Clinical assessment of the accuracy of blood glucose measurement devices.

PubMed

Pfützner, Andreas; Mitri, Michael; Musholt, Petra B; Sachsenheimer, Daniela; Borchert, Marcus; Yap, Andrew; Forst, Thomas

2012-04-01

Blood glucose meters for patient self-measurement need to comply with the accuracy standards of the ISO 15197 guideline. We investigated the accuracy of the two new blood glucose meters BG*Star and iBG*Star (Sanofi-Aventis) in comparison to four other competitive devices (Accu-Chek Aviva, Roche Diagnostics; FreeStyle Freedom Lite, Abbott Medisense; Contour, Bayer; OneTouch Ultra 2, Lifescan) at different blood glucose ranges in a clinical setting with healthy subjects and patients with type 1 and type 2 diabetes. BGStar and iBGStar are employ dynamic electrochemistry, which is supposed to result in highly accurate results. The study was performed on 106 participants (53 female, 53 male, age (mean ± SD): 46 ± 16 years, type 1: 32 patients, type 2: 34 patients, and 40 healthy subjects). Two devices from each type and strips from two different production lots were used for glucose assessment (∼200 readings/meter). Spontaneous glucose assessments and glucose or insulin interventions under medical supervision were applied to perform measurements in the different glucose ranges in accordance with the ISO 15197 requirements. Sample values <50 mg/dL and >400 mg/dL were prepared by laboratory manipulations. The YSI glucose analyzer (glucose oxidase method) served as the standard reference method which may be considered to be a limitation in light of glucose hexokinase-based meters. For all devices, there was a very close correlation between the glucose results compared to the YSI reference method results. The correlation coefficients were r = 0.995 for BGStar and r = 0.992 for iBGStar (Aviva: 0.995, Freedom Lite: 0.990, Contour: 0.993, Ultra 2: 0.990). Error-grid analysis according to Parkes and Clarke revealed both 100% of the readings to be within the clinically acceptable areas (Clarke: A + B with BG*Star (100 + 0), Aviva (97 + 3), and Contour (97 + 3); and 99.5% with iBG*Star (97.5 + 2), Freedom Lite (98 + 1.5), and Ultra

The Clinical Relevance of Force Platform Measures in Multiple Sclerosis: A Review

PubMed Central

Prosperini, Luca; Pozzilli, Carlo

2013-01-01

Balance impairment and falls are frequent in patients with multiple sclerosis (PwMS), and they may occur even at the earliest stage of the disease and in minimally impaired patients. The introduction of computer-based force platform measures (i.e., static and dynamic posturography) has provided an objective and sensitive tool to document both deficits and improvements in balance. By using more challenging test conditions, force platform measures can also reveal subtle balance disorders undetectable by common clinical scales. Furthermore, posturographic techniques may also allow to reliably identify PwMS who are at risk of accidental falls. Although force platform measures offer several theoretical advantages, only few studies extensively investigated their role in better managing PwMS. Standardised procedures, as well as clinical relevance of changes detected by static or dynamic posturography, are still lacking. In this review, we summarized studies which investigated balance deficit by means of force platform measures, focusing on their ability in detecting patients at high risk of falls and in estimating rehabilitation-induced changes, highlighting the pros and the cons with respect to clinical scales. PMID:23766910

Commutability of control materials for external quality assessment of serum apolipoprotein A-I measurement.

PubMed

Zeng, Jie; Qi, Tianqi; Wang, Shu; Zhang, Tianjiao; Zhou, Weiyan; Zhao, Haijian; Ma, Rong; Zhang, Jiangtao; Yan, Ying; Dong, Jun; Zhang, Chuanbao; Chen, Wenxiang

2018-04-25

The aim of the current study was to evaluate the