importance of the Heel Drop Test and a New Clinical Score for Adult Appendicitis

    Science.gov (United States)

    Ahn, Shin; Lee, Hyeji; Choi, Wookjin; Ahn, Ryeok; Hong, Jung-Suk; Sohn, Chang Hwan; Seo, Dong Woo; Lee, Yoon-Seon; Lim, Kyung Soo; Kim, Won Young

    2016-01-01

    Objective We tried to evaluate the accuracy of the heel drop test in patients with suspected appendicitis and tried to develop a new clinical score, which incorporates the heel drop test and other parameters, for the diagnosis of this condition. Methods We performed a prospective observational study on adult patients with suspected appendicitis at two academic urban emergency departments between January and August 2015. The predictive characteristics of each parameter, along with heel drop test results were calculated. A composite score was generated by logistic regression analysis. The performance of the generated score was compared to that of the Alvarado score. Results Of the 292 enrolled patients, 165 (56.5%) had acute appendicitis. The heel drop test had a higher predictive value than rebound tenderness. Variables and their points included in the new (MESH) score were pain migration (2), elevated white blood cell (WBC) >10,000/μL (3), shift to left (2), and positive heel drop test (3). The MESH score had a higher AUC than the Alvarado score (0.805 vs. 0.701). Scores of 5 and 11 were chosen as cut-off values; a MESH score ≥5 compared to an Alvarado score ≥5, and a MESH score ≥8 compared to an Alvarado score ≥7 showed better performance in diagnosing appendicitis. Conclusion MESH (migration, elevated WBC, shift to left, and heel drop test) is a simple clinical scoring system for assessing patients with suspected appendicitis and is more accurate than the Alvarado score. Further validation studies are needed. PMID:27723842

  1. Clinical Importance of the Heel Drop Test and a New Clinical Score for Adult Appendicitis.

    Directory of Open Access Journals (Sweden)

    Shin Ahn

    Full Text Available We tried to evaluate the accuracy of the heel drop test in patients with suspected appendicitis and tried to develop a new clinical score, which incorporates the heel drop test and other parameters, for the diagnosis of this condition.We performed a prospective observational study on adult patients with suspected appendicitis at two academic urban emergency departments between January and August 2015. The predictive characteristics of each parameter, along with heel drop test results were calculated. A composite score was generated by logistic regression analysis. The performance of the generated score was compared to that of the Alvarado score.Of the 292 enrolled patients, 165 (56.5% had acute appendicitis. The heel drop test had a higher predictive value than rebound tenderness. Variables and their points included in the new (MESH score were pain migration (2, elevated white blood cell (WBC >10,000/μL (3, shift to left (2, and positive heel drop test (3. The MESH score had a higher AUC than the Alvarado score (0.805 vs. 0.701. Scores of 5 and 11 were chosen as cut-off values; a MESH score ≥5 compared to an Alvarado score ≥5, and a MESH score ≥8 compared to an Alvarado score ≥7 showed better performance in diagnosing appendicitis.MESH (migration, elevated WBC, shift to left, and heel drop test is a simple clinical scoring system for assessing patients with suspected appendicitis and is more accurate than the Alvarado score. Further validation studies are needed.

  2. Initial clinical test of a breast-PET scanner.

    Science.gov (United States)

    Raylman, Raymond R; Abraham, Jame; Hazard, Hannah; Koren, Courtney; Filburn, Shannon; Schreiman, Judith S; Kurian, Sobha; Majewski, Stan; Marano, Gary D

    2011-02-01

    The goal of this initial clinical study was to test a new positron emission/tomography imager and biopsy system (PEM/PET) in a small group of selected subjects to assess its clinical imaging capabilities. Specifically, the main task of this study is to determine whether the new system can successfully be used to produce images of known breast cancer and compare them to those acquired by standard techniques. The PEM/PET system consists of two pairs of rotating radiation detectors located beneath a patient table. The scanner has a spatial resolution of ∼2 mm in all three dimensions. The subjects consisted of five patients diagnosed with locally advanced breast cancer ranging in age from 40 to 55 years old scheduled for pre-treatment, conventional whole body PET imaging with F-18 Fluorodeoxyglucose (FDG). The primary lesions were at least 2 cm in diameter. The images from the PEM/PET system demonstrated that this system is capable of identifying some lesions not visible in standard mammograms. Furthermore, while the relatively large lesions imaged in this study where all visualised by a standard whole body PET/CT scanner, some of the morphology of the tumours (ductal infiltration, for example) was better defined with the PEM/PET system. Significantly, these images were obtained immediately following a standard whole body PET scan. The initial testing of the new PEM/PET system demonstrated that the new system is capable of producing good quality breast-PET images compared standard methods. © 2011 The Authors. Journal of Medical Imaging and Radiation Oncology © 2011 The Royal Australian and New Zealand College of Radiologists.

  3. Usability Testing of a Complex Clinical Decision Support Tool in the Emergency Department: Lessons Learned.

    Science.gov (United States)

    Press, Anne; McCullagh, Lauren; Khan, Sundas; Schachter, Andy; Pardo, Salvatore; McGinn, Thomas

    2015-09-10

    As the electronic health record (EHR) becomes the preferred documentation tool across medical practices, health care organizations are pushing for clinical decision support systems (CDSS) to help bring clinical decision support (CDS) tools to the forefront of patient-physician interactions. A CDSS is integrated into the EHR and allows physicians to easily utilize CDS tools. However, often CDSS are integrated into the EHR without an initial phase of usability testing, resulting in poor adoption rates. Usability testing is important because it evaluates a CDSS by testing it on actual users. This paper outlines the usability phase of a study, which will test the impact of integration of the Wells CDSS for pulmonary embolism (PE) diagnosis into a large urban emergency department, where workflow is often chaotic and high stakes decisions are frequently made. We hypothesize that conducting usability testing prior to integration of the Wells score into an emergency room EHR will result in increased adoption rates by physicians. The objective of the study was to conduct usability testing for the integration of the Wells clinical prediction rule into a tertiary care center's emergency department EHR. We conducted usability testing of a CDS tool in the emergency department EHR. The CDS tool consisted of the Wells rule for PE in the form of a calculator and was triggered off computed tomography (CT) orders or patients' chief complaint. The study was conducted at a tertiary hospital in Queens, New York. There were seven residents that were recruited and participated in two phases of usability testing. The usability testing employed a "think aloud" method and "near-live" clinical simulation, where care providers interacted with standardized patients enacting a clinical scenario. Both phases were audiotaped, video-taped, and had screen-capture software activated for onscreen recordings. Phase I: Data from the "think-aloud" phase of the study showed an overall positive outlook on

  4. Validity of Forced Eyelid Closure Test: A Novel Clinical Screening Test for Ocular Myasthenia Gravis.

    Science.gov (United States)

    Apinyawasisuk, Supanut; Zhou, Xinkai; Tian, Jack J; Garcia, Giancarlo A; Karanjia, Rustum; Sadun, Alfredo A

    2017-09-01

    Forced eyelid closure test (FECT) is a clinical screening test developed from the original Cogan lid twitch (CLT) sign to assist in the diagnosis of ocular myasthenia gravis (OMG), We evaluated the sensitivity and specificity of FECT compared with CLT and benchmarked to standard diagnostic tests. This study was a retrospective chart review of 48 patients using electronic medical records of those that presented with ptosis and/or diplopia at Doheny Eye Institute, University of California, Los Angeles between February 2015 and April 2016. Patients without FECT testing were excluded. FECT and CLT results, and final diagnosis were recorded. To perform FECT, the patient was asked to squeeze his or her eyelids shut for 5-10 seconds then open quickly and fixate in primary position. The excessive upward overshoot of eyelids movement indicated a positive FECT. The test was performed by a neuro-ophthalmologist before establishing the diagnosis. Patients who had equivocal test results and/or inconclusive final diagnosis were excluded. Of the 48 patients studied, 18 patients (37.5%) had positive FECT; 15 of whom had a final diagnosis of OMG (83.3%). Of the 30 patients with negative FECT, 1 had OMG (3.3%). Of the 48 patients, 35 patients also had a documented CLT result (72.9%). CLT was positive in 11 of these 35 patients (31.4%), and 9 of these 11 had OMG (81.8%). Of the 24 patients with negative CLT, 2 of them had OMG (8.3%). Sensitivity and specificity of FECT were 94% and 91% (joint 95% confidence region: sensitivity × specificity = [0.70, 1] × [0.75, 1]). The relative true-positive fraction (rTPF) between FECT and CLT was 1.15; the relative false-positive fraction was 1.31. FECT is a simple clinical screening test with good sensitivity and specificity for OMG.

  5. Combined use of clinical pre-test probability and D-dimer test in the diagnosis of preoperative deep venous thrombosis in colorectal cancer patients

    DEFF Research Database (Denmark)

    Stender, Mogens Tornby; Frøkjaer, Jens Brøndum; Hagedorn Nielsen, Tina Sandie

    2008-01-01

    preoperative DVT in colorectal cancer patients admitted for surgery. Preoperative D-dimer test and compression ultrasonography for DVT were performed in 193 consecutive patients with newly diagnosed colorectal cancer. Diagnostic accuracy indices of the D-dimer test were assessed according to the PTP score......The preoperative prevalence of deep venous thrombosis (DVT) in patients with colorectal cancer may be as high as 8%. In order to minimize the risk of pulmonary embolism, it is important to rule out preoperative DVT. A large study has confirmed that a negative D-dimer test in combination with a low...... clinical pre-test probability (PTP) can be safely used to rule out the tentative diagnosis of DVT in cancer patients. However, the accuracy in colorectal cancer patients is uncertain. This study assessed the diagnostic accuracy of a quantitative D-dimer assay in combination with the PTP score in ruling out...

  6. A NEW CLINICAL MUSCLE FUNCTION TEST FOR ASSESSMENT OF HIP EXTERNAL ROTATION STRENGTH: AUGUSTSSON STRENGTH TEST.

    Science.gov (United States)

    Augustsson, Jesper

    2016-08-01

    Dynamic clinical tests of hip strength applicable on patients, non-athletes and athletes alike, are lacking. The aim of this study was therefore to develop and evaluate the reliability of a dynamic muscle function test of hip external rotation strength, using a novel device. A second aim was to determine if gender differences exist in absolute and relative hip strength using the new test. Fifty-three healthy sport science students (34 women and 19 men) were tested for hip external rotation strength using a device that consisted of a strap connected in series with an elastic resistance band loop, and a measuring tape connected in parallel with the elastic resistance band. The test was carried out with the subject side lying, positioned in 45 ° of hip flexion and the knees flexed to 90 ° with the device firmly fastened proximally across the knees. The subject then exerted maximal concentric hip external rotation force against the device thereby extending the elastic resistance band. The displacement achieved by the subject was documented by the tape measure and the corresponding force production was calculated. Both right and left hip strength was measured. Fifteen of the subjects were tested on repeated occasions to evaluate test-retest reliability. No significant test-retest differences were observed. Intra-class correlation coefficients ranged 0.93-0.94 and coefficients of variation 2.76-4.60%. In absolute values, men were significantly stronger in hip external rotation than women (right side 13.2 vs 11.0 kg, p = 0.001, left side 13.2 vs 11.5 kg, p = 0.002). There were no significant differences in hip external rotation strength normalized for body weight (BW) between men and women (right side 0.17 kg/BW vs 0.17 kg/BW, p = 0.675, left side 0.17 kg/BW vs 0.18 kg/BW, p = 0.156). The new muscle function test showed high reliability and thus could be useful for measuring dynamic hip external rotation strength in patients, non-athletes and athletes

  7. 'False-positive' and 'false-negative' test results in clinical urine drug testing.

    Science.gov (United States)

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

    2009-08-01

    The terms 'false-positive' and 'false-negative' are widely used in discussions of urine drug test (UDT) results. These terms are inadequate because they are used in different ways by physicians and laboratory professionals and they are too narrow to encompass the larger universe of potentially misleading, inappropriate and unexpected drug test results. This larger universe, while not solely comprised of technically 'true' or 'false' positive or negative test results, presents comparable interpretive challenges with corresponding clinical implications. In this review, we propose the terms 'potentially inappropriate' positive or negative test results in reference to UDT results that are ambiguous or unexpected and subject to misinterpretation. Causes of potentially inappropriate positive UDT results include in vivo metabolic conversions of a drug, exposure to nonillicit sources of a drug and laboratory error. Causes of potentially inappropriate negative UDT results include limited assay specificity, absence of drug in the urine, presence of drug in the urine, but below established assay cutoff, specimen manipulation and laboratory error. Clinical UDT interpretation is a complicated task requiring knowledge of recent prescription, over-the-counter and herbal drug administration, drug metabolism and analytical sensitivities and specificities.

  8. Drug susceptibility testing of clinical isolates of streptococci and enterococci by the Phoenix automated microbiology system

    Directory of Open Access Journals (Sweden)

    Sokeng Gertrude

    2007-05-01

    Full Text Available Abstract Background Drug resistance is an emerging problem among streptococcal and enterococcal species. Automated diagnostic systems for species identification and antimicrobial susceptibility testing (AST have become recently available. We evaluated drug susceptibility of clinical isolates of streptococci and enterococci using the recent Phoenix system (BD, Sparks, MD. Diagnostic tools included the new SMIC/ID-2 panel for streptococci, and the PMIC/ID-14 for enterococci. Two-hundred and fifty isolates have been investigated: β-hemolytic streptococci (n = 65, Streptococcus pneumoniae (n = 50, viridans group streptococci (n = 32, Enterococcus faecium (n = 40, Enterococcus faecalis (n = 43, other catalase-negative cocci (n = 20. When needed, species ID was determined using molecular methods. Test bacterial strains were chosen among those carrying clinically-relevant resistance determinants (penicillin, macrolides, fluoroquinolones, glycopeptides. AST results of the Phoenix system were compared to minimal inhibitory concentration (MIC values measured by the Etest method (AB Biodisk, Solna, Sweden. Results Streptococci: essential agreement (EA and categorical agreement (CA were 91.9% and 98.8%, respectively. Major (ME and minor errors (mE accounted for 0.1% and 1.1% of isolates, respectively. No very major errors (VME were produced. Enterococci: EA was 97%, CA 96%. Small numbers of VME (0.9%, ME (1.4% and mE (2.8% were obtained. Overall, EA and CA rates for most drugs were above 90% for both genera. A few VME were found: a teicoplanin and high-level streptomycin for E. faecalis, b high-level gentamicin for E. faecium. The mean time to results (± SD was 11.8 ± 0.9 h, with minor differences between streptococci and enterococci. Conclusion The Phoenix system emerged as an effective tool for quantitative AST. Panels based on dilution tests provided rapid and accurate MIC values with regard to clinically-relevant streptococcal and enterococcal

  9. 2016 American College of Rheumatology/European League Against Rheumatism Criteria for Minimal, Moderate, and Major Clinical Response in Juvenile Dermatomyositis: An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative.

    Science.gov (United States)

    Rider, Lisa G; Aggarwal, Rohit; Pistorio, Angela; Bayat, Nastaran; Erman, Brian; Feldman, Brian M; Huber, Adam M; Cimaz, Rolando; Cuttica, Rubén J; de Oliveira, Sheila Knupp; Lindsley, Carol B; Pilkington, Clarissa A; Punaro, Marilynn; Ravelli, Angelo; Reed, Ann M; Rouster-Stevens, Kelly; van Royen-Kerkhof, Annet; Dressler, Frank; Magalhaes, Claudia Saad; Constantin, Tamás; Davidson, Joyce E; Magnusson, Bo; Russo, Ricardo; Villa, Luca; Rinaldi, Mariangela; Rockette, Howard; Lachenbruch, Peter A; Miller, Frederick W; Vencovsky, Jiri; Ruperto, Nicolino

    2017-05-01

    To develop response criteria for juvenile dermatomyositis (DM). We analyzed the performance of 312 definitions that used core set measures from either the International Myositis Assessment and Clinical Studies Group (IMACS) or the Paediatric Rheumatology International Trials Organisation (PRINTO) and were derived from natural history data and a conjoint analysis survey. They were further validated using data from the PRINTO trial of prednisone alone compared to prednisone with methotrexate or cyclosporine and the Rituximab in Myositis (RIM) trial. At a consensus conference, experts considered 14 top candidate criteria based on their performance characteristics and clinical face validity, using nominal group technique. Consensus was reached for a conjoint analysis-based continuous model with a total improvement score of 0-100, using absolute percent change in core set measures of minimal (≥30), moderate (≥45), and major (≥70) improvement. The same criteria were chosen for adult DM/polymyositis, with differing thresholds for improvement. The sensitivity and specificity were 89% and 91-98% for minimal improvement, 92-94% and 94-99% for moderate improvement, and 91-98% and 85-86% for major improvement, respectively, in juvenile DM patient cohorts using the IMACS and PRINTO core set measures. These criteria were validated in the PRINTO trial for differentiating between treatment arms for minimal and moderate improvement (P = 0.009-0.057) and in the RIM trial for significantly differentiating the physician's rating for improvement (P < 0.006). The response criteria for juvenile DM consisted of a conjoint analysis-based model using a continuous improvement score based on absolute percent change in core set measures, with thresholds for minimal, moderate, and major improvement. © 2017, American College of Rheumatology.

  10. 2016 American College of Rheumatology/European League Against Rheumatism Criteria for Minimal, Moderate, and Major Clinical Response in Juvenile Dermatomyositis: An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative.

    Science.gov (United States)

    Rider, Lisa G; Aggarwal, Rohit; Pistorio, Angela; Bayat, Nastaran; Erman, Brian; Feldman, Brian M; Huber, Adam M; Cimaz, Rolando; Cuttica, Rubén J; de Oliveira, Sheila Knupp; Lindsley, Carol B; Pilkington, Clarissa A; Punaro, Marilynn; Ravelli, Angelo; Reed, Ann M; Rouster-Stevens, Kelly; van Royen-Kerkhof, Annet; Dressler, Frank; Saad Magalhaes, Claudia; Constantin, Tamás; Davidson, Joyce E; Magnusson, Bo; Russo, Ricardo; Villa, Luca; Rinaldi, Mariangela; Rockette, Howard; Lachenbruch, Peter A; Miller, Frederick W; Vencovsky, Jiri; Ruperto, Nicolino

    2017-05-01

    To develop response criteria for juvenile dermatomyositis (DM). We analysed the performance of 312 definitions that used core set measures from either the International Myositis Assessment and Clinical Studies Group (IMACS) or the Paediatric Rheumatology International Trials Organisation (PRINTO) and were derived from natural history data and a conjoint analysis survey. They were further validated using data from the PRINTO trial of prednisone alone compared to prednisone with methotrexate or cyclosporine and the Rituximab in Myositis (RIM) trial. At a consensus conference, experts considered 14 top candidate criteria based on their performance characteristics and clinical face validity, using nominal group technique. Consensus was reached for a conjoint analysis-based continuous model with a total improvement score of 0-100, using absolute per cent change in core set measures of minimal (≥30), moderate (≥45), and major (≥70) improvement. The same criteria were chosen for adult DM/polymyositis, with differing thresholds for improvement. The sensitivity and specificity were 89% and 91-98% for minimal improvement, 92-94% and 94-99% for moderate improvement, and 91-98% and 85-86% for major improvement, respectively, in juvenile DM patient cohorts using the IMACS and PRINTO core set measures. These criteria were validated in the PRINTO trial for differentiating between treatment arms for minimal and moderate improvement (p=0.009-0.057) and in the RIM trial for significantly differentiating the physician's rating for improvement (p<0.006). The response criteria for juvenile DM consisted of a conjoint analysis-based model using a continuous improvement score based on absolute per cent change in core set measures, with thresholds for minimal, moderate, and major improvement. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  11. Tongue-base suspension with a soft tissue-to-bone anchor for obstructive sleep apnea: preliminary clinical results of a new minimally invasive technique.

    Science.gov (United States)

    DeRowe, A; Gunther, E; Fibbi, A; Lehtimaki, K; Vahatalo, K; Maurer, J; Ophir, D

    2000-01-01

    The Repose system is a new minimally invasive technique for tongue-base suspension in the treatment of sleep-disordered breathing caused by tongue-base collapse. It involves the insertion of a titanium miniscrew with attached suture into the anterior intraoral mandible and passing the suture through the tongue base. The procedure was performed in 16 patients with sleep-disordered breathing. Fourteen patients reported an improvement in daytime sleepiness, and their bed partners reported an improvement in snoring. The mean respiratory distress index before surgery was 35. Two months after surgery, the mean respiratory distress index was 17, an improvement of 51.4% (P = 0.001, 2-tailed t test). These preliminary results show the initial efficacy and safety of this new surgical procedure.

  12. Comparison of intermaxillary fixation screw versus eyelet interdental wiring for intermaxillary fixation in minimally displaced mandibular fracture: a randomized clinical study.

    Science.gov (United States)

    Ingole, Pranav D; Garg, Anoop; Shenoi, S Ramakrishna; Badjate, Samprati J; Budhraja, Nilima

    2014-05-01

    The aim of the present randomized study was to evaluate the efficacy of intermaxillary fixation screw (IMFS) versus eyelet interdental wiring for intermaxillary fixation (IMF) in minimally displaced mandibular fractures. A total of 50 patients with a minimally displaced mandibular fracture were enrolled, with 25 patients randomly selected for each group. In group I (study group, n = 25), the patients were treated using IMFS, and in group II (control group, n = 25), they received eyelet interdental wiring. Both techniques were assessed for the following parameters: time required for placement and removal of each type of IMF technique, time required for placement of IMF wires, postoperative occlusion, stability of the IMF wire, local anesthesia requirement during removal of each fixation type, oral hygiene status, glove perforation rate, and complications associated with both techniques. The collected data were analyzed using Student's unpaired t test or χ2 test. P wire in group I was 2.1 minutes and in group II was 6 minutes. The oral hygiene status was assessed, and the mean plaque index score for groups I and II was 1.44 and 2.12, respectively (P = .00). The glove perforation rate was much less in group I than in group II. Finally, the most common complication in both groups was mucosal growth. The results established the supremacy of IMFS compared with eyelet interdental wiring. Thus, we have concluded that IMFS, in the present scenario, is a safe and time-saving technique. IMFS is a cost-effective, straightforward, and viable alternative to cumbersome eyelet interdental and other wiring techniques for providing IMF, with satisfactory occlusion during closed reduction or intraoperative open reduction internal fixation of fractures. In addition, oral hygiene can be maintained, and the glove perforation rate was very low using IMFS. The relatively small sample size and limited follow-up period were the study limitations. Copyright © 2014 American Association of

  13. Immediate implant placement and provisional crown fabrication after a minimally invasive extraction of a peg-shaped maxillary lateral incisor: a clinical report.

    Science.gov (United States)

    Turkyilmaz, Ilser; Suarez, Jose Carlos; Company, Andrea M

    2009-09-01

    The aim of this case report is to describe the replacement of a maxillary peg-shaped lateral incisor with the placement of an immediate implant and a provisional restoration following a minimally invasive extraction to preserve anterior esthetics. Extraction sites in the anterior maxilla can present restorative challenges with regard to esthetics. Resistance to wearing a temporary removable partial denture during healing makes immediate implant therapy an appealing alternative to patients. Implant placement into fresh extraction sockets using no flap elevation has recently become more popular due to some advantages including less bleeding, swelling, and the preservation of existing soft tissue contours. A 20-year-old woman with a peg-shaped maxillary left lateral incisor was treated using an implant placed into the fresh extraction socket using a flapless approach and immediate provisional crown fabrication. Flapless implant placement helps to preserve site morphology by protecting and supporting existing hard and soft tissues while minimizing surgical trauma to the adjacent tissues. Using a previously fabricated acrylic index, a provisional acrylic crown was fabricated on the adjusted temporary abutment and delivered to the patient the same day during the extraction visit. This report describes the diagnosis and treatment of an over-prepared peg-shaped maxillary left lateral incisor associated with multiple crown decementations. The tooth was extracted without flap elevation and an implant was inserted immediately using flapless surgery and placement of an immediate provisional single crown. Flapless implant insertion into fresh extraction sockets and placement of immediate provisional crowns in cases involving the maxillary anterior region represent a viable treatment option in appropriate clinical situations where esthetics are a high priority. The strategy preserves optimum gingival contours and papillary height may be a viable option compared to fixed partial

  14. Combined clinical and genetic testing algorithm for cervical cancer diagnosis.

    Science.gov (United States)

    Liou, Yu-Ligh; Zhang, Tao-Lan; Yan, Tian; Yeh, Ching-Tung; Kang, Ya-Nan; Cao, Lanqin; Wu, Nayiyuan; Chang, Chi-Feng; Wang, Huei-Jen; Yen, Carolyn; Chu, Tang-Yuan; Zhang, Yi; Zhang, Yu; Zhou, Honghao

    2016-01-01

    Opportunistic screening in hospitals is widely used to effectively reduce the incidence rate of cervical cancer in China and other developing countries. This study aimed to identify clinical risk factor algorithms that combine gynecologic examination and molecular testing (paired box gene 1 (PAX1) or zinc finger protein 582 (ZNF582) methylation or HPV16/18) results to improve diagnostic accuracy. The delta Cp of methylated PAX1 and ZNF582 was obtained via quantitative methylation-specific PCR in a training set (57 CIN2- and 43 cervical intraepithelial neoplasia ≥grade 3 (CIN3+) women), and the individual and combination gene sensitivities and specificities were determined. The detection accuracy of three algorithms combining gynecologic findings and genetic test results was then compared in a randomized case-control study comprising 449 women referred for colposcopic examination by gynecologists in the outpatient department of Xiangya Hospital between November 2011 and March 2013. Significant association was observed between CIN3+ and methylated PAX1 or ZNF582 in combination with HPV16/18 (OR:15.52, 95 % CI:7.73-31.18). The sensitivities and specificities of methylated PAX1 or ZNF582 combined with HPV16/18 for CIN3+ women were 89.2 and 76.0 %, or 85.4 and 80.1 %, respectively. Of the three algorithms applied to cohort data and validated in the study, two indicated 100 % sensitivity in detecting cervical cancer and a low rate of referrals for colposcopy. These algorithms might contribute to precise and objective cervical cancer diagnostics in the outpatient departments of hospitals in countries with high mortality and low screening rates or areas with uneven resource distribution.

  15. Clinically important differences for the upper-extremity Fugl-Meyer Scale in people with minimal to moderate impairment due to chronic stroke.

    Science.gov (United States)

    Page, Stephen J; Fulk, George D; Boyne, Pierce

    2012-06-01

    The upper-extremity portion of the Fugl-Meyer Scale (UE-FM) is one of the most established and commonly used outcome measures in stroke rehabilitative trials. Empirical work is needed to determine the amount of change in UE-FM scores that can be regarded as important and clinically meaningful for health professionals, patients, and other stakeholders. This study used anchor-based methods to estimate the clinically important difference (CID) for the UE-FM in people with minimal to moderate impairment due to chronic stroke. One hundred forty-six individuals with stable, mild to moderate upper-extremity (UE) hemiparesis were administered the UE-FM before and after an intervention targeting their affected UEs. The treating therapists rated each participant's perceived amount of UE motor recovery on a global rating of change (GROC) scale evaluating several facets of UE movement (grasp, release, move the affected UE, perform 5 important functional tasks with the affected UE, overall UE function). Estimated CID of the UE-FM scores was calculated using receiver operating characteristic (ROC) curve with the GROC scores as the anchor. The ROC curve analysis revealed that change in UE-FM scores during the intervention period distinguished participants who experienced clinically important improvement from those that did not based on the therapists' GROC scores. The area under the curve ranged from 0.61 to 0.70 for the different facets of UE movement. The estimated CID of the UE-FM scores ranged from 4.25 to 7.25 points, depending on the different facets of UE movement.

  16. Vestibular migraine in children and adolescents: clinical findings and laboratory tests

    Directory of Open Access Journals (Sweden)

    Thyra eLanghagen

    2015-01-01

    Full Text Available Introduction: Vestibular migraine (VM is the most common cause of episodic vertigo in children. We summarize the clinical findings and of laboratory test results in a cohort of children and adolescents with VM. We discuss the limitations of current classification criteria for dizzy children. Methods: A retrospective chart analysis was performed on 118 children with suspected VM at a tertiary care center. Patients with complaints related to migraine and who presented with vertigo/dizziness were grouped in the following categories: (1 definite vestibular migraine (dVM; (2 probable vestibular migraine (pVM; (3 suspected vestibular migraine (sVM; (4 benign paroxysmal vertigo (BPV; and (5 migraine with/without aura (oM according to the International Classification of Headache Disorders, 3rd edition (beta version. Results: The mean age of all patients was 12±3 years (range 3-18 years, 70 females. 36 patients (30% fulfilled criteria for dVM, 33 (28% for pVM, 34 (29% for sVM, 7 (6% for BPV, and 8 (7% for oM. Somatoform vertigo co-occurred in 27% patients. Episodic syndromes were reported in 8%; the family history of migraine was positive in 65%. Mild central ocular motor signs were found in 24% (most frequently horizontal saccadic pursuit. Laboratory tests showed that about 20% had pathological function of the horizontal vestibulo-ocular reflex, and almost 50% had abnormal postural sway patterns. Conclusion: Patients with definite, probable, and suspected VM do not differ in the frequency of ocular motor, vestibular, or postural abnormalities. VM is the best explanation for their symptoms. It is essential to establish diagnostic criteria in clinical studies. In clinical practice, however, the most reasonable diagnosis should be made in order to begin treatment. Such a procedure also minimizes the fear of the parents and children, reduces the need to interrupt leisure time and school activities, and prevents the development of somatoform vertigo.

  17. Acute vestibular syndrome: clinical head impulse test versus video head impulse test.

    Science.gov (United States)

    Celebisoy, Nese

    2018-03-05

    HINTS battery involving head impulse test (HIT), nystagmus, and test of skew is the critical bedside examination to differentiate acute unilateral peripheral vestibulopathy from posterior circulation stroke (PCS) in acute vestibular syndrome (AVS). The highest sensitivity component of the battery has been reported to be the horizontal HIT, whereas skew deviation is defined as the most specific but non-sensitive sign for PCS. Video-oculography-based HIT (vHIT) may have an additional power in making the differentiation. If vHIT is undertaken, then both gain and gain asymmetry should be taken into account as anterior inferior cerebellar artery (AICA) strokes are at risk of being misclassified based on VOR gain alone. Further refinement in video technology, increased operator proficiency and incorporation with saccade analysis will increase the sensitivity of vHIT for PCS diagnosis. For the time being, clinical examination seems adequate in frontline diagnostic evaluation of AVS.

  18. [Vasculitic Peripheral Neuropathies: Clinical Features and Diagnostic Laboratory Tests].

    Science.gov (United States)

    Ogata, Katsuhisa

    2016-03-01

    Vasculitic peripheral neuropathy (VPN) occurs due to ischemic changes of peripheral nerves, resulting from a deficit of vascular blood supply due to damaged vasa nervorum leading to vasculitis. VPN usually manifests as sensorimotor or sensory disturbances accompanied by pain, presenting as a type of multiple mononeuropathy, with a scattered distribution in distal limbs. VPN may also present as a mononeuropathy, distal symmetric polyneuropathy, plexopathy, or radiculopathy. The rapidity of VPN is variable, ranging from days to months, with symptoms occasionally changing with the appearance of new lesions. Careful history taking and neurological examination provides an exact diagnosis. The most common cause of VPN is primary vasculitis predominantly affecting small vessels, including vasa nervorum, anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, and polyarteritis nodosa. Similar vasculitic processes can also result from a systemic collagen disorder or secondary vasculitis. Electrophysiological studies and pathological investigation of biopsied peripheral nerves and muscles are important for diagnosis of vasculitis. Serological tests, including ANCA, are useful for diagnosis of vasculitis. Accurate neurological examinations are essential for diagnosis and evaluation of clinical course.

  19. Development and implementation of a coagulation factor testing method utilizing autoverification in a high-volume clinical reference laboratory environment

    Directory of Open Access Journals (Sweden)

    Paul W Riley

    2017-01-01

    Full Text Available Background: Testing coagulation factor activities requires that multiple dilutions be assayed and analyzed to produce a single result. The slope of the line created by plotting measured factor concentration against sample dilution is evaluated to discern the presence of inhibitors giving rise to nonparallelism. Moreover, samples producing results on initial dilution falling outside the analytic measurement range of the assay must be tested at additional dilutions to produce reportable results. Methods: The complexity of this process has motivated a large clinical reference laboratory to develop advanced computer algorithms with automated reflex testing rules to complete coagulation factor analysis. A method was developed for autoverification of coagulation factor activity using expert rules developed with on an off the shelf commercially available data manager system integrated into an automated coagulation platform. Results: Here, we present an approach allowing for the autoverification and reporting of factor activity results with greatly diminished technologist effort. Conclusions: To the best of our knowledge, this is the first report of its kind providing a detailed procedure for implementation of autoverification expert rules as applied to coagulation factor activity testing. Advantages of this system include ease of training for new operators, minimization of technologist time spent, reduction of staff fatigue, minimization of unnecessary reflex tests, optimization of turnaround time, and assurance of the consistency of the testing and reporting process.

  20. Development and Implementation of a Coagulation Factor Testing Method Utilizing Autoverification in a High-volume Clinical Reference Laboratory Environment.

    Science.gov (United States)

    Riley, Paul W; Gallea, Benoit; Valcour, Andre

    2017-01-01

    Testing coagulation factor activities requires that multiple dilutions be assayed and analyzed to produce a single result. The slope of the line created by plotting measured factor concentration against sample dilution is evaluated to discern the presence of inhibitors giving rise to nonparallelism. Moreover, samples producing results on initial dilution falling outside the analytic measurement range of the assay must be tested at additional dilutions to produce reportable results. The complexity of this process has motivated a large clinical reference laboratory to develop advanced computer algorithms with automated reflex testing rules to complete coagulation factor analysis. A method was developed for autoverification of coagulation factor activity using expert rules developed with on an off the shelf commercially available data manager system integrated into an automated coagulation platform. Here, we present an approach allowing for the autoverification and reporting of factor activity results with greatly diminished technologist effort. To the best of our knowledge, this is the first report of its kind providing a detailed procedure for implementation of autoverification expert rules as applied to coagulation factor activity testing. Advantages of this system include ease of training for new operators, minimization of technologist time spent, reduction of staff fatigue, minimization of unnecessary reflex tests, optimization of turnaround time, and assurance of the consistency of the testing and reporting process.

  1. Strategies to Minimize Antibiotic Resistance

    Directory of Open Access Journals (Sweden)

    Sang Hee Lee

    2013-09-01

    Full Text Available Antibiotic resistance can be reduced by using antibiotics prudently based on guidelines of antimicrobial stewardship programs (ASPs and various data such as pharmacokinetic (PK and pharmacodynamic (PD properties of antibiotics, diagnostic testing, antimicrobial susceptibility testing (AST, clinical response, and effects on the microbiota, as well as by new antibiotic developments. The controlled use of antibiotics in food animals is another cornerstone among efforts to reduce antibiotic resistance. All major resistance-control strategies recommend education for patients, children (e.g., through schools and day care, the public, and relevant healthcare professionals (e.g., primary-care physicians, pharmacists, and medical students regarding unique features of bacterial infections and antibiotics, prudent antibiotic prescribing as a positive construct, and personal hygiene (e.g., handwashing. The problem of antibiotic resistance can be minimized only by concerted efforts of all members of society for ensuring the continued efficiency of antibiotics.

  2. Army Drug Development Program. Phase 1. Clinical Testing

    Science.gov (United States)

    1981-02-01

    previous studies of WR 194,965’HTPC^ (an antimalarial of the Mannich base class), the top tolerated single dose in man was...significant. O0NC1IJSION: rto adverse reaction to drug. BMI-MBB 114 INDIVI0IAL FJlIUlxn’ FINAL SUMMARY EXPKRIMfWT ND. 15: QDMriNUATION OF...Other laboratory abnormalities were minimal or inoonnistent and rot considered significant. ODNgjJSION: No .»Iverse reaction to drug

  3. A minimal molecular toolkit for mineral deposition? Biochemistry and proteomics of the test matrix of adult specimens of the sea urchin Paracentrotus lividus.

    Science.gov (United States)

    Karakostis, Konstantinos; Zanella-Cléon, Isabelle; Immel, Françoise; Guichard, Nathalie; Dru, Philippe; Lepage, Thierry; Plasseraud, Laurent; Matranga, Valeria; Marin, Frédéric

    2016-03-16

    The sea urchin endoskeleton consists of a magnesium-rich biocalcite comprising a small amount of occluded organic macromolecules. This structure constitutes a key-model for understanding the mineral--organics interplay, and for conceiving in vitro bio-inspired materials with tailored properties. Here we employed a deep-clean technique to purify the occluded proteins from adult Paracentrotus lividus tests. We characterized them by 1- and 2D-electrophoreses, ELISA and immunoblotting, and using liquid chromatography coupled with Mass Spectrometry (nanoLC-MS/MS), we identified two metalloenzymes (carbonic anhydrase and MMP), a set of MSP130 family members, several C-type lectins (SM29, SM41, PM27) and cytoskeletal proteins. We demonstrate the effect of the protein extract on the crystals, with an in vitro crystallization assay. We suggest that this small set of biomineralization proteins may represent a 'minimal molecular crystallization toolkit'. Biominerals often exhibit superior chemical properties, when compared to their inorganic counterparts. This is due pro parte to the proteins that are occluded in the mineral. However, the limited available studies on biomineralization have not yet succeeded in identifying a minimal set of proteins directly involved in the formation of the biomineral in vivo and sufficiently required for in vitro precipitation. Indeed, the high number of proteins identified by high-throughput screening in the recent years does not encourage the possibility of recreating or tailoring the mineral in vitro. Thus, the identification of biomineralization proteins involved in protein-mineral interactions is highly awaited. In the present study, we used the sea urchin, Paracentrotus lividus (P. lividus), to identify the native proteins directly taking part in protein-mineral interactions. We employed an improved deep-clean technique to extract and purify the native occluded skeletal matrix proteins from the test and identified them by the highly

  4. 2016 American College of Rheumatology/European League Against Rheumatism criteria for minimal, moderate, and major clinical response in adult dermatomyositis and polymyositis: An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative.

    Science.gov (United States)

    Aggarwal, Rohit; Rider, Lisa G; Ruperto, Nicolino; Bayat, Nastaran; Erman, Brian; Feldman, Brian M; Oddis, Chester V; Amato, Anthony A; Chinoy, Hector; Cooper, Robert G; Dastmalchi, Maryam; Fiorentino, David; Isenberg, David; Katz, James D; Mammen, Andrew; de Visser, Marianne; Ytterberg, Steven R; Lundberg, Ingrid E; Chung, Lorinda; Danko, Katalin; García-De la Torre, Ignacio; Song, Yeong Wook; Villa, Luca; Rinaldi, Mariangela; Rockette, Howard; Lachenbruch, Peter A; Miller, Frederick W; Vencovsky, Jiri

    2017-05-01

    To develop response criteria for adult dermatomyositis (DM) and polymyositis (PM). Expert surveys, logistic regression, and conjoint analysis were used to develop 287 definitions using core set measures. Myositis experts rated greater improvement among multiple pairwise scenarios in conjoint analysis surveys, where different levels of improvement in 2 core set measures were presented. The PAPRIKA (Potentially All Pairwise Rankings of All Possible Alternatives) method determined the relative weights of core set measures and conjoint analysis definitions. The performance characteristics of the definitions were evaluated on patient profiles using expert consensus (gold standard) and were validated using data from a clinical trial. The nominal group technique was used to reach consensus. Consensus was reached for a conjoint analysis-based continuous model using absolute per cent change in core set measures (physician, patient, and extramuscular global activity, muscle strength, Health Assessment Questionnaire, and muscle enzyme levels). A total improvement score (range 0-100), determined by summing scores for each core set measure, was based on improvement in and relative weight of each core set measure. Thresholds for minimal, moderate, and major improvement were ≥20, ≥40, and ≥60 points in the total improvement score. The same criteria were chosen for juvenile DM, with different improvement thresholds. Sensitivity and specificity in DM/PM patient cohorts were 85% and 92%, 90% and 96%, and 92% and 98% for minimal, moderate, and major improvement, respectively. Definitions were validated in the clinical trial analysis for differentiating the physician rating of improvement (p<0.001). The response criteria for adult DM/PM consisted of the conjoint analysis model based on absolute per cent change in 6 core set measures, with thresholds for minimal, moderate, and major improvement. Published by the BMJ Publishing Group Limited. For permission to use (where not

  5. Accuracy of a direct drill-guiding system with minimal tolerance of surgical instruments used for implant surgery: a prospective clinical study.

    Science.gov (United States)

    Lee, Du-Hyeong; An, Seo-Young; Hong, Min-Ho; Jeon, Kyoung-Bae; Lee, Kyu-Bok

    2016-06-01

    A recently introduced direct drill-guiding implant surgery system features minimal tolerance of surgical instruments in the metal sleeve by using shank-modified drills and a sleeve-incorporated stereolithographic guide template. The purpose of this study was to evaluate the accuracy of this new guided surgery system in partially edentulous patients using geometric analyses. For the study, 21 implants were placed in 11 consecutive patients using the direct drill-guiding implant surgery system. The stereolithographic surgical guide was fabricated using cone-beam computed tomography, digital scanning, computer-aided design and computer-assisted manufacturing, and additive manufacturing processes. After surgery, the positional and angular deviations between planned and placed implants were measured at the abutment level using implant-planning software. The Kruskal-Wallis test and Mann-Whitney U test were used to compare the deviations (α=.05). The mean horizontal deviations were 0.593 mm (SD 0.238) mesiodistally and 0.691 mm (SD 0.344) buccolingually. The mean vertical deviation was 0.925 mm (SD 0.376) occlusogingivally. The vertical deviation was significantly larger than the horizontal deviation (P=.018). The mean angular deviation was 2.024 degrees (SD 0.942) mesiodistally and 2.390 degrees (SD 1.142) buccolingually. The direct drill-guiding implant surgery system demonstrates high accuracy in placing implants. Use of the drill shank as the guiding component is an effective way for reducing tolerance.

  6. Red Blood Cell Mechanical Fragility Test for Clinical Research Applications.

    Science.gov (United States)

    Ziegler, Luke A; Olia, Salim E; Kameneva, Marina V

    2017-07-01

    Red blood cell (RBC) susceptibility to mechanically induced hemolysis, or RBC mechanical fragility (MF), is an important parameter in the characterization of erythrocyte membrane health. The rocker bead test (RBT) and associated calculated mechanical fragility index (MFI) is a simple method for the assessment of RBC MF. Requiring a minimum of 15.5 mL of blood and necessitating adjustment of hematocrit (Ht) to a "standard" value (40%), the current RBT is not suitable for use in most studies involving human subjects. To address these limitations, we propose a 6.5 mL reduced volume RBT and corresponding modified MFI (MMFI) that does not require prior Ht adjustment. This new method was assessed for i) correlation to the existing text, ii) to quantify the effect of Ht on MFI, and iii) validation by reexamining the protective effect of plasma proteins on RBC MF. The reduced volume RBT strongly correlated (r = 0.941) with the established large volume RBT at matched Hts, and an equation was developed to calculate MMFI: a numerical estimation (R 2  = 0.923) of MFI if performed with the reduced volume RBT at "standard" (40%) Ht. An inversely proportional relationship was found between plasma protein concentration and RBC MF using the MMFI-reduced volume method, supporting previous literature findings. The new reduced volume RBT and modified MFI will allow for the measurement of RBC MF in clinical and preclinical studies involving humans or small animals. © 2017 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

  7. Estimation of minimal clinically important change of the Japanese version of EQ-5D in patients with chronic noncancer pain: a retrospective research using real-world data.

    Science.gov (United States)

    Yoshizawa, Kazutake; Kobayashi, Hisanori; Fujie, Motoko; Ogawa, Yoshimasa; Yajima, Tsutomu; Kawai, Koji

    2016-03-01

    Quality of life (QoL) is routinely assessed and evaluated in medical research. However, in Japan, there is a lack of solid cutoff criteria for evaluating QoL improvement in chronic noncancer pain management. The present study was conducted to identify the minimal clinically important change (MCIC) of the Japanese version of EuroQol-5D 3L(EQ-5D) utility score and numeric rating scale (NRS) with an emphasis on chronic noncancer pain. The data source for this post hoc research was the post-marketing surveillance (PMS) data for a tramadol/acetaminophen combination tablet, which was previously conducted in real-world settings. The parameters extracted from the PMS data were sociodemographic characteristics, NRS, EQ-5D, and dichotomous physician's global impression of treatment effectiveness (PGI). The optimal cutoff points of MCIC for EQ-5D utility and NRS scores were evaluated using receiver operating characteristics (ROC) analysis. An anchor-based approach using PGI was applied. Data of 710 patients with chronic noncancer pain were extracted from the PMS database. The NRS score decreased by 2.7 (standard deviation, 2.3) points, whereas the EQ-5D score increased by 0.16 (0.20) points at 4 weeks from baseline. The changes from baseline in NRS and EQ-5D were significantly correlated (r = 0.53, p 0.80 in both analyses. These results demonstrated novel cutoff criteria for the Japanese version of EQ-5D, focusing on patients with chronic noncancer pain. The obtained criteria were fairly consistent and can be confidently utilized as an evaluation tool in medical research on chronic noncancer pain in Japan, with additional functionality and usability for QoL assessment in pain management practice. The data source of this post hoc research was a PMS study with the identifier number UMIN000015901 at umin.ac.jp, UMIN clinical trial registry (UMIN-CTR).

  8. Digital workflow in full-arch implant rehabilitation with segmented minimally veneered monolithic zirconia fixed dental prostheses: 2-year clinical follow-up.

    Science.gov (United States)

    Papaspyridakos, Panos; Kang, Kiho; DeFuria, Catherine; Amin, Sarah; Kudara, Yukio; Weber, Hans-Peter

    2018-01-01

    To illustrate a digital workflow in full-arch implant rehabilitation with minimally veneered monolithic zirconia and to report the outcomes including technical complications. Three patients (5 edentulous arches) received full-arch fixed implant rehabilitation with monolithic zirconia and mild facial porcelain veneering involving a digital workflow. The incisal edges and occluding surface areas were milled out of monolithic zirconia to reduce the possibility of chipping. Porcelain veneering was applied on the facial aspect to improve the esthetic result. Outcomes and technical complications are reported after 2 years of clinical and radiographic follow-up. Implant and prosthesis survival rates were 100% after a short-term follow-up of 2 years. Technical complications were encountered in one patient. They did not adversely affect prosthesis survival or patient satisfaction and were easily addressed. A digital workflow for the design and fabrication of full-arch monolithic zirconia implant fixed implant prostheses has benefits, but caution is necessary during CAD planning of the prosthesis to ensure a successful outcome. Long-term clinical studies are needed to corroborate the findings discussed in this report. This article presents an integrated digital workflow that was implemented for the implant-prosthodontic rehabilitation of three edentulous patients with monolithic zirconia prostheses. Monolithic zirconia has been successfully incorporated in implant prosthodontics in an effort to reduce the technical complications associated with bilayered ceramics. This workflow simplifies design and fabrication of the zirconia prostheses. However, caution should be taken during CAD planning of the prosthesis to make sure the zirconia cylinder is sufficiently thick at the interface with the titanium insert. Additionally, when cutback is planned for facial porcelain veneering, the functional occluding cusps and incisal edges should be fabricated in monolithic zirconia to avoid

  9. Protein Supplementation Has Minimal Effects on Muscle Adaptations during Resistance Exercise Training in Young Men: A Double-Blind Randomized Clinical Trial.

    Science.gov (United States)

    Reidy, Paul T; Borack, Michael S; Markofski, Melissa M; Dickinson, Jared M; Deer, Rachel R; Husaini, Syed H; Walker, Dillon K; Igbinigie, Sherry; Robertson, Shay M; Cope, Mark B; Mukherjea, Ratna; Hall-Porter, Janine M; Jennings, Kristofer; Volpi, Elena; Rasmussen, Blake B

    2016-09-01

    To our knowledge the efficacy of soy-dairy protein blend (PB) supplementation with resistance exercise training (RET) has not been evaluated in a longitudinal study. Our aim was to determine the effect of PB supplementation during RET on muscle adaptation. In this double-blind randomized clinical trial, healthy young men [18-30 y; BMI (in kg/m(2)): 25 ± 0.5] participated in supervised whole-body RET at 60-80% 1-repetition maximum (1-RM) for 3 d/wk for 12 wk with random assignment to daily receive 22 g PB (n = 23), whey protein (WP) isolate (n = 22), or an isocaloric maltodextrin (carbohydrate) placebo [(MDP) n = 23]. Serum testosterone, muscle strength, thigh muscle thickness (MT), myofiber cross-sectional area (mCSA), and lean body mass (LBM) were assessed before and after 6 and 12 wk of RET. All treatments increased LBM (P 0.10) between treatments. Testosterone was not altered. PB supplementation during 3 mo of RET tended to slightly enhance gains in whole-body and arm LBM, but not leg muscle mass, compared with RET without protein supplementation. Although protein supplementation minimally enhanced gains in LBM of healthy young men, there was no enhancement of gains in strength. This trial was registered at clinicaltrials.gov as NCT01749189. © 2016 American Society for Nutrition.

  10. Disparity in Cutaneous Pigmentary Response to LED vs Halogen Incandescent Visible Light: Results from a Single Center, Investigational Clinical Trial Determining a Minimal Pigmentary Visible Light Dose.

    Science.gov (United States)

    Soleymani, Teo; Cohen, David E; Folan, Lorcan M; Okereke, Uchenna R; Elbuluk, Nada; Soter, Nicholas A

    2017-11-01

    Background: While most of the attention regarding skin pigmentation has focused on the effects of ultraviolet radiation, the cutaneous effects of visible light (400 to 700nm) are rarely reported. The purpose of this study was to investigate the cutaneous pigmentary response to pure visible light irradiation, examine the difference in response to different sources of visible light irradiation, and determine a minimal pigmentary dose of visible light irradiation in melanocompetent subjects with Fitzpatrick skin type III - VI. The study was designed as a single arm, non-blinded, split-side dual intervention study in which subjects underwent visible light irradiation using LED and halogen incandescent light sources delivered at a fluence of 0.14 Watts/cm2 with incremental dose progression from 20 J/cm2 to 320 J/cm2. Pigmentation was assessed by clinical examination, cross-polarized digital photography, and analytic colorimetry. Immediate, dose-responsive pigment darkening was seen with LED light exposure in 80% of subjects, beginning at 60 Joules. No pigmentary changes were seen with halogen incandescent light exposure at any dose in any subject. This study is the first to report a distinct difference in cutaneous pigmentary response to different sources of visible light, and the first to demonstrate cutaneous pigment darkening from visible LED light exposure. Our findings raise the concern that our increasing daily artificial light surroundings may have clandestine effects on skin biology. J Drugs Dermatol. 2017;16(11):1105-1110..

  11. Qualifying and quantifying minimal hepatic encephalopathy

    DEFF Research Database (Denmark)

    Morgan, Marsha Y; Amodio, Piero; Cook, Nicola A

    2016-01-01

    Minimal hepatic encephalopathy is the term applied to the neuropsychiatric status of patients with cirrhosis who are unimpaired on clinical examination but show alterations in neuropsychological tests exploring psychomotor speed/executive function and/or in neurophysiological variables......, liver-related mortality and morbidity. Patients will only benefit in this way if they can be effectively diagnosed. Corporate efforts and consensus agreements are needed to develop effective diagnostic algorithms....

  12. Reliability, Validity, and Minimal Detectable Change of Balance Evaluation Systems Test and Its Short Versions in Older Cancer Survivors: A Pilot Study.

    Science.gov (United States)

    Huang, Min H; Miller, Kara; Smith, Kristin; Fredrickson, Kayle; Shilling, Tracy

    2016-01-01

    Cancer is primarily a disease of older adults. About 77% of all cancers are diagnosed in persons aged 55 years and older. Cancer and its treatment can cause diverse sequelae impacting body systems underlying balance control. No study has examined the psychometric properties of balance assessment tools in older cancer survivors, presenting a significant challenge in the selection of outcome measures for clinicians treating this fast-growing population. This study aimed to determine the reliability, validity, and minimal detectable change (MDC) of the Balance Evaluation System Test (BESTest), Mini-Balance Evaluation Systems Test (Mini-BESTest), and Brief-Balance Evaluation Systems Test (Brief-BESTest) in community-dwelling older cancer survivors. This study was a cross-sectional design. Twenty breast and 8 prostate cancer survivors participated [age (SD) = 68.4 (8.13) years]. The BESTest and Activity-specific Balance Confidence (ABC) Scale were administered during the first session. Scores of Mini-BESTest and Brief-BESTest were extracted on the basis of the scores of BESTest. The BESTest was repeated within 1 to 2 weeks by the same rater to determine the test-retest reliability. For the analysis of the inter-rater reliability, 21 participants were randomly selected to be evaluated by 2 raters. A primary rater administered the test. The 2 raters independently and concurrently scored the performance of the participants. Each rater recorded the ratings separately on the scoring sheet. No discussion among the raters was allowed throughout the testing. Intraclass correlation coefficients (ICCs), standard error of measurement, minimal detectable change (MDC), and Bland-Altman plots were calculated. Concurrent validity of these balance tests with the ABC Scale was examined using the Spearman correlation. The BESTest, Mini-BESTest, and Brief-BESTest had high test-retest (ICC = 0.90-0.94) and interrater reliability (ICC = 0.86-0.96), small standard error of measurement (0

  13. HEPATIC MALIGNANCIES - CLINICAL-FEATURES AND LABORATORY TESTS

    NARCIS (Netherlands)

    Beuers, U.

    1991-01-01

    While both primary and secondary hepatic malignancies grow continuously, clinically they remain silent and usually are detected late in their course. Common clinical symptoms include a triad of abdominal pain, weight loss, and malaise. The prominent physical finding is hepatomegaly. Standard

  14. Clinical utility of the erythrocyte sedimentation rate test and ...

    African Journals Online (AJOL)

    Background: The erythrocyte sedimentation rate (ESR) is a relatively non-specific test that is often ignored during the diagnosis and monitoring of disease. However, in recent times, the test is often requested alongside haemoglobin electrophoretic pattern as pre marital test. This study was aimed at determining the ESR ...

  15. Incorporation of gypsum waste in ceramic block production: Proposal for a minimal battery of tests to evaluate technical and environmental viability of this recycling process.

    Science.gov (United States)

    Godinho-Castro, Alcione P; Testolin, Renan C; Janke, Leandro; Corrêa, Albertina X R; Radetski, Claudemir M

    2012-01-01

    Civil engineering-related construction and demolition debris is an important source of waste disposed of in municipal solid waste landfills. After clay materials, gypsum waste is the second largest contributor to the residential construction waste stream. As demand for sustainable building practices grows, interest in recovering gypsum waste from construction and demolition debris is increasing, but there is a lack of standardized tests to evaluate the technical and environmental viability of this solid waste recycling process. By recycling gypsum waste, natural deposits of gypsum might be conserved and high amounts of the waste by-product could be reused in the civil construction industry. In this context, this paper investigates a physical property (i.e., resistance to axial compression), the chemical composition and the ecotoxicological potential of ceramic blocks constructed with different proportions of clay, cement and gypsum waste, and assesses the feasibility of using a minimal battery of tests to evaluate the viability of this recycling process. Consideration of the results for the resistance to axial compression tests together with production costs revealed that the best formulation was 35% of plastic clay, 35% of non-plastic clay, 10% of Portland cement and 20% of gypsum waste, which showed a mean resistance of 4.64MPa. Energy dispersive X-ray spectrometry showed calcium and sulfur to be the main elements, while quartz, gypsum, ettringite and nacrite were the main crystalline compounds found in this formulation. Ecotoxicity tests showed that leachate from this formulation is weakly toxic toward daphnids and bacteria (EC(20%)=69.0 and 75.0, respectively), while for algae and fish the leachate samples were not toxic at the EC(50%) level. Overall, these results show that the addition of 20% of gypsum waste to the ceramic blocks could provide a viable substitute for clay in the ceramics industry and the tests applied in this study proved to be a useful tool

  16. Six-minute stepper test: a valid clinical exercise tolerance test for COPD patients

    Directory of Open Access Journals (Sweden)

    Grosbois JM

    2016-03-01

    .005. Performances on the 6MST and 6MWT were significantly improved after PR (570 vs 488 steps, P=0.001 and 448 vs 406 m, respectively; P<0.0001. Improvements of the 6MST and 6MWT after PR were significantly correlated (r=0.34; P=0.03.Conclusion: The results of this study show that the 6MST is a valid test to evaluate exercise tolerance in COPD patients. The use of this test in clinical practice appears to be particularly relevant for the assessment of patients managed by home PR. Keywords: 6-minute stepper test, 6-minute walk test, exercise tolerance, pulmonary rehabilitation, cardiopulmonary exercise testing, validity

  17. [The functional tests in clinical diagnostic laboratory: the detection of magnesium deficiency in the loading test].

    Science.gov (United States)

    Kondakov, A V; Kobylianskiĭ, A G; Tishchenkov, V G; Titov, V N

    2012-06-01

    The article deals with the value and role of functional tests in practice of clinical diagnostic laboratories. The possibilities of evaluation of biological function of homeostasis according the changes of magnesium ions or calcium concentration in urine or blood hence reflecting the deficiency of these ions in vivo. The magnesium tolerant test is described It is demonstrated that it can be applied both in curative preventive institutions and ambulatories. In the examined group of patients, 78% had physiologic parameters of magnesium concentration, 17% suffered from hypermagnesiumuria and 5%--from hypermagnesiumuria. The magnesium deficiency of different degree was detected in 87% of patients. In the most part of patients with magnesium deficiency normomagnesiumuria was detected. Only in one case with normomagnesiumuria the magnesium deficiency was absent. In 30% of patients with magnesium deficiency the concentration of cation in day urine decreased up to 2.2 times after load dose. In absence of deficiency the monotony of cation's excretion was noted. Under the magnesium deficiency the character of process changed but velocity of excretion of magnesium after load probe slightly decreased relative to values before the load. The impact of alcohol under established magnesium deficiency results in increasing of velocity of excretion of this analyte. In patient with diabetes mellitus type II six months before the diagnosis of this disease the hidden deficiency of magnesium was detected. The magnesium deficiency was not detected after the antidiabetic treatment was applied The results permit to postulate the possibility of application oral load test with magnesium to assess the impact of various stress, physical, emotional and psychological factors. The detection of magnesium deficiency permit to broad the complex treatment, to accelerate and to enhance the results of treatment of diseases. Besides, the evaluation of patient's condition according the reaction of the

  18. Non-clinical and Pre-clinical Testing to Demonstrate Safety of the Barostim Neo Electrode for Activation of Carotid Baroreceptors in Chronic Human Implants.

    Science.gov (United States)

    Wilks, Seth J; Hara, Seth A; Ross, Erika K; Nicolai, Evan N; Pignato, Paul A; Cates, Adam W; Ludwig, Kip A

    2017-01-01

    The Barostim neo™ electrode was developed by CVRx, Inc.to deliver baroreflex activation therapy (BAT)™ to treat hypertension and heart failure. The neo electrode concept was designed to deliver electrical stimulation to the baroreceptors within the carotid sinus bulb, while minimizing invasiveness of the implant procedure. This device is currently CE marked in Europe, and in a Pivotal (akin to Phase III) Trial in the United States. Here we present the in vitro and in vivo safety testing that was completed in order to obtain necessary regulatory approval prior to conducting human studies in Europe, as well as an FDA Investigational Device Exemption (IDE) to conduct a Pivotal Trial in the United States. Stimulated electrodes (10 mA, 500 μs, 100 Hz) were compared to unstimulated electrodes using optical microscopy and several electrochemical techniques over the course of 27 weeks. Electrode dissolution was evaluated by analyzing trace metal content of solutions in which electrodes were stimulated. Lastly, safety testing under Good Laboratory Practice guidelines was conducted in an ovine animal model over a 12 and 24 week time period, with results processed and evaluated by an independent histopathologist. Long-term stimulation testing indicated that the neo electrode with a sputtered iridium oxide coating can be stimulated at maximal levels for the lifetime of the implant without clinically significant dissolution of platinum or iridium, and without increasing the potential at the electrode interface to cause hydrolysis or significant tissue damage. Histological examination of tissue that was adjacent to the neo electrodes indicated no clinically significant signs of increased inflammation and no arterial stenosis as a result of 6 months of continuous stimulation. The work presented here involved rigorous characterization and evaluation testing of the neo electrode, which was used to support its safety for chronic implantation. The testing strategies discussed

  19. Evaluation of rapid alternative methods for drug susceptibility testing in clinical isolates of Mycobacterium tuberculosis

    Directory of Open Access Journals (Sweden)

    Luciano Mengatto

    2006-08-01

    Full Text Available A study was carried out to compare the performance of a commercial method (MGIT and four inexpensive drug susceptibility methods: nitrate reductase assay (NRA, microscopic observation drug susceptibility (MODS assay, MTT test, and broth microdilution method (BMM. A total of 64 clinical isolates of Mycobacterium tuberculosis were studied. The Lowenstein-Jensen proportion method (PM was used as gold standard. MGIT, NRA, MODS, and MTT results were available on an average of less than 10 days, whereas BMM results could be reported in about 20 days. Most of the evaluated tests showed excellent performance for isoniazid and rifampicin, with sensitivity and specificity values > 90%. With most of the assays, sensitivity for ethambutol was low (62-87% whereas for streptomycin, sensitivity values ranged from 84 to 100%; NRA-discrepancies were associated with cultures with a low proportion of EMB-resistant organisms while most discrepancies with quantitative tests (MMT and BMM were seen with isolates whose minimal inhibitory concentrations fell close the cutoff. MGIT is reliable but still expensive. NRA is the most inexpensive and easiest method to perform without changing the organization of the routine PM laboratory performance. While MODS, MTT, and BMM, have the disadvantage from the point of view of biosafety, they offer the possibility of detecting partial resistant strains. This study shows a very good level of agreement of the four low-cost methods compared to the PM for rapid detection of isoniazid, rifampicin and streptomycin resistance (Kappa values > 0.8; more standardization is needed for ethambutol.

  20. Measuring teamwork performance: Validity testing of the Team Emergency Assessment Measure (TEAM) with clinical resuscitation teams.

    Science.gov (United States)

    Cooper, Simon; Cant, Robyn; Connell, Cliff; Sims, Lyndall; Porter, Joanne E; Symmons, Mark; Nestel, Debra; Liaw, Sok Ying

    2016-04-01

    To test the resuscitation non-technical Team Emergency Assessment Measure (TEAM) for feasibility, validity and reliability, in two Australian Emergency Departments (ED). Non-technical (teamwork) skills have been identified as inadequate and as such have a significant impact on patient safety. Valid and reliable teamwork assessment tools are an important element of performance assessment and debriefing processes. A quasi experimental design based on observational ratings of resuscitation non-technical skills in two metropolitan ED. Senior nursing staff rated 106 adult resuscitation team events over a ten month period where three or more resuscitation team members attended. Resuscitation events, team performance and validity and reliability data was collected for the TEAM. Most rated events were for full cardiac resuscitation (43%) with 3-15 team members present for an average of 45 min. The TEAM was found to be feasible and quickly completed with minimal or no training. Discriminant validity was good as was internal consistency with a Cronbach alpha of 0.94. Uni-dimensional and concurrent validity also reached acceptable standards, 0.94 and >0.63 (p=teamwork' construct was identified. Non-technical skills overall were good but leadership was rated notably lower than task and teamwork performance indicating a need for leadership training. The TEAM is a feasible, valid and reliable non-technical assessment measure in simulated and real clinical settings. Emergency teams need to develop leadership skills through training and reflective debriefing. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  1. Ultrasound Augmented Thrombolysis, From Test Tubes to Clinical Applications

    Science.gov (United States)

    Culp, William C.

    2006-05-01

    Ultrasound acceleration of thrombolysis with tissue plasminogen activator (tPA) or microbubbles has developed from bench top models to early clinical experience over the course of the last dozen years. Thrombosis of arteries and veins, especially thrombosis of cerebral arteries causing stroke, is a massive clinical problem with limited therapy associated with high complication rates. Ultrasound augmentation of thrombolysis using standard thrombolytic drugs or microbubble augmented ultrasonographic thrombolysis may prove to be the more efficacious and safer therapy of choice in the near future.

  2. Inter- and intrarater reliability of two proprioception tests using clinical applicable measurement tools in subjects with and without knee osteoarthritis.

    Science.gov (United States)

    Baert, Isabel A C; Lluch, Enrique; Struyf, Thomas; Peeters, Greta; Van Oosterwijck, Sophie; Tuynman, Joanna; Rufai, Salim; Struyf, Filip

    2017-11-21

    The therapeutic value of proprioceptive-based exercises in knee osteoarthritis (KOA) management warrants investigation of proprioceptive testing methods easily accessible in clinical practice. To estimate inter- and intrarater reliability of the knee joint position sense (KJPS) test and knee force sense (KFS) test in subjects with and without KOA. Cross-sectional test-retest design. Two blinded raters performed independently repeated measures of the KJPS and KFS test, using an analogue inclinometer and handheld dynamometer, respectively, in eight KOA patients (12 symptomatic knees) and 26 healthy controls (52 asymptomatic knees). Intraclass correlation coefficients (ICCs; model 2,1), standard error of measurement (SEM) and minimal detectable change with 95% confidence bounds (MDC 95 ) were calculated. For KJPS, results showed good to excellent test-retest agreement (ICCs 0.70-0.95 in KOA patients; ICCs 0.65-0.85 in healthy controls). A 2° measurement error (SEM 1°) was reported when measuring KJPS in multiple test positions and calculating mean repositioning error. Testing KOA patients pre and post therapy a repositioning error larger than 4° (MDC 95 ) is needed to consider true change. Measuring KFS using handheld dynamometry showed poor to fair interrater and poor to excellent intrarater reliability in subjects with and without KOA. Measuring KJPS in multiple test positions using an analogue inclinometer and calculating mean repositioning error is reliable and can be used in clinical practice. We do not recommend the use of the KFS test to clinicians. Further research is required to establish diagnostic accuracy and validity of our KJPS test in larger knee pain populations. Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. The cost of implementing rapid HIV testing in sexually transmitted disease clinics in the United States.

    Science.gov (United States)

    Eggman, Ashley A; Feaster, Daniel J; Leff, Jared A; Golden, Matthew R; Castellon, Pedro C; Gooden, Lauren; Matheson, Tim; Colfax, Grant N; Metsch, Lisa R; Schackman, Bruce R

    2014-09-01

    Rapid HIV testing in high-risk populations can increase the number of persons who learn their HIV status and avoid spending clinic resources to locate persons identified as HIV infected. We determined the cost to sexually transmitted disease (STD) clinics of point-of-care rapid HIV testing using data from 7 public clinics that participated in a randomized trial of rapid testing with and without brief patient-centered risk reduction counseling in 2010. Costs included counselor and trainer time, supplies, and clinic overhead. We applied national labor rates and test costs. We calculated median clinic start-up costs and mean cost per patient tested, and projected incremental annual costs of implementing universal rapid HIV testing compared with current testing practices. Criteria for offering rapid HIV testing and methods for delivering nonrapid test results varied among clinics before the trial. Rapid HIV testing cost an average of US $22/patient without brief risk reduction counseling and US $46/patient with counseling in these 7 clinics. Median start-up costs per clinic were US $1100 and US $16,100 without and with counseling, respectively. Estimated incremental annual costs per clinic of implementing universal rapid HIV testing varied by whether or not brief counseling is conducted and by current clinic testing practices, ranging from a savings of US $19,500 to a cost of US $40,700 without counseling and a cost of US $98,000 to US $153,900 with counseling. Universal rapid HIV testing in STD clinics with same-day results can be implemented at relatively low cost to STD clinics, if brief risk reduction counseling is not offered.

  4. The clinical diagnosis of meniscal tear is not easy. Reliability of two clinical meniscal tests and magnetic resonance imaging.

    Science.gov (United States)

    Rinonapoli, G; Carraro, A; Delcogliano, A

    2011-01-01

    to clarify the reliability of two clinical meniscal tests, McMurray's and Apley's and the MRI imaging, in order to establish how to reduce unjustified arthroscopies. 102 patients were selected out of 160. All patients were submitted to a triple clinical examination (by a young surgeon and two skilled surgeons), MRI and an arthroscopic procedure. The investigated clinical tests were McMurray's and Apley's test. The positivity or negativity of the tests and MRI were compared to arthroscopic findings. Arthroscopy is considered the gold standard for the diagnosis of meniscal lesions. We measured the length of the meniscal lesions in order to correlate it to the clinical findings. From the clinical examination, we got the following data: McMurray's test: sensitivity 79.7%, specificity 78.5%, accuracy 79.4%, positive likelihood ratio 3.7, negative likelihood ratio 0.2. Apley's test: sensitivity 83.7%, specificity 71.4%, accuracy 80.3%, positive likelihood ratio 2.9, negative likelihood ratio 0.2. The composite assessment is strictly dependent on how the discordance of the two tests is evaluated. The assessment of the clinical tests was done even in relation to medial or lateral meniscal lesion. No statistical difference was found about the length of the meniscal tear. MRI gave the following results: sensitivity 78.3%, specificity 85.7%, accuracy 80.3%. If we use, as diagnostic means, McMurray's and Apley's clinical tests and MRI as imaging procedure, we have an accuracy of about 80%. It is important to keep in mind that it is not possible to have the absolute certainty of make a correct diagnosis in case of meniscal lesions. Patients, too, have to be informed about the risk of a negative arthroscopy.

  5. Testing DEA Models of Efficiency in Norwegian Psychiatric Outpatient Clinics

    OpenAIRE

    Kittelsen, Sverre A.C.; Magnussen, Jon

    2009-01-01

    While measures of output in mental health care are even harder to find than in other health care activities, some indicators are available. In modelling productive efficiency the problem is to select the output variables that best reflect the use of resources, in the sense that these variables have a significant impact on measures of efficiency. The paper analyses cross-sectional data on the psychiatric outpatient clinics of Norway using the Data Envelopment Analysis (DEA) non-parametric effi...

  6. Assigning ethical weights to clinical signs observed during toxicity testing.

    Science.gov (United States)

    Ringblom, Joakim; Törnqvist, Elin; Hansson, Sven Ove; Rudén, Christina; Öberg, Mattias

    2017-01-01

    Reducing the number of laboratory animals used and refining experimental procedures to enhance animal welfare are fundamental questions to be considered in connection with animal experimentation. Here, we explored the use of cardinal ethical weights for clinical signs and symptoms in rodents by conducting trade-off interviews with members of Swedish Animal Ethics Committees in order to derive such weights for nine typical clinical signs of toxicity. The participants interviewed represent researchers, politically nominated political nominees and representatives of animal welfare organizations. We observed no statistically significant differences between these groups with respect to the magnitude of the ethical weights assigned, though the political nominees tended to assign lower weights. Overall, hunched posture was considered the most severe clinical sign and body weight loss the least severe. The ethical weights assigned varied considerably between individuals, from zero to infinite value, indicating discrepancies in prioritization of reduction and refinement. Cardinal ethical weights may be utilized to include both animal welfare refinement and reduction of animal use in designing as well as in retrospective assessment of animal experiments. Such weights may also be used to estimate ethical costs of animal experiments.

  7. Minimal hepatic encephalopathy: A review.

    Science.gov (United States)

    Nardone, Raffaele; Taylor, Alexandra C; Höller, Yvonne; Brigo, Francesco; Lochner, Piergiorgio; Trinka, Eugen

    2016-10-01

    Minimal hepatic encephalopathy (MHE) is the earliest form of hepatic encephalopathy and can affect up to 80% of patients with liver cirrhosis. By definition, MHE is characterized by cognitive function impairment in the domains of attention, vigilance and integrative function, but obvious clinical manifestation are lacking. MHE has been shown to affect daily functioning, quality of life, driving and overall mortality. The diagnosis can be achieved through neuropsychological testing, recently developed computerized psychometric tests, such as the critical flicker frequency and the inhibitory control tests, as well as neurophysiological procedures. Event related potentials can reveal subtle changes in patients with normal neuropsychological performances. Spectral analysis of electroencephalography (EEG) and quantitative analysis of sleep EEG provide early markers of cerebral dysfunction in cirrhotic patients with MHE. Neuroimaging, in particular MRI, also increasingly reveals diffuse abnormalities in intrinsic brain activity and altered organization of functional connectivity networks. Medical treatment for MHE to date has been focused on reducing serum ammonia levels and includes non-absorbable disaccharides, probiotics or rifaximin. Liver transplantation may not reverse the cognitive deficits associated with MHE. We performed here an updated review on epidemiology, burden and quality of life, neuropsychological testing, neuroimaging, neurophysiology and therapy in subjects with MHE. Copyright © 2016 Elsevier Ireland Ltd and Japan Neuroscience Society. All rights reserved.

  8. Clinical and para-clinical tests in the routine examination of headache patients

    DEFF Research Database (Denmark)

    Friberg, L; Sandrini, G; Jänig, W

    2000-01-01

    Para-clinical examinations in the diagnosis and treatment control of headache patients vary considerably between clinics and headache centers. Among the neurological societies in Europe there has been a consensus that some common procedures and recommendations should be created. In the Fall of 19...

  9. Test-Retest Reliability and Minimal Detectable Change of Randomized Dichotic Digits in Learning-Disabled Children: Implications for Dichotic Listening Training.

    Science.gov (United States)

    Mahdavi, Mohammad Ebrahim; Pourbakht, Akram; Parand, Akram; Jalaie, Shohreh

    2018-03-01

    Evaluation of dichotic listening to digits is a common part of many studies for diagnosis and managing auditory processing disorders in children. Previous researchers have verified test-retest relative reliability of dichotic digits results in normal children and adults. However, detecting intervention-related changes in the ear scores after dichotic listening training requires information regarding trial-to-trial typical variation of individual ear scores that is estimated using indices of absolute reliability. Previous studies have not addressed absolute reliability of dichotic listening results. To compare the results of the Persian randomized dichotic digits test (PRDDT) and its relative and absolute indices of reliability between typical achieving (TA) and learning-disabled (LD) children. A repeated measures observational study. Fifteen LD children were recruited from a previously performed study with age range of 7-12 yr. The control group consisted of 15 TA schoolchildren with age range of 8-11 yr. The Persian randomized dichotic digits test was administered on the children under free recall condition in two test sessions 7-12 days apart. We compared the average of the ear scores and ear advantage between TA and LD children. Relative indices of reliability included Pearson's correlation and intraclass correlation (ICC 2,1 ) coefficients and absolute reliability was evaluated by calculation of standard error of measurement (SEM) and minimal detectable change (MDC) using the raw ear scores. The Pearson correlation coefficient indicated that in both groups of children the ear scores of test and retest sessions were strongly and positively (greater than +0.8) correlated. The ear scores showed excellent ICC coefficient of consistency (0.78-0.82) and fair to excellent ICC coefficient of absolute agreement (0.62-0.74) in TA children and excellent ICC coefficients of consistency and absolute agreement in LD children (0.76-0.87). SEM and SEM% of the ear scores in TA

  10. The Diagnostic Accuracy of Clinical Diagnostic Tests for Thoracic Outlet Syndrome.

    Science.gov (United States)

    Hixson, Krista M; Horris, Hannah B; McLeod, Tamara C Valovich; Bacon, Cailee E Welch

    2017-09-01

    Clinical Scenario: Thoracic outlet syndrome is quite challenging to diagnose. Currently, there are myriad diagnostic procedures used in the diagnosis of all types of thoracic outlet syndrome. However, controversy exists over which diagnostic procedures produce accurate findings. Can clinical diagnostic tests accurately diagnose patients presenting with symptoms of thoracic outlet syndrome? Summary of Key Findings: A thorough literature search returned 6 possible studies; 3 studies met the inclusion criteria and were included. Two studies supported the use of clinical diagnostic tests for the diagnosis of thoracic outlet syndrome. One study reported high false-positive rates among clinical diagnostic tests for thoracic outlet syndrome. One study reported that clinical diagnostic test findings correlate to provocative positioned magnetic resonance imaging findings. Clinical Bottom Line: There is moderate evidence to support the use of the Halstead maneuver (also known as the costoclavicular maneuver or exaggerated military brace test), Wright's test, Cyriax Release test, and supraclavicular pressure test to have good diagnostic accuracy for the provocation of symptoms in patients presenting with upper extremity pathology. However, these clinical diagnostic tests do not appear to allow for the differential diagnosis of thoracic outlet syndrome exclusively. The use of the Adson's test and Roos test should be discontinued for the differential diagnosis of thoracic outlet syndrome. Strength of Recommendation: Grade B evidence exists to support the accuracy of the Halstead maneuver, Wright's test, Cyriax Release test, and supraclavicular pressure test for the diagnosis of upper extremity pathology in general. Grade C evidence exists for the use of these clinical diagnostic tests to exclusively diagnose thoracic outlet syndrome.

  11. Clinical approach to obscure GI bleeding - Diagnostic testing and management

    Directory of Open Access Journals (Sweden)

    Prashanth Prabakaran

    2013-01-01

    Full Text Available Obscure gastrointestinal bleeding (OGIB can present as a diagnostic dilemma and management can be challenging. The search for causes of OGIB is usually centered on visualizing the small bowel, and in the past decade, the technology to visualize the entire small bowel has significantly advanced. Moreover, small bowel endoscopic imaging has replaced, in many instances, prior radiographic evaluation for obscure GI bleeding. These new modalities, such as small bowel capsule endoscopy (CE, balloon-assisted deep enteroscopy [double balloon enteroscopy (DBE and single balloon enteroscopy (SBE], and overtube-assisted deep enteroscopy (spiral enteroscopy, are paving the way toward more accurately identifying and treating patients with OGIB. We will review the diagnostic modalities available in evaluating a patient with OGIB and also propose the management based on clinical and endoscopic findings.

  12. Quality assessment in in vivo NMR spectroscopy: III. Clinical test objects: design, construction, and solutions

    DEFF Research Database (Denmark)

    Leach, M.O.; Collins, D.J.; Keevil, S

    1995-01-01

    Based on the requirements of test protocols developed to evaluate clinical MRS single slice and volume localisation sequences, two clinical test objects, STO1 and STO2 have been developed. The properties of a range of potential construction materials have been assessed, demonstrating that the water...

  13. Accuracy of clinical tests in the diagnosis of anterior cruciate ligament injury: A systematic review

    NARCIS (Netherlands)

    M.S. Swain (Michael S.); N. Henschke (Nicholas); S.J. Kamper (Steven); A.S. Downie (Aron S.); B.W. Koes (Bart); C. Maher (Chris)

    2014-01-01

    textabstractBackground: Numerous clinical tests are used in the diagnosis of anterior cruciate ligament (ACL) injury but their accuracy is unclear. The purpose of this study is to evaluate the diagnostic accuracy of clinical tests for the diagnosis of ACL injury.Methods: Study Design: Systematic

  14. 42 CFR 493.1453 - Condition: Laboratories performing high complexity testing; clinical consultant.

    Science.gov (United States)

    2010-10-01

    ... Condition: Laboratories performing high complexity testing; clinical consultant. The laboratory must have a... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing high complexity testing; clinical consultant. 493.1453 Section 493.1453 Public Health CENTERS FOR MEDICARE & MEDICAID...

  15. Repeat Chlamydia trachomatis testing among heterosexual STI outpatient clinic visitors in the Netherlands: a longitudinal study.

    Science.gov (United States)

    Visser, Maartje; van Aar, Fleur; Koedijk, Femke D H; Kampman, Carolina J G; Heijne, Janneke C M

    2017-12-20

    Chlamydia infections are common in both men and women, are often asymptomatic and can cause serious complications. Repeat testing in high-risk groups is therefore indicated. In the Netherlands, guidelines on repeat chlamydia testing differ between testing facilities, and knowledge on repeat testing behaviour is limited. Here, we analyse the current repeat testing behaviour of heterosexual STI clinic visitors, and aim to identify groups for which repeat testing advice could be advantageous. Longitudinal surveillance data from all Dutch STI outpatient clinics were used, which included all STI clinic consultations carried out among heterosexual men and women between June 2014 and December 2015. Repeat testing was defined as returning to the same STI clinic between 35 days and 12 months after initial consultation. We calculated chlamydia positivity at repeat test stratified by initial test result and time between consultations. Logistic regression analyses were used to identify predictors of repeat testing, and predictors of having a chlamydia positive repeat test. In total, 140,486 consultations in 75,487 women and 46,286 men were available for analyses. Overall, 15.4% of women and 11.1% of men returned to the STI clinic within the study period. Highest chlamydia positivity at repeat test was seen 3-5 months after initial positive test. Among both women and men, repeat testing was associated with non-Western ethnicity, having had more than two sex partners in the past 6 months, reporting STI symptoms, having a history of STI, and having a chlamydia positive initial test. Among repeat testers, chlamydia positive repeat test was most strongly associated with younger age, followed by a chlamydia positive initial test. Repeat testing most often resulted in a positive test result among young heterosexuals (<25) and heterosexuals of any age with a chlamydia infection at the initial consultation. Further efforts are needed to determine optimal repeat testing strategies.

  16. Selection and measurement of control antidepressants in clinical tests for Chinese: A systematic review.

    Science.gov (United States)

    Liu, Hao; Yang, Zhi-Min; Geng, Ying; Yang, Huan; Zhao, De-Heng; Xiao, Wei-Dong; Wang, Gao-Hua

    2017-10-01

    The study aims to help domestic application units and research institutions improve their research quality of antidepressant clinical tests by studying and analyzing the current status and problems in selecting control drugs during domestic antidepressant clinical tests and illustrating some key problems that should be noted when selecting the control drug in such researches. Considering the current domestic and overseas status of control drug selection in antidepressant clinical tests, various considerations, and misunderstandings on control drug selection in domestic antidepressant clinical tests were clarified and described, and possible factors that may influence the absolute effect of antidepressants were analyzed. Furthermore, problems that should be noted in selecting control drugs for the antidepressant clinical test, especially the placebo control, were stated. During the antidepressant clinical research, selecting placebo controls conform to moral philosophy and safety requirements. To verify the absolute effect of a test drug, a placebo control should be set or 3-arm tests should be conducted as far as possible. Possible factors that may affect the absolute effect of the test drug, including illness severity of the subject at baseline and research scale, should be given consideration. Application units and research institutions should consider the selection of subjects, control the failure rate, strengthen safety risks, and control and intensify quality control to further improve the overall quality and research level of domestic antidepressant clinical tests.

  17. Selection and measurement of control antidepressants in clinical tests for Chinese

    Science.gov (United States)

    Liu, Hao; Yang, Zhi-Min; Geng, Ying; Yang, Huan; Zhao, De-Heng; Xiao, Wei-Dong; Wang, Gao-Hua

    2017-01-01

    Abstract Objective: The study aims to help domestic application units and research institutions improve their research quality of antidepressant clinical tests by studying and analyzing the current status and problems in selecting control drugs during domestic antidepressant clinical tests and illustrating some key problems that should be noted when selecting the control drug in such researches. Methods: Considering the current domestic and overseas status of control drug selection in antidepressant clinical tests, various considerations, and misunderstandings on control drug selection in domestic antidepressant clinical tests were clarified and described, and possible factors that may influence the absolute effect of antidepressants were analyzed. Furthermore, problems that should be noted in selecting control drugs for the antidepressant clinical test, especially the placebo control, were stated. Results: During the antidepressant clinical research, selecting placebo controls conform to moral philosophy and safety requirements. To verify the absolute effect of a test drug, a placebo control should be set or 3-arm tests should be conducted as far as possible. Possible factors that may affect the absolute effect of the test drug, including illness severity of the subject at baseline and research scale, should be given consideration. Conclusions: Application units and research institutions should consider the selection of subjects, control the failure rate, strengthen safety risks, and control and intensify quality control to further improve the overall quality and research level of domestic antidepressant clinical tests. PMID:29069004

  18. Cost analysis of a novel HIV testing strategy in community pharmacies and retail clinics.

    Science.gov (United States)

    Lecher, Shirley Lee; Shrestha, Ram K; Botts, Linda W; Alvarez, Jorge; Moore, James H; Thomas, Vasavi; Weidle, Paul J

    2015-01-01

    To document the cost of implementing point-of-care (POC) human immunodeficiency virus (HIV) rapid testing in busy community pharmacies and retail clinics. Providing HIV testing services in community pharmacies and retail clinics is an innovative way to expand HIV testing. The cost of implementing POC HIV rapid testing in a busy retail environment needs to be documented to provide program and policy leaders with adequate information for planning and budgeting. Cost analysis from a pilot project that provided confidential POC HIV rapid testing services in community pharmacies and retail clinics. The pharmacy sites were operated under several different ownership structures (for-profit, nonprofit, sole proprietorship, corporation, public, and private) in urban and rural areas. We included data from the initial six sites that participated in the project. We collected the time spent by pharmacy and retail clinic staff for pretest and posttest counseling in an activity log for time-in-motion for each interaction. Pharmacists and retail clinic staff. HIV rapid testing. The total cost was calculated to include costs of test kits, control kits, shipping, test supplies, training, reporting, program administration, and advertising. The six sites trained 22 staff to implement HIV testing. A total of 939 HIV rapid tests were conducted over a median time of 12 months, of which 17 were reactive. Median pretest counseling time was 2 minutes. Median posttest counseling time was 2 minutes for clients with a nonreactive test and 10 minutes for clients with a reactive test. The average cost per person tested was an estimated $47.21. When we considered only recurrent costs, the average cost per person tested was $32.17. Providing POC HIV rapid testing services required a modest amount of staff time and costs that are comparable to other services offered in these settings. HIV testing in pharmacies and retail clinics can provide an additional alternative venue for increasing the

  19. Outcomes in cases of lumbar degenerative spondylolisthesis more than 5 years after treatment with minimally invasive decompression: examination of pre- and postoperative slippage, intervertebral disc changes, and clinical results.

    Science.gov (United States)

    Mori, Gen; Mikami, Yasuo; Arai, Yuji; Ikeda, Takumi; Nagae, Masateru; Tonomura, Hitoshi; Takatori, Ryota; Sawada, Koshiro; Fujiwara, Hiroyoshi; Kubo, Toshikazu

    2016-03-01

    There are reports that fusion is the standard treatment of choice for cases of lumbar degenerative spondylolisthesis (LDS) associated with lumbar spinal canal stenosis with a large degree of slippage. The reasons why, however, have not been clarified. On the other hand, it is known that the progress of slippage decreases and restabilization occurs over the natural course of LDS. Therefore, if minimally invasive decompression could be performed, there would be little possibility of it influencing the natural course of LDS, so it would not be necessary to include preoperative percentage slip in the criteria for the selection of fusion. This study examined the course of LDS cases more than 5 years after treatment with minimally invasive decompression to determine whether pre- and postoperative slippage and disc changes influence the clinical results. A total of 51 intervertebral segments in 51 cases with the chief complaint of radicular or cauda equina symptoms due to lumbar spinal canal stenosis were examined after prospective treatment with minimally invasive decompression for LDS. The mean age of the patients at the time of surgery was 66.7 years and the mean follow-up period was 7 years 4 months. Minimally invasive decompression was performed regardless of the degree of low-back pain or percentage slip. The outcome variables were clinical results and changes in imaging findings. Over the follow-up period, postoperative percentage slip increased and disc height decreased, but the Japanese Orthopaedic Association score improved. Regardless of the preoperative percentage slip, disc height, or degree of intervertebral disc degeneration or segmental instability, the clinical results were favorable. In the high preoperative percentage slip group, low disc height group, and progressive disc degeneration group, there was little postoperative progress of slippage. In the group with a postoperative slippage increase of more than 5%, slippage increased significantly at

  20. Changes in cervical cancer screening behavior for women attending Pap Test Week clinics.

    Science.gov (United States)

    Poliquin, V; Decker, K; Altman, Ad; Lotocki, R

    2013-01-01

    This retrospective study of all women who accessed the 2006 Manitoba Pap Test Week clinics was designed to determine factors associated with inadequate cervical cancer screening and changes in cervical cancer screening behavior. Data were acquired using the CervixCheck Manitoba registry and an ancillary database of demographic information collected from clinic attendees. The study included 1124 women. Of these, 53% (n = 598) were under-screened (no Pap test in the previous 2 years) prior to accessing the clinics. Logistic regression analyses demonstrated that older age (odds ratio [OR] = 1.02, 95% confidence interval [CI] 1.01-1.03), no doctor (OR = 1.4, 95% CI 1.05-1.54), and living in Canada Pap Test Week clinics. Thirty-seven percent (n = 223) of under-screened women demonstrated improved screening status subsequent to the 2006 Pap Test Week (had a subsequent Papanicolaou [Pap] test performed within 2 years) and these women were more likely to live in an urban setting (P = 0.003), be younger (P Pap test result in 2006 (P Pap test performed at a Pap Test Week clinic compared to having a Pap test performed elsewhere (37% versus 60%, P Pap Test Week clinics whose screening status might be most modifiable.

  1. [Clinical diagnosis of overtraining using blood tests: current knowledge].

    Science.gov (United States)

    Petibois, C; Cazorla, G; Déléris, G; Gin, H

    2001-08-01

    Overtraining results from an imbalance between training load-induced fatigue and organism's recovery abilities. Its etiology is complex and to date there is no useful clinical diagnostic tool. The purpose of this review is to discuss the blood chemistry parameters potentially useful for diagnosing overtraining in athletes. Chronic alterations of the myocyte structure may cause high plasma concentration increases of myoglobin, troponin I and creatine kinase enzyme, resulting in chemical and/or mechanical aggression. Monitoring reactive oxygen species' activity appears to be a good tool for evaluation of the metabolic stress level experienced by skeletal muscles. In energetic metabolism, a succession of chronic glycogen depletions might change the use of amino acids and lipids, inducing transient but severe hypoglycemia during exercise. A higher oxidation of circulating glutamine might cause immunosuppression (lower reactivity to inflammations and cellular traumatisms), inhibiting alarm signals during acute training. A higher branched-chain amino acid oxidation might favor free tryptophan's entry into the cerebral area, enhancing serotonin synthesis. As a consequence, asthenia and a loss of sensitivity to muscular and tendon traumatism might appear. Exercise anemia might also be a worsening factor of the physiological situation of the tired athlete, inducing predisposition to overtraining by the lower inflammation reactivity of depleted hepatic and muscular proteins. Early diagnosis of overtraining diagnosis may be established only from a battery of analyses, which should include the whole of the potential parameters. These remain unpredictable and do not allow systematic determination of new cases. Only a longitudinal study of the physiological situation appears to allow the necessary conditions for detecting overtraining in the early stages of its process for each subject.

  2. Test Cost and Test Accuracy in Clinical Laboratories in Kampala, Uganda.

    Science.gov (United States)

    Amukele, Timothy K; Jones, Robert; Elbireer, Ali

    2018-04-25

    To assess the accuracy and costs of laboratory tests in Kampala, Uganda. A random selection of 78 laboratories tested external quality assurance samples at market rates. There were 40 moderate- to high-complexity and 38 low-complexity laboratories. Four percent (3/78) of these laboratories were accredited and 94% (73/78) were private. The 40 moderate- to high-complexity laboratories performed malaria blood smear, urine human chorionic gonadotropin (hCG), human immunodeficiency virus (HIV), syphilis, glucose, and three-panel tests: CBC, liver function tests, and kidney function tests. The 38 low-complexity laboratories performed malaria blood smear, urine hCG, and syphilis testing only. Hematology, HIV, syphilis, and malarial proficiency testing samples were prepared by accredited laboratories in Kampala. All other samples were provided by the Royal College of Pathologists of Australia. 77.1% of all results were accurate (met target values). It varied widely by laboratory (50%-100%), test identity (malaria blood smear, 96%; serum urea nitrogen, 38%), and test type (quantitative: 66% [31%-89%], qualitative: 91% [68%-97%]). Test prices varied by up to 3,600%, and there was no correlation between test cost and accuracy (r2 = 0.02). There were large differences in accuracy and price across laboratories in Kampala. Price was not associated with quality.

  3. Medical Physics: Forming and testing solutions to clinical problems.

    Science.gov (United States)

    Tsapaki, Virginia; Bayford, Richard

    2015-11-01

    According to the European Federation of Organizations for Medical Physics (EFOMP) policy statement No. 13, "The rapid advance in the use of highly sophisticated equipment and procedures in the medical field increasingly depends on information and communication technology. In spite of the fact that the safety and quality of such technology is vigorously tested before it is placed on the market, it often turns out that the safety and quality is not sufficient when used under hospital working conditions. To improve safety and quality for patient and users, additional safeguards and related monitoring, as well as measures to enhance quality, are required. Furthermore a large number of accidents and incidents happen every year in hospitals and as a consequence a number of patients die or are injured. Medical Physicists are well positioned to contribute towards preventing these kinds of events". The newest developments related to this increasingly important medical speciality were presented during the 8th European Conference of Medical Physics 2014 which was held in Athens, 11-13 September 2014 and hosted by the Hellenic Association of Medical Physicists (HAMP) in collaboration with the EFOMP and are summarized in this issue. Copyright © 2015 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

  4. The clinical utility of naturalistic action test in differentiating mild cognitive impairment from early dementia in memory clinic.

    Science.gov (United States)

    Bruce, Irene; Ntlholang, Ontefetse; Crosby, Lisa; Cunningham, Conal; Lawlor, Brian

    2016-03-01

    This study aimed to examine the validity of the Naturalistic Action Test in differentiating Mild Cognitive Impairment from early dementia compared to clinical diagnosis and ascertain Naturalistic Action Test cut-off points. This was a cross-sectional study of 70 consecutive patients diagnosed with Mild Cognitive Impairment attending the memory clinic in St James's Hospital, Dublin, Ireland. Patients with a diagnosis of Mild Cognitive Impairment who attended for routine annual assessment were asked to participate in the study. The Naturalistic Action Test was carried out after the patient had completed their routine assessment in the clinic. The Area under the Curve, AUC ± SE was 0.808 ± 0.058, p Test. The difference was not related to age, sex, level of education or informant. Using the Youden index, we determined a Naturalistic Action Test cut-off score of ≥11 for Mild Cognitive Impairment in our study (PPV 50%, NPV 91%, sensitivity 78%, specificity 73% and accuracy of 74%). There was discrepancy in 18 patients using the new cut-off point (≥11 for Mild Cognitive Impairment vs ≤10 for dementia). The Naturalistic Action Test is a useful tool that can increase diagnostic accuracy in differentiating Mild Cognitive Impairment from early dementia. Copyright © 2015 John Wiley & Sons, Ltd.

  5. A clinical audit of provider-initiated HIV counselling and testing in a ...

    African Journals Online (AJOL)

    Background. Early initiation of antiretroviral therapy reduces transmission of HIV and prolongs life. Expansion of HIV testing is therefore pivotal in overcoming the HIV pandemic. Provider-initiated counselling and testing (PICT) at first clinical contact is one way of increasing the number of individuals tested. Our impression is ...

  6. Concurrent Validity and Clinical Usefulness of Several Individually Administered Tests of Children's Social-Emotional Cognition

    Science.gov (United States)

    McKown, Clark

    2007-01-01

    In this study, the validity of 5 tests of children's social-emotional cognition, defined as their encoding, memory, and interpretation of social information, was tested. Participants were 126 clinic-referred children between the ages of 5 and 17. All 5 tests were evaluated in terms of their (a) concurrent validity, (b) incremental validity, and…

  7. Minimal Reducts with Grasp

    Directory of Open Access Journals (Sweden)

    Iris Iddaly Mendez Gurrola

    2011-03-01

    Full Text Available The proper detection of patient level of dementia is important to offer the suitable treatment. The diagnosis is based on certain criteria, reflected in the clinical examinations. From these examinations emerge the limitations and the degree in which each patient is in. In order to reduce the total of limitations to be evaluated, we used the rough set theory, this theory has been applied in areas of the artificial intelligence such as decision analysis, expert systems, knowledge discovery, classification with multiple attributes. In our case this theory is applied to find the minimal limitations set or reduct that generate the same classification that considering all the limitations, to fulfill this purpose we development an algorithm GRASP (Greedy Randomized Adaptive Search Procedure.

  8. College of American Pathologists' laboratory standards for next-generation sequencing clinical tests.

    Science.gov (United States)

    Aziz, Nazneen; Zhao, Qin; Bry, Lynn; Driscoll, Denise K; Funke, Birgit; Gibson, Jane S; Grody, Wayne W; Hegde, Madhuri R; Hoeltge, Gerald A; Leonard, Debra G B; Merker, Jason D; Nagarajan, Rakesh; Palicki, Linda A; Robetorye, Ryan S; Schrijver, Iris; Weck, Karen E; Voelkerding, Karl V

    2015-04-01

    The higher throughput and lower per-base cost of next-generation sequencing (NGS) as compared to Sanger sequencing has led to its rapid adoption in clinical testing. The number of laboratories offering NGS-based tests has also grown considerably in the past few years, despite the fact that specific Clinical Laboratory Improvement Amendments of 1988/College of American Pathologists (CAP) laboratory standards had not yet been developed to regulate this technology. To develop a checklist for clinical testing using NGS technology that sets standards for the analytic wet bench process and for bioinformatics or "dry bench" analyses. As NGS-based clinical tests are new to diagnostic testing and are of much greater complexity than traditional Sanger sequencing-based tests, there is an urgent need to develop new regulatory standards for laboratories offering these tests. To develop the necessary regulatory framework for NGS and to facilitate appropriate adoption of this technology for clinical testing, CAP formed a committee in 2011, the NGS Work Group, to deliberate upon the contents to be included in the checklist. Results . -A total of 18 laboratory accreditation checklist requirements for the analytic wet bench process and bioinformatics analysis processes have been included within CAP's molecular pathology checklist (MOL). This report describes the important issues considered by the CAP committee during the development of the new checklist requirements, which address documentation, validation, quality assurance, confirmatory testing, exception logs, monitoring of upgrades, variant interpretation and reporting, incidental findings, data storage, version traceability, and data transfer confidentiality.

  9. Repeat HIV Testing and Incident Rates among Individuals Attending Voluntary Counseling and Testing Clinics in Wuxi, China: A Retrospective Study.

    Science.gov (United States)

    Meng, Xiao Jun; Grulich, Andrew; Wang, Xu Wen; Yin, Han Lu; Gu, Jing; Zhang, Xuan; Gu, Jing; Zou, Hua Chun

    2018-01-01

    We aimed to elucidate the rates of repeat HIV testing and incident HIV diagnosis, and baseline CD4+ T cell count among individuals attending HIV voluntary counseling and testing (VCT) clinics in Wuxi, China. A repeat HIV testing within 12 months was recorded if individuals had their first test with negative results, during 2013-2014 and retested within 12 months. An incident HIV diagnosis was recorded if individuals had their first test with negative results, during 2013-2015 and had a subsequent positive result at any point by the end of 2015. Data on HIV testing and diagnosis among individuals attending 32 VCT clinics from 2013 to 2015 and HIV diagnosis from other clinical services in Wuxi, China, were retrieved. A multivariate logistic regression model was used to analyze factors associated with repeat HIV testing. Cox regression was used to evaluate factors associated with incident HIV diagnosis. From 2013 to 2014, 11,504 individuals tested HIV negative at their first recorded test, with 655 (5.7%) retesting within 12 months. Higher repeat HIV testing within 12 months was associated with male gender [adjusted odds ratio (aOR) = 1.7, 95% confidence interval (CI): 1.4-2.2], risk behaviors [commercial heterosexual behaviors (aOR = 1.4, CI: 1.1-1.6), male-male sexual behaviors (aOR = 3.7, CI: 2.7-4.9)], injection drug use (aOR = 9.9, CI: 6.5-15.1), and having taken HIV tests previously (aOR = 2.0, CI: 1.6-2.4). From 2013 to 2015, 1,088 individuals tested negative on HIV test at their visit and at ⋝ 2 subsequent tests; of them 30 had incident HIV diagnosis. The overall rate of incident HIV diagnosis among all VCT individuals was 1.6 (95% CI: 1.1-2.1) per 100 person-years. Incident HIV diagnosis was associated with male gender [adjusted hazard ratio (aHR) = 8.5, 95% CI: 1.9-38.1], attending hospital-based VCT clinics (aHR = 7.8, 95% CI: 1.1-58.3), and male-male sexual behavior (aHR = 8.4, 95% CI: 1.5-46.7). Individuals diagnosed at VCT clinics had higher CD4+ T

  10. Skin signs in Ehlers-Danlos syndrome: clinical tests and para-clinical methods

    DEFF Research Database (Denmark)

    Remvig, L; Duhn, Ph; Ullman, S

    2010-01-01

    The criteria for Ehlers-Danlos syndrome (EDS) and the hypermobility syndrome (HMS) should be reliable. Examination for general joint hypermobility has high reliability but there is only sparse information on the reliability of skin tests, and no information on the level of normal skin extensibility...

  11. [How do hospital clinical laboratories and laboratory testing companies cooperate and build reciprocal relations?].

    Science.gov (United States)

    Kawano, Seiji

    2014-12-01

    As the 2nd Joint Symposium of the Japanese Society of Laboratory Medicine and the Japanese Association of Laboratory Pathologists, the symposium on clinical test out-sourcing and branch laboratories was held at the 60th General Meeting of the Japanese Society of Laboratory Medicine on November 2nd, 2013 in Kobe. For the symposium, we conducted a questionnaire survey on the usage of clinical test out-sourcing and the introduction of branch laboratories to clinical laboratories of Japanese university hospitals, both private and public, between July 25th and August 20th, 2013. Seventy-two hospitals responded to the questionnaire survey, consisting of 41 public medical school hospitals and 31 private ones. According to the survey, the selection of each clinical test for out-sourcing was mainly determined by the capacities of hospital clinical laboratories and their equipment, as well as the profitability of each test. The main concerns of clinical laboratory members of university hospitals involved the continuity of measurement principles, traceability, and standardization of reference values for each test. They strongly requested the interchangeability and computerization of test data between laboratory testing companies. A branch laboratory was introduced to six hospitals, all of which were private medical college hospitals, out of 72 university hospitals, and eight of the other hospitals were open to its introduction. The merits and demerits of introducing a branch laboratory were also discussed. (Review).

  12. Correlation Between Screening Mammography Interpretive Performance on a Test Set and Performance in Clinical Practice.

    Science.gov (United States)

    Miglioretti, Diana L; Ichikawa, Laura; Smith, Robert A; Buist, Diana S M; Carney, Patricia A; Geller, Berta; Monsees, Barbara; Onega, Tracy; Rosenberg, Robert; Sickles, Edward A; Yankaskas, Bonnie C; Kerlikowske, Karla

    2017-10-01

    Evidence is inconsistent about whether radiologists' interpretive performance on a screening mammography test set reflects their performance in clinical practice. This study aimed to estimate the correlation between test set and clinical performance and determine if the correlation is influenced by cancer prevalence or lesion difficulty in the test set. This institutional review board-approved study randomized 83 radiologists from six Breast Cancer Surveillance Consortium registries to assess one of four test sets of 109 screening mammograms each; 48 radiologists completed a fifth test set of 110 mammograms 2 years later. Test sets differed in number of cancer cases and difficulty of lesion detection. Test set sensitivity and specificity were estimated using woman-level and breast-level recall with cancer status and expert opinion as gold standards. Clinical performance was estimated using women-level recall with cancer status as the gold standard. Spearman rank correlations between test set and clinical performance with 95% confidence intervals (CI) were estimated. For test sets with fewer cancers (N = 15) that were more difficult to detect, correlations were weak to moderate for sensitivity (woman level = 0.46, 95% CI = 0.16, 0.69; breast level = 0.35, 95% CI = 0.03, 0.61) and weak for specificity (0.24, 95% CI = 0.01, 0.45) relative to expert recall. Correlations for test sets with more cancers (N = 30) were close to 0 and not statistically significant. Correlations between screening performance on a test set and performance in clinical practice are not strong. Test set performance more accurately reflects performance in clinical practice if cancer prevalence is low and lesions are challenging to detect. Copyright © 2017 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

  13. Improving clinical cognitive testing: report of the AAN Behavioral Neurology Section Workgroup.

    Science.gov (United States)

    Daffner, Kirk R; Gale, Seth A; Barrett, A M; Boeve, Bradley F; Chatterjee, Anjan; Coslett, H Branch; D'Esposito, Mark; Finney, Glen R; Gitelman, Darren R; Hart, John J; Lerner, Alan J; Meador, Kimford J; Pietras, Alison C; Voeller, Kytja S; Kaufer, Daniel I

    2015-09-08

    To evaluate the evidence basis of single-domain cognitive tests frequently used by behavioral neurologists in an effort to improve the quality of clinical cognitive assessment. Behavioral Neurology Section members of the American Academy of Neurology were surveyed about how they conduct clinical cognitive testing, with a particular focus on the Neurobehavioral Status Exam (NBSE). In contrast to general screening cognitive tests, an NBSE consists of tests of individual cognitive domains (e.g., memory or language) that provide a more comprehensive diagnostic assessment. Workgroups for each of 5 cognitive domains (attention, executive function, memory, language, and spatial cognition) conducted evidence-based reviews of frequently used tests. Reviews focused on suitability for office-based clinical practice, including test administration time, accessibility of normative data, disease populations studied, and availability in the public domain. Demographic and clinical practice data were obtained from 200 respondents who reported using a wide range of cognitive tests. Based on survey data and ancillary information, between 5 and 15 tests in each cognitive domain were reviewed. Within each domain, several tests are highlighted as being well-suited for an NBSE. We identified frequently used single-domain cognitive tests that are suitable for an NBSE to help make informed choices about clinical cognitive assessment. Some frequently used tests have limited normative data or have not been well-studied in common neurologic disorders. Utilizing standardized cognitive tests, particularly those with normative data based on the individual's age and educational level, can enhance the rigor and utility of clinical cognitive assessment. © 2015 American Academy of Neurology.

  14. Lawrence Livermore National Laboratory (LLNL) Experimental Test Site (Site 300) Salinity Evaluation and Minimization Plan for Cooling Towers and Mechanical Equipment Discharges

    Energy Technology Data Exchange (ETDEWEB)

    Daily III, W D

    2010-02-24

    This document was created to comply with the Central Valley Regional Water Quality Control Board (CVRWQCB) Waste Discharge Requirement (Order No. 98-148). This order established new requirements to assess the effect of and effort required to reduce salts in process water discharged to the subsurface. This includes the review of technical, operational, and management options available to reduce total dissolved solids (TDS) concentrations in cooling tower and mechanical equipment water discharges at Lawrence Livermore National Laboratory's (LLNL's) Experimental Test Site (Site 300) facility. It was observed that for the six cooling towers currently in operation, the total volume of groundwater used as make up water is about 27 gallons per minute and the discharge to the subsurface via percolation pits is 13 gallons per minute. The extracted groundwater has a TDS concentration of 700 mg/L. The cooling tower discharge concentrations range from 700 to 1,400 mg/L. There is also a small volume of mechanical equipment effluent being discharged to percolation pits, with a TDS range from 400 to 3,300 mg/L. The cooling towers and mechanical equipment are maintained and operated in a satisfactory manner. No major leaks were identified. Currently, there are no re-use options being employed. Several approaches known to reduce the blow down flow rate and/or TDS concentration being discharged to the percolation pits and septic systems were reviewed for technical feasibility and cost efficiency. These options range from efforts as simple as eliminating leaks to implementing advanced and innovative treatment methods. The various options considered, and their anticipated effect on water consumption, discharge volumes, and reduced concentrations are listed and compared in this report. Based on the assessment, it was recommended that there is enough variability in equipment usage, chemistry, flow rate, and discharge configurations that each discharge location at Site 300

  15. Clinical utility and validity of minoxidil response testing in androgenetic alopecia.

    Science.gov (United States)

    Goren, Andy; Shapiro, Jerry; Roberts, Janet; McCoy, John; Desai, Nisha; Zarrab, Zoulikha; Pietrzak, Aldona; Lotti, Torello

    2015-01-01

    Clinical response to 5% topical minoxidil for the treatment of androgenetic alopecia (AGA) is typically observed after 3-6 months. Approximately 40% of patients will regrow hair. Given the prolonged treatment time required to elicit a response, a diagnostic test for ruling out nonresponders would have significant clinical utility. Two studies have previously reported that sulfotransferase enzyme activity in plucked hair follicles predicts a patient's response to topical minoxidil therapy. The aim of this study was to assess the clinical utility and validity of minoxidil response testing. In this communication, the present authors conducted an analysis of completed and ongoing studies of minoxidil response testing. The analysis confirmed the clinical utility of a sulfotransferase enzyme test in successfully ruling out 95.9% of nonresponders to topical minoxidil for the treatment of AGA. © 2014 Wiley Periodicals, Inc.

  16. Radioselenium pancreozymin-secretin test as a clinical test for pancreatic exocrine function

    International Nuclear Information System (INIS)

    Shichiri, M.; Etani, N.; Yoshida, M.; Harano, Y.; Hoshi, M.; Shigeta, Y.; Abe, H.

    1975-01-01

    The appearance of radioselenium in the protein fraction of duodenal aspirates has been studied after an intravenous injection of 75 Se-selenomethionine. The continuous flow of pancreatic juice was stimulated by pancreozymin at 120 minutes and by secretin at 140 minutes. A good distinction between normal subjects and patients with pancreatic disease was obtained by measuring 75 Se-radioactivity in the protein fraction of duodenal aspirates; either cumulative radioactivity during the combined 80-minute post-pancreozymin-secretin period, or maximum 75 Se-specific activity during the postsecretin period was used as an index. The test presented here might be a useful and sufficiently reliable method for detecting abnormal pancreatic exocrine function. This test can be performed along with the conventional pancreozymin-secretin test, serum enzyme response to pancreozymin and secretin, and pancreatic scintiscanning

  17. Percent weight reduction required to achieve minimal clinically important improvements in health-related quality of life among African Americans: A secondary analysis of the fit body and soul study.

    Science.gov (United States)

    Garvin, Jane T; Williams, Lovoria B; Joshua, Thomas V; Looney, Stephen W; Marion, Lucy N

    2017-08-01

    To calculate the percent weight reduction required to achieve minimal clinically important improvement (MCII) in health-related quality of life (HRQOL). Secondary data analysis from the longitudinal cohort of a single-blinded, cluster-randomized community trial to test the efficacy of the faith-based adaptation of the Diabetes Prevention Program. African-American churches. This study included 472 congregants with a body mass index of ≥25 and fasting plasma glucose<126mg/dl. Percent weight reduction required to achieve the MCII in HRQOL measured by two instruments, SF-12 and EQ-5D, one year following baseline. The percent weight reduction required to achieve established MCII in SF-12 Physical Component Summary (PCS), SF-12 Mental Component Summary (MCS), and EQ-5D Health Status (HS) at one-year follow-up were calculated using fitted linear regression models. In addition to models for the total sample, we generated models, stratified by baseline BMI, PCS, and HS, to calculate the percent weight reduction required to achieve MCII in HRQOL for those most in need of weight reduction and those in need of improved HRQOL. The percent weight reduction was a significant predictor of improvement in the SF-12PCS and the EQ-5DHS but not SF-12MCS. To achieve a MCII in SF-12PCS and EQ-5DHS, 18% and 30% weight reductions were required, respectively. A smaller percent weight reduction was required when the baseline BMI was ≥40. Improvements in HRQOL among African-American congregants seeking weight reduction required more than the 3-5% weight reduction associated with improvements in physical health. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. The Society for Translational Medicine: clinical practice guidelines for sperm DNA fragmentation testing in male infertility

    Science.gov (United States)

    Cho, Chak-Lam; Majzoub, Ahmad; Esteves, Sandro C.

    2017-01-01

    Sperm DNA fragmentation (SDF) testing has been emerging as a valuable tool for male fertility evaluation. While the essential role of sperm DNA integrity in human reproduction was extensively studied, the clinical indication of SDF testing is less clear. This clinical practice guideline provides recommendations of clinical utility of the test supported by evidence. It is intended to serve as a reference for fertility specialists in identifying the circumstances in which SDF testing should be of greatest clinical value. SDF testing is recommended in patients with clinical varicocele and borderline to normal semen parameters as it can better select varicocelectomy candidates. Outcomes of natural pregnancy and assisted reproductive techniques (ART) can be predicted by result of SDF tests. High SDF is also linked with recurrent pregnancy loss (RPL) and failure of ART. Result of SDF testing may change the management decision by selecting the most appropriate ART with the highest success rate for infertile couples. Several studies have demonstrated the benefit in using testicular instead of ejaculated sperm in men with high SDF, oligozoospermia or recurrent in vitro fertilization (IVF) failure. Infertile men with modifiable lifestyle factor may benefit from SDF testing by reinforcing risk factor modification and monitoring patient’s progress to intervention. PMID:29082206

  19. [Clinical aspects of children presenting specific IgM antibodies to cytomegalovirus by immunofluorescent test].

    Science.gov (United States)

    Yamamoto, A Y; Gonçalves, A L; Figueiredo, L T; Carlucci, R H

    1994-01-01

    Clinical data observed in 25 children presenting IgM specific antibodies to cytomegalovirus (CMV) by immunofluorescent test are reported. The children were grouped by the presented clinical picture in: neonatal hepatitis, mononucleosis syndrome,pneumonitis, neurologic disease, ocular abnormalities, and thrombocytopenic purpure. Clinical aspects of CMV infection were analyzed and compared with data reported in the literature. CMV infections can involve multiple organs and this viral disease must to be considered on differential diagnosis of many infectious diseases.

  20. Highlights from the 2016 HIV diagnostics conference: The new landscape of HIV testing in laboratories, public health programs and clinical practice.

    Science.gov (United States)

    Wesolowski, Laura G; Parker, Monica M; Delaney, Kevin P; Owen, S Michele

    2017-06-01

    The 2016 HIV Diagnostics Conference, held in Atlanta, Georgia, was attended by public health officials, laboratorians, HIV testing program managers, surveillance coordinators and industry representatives. The conference addressed test performance data, the implementation of new testing algorithms, quality assurance, and the application of new tests in a variety of settings. With regard to the recommended Centers for Disease Control and Prevention/Association of Public Health Laboratories HIV laboratory testing algorithm, the conference featured performance data, implementation challenges such as a lack of test options for the second and third steps, as well as data needs for new tests that may be used as part of the algorithm. There are delays when nucleic acid testing is needed with the algorithm. Novel tests such as point of care nucleic acid tests are needed on the U.S. market to readily identify acute infection. Multiplex tests are being developed which allow for the simultaneous detection of multiple pathogens. CDC staff highlighted new guidance for testing in non-clinical settings. Innovative approaches to linking testing and care in some settings have led to identification of early infections, improved receipt of test results and expedited initiation of therapy. Work continues to optimize testing so that infections are accurately identified as early as possible and time to treatment is minimized to improve health outcomes and prevent transmission. Published by Elsevier B.V.

  1. 42 CFR 493.1415 - Condition: Laboratories performing moderate complexity testing; clinical consultant.

    Science.gov (United States)

    2010-10-01

    ... § 493.1415 Condition: Laboratories performing moderate complexity testing; clinical consultant. The laboratory must have a clinical consultant who meets the qualification requirements of § 493.1417 of this... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing moderate...

  2. Clinical Practice: Direct-to-consumer genetic testing: To test or not to ...

    African Journals Online (AJOL)

    In direct-to-consumer (DTC) genetic testing, laboratory-based genetic services are offered directly to the public without an independent healthcare professional being involved. The committee of the Southern African Society for Human Genetics (SASHG) appeals to the public and clinicians to be cautious when considering ...

  3. Inter-tester reliability of selected clinical tests for long-lasting temporomandibular disorders.

    Science.gov (United States)

    Julsvoll, Elisabeth Heggem; Vøllestad, Nina Køpke; Opseth, Gro; Robinson, Hilde Stendal

    2017-09-01

    Clinical tests used to examine patients with temporomandibular disorders vary in methodological quality, and some are not tested for reliability. The purpose of this cross-sectional study was to evaluate inter-tester reliability of clinical tests and a cluster of tests used to examine patients with long-lasting temporomandibular disorders. Forty patients with pain in the temporomandibular area treated by health-professionals were included. They were between 18-70 years, had 65 symptomatic (33 right/32 left) and 15 asymptomatic joints. Two manual therapists examined all participants with selected tests. Percentage agreement and the kappa coefficient ( k ) with 95% confidence interval (CI) were used to evaluate the tests with categorical outcomes. For tests with continuous outcomes, the relative inter-tester reliability was assessed by the intraclass-correlation-coefficient (ICC 3,1 , 95% CI) and the absolute reliability was calculated by the smallest detectable change (SDC). The best reliability among single tests was found for the dental stick test, the joint-sound test ( k  = 0.80-1.0) and range of mouth-opening (ICC 3,1 (95% CI) = 0.97 (0.95-0.98) and SDC = 4 mm). The reliability of cluster of tests was excellent with both four and five positive tests out of seven. The reliability was good to excellent for the clinical tests and the cluster of tests when performed by experienced therapists. The tests are feasible for use in the clinical setting. They require no advanced equipment and are easy to perform.

  4. Lack of Correlation between Severity of Clinical Symptoms, Skin Test Reactivity, and Radioallergosorbent Test Results in Venom-Allergic Patients

    Directory of Open Access Journals (Sweden)

    Warrington RJ

    2006-06-01

    Full Text Available Abstract Purpose To retrospectively examine the relation between skin test reactivity, venom-specific immunoglobulin E (IgE antibody levels, and severity of clinical reaction in patients with insect venom allergy. Method Thirty-six patients (including 15 females who presented with a history of allergic reactions to insect stings were assessed. The mean age at the time of the reactions was 33.4 ± 15.1 years (range, 4-76 years, and patients were evaluated 43.6 ± 90 months (range, 1-300 months after the reactions. Clinical reactions were scored according to severity, from 1 (cutaneous manifestations only to 3 (anaphylaxis with shock. These scores were compared to scores for skin test reactivity (0 to 5, indicating the log increase in sensitivity from 1 μg/mL to 0.0001 μg/mL and radioallergosorbent test (RAST levels (0 to 4, indicating venom-specific IgE levels, from undetectable to >17.5 kilounits of antigen per litre [kUA/L]. Results No correlation was found between skin test reactivity (Spearman's coefficient = 0.15, p = .377 or RAST level (Spearman's coefficient = 0.32, p = .061 and the severity of reaction. Skin test and RAST scores both differed significantly from clinical severity (p p = .042. There was no correlation between skin test reactivity and time since reaction (Spearman's coefficient = 0.18, p = .294 nor between RAST and time since reaction (r = 0.1353, p = .438. Elimination of patients tested more than 12 months after their reaction still produced no correlation between skin test reactivity (p = .681 or RAST score (p = .183 and the severity of the clinical reaction. Conclusion In venom-allergic patients (in contrast to reported findings in cases of inhalant IgE-mediated allergy, there appears to be no significant correlation between the degree of skin test reactivity or levels of venom-specific IgE (determined by RAST and the severity of the clinical reaction.

  5. 75 FR 30041 - Medicare Program; Public Meeting in Calendar Year 2010 for New Clinical Laboratory Tests Payment...

    Science.gov (United States)

    2010-05-28

    ... clinical diagnostic laboratory tests under Part B of title XVIII of the Social Security Act (the Act) that... tests are any clinical diagnostic laboratory tests with respect to which a new or substantially revised... Year 2010 for New Clinical Laboratory Tests Payment Determinations AGENCY: Centers for Medicare...

  6. Provider-initiated HIV testing in rural Haiti: low rate of missed opportunities for diagnosis of HIV in a primary care clinic

    Directory of Open Access Journals (Sweden)

    Freedberg Kenneth A

    2007-11-01

    Full Text Available Abstract As HIV treatment is scaled-up in resource-poor settings, the timely identification of persons with HIV infection remains an important challenge. Most people with HIV are unaware of their status, and those who are often present late in the course of their illness. Free-standing voluntary counseling and testing sites often have poor uptake of testing. We aimed to evaluate a 'provider-initiated' HIV testing strategy in a primary care clinic in rural resource-poor Haiti by reviewing the number of visits made to clinic before an HIV test was performed in those who were ultimately found to have HIV infection. In collaboration with the Haitian Ministry of Health, a non-governmental organization (Partners In Health scaled up HIV care in central Haiti by reinforcing primary care clinics, instituting provider-initiated HIV testing and by providing HIV treatment in the context of primary medical care, free of charge to patients. Among a cohort of people with HIV infection, we assessed retrospectively for delays in or 'missed opportunities' for diagnosis of HIV by the providers in one clinic. Of the first 117 patients diagnosed with HIV in one clinic, 100 (85% were diagnosed at the first medical encounter. Median delay in diagnosis for the remaining 17 was only 62 days (IQR 19 – 122; range 1 – 272. There was no statistical difference in CD4 cell count between those with and without a delay. 3787 HIV tests were performed in the period reviewed. Provider-initiated testing was associated with high volume uptake of HIV testing and minimal delay between first medical encounter and diagnosis of HIV infection. In scale up of HIV care, provider-initiated HIV testing at primary care clinics can be a successful strategy to identify patients with HIV infection.

  7. Minimal change disease

    Science.gov (United States)

    Minimal change nephrotic syndrome; Nil disease; Lipoid nephrosis; Idiopathic nephrotic syndrome of childhood ... which filter blood and produce urine. In minimal change disease, there is damage to the glomeruli. These ...

  8. Carbon Dioxide Flush of an Integrated Minimized Perfusion Circuit Prior to Priming Prevents Spontaneous Air Release Into the Arterial Line During Clinical Use.

    Science.gov (United States)

    Stehouwer, Marco C; de Vroege, Roel; Hoohenkerk, Gerard J F; Hofman, Frederik N; Kelder, Johannes C; Buchner, Bas; de Mol, Bastian A; Bruins, Peter

    2017-11-01

    Recently, an oxygenator with an integrated centrifugal blood pump (IP) was designed to minimize priming volume and to reduce blood foreign surface contact even further. The use of this oxygenator with or without integrated arterial filter was compared with a conventional oxygenator and nonintegrated centrifugal pump. To compare the air removal characteristics 60 patients undergoing coronary artery bypass grafting were alternately assigned into one of three groups to be perfused with a minimized extracorporeal circuit either with the conventional oxygenator, the oxygenator with IP, or the oxygenator with IP plus integrated arterial filter (IAF). Air entering and leaving the three devices was measured accurately with a bubble counter during cardiopulmonary bypass. No significant differences between all groups were detected, considering air entering the devices. Our major finding was that in both integrated devices groups incidental spontaneous release of air into the arterial line in approximately 40% of the patients was observed. Here, detectable bolus air (>500 µm) was shown in the arterial line, whereas in the minimal extracorporeal circulation circuit (MECC) group this phenomenon was not present. We decided to conduct an amendment of the initial design with METC-approval. Ten patients were assigned to be perfused with an oxygenator with IP and IAF. Importantly, the integrated perfusion systems used in these patients were flushed with carbon dioxide (CO 2 ) prior to priming of the systems. In the group with CO 2 flush no spontaneous air release was observed in all cases and this was significantly different from the initial study with the group with the integrated device and IAF. This suggests that air spilling may be caused by residual air in the integrated device. In conclusion, integration of a blood pump may cause spontaneous release of large air bubbles (>500 µm) into the arterial line, despite the presence of an integrated arterial filter. CO 2 flushing of

  9. Integrating usability testing and think-aloud protocol analysis with "near-live" clinical simulations in evaluating clinical decision support.

    Science.gov (United States)

    Li, Alice C; Kannry, Joseph L; Kushniruk, Andre; Chrimes, Dillon; McGinn, Thomas G; Edonyabo, Daniel; Mann, Devin M

    2012-11-01

    Usability evaluations can improve the usability and workflow integration of clinical decision support (CDS). Traditional usability testing using scripted scenarios with think-aloud protocol analysis provide a useful but incomplete assessment of how new CDS tools interact with users and clinical workflow. "Near-live" clinical simulations are a newer usability evaluation tool that more closely mimics clinical workflow and that allows for a complementary evaluation of CDS usability as well as impact on workflow. This study employed two phases of testing a new CDS tool that embedded clinical prediction rules (an evidence-based medicine tool) into primary care workflow within a commercial electronic health record. Phase I applied usability testing involving "think-aloud" protocol analysis of 8 primary care providers encountering several scripted clinical scenarios. Phase II used "near-live" clinical simulations of 8 providers interacting with video clips of standardized trained patient actors enacting the clinical scenario. In both phases, all sessions were audiotaped and had screen-capture software activated for onscreen recordings. Transcripts were coded using qualitative analysis methods. In Phase I, the impact of the CDS on navigation and workflow were associated with the largest volume of negative comments (accounting for over 90% of user raised issues) while the overall usability and the content of the CDS were associated with the most positive comments. However, usability had a positive-to-negative comment ratio of only 0.93 reflecting mixed perceptions about the usability of the CDS. In Phase II, the duration of encounters with simulated patients was approximately 12 min with 71% of the clinical prediction rules being activated after half of the visit had already elapsed. Upon activation, providers accepted the CDS tool pathway 82% of times offered and completed all of its elements in 53% of all simulation cases. Only 12.2% of encounter time was spent using the

  10. A clinical audit of thrombophilia testing in pediatric patients with acute thromboembolic events: impact on management.

    Science.gov (United States)

    Gavva, Chakri; Sarode, Ravindra; Zia, Ayesha

    2017-11-28

    Routine testing for inherited and acquired thrombophilia defects is frequently performed in pediatric patients with thromboembolic events (TEEs). No consensus guidelines exist regarding the timing of testing or the type of patients to be tested. The primary objective of our study, therefore, was to determine whether thrombophilia testing during the acute TEE setting affected clinical management in pediatric patients. A secondary aim included estimation of potential harm from thrombophilia testing. We retrospectively reviewed data on all pediatric patients diagnosed with a TEE during a 1-year period. Fifty-two (51%) of 102 patients with a TEE underwent thrombophilia testing during the acute phase, with 26 patients (50%) having a positive test result during the acute phase. Only 12% of patients tested were confirmed to have a thrombophilia eventually, yielding a false-positive rate of ∼7% for testing when performed in the acute setting. There were no changes to the acute management, regardless of a positive or negative result. Testing resulted in unnecessary blood loss in 12 patients younger than 1 year and acute testing cost approximately $82 000. Our data show that thrombophilia testing during acute TEEs in pediatric patients did not impact clinical management. There is also a potential for false-positive tests leading to unnecessary long-term anticoagulation. These findings suggest against thrombophilia testing during acute TEE setting in children.

  11. Minimally invasive transmuscular approach for the treatment of lumbar herniated disc: far lateral lumbar disc herniation: a clinical study. Applications for cervical and thoracic disc herniation.

    Science.gov (United States)

    Peltier, E; Blondel, B; Dufour, H; Fuentes, S

    2013-06-01

    In this study, we are using a recently developed method: a minimally invasive retractor system and an operating microscope to treat far lateral lumbar herniated disc. This method decreases tissue dissection and blood loss, and improves postoperative recovery. This is a retrospective study of 46 patients, there was 25 female and 21 male. They all underwent minimal invasive surgery. The average age was 56 years old (19-83 years). Lumbar disc herniation is a common pathology. Far lateral disc herniation accounts for 2.6% to 11.2% of all lumbar disc herniation. A few surgical techniques have been describes to treat this type of disc pathology. All patients were operated under general anesthesia. The fluoroscopic guidance was absolutely necessary. A 12-15 mm skin incision was made on the side of the disc herniation (30 mm from the midline). Then, we inserted a tubular retractor system (muscle splitting approach) followed by a 14 mm diameter-working channel. Under operating microscope the pars interarticularis was dreamed to expose the nerve root and the disc. After removing the intertransverse ligament, we removed the herniated disc. The average time of surgery was 55 min. The operating time decreased with the experience of the surgical team. Postoperatively the radicular pain was around 2 (using an analogical visual scale), over 7 preoperatively. The length of hospitalization was 3 days. There were no complications in our study. The average follow-up was 2 years (6-36 months). There was no complication, no postoperative infection. This technique combines the advantages of endoscopic surgery and microscope guided surgery (3D vision) and provides good functional results in this study.

  12. A clinical decision support system for diagnosis of Allergic Rhinitis based on intradermal skin tests.

    Science.gov (United States)

    Jabez Christopher, J; Khanna Nehemiah, H; Kannan, A

    2015-10-01

    Allergic Rhinitis is a universal common disease, especially in populated cities and urban areas. Diagnosis and treatment of Allergic Rhinitis will improve the quality of life of allergic patients. Though skin tests remain the gold standard test for diagnosis of allergic disorders, clinical experts are required for accurate interpretation of test outcomes. This work presents a clinical decision support system (CDSS) to assist junior clinicians in the diagnosis of Allergic Rhinitis. Intradermal Skin tests were performed on patients who had plausible allergic symptoms. Based on patient׳s history, 40 clinically relevant allergens were tested. 872 patients who had allergic symptoms were considered for this study. The rule based classification approach and the clinical test results were used to develop and validate the CDSS. Clinical relevance of the CDSS was compared with the Score for Allergic Rhinitis (SFAR). Tests were conducted for junior clinicians to assess their diagnostic capability in the absence of an expert. The class based Association rule generation approach provides a concise set of rules that is further validated by clinical experts. The interpretations of the experts are considered as the gold standard. The CDSS diagnoses the presence or absence of rhinitis with an accuracy of 88.31%. The allergy specialist and the junior clinicians prefer the rule based approach for its comprehendible knowledge model. The Clinical Decision Support Systems with rule based classification approach assists junior doctors and clinicians in the diagnosis of Allergic Rhinitis to make reliable decisions based on the reports of intradermal skin tests. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. Clinical results of early and late operative correction of undescended testes

    DEFF Research Database (Denmark)

    Thorup, Jørgen Mogens; Kvist, N; Tygstrup, I

    1984-01-01

    Operative treatment of undescended testes was performed in 556 boys (695 testes). The histopathological changes in the testicular tissue were more severe in older patients. However, post-operative clinical results were found to be significantly better in boys treated immediately before puberty than...

  14. GRADE Guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health

    NARCIS (Netherlands)

    Schünemann, Holger J.; Mustafa, Reem; Brozek, Jan; Santesso, Nancy; Alonso-Coello, Pablo; Guyatt, Gordon; Scholten, Rob; Langendam, Miranda; Leeflang, Mariska M.; Akl, Elie A.; Singh, Jasvinder A.; Meerpohl, Joerg; Hultcrantz, Monica; Bossuyt, Patrick; Oxman, Andrew D.; Singh, Jasvinder; Lange, Stefan; Parmelli, Elena; Moberg, Jenny; Rosenbaum, Sarah; Brignardello-Petersen, Romina; Wiercioch, Wojtek; Davoli, Marina; Nowak, Artur; Dietl, Bart

    2016-01-01

    Objectives: To describe the grading of recommendations assessment, development and evaluation (GRADE) interactive evidence to decision (EtD) frameworks for tests and test strategies for clinical, public health, or coverage decisions. Study Design and Setting: As part of the GRADE Working Group's

  15. GRADE Guidelines : 16. GRADE evidence to decision frameworks for tests in clinical practice and public health

    NARCIS (Netherlands)

    Schünemann, Holger J.; Mustafa, Reem A.; Brozek, Jan; Santesso, Nancy; Alonso-Coello, Pablo; Guyatt, Gordon; Scholten, Rob; Langendam, Miranda W; Leeflang, Mariska; Akl, Elie A.; Singh, Jasvinder A.; Meerpohl, Joerg; Hultcrantz, Monica; Bossuyt, Patrick Mm; Oxman, Andrew D.; Schünemann, Holger J.; Mustafa, Reem A.; Brozek, Jan; Santesso, Nancy; Alonso-Coello, Pablo; Scholten, Rob; Langendam, Miranda W; Bossuyt, Patrick Mm; Leeflang, Mariska; Singh, Jasvinder; Meerpohl, Joerg; Hultcrantz, Monica; Guyatt, Gordon; Oxman, Andrew D.; Lange, Stefan; Parmelli, Elena; Moberg, Jenny; Rosenbaum, Sarah; Brignardello-Petersen, Romina; Wiercioch, Wojtek; Davoli, Marina; Nowak, Artur; Dietl, Bart

    2016-01-01

    Objectives To describe the grading of recommendations assessment, development and evaluation (GRADE) interactive evidence to decision (EtD) frameworks for tests and test strategies for clinical, public health, or coverage decisions. Study Design and Setting As part of the GRADE Working Group's

  16. Ethical scrutiny of HIV testing in the ante-natal clinic of a secondary ...

    African Journals Online (AJOL)

    Background: HIV testing has been shown to be a crucial gateway to treatment, prevention, and support services; hence the urgent need to swiftly scale-up testing in a wide range of clinical encounters, as a means of controlling the pandemic. Fears have however been expressed that such swift scale-ups might result in ...

  17. Trial by Dutch Laboratories for Evaluation of Non-Invasive Prenatal Testing. Part I - Clinical Impact

    NARCIS (Netherlands)

    Oepkes, Dick; Page-Christiaens, Lieve C; Bax, Caroline J; Bekker, Mireille N; Bilardo, Catia M; Boon, Elles M J; Schuring-Blom, G Heleen; Coumans, Audrey B C; Faas, Brigitte H; Galjaard, Robert-Jan H; Go, Attie T; Henneman, Lidewij; Macville, Merryn V E; Pajkrt, Eva; Suijkerbuijk, Ron F; Huijsdens-vanAmsterdam, Karin; Van Opstal, Diane; Verweij, E J Joanne; Weiss, Marjan M; Sistermans, Erik A

    2016-01-01

    OBJECTIVE: To evaluate the clinical impact of nationwide implementation of genome-wide Non-Invasive Prenatal Testing (NIPT) in pregnancies at increased risk for fetal trisomies 21, 18 and 13. METHOD: Women with elevated risk based on first trimester combined testing (FCT ≥ 1:200) or medical history,

  18. Accuracy of diagnostic tests for clinically suspected upper extremity deep vein thrombosis: a systematic review

    NARCIS (Netherlands)

    Di Nisio, M.; van Sluis, G. L.; Bossuyt, P. M. M.; Büller, H. R.; Porreca, E.; Rutjes, A. W. S.

    2010-01-01

    Background: The best available test for the diagnosis of upper extremity deep venous thrombosis (UEDVT) is contrast venography. The aim of this systematic review was to assess whether the diagnostic accuracy of other tests for clinically suspected UEDVT is high enough to justify their use in

  19. HIV Rapid Testing in Substance Abuse Treatment: Implementation Following a Clinical Trial

    Science.gov (United States)

    Haynes, L. F.; Korte, J. E.; Holmes, B. E.; Gooden, L.; Matheson, T.; Feaster, D. J.; Leff, J. A.; Wilson, L.; Metsch, L. R.; Schackman, B. R.

    2011-01-01

    The Substance Abuse Mental Health Services Administration has promoted HIV testing and counseling as an evidence-based practice. Nevertheless, adoption of HIV testing in substance abuse treatment programs has been slow. This article describes the experience of a substance abuse treatment agency where, following participation in a clinical trial,…

  20. Concerns about Genetic Testing for Schizophrenia among Young Adults at Clinical High Risk for Psychosis.

    Science.gov (United States)

    Lawrence, Ryan E; Friesen, Phoebe; Brucato, Gary; Girgis, Ragy R; Dixon, Lisa

    Genetic tests for schizophrenia may introduce risks and benefits. Among young adults at clinical high-risk for psychosis, little is known about their concerns and how they assess potential risks. We conducted semi-structured interviews with 15 young adults at clinical high-risk for psychosis to ask about their concerns. Participants expressed concerns about test reliability, data interpretation, stigma, psychological harm, family planning, and privacy. Participants' responses showed some departure from the ethics literature insofar as participants were primarily interested in reporting their results to people to whom they felt emotionally close, and expressed little consideration of biological closeness. Additionally, if tests showed an increased genetic risk for schizophrenia, four clinical high-risk persons felt obligated to tell an employer and another three would "maybe" tell an employer, even in the absence of clinical symptoms. These findings suggest opportunities for clinicians and genetic counselors to intervene with education and support.

  1. Regularity of Minimal Surfaces

    CERN Document Server

    Dierkes, Ulrich; Tromba, Anthony J; Kuster, Albrecht

    2010-01-01

    "Regularity of Minimal Surfaces" begins with a survey of minimal surfaces with free boundaries. Following this, the basic results concerning the boundary behaviour of minimal surfaces and H-surfaces with fixed or free boundaries are studied. In particular, the asymptotic expansions at interior and boundary branch points are derived, leading to general Gauss-Bonnet formulas. Furthermore, gradient estimates and asymptotic expansions for minimal surfaces with only piecewise smooth boundaries are obtained. One of the main features of free boundary value problems for minimal surfaces is t

  2. HIV-1 tropism testing and clinical management of CCR5 antagonists: Quebec review and recommendations

    Science.gov (United States)

    Tremblay, Cécile; Hardy, Isabelle; Lalonde, Richard; Trottier, Benoit; Tsarevsky, Irina; Vézina, Louis-Philippe; Roger, Michel; Wainberg, Mark; Baril, Jean-Guy

    2013-01-01

    HIV-1 tropism assays play a crucial role in determining the response to CCR5 receptor antagonists. Initially, phenotypic tests were used, but limited access to these tests prompted the development of alternative strategies. Recently, genotyping tropism has been validated using a Canadian technology in clinical trials investigating the use of maraviroc in both experienced and treatment-naive patients. The present guidelines review the evidence supporting the use of genotypic assays and provide recommendations regarding tropism testing in daily clinical management. PMID:24489562

  3. Minimal sequential Hausdorff spaces

    Directory of Open Access Journals (Sweden)

    Bhamini M. P. Nayar

    2004-01-01

    Full Text Available A sequential space (X,T is called minimal sequential if no sequential topology on X is strictly weaker than T. This paper begins the study of minimal sequential Hausdorff spaces. Characterizations of minimal sequential Hausdorff spaces are obtained using filter bases, sequences, and functions satisfying certain graph conditions. Relationships between this class of spaces and other classes of spaces, for example, minimal Hausdorff spaces, countably compact spaces, H-closed spaces, SQ-closed spaces, and subspaces of minimal sequential spaces, are investigated. While the property of being sequential is not (in general preserved by products, some information is provided on the question of when the product of minimal sequential spaces is minimal sequential.

  4. Sensor-based supporting mobile system Parkinson disease clinical tests utilising biomedical and RFID technologies

    Directory of Open Access Journals (Sweden)

    Chmielewski Mariusz

    2017-01-01

    Full Text Available This paper discusses method and tool for assisting clinical tests of pharmaceutical drugs utilising sensors and mobile technologies. Emerging sensor and mobile technologies deliver new opportunities to gather and process medical data. Presented analytical approach implements such observations and delivers new, convenient means for remote patient monitoring. Clinical tests are highly specialised process requiring methodology and tools to support such research. Currently available methods rely mostly on analogue approach (booklets, requiring the clinical test participant to fill in health state daily. Such approach often can be biased by unpunctual, not precise reporting. The mobile device can support this process by automatic scheduling and recording an actual time of reports and most of all it can record the inertial and biometric sensor data during the survey process. Presented analytical method (tremors recognition and mobile tool offers consistent approach to clinical test assistance transforming and Android smartphone into remote reporting and notification tool. The tool offers additionally features for sensor based diagnostics support for PD tremor recognition as well as specific clonic and tonic symptoms (dedicated for further system extensions towards epilepsy. Capabilities of the system delivers also RFID mechanisms for efficient on-site clinical test authorisation and configuration. This feature simplifies application installation and automatic set-up considering the participant, clinical test configuration, schedule, smartphone and sensor data. Such a composition delivers convenient and reliable tool which can assist patients and medical staff during the process objectifying the clinical tests results and helping to ensure good quality of the data, quickly available and easily accessible.

  5. [Routines of organization of clinical tests and interviews in the ELSA-Brasil investigation center].

    Science.gov (United States)

    Bensenor, Isabela M; Griep, Rosane H; Pinto, Karina Araújo; Faria, Carolina Perim de; Felisbino-Mendes, Mariana; Caetano, Edna I; Albuquerque, Liliane da Silva; Schmidt, Maria Inês

    2013-06-01

    The ELSA-Brasil (Estudo Longitudinal de Saúde do Adulto - Brazilian Longitudinal Study for Adult Health) is a prospective cohort study with extensive assessments throughout time. This article describes the routine of clinical tests and interviews performed with participants and the structuring of the Research Center physical space and teams. The ELSA-Brasil assumes that participants will be present at the Research Center to have the tests and interviews performed, according to standard protocols developed by this study. Considering the multiplicity of activities involved, each with specific needs for standardization, several predetermined orders of clinical tests and interviews were created. This ensured a high standard of quality in data collection without harm to participants' comfort. Each participant was previously assigned to a specific sequence of clinical tests and interviews with a predefined arrival time, mean length of stay of five to six hours and departure time.

  6. Psychometric testing of the abbreviated Clinical Learning Environment Inventory (CLEI-19).

    Science.gov (United States)

    Salamonson, Yenna; Bourgeois, Sharon; Everett, Bronwyn; Weaver, Roslyn; Peters, Kath; Jackson, Debra

    2011-12-01

    This paper is a report of a test of the psychometric properties of a 19-item version of the Clinical Learning Environment Inventory. Although the clinical learning environment provides the 'real-life' context essential for preparing nursing students for their professional role, the quality of student learning is influenced by the quality of the clinical placement. Nursing students completed an abbreviated (19-item) form of the Clinical Learning Environment Inventory to rate their perception of the clinical learning environment. Descriptive statistics, principal component analysis, discriminant validity and Cronbach's alpha reliabilities were computed. Between March and December 2009, 231 online surveys were submitted. The mean age of participants was 30.3 years (sd: 10.4) and 87% were female. All 19 items loaded on two factors, 'Clinical Facilitator Support of Learning' and 'Satisfaction with Clinical Placement', with factor loadings above the 0.4 threshold. Cronbach's alpha coefficient was 0.93 for the total Clinical Learning Environment Inventory-19, with subscales ranging from 0.92 to 0.94. Multiple regression uncovered that participants who engaged in health-related paid work were independently and significantly more positive on the 'Clinical Facilitator Support of Learning' subscale, whereas those who worked >16 hours a week, or allocated the afternoon shift were independently and significantly more negative on the 'Satisfaction with Clinical Placement' subscale. Providing an effective and productive clinical experience is vital in preparing nursing students to become competent clinicians. The Clinical Learning Environment Inventory-19 offers a useful measure to explore nursing students' satisfaction with two aspects of this clinical experience--clinical facilitator support of learning and the clinical learning environment. © 2011 Blackwell Publishing Ltd.

  7. The progestogen challenge test in postmenopausal women: clinical and morphologic aspects

    OpenAIRE

    Bortoletto, Claudia de Carvalho Ramos [UNIFESP; Baracat, Edmund Chada [UNIFESP; Goncalves, Wagner Jose [UNIFESP; Stávale, João Norberto [UNIFESP; Lima, Geraldo Rodrigues de [UNIFESP; Novo, Neil Ferreira [UNIFESP

    1996-01-01

    The clinical aspects and anatomopathological patterns of 150 postmenopausal women were studied using the progestogen challenge test. An endometrial biopsy was obtained and submitted to the progestogen test. A histopathological analysis of the uterine mucosa from women with a positive progestogen test revealed that the endometrium was active in 44 percent of cases and atrophic or inactive in 56 percent. In contrast, among women with a negative response, the endometrium was atrophic in 94 perce...

  8. Clinical experience from Thailand noninvasive prenatal testing as screening tests for trisomies 21, 18 and 13 in 4736 pregnancies

    DEFF Research Database (Denmark)

    Manotaya, S.; Xu, H.; Uerpairojkit, B.

    2016-01-01

    PurposeThe purpose of this article is to report the clinical experience and performance of massively parallel sequencing-based noninvasive prenatal testing (NIPT) as a screening method in detecting trisomy 21, 18, and 13 (T21/T18/T13) in a mixed-risk population in Thailand. MethodsIn a 30-month...... period, 121 medical centers in Thailand offered NIPT as clinical screening tests for fetal T21, T18, and T13 in the mixed-risk population. All NIPT-positive cases were recommended to undergo invasive prenatal diagnosis. ResultsA total of 4736 participants received the NIPT test, including 2840 high......-risk pregnancies, either with advanced maternal age or positive serum biochemical tests, and 1889 low-risk pregnancies without conventional indications; 99.9% (4732/4736) of the participants with a median maternal age of 35years old received reports, and 1.3% (63/4732) were classified as test positive, including...

  9. Similar clinical features among patients with severe adult growth hormone deficiency diagnosed with insulin tolerance test or arginine or glucagon stimulation tests

    DEFF Research Database (Denmark)

    Toogood, Andrew; Brabant, Georg; Maiter, Dominique

    2012-01-01

    To determine whether insulin tolerance tests (ITTs), arginine stimulation tests (ASTs), and glucagon stimulation tests (GST) identify patients who have similar clinical features of growth hormone (GH) deficiency when a diagnostic GH threshold of 3 μg/L is used.......To determine whether insulin tolerance tests (ITTs), arginine stimulation tests (ASTs), and glucagon stimulation tests (GST) identify patients who have similar clinical features of growth hormone (GH) deficiency when a diagnostic GH threshold of 3 μg/L is used....

  10. Assessing clinical reasoning in pediatric emergency medicine: validity evidence for a Script Concordance Test.

    Science.gov (United States)

    Carrière, Benoit; Gagnon, Robert; Charlin, Bernard; Downing, Steven; Bordage, Georges

    2009-05-01

    Clinical reasoning is a crucial skill for all residents to acquire during their training. During most patient encounters in pediatric emergency medicine, physicians and trainees are challenged by diagnostic, investigative, and treatment uncertainties. The Script Concordance Test may provide a means to assess reasoning skills in the context of uncertainty in the practice of pediatric emergency medicine. We gathered validity evidence for the use of a pediatric emergency medicine Script Concordance Test to evaluate residents' reasoning skills. A 1-hour test containing 60 questions nested in 38 cases was administered to 53 residents at the end of their pediatric emergency medicine rotation at 1 academic institution. Twelve experienced pediatricians were part of a reference panel to establish the basis for the scoring process. An optimized version of the test, based on positive item discrimination data, contained 30 cases and 50 questions. Scores ranged from 48% to 82%, with a mean score of 69.9 (SD=11.5). The reliability of the optimized test (Cronbach's alpha) was 0.77. Performance on the test increased as the level of experience of the residents increased. The residents considered the Script Concordance Test true to real-life clinical problems and had enough time to complete the test. This pediatric emergency medicine Script Concordance Test was reliable and useful to assess the progression of clinical reasoning during residency training.

  11. Risk factors for and role of OprD protein in increasing minimal inhibitory concentrations of carbapenems in clinical isolates of Pseudomonas aeruginosa.

    Science.gov (United States)

    Hirabayashi, Aki; Kato, Daizo; Tomita, Yuka; Iguchi, Mitsutaka; Yamada, Keiko; Kouyama, Yuichi; Morioka, Hiroshi; Tetsuka, Nobuyuki; Yagi, Tetsuya

    2017-11-01

    This study examined the risk factors for, and molecular mechanisms underlying, the increase in carbapenem minimum inhibitory concentrations (MICs) in clinical isolates of Pseudomonas aeruginosa. Consecutive clinical isolates of P. aeruginosa were collected. The MicroScan WalkAway system detected more than fourfold increases in the MICs of carbapenems in P. aeruginosa isolates serially recovered from some patients during their clinical course. The clinical risk factors associated with this increase were examined by multiple logistic regression analysis. Western blot analysis and nucleotide sequencing of the oprD gene of 19 clonally related and paired P. aeruginosa isolates from the same patients were undertaken to examine the mechanisms underlying the increase in MICs. The results showed that prior use of carbapenems (OR, 2.799; 95 % CI, 1.088-7.200; P=0.033) and the use of ventilators or tracheostomies (OR, 2.648; 95 % CI, 1.051-6.671; P=0.039) were risk factors for increased carbapenem MICs. Analysis of the underlying mechanisms revealed that loss of functional OprD protein due to mutation of the oprD gene tended to occur in P. aeruginosa isolates with imipenem MICs of more than 8 µg ml -1 ; a reduction in OprD expression was observed in P. aeruginosa isolates with imipenem MICs of 4 or 8 µg ml -1 . This difference in the resistance mechanism was not correlated with the MICs of meropenem. This difference in the resistance mechanism of P. aeruginosa indicates a critical breakpoint at an imipenem MIC of 8 µg ml -1 , in accordance with EUCAST criteria. Reducing carbapenem use will prevent P. aeruginosa clinical isolates from developing resistance to carbapenems.

  12. Clinical evaluation of a 51Cr-labeled red blood cell survival test for in vivo blood compatibility testing

    International Nuclear Information System (INIS)

    Pineda, A.A.; Dharkar, D.D.; Wahner, H.W.

    1984-01-01

    Modified red blood cell survival studies with use of 51Cr were performed in three groups of subjects. Group 1 consisted of normal subjects who were given labeled autologous blood, group 2 were subjects in need of blood transfusions and given labeled ABO and Rh crossmatch-compatible blood, and group 3 were patients in need of blood transfusion but in whom problems arose in finding compatible blood. The results of the studies suggest that for patients with blood compatibility problems, normal red blood cell survival values at 1 hour do not exclude the possibility of severe hemolysis 24 hours later. Thus, if a 1-hour test result is normal, the procedure should be extended routinely to 24 hours. Moreover, the test can be used to evaluate the clinical importance of antibodies. We showed that anti-Yka and anti-Lan were clinically significant, but high-titer, low-avidity antibodies, anti-Kna, anti-I, and anti-HI were clinically insignificant in the cases studied. This finding emphasizes the importance of an in vivo test for the final compatibility evaluation in complicated blood replacement problems

  13. Minimal Invasive Approach for Lips Venous Lake Treatment by 980 nm Diode Laser with Emphasis on the Aesthetic Results. А Clinical Series.

    Science.gov (United States)

    Voynov, Parvan P; Tomov, Georgi T; Mateva, Nonka G

    2016-01-01

    A venous lake (VL) is a vascular lesion with common occurrence in many patients, manifested as a dark blue-to-violet compressible papule, caused by dilation of venules. The main reasons for the treatment of VL are aesthetic. The haemorrhaging episodes or impairment of oral normal functions are also under considerations. Treatment of lip VL includes surgical excision, selective photocoagulation, cryotherapy, sclerotherapy and electrodessication. The high-intensity diode laser is an option. The 980 nm diode laser is selectively absorbed by haemoglobin and selectively destroys blood vessels, minimising injury to the surrounding healthy skin. The purpose of this study was to evaluate the effectiveness of diode laser in the treatment of VL lesions with the accent on the postoperative defects and aesthetic results. 35 patients aged 37 to 71 were included in this study. A 980 nm diode laser was used in noncontact mode, under local anaesthesia in continuous wave (2-3W, for 20-60s). All patients received only one procedure. Healing process was completed within 2 to 4 weeks after treatment with no scarring. None of the typical adverse effects were observed in the process of healing. Selective photocoagulation is an effective method for treatment of VL. Lower morbidity, minimal patient discomfort and satisfactory functional and aesthetic results are favourable for patients. To optimise the results and to reduce the adverse effects, basic knowledge on lasers and laser-tissue interactions is requisite.

  14. GA(2)LEN skin test study II: clinical relevance of inhalant allergen sensitizations in Europe

    DEFF Research Database (Denmark)

    Burbach, G J; Heinzerling, L M; Edenharter, G

    2009-01-01

    BACKGROUND: Skin prick testing is the standard for diagnosing IgE-mediated allergies. A positive skin prick reaction, however, does not always correlate with clinical symptoms. A large database from a Global Asthma and Allergy European Network (GA(2)LEN) study with data on clinical relevance was ...... the clinical relevance of positive skin prick tests and calls for further studies, which may, ultimately, help increase the positive predictive value of allergy testing.......BACKGROUND: Skin prick testing is the standard for diagnosing IgE-mediated allergies. A positive skin prick reaction, however, does not always correlate with clinical symptoms. A large database from a Global Asthma and Allergy European Network (GA(2)LEN) study with data on clinical relevance...... was used to determine the clinical relevance of sensitizations against the 18 most frequent inhalant allergens in Europe. The study population consisted of patients referred to one of the 17 allergy centres in 14 European countries (n = 3034, median age = 33 years). The aim of the study was to assess...

  15. Introduction and Administration of the Clinical Skill Test of the Medical Licensing Examination, Republic of Korea (2009

    Directory of Open Access Journals (Sweden)

    Kun Sang Kim

    2010-12-01

    Full Text Available The first trial of the clinical skill test as part of the Korean Medical Licensing Examination was done from September 23 to December 1, 2009, in the clinical skill test center located in the National Health Personnel Licensing Examination Board (NHPLEB building, Seoul. Korea is the first country to introduce the clinical skill test as part of the medical licensing examination in Asia. It is a report on the introduction and administration of the test. The NHPLEB launched researches on the validity of introducing the clinical skill test and on the best implementation methods in 2000. Since 2006, lists of subjects of test items for the clinical skill test has been developed. The test consisted of two types of evaluation, i.e., a clinical performance examination (CPX with a standardized patient (SP and objective structured clinical examination (OSCE. The proctor (medical faculty member and SP rate the examinees’ proficiency for the OSCE and CPX respectively. Out of 3,456 applicants, 3,289 examinees (95.2% passed the test. Out of 167 examinees who failed the clinical skill test, 142 passed the written test. This means that the clinical skill test showed characteristics independent from the written test. This successful implementation of the clinical skill test is going to improve the medical graduates’ performance of clinical skills.

  16. Exercise testing in asymptomatic or minimally symptomatic aortic regurgitation: relationship of left ventricular ejection fraction to left ventricular filling pressure during exercise

    International Nuclear Information System (INIS)

    Boucher, C.A.; Wilson, R.A.; Kanarek, D.J.; Hutter, A.M. Jr.; Okada, R.D.; Liberthson, R.R.; Strauss, H.W.; Pohost, G.M.

    1983-01-01

    Exercise radionuclide angiography is being used to evaluate left ventricular function in patients with aortic regurgitation. Ejection fraction is the most common variable analyzed. To better understand the rest and exercise ejection fraction in this setting, 20 patients with asymptomatic or minimally symptomatic severe aortic regurgitation were studied. All underwent simultaneous supine exercise radionuclide angiography and pulmonary gas exchange measurement and underwent rest and exercise measurement of pulmonary artery wedge pressure (PAWP) during cardiac catheterization. Eight patients had a peak exercise PAWP less than 15 mm Hg (group 1) and 12 had a peak exercise PAWP greater than or equal to 15 mm Hg (group 2). Group 1 patients were younger and more were in New York Heart Association class I. The two groups had similar cardiothoracic ratios, changes in ejection fractions with exercise, and rest and exercise regurgitant indexes. Using multiple regression analysis, the best correlate of the exercise PAWP was peak oxygen uptake (r . -0.78, p less than 0.01). No other measurement added significantly to the regression. When peak oxygen uptake was excluded, rest and exercise ejection fraction also correlated significantly (r . -0.62 and r . -0.60, respectively, p less than 0.01). Patients with asymptomatic or minimally symptomatic severe aortic regurgitation have a wide spectrum of cardiac performance in terms of the PAWP during exercise. The absolute rest and exercise ejection fraction and the level of exercise achieved are noninvasive variables that correlate with exercise PAWP in aortic regurgitation, but the change in ejection fraction with exercise by itself is not

  17. Predictive value of 14CO2 breath tests for clinical use of 13CO2 breath tests

    International Nuclear Information System (INIS)

    Glaubitt, D.M.H.

    1975-01-01

    The knowledge of the efficiency of 14 CO 2 breath tests makes possible the comparison of the efficiency of analogous tests using the stable isotope 13 C. 14 CO 2 exhalation studies render overall information. After parenteral administration of a 14 C labeled substrate, 14 CO 2 breath tests permit insight into the metabolism of the 14 C substrate and the associated intermediary metabolism. If the 14 C substrate is given orally or by intraduodenal instillation, 14 CO 2 breath tests supply information not only about gastrointenstinal absorption and digestion but also about the intermediary metabolism yielding 14 CO 2 , after the administered substrate or its degradation products have been absorbed in the gastrointestinal tract. The fraction of 14 CO 2 arising from absorption, digestion and intermediary metabolism can be estimated only by additional methods. 14 CO 2 breath tests are unable to delineate single metabolic reactions involved in the formation of carbon dioxide. Under these considerations the clinical application of 14 CO 2 breath tests may provide diagnostically useful results, especially in internal medicine and surgery. The tests are suitable for intraindividual assessment of the course of a disease and of therapeutic effects. They may be important in the research of the metabolism of 14 C labeled substrates

  18. Clinical diagnosis of Graves’ or non-Graves’ hyperthyroidism compared to TSH receptor antibody test

    Directory of Open Access Journals (Sweden)

    Lauren Bell

    2018-04-01

    Full Text Available Background: TSH receptor antibody (TRAb is considered the gold standard diagnostic test for the autoimmunity of Graves’ disease (GD, which is commonly diagnosed clinically. Aim: To evaluate the true positive (sensitivity and true negative (specificity rates of clinical diagnosis of GD or non-GD hyperthyroidism compared to the TRAb test. Setting: University teaching hospital in North West England. Participants: Patients in the Endocrinology service who had a TRAb measurement between December 2009 and October 2015. Methods: Electronic patient records were studied retrospectively for a pre-TRAb clinical diagnosis of GD or non-GD hyperthyroidism. We examined descriptive statistics and binary classification tests; Fisher exact test was used to analyse contingency tables. Results: We identified 316 patients with a mean age of 45 (range, 17–89 years; 247 (78% were women. Compared to the TRAb result, clinical diagnosis had a sensitivity of 88%, specificity 66%, positive predictive value 72%, negative predictive value 84%, false negative rate 12%, false positive rate 34%, positive likelihood ratio 2.6 and negative likelihood ratio 0.2 (P < 0.0001. Conclusions: Clinicians were liable to both over- and under-diagnose GD. The TRAb test can help reduce the number of incorrect or unknown diagnoses in the initial clinical assessment of patients presenting with hyperthyroidism.

  19. Molecular identification and amphotericin B susceptibility testing of clinical isolates of Aspergillus from 11 hospitals in Korea.

    Science.gov (United States)

    Heo, Min Seok; Shin, Jong Hee; Choi, Min Ji; Park, Yeon Joon; Lee, Hye Soo; Koo, Sun Hoe; Lee, Won Gil; Kim, Soo Hyun; Shin, Myung Geun; Suh, Soon Pal; Ryang, Dong Wook

    2015-11-01

    We investigated the species distribution and amphotericin B (AMB) susceptibility of Korean clinical Aspergillus isolates by using two Etests and the CLSI broth microdilution method. A total of 136 Aspergillus isolates obtained from 11 university hospitals were identified by sequencing the internal transcribed spacer (ITS) and β-tubulin genomic regions. Minimal inhibitory concentrations (MICs) of AMB were determined in Etests using Mueller-Hinton agar (Etest-MH) and RPMI agar (Etest-RPG), and categorical agreement with the CLSI method was assessed by using epidemiological cutoff values. ITS sequencing identified the following six Aspergillus species complexes: Aspergillus fumigatus (42.6% of the isolates), A. niger (23.5%), A. flavus (17.6%), A. terreus (11.0%), A. versicolor (4.4%), and A. ustus (0.7%). Cryptic species identifiable by β-tubulin sequencing accounted for 25.7% (35/136) of the isolates. Of all 136 isolates, 36 (26.5%) had AMB MICs of ≥2 μg/mL by the CLSI method. The categorical agreement of Etest-RPG with the CLSI method was 98% for the A. fumigatus, A. niger, and A. versicolor complexes, 87% for the A. terreus complex, and 37.5% for the A. flavus complex. That of Etest-MH was ≤75% for the A. niger, A. flavus, A. terreus, and A. versicolor complexes but was higher for the A. fumigatus complex (98.3%). Aspergillus species other than A. fumigatus constitute about 60% of clinical Aspergillus isolates, and reduced AMB susceptibility is common among clinical isolates of Aspergillus in Korea. Molecular identification and AMB susceptibility testing by Etest-RPG may be useful for characterizing Aspergillus isolates of clinical relevance.

  20. Rapid voluntary testing and counseling for HIV. Acceptability and feasibility in Zambian antenatal care clinics.

    Science.gov (United States)

    Bakari, J P; McKenna, S; Myrick, A; Mwinga, K; Bhat, G J; Allen, S

    2000-11-01

    Voluntary testing and counseling (VTC) for HIV/AIDS is now widely accepted as an effective HIV prevention and control strategy among heterosexual couples in sub-Saharan Africa. The most appropriate format and venue for VTC remains a topic of debate among clinicians and public health professionals. Our research done in Lusaka, Zambia, took a tripartite approach to exploring the most acceptable format and venue for VTC: a community survey of attitudes towards VTC, a pre- and postcounseling knowledge survey, and a pilot study of same-day VTC in urban antenatal care clinics. A community survey of 181 individuals was conducted in July-August 1996 based on a structured questionnaire. A pre- and post-VTC intervention knowledge survey was conducted during the same period among 82 couples attending the Zambia-UAB HIV Research Project (ZUHRP) HIV VTC center in Lusaka. Finally, same-day HIV VTC was pilot tested in six antenatal clinic locations during February-May 1997 and June-August 1998. The community survey revealed that 98% of participants support promotion of HIV VTC in the community and 83.8% prefer the same-day testing format. The knowledge survey revealed misconceptions about discordance within a couple and perinatal transmission of HIV. Pilot testing in antenatal clinics was well received, with 84% of pregnant women requesting testing and 25% having positive HIV serologies. Women with primary school or less education, those seeking antenatal care in local clinics, and those seen before the third trimester of pregnancy were more likely to request HIV testing. Testing and counseling for HIV were shown to be feasible and effective in the antenatal clinic setting. Implementation of same-day HIV VTC in antenatal clinics is an effective strategy to prevent vertical transmission and should be expanded to include couples to leverage a decrease in heterosexual transmission as well.

  1. 76 FR 10600 - Medicare Program; Public Meeting in Calendar Year 2011 for New Clinical Laboratory Tests Payment...

    Science.gov (United States)

    2011-02-25

    ... payment determinations for new clinical diagnostic laboratory tests under Part B of title XVIII of the... amount of, payment for any clinical diagnostic laboratory tests with respect to which a new or... Year 2011 for New Clinical Laboratory Tests Payment Determinations AGENCY: Centers for Medicare...

  2. 78 FR 31560 - Medicare Program; Public Meeting in Calendar Year 2013 for New Clinical Laboratory Test Payment...

    Science.gov (United States)

    2013-05-24

    ... for coding and payment determinations for new clinical diagnostic laboratory tests under Part B of..., and amount of, payment for any clinical diagnostic laboratory test with respect to which a new or... [CMS-1451-N] Medicare Program; Public Meeting in Calendar Year 2013 for New Clinical Laboratory Test...

  3. 42 CFR 414.506 - Procedures for public consultation for payment for a new clinical diagnostic laboratory test.

    Science.gov (United States)

    2010-10-01

    ... a new clinical diagnostic laboratory test. 414.506 Section 414.506 Public Health CENTERS FOR... FOR PART B MEDICAL AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.506 Procedures for public consultation for payment for a new clinical diagnostic laboratory test...

  4. The script concordance test as a tool to evaluate clinical reasoning in neonatology.

    Science.gov (United States)

    Ben Hamida, Emira; Ayadi, Imen; Marrakchi, Zahra; Quinton, André

    2017-05-01

    Script concordance test aims to evaluate knowledge organization, which represents an essential component of the clinical competence. To build a script concordance test and demonstrate its relevance in the evaluation of Neonatology skills. A script concordance test including 20 vignettes and 20 items, was provided to 52 fourth year medical students and 11 family medicine interns. Script concordance test scores obtained by experts were higher then those obtained by students and family medicine interns. The scores (out of 100) were 82.52 ± 7.35 CI95% [77.26-87.78] for the experts, 58.52 ± 9.72 CI95% [55.82-61.23] for the students, and 63.17±11.36 IC95%  [55.53-70.81] (p<0.0001) for the interns. Our data suggest that script concordance tests could be used to assess the acquisition of clinical reasoning among fourth year medical students in neonatolgy.

  5. Clinical tests to diagnose lumbar spondylolysis and spondylolisthesis: A systematic review.

    Science.gov (United States)

    Alqarni, Abdullah M; Schneiders, Anthony G; Cook, Chad E; Hendrick, Paul A

    2015-08-01

    The aim of this paper was to systematically review the diagnostic ability of clinical tests to detect lumbar spondylolysis and spondylolisthesis. A systematic literature search of six databases, with no language restrictions, from 1950 to 2014 was concluded on February 1, 2014. Clinical tests were required to be compared against imaging reference standards and report, or allow computation, of common diagnostic values. The systematic search yielded a total of 5164 articles with 57 retained for full-text examination, from which 4 met the full inclusion criteria for the review. Study heterogeneity precluded a meta-analysis of included studies. Fifteen different clinical tests were evaluated for their ability to diagnose lumbar spondylolisthesis and one test for its ability to diagnose lumbar spondylolysis. The one-legged hyperextension test demonstrated low to moderate sensitivity (50%-73%) and low specificity (17%-32%) to diagnose lumbar spondylolysis, while the lumbar spinous process palpation test was the optimal diagnostic test for lumbar spondylolisthesis; returning high specificity (87%-100%) and moderate to high sensitivity (60-88) values. Lumbar spondylolysis and spondylolisthesis are identifiable causes of LBP in athletes. There appears to be utility to lumbar spinous process palpation for the diagnosis of lumbar spondylolisthesis, however the one-legged hyperextension test has virtually no value in diagnosing patients with spondylolysis. Copyright © 2015 Elsevier Ltd. All rights reserved.

  6. Perceived and actual arm performance in multiple sclerosis: relationship with clinical tests according to hand dominance.

    Science.gov (United States)

    Lamers, Ilse; Kerkhofs, Lore; Raats, Joke; Kos, Daphne; Van Wijmeersch, Bart; Feys, Peter

    2013-09-01

    The real-life relevance of frequently applied clinical arm tests is not well known in multiple sclerosis (MS). This study aimed to determine the relation between real-life arm performance and clinical tests in MS. Thirty wheelchair-bound MS patients and 30 healthy controls were included. Actual and perceived real-life arm performance was measured by using accelerometry and a self-reported measure (Motor Activity Log). Clinical tests on 'body functions & structures' (JAMAR handgrip strength, Motricity Index (MI), Fugl Meyer (FM)) and 'activity' level (Nine Hole Peg Test (NHPT), Action Research Arm test) of the International Classification of Functioning were conducted. Statistical analyses were performed separately for current dominant and non-dominant arm. For all outcome measures, MS patients scored with both arms significantly lower than the control group. Higher correlations between actual arm performance and clinical tests were found for the non-dominant arm (0.63-0.80). The FM (55%) was a good predictor of actual arm performance, while the MI (46%) and NHPT (55%) were good predictors of perceived arm performance. Real-life arm performance is decreased in wheelchair-bound MS patients and can be best predicted by measures on 'body functions & structures' level and fine motor control. Hand dominance influenced the magnitude of relationships.

  7. Long-term clinical effects of ventricular pacing reduction with a changeover mode to minimize ventricular pacing in a general pacemaker population.

    Science.gov (United States)

    Stockburger, Martin; Boveda, Serge; Moreno, Javier; Da Costa, Antoine; Hatala, Robert; Brachmann, Johannes; Butter, Christian; Garcia Seara, Javier; Rolando, Mara; Defaye, Pascal

    2015-01-14

    Right ventricular pacing (VP) has been hypothesized to increase the risk in heart failure (HF) and atrial fibrillation (AF). The ANSWER study evaluated, whether an AAI-DDD changeover mode to minimize VP (SafeR) improves outcome compared with DDD in a general dual-chamber pacemaker population. ANSWER was a randomized controlled multicentre trial assessing SafeR vs. standard DDD in sinus node disease (SND) or AV block (AVB) patients. After a 1-month run-in period, they were randomized (1 : 1) and followed for 3 years. Pre-specified co-primary end-points were VP and the composite of hospitalization for HF, AF, or cardioversion. Pre-specified secondary end-points were cardiac death or HF hospitalizations and cardiovascular hospitalizations. ANSWER enrolled 650 patients (52.0% SND, 48% AVB) at 43 European centres and randomized in SafeR (n = 314) or DDD (n = 318). The SafeR mode showed a significant decrease in VP compared with DDD (11.5 vs. 93.6%, P hospitalization for HF, AF, or cardioversion, nor in the individual components. SafeR showed a 51% risk reduction (RR) in experiencing cardiac death or HF hospitalization [HR = 0.49; 95% CI (0.27-0.90); P = 0.02] and 30% RR in experiencing cardiovascular hospitalizations [HR = 0.70; 95% CI (0.49-1.00); P = 0.05]. SafeR safely and significantly reduced VP in a general pacemaker population though had no effect on hospitalization for HF, AF, or cardioversion, when compared with DDD. © The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology.

  8. Introducing the Concept of the Minimally Important Difference to Determine a Clinically Relevant Change on Patient-Reported Outcome Measures in Patients with Intermittent Claudication

    International Nuclear Information System (INIS)

    Conijn, Anne P.; Jonkers, Wilma; Rouwet, Ellen V.; Vahl, Anco C.; Reekers, Jim A.; Koelemay, Mark J. W.

    2015-01-01

    PurposeThe minimally important difference (MID) represents the smallest change in score on patient-reported outcome measures that is relevant to patients. The aim of this study was to introduce the MID for the Vascular Quality of Life Questionnaire (VascuQol) and the walking impairment questionnaire (WIQ) for patients with intermittent claudication (IC).MethodsIn this multicenter study, we recruited 294 patients with IC between July and October 2012. Patients completed the VascuQol, with scores ranging from 1 to 7 (worst to best), and the WIQ, with scores ranging from 0 to 1 (worst to best) at first visit and after 4 months follow-up. In addition, patients answered an anchor-question rating their health status compared to baseline, as being improved, unchanged, or deteriorated. The MID for improvement and deterioration was calculated by an anchor-based approach, and determined with the upper and lower limits of the 95 % confidence interval of the mean change of the group who had not changed according to the anchor-question.ResultsFor the MID analyses of the VascuQol and WIQ, 163 and 134 patients were included, respectively. The MID values for the VascuQol (mean baseline score 4.25) were 0.87 for improvement and 0.23 for deterioration. For the WIQ (mean baseline score 0.39), we found MID values of 0.11 and −0.03 for improvement and deterioration, respectively.ConclusionIn this study, we calculated the MID for the VascuQol and the WIQ. Applying these MID facilitates better interpretation of treatment outcomes and can help to set treatment goals for individual care

  9. Introducing the Concept of the Minimally Important Difference to Determine a Clinically Relevant Change on Patient-Reported Outcome Measures in Patients with Intermittent Claudication

    Energy Technology Data Exchange (ETDEWEB)

    Conijn, Anne P., E-mail: a.p.conijn@amc.nl [Academic Medical Center, Departments of Vascular Surgery and Interventional Radiology (Netherlands); Jonkers, Wilma, E-mail: wilma.jonkers@achmea.nl [Achmea Insurances, Division of Health Care (Netherlands); Rouwet, Ellen V., E-mail: e.rouwet@erasmusmc.nl [Erasmus Medical Center, Department of Vascular Surgery (Netherlands); Vahl, Anco C., E-mail: a.c.vahl@olvg.nl [Onze Lieve Vrouwe Gasthuis, Department of Vascular Surgery (Netherlands); Reekers, Jim A., E-mail: j.a.reekers@amc.nl [Academic Medical Center, Department of Radiology (Netherlands); Koelemay, Mark J. W., E-mail: m.j.koelemaij@amc.nl [Academic Medical Center, Department of vascular surgery (Netherlands)

    2015-10-15

    PurposeThe minimally important difference (MID) represents the smallest change in score on patient-reported outcome measures that is relevant to patients. The aim of this study was to introduce the MID for the Vascular Quality of Life Questionnaire (VascuQol) and the walking impairment questionnaire (WIQ) for patients with intermittent claudication (IC).MethodsIn this multicenter study, we recruited 294 patients with IC between July and October 2012. Patients completed the VascuQol, with scores ranging from 1 to 7 (worst to best), and the WIQ, with scores ranging from 0 to 1 (worst to best) at first visit and after 4 months follow-up. In addition, patients answered an anchor-question rating their health status compared to baseline, as being improved, unchanged, or deteriorated. The MID for improvement and deterioration was calculated by an anchor-based approach, and determined with the upper and lower limits of the 95 % confidence interval of the mean change of the group who had not changed according to the anchor-question.ResultsFor the MID analyses of the VascuQol and WIQ, 163 and 134 patients were included, respectively. The MID values for the VascuQol (mean baseline score 4.25) were 0.87 for improvement and 0.23 for deterioration. For the WIQ (mean baseline score 0.39), we found MID values of 0.11 and −0.03 for improvement and deterioration, respectively.ConclusionIn this study, we calculated the MID for the VascuQol and the WIQ. Applying these MID facilitates better interpretation of treatment outcomes and can help to set treatment goals for individual care.

  10. Minimal TUD spaces

    Directory of Open Access Journals (Sweden)

    A.E. McCluskey

    2002-04-01

    Full Text Available A topological space is TUD if the derived set of each point is the union of disjoint closed sets. We show that there is a minimal TUD space which is not just the Alexandroff topology on a linear order. Indeed the structure of the underlying partial order of a minimal TUD space can be quite complex. This contrasts sharply with the known results on minimality for weak separation axioms.

  11. Hip joint pathology: relationship between patient history, physical tests, and arthroscopy findings in clinical practice.

    Science.gov (United States)

    Tijssen, M; van Cingel, R E H; de Visser, E; Hölmich, P; Nijhuis-van der Sanden, M W G

    2017-03-01

    The purpose of this retrospective cohort study was to (a) describe the clinical presentation of femoroacetabular impingement (FAI) and hip labral pathology; (b) describe the accuracy of patient history and physical tests for FAI and labral pathology as confirmed by hip arthroscopy. Patients (18-65 years) were included if they were referred to a physical therapist to gather pre-operative data and were then diagnosed during arthroscopy. Results of pre-operative patient history and physical tests were collected and compared to arthroscopy. Data of 77 active patients (mean age: 37 years) were included. Groin as main location of pain, the Anterior Impingement test (AIT), Flexion-Abduction-External Rotation (FABER) test, and Fitzgerald test had a high sensitivity (range 0.72-0.91). Sensitivity increased when combining these tests (0.97) as either groin as main location of pain and a positive FABER test or a positive AIT and a positive FABER test were the shortest most sensitive combinations. The results of this study point out that in clinical practice absence of groin as main location of pain combined with a negative FABER test or the combination of a negative AIT and a negative FABER test are suggested to rule out the diagnosis of symptomatic FAI and/or labral pathology. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  12. European recommendations for the clinical use of HIV drug resistance testing: 2011 update

    DEFF Research Database (Denmark)

    Vandamme, Anne-Mieke; Camacho, Ricardo J; Ceccherini-Silberstein, Francesca

    2011-01-01

    is needed after treatment failure. The Panel recommends genotyping in most situations, using updated and clinically evaluated interpretation systems. It is mandatory that laboratories performing HIV resistance tests take part regularly in external quality assurance programs, and that they consider storing...... samples in situations where resistance testing cannot be performed as recommended. Similarly, it is necessary that HIV clinicians and virologists take part in continuous education and discuss problematic clinical cases. Indeed, resistance test results should be used in the context of all other clinically......The European HIV Drug Resistance Guidelines Panel, established to make recommendations to clinicians and virologists, felt that sufficient new information has become available to warrant an update of its recommendations, explained in both pocket guidelines and this full paper. The Panel makes...

  13. Reasons for HIV antibody test refusal in a heterosexual sexually transmitted disease clinic population.

    Science.gov (United States)

    Simon, P A; Weber, M; Ford, W L; Cheng, F; Kerndt, P R

    1996-11-01

    To evaluate acceptance of confidential HIV antibody testing and reasons for test refusal among heterosexual clients of Los Angeles County sexually transmitted disease (STD) clinics. From January 1993 through June 1994, all blood specimens routinely collected for syphilis serology were tested blindly for HIV antibody at seven STD clinics. Patients were counseled and offered a confidential HIV test. Rate of refusal of confidential testing and primary reason for test refusal were examined by demographic group and HIV serostatus, as determined in the blinded survey, for all heterosexual clients. Of 20,125 persons offered confidential testing, 35.6% refused the test. Test refusal was higher among men (38.7%) than women [31.1%; adjusted odds ratio (OR), 1.4; 95% confidence interval (CI), 1.3-1.4] and among blacks (38.6%) than whites (28.6%; adjusted OR, 1.7; 95% CI, 1.5-2.0). The most common reason for refusal was 'already know my HIV status' (40.6%), followed by 'don't want to know' (23.9%), and 'not at risk' (19.4%). Confidentiality concerns were cited as the primary reason for refusal by 2.2%. Among the 180 (0.9%) persons who tested positive in the blinded survey, 99 (55.0%) refused the confidential test. Of the 44 seropositive persons who refused the confidential test because they "already knew their HIV status', 29 (65.9%) reported their previous test to be negative. Efforts are needed to increase acceptance of confidential HIV testing in this heterosexual population and should (1) include a client-centered counseling approach that facilitates accurate self-assessment of risk and addresses the misperception that a prior negative test result implies an absence of risk, and (2) highlight the potential benefits of early intervention medical and psychosocial services.

  14. Clinical experience from Thailand: noninvasive prenatal testing as screening tests for trisomies 21, 18 and 13 in 4736 pregnancies.

    Science.gov (United States)

    Manotaya, S; Xu, H; Uerpairojkit, B; Chen, F; Charoenvidhya, D; Liu, H; Petcharaburanin, N; Liu, Y; Tang, S; Wang, X; Dansakul, S; Thomsopa, T; Gao, Y; Zhang, H; Xu, H; Jiang, Hui

    2016-03-01

    The purpose of this article is to report the clinical experience and performance of massively parallel sequencing-based noninvasive prenatal testing (NIPT) as a screening method in detecting trisomy 21, 18, and 13 (T21/T18/T13) in a mixed-risk population in Thailand. In a 30-month period, 121 medical centers in Thailand offered NIPT as clinical screening tests for fetal T21, T18, and T13 in the mixed-risk population. All NIPT-positive cases were recommended to undergo invasive prenatal diagnosis. A total of 4736 participants received the NIPT test, including 2840 high-risk pregnancies, either with advanced maternal age or positive serum biochemical tests, and 1889 low-risk pregnancies without conventional indications; 99.9% (4732/4736) of the participants with a median maternal age of 35 years old received reports, and 1.3% (63/4732) were classified as test positive, including 36 T21, 19 T18, and 8 T13; 82.5% (52/63) took prenatal diagnosis, and 11.5% (6/52) false-positive cases were observed. The positive predictive values for the detection of T21, T18, and T13 were 94.4%, 79.0%, and 87.5%, respectively. With stringent protocol, our prospective large-scale multicenter nationwide study demonstrated that NIPT showed excellent performance as screening tests for the detection of fetal T21, T18, and T13 in mixed-risk pregnancies in Thailand. © 2016 John Wiley & Sons, Ltd.

  15. Clinical Trunk Muscle Endurance Tests In Subjects With And Without Low Back Pain

    Directory of Open Access Journals (Sweden)

    Ismaeil Ebrahimi

    2005-08-01

    Full Text Available Study design: A cross-sectional non-experimental study. Objectives: To collectively detect the reliability and feasibility of the five types of clinical tests that have been used to measure endurance of the trunk muscles in subjects with and without low back pain (LBP and identifY the sensitivity of each test to predict the probability of the occurrence ofLBP. Background: Testing spinal muscle endurance seems to be very important in prediction, prevention and rehabilitation ofLBP. Several types of methods of static endurance testing such as: Sorensen test, prone isometric chest raise test, prone double straight-leg raise test, supine isometric chest raise test and supine double straight-leg raise test regarding their utilization have been reported in the literature. However, identification ofthe tests that have more dominant sensitivity on assessment ofLBP has not yet been determined. Information regarding the sensitivity of each test is needed for effective prevention and appropriate treatment strategies. Methods: A total of200 subjects pmiicipated in this study. Subjects were categorized into four groups: asymptomatic males (N= 50, mean age= 38+ 12 years, asymptomatic females (N= 50, mean age= 43+ 11 years, males with LBP (N= 50, mean age= 39+ 12 years, and females with LBP (N= 50, mean age= 43+ 12 years. Five clinical tests were measured in each group and the relative association of each test on LBP was assessed. Results: Among all the performed tests, the prone double straight-leg raise test had the highest association with LBP. Other tests such as the prone isometric chest raise test, Supine isometric chest raise test and Supine double straight-leg raise test had low association with LBP in comparison with the prone double straight-leg raise test. Conclusion: It seems that the prone double straight-leg raise test has more association with LBP than other tests and could be used as a useful method for testing spinal muscle endurance

  16. Four small supernumerary marker chromosomes derived from chromosomes 6, 8, 11 and 12 in a patient with minimal clinical abnormalities: a case report

    Directory of Open Access Journals (Sweden)

    Hamid Ahmed B

    2010-08-01

    Full Text Available Abstract Introduction Small supernumerary marker chromosomes are still a problem in cytogenetic diagnostic and genetic counseling. This holds especially true for the rare cases with multiple small supernumerary marker chromosomes. Most such cases are reported to be clinically severely affected due to the chromosomal imbalances induced by the presence of small supernumerary marker chromosomes. Here we report the first case of a patient having four different small supernumerary marker chromosomes which, apart from slight developmental retardation in youth and non-malignant hyperpigmentation, presented no other clinical signs. Case presentation Our patient was a 30-year-old Caucasian man, delivered by caesarean section because of macrosomy. At birth he presented with bilateral cryptorchidism but no other birth defects. At age of around two years he showed psychomotor delay and a bilateral convergent strabismus. Later he had slight learning difficulties, with normal social behavior and now lives an independent life as an adult. Apart from hypogenitalism, he has multiple hyperpigmented nevi all over his body, short feet with pes cavus and claw toes. At age of 30 years, cytogenetic and molecular cytogenetic analysis revealed a karyotype of 50,XY,+min(6(:p11.1-> q11.1:,+min(8(:p11.1->q11.1:,+min(11(:p11.11->q11:,+min(12(:p11.2~12->q10:, leading overall to a small partial trisomy in 12p11.1~12.1. Conclusions Including this case, four single case reports are available in the literature with a karyotype 50,XN,+4mar. For prenatally detected multiple small supernumerary marker chromosomes in particular we learn from this case that such a cytogenetic condition may be correlated with a positive clinical outcome.

  17. cExternal beam radiation results in minimal changes in post void residual urine volumes during the treatment of clinically localized prostate cancer

    Directory of Open Access Journals (Sweden)

    Wallner Kent E

    2009-07-01

    Full Text Available Abstract Background To evaluate the impact of external beam radiation therapy (XRT on weekly ultrasound determined post-void residual (PVR urine volumes in patients with prostate cancer. Methods 125 patients received XRT for clinically localized prostate cancer. XRT was delivered to the prostate only (n = 66 or if the risk of lymph node involvement was greater than 10% to the whole pelvis followed by a prostate boost (n = 59. All patients were irradiated in the prone position in a custom hip-fix mobilization device with an empty bladder and rectum. PVR was obtained at baseline and weekly. Multiple clinical and treatment parameters were evaluated as predictors for weekly PVR changes. Results The mean patient age was 73.9 years with a mean pre-treatment prostate volume of 53.3 cc, a mean IPSS of 11.3 and a mean baseline PVR of 57.6 cc. During treatment, PVR decreased from baseline in both cohorts with the absolute difference within the limits of accuracy of the bladder scanner. Alpha-blockers did not predict for a lower PVR during treatment. There was no significant difference in mean PVR urine volumes or differences from baseline in either the prostate only or pelvic radiation groups (p = 0.664 and p = 0.458, respectively. Patients with a larger baseline PVR (>40 cc had a greater reduction in PVR, although the greatest reduction was seen between weeks one and three. Patients with a small PVR ( Conclusion Prostate XRT results in clinically insignificant changes in weekly PVR volumes, suggesting that radiation induced bladder irritation does not substantially influence bladder residual urine volumes.

  18. Clinical patch test data evaluated by multivariate analysis. Danish Contact Dermatitis Group

    DEFF Research Database (Denmark)

    Christophersen, J; Menné, T; Tanghøj, P

    1989-01-01

    The aim of the present study was to evaluate the influence of individual explanatory factors, such as sex, age, atopy, test time and presence of diseased skin, on clinical patch test results, by application of multivariate statistical analysis. The study population was 2166 consecutive patients...... patch tested with the standard series of the International Contact Dermatitis Research Group (ICDRG) by members of the Danish Contact Dermatitis Group (DCDG) over a period of 6 months. For the 8 test allergens most often found positive (nickel, fragrance-mix, cobalt, chromate, balsam of Peru, carba...

  19. Clinical and radiographic outcome of dynamic cervical implant (DCI) arthroplasty for degenerative cervical disc disease: a minimal five-year follow-up.

    Science.gov (United States)

    Wang, Lin-Nan; Hu, Bo-Wen; Wang, Lei; Song, Yue-Ming; Yang, Xi; Liu, Li-Min; Liu, Hao

    2018-04-04

    To evaluate the mid- to long-term clinical and radiographic outcomes of anterior cervical discectomy and dynamic cervical implant (DCI) arthroplasty for degenerative cervical disc disease. From April 2010 to October 2010, 38 patients with single- or double-level cervical disc herniation underwent anterior cervical discectomy and DCI arthroplasty. The clinical results and radiographic outcomes of these 38 patients (42 levels) were retrospectively evaluated. The clinical results included the visual analogue scale, Japanese Orthopaedic Association score, Neck Disability Index score, 36-item short form health survey questionnaire, and incidences of complications and neurological deterioration. Radiographic results including cervical alignment, intervertebral height, cervical range of motion (ROM), ROM of the functional spinal unit, adjacent intervertebral ROM, migration, subsidence, and heterotopic ossification (HO) were assessed on plain radiography, three-dimensional computed tomography, and magnetic resonance imaging. The mean follow-up period was 72.3 months (range 68-78 months). During follow-up, all patients showed significant improvements in the visual analogue scale score, Japanese Orthopaedic Association score, Neck Disability Index score, 36-item short form health survey physical component summary score and mental component summary score. The ROM of the functional spinal unit was partly reduced. The DCI migrated forward in 10 of 42 (23.8%) cases, and HO was detected in 24 of the 42 (57.1%) DCI segments. Subsidence was observed in 14 of 42 (33.3%) DCI segments. Two patients experienced symptom recurrence, and were treated conservatively. The clinical efficacy of DCI arthroplasty was maintained during mid- to long-term follow-up. HO formation is a common phenomenon, leading to a substantial decrease in ROM at the index level and recurrence of neurological symptoms. The incidence of implant subsidence and migration is relatively high, leaving a potential risk

  20. Reliability of ultrasound thickness measurement of the abdominal muscles during clinical isometric endurance tests.

    Science.gov (United States)

    ShahAli, Shabnam; Arab, Amir Massoud; Talebian, Saeed; Ebrahimi, Esmaeil; Bahmani, Andia; Karimi, Noureddin; Nabavi, Hoda

    2015-07-01

    The study was designed to evaluate the intra-examiner reliability of ultrasound (US) thickness measurement of abdominal muscles activity when supine lying and during two isometric endurance tests in subjects with and without Low back pain (LBP). A total of 19 women (9 with LBP, 10 without LBP) participated in the study. Within-day reliability of the US thickness measurements at supine lying and the two isometric endurance tests were assessed in all subjects. The intra-class correlation coefficient (ICC) was used to assess the relative reliability of thickness measurement. The standard error of measurement (SEM), minimal detectable change (MDC) and the coefficient of variation (CV) were used to evaluate the absolute reliability. Results indicated high ICC scores (0.73-0.99) and also small SEM and MDC scores for within-day reliability assessment. The Bland-Altman plots of agreement in US measurement of the abdominal muscles during the two isometric endurance tests demonstrated that 95% of the observations fall between the limits of agreement for test and retest measurements. Together the results indicate high intra-tester reliability for the US measurement of the thickness of abdominal muscles in all the positions tested. According to the study's findings, US imaging can be used as a reliable method for assessment of abdominal muscles activity in supine lying and the two isometric endurance tests employed, in participants with and without LBP. Copyright © 2014 Elsevier Ltd. All rights reserved.

  1. Reducing blood volume requirements for clinical pathology testing in toxicologic studies-points to consider.

    Science.gov (United States)

    Poitout-Belissent, Florence; Aulbach, Adam; Tripathi, Niraj; Ramaiah, Lila

    2016-12-01

    In preclinical safety assessment, blood volume requirements for various endpoints pose a major challenge. The goal of this working group was to review current practices for clinical pathology (CP) testing in preclinical toxicologic studies, and to discuss advantages and disadvantages of methods for reducing blood volume requirements. An industry-wide survey was conducted to gather information on CP instrumentation and blood collection practices for hematology, clinical biochemistry, and coagulation evaluation in laboratory animals involved in preclinical studies. Based on the survey results and collective experience of the authors, the working group proposes the following "points to consider" for CP testing: (1) For most commercial analyzers, 0.5 mL and 0.8 mL of whole blood are sufficient for hematology and biochemistry evaluation, respectively. (2) Small analyzers with low volume requirements and low throughput have limited utility in preclinical studies. (3) Sample pooling or dilution is inappropriate for many CP methods. (4) Appropriate collection sites should be determined based on blood volume requirements and technical expertise. (5) Microsampling does not provide sufficient volume given current analyzer and quality assurance requirements. (6) Study design considerations include: the use of older/larger animals (rodents), collection of CP samples before toxicokinetic samples, use of separate subsets of mice for hematology and clinical biochemistry testing, use of a priority list for clinical biochemistry, and when possible, eliminating coagulation testing. © 2016 American Society for Veterinary Clinical Pathology.

  2. Clinical evaluation and stress test have limited value in the diagnosis of in-stent restenosis.

    Science.gov (United States)

    Andersen, Karl; Steinthórsdóttir, Sandra Dís; Haraldsdottir, Sigurdis; Gudnason, Thorarinn

    2009-12-01

    In-stent restenosis (ISR) is the main limitation of percutaneous coronary interventions (PCI), occurring in approximately 25% of cases. Although frequently asymptomatic, many PCI patients present with recurrent symptoms of chest pain at follow-up raising a clinical suspicion of ISR. The diagnosis of ISR can be challenging in these patients and difficult to rule out without repeat coronary angiography. We prospectively investigated the diagnostic accuracy of clinical evaluation and exercise stress testing to detect ISR as compared to coronary angiography, in a consecutive, unselected cohort of PCI patients. We studied 91 patients with a total of 143 stents. Clinical evaluation predicted ISR to be likely in 19% of cases and the exercise test was positive in 29%. The binary restenosis rate was 21%. Clinical evaluation had a positive predictive value of 29% and accuracy of 71%, while exercise stress testing had a positive predictive value of 19% and accuracy of 65%. In conclusion, we found the diagnostic accuracy of clinical evaluation to be low and not significantly improved by exercise stress testing when evaluating PCI patients for ISR.

  3. Testing a model of research intention among U.K. clinical psychologists: a logistic regression analysis.

    Science.gov (United States)

    Eke, Gemma; Holttum, Sue; Hayward, Mark

    2012-03-01

    Previous research highlights barriers to clinical psychologists conducting research, but has rarely examined U.K. clinical psychologists. The study investigated U.K. clinical psychologists' self-reported research output and tested part of a theoretical model of factors influencing their intention to conduct research. Questionnaires were mailed to 1,300 U.K. clinical psychologists. Three hundred and seventy-four questionnaires were returned (29% response-rate). This study replicated in a U.K. sample the finding that the modal number of publications was zero, highlighted in a number of U.K. and U.S. studies. Research intention was bimodally distributed, and logistic regression classified 78% of cases successfully. Outcome expectations, perceived behavioral control and normative beliefs mediated between research training environment and intention. Further research should explore how research is negotiated in clinical roles, and this issue should be incorporated into prequalification training. © 2012 Wiley Periodicals, Inc.

  4. Impact of a Routine, Opt-Out HIV Testing Program on HIV Testing and Case Detection in North Carolina Sexually-Transmitted Disease Clinics

    OpenAIRE

    Klein, Pamela W.; Messer, Lynne C.; Myers, Evan R.; Weber, David J.; Leone, Peter A.; Miller, William C.

    2014-01-01

    The impact of routine, opt-out HIV testing programs in clinical settings is inconclusive. The objective of this study was to estimate the impact of an expanded, routine HIV testing program in North Carolina sexually transmitted disease (STD) clinics on HIV testing and case detection.

  5. Molecular testing for hereditary retinal disease as part of clinical care.

    Science.gov (United States)

    Downs, Katy; Zacks, David N; Caruso, Rafael; Karoukis, Athanasios J; Branham, Kari; Yashar, Beverly M; Haimann, Mark H; Trzupek, Karmen; Meltzer, Meira; Blain, Delphine; Richards, Julia E; Weleber, Richard G; Heckenlively, John R; Sieving, Paul A; Ayyagari, Radha

    2007-02-01

    To describe clinical molecular testing for hereditary retinal degenerations, highlighting results, interpretation, and patient education. Mutation analysis of 8 retinal genes was performed by dideoxy sequencing. Pretest and posttest genetic counseling was offered to patients. The laboratory report listed results and provided individualized interpretation. A total of 350 tests were performed. The molecular basis of disease was determined in 133 of 266 diagnostic tests; the disease-causing mutations were not identified in the remaining 133 diagnostic tests. Predictive and carrier tests were requested for 9 and 75 nonsymptomatic patients with known familial mutations, respectively. Molecular testing can confirm a clinical diagnosis, identify carrier status, and confirm or rule out the presence of a familial mutation in nonsymptomatic at-risk relatives. Because causative mutations cannot be identified in all patients with retinal diseases, it is essential that patients are counseled before testing regarding the benefits and limitations of this emerging diagnostic tool. The molecular definition of the genetic basis of disease provides a unique adjunct to the clinical care of patients with hereditary retinal degenerations.

  6. How to diagnose neuropathic pain? The contribution from clinical examination, pain questionnaires and diagnostic tests.

    Science.gov (United States)

    La Cesa, S; Tamburin, S; Tugnoli, V; Sandrini, G; Paolucci, S; Lacerenza, M; Marchettini, P; Cruccu, G; Truini, A

    2015-12-01

    Patients with peripheral and central nervous system diseases may suffer from different types of pain, namely nociceptive, neuropathic and mixed pain. Although in some cases, the distinction between these types of pain is clinically evident, yet in some patients an accurate differential diagnosis requires dedicated clinical examination, screening questionnaires and diagnostic techniques some of which are available only in specialized pain centres. This review briefly addresses the currently agreed definitions of the different types of pain and shows how clinical examination, pain questionnaires and diagnostic tests can help the clinicians in identifying neuropathic pain.

  7. Clinical value of radiocontrast media skin tests as a prescreening and diagnostic tool in hypersensitivity reactions.

    Science.gov (United States)

    Kim, Sae-Hoon; Jo, Eun-Jung; Kim, Mi-Yeong; Lee, Seung-Eun; Kim, Min-Hye; Yang, Min-Suk; Song, Woo-Jung; Choi, Sang-Il; Kim, Jae-Hyoung; Chang, Yoon-Seok

    2013-04-01

    Some radiocontrast media (RCM) hypersensitivity reactions may have underlying IgE- or T-cell-mediated mechanisms. RCM skin testing may be useful for predicting future reactions. To investigate the clinical value of RCM skin testing before computed tomography and after RCM hypersensitivity reactions. Patients who underwent RCM skin testing were a prospective sample of convenience at a single medical center and were tested just before their pending nonionic RCM-enhanced computed tomogram. In addition, skin test data of patients who were referred to the allergy clinic because of their previous RCM hypersensitivity reactions were reviewed retrospectively. A total of 1048 patients enrolled in the study prospectively. Of these, 672 (64.1%) had never been exposed to RCM. Of the 376 previously exposed to RCM, 61 (16.2%) had a history of at least one mild RCM-associated reaction, 56 (91.8%) had immediate reactions, and 5 had no-immediate reactions. There was only 1 positive immediate hypersensitivity RCM skin test result (0.09%). There were 51 mild immediate reactions (4.9%), 1 moderate immediate reaction (0.09%), 8 mild nonimmediate reactions (0.76%), and 1 moderate nonimmediate reaction (0.09%). There was only 1 positive delayed hypersensitivity skin test result (0.09%), retrospectively determined, in 1 (11.1%) of the nonimmediate RCM-associated reactions. Sensitivity of RCM skin testing was significantly higher with severe immediate reactions (57.1%) than mild reactions (12.9%) and moderate reactions (25.0%) in the retrospective review of diagnostic skin test data (P = .03). RCM skin testing for screening is of no clinical utility in predicting hypersensitivity reactions. RCM skin testing may have modest utility in retrospectively evaluating severe adverse reactions. Copyright © 2013 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  8. Contribution of a Real Depth Distance Stereoacuity Test to Clinical Management

    Science.gov (United States)

    Young, B. J.; Sueke, H.; Wylie, J. M.; Kaye, S. B.

    2009-01-01

    Measurement of Stereopsis forms an important part of the clinical assessment of patients with disorders of ocular motility. The introduction of a real depth distance stereoacuity test (FD2) was evaluated in clinical practice and to what extent the introduction affected clinical management. Seventy-three patients under evaluation before and following the introduction of the test were included. Combined thresholds were measured at near using the Frisby and TNO test and at distance using the FD2. Fifty healthy controls were included. Forty-five patients demonstrated Stereopsis using the FD2 and 23 of these had a change in their management based in part on their responses using the FD2. Patients with evidence of Stereopsis using the FD2 were significantly more likely to have change in their management than expected from the whole sample (P = .02). The introduction of a real depth distance stereoacuity test into clinical practice contributed to a change in management when used in conjunction with other tests. The usefulness of the FD2 is limited by its range at 6 m. Use at closer distances necessitates the calculation of binocular threshold from the combined and monocular threshold. PMID:20309416

  9. Contribution of a Real Depth Distance Stereoacuity Test to Clinical Management

    Directory of Open Access Journals (Sweden)

    B. J. Young

    2009-01-01

    Full Text Available Measurement of Stereopsis forms an important part of the clinical assessment of patients with disorders of ocular motility. The introduction of a real depth distance stereoacuity test (FD2 was evaluated in clinical practice and to what extent the introduction affected clinical management. Seventy-three patients under evaluation before and following the introduction of the test were included. Combined thresholds were measured at near using the Frisby and TNO test and at distance using the FD2. Fifty healthy controls were included. Forty-five patients demonstrated Stereopsis using the FD2 and 23 of these had a change in their management based in part on their responses using the FD2. Patients with evidence of Stereopsis using the FD2 were significantly more likely to have change in their management than expected from the whole sample (=.02. The introduction of a real depth distance stereoacuity test into clinical practice contributed to a change in management when used in conjunction with other tests. The usefulness of the FD2 is limited by its range at 6 m. Use at closer distances necessitates the calculation of binocular threshold from the combined and monocular threshold.

  10. EMG of the hip adductor muscles in six clinical examination tests.

    Science.gov (United States)

    Lovell, Gregory A; Blanch, Peter D; Barnes, Christopher J

    2012-08-01

    To assess activation of muscles of hip adduction using EMG and force analysis during standard clinical tests, and compare athletes with and without a prior history of groin pain. Controlled laboratory study. 21 male athletes from an elite junior soccer program. Bilateral surface EMG recordings of the adductor magnus, adductor longus, gracilis and pectineus as well as a unilateral fine-wire EMG of the pectineus were made during isometric holds in six clinical examination tests. A load cell was used to measure force data. Test type was a significant factor in the EMG output for all four muscles (all muscles p magnus, adductor longus and gracilis. EMG activation for pectineus was highest in Hips 90. Injury history was a significant factor in the EMG output for the adductor longus (p magnus. For force data, clinical test type was a significant factor (p force. All other factors had no significant effect on the force outputs. Hip adduction strength assessment is best measured at hips 0 (which produced most force) or 45° flexion (which generally gave the highest EMG output). Muscle EMG varied significantly with clinical test position. Athletes with previous groin injury had a significant fall in some EMG outputs. Copyright © 2011 Elsevier Ltd. All rights reserved.

  11. Point-of-care testing for chlamydia and gonorrhoea: implications for clinical practice.

    Directory of Open Access Journals (Sweden)

    Lisa Natoli

    Full Text Available Point-of-care (POC testing for chlamydia (CT and gonorrhoea (NG offers a new approach to the diagnosis and management of these sexually transmitted infections (STIs in remote Australian communities and other similar settings. Diagnosis of STIs in remote communities is typically symptom driven, and for those who are asymptomatic, treatment is generally delayed until specimens can be transported to the reference laboratory, results returned and the patient recalled. The objective of this study was to explore the clinical implications of using CT/NG POC tests in routine clinical care in remote settings.In-depth qualitative interviews were conducted with a purposively selected group of 18 key informants with a range of sexual health and laboratory expertise.Participants highlighted the potential impact POC testing would have on different stages of the current STI management pathway in remote Aboriginal communities and how the pathway would change. They identified implications for offering a POC test, specimen collection, conducting the POC test, syndromic management of STIs, pelvic inflammatory disease diagnosis and management, interpretation and delivery of POC results, provision of treatment, contact tracing, management of client flow and wait time, and re-testing at 3 months after infection.The introduction of POC testing to improve STI service delivery requires careful consideration of both its advantages and limitations. The findings of this study will inform protocols for the implementation of CT/NG POC testing, and also STI testing and management guidelines.

  12. Point-of-Care Testing for Chlamydia and Gonorrhoea: Implications for Clinical Practice

    Science.gov (United States)

    Natoli, Lisa; Maher, Lisa; Shephard, Mark; Hengel, Belinda; Tangey, Annie; Badman, Steven G.; Ward, James; Guy, Rebecca J.

    2014-01-01

    Objectives Point-of-care (POC) testing for chlamydia (CT) and gonorrhoea (NG) offers a new approach to the diagnosis and management of these sexually transmitted infections (STIs) in remote Australian communities and other similar settings. Diagnosis of STIs in remote communities is typically symptom driven, and for those who are asymptomatic, treatment is generally delayed until specimens can be transported to the reference laboratory, results returned and the patient recalled. The objective of this study was to explore the clinical implications of using CT/NG POC tests in routine clinical care in remote settings. Methods In-depth qualitative interviews were conducted with a purposively selected group of 18 key informants with a range of sexual health and laboratory expertise. Results Participants highlighted the potential impact POC testing would have on different stages of the current STI management pathway in remote Aboriginal communities and how the pathway would change. They identified implications for offering a POC test, specimen collection, conducting the POC test, syndromic management of STIs, pelvic inflammatory disease diagnosis and management, interpretation and delivery of POC results, provision of treatment, contact tracing, management of client flow and wait time, and re-testing at 3 months after infection. Conclusions The introduction of POC testing to improve STI service delivery requires careful consideration of both its advantages and limitations. The findings of this study will inform protocols for the implementation of CT/NG POC testing, and also STI testing and management guidelines. PMID:24956111

  13. A Window Into Clinical Next-Generation Sequencing-Based Oncology Testing Practices.

    Science.gov (United States)

    Nagarajan, Rakesh; Bartley, Angela N; Bridge, Julia A; Jennings, Lawrence J; Kamel-Reid, Suzanne; Kim, Annette; Lazar, Alexander J; Lindeman, Neal I; Moncur, Joel; Rai, Alex J; Routbort, Mark J; Vasalos, Patricia; Merker, Jason D

    2017-12-01

    - Detection of acquired variants in cancer is a paradigm of precision medicine, yet little has been reported about clinical laboratory practices across a broad range of laboratories. - To use College of American Pathologists proficiency testing survey results to report on the results from surveys on next-generation sequencing-based oncology testing practices. - College of American Pathologists proficiency testing survey results from more than 250 laboratories currently performing molecular oncology testing were used to determine laboratory trends in next-generation sequencing-based oncology testing. - These presented data provide key information about the number of laboratories that currently offer or are planning to offer next-generation sequencing-based oncology testing. Furthermore, we present data from 60 laboratories performing next-generation sequencing-based oncology testing regarding specimen requirements and assay characteristics. The findings indicate that most laboratories are performing tumor-only targeted sequencing to detect single-nucleotide variants and small insertions and deletions, using desktop sequencers and predesigned commercial kits. Despite these trends, a diversity of approaches to testing exists. - This information should be useful to further inform a variety of topics, including national discussions involving clinical laboratory quality systems, regulation and oversight of next-generation sequencing-based oncology testing, and precision oncology efforts in a data-driven manner.

  14. Performance Validity Testing in Neuropsychology: Scientific Basis and Clinical Application-A Brief Review.

    Science.gov (United States)

    Greher, Michael R; Wodushek, Thomas R

    2017-03-01

    Performance validity testing refers to neuropsychologists' methodology for determining whether neuropsychological test performances completed in the course of an evaluation are valid (ie, the results of true neurocognitive function) or invalid (ie, overly impacted by the patient's effort/engagement in testing). This determination relies upon the use of either standalone tests designed for this sole purpose, or specific scores/indicators embedded within traditional neuropsychological measures that have demonstrated this utility. In response to a greater appreciation for the critical role that performance validity issues play in neuropsychological testing and the need to measure this variable to the best of our ability, the scientific base for performance validity testing has expanded greatly over the last 20 to 30 years. As such, the majority of current day neuropsychologists in the United States use a variety of measures for the purpose of performance validity testing as part of everyday forensic and clinical practice and address this issue directly in their evaluations. The following is the first article of a 2-part series that will address the evolution of performance validity testing in the field of neuropsychology, both in terms of the science as well as the clinical application of this measurement technique. The second article of this series will review performance validity tests in terms of methods for development of these measures, and maximizing of diagnostic accuracy.

  15. Clinical symptoms, signs and tests for identification of impending and current water-loss dehydration in older people.

    Science.gov (United States)

    Hooper, Lee; Abdelhamid, Asmaa; Attreed, Natalie J; Campbell, Wayne W; Channell, Adam M; Chassagne, Philippe; Culp, Kennith R; Fletcher, Stephen J; Fortes, Matthew B; Fuller, Nigel; Gaspar, Phyllis M; Gilbert, Daniel J; Heathcote, Adam C; Kafri, Mohannad W; Kajii, Fumiko; Lindner, Gregor; Mack, Gary W; Mentes, Janet C; Merlani, Paolo; Needham, Rowan A; Olde Rikkert, Marcel G M; Perren, Andreas; Powers, James; Ranson, Sheila C; Ritz, Patrick; Rowat, Anne M; Sjöstrand, Fredrik; Smith, Alexandra C; Stookey, Jodi J D; Stotts, Nancy A; Thomas, David R; Vivanti, Angela; Wakefield, Bonnie J; Waldréus, Nana; Walsh, Neil P; Ward, Sean; Potter, John F; Hunter, Paul

    2015-04-30

    There is evidence that water-loss dehydration is common in older people and associated with many causes of morbidity and mortality. However, it is unclear what clinical symptoms, signs and tests may be used to identify early dehydration in older people, so that support can be mobilised to improve hydration before health and well-being are compromised. To determine the diagnostic accuracy of state (one time), minimally invasive clinical symptoms, signs and tests to be used as screening tests for detecting water-loss dehydration in older people by systematically reviewing studies that have measured a reference standard and at least one index test in people aged 65 years and over. Water-loss dehydration was defined primarily as including everyone with either impending or current water-loss dehydration (including all those with serum osmolality ≥ 295 mOsm/kg as being dehydrated). Structured search strategies were developed for MEDLINE (OvidSP), EMBASE (OvidSP), CINAHL, LILACS, DARE and HTA databases (The Cochrane Library), and the International Clinical Trials Registry Platform (ICTRP). Reference lists of included studies and identified relevant reviews were checked. Authors of included studies were contacted for details of further studies. Titles and abstracts were scanned and all potentially relevant studies obtained in full text. Inclusion of full text studies was assessed independently in duplicate, and disagreements resolved by a third author. We wrote to authors of all studies that appeared to have collected data on at least one reference standard and at least one index test, and in at least 10 people aged ≥ 65 years, even where no comparative analysis has been published, requesting original dataset so we could create 2 x 2 tables. Diagnostic accuracy of each test was assessed against the best available reference standard for water-loss dehydration (serum or plasma osmolality cut-off ≥ 295 mOsm/kg, serum osmolarity or weight change) within each study. For

  16. Meant to make a difference, the clinical experience of minimally invasive endodontics with the self-adjusting file system in India

    Directory of Open Access Journals (Sweden)

    Ajinkya M Pawar

    2014-01-01

    Full Text Available The vital steps in any endodontic treatment are thorough mechanical shaping and chemical cleaning followed by obtaining a fluid tight impervious seal by an inert obturating material. For the past two decades, introduction and use of rotary nickel-titanium (Ni-Ti files have changed our concepts of endodontic treatment from conventional to contemporary. They have reported good success rates, but still have many drawbacks. The Self-Adjusting File (SAF introduces a new era in endodontics by performing the vital steps of shaping and cleaning simultaneously. The SAF is a hollow file in design that adapts itself three-dimensionally to the root canal and is a single file system, made up of Ni-Ti lattice. The case series presented in the paper report the clinical experience, while treating primary endodontic cases with the SAF system in India.

  17. Minimizing Mutual Couping

    DEFF Research Database (Denmark)

    2010-01-01

    Disclosed herein are techniques, systems, and methods relating to minimizing mutual coupling between a first antenna and a second antenna.......Disclosed herein are techniques, systems, and methods relating to minimizing mutual coupling between a first antenna and a second antenna....

  18. Reliability measure of a clinical test: Appreciation of Music in Cochlear Implantees (AMICI).

    Science.gov (United States)

    Cheng, Min-Yu; Spitzer, Jaclyn B; Shafiro, Valeriy; Sheft, Stanley; Mancuso, Dean

    2013-01-01

    The goals of this study were (1) to investigate the reliability of a clinical music perception test, Appreciation of Music in Cochlear Implantees (AMICI), and (2) examine associations between the perception of music and speech. AMICI was developed as a clinical instrument for assessing music perception in persons with cochlear implants (CIs). The test consists of four subtests: (1) music versus environmental noise discrimination, (2) musical instrument identification (closed-set), (3) musical style identification (closed-set), and (4) identification of musical pieces (open-set). To be clinically useful, it is crucial for AMICI to demonstrate high test-retest reliability, so that CI users can be assessed and retested after changes in maps or programming strategies. Thirteen CI subjects were tested with AMICI for the initial visit and retested again 10-14 days later. Two speech perception tests (consonant-nucleus-consonant [CNC] and Bamford-Kowal-Bench Speech-in-Noise [BKB-SIN]) were also administered. Test-retest reliability and equivalence of the test's three forms were analyzed using paired t-tests and correlation coefficients, respectively. Correlation analysis was also conducted between results from the music and speech perception tests. Results showed no significant difference between test and retest (p > 0.05) with adequate power (0.9) as well as high correlations between the three forms (Forms A and B, r = 0.91; Forms A and C, r = 0.91; Forms B and C, r = 0.95). Correlation analysis showed high correlation between AMICI and BKB-SIN (r = -0.71), and moderate correlation between AMICI and CNC (r = 0.4). The study showed AMICI is highly reliable for assessing musical perception in CI users. American Academy of Audiology.

  19. [Repeatability of insulin sensitivity estimation using the Minimal Model and comparison with a modified short low-dose insulin tolerance test].

    Science.gov (United States)

    Rey, R H; Masnatta, L D; Pirola, D; Cuniberti, L A; Maceira, C; Werba, J P

    1996-01-01

    Hyperinsulinemia and insulin-resistance are metabolic disturbances associated with obesity, essential hypertension, hypertriglyceridemia, glucose intolerance, overt non-insulin dependent diabetes mellitus, polymetabolic syndrome and atherosclerotic disease. The assessment of in vivo insulin sensitivity (SAI in vivo) changes achieved by life style modifications or drug interventions require a reproducible technique. To evaluate the day-to-day intra-individual repeatability of SAI-in vivo, we determined the variation in the SI index (calculated from the Minimal Model of Bergman modified by insulin or MMins) in 11 subjects with a wide range of insulin-resistance. SI (first study) varied from 0.82 to 8.48 x 10(-4) min-1/microU.mL (4.43 +/- 2.85 x 10(-4) min-1/microU.mL mean +/- SD) and highly correlated with SI (second study) (r = 0.89; p = 0.0002). The average interday coefficient of variation was 20.9 +/- 13.9% and was similar in subjects with low or high SI values. We also measured SAI in vivo by assessing the rate of serum glucose decline induced by human cristalline insulin 0.025 U/kg IV dose after a 12-14 hours fasting period (a modified Bonora's method or BBD) in 11 subjects. No subject presented biochemical or symptomatic hypoglycemia. SAI in vivo values determined by BBD varied from 21 a 234 mumol/ml/min (134 +/- 64.8 mumol/ml/min, mean +/- SD). We found a highly significant correlation between SI values obtained from MMins and SAI in vivo assessed by the BBD (r = 0.89, p = 0.0002). Our results suggest that the Mmins is a fairly reproducible procedure and that a BBD is an acceptable option to quantify SAI in vivo, mainly when a fast-execution practice is necessary or cost restrictions are required.

  20. A Pragmatic Approach to Patch Testing Atopic Dermatitis Patients: Clinical Recommendations Based on Expert Consensus Opinion.

    Science.gov (United States)

    Chen, Jennifer K; Jacob, Sharon E; Nedorost, Susan T; Hanifin, Jon M; Simpson, Eric L; Boguniewicz, Mark; Watsky, Kalman L; Lugo-Somolinos, Aida; Hamann, Carsten R; Eberting, Cheryl Lee; Silverberg, Jonathan I; Thyssen, Jacob P

    2016-01-01

    Allergic contact dermatitis (ACD) may complicate the clinical course of atopic dermatitis (AD), and patch testing remains the criterion standard for diagnosing ACD. To date, there have been no guidelines or consensus recommendations on when and how to patch test individuals with AD. Failure to patch test when appropriate may result in overlooking an important and potentially curable complicating comorbidity. In this article, we present consensus recommendations regarding when to perform patch testing in the AD patient, best practices, and common pitfalls. Patch testing should be considered in AD patients with dermatitis that fails to improve with topical therapy; with atypical/changing distribution of dermatitis, or pattern suggestive of ACD; with therapy-resistant hand eczema in the working population; with adult- or adolescent-onset AD; and/or before initiating systemic immunosuppressants for the treatment of dermatitis. A suggested patch testing algorithm for AD patients is provided.

  1. "Think aloud" and "Near live" usability testing of two complex clinical decision support tools.

    Science.gov (United States)

    Richardson, Safiya; Mishuris, Rebecca; O'Connell, Alexander; Feldstein, David; Hess, Rachel; Smith, Paul; McCullagh, Lauren; McGinn, Thomas; Mann, Devin

    2017-10-01

    Low provider adoption continues to be a significant barrier to realizing the potential of clinical decision support. "Think Aloud" and "Near Live" usability testing were conducted on two clinical decision support tools. Each was composed of an alert, a clinical prediction rule which estimated risk of either group A Streptococcus pharyngitis or pneumonia and an automatic order set based on risk. The objective of this study was to further understanding of the facilitators of usability and to evaluate the types of additional information gained from proceeding to "Near Live" testing after completing "Think Aloud". This was a qualitative observational study conducted at a large academic health care system with 12 primary care providers. During "Think Aloud" testing, participants were provided with written clinical scenarios and asked to verbalize their thought process while interacting with the tool. During "Near Live" testing participants interacted with a mock patient. Morae usability software was used to record full screen capture and audio during every session. Participant comments were placed into coding categories and analyzed for generalizable themes. Themes were compared across usability methods. "Think Aloud" and "Near Live" usability testing generated similar themes under the coding categories visibility, workflow, content, understand-ability and navigation. However, they generated significantly different themes under the coding categories usability, practical usefulness and medical usefulness. During both types of testing participants found the tool easier to use when important text was distinct in its appearance, alerts were passive and appropriately timed, content was up to date, language was clear and simple, and each component of the tool included obvious indicators of next steps. Participant comments reflected higher expectations for usability and usefulness during "Near Live" testing. For example, visit aids, such as automatically generated order sets

  2. Regenerative periodontal therapy of infrabony defects using minimally invasive surgery and a collagen-enriched bovine-derived xenograft: a 1-year prospective study on clinical and aesthetic outcome.

    Science.gov (United States)

    Cosyn, Jan; Cleymaet, Roberto; Hanselaer, Lore; De Bruyn, Hugo

    2012-10-01

    To evaluate the clinical and aesthetic outcome of regenerative periodontal therapy (RPT) using minimally invasive surgery and a collagen-enriched bovine-derived xenograft (1); to identify risk factors for failure (clinical attachment level (CAL) gain ≤ 1 mm) and advanced gingival recession (REC) increase (>1 mm) (2). Ninety-five non-smoking patients, with ≤ 25% full-mouth plaque and bleeding presenting ≥ 6 months after initial periodontal therapy with ≥ 1 isolated inter-dental infrabony defect were recruited. Patients were consecutively treated by the same clinician using minimally invasive surgery and a collagen-enriched bovine-derived xenograft. Clinical, radiographic and aesthetic data were collected before surgery and up to 1 year. Multivariate analyses were used to identify risk factors for failure and advanced REC increase. Eighty-four patients (39 men, 45 women; mean age 53) complied and demonstrated mean probing depth (PD) of 7.8 mm, CAL of 10.0 mm and defect depth of 5.2 mm before surgery. At 1 year, postsurgery mean PD reduction was 3.5 mm (range 0.0-8.0), CAL gain was 3.1 mm (range 0.0-7.0) and radiographic defect fill was 53% (range 0-100). Forty-nine percentage showed ≥ 4 mm CAL gain, whereas 15% were considered failures. Mean inter-dental and midfacial REC increase was 0.3 mm (range-2.0-2.0) and 0.5 mm (range-1.5-2.0) respectively. Midfacial REC increase and contour deterioration contributed most to a small, yet significant reduction in the Pink Esthetic Score from 10.06 to 9.42 (p = 0.002). Risk factors for failure included defects with a non-supportive anatomy (OR: ≥ 10.4), plaque (OR: 14.7) and complication(s) (OR: 12.0). Risk factors for advanced midfacial REC increase included defects with a non-supportive anatomy (OR: 58.8) and a thin-scalloped gingival biotype (OR: 76.9). RPT using minimally invasive surgery and a collagen-enriched bovine-derived xenograft demonstrated favourable clinical outcome after 1 year, even though soft

  3. Wedge-Splitting Test – Determination of Minimal Starting Notch Length for Various Cement Based Composites. Part I: Cohesive Crack Modelling

    Czech Academy of Sciences Publication Activity Database

    Veselý, V.; Řoutil, L.; Seitl, Stanislav

    2011-01-01

    Roč. 452-453, - (2011), s. 77-80 ISSN 1013-9826 R&D Projects: GA AV ČR KJB200410901 Institutional research plan: CEZ:AV0Z20410507 Keywords : wedge-splitting test * cementitious composites * quasi-brittle fracture * brittleness Subject RIV: JL - Materials Fatigue, Friction Mechanics

  4. Mediastinal staging of non-small-cell lung cancer among Australasian thoracic physicians: clinical practice and constraints on minimally invasive techniques.

    Science.gov (United States)

    Dabscheck, E J; Steinfort, D P; Irving, L B; Hew, M

    2012-06-01

    We determined current practice among Australasian thoracic physicians in the mediastinal staging of non-small-cell lung cancer (NSCLC). We focused on the availability of endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA) and constraints to its use, as there has been no systematic analysis regarding the availability and uptake of this new technology among thoracic physicians. Physician members of the Thoracic Society of Australia and New Zealand were emailed a survey seeking their current approach to three scenarios requiring mediastinal staging of NSCLC. Respondents were also asked for their preferred investigation for each scenario if any current constraints were removed. Relevant demographic information was sought. We received 164 responses from 512 Australasian physicians (34%). Without constraints, EBUS-TBNA was the preferred investigation for all three clinical scenarios, but only 33% of respondents had access to EBUS-TBNA. Constraints included lack of availability and lack of expertise. Reduced EBUS-TBNA access was associated with a number of clinician factors. Australasian thoracic physicians prefer EBUS-TBNA for the mediastinal staging of NSCLC, but access to EBUS-TBNA services is limited. We recommend targeted measures to improve access to EBUS-TBNA use and optimise mediastinal staging of NSCLC. © 2011 The Authors. Internal Medicine Journal © 2011 Royal Australasian College of Physicians.

  5. Minimizing the problem of poor compliance in adolescents. Clinical experience with a modern low-dose gestodene-containing oral contraceptive.

    Science.gov (United States)

    Brill, K

    1997-06-17

    Adolescents represent a particularly difficult group with respect to compliance. Not only is incorrect pill intake a common problem, but unnecessary discontinuation also occurs regularly. Reasons for poor compliance are varied, but inadequate information and problems with cycle control and weight gain are particularly important. Choosing a well-tolerated oral contraceptive can help to improve compliance, and clinical experience from a large, multicenter trial suggests that monophasic gestodene (75 micrograms gestodene/30 micrograms ethinylestradiol) is a suitable preparation for this group of women. An investigation of 5,602 adolescents with an average age of 16.4 years found good contraceptive reliability and excellent cycle control. The incidence of spotting and breakthrough bleeding was low and declined during the course of the study. The preparation was tolerated well, and the incidence of adverse events was low, with only 4.4% of women withdrawing from the study due to adverse events. An increase in body weight was uncommon. At the end of the study, 85.0% of adolescents rated monophasic gestodene as good and 9.6% as satisfactory.

  6. The role of KRAS rs61764370 in invasive epithelial ovarian cancer: implications for clinical testing

    DEFF Research Database (Denmark)

    Pharoah, Paul D P; Palmieri, Rachel T; Ramus, Susan J

    2011-01-01

    PURPOSE: An assay for the single nucleotide polymorphism (SNP) rs61764370 has recently been commercially marketed as a clinical test to aid ovarian cancer risk evaluation in women with family histories of the disease. rs67164370 is in a 3'UTR miRNA binding site of the KRAS oncogene, and is a cand...

  7. Bridging the gap between clinical failure and laboratory fracture strength tests using a fractographic approach

    NARCIS (Netherlands)

    Aboushelib, M.N.; Feilzer, A.J.; Kleverlaan, C.J.

    2009-01-01

    Objective: The aim of this study was to analyze and to compare the fracture type and the stress at failure of clinically fractured zirconia-based all ceramic restorations with that of morphologically similar replicas tested in a laboratory setup. Methods: Replicas of the same shape and dimensions

  8. The role of KRAS rs61764370 in invasive epithelial ovarian cancer: implications for clinical testing

    NARCIS (Netherlands)

    Pharoah, P.D.; Palmieri, R.T.; Ramus, S.J.; Gayther, S.A.; Andrulis, I.L.; Anton-Culver, H.; Antonenkova, N.; Antoniou, A.C.; Goldgar, D.; Beattie, M.S.; Beckmann, M.W.; Birrer, M.J.; Bogdanova, N.; Bolton, K.L.; Brewster, W.; Brooks-Wilson, A.; Brown, R.; Butzow, R.; Caldes, T.; Caligo, M.A.; Campbell, I.; Chang-Claude, J.; Chen, Y.A.; Cook, L.S.; Couch, F.J.; Cramer, D.W; Cunningham, J.M.; Despierre, E.; Doherty, J.A.; Dork, T.; Durst, M.; Eccles, D.M.; Ekici, A.B.; Easton, D.; Fasching, P.A.; Fazio, A. de; Fenstermacher, D.A.; Flanagan, J.M.; Fridley, B.L.; Friedman, E.; Gao, B.; Sinilnikova, O.; Gentry-Maharaj, A.; Godwin, A.K.; Goode, E.L.; Goodman, M.T.; Gross, J.; Hansen, T.V.; Harnett, P.; Rookus, M.; Heikkinen, T.; Hein, R.; Hogdall, C.; Hogdall, E.; Iversen, E.S.; Jakubowska, A.; Johnatty, S.E.; Karlan, B.Y.; Kauff, N.D.; Kaye, S.B.; Chenevix-Trench, G.; Kelemen, L.E.; Kiemeney, L.A.L.M.; Kjaer, S.K.; Lambrechts, D.; Lapolla, J.P.; Lazaro, C.; Le, N.D.; Leminen, A.; Leunen, K.; Levine, D.A.; Lu, Y.; Lundvall, L.; MacGregor, S.; Marees, T.; Massuger, L.F.A.G.; McLaughlin, J.R.; Menon, U.; Montagna, M.; Moysich, K.B.; Narod, S.A.; Nathanson, K.L.; Nedergaard, L.; Ness, R.B.; Nevanlinna, H.; Nickels, S.; Osorio, A.; Paul, J.; Pearce, C.L.; Phelan, C.M.; Pike, M.C.; Radice, P.; Rossing, M.A.; Schildkraut, J.M.; Sellers, T.A.; Singer, C.F.; Song, H.; Stram, D.O.; Sutphen, R.; Lindblom, A.; et al.,

    2011-01-01

    PURPOSE: An assay for the single-nucleotide polymorphism (SNP), rs61764370, has recently been commercially marketed as a clinical test to aid ovarian cancer risk evaluation in women with family histories of the disease. rs67164370 is in a 3'-UTR miRNA binding site of the KRAS oncogene and is a

  9. Patch test results of hand eczema patients : relation to clinical types

    NARCIS (Netherlands)

    Boonstra, M B; Christoffers, W A; Coenraads, P J; Schuttelaar, M L A

    BACKGROUND: Allergic contact dermatitis is a well-known cause of hand eczema, although the influence of contact allergens on different clinical types of hand eczema remains still unclear. OBJECTIVE: To identify most common positive tested allergens among hand eczema patients and to define the

  10. Development and validation of a clinical cancer genomic profiling test based on massively parallel DNA sequencing.

    Science.gov (United States)

    Frampton, Garrett M; Fichtenholtz, Alex; Otto, Geoff A; Wang, Kai; Downing, Sean R; He, Jie; Schnall-Levin, Michael; White, Jared; Sanford, Eric M; An, Peter; Sun, James; Juhn, Frank; Brennan, Kristina; Iwanik, Kiel; Maillet, Ashley; Buell, Jamie; White, Emily; Zhao, Mandy; Balasubramanian, Sohail; Terzic, Selmira; Richards, Tina; Banning, Vera; Garcia, Lazaro; Mahoney, Kristen; Zwirko, Zac; Donahue, Amy; Beltran, Himisha; Mosquera, Juan Miguel; Rubin, Mark A; Dogan, Snjezana; Hedvat, Cyrus V; Berger, Michael F; Pusztai, Lajos; Lechner, Matthias; Boshoff, Chris; Jarosz, Mirna; Vietz, Christine; Parker, Alex; Miller, Vincent A; Ross, Jeffrey S; Curran, John; Cronin, Maureen T; Stephens, Philip J; Lipson, Doron; Yelensky, Roman

    2013-11-01

    As more clinically relevant cancer genes are identified, comprehensive diagnostic approaches are needed to match patients to therapies, raising the challenge of optimization and analytical validation of assays that interrogate millions of bases of cancer genomes altered by multiple mechanisms. Here we describe a test based on massively parallel DNA sequencing to characterize base substitutions, short insertions and deletions (indels), copy number alterations and selected fusions across 287 cancer-related genes from routine formalin-fixed and paraffin-embedded (FFPE) clinical specimens. We implemented a practical validation strategy with reference samples of pooled cell lines that model key determinants of accuracy, including mutant allele frequency, indel length and amplitude of copy change. Test sensitivity achieved was 95-99% across alteration types, with high specificity (positive predictive value >99%). We confirmed accuracy using 249 FFPE cancer specimens characterized by established assays. Application of the test to 2,221 clinical cases revealed clinically actionable alterations in 76% of tumors, three times the number of actionable alterations detected by current diagnostic tests.

  11. Physiological and biochemical basis of clinical liver function tests: a review

    NARCIS (Netherlands)

    Hoekstra, Lisette T.; de Graaf, Wilmar; Nibourg, Geert A. A.; Heger, Michal; Bennink, Roelof J.; Stieger, Bruno; van Gulik, Thomas M.

    2013-01-01

    To review the literature on the most clinically relevant and novel liver function tests used for the assessment of hepatic function before liver surgery. Postoperative liver failure is the major cause of mortality and morbidity after partial liver resection and develops as a result of insufficient

  12. External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance

    NARCIS (Netherlands)

    Murphy, S.C.; Hermsen, C.C.; Douglas, A.D.; Edwards, N.J.; Petersen, I.; Fahle, G.A.; Adams, M.; Berry, A.A.; Billman, Z.P.; Gilbert, S.C.; Laurens, M.B.; Leroy, O.; Lyke, K.E.; Plowe, C.V.; Seilie, A.M.; Strauss, K.A.; Teelen, K.; Hill, A.V.; Sauerwein, R.W.

    2014-01-01

    Nucleic acid testing (NAT) for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal

  13. Integrating Clinical Assessment with Cognitive Neuroscience: Construct Validation of the California Verbal Learning Test.

    Science.gov (United States)

    Delis, Dean C.; And Others

    1988-01-01

    Explored validity of new clinical test of verbal memory incorporating constructs from normal and pathological memory research, to quantify the ways examinees learn verbal material. Factor analyses of normal subjects and neurological patients indicated that verbal memory consisted of a number of component factors, reflecting learning strategy,…

  14. Diagnostic accuracy of clinical tests for the diagnosis of hip femoroacetabular impingement/labral tear

    DEFF Research Database (Denmark)

    Reiman, M P; Goode, A P; Cook, C E

    2015-01-01

    screening accuracy. CONCLUSIONS: Few hip physical examination tests for diagnosing FAI/ALT have been investigated in enough studies of substantial quality to direct clinical decision-making. Further high-quality studies across a wider spectrum of hip pathology patients are recommended to discern...

  15. Hip joint pathology: relationship between patient history, physical tests, and arthroscopy findings in clinical practice

    NARCIS (Netherlands)

    Tijssen, M.; Cingel, R.E. van; Visser, E de; Holmich, P.; Nijhuis-Van der Sanden, M.W.G.

    2017-01-01

    The purpose of this retrospective cohort study was to (a) describe the clinical presentation of femoroacetabular impingement (FAI) and hip labral pathology; (b) describe the accuracy of patient history and physical tests for FAI and labral pathology as confirmed by hip arthroscopy. Patients (18-65

  16. Computerized Neuropsychological Assessment in Aging: Testing Efficacy and Clinical Ecology of Different Interfaces

    Directory of Open Access Journals (Sweden)

    Matteo Canini

    2014-01-01

    Full Text Available Digital technologies have opened new opportunities for psychological testing, allowing new computerized testing tools to be developed and/or paper and pencil testing tools to be translated to new computerized devices. The question that rises is whether these implementations may introduce some technology-specific effects to be considered in neuropsychological evaluations. Two core aspects have been investigated in this work: the efficacy of tests and the clinical ecology of their administration (the ability to measure real-world test performance, specifically (1 the testing efficacy of a computerized test when response to stimuli is measured using a touch-screen compared to a conventional mouse-control response device; (2 the testing efficacy of a computerized test with respect to different input modalities (visual versus verbal; and (3 the ecology of two computerized assessment modalities (touch-screen and mouse-control, including preference measurements of participants. Our results suggest that (1 touch-screen devices are suitable for administering experimental tasks requiring precise timings for detection, (2 intrinsic nature of neuropsychological tests should always be respected in terms of stimuli presentation when translated to new digitalized environment, and (3 touch-screen devices result in ecological instruments being proposed for the computerized administration of neuropsychological tests with a high level of preference from elderly people.

  17. Design and testing of classroom and clinical teaching evaluation tools for nursing education.

    Science.gov (United States)

    Emerson, Roberta J; Records, Kathie

    2007-01-01

    Student evaluations of teaching provide administrators an overall picture of the effectiveness of personnel and contribute data for promotion and merit decisions. These evaluations must be assessed for their relevance, validity, and reliability. This paper describes the development process and psychometric testing for clinical (n = 149) and didactic (n = 148) student evaluation of teaching forms for undergraduate and graduate courses in one college of nursing. Validity and reliability results were quite strong for the instruments, both of which evidenced a one-factor solution with factor loadings ranging from .68-.88 and Cronbach's alphas of .96 (Classroom) and .95 (Clinical). The clinical and classroom evaluation tools are relatively short, decreasing the burden on students who need to complete the instruments for multiple instructors in any one semester. Initial testing of the psychometric properties of the tools supports their continued use in colleges of nursing.

  18. Inter-examiner reproducibility of clinical tests and criteria to identify subacromial impingement syndrome

    DEFF Research Database (Denmark)

    Vind, Mikkel; Bogh, Søren Bie; Larsen, Camilla Marie

    2011-01-01

    impingement symptoms (SIS) are not available. Objective To test the inter-examiner reproducibility of selected tests and criteria suggested for classifying SIS and the mutual dependencies of each of the individual tests and SIS. Method A standardised three-phase protocol for clinical reproducibility studies...... was followed, consisting of a training, an overall agreement and a study phase. To proceed to the study phase, an overall agreement of 0.80 was required. In total 10, 20 and 44 subjects were included in the three phases, respectively. The case prevalence in the study phase was 50%. The inclusion criterion...

  19. An immunologic model for rapid vaccine assessment -- a clinical trial in a test tube.

    Science.gov (United States)

    Higbee, Russell G; Byers, Anthony M; Dhir, Vipra; Drake, Donald; Fahlenkamp, Heather G; Gangur, Jyoti; Kachurin, Anatoly; Kachurina, Olga; Leistritz, Del; Ma, Yifan; Mehta, Riyaz; Mishkin, Eric; Moser, Janice; Mosquera, Luis; Nguyen, Mike; Parkhill, Robert; Pawar, Santosh; Poisson, Louis; Sanchez-Schmitz, Guzman; Schanen, Brian; Singh, Inderpal; Song, Haifeng; Tapia, Tenekua; Warren, William; Wittman, Vaughan

    2009-09-01

    While the duration and size of human clinical trials may be difficult to reduce, there are several parameters in pre-clinical vaccine development that may be possible to further optimise. By increasing the accuracy of the models used for pre-clinical vaccine testing, it should be possible to increase the probability that any particular vaccine candidate will be successful in human trials. In addition, an improved model will allow the collection of increasingly more-informative data in pre-clinical tests, thus aiding the rational design and formulation of candidates entered into clinical evaluation. An acceleration and increase in sophistication of pre-clinical vaccine development will thus require the advent of more physiologically-accurate models of the human immune system, coupled with substantial advances in the mechanistic understanding of vaccine efficacy, achieved by using this model. We believe the best viable option available is to use human cells and/or tissues in a functional in vitro model of human physiology. Not only will this more accurately model human diseases, it will also eliminate any ethical, moral and scientific issues involved with use of live humans and animals. An in vitro model, termed "MIMIC" (Modular IMmune In vitro Construct), was designed and developed to reflect the human immune system in a well-based format. The MIMIC System is a laboratory-based methodology that replicates the human immune system response. It is highly automated, and can be used to simulate a clinical trial for a diverse population, without putting human subjects at risk. The MIMIC System uses the circulating immune cells of individual donors to recapitulate each individual human immune response by maintaining the autonomy of the donor. Thus, an in vitro test system has been created that is functionally equivalent to the donor's own immune system and is designed to respond in a similar manner to the in vivo response. 2009 FRAME.

  20. Estimation of maximal oxygen uptake via submaximal exercise testing in sports, clinical, and home settings.

    Science.gov (United States)

    Sartor, Francesco; Vernillo, Gianluca; de Morree, Helma M; Bonomi, Alberto G; La Torre, Antonio; Kubis, Hans-Peter; Veicsteinas, Arsenio

    2013-09-01

    Assessment of the functional capacity of the cardiovascular system is essential in sports medicine. For athletes, the maximal oxygen uptake [Formula: see text] provides valuable information about their aerobic power. In the clinical setting, the (VO(2max)) provides important diagnostic and prognostic information in several clinical populations, such as patients with coronary artery disease or heart failure. Likewise, VO(2max) assessment can be very important to evaluate fitness in asymptomatic adults. Although direct determination of [VO(2max) is the most accurate method, it requires a maximal level of exertion, which brings a higher risk of adverse events in individuals with an intermediate to high risk of cardiovascular problems. Estimation of VO(2max) during submaximal exercise testing can offer a precious alternative. Over the past decades, many protocols have been developed for this purpose. The present review gives an overview of these submaximal protocols and aims to facilitate appropriate test selection in sports, clinical, and home settings. Several factors must be considered when selecting a protocol: (i) The population being tested and its specific needs in terms of safety, supervision, and accuracy and repeatability of the VO(2max) estimation. (ii) The parameters upon which the prediction is based (e.g. heart rate, power output, rating of perceived exertion [RPE]), as well as the need for additional clinically relevant parameters (e.g. blood pressure, ECG). (iii) The appropriate test modality that should meet the above-mentioned requirements should also be in line with the functional mobility of the target population, and depends on the available equipment. In the sports setting, high repeatability is crucial to track training-induced seasonal changes. In the clinical setting, special attention must be paid to the test modality, because multiple physiological parameters often need to be measured during test execution. When estimating VO(2max), one has

  1. Clinical correlation between the 6-min walk test andcardiopulmonary exercise testing in patients with pulmonary arterial hypertension.

    Science.gov (United States)

    Acar, Serap; Savcı, Sema; Kardibak, Didem; Özcan Kahraman, Buse; Akdeniz, Bahri; Özpelit, Ebru; Sevinç, Can

    2016-12-20

    The aims of the present study were to assess the relationship between the distance walked during the 6-min walk test (6MWT) and exercise capacity as determined by cardiopulmonary exercise testing (CPET) in patients with pulmonary arterial hypertension (PAH) and to investigate the prognostic value of the 6MWT in comparison to clinical parameters of CPET and echocardiography findings. Thirty PAH patients participated in the study. Subject characteristics and New York Heart Association (NYHA) classifications were recorded. All subjects completed the 6MWT and CPET. Relationships among the variables were analyzed by the Pearson correlation test. Correlation coefficients between 6MWT distance and other variables were determined by linear regression analysis. Distance walked in the 6MWT was significantly correlated with the following exercise parameters: peak oxygen consumption, work load, and metabolic equivalents. Additionally, cardiac index was correlated with peak oxygen consumption and metabolic equivalents. We also showed that cardiac index and age were two significant determinants for exercise performance, accounting for 35.4% of the variance in the 6MWT. The 6MWT provides information that may be a better index for the patient's NYHA functional class determination than maximal exercise testing.

  2. Follow-up of Women With Negative Pap Test Results and Abnormal Clinical Signs or Symptoms.

    Science.gov (United States)

    Ocque, Rebecca; Austin, R Marshall

    2016-04-01

    Abnormal signs or symptoms recorded on Papanicolaou (Pap) test requisitions may reflect disease not detected with Pap testing. Since 2009, these cases have been reviewed in our laboratory by a second cytotechnologist and a cytopathologist. The objective of this study was to document follow-up findings on these patients. A search for Pap test results of "Negative for intraepithelial lesion or malignancy, abnormal clinical signs or symptoms" was performed for cases from January 1, 2009, to October 10, 2013. Clinical information and follow-up findings were documented. 1,104 cases were identified. Signs and symptoms were abnormal bleeding 897 (81%), polyps 83 (8%), pelvic mass 54 (5%), visible cervical lesions 48 (4%), vaginal lesions 17 (2%) and endometrial masses 6 (0.5%). Six hundred sixty-seven (60%) had follow-up results, including 517 with histopathologic diagnoses. Two-hundred thirty-three (45%) had nonspecific benign diagnoses, 216 (42%) had benign tumor-like conditions, 28 (4%) had insufficient specimens, 16 (3%) had precancerous diagnoses and 23 (4%) had malignancies. Endometrial malignancy was identified in 14 (61%), ovarian in 6 (26%), and miscellaneous in 3 (13%). No cervical cancers were identified. We report follow-up findings from patients with abnormal clinical signs or symptoms, negative Pap test results, and follow-up recommendations highlighting reported abnormal signs or symptoms. Abnormal clinical signs and symptoms should routinely be considered in assessment and management of patients with negative cervical screening test results. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  3. Positive nickel patch tests in infants are of low clinical relevance and rarely reproducible.

    Science.gov (United States)

    Mortz, Charlotte G; Kjaer, Henrik F; Eller, Esben; Osterballe, Morten; Norberg, Lene A; Høst, Arne; Bindslev-Jensen, Carsten; Andersen, Klaus E

    2013-02-01

    We have previously reported patch test reactivity to nickel sulphate in a cohort of unselected infants tested repeatedly at 3-18 months of age. A reproducible positive reaction at 12 and 18 months was selected as a sign of nickel sensitivity provided a patch test with an empty Finn chamber was negative. A reproducible positive reaction was seen in 8.6% of the infants. The objective of this study is to follow-up on infants with alleged nickel sensitivity. A total of 562 infants were included in the cohort and patch tested with nickel sulphate (ICDRG guidelines). The 26 children with a positive patch test reaction to nickel sulphate at 12 and 18 months were offered repeated patch tests at 3 and 6 yr. Among the 21 children tested at both 12 months, 18 months and at 3 and 6 yr only 2 of 21 had reproducible nickel reactions (one clinically relevant), 13 of 21 were negative and 6 of 21 were negative at 3 or 6 yr. Only 9.5% of the children had reproducible nickel sulphate reactivity, while 62% became negative. The results are noteworthy and can be interpreted in different ways: Repeated nickel patch tests did not cause patch test sensitization. The test reactions in infancy are probably of irritant or non-specific nature. Hence, nickel patch tests should only be performed in small children if there is a clinical suspicion of nickel-induced allergic contact dermatitis. © 2012 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.

  4. Implementation of a minimal set of biological tests to assess the ecotoxic effects of effluents from land-based marine fish farms.

    Science.gov (United States)

    Carballeira, C; De Orte, M R; Viana, I G; Carballeira, A

    2012-04-01

    Environmental monitoring plans (EMP) that include chemical analysis of water, a battery of bioassays and the study of local hydrodynamic conditions are required for land-based marine aquaculture. In this study, the following standardized toxicity tests were performed to assess the toxicity of effluents from eight land-base marine fish farms (LBMFFs) located on the northwest coast of Spain: bacterial bioluminescence (with Vibrio fischeri at 15 and 30 min), microalgal growth (with Phaeodactyllum tricornutum and Isochrysis galbana) and sea urchin larval development (with Paracentrotus lividus and Arbacia lixula). These bioassays were evaluated for inclusion in routine fish farm monitoring. Effective concentrations (EC(5), EC(10), EC(20), EC(50)) for each bioassay were calculated from dose-response curves, obtained by fitting the bioassay results to the best parametric model. Moreover, a graphical method of integrating the results from the battery of bioassays and classifying the toxicity was proposed, and the potential ecotoxic effects probe (PEEP) index was calculated. The bacterial bioluminiscence test at 30min, growth of I. galbana and larval development of A. lixula were found to be the most sensitive and useful tests. Graphical integration of these test results enabled definition of the ecotoxicological profiles of the different farms. The PEEP index, considering EC(20), efficiently reflected the toxic loading potential of LBMFF effluents. In conclusion, a battery of bioassays with species from different low trophic levels is recommended as a rapid and cost-effective methodology for assessing LBMFF discharges. The graphical integration method and the PEEP index are proposed for consideration in EMPs for such farms. Copyright © 2011 Elsevier Inc. All rights reserved.

  5. Test-retest reliability of the Clinical Learning Environment, Supervision and Nurse Teacher (CLES + T) scale.

    Science.gov (United States)

    Gustafsson, Margareta; Blomberg, Karin; Holmefur, Marie

    2015-07-01

    The Clinical Learning Environment, Supervision and Nurse Teacher (CLES + T) scale evaluates the student nurses' perception of the learning environment and supervision within the clinical placement. It has never been tested in a replication study. The aim of the present study was to evaluate the test-retest reliability of the CLES + T scale. The CLES + T scale was administered twice to a group of 42 student nurses, with a one-week interval. Test-retest reliability was determined by calculations of Intraclass Correlation Coefficients (ICCs) and weighted Kappa coefficients. Standard Error of Measurements (SEM) and Smallest Detectable Difference (SDD) determined the precision of individual scores. Bland-Altman plots were created for analyses of systematic differences between the test occasions. The results of the study showed that the stability over time was good to excellent (ICC 0.88-0.96) in the sub-dimensions "Supervisory relationship", "Pedagogical atmosphere on the ward" and "Role of the nurse teacher". Measurements of "Premises of nursing on the ward" and "Leadership style of the manager" had lower but still acceptable stability (ICC 0.70-0.75). No systematic differences occurred between the test occasions. This study supports the usefulness of the CLES + T scale as a reliable measure of the student nurses' perception of the learning environment within the clinical placement at a hospital. Copyright © 2015 Elsevier Ltd. All rights reserved.

  6. Clinical pharmacogenomics testing in the era of next generation sequencing: challenges and opportunities for precision medicine.

    Science.gov (United States)

    Ji, Yuan; Si, Yue; McMillin, Gwendolyn A; Lyon, Elaine

    2018-04-23

    The rapid development and dramatic decrease in cost of sequencing techniques have ushered the implementation of genomic testing in patient care. Next generation DNA sequencing (NGS) techniques have been used increasingly in clinical laboratories to scan the whole or part of the human genome in order to facilitate diagnosis and/or prognostics of genetic disease. Despite many hurdles and debates, pharmacogenomics (PGx) is believed to be an area of genomic medicine where precision medicine could have immediate impact in the near future. Areas covered: This review focuses on lessons learned through early attempts of clinically implementing PGx testing; the challenges and opportunities that PGx testing brings to precision medicine in the era of NGS. Expert commentary: Replacing targeted analysis approach with NGS for PGx testing is neither technically feasible nor necessary currently due to several technical limitations and uncertainty involved in interpreting variants of uncertain significance for PGx variants. However, reporting PGx variants out of clinical whole exome or whole genome sequencing (WES/WGS) might represent additional benefits for patients who are tested by WES/WGS.

  7. Antibiotic allergies in children and adults: from clinical symptoms to skin testing diagnosis.

    Science.gov (United States)

    Romano, Antonino; Caubet, Jean-Christoph

    2014-01-01

    Hypersensitivity reactions to β-lactam and non-β-lactam antibiotics are commonly reported. They can be classified as immediate or nonimmediate according to the time interval between the last drug administration and their onset. Immediate reactions occur within 1 hour after the last drug administration and are manifested clinically by urticaria and/or angioedema, rhinitis, bronchospasm, and anaphylactic shock; they may be mediated by specific IgE-antibodies. Nonimmediate reactions occur more than 1 hour after the last drug administration. The most common manifestations are maculopapular exanthems; specific T lymphocytes may be involved in this type of manifestation. The diagnostic evaluation of hypersensitivity reactions to antibiotics is usually complex. The patient's history is fundamental; the allergic examination is based mainly on in vivo tests selected on the basis of the clinical features and the type of reaction, immediate or nonimmediate. Immediate reactions can be assessed by immediate-reading skin tests and, in selected cases, drug provocation tests. Nonimmediate reactions can be assessed by delayed-reading skin tests, patch tests, and drug provocation tests. However, skin tests have been well validated mainly for β-lactams but less for other classes of antibiotics. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  8. How does additional diagnostic testing influence the initial diagnosis in patients with cognitive complaints in a memory clinic setting?

    NARCIS (Netherlands)

    Meijs, A.P.; Claassen, J.A.H.R.; Olde Rikkert, M.G.M.; Schalk, B.W.M; Meulenbroek, O.V.; Kessels, R.P.C.; Melis, R.J.F.

    2015-01-01

    Background: patients suspected of dementia frequently undergo additional diagnostic testing (e.g. brain imaging or neuropsychological assessment) after standard clinical assessment at a memory clinic. This study investigates the use of additional testing in an academic outpatient memory clinic and

  9. How does additional diagnostic testing influence the initial diagnosis in patients with cognitive complaints in a memory clinic setting?

    NARCIS (Netherlands)

    Meijs, A.P.; Claassen, J.A.; Olde Rikkert, M.G.M.; Schalk, B.W.M; Meulenbroek, O.V.; Kessels, R.P.C.; Melis, R.J.F.

    2015-01-01

    BACKGROUND: patients suspected of dementia frequently undergo additional diagnostic testing (e.g. brain imaging or neuropsychological assessment) after standard clinical assessment at a memory clinic. This study investigates the use of additional testing in an academic outpatient memory clinic and

  10. 42 CFR 414.509 - Reconsideration of basis for and amount of payment for a new clinical diagnostic laboratory test.

    Science.gov (United States)

    2010-10-01

    ... for a new clinical diagnostic laboratory test. 414.509 Section 414.509 Public Health CENTERS FOR... FOR PART B MEDICAL AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.509 Reconsideration of basis for and amount of payment for a new clinical diagnostic laboratory...

  11. Mosaicism for a pathogenic MFN2 mutation causes minimal clinical features of CMT2A in the parent of a severely affected child.

    Science.gov (United States)

    Schon, Katherine; Spasic-Boskovic, Olivera; Brugger, Kim; Graves, Tracey D; Abbs, Stephen; Park, Soo-Mi; Ambegaonkar, Gautam; Armstrong, Ruth

    2017-01-01

    Charcot-Marie-Tooth disease (CMT) refers to a genetically heterogeneous group of disorders which cause a peripheral motor and sensory neuropathy. The overall prevalence is 1 in 2500 individuals. Mutations in the MFN2 gene are the commonest cause for the axonal (CMT2) type. We describe a Caucasian 5-year old girl affected by CMT2A since the age of 2 years. She presented with unsteady gait, in-turning of the feet and progressive foot deformities. Nerve conduction studies suggested an axonal neuropathy and molecular testing identified a previously reported pathogenic variant c.1090C > T, p.(Arg364Trp) in the MFN2 gene. This variant was also detected in a mosaic state in blood and saliva by Sanger sequencing in her subjectively healthy father. Next generation sequencing showed that the level of mosaicism was 21% in blood and 24% in saliva. A high recurrence risk was given because the father had proven somatic mosaicism and an affected child implying gonadal mosaicism. The parents were referred for pre-implantation genetic diagnosis. To the best of our knowledge, this is the first reported case of somatic mosaicism for MFN2. This study has important implications for genetic counselling in families with CMT2A.

  12. Efficacy of clinical diagnostic criteria for familial hypercholesterolemia genetic testing in Poland.

    Science.gov (United States)

    Mickiewicz, Agnieszka; Chmara, Magdalena; Futema, Marta; Fijalkowski, Marcin; Chlebus, Krzysztof; Galaska, Rafał; Bandurski, Tomasz; Pajkowski, Marcin; Zuk, Monika; Wasag, Bartosz; Limon, Janusz; Rynkiewicz, Andrzej; Gruchala, Marcin

    2016-06-01

    Familial hypercholesterolemia (FH), which leads to premature cardiovascular events, still remains underrecognized and undertreated in most countries. Untreated FH individuals aged 20-39 years are at 100-fold higher risk of mortality from coronary heart disease compared to those of a general population. Therefore, special efforts should be implemented to diagnose FH patients at early stages of life. The aim of this study was to evaluate the efficacy of the revised Dutch Lipid Clinic Network (DLCN) criteria proposed by the Polish Lipid Experts Forum to select index FH patients for DNA mutational analysis in Poland. The study included 193 unrelated adult patients (mean age 48 ± 13 years) with clinical diagnosis of FH based on the revised DLCN score, tested sequentially for mutations in LDLR and APOB genes using bidirectional Sanger sequencing and MLPA techniques. The cut-off points of the clinical FH criteria score were assessed by ROC statistics to identify patients with the highest probability of carrying an FH-causing mutation. The causal heterozygous LDLR or APOB mutation was identified in 41% (80/193) of probands. Adults aged <40 years were more likely to carry an FH-causing mutation compared to subjects aged ≥40 years (65% vs. 33%; p < 0.001). LDL-C thresholds for the molecular diagnosis of FH were 5.79 mmol/l for individuals aged<40 and 6.7 mmol/l for subjects ≥40 years old. The threshold values of the clinical diagnostic score for efficient selection of patients for genetic testing were 5 and 7 points for individuals aged <40 and ≥40 years, respectively. The study validated the efficacy of proposed clinical FH criteria for the disease diagnosis in Poland. The clinical criteria score thresholds for positive FH molecular diagnosis differ depending on age (<40 and ≥40 years). We propose that in the healthcare systems with limited genetic testing resources individuals younger than 40 years, who fulfill the clinical criteria for possible

  13. Utility of repeat testing of critical values: a Q-probes analysis of 86 clinical laboratories.

    Science.gov (United States)

    Lehman, Christopher M; Howanitz, Peter J; Souers, Rhona; Karcher, Donald S

    2014-06-01

    A common laboratory practice is to repeat critical values before reporting the test results to the clinical care provider. This may be an unnecessary step that delays the reporting of critical test results without adding value to the accuracy of the test result. To determine the proportions of repeated chemistry and hematology critical values that differ significantly from the original value as defined by the participating laboratory, to determine the threshold differences defined by the laboratory as clinically significant, and to determine the additional time required to analyze the repeat test. Participants prospectively reviewed critical test results for 4 laboratory tests: glucose, potassium, white blood cell count, and platelet count. Participants reported the following information: initial and repeated test result; time initial and repeat results were first known to laboratory staff; critical result notification time; if the repeat result was still a critical result; if the repeat result was significantly different from the initial result, as judged by the laboratory professional or policy; significant difference threshold, as defined by the laboratory; the make and model of the instrument used for primary and repeat testing. Routine, repeat analysis of critical values is a common practice. Most laboratories did not formally define a significant difference between repeat results. Repeated results were rarely considered significantly different. Median repeated times were at least 17 to 21 minutes for 10% of laboratories. Twenty percent of laboratories reported at least 1 incident in the last calendar year of delayed result reporting that clinicians indicated had adversely affected patient care. Routine repeat analysis of automated chemistry and hematology critical values is unlikely to be clinically useful and may adversely affect patient care.

  14. What every clinical geneticist should know about testing for osteogenesis imperfecta in suspected child abuse cases.

    Science.gov (United States)

    Pepin, Melanie G; Byers, Peter H

    2015-12-01

    Non-accidental injury (NAI) is a major medical concern in the United States. One of the challenges in evaluation of children with unexplained fractures is that genetic forms of bone fragility are one of the differential diagnoses. Infants who present with fractures with mild forms of osteogenesis imperfecta (OI) (OI type I or OI type IV), the most common genetic form of bone disease leading to fractures might be missed if clinical evaluation alone is used to make the diagnosis. Diagnostic clinical features (blue sclera, dentinogenesis imperfecta, Wormian bones on X-rays or positive family history) may not be present or apparent at the age of evaluation. The evaluating clinician faces the decision about whether genetic testing is necessary in certain NAI cases. In this review, we outline clinical presentations of mild OI and review the history of genetic testing for OI in the NAI versus OI setting. We summarize our data of molecular testing in the Collagen Diagnostic Laboratory (CDL) from 2008 to 2014 where NAI was noted on the request for DNA sequencing of COL1A1 and COL1A2. We provide recommendations for molecular testing in the NAI versus OI setting. First, DNA sequencing of COL1A1, COL1A2, and IFITM5 simultaneously and duplication/deletion testing is recommended. If a causative variant is not identified, in the absence of a pathologic clinical phenotype, no additional gene testing is indicated. If a VUS is found, parental segregation studies are recommended. © 2015 Wiley Periodicals, Inc.

  15. Handgrip strength test as a complementary tool in monitoring asthma in daily clinical practice in children.

    Science.gov (United States)

    Latorre-Román, Pedro Ángel; Navarro-Martínez, Ana Vanesa; Mañas-Bastidas, Alfonso; García-Pinillos, Felipe

    2014-12-01

    The aim of this study was to demonstrate that handgrip strength test can discriminate the presence/absence of asthma and between intermittent and moderate persistent asthma in children. 140 children (70 healthy and 70 with asthma) completed the Pediatric Asthma Quality of Life Questionnaire (PAQLQ) and performed the handgrip strength test. Forty-eight hours later, subjects performed spirometry. The results showed Handgrip strength was significantly lower (pstrength test was a predictive factor for asthma (cut-off at 16.84 kg) and for severity of pathology (cut-off at 15.06 kg). Handgrip strength was reduced in children with asthma. Handgrip strength was positively associated with lung capacity and quality of life. The fact that the handgrip strength test was able to discriminate between presence/absence of asthma and between intermittent and moderate persistent asthma in children suggested that this test could be used as a complementary tool in the monitoring of asthma in daily clinical practice.

  16. PSA testing without clinical indication for prostate cancer in relation to socio-demographic and clinical characteristics in the Danish Diet, Cancer and Health Study

    DEFF Research Database (Denmark)

    Karlsen, Randi V; Larsen, Signe B; Christensen, Jane

    2013-01-01

    Background. Social differences in prostate cancer (PC) incidence and mortality might be related to testing for prostate-specific antigen (PSA). Although routine PSA screening is not recommended in Denmark, testing without clinical indication increased during the past decade. We evaluated...... associations between socio-demographic or clinical characteristics and PSA testing without clinical indication. Material and methods. In the Danish Diet, Cancer and Health Cohort, we identified 1051 men with PC diagnosed in 1993-2008. Diagnostic and clinical characteristics were obtained from medical records......, and socio-demographic information was retrieved from administrative registers. We used general logistic regression analysis to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for associations between socio-demographic or clinical characteristics and PSA testing without clinical indication. Cox...

  17. Minimalism. Clip and Save.

    Science.gov (United States)

    Hubbard, Guy

    2002-01-01

    Provides background information on the art movement called "Minimalism" discussing why it started and its characteristics. Includes learning activities and information on the artist, Donald Judd. Includes a reproduction of one of his art works and discusses its content. (CMK)

  18. Ruled Laguerre minimal surfaces

    KAUST Repository

    Skopenkov, Mikhail

    2011-10-30

    A Laguerre minimal surface is an immersed surface in ℝ 3 being an extremal of the functional ∫ (H 2/K-1)dA. In the present paper, we prove that the only ruled Laguerre minimal surfaces are up to isometry the surfaces ℝ (φλ) = (Aφ, Bφ, Cφ + D cos 2φ) + λ(sin φ, cos φ, 0), where A,B,C,D ε ℝ are fixed. To achieve invariance under Laguerre transformations, we also derive all Laguerre minimal surfaces that are enveloped by a family of cones. The methodology is based on the isotropic model of Laguerre geometry. In this model a Laguerre minimal surface enveloped by a family of cones corresponds to a graph of a biharmonic function carrying a family of isotropic circles. We classify such functions by showing that the top view of the family of circles is a pencil. © 2011 Springer-Verlag.

  19. Utility and necessity of repeat testing of critical values in the clinical chemistry laboratory.

    Science.gov (United States)

    Niu, Aijun; Yan, Xianxia; Wang, Lin; Min, Yan; Hu, Chengjin

    2013-01-01

    Routine repeat testing of critical values is a long-standing practice in many clinical laboratories; however, its usefulness and necessity remain to be empirically established and no regulatory requirements yet exist for verification of the critical value results obtained by repeat analysis. To determine whether repeat testing of critical values is useful and necessary in a clinical chemistry laboratory. A total of 601 chemistry critical values (potassium, n = 255; sodium, n = 132; calcium, n = 108; glucose, n = 106) obtained from 72,259 routine clinical chemistry specimens were repeat tested. The absolute value and the percentage of difference between the two testing runs were calculated for each of the four critical values and then compared with the allowable error limit put forth in the College of American Pathologists (CAP). Among the repeat data for the 601 critical values, a total of 24 showed large differences between the initial result and the repeated result which exceeded the CAP limits for allowable error. The number and rates (%) of large differences for within and outside the analytical measurement range (AMR) were 12 (2.1%) and 12 (41.4%), respectively. For the 572 critical values within the AMR for each test category, the mean absolute difference (mmol/L) and difference(%) between the two testing runs were: potassium, 0.1 mmol/L (2.7%); sodium, 2.1 mmol/L (1.7%); calcium, 0.05 mmol/L (3.0%); glucose, 0.18 mmol/L (2.6%). When the initial chemistry critical values are within the AMR, repeated testing does not improve accuracy and is therefore unnecessary. When the initial chemistry critical values are outside the AMR, however, the benefit of repeated testing justifies its performance and makes it necessary. Performing repeat clinical testing on a case-by-case, rather than routine, basis can improve patient care by delivering critical values more rapidly while providing savings on reagent costs associated with unnecessary repeat testing.

  20. Development, in vitro testing, and clinical use of a 3.5 mm-diameter zirconia abutment.

    Science.gov (United States)

    Grunder, Ueli; Spielmann, Hans-Peter; Snétivy, Daniel

    2010-01-01

    The use of small-diameter implants is indicated when small missing teeth have to be replaced, especially in esthetic zones. Nevertheless, the small diameter can pose a limiting factor with respect to what materials can be used for the final crown. In most cases, full-ceramic crowns in combination with a ceramic abutment are usually the material of choice for final reconstructions. To date, based on mechanical considerations, a 3.5 mm implant diameter has been a contraindication for using ceramic abutments. The authors describe here the development, in vitro testing, and clinical use of a zirconium abutment with a 3.5 mm diameter. The advantages of this small-diameter zirconia abutment include a minimum platform height that offers optimal prosthetic flexibility, and an accurate transfer of the implant position on to the master model. Furthermore, a precise rotational orientation for single-tooth restorations, optimal mechanical stability, and optimal fatigue resistance can be achieved. The microgap is minimized and protection against overload is afforded. In the reported case, high patient satisfaction was achieved due also to an esthetically pleasing final result.

  1. The clinical application of UGT1A1 pharmacogenetic testing: Gene-environment interactions

    Directory of Open Access Journals (Sweden)

    Marques Sara

    2010-04-01

    Full Text Available Abstract Over the past decade, the number of pharmacogenetic tests has increased considerably, allowing for the development of our knowledge of their clinical application. The uridine diphosphate glucuronosyltransferase 1A1 gene (UGT1A1 assay is an example of a pharmacogenetic test. Numerous variants have been found in UGT1A1, the main conjugating enzyme of bilirubin and drugs such as the anticancer drug irinotecan. Recently, the US Food and Drug Administration (FDA recommended testing for the presence of UGT1A1*28, an allele correlated with decreased transcriptional activity, to predict patients at risk of irinotecan toxicity. The administration of other drugs -- such as inhibitors of the UGT1A1 enzyme -- can clinically mimic the *28 phenotype, whereas inducers of UGT1A1 can increase the glucuronidation rate of the enzyme. The *28 polymorphism is not present in all ethnicities at a similar frequency, which suggests that it is important to study different populations to determine the clinical relevance of testing for UGT1A1*28 and to identify other clinically relevant UGT1A1 variants. Environmental factors such as lifestyle can also affect UGT1A1 activity. This review is a critical analysis of studies on drugs that can be affected by the presence of UGT1A1*28, the distribution of this polymorphism around the globe, distinct variants that may be clinically significant in African and Asian populations and how lifestyle can affect treatment outcomes that depend on UGT1A1 activity.

  2. Is the 1-minute sit-to-stand test a good tool for the evaluation of the impact of pulmonary rehabilitation? Determination of the minimal important difference in COPD.

    Science.gov (United States)

    Vaidya, Trija; de Bisschop, Claire; Beaumont, Marc; Ouksel, Hakima; Jean, Véronique; Dessables, François; Chambellan, Arnaud

    2016-01-01

    The 1-minute sit-to-stand (STS) test could be valuable to assess the level of exercise tolerance in chronic obstructive pulmonary disease (COPD). There is a need to provide the minimal important difference (MID) of this test in pulmonary rehabilitation (PR). COPD patients undergoing the 1-minute STS test before PR were included. The test was performed at baseline and the end of PR, as well as the 6-minute walk test, and the quadriceps maximum voluntary contraction (QMVC). Home and community-based programs were conducted as recommended. Responsiveness to PR was determined by the difference in the 1-minute STS test between baseline and the end of PR. The MID was evaluated using distribution and anchor-based methods. Forty-eight COPD patients were included. At baseline, the significant predictors of the number of 1-minute STS repetitions were the 6-minute walk distance (6MWD) ( r =0.574; P sensibility: 80%, specificity: 60%) with area under curve of 0.716. The 1-minute STS test is simple and sensitive to measure the efficiency of PR. An improvement of at least three repetitions is consistent with physical benefits after PR.

  3. [Real-time quantitative detection of E2A-PBX1 fusion gene in children with acute lymphoblastic leukemia and its clinical application in minimal residual disease monitoring].

    Science.gov (United States)

    Zhang, Rong; Liao, Jing; Li, Ge; Sun, Huai-Qiang; Shi, Yu-Jun; Yang, Ji-Yun

    2013-06-01

    To establish a real-time reverse transcription-polymerase chain reaction (RT-PCR) for quantitative detection of E2A-PBX1 fusion gene mRNA in acute lymphoblastic leukemia (ALL) children and to explore its clinical significance in minimal residual disease monitoring and prognosis evaluation. Real-time RT-PCR was used to quantitatively detect the mRNA expression of E2A-PBX1 gene in 11 newly diagnosed ALL patients at diagnosis (11 cases), complete remission (11 cases) and periods of relapse (3 cases). Ten children with normal bone marrow cell morphology and without hematopathy or tumor diseases were used as the control group. The median expression levels of E2A-PBX1 fusion gene in the ALL group at diagnosis and the relapse group were significantly higher than in the control and complete remission groups (PE2A-PBX1 negative patients on day 33 during induction of remission, the recurrence rate increased and disease free survival rate at 3 year decreased significantly in E2A-PBX1 positive patients decreased (PE2A-PBX1 levels by real-time RT-PCR is useful for monitoing minimal residual disease, prediction of relapse and individual treatment. The expression level of E2A-PBX1 gene on day 33 during induction of remission can be used for prognosis evaluation.

  4. Clinical, social and ethical issues associated with non-invasive prenatal testing for aneuploidy.

    Science.gov (United States)

    Griffin, Blanche; Edwards, Samantha; Chitty, Lyn S; Lewis, Celine

    2018-03-01

    Non-invasive prenatal testing (NIPT), based on analysis of cell-free foetal DNA, is rapidly becoming a preferred method to screen for chromosomal aneuploidy with the technology now available in over 90 countries. This review provides an up-to-date discussion of the key clinical, social and ethical implications associated with this revolutionary technology. Stakeholders are positive about a test that is highly accurate, safe, can be perfomed early in pregnancy, identifies affected pregnancies that might otherwise have been missed and reduces the need for invasive testing. Nevertheless, professional societies currently recommend it as an advanced screening test due to the low false positive rate (FPR). Despite the practical and psychological benefits, a number of concerns have been raised which warrant attention. These include the potential for routinisation of testing and subsequent impact on informed decision-making, an "easy" blood test inadvertently contributing to women feeling pressured to take the test, fears NIPT will lead to less tolerance and support for those living with Down syndrome and the heightened expectation of having "perfect babies". These issues can be addressed to some extent through clinician education, patient information and establishing national and international consensus in the development of comprehensive and regularly updated guidelines. As the number of conditions we are able to test for non-invasively expands it will be increasingly important to ensure pre-test counselling can be delivered effectively supported by knowledgeable healthcare professionals.

  5. CUSUM-Logistic Regression analysis for the rapid detection of errors in clinical laboratory test results.

    Science.gov (United States)

    Sampson, Maureen L; Gounden, Verena; van Deventer, Hendrik E; Remaley, Alan T

    2016-02-01

    The main drawback of the periodic analysis of quality control (QC) material is that test performance is not monitored in time periods between QC analyses, potentially leading to the reporting of faulty test results. The objective of this study was to develop a patient based QC procedure for the more timely detection of test errors. Results from a Chem-14 panel measured on the Beckman LX20 analyzer were used to develop the model. Each test result was predicted from the other 13 members of the panel by multiple regression, which resulted in correlation coefficients between the predicted and measured result of >0.7 for 8 of the 14 tests. A logistic regression model, which utilized the measured test result, the predicted test result, the day of the week and time of day, was then developed for predicting test errors. The output of the logistic regression was tallied by a daily CUSUM approach and used to predict test errors, with a fixed specificity of 90%. The mean average run length (ARL) before error detection by CUSUM-Logistic Regression (CSLR) was 20 with a mean sensitivity of 97%, which was considerably shorter than the mean ARL of 53 (sensitivity 87.5%) for a simple prediction model that only used the measured result for error detection. A CUSUM-Logistic Regression analysis of patient laboratory data can be an effective approach for the rapid and sensitive detection of clinical laboratory errors. Published by Elsevier Inc.

  6. Comparison of Psychomotor Development Screening Test and Clinical Assessment of Psychomotor Development

    Science.gov (United States)

    Radmilović, Goranka; Matijević, Valentina; Zavoreo, Iris

    2016-12-01

    Numerous adverse factors are acting in the prenatal, perinatal and postnatal period of life and may be the cause of later mild or severe deviations from normal psychomotor development. Therefore, it is crucial to identify infants with neurological risk factors and infants that already have a delay from orderly development, in order to immediately initiate the rehabilitation process. The aim of this study was to determine whether there is difference in the assessment of psychomotor development in neurological risk children based on the psychomotor development test (Croatian, Razvoj psihomotorike, RPM test) and clinical evaluation of neuromotor development. RPM test is designed for rough estimate of psychomotor development in children in the first two years of life. The study included 15 full term children (8 male and 7 female) with clinical diagnosis of mild paraparesis and mild deviation from normal psychological and social development, and 15 full term children (8 male and 7 female) without neurological risk factors and deviations from normal psychomotor development, all at the age of 12-24 months. Of the 15 children diagnosed with mild paraparesis, none had delayed psychomotor development, 6.7% had suspect development and 93.3% had normal development on RPM test. All children in the control group had normal development on RPM test. According to the results, the RPM test is not sensitive enough to detect mild neurodevelopmental disorders.

  7. Current quality assurance concepts and considerations for quality control of in-clinic biochemistry testing.

    Science.gov (United States)

    Lester, Sally; Harr, K E; Rishniw, Mark; Pion, Paul

    2013-01-15

    Quality assurance is an implied concept inherent in every consumer's purchase of a product or service. In laboratory testing, quality assurance encompasses preanalytic (sampling, transport, and handling prior to testing), analytic (measurement), and postanalytic (reporting and interpretation) factors. Quality-assurance programs require that procedures are in place to detect errors in all 3 components and that the procedures are characterized by both documentation and correction of errors. There are regulatory bodies that provide mandatory standards for and regulation of human medical laboratories. No such regulations exist for veterinary laboratory testing. The American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards Committee was formed in 1996 in response to concerns of ASVCP members about quality assurance and quality control in laboratories performing veterinary testing. Guidelines for veterinary laboratory testing have been developed by the ASVCP. The purpose of this report was to provide an overview of selected quality-assurance concepts and to provide recommendations for quality control for in-clinic biochemistry testing in general veterinary practice.

  8. Clinical findings as predictors of positivity of head-up tilt table test in neurocardiogenic syncope.

    Science.gov (United States)

    Asensio, Enrique; Oseguera, Jorge; Loría, Alvar; Gómez, María; Narváez, René; Dorantes, Joel; Hernández, Pablo; Orea, Arturo; Rebollar, Verónica; Ocaranza, Raymundo

    2003-01-01

    Neurocardiogenic (vasovagal) syncope occurs frequently and can be diagnosed with the head-up tilt table (HUTT) test. Our objective in this study was to identify clinical predictors of the positivity of HUTT test in neurocardiogenic syncope. We conducted a prospective study of 117 cases (81 women and 36 men, 13-85 years of age) referred to our Institution for HUTT testing. The ability of 10 symptoms and signs of clinical history to predict HUTT positivity were evaluated using logistic regression analysis. We observed a low rate of test-negative cases (24%) and 89 positives. Nearly all positives (87/89) were neurocardiogenic, principally of vasodepressor and mixed types (43 and 34 cases, respectively) and a few were cardioinhibitory (10, mostly young males). Regression analysis established that dizziness, nausea, and diaphoresis in past history were associated with HUTT positivity nearly 25 times more frequently than when absent. Our three conclusions are that syncope in absence of heart disease accompanied by dizziness, nausea, and diaphoresis may be treated as neurocardiogenic in settings where no HUTT is available. In addition, our low rate of negative tests may have been the result of our reexamining referrals prior to deciding test performance, and high frequency of young males in cardioinhibitory syncope needs further research.

  9. Pre-clinical evaluation of ceramic femoral head resurfacing prostheses using computational models and mechanical testing.

    Science.gov (United States)

    Dickinson, A S; Browne, M; Wilson, K C; Leffers, J R T; Taylor, A C

    2011-09-01

    Ceramic-on-ceramic hip resurfacing can potentially offer the bone-conserving advantages of resurfacing while eliminating metal ion release. Thin-walled ceramic resurfacing heads are conceivable following developments in the strength and reliability of ceramic materials, but verification of new designs is required. The present study aimed to develop a mechanical pre-clinical analysis verification process for ceramic resurfacing heads, using the DeltaSurf prosthesis design as a case study. Finite element analysis of a range of in vivo scenarios was used to design a series of physiologically representative mechanical tests, which were conducted to verify the strength of the prosthesis. Tests were designed to simulate ideal and worst-case in vivo loading and support, or to allow comparison with a clinically successful metallic device. In tests simulating ideal loading and support, the prosthesis sustained a minimum load of 39 kN before fracture, and survived 10 000 000 fatigue cycles of 0.534 kN to 5.34 kN. In worst-case tests representing a complete lack of superior femoral head bone support or pure cantilever loading of the prosthesis stem, the design demonstrated strength comparable to that of the equivalent metal device. The developed mechanical verification test programme represents an improvement in the state of the art where international test standards refer largely to total hip replacement prostheses. The case study's novel prosthesis design performed with considerable safety margins compared with extreme in vivo loads, providing evidence that the proposed ceramic resurfacing heads should have sufficient strength to perform safely in vivo. Similar verification tests should be designed and conducted for novel ceramic prosthesis designs in the future, leading the way to clinical evaluation.

  10. Association with isokinetic ankle strength measurements and normal clinical muscle testing in sciatica patients.

    Science.gov (United States)

    Ustun, N; Erol, O; Ozcakar, L; Ceceli, E; Ciner, O Akar; Yorgancioglu, Z R

    2013-01-01

    Sensitive muscle strength tests are needed to measure muscle strength in the diagnosis and management of sciatica patients. The aim of this study was to assess the isokinetic muscle strength in sciatica patients' and control subjects' ankles that exhibited normal ankle muscle strength when measured clinically. Forty-six patients with L5 and/or S1 nerve compression, and whose age, sex, weight, and height matched 36 healthy volunteers, were recruited to the study. Heel-walking, toe-walking, and manual muscle testing were used to perform ankle dorsiflexion and plantar flexion strengths in clinical examination. Patients with normal ankle dorsiflexion and plantar flexion strengths assessed by manual muscle testing and heel-and toe-walking tests were included in the study. Bilateral isokinetic (concentric/concentric) ankle plantar-flexion-dorsiflexion measurements of the patients and controls were performed within the protocol of 30°/sec (5 repetitions). Peak torque and peak torque/body weight were obtained for each ankle motion of the involved limb at 30°/s speed. L5 and/or S1 nerve compression was evident in 46 patients (76 injured limbs). Mean disease duration was two years. The plantar flexion muscle strength of the patients was found to be lower than that of the controls (p=0.036). The dorsiflexion muscle strength of the patients was found to be the same as that of the controls (p=0.211). Isokinetic testing is superior to clinical muscle testing when evaluating ankle plantar flexion torque in sciatica patients. Therefore, isokinetic muscle testing may be helpful when deciding whether to place a patient into a focused rehabilitation program.

  11. SU-F-T-313: Clinical Results of a New Customer Acceptance Test for Elekta VMAT

    International Nuclear Information System (INIS)

    Rusk, B; Fontenot, J

    2016-01-01

    Purpose: To report the results of a customer acceptance test (CAT) for VMAT treatments for two matched Elekta linear accelerators. Methods: The CAT tests were performed on two clinically matched Elekta linear accelerators equipped with a 160-leaf MLC. Functional tests included performance checks of the control system during dynamic movements of the diaphragms, MLC, and gantry. Dosimetric tests included MLC picket fence tests at static and variable dose rates and a diaphragm alignment test, all performed using the on-board EPID. Additionally, beam symmetry during arc delivery was measured at the four cardinal angles for high and low dose rate modes using a 2D detector array. Results of the dosimetric tests were analyzed using the VMAT CAT analysis tool. Results: Linear accelerator 1 (LN1) met all stated CAT tolerances. Linear accelerator 2 (LN2) passed the geometric, beam symmetry, and MLC position error tests but failed the relative dose average test for the diaphragm abutment and all three picket fence fields. Though peak doses in the abutment regions were consistent, the average dose was below the stated tolerance corresponding to a leaf junction that was too narrow. Despite this, no significant differences in patient specific VMAT quality assurance measured were observed between the accelerators and both passed monthly MLC quality assurance performed with the Hancock test. Conclusion: Results from the CAT showed LN2 with relative dose averages in the abutment regions of the diaphragm and MLC tests outside the tolerances resulting from differences in leaf gap distances. Tolerances of the dose average tests from the CAT may be small enough to detect MLC errors which do not significantly affect patient QA or the routine MLC tests.

  12. Diagnostic accuracy of five orthopedic clinical tests for diagnosis of superior labrum anterior posterior (SLAP) lesions.

    Science.gov (United States)

    Cook, Chad; Beaty, Stacy; Kissenberth, Michael J; Siffri, Paul; Pill, Stephan G; Hawkins, Richard J

    2012-01-01

    The clinical diagnosis of a superior labral anterior posterior (SLAP) tear is extremely challenging. Most studies that advocate selected tests have errors in study design or significant bias, or both. The purpose of this study was to identify the diagnostic utility of the Active Compression/O'Brien's test, Biceps Load II test, Dynamic Labral Shear test (O'Driscoll's test), Speed's test, and the Labral Tension test when diagnosing isolated SLAP lesions (SLAP-only) and a SLAP lesion with concomitant disorders (eg, rotator cuff tear), as stand-alone and clustered tests, with diagnostic confirmation by arthroscopic surgery. This diagnostic accuracy study was a case-based, case-control design that included 87 individuals with variable shoulder pathology. Of the 5 tests, only the Biceps Load II test demonstrated utility in identifying patients with a SLAP-only lesion, with a positive predictive value of 26 (95% confidence limits [CL], 18, 31), negative predictive value of 93 (95% CL, 84, 97), positive likelihood ratio of 1.7 (95% CL, 1.1, 2.6), and negative likelihood ratio of 0.39 (95% CL, 0.14, 0.91). No tests demonstrated diagnostic utility when diagnosing any SLAP lesion, including those with concomitant diagnoses. No clusters demonstrated better diagnostic accuracy than stand-alone findings. There are a number of potential reasons for the poor utility in the 5 test findings. The heterogeneous sample included patients with a variety of shoulder disorders. The study was organized using very strict methodologic controls that should reduce the risk of bias, which normally overinflates the accuracy of a specific tool. The findings may truly reflect the stand-alone, diagnostic utility of the 5 tests, suggesting when used alone provides little usefulness toward decision making of the diagnostic clinician. Copyright © 2012 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

  13. Repeat testing of low-level HIV-1 RNA: assay performance and implementation in clinical trials.

    Science.gov (United States)

    White, Kirsten; Garner, Will; Wei, Lilian; Eron, Joseph J; Zhong, Lijie; Miller, Michael D; Martin, Hal; Plummer, Andrew; Tran-Muchowski, Cecilia; Lindstrom, Kim; Porter, James; Piontkowsky, David; Light, Angela; Reiske, Heinz; Quirk, Erin

    2018-02-08

    Assess the performance of HIV-1 RNA repeat testing of stored samples in cases of low-level viremia during clinical trials. Prospective and retrospective analysis of randomized clinical trial samples and reference standards. To evaluate assay variability of the Cobas AmpliPrep/Cobas TaqMan HIV-1 Test, v2.0, three separate sources of samples were utilized: the World Health Organization (WHO) HIV reference standard (assayed using 50 independent measurements at six viral loads <200 copies/ml), retrospective analysis of four to six aliquots of plasma samples from four clinical trial participants, and prospective repeat testing of 120 samples from participants in randomized trials with low-level viremia. The TaqMan assay on the WHO HIV-1 RNA standards at viral loads <200 copies/ml performed within the expected variability according to assay specifications. However, standards with low viral loads of 36 and 18 copies/ml reported values of at least 50 copies/ml in 66 and 18% of tests, respectively. In participants treated with antiretrovirals who had unexpected viremia of 50-200 copies/ml after achieving <50 copies/ml, retesting of multiple aliquots of stored plasma found <50 copies/ml in nearly all cases upon retesting (14/15; 93%). Repeat testing was prospectively implemented in four clinical trials for all samples with virologic rebound of 50-200 copies/ml (n = 120 samples from 92 participants) from which 42% (50/120) had a retest result of less than 50 copies/ml and 58% (70/120) retested at least 50 copies/ml. The TaqMan HIV-1 RNA assay shows variability around 50 copies/ml that affects clinical trial results and may impact clinical practice. In participants with a history of viral load suppression, unexpected low-level viremia may be because of assay variability rather than low-drug adherence or true virologic failure. Retesting a stored aliquot of the same sample may differentiate between assay variability and virologic failure as the source

  14. Using the Script Concordance Test to Evaluate Clinical Reasoning Skills in Psychiatry.

    Science.gov (United States)

    Kazour, François; Richa, Sami; Zoghbi, Marouan; El-Hage, Wissam; Haddad, Fady G

    2017-02-01

    Although clinical reasoning is a major component of psychiatric training, most evaluating tools do not assess this skill properly. Clinicians mobilize networks of organized knowledge (scripts) to assess ambiguous or uncertain situations. The Script Concordance Test (SCT) was developed to assess clinical reasoning in an uncertainty context. The objective of this study was to test the usefulness of the SCT to assess the reasoning capacities of interns (7th year medical students) during the psychiatry training. The authors designed a SCT for psychiatry teaching, adapted to interns. The test contained 20 vignettes of five questions each. A reference panel of senior psychiatrists underwent the test, and we used their scoring as a reference for the student group. The SCT assessed the competence of students at the beginning and the end of their training in psychiatry. A panel of 10 psychiatrists and 47 interns participated to this study. As expected, the reference panel performed significantly (ppsychiatry rotation. The students improved significantly (ppsychiatry. This study shows the feasibility of this procedure and its utility in the field of psychiatry for evaluating medical students in their clinical reasoning competence. It can provide a valid alternative to classical evaluation methods.

  15. Improving Decision Making about Genetic Testing in the Clinic: An Overview of Effective Knowledge Translation Interventions.

    Directory of Open Access Journals (Sweden)

    France Légaré

    Full Text Available Knowledge translation (KT interventions are attempts to change behavior in keeping with scientific evidence. While genetic tests are increasingly available to healthcare consumers in the clinic, evidence about their benefits is unclear and decisions about genetic testing are thus difficult for all parties.We sought to identify KT interventions that involved decisions about genetic testing in the clinical context and to assess their effectiveness for improving decision making in terms of behavior change, increased knowledge and wellbeing.We searched for trials assessing KT interventions in the context of genetic testing up to March 2014 in all systematic reviews (n = 153 published by two Cochrane review groups: Effective Practice and Organisation of Care (EPOC and Consumers and Communication.We retrieved 2473 unique trials of which we retained only 28 (1%. Two EPOC reviews yielded two trials of KT interventions: audit and feedback (n = 1 and educational outreach (n = 1. Both targeted health professionals and the KT intervention they assessed was found to be effective. Four Consumers and Communication reviews yielded 26 trials: decision aids (n = 15, communication of DNA-based disease risk estimates (n = 7, personalized risk communication (n = 3 and mobile phone messaging (n = 1. Among these, 25 trials targeted only health consumers or patients and the KT interventions were found to be effective in four trials, partly effective in seven, and ineffective in four. Lastly, only one trial targeted both physicians and patients and was found to be effective.More research on the effectiveness of KT interventions regarding genetic testing in the clinical context may contribute to patients making informed value-based decisions and drawing the maximum benefit from clinical applications of genetic and genomic innovations.

  16. Analysis of clinical features, serologic and cerebrospinal fluid tests in patients with neurosyphilis at different stages

    Directory of Open Access Journals (Sweden)

    Bao-jie WANG

    2016-08-01

    Full Text Available Objective To summarize the clinical features, serologic, cerebrospinal fluid (CSF tests in patients with neurosyphilis at different stages.  Methods A retrospective analysis was made on the clinical features, imaging, serologic and CSF tests, treatment and prognosis of 12 cases diagnosed as neurosyphilis. In those cases, 5 cases were early-stage neurosyphilis, including 4 syphilitic meningitis (meningomyelitis and one meningovascular syphilis; 7 cases were late-stage neurosyphilis, all of whom were general paresis.  Results The serum Treponema pallidum antibody (TP-Ab and rapid plasma regain (RPR tests were positive in all 12 cases. The CSF TP-Ab tests of 12 cases were all positive and CSF RPR tests were positive in 9 cases. In 5 cases of early-stage neurosyphilis, one case had elevated intracranial pressure (ICP, 3 cases presented with elevated white blood cell (WBC, 4 cases had elevated protein concentration. In 7 cases of late-stage neurosyphilis, one case had elevated ICP, 7 cases presented with elevated WBC and protein concentration. CSF cytology showed lymphocyte reaction, mainly small lymphocytes. All cases were treated with different doses of intravenous penicillin or ceftriaxone sodium by intramuscular injection, among whom 8 cases presented improved neuropsychiatric symptoms, while 4 cases had no significant improvement.  Conclusions Neurosyphilis is easy to be misdiagnosed because of various styles of onset and nontypical clinical manifestations. A definite diagnosis depends on clinical manifestations and serologic and CSF examinations. Early diagnosis and standard treatment is essential for improving prognosis and reducing complications. DOI: 10.3969/j.issn.1672-6731.2016.07.005

  17. Diagnostic accuracy of the gravity stress test and clinical signs in cases of isolated supination-external rotation-type lateral malleolar fractures.

    Science.gov (United States)

    Nortunen, S; Flinkkilä, T; Lantto, I; Kortekangas, T; Niinimäki, J; Ohtonen, P; Pakarinen, H

    2015-08-01

    We prospectively assessed the diagnostic accuracy of the gravity stress test and clinical findings to evaluate the stability of the ankle mortise in patients with supination-external rotation-type fractures of the lateral malleolus without widening of the medial clear space. The cohort included 79 patients with a mean age of 44 years (16 to 82). Two surgeons assessed medial tenderness, swelling and ecchymosis and performed the external rotation (ER) stress test (a reference standard). A diagnostic radiographer performed the gravity stress test. For the gravity stress test, the positive likelihood ratio (LR) was 5.80 with a 95% confidence interval (CI) of 2.75 to 12.27, and the negative LR was 0.15 (95% CI 0.07 to 0.35), suggesting a moderate change from the pre-test probability. Medial tenderness, both alone and in combination with swelling and/or ecchymosis, indicated a small change (positive LR, 2.74 to 3.25; negative LR, 0.38 to 0.47), whereas swelling and ecchymosis indicated only minimal changes (positive LR, 1.41 to 1.65; negative LR, 0.38 to 0.47). In conclusion, when gravity stress test results are in agreement with clinical findings, the result is likely to predict stability of the ankle mortise with an accuracy equivalent to ER stress test results. When clinical examination suggests a medial-side injury, however, the gravity stress test may give a false negative result. ©2015 The British Editorial Society of Bone & Joint Surgery.

  18. Evaluation of Methacholine Challenge Test Results in Chronic Cough Patients Referring to Clinic of Pulmonary Disease

    Directory of Open Access Journals (Sweden)

    Derakhshan Deilami Gholamreza

    2009-10-01

    Full Text Available Chronic cough is a common problem in patients visiting physicians and its prevalence in different populations range from 3 to 40%. Postnasal drip, asthma and gastroesophageal reflux are the known cause of chronic cough. Although diagnosis of asthma is usually made by clinical signs and spirometeric results, methacholine challenge test is a good diagnostic test in patients who show normal physical examination and spirometeric results. In this study, the results of methacholine challenge test in chronic cough patients are investigated. This is a cross sectional study performed on patients suffering from chronic cough (over 8 weeks, who went to Pulmonary Disease Clinic of Imam Khomeini Hospital in 2006. Postnasal drip, gastroesophageal reflux was evaluated and ruled out in all patients. Then they were tested by methacholine inhalation using low to high doses of methacholine. The results of test was defined as 20% fall in FEV1 and its relationship with age, sex, history of allergic disease, family history of asthma and smoking status was investigated. 81 patients (36 female and 45 male entered this study who had mean age of 32.5 ± 13.06 years. 81.5% of patients had never smoked or closed contact with smokers, 6.2% were passive smokers, 8.6% were smokers and 3.7% had quit smoking. 37% had suffered from chronic cough less than 6 months, 11% for 6-11 months and 52% for more than 12 months. In 26% of patients, family history of asthma was present and 34.5% had a history of one type of allergy. In 29.5% the results of methacholine challenge test was positive, among them 45.8% showed an intense response and 54.2% a moderate response. The test results and its intensity had no statistically significant relationship with age, sex, smoking status, the duration of cough and family history of asthma, but the relationship between methacholine challenge test and the history of allergic disease was significant. Methacholine challenge test can be used as a

  19. 2016 American College of Rheumatology/European League Against Rheumatism Criteria for Minimal, Moderate, and Major Clinical Response in Juvenile Dermatomyositis : An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative

    NARCIS (Netherlands)

    Rider, Lisa G.; Aggarwal, Rohit; Pistorio, Angela; Bayat, Nastaran; Erman, Brian; Feldman, Brian M.; Huber, Adam M.; Cimaz, Rolando; Cuttica, Rubén J.; De Oliveira, Sheila Knupp; Lindsley, Carol B.; Pilkington, Clarissa A.; Punaro, Marilynn; Ravelli, Angelo; Reed, Ann M.; Rouster-Stevens, Kelly; van Royen-Kerkhof, Annet; Dressler, Frank; Magalhaes, Claudia Saad; Constantin, Tamás; Davidson, Joyce E.; Magnusson, Bo; Russo, Ricardo; Villa, Luca; Rinaldi, Mariangela; Rockette, Howard; Lachenbruch, Peter A.; Miller, Frederick W.; Vencovsky, Jiri; Ruperto, Nicolino; Rider, Lisa G.; Ruperto, Nicolino; Miller, Frederick W.; Aggarwal, Rohit; Erman, Brian; Bayat, Nastaran; Pistorio, Angela; Huber, Adam M.; Feldman, Brian M.; Hansen, Paul; Rockette, Howard; Lachenbruch, Peter A.; Ruperto, Nicolino; Rider, Lisa G.; Apaz, Maria T; Bowyer, Suzanne; Cimaz, Rolando; Constantin, Tamás; Curran, Megan; Davidson, Joyce E.; Feldman, Brian M.; Griffin, Thomas; Huber, Adam H.; Jones, Olcay; Kim, Susan; Lang, Bianca; Lindsley, Carol; Lovell, Daniel J.; Saad Magalhaes, Claudia; Pachman, Lauren M.; Pilkington, Clarissa; Ponyi, Andrea; Punaro, Marilynn; Quartier, Pierre; Ramanan, Athimalaipet V; Ravelli, Angelo; Reed, Ann M.; Rennebohm, Robert; Sherry, David D.; Silva, Clovis A.; Stringer, Elizabeth; van Royen-Kerkhof, Annet; Wallace, Carol; Miller, Frederick W.; Oddis, Chester V.; Reed, Ann M.; Rider, Lisa G.; Ruperto, Nicolino; Apaz, Maria T; Avcin, Tadej; Becker, Mara; Beresford, Michael W.; Cimaz, Rolando; Constantin, Tamás; Curran, Megan; Cuttica, Ruben; Davidson, Joyce E.; Dressler, Frank; Dvergsten, Jeffrey; Feitosa de Oliveira, Sheila Knupp; Feldman, Brian M.; Leme Ferriani, Virginia Paes; Flato, Berit; Gerloni, Valeria; Griffin, Thomas; Henrickson, Michael; Hinze, Claas; Hoeltzel, Mark; Huber, Adam M.; Ibarra, Maria; Ilowite, Norman T; Imundo, Lisa; Jones, Olcay; Kim, Susan; Kingsbury, Daniel; Lang, Bianca; Lindsley, Carol; Lovell, Daniel J.; Martini, Alberto; Saad Magalhaes, Claudia; Magnusson, Bo; Maguiness, Sheilagh; Maillard, Susan; Mathiesen, Pernille; McCann, Liza J.; Nielsen, Susan; Pachman, Lauren M.; Passo, Murray; Pilkington, Clarissa; Punaro, Marilynn; Quartier, Pierre; Rabinovich, Egla; Ramanan, Athimalaipet V; Ravelli, Angelo; Reed, Ann M.; Rennebohm, Robert; Rider, Lisa G.; Rivas-Chacon, Rafael; Byun Robinson, Angela; Rouster-Stevens, Kelly; Russo, Ricardo; Rutkowska-Sak, Lidia; Sallum, Adriana; Sanner, Helga; Schmeling, Heinrike; Selcen, Duygu; Shaham, Bracha; Sherry, David D.; Silva, Clovis A.; Spencer, Charles H.; Sundel, Robert; Tardieu, Marc; Thatayatikom, Akaluck; van der Net, Janjaap; van Royen-Kerkhof, Annet; Wahezi, Dawn; Wallace, Carol; Zulian, Francesco; analysis, Conjoint; Cimaz, Rolando; Constantin, Tamás; Cuttica, Ruben; Davidson, Joyce E.; Dressler, Frank; Knupp Feitosa de Oliveira, Sheila; Feldman, Brian M.; Griffin, Thomas; Henrickson, Michael; Huber, Adam M.; Imundo, Lisa; Lang, Bianca; Lindsley, Carol; Saad Magalhaes, Claudia; Magnusson, Bo; Maillard, Susan; Pachman, Lauren M.; Passo, Murray; Pilkington, Clarissa; Punaro, Marilynn; Ravelli, Angelo; Reed, Ann M.; Rider, Lisa G.; Rouster-Stevens, Kelly; Russo, Ricardo; Shaham, Bracha; Sundel, Robert; van der Net, Janjaap; van Royen-Kerkhof, Annet; Cimaz, Rolando; Cuttica, Rubén J.; Knupp Feitosa de Oliveira, Sheila; Feldman, Brian M.; Huber, Adam M.; Lindsley, Carol B.; Pilkington, Clarissa; Punaro, Marilynn; Ravelli, Angelo; Reed, Ann M.; Rouster-Stevens, Kelly; van Royen-Kerkhof, Annet; Amato, Anthony A; Chinoy, Hector; Cooper, Robert G.; Dastmalchi, Maryam; de Visser, Marianne; Fiorentino, David; Isenberg, David; Katz, James; Mammen, Andrew; Oddis, Chester V.; Ytterberg, Steven R.

    2017-01-01

    Objective: To develop response criteria for juvenile dermatomyositis (DM). Methods: We analyzed the performance of 312 definitions that used core set measures from either the International Myositis Assessment and Clinical Studies Group (IMACS) or the Paediatric Rheumatology International Trials

  20. 2016 American College of Rheumatology/European League Against Rheumatism Criteria for Minimal, Moderate, and Major Clinical Response in Juvenile Dermatomyositis An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative

    NARCIS (Netherlands)

    Rider, Lisa G.; Aggarwal, Rohit; Pistorio, Angela; Bayat, Nastaran; Erman, Brian; Feldman, Brian M.; Huber, Adam M.; Cimaz, Rolando; Cuttica, Rubén J.; de Oliveira, Sheila Knupp; Lindsley, Carol B.; Pilkington, Clarissa A.; Punaro, Marilynn; Ravelli, Angelo; Reed, Ann M.; Rouster-Stevens, Kelly; van Royen-Kerkhof, Annet; Dressler, Frank; Magalhaes, Claudia Saad; Constantin, Tamás; Davidson, Joyce E.; Magnusson, Bo; Russo, Ricardo; Villa, Luca; Rinaldi, Mariangela; Rockette, Howard; Lachenbruch, Peter A.; Miller, Frederick W.; Vencovsky, Jiri; Ruperto, Nicolino; Hansen, Paul; Apaz, Maria; Bowyer, Suzanne; Curran, Megan; Davidson, Joyce; Griffin, Thomas; Huber, Adam H.; Jones, Olcay; Kim, Susan; Lang, Bianca; Lindsley, Carol; Lovell, Daniel; Saad Magalhaes, Claudia; Pachman, Lauren M.; Pilkington, Clarissa; Ponyi, Andrea; Quartier, Pierre; Ramanan, Athimalaipet V.; Reed, Ann; Rennebohm, Robert

    2017-01-01

    Objective. To develop response criteria for juvenile dermatomyositis (DM). Methods. We analyzed the performance of 312 definitions that used core set measures from either the International Myositis Assessment and Clinical Studies Group (IMACS) or the Paediatric Rheumatology International Trials

  1. Catheter-based flow measurements in hemodialysis fistulas - Bench testing and clinical performance

    DEFF Research Database (Denmark)

    Heerwagen, Søren T; Lönn, Lars; Schroeder, Torben V

    2012-01-01

    Purpose: The purpose of this study was to perform bench and clinical testing of a catheter-based intravascular system capable of measuring blood flow in hemodialysis vascular accesses during endovascular procedures. Methods: We tested the Transonic ReoCath Flow Catheter System which uses...... the thermodilution method. A simulated vascular access model was constructed for the bench test. In total, 1960 measurements were conducted and the results were used to determine the accuracy and precision of the catheters, the effects of external factors (e.g., catheter placement, injection duration), and to test....... Blood flow measurements provide unique information on the hemodynamic status of a vascular access and have the potential to optimize results of interventions....

  2. European recommendations for the clinical use of HIV drug resistance testing: 2011 update

    DEFF Research Database (Denmark)

    Vandamme, Anne-Mieke; Camacho, Ricardo J; Ceccherini-Silberstein, Francesca

    2011-01-01

    is needed after treatment failure. The Panel recommends genotyping in most situations, using updated and clinically evaluated interpretation systems. It is mandatory that laboratories performing HIV resistance tests take part regularly in external quality assurance programs, and that they consider storing......The European HIV Drug Resistance Guidelines Panel, established to make recommendations to clinicians and virologists, felt that sufficient new information has become available to warrant an update of its recommendations, explained in both pocket guidelines and this full paper. The Panel makes...... the following recommendations concerning the indications for resistance testing: for HIV-1 (i) test earliest sample for protease and reverse transcriptase drug resistance in drug-naive patients with acute or chronic infection; (ii) test protease and reverse transcriptase drug resistance at virologic failure...

  3. The Impact of a Computerized Clinical Decision Support Tool on Inappropriate Clostridium difficile Testing.

    Science.gov (United States)

    White, Duncan R; Hamilton, Keith W; Pegues, David A; Hanish, Asaf; Umscheid, Craig A

    2017-10-01

    OBJECTIVE To evaluate the effectiveness of a computerized clinical decision support intervention aimed at reducing inappropriate Clostridium difficile testing DESIGN Retrospective cohort study SETTING University of Pennsylvania Health System, comprised of 3 large tertiary-care hospitals PATIENTS All adult patients admitted over a 2-year period INTERVENTION Providers were required to use an order set integrated into a commercial electronic health record to order C. difficile toxin testing. The order set identified patients who had received laxatives within the previous 36 hours and displayed a message asking providers to consider stopping laxatives and reassessing in 24 hours prior to ordering C. difficile testing. Providers had the option to continue or discontinue laxatives and to proceed with or forgo testing. The primary endpoint was the change in inappropriate C. difficile testing, as measured by the number of patients who had C. difficile testing ordered while receiving laxatives. RESULTS Compared to the 1-year baseline period, the intervention resulted in a decrease in the proportion of inappropriate C. difficile testing (29.6% vs 27.3%; P=.02). The intervention was associated with an increase in the number of patients who had laxatives discontinued and did not undergo C. difficile testing (5.8% vs 46.4%; Ptesting (5.4% vs 35.2%; Ptesting and improving the timely discontinuation of laxatives. Infect Control Hosp Epidemiol 2017;38:1204-1208.

  4. Mainstreaming cancer genetics: A model integrating germline BRCA testing into routine ovarian cancer clinics.

    Science.gov (United States)

    Kentwell, Maira; Dow, Eryn; Antill, Yoland; Wrede, C David; McNally, Orla; Higgs, Emily; Hamilton, Anne; Ananda, Sumitra; Lindeman, Geoffrey J; Scott, Clare L

    2017-04-01

    Owing to the rapid increase in clinical need, we aimed to implement and review the performance of a mainstreaming model of germline BRCA1/2 genetic testing in eligible women with high grade non-mucinous epithelial ovarian cancer via a Genetic Counselor embedded in the gynecology oncology clinic. The model implemented involved a specialized referral form, weekly genetics-lead multidisciplinary review of referrals, and pre- and post-test genetic counseling provided by an embedded genetic counselor during chemotherapy chair time. Performance and outcomes were retrospectively audited over the following two consecutive one year periods, including survey data on medical specialist comfort with mainstreaming and the model. Sixty-four women underwent mainstreamed BRCA1/2 testing over the two year post-implementation period with a rate of detection of BRCA1/2 pathogenic variants of 17%. The referral rate for eligible women significantly increased to over 90% (pgenetic testing results was less than five months, with >90% of patients receiving results during first line chemotherapy. Genetic counseling time decreased from 120 to 54min. Cancer specialists were comfortable with the model. The mainstreaming model proved effective, increasing uptake of genetic testing in eligible patients to over 90%; it was efficient for patients, genetic counselors and cancer specialists and acceptable to cancer specialists. It facilitated co-location of genetic and oncology service delivery but separation of clinical responsibility for genetic testing to a specialist genetics service, ensuring accurate and robust patient-centred care. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Clinical acceptance testing and scanner comparison of ultrasound shear wave elastography.

    Science.gov (United States)

    Long, Zaiyang; Tradup, Donald J; Song, Pengfei; Stekel, Scott F; Chen, Shigao; Glazebrook, Katrina N; Hangiandreou, Nicholas J

    2018-03-15

    Because of the rapidly growing use of ultrasound shear wave elastography (SWE) in clinical practices, there is a significant need for development of clinical physics performance assessment methods for this technology. This study aims to report two clinical medical physicists' tasks: (a) acceptance testing (AT) of SWE function on ten commercial ultrasound systems for clinical liver application and (b) comparison of SWE measurements of targets across vendors for clinical musculoskeletal application. For AT, ten GE LOGIQ E9 XDclear 2.0 scanners with ten C1-6-D and ten 9L-D transducers were studied using two commercial homogenous phantoms. Five measurements were acquired at two depths for each scanner/transducer pair by two operators. Additional tests were performed to access effects of different coupling media, phantom locations and operators. System deviations were less than 5% of group mean or three times standard deviation; therefore, all systems passed AT. A test protocol was provided based on results that no statistically significant difference was observed between using ultrasound gel and salt water for coupling, among different phantom locations, and that interoperator and intraoperator coefficient of variation was less than 3%. For SWE target measurements, two systems were compared - a Supersonic Aixplorer scanner with a SL10-2 and a SL15-4 transducer, and an abovementioned GE scanner with 9L-D transducer. Two stepped cylinders with diameters of 4.05-10.40 mm were measured both longitudinally and transaxially. Target shear wave speed quantification was performed using an in-house MATLAB program. Using the target shear wave speed deduced from phantom specs as a reference, SL15-4 performed the best at the measured depth. However, it was challenging to reliably measure a 4.05 mm target for either system. The reported test methods and results could provide important information when dealing with SWE-related tasks in the clinical environment. © 2018 The Authors

  6. Economic impact of rapid diagnostic methods in Clinical Microbiology: Price of the test or overall clinical impact.

    Science.gov (United States)

    Cantón, Rafael; Gómez G de la Pedrosa, Elia

    2017-12-01

    The need to reduce the time it takes to establish a microbiological diagnosis and the emergence of new molecular microbiology and proteomic technologies has fuelled the development of rapid and point-of-care techniques, as well as the so-called point-of-care laboratories. These laboratories are responsible for conducting both techniques partially to response to the outsourcing of the conventional hospital laboratories. Their introduction has not always been accompanied with economic studies that address their cost-effectiveness, cost-benefit and cost-utility, but rather tend to be limited to the unit price of the test. The latter, influenced by the purchase procedure, does not usually have a regulated reference value in the same way that medicines do. The cost-effectiveness studies that have recently been conducted on mass spectrometry in the diagnosis of bacteraemia and the use of antimicrobials have had the greatest clinical impact and may act as a model for future economic studies on rapid and point-of-care tests. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  7. Certain performance values arising from mammographic test set readings correlate well with clinical audit.

    Science.gov (United States)

    Soh, BaoLin Pauline; Lee, Warwick Bruce; Mello-Thoms, Claudia; Tapia, Kriscia; Ryan, John; Hung, Wai Tak; Thompson, Graham; Heard, Rob; Brennan, Patrick

    2015-08-01

    Test sets have been increasingly utilised to augment clinical audit in breast screening programmes; however, their relationship has never been satisfactorily understood. This study examined the relationship between mammographic test set performance and clinical audit data. Clinical audit data over a 2-year period was generated for each of 20 radiologists. Sixty mammographic examinations, consisting of 40 normal and 20 cancer cases, formed the test set. Readers located any identifiable cancer, and levels of confidence were scored from 2 to 5, where a score of 3 and above is considered a recall rating. Jackknifing free response operating characteristic (JAFROC) figure-of-merit (FOM), location sensitivity and specificity were calculated for individual readers and then compared with clinical audit values using Spearman's rho. JAFROC FOM showed significant correlations to: recall rate at a first round of screening (r = 0.51; P = 0.02); rate of small invasive cancers per 10 000 reads (r = 0.5; P = 0.02); percentage of all cancers read that were not recalled (r = -0.51; P = 0.02); and sensitivity (r = 0.51; P = 0.02). Location sensitivity demonstrated significant correlations with: rate of small invasive cancers per 10 000 reads (r = 0.46; P = 0.04); rate of DCIS (ductal carcinoma in situ) per 10 000 reads (r = 0.44; P = 0.05); detection rate of all invasive cancers and DCIS per 10 000 reads (r = 0.54; P = 0.01); percentage of all cancers read that were not recalled (r = -0.57; P = 0.009); and sensitivity (r = 0.57; P = 0.009). No other significant relationships were noted. Performance indicators from test set demonstrate significant correlations with specific aspects of clinical performance, although caution needs to be exercised when generalising test set specificity to the clinical situation. © 2015 The Royal Australian and New Zealand College of Radiologists.

  8. Rapid antimicrobial susceptibility testing of clinical isolates by digital time-lapse microscopy

    DEFF Research Database (Denmark)

    Fredborg, M; Rosenvinge, F S; Spillum, E

    2015-01-01

    (168 antimicrobial agent-organism combinations) demonstrated 3.6 % minor, no major and 1.2 % very major errors of the oCelloScope system compared to conventional susceptibility testing, as well as a rapid and correct phenotypic detection of strains with methicillin-resistant Staphylococcus aureus (MRSA......Rapid antimicrobial susceptibility testing (AST) is essential for early and appropriate therapy. Methods with short detection time enabling same-day treatment optimisation are highly favourable. In this study, we evaluated the potential of a digital time-lapse microscope system, the o......CelloScope system, to perform rapid AST. The oCelloScope system demonstrated a very high accuracy (96 % overall agreement) when determining the resistance profiles of four reference strains, nine clinical isolates, including multi-drug-resistant isolates, and three positive blood cultures. AST of clinical isolates...

  9. A multi-centre phase IIa clinical study of predictive testing for preeclampsia

    DEFF Research Database (Denmark)

    Navaratnam, Kate; Alfirevic, Zarko; Baker, Philip N

    2013-01-01

    5% of first time pregnancies are complicated by pre-eclampsia, the leading cause of maternal death in Europe. No clinically useful screening test exists; consequentially clinicians are unable to offer targeted surveillance or preventative strategies. IMPROvED Consortium members have pioneered...... a personalised medicine approach to identifying blood-borne biomarkers through recent technological advancements, involving mapping of the blood metabolome and proteome. The key objective is to develop a sensitive, specific, high-throughput and economically viable early pregnancy screening test for pre-eclampsia....

  10. Using mobile clinics to deliver HIV testing and other basic health services in rural Malawi.

    Science.gov (United States)

    Lindgren, T G; Deutsch, K; Schell, E; Bvumbwe, A; Hart, K B; Laviwa, J; Rankin, S H

    2011-01-01

    The majority of Malawians are impoverished and primarily dependant on subsistence farming, with 85% of the population living in a rural area. The country is highly affected by HIV and under-resourced rural health centers struggle to meet the government's goal of expanding HIV testing, antiretroviral treatment, and other basic services. This report describes the work of two four-wheel drive mobile clinics launched in 2008 to fill an identified service gap in the remote areas of Mulanje District, Malawi. The program was developed by an international non-governmental organization, Global AIDS Interfaith Alliance (GAIA), and the Mulanje District Health Office, with funding from the Elizabeth Taylor HIV/AIDS Foundation. The clinics provide: (1) rapid HIV testing and treatment referral; (2) diagnosis and treatment of malaria; (3) sputum collection for TB screening; (4) diagnosis and treatment of sexually transmitted and opportunistic infections; and (5) pre-natal care. The clinic vehicles provide medical supplies and personnel (a clinical officer, nurse, and nurse aide) to set up clinics in community buildings such as churches or schools. In such a project, the implementation process and schedule can be affected by medication, supply chain and infrastructural issues, as well as governmental and non-governmental requirements. Timelines should be sufficiently flexible to accommodate unexpected delays. Once established, service scheduling should be flexible and responsive; for instance, malaria treatment rather than HIV testing was most urgently needed in the season when these services were launched. Assessing the impact of healthcare delivery in Malawi is challenging. Although mobile clinic and the government Health Management Information System (HMIS) data were matched, inconsistent variables and gaps in data made direct comparisons difficult. Data collection was compromised by the competing demand of high patient volume; however, rather than reducing the burden on

  11. Current practices and challenges in the standardization and harmonization of clinical laboratory tests123

    Science.gov (United States)

    Vesper, Hubert W; Myers, Gary L; Miller, W Greg

    2016-01-01

    Effective patient care, clinical research, and public health efforts require comparability of laboratory results independent of time, place, and measurement procedure. Comparability is achieved by establishing metrological traceability, which ensures that measurement procedures measure the same quantity and that the calibration of measurement procedures is traceable to a common reference system consisting of reference methods and materials. Whereas standardization ensures traceability to the International System of Units, harmonization ensures traceability to a reference system agreed on by convention. This article provides an overview of standardization and harmonization with an emphasis on commutability as an important variable that affects testing accuracy. Commutability of reference materials is required to ensure that traceability is established appropriately and that laboratory results are comparable. The use of noncommutable reference materials leads to inaccurate results. Whereas procedures and protocols for standardizing measurements are established and have been successfully applied in efforts such as the Hormones Standardization Program of the CDC, harmonization activities require new, more complex procedures and approaches. The American Association for Clinical Chemistry, together with its domestic and international partners, formed the International Consortium for Harmonization of Clinical Laboratory Results to coordinate harmonization efforts. Reference systems, as well as procedures and protocols to establish traceability of clinical laboratory tests, have been established and continue to be developed by national and international groups and organizations. Serum tests of thyroid function, including those for the thyroid hormones thyroxine and triiodothyronine, are among the clinical procedures for which standardization efforts are well under way. Approaches to the harmonization of measurement procedures for serum concentrations of thyroid

  12. The Script Concordance Test: a new tool assessing clinical judgement in neurology.

    Science.gov (United States)

    Lubarsky, Stuart; Chalk, Colin; Kazitani, Driss; Gagnon, Robert; Charlin, Bernard

    2009-05-01

    Clinical judgment, the ability to make appropriate decisions in uncertain situations, is central to neurological practice, but objective measures of clinical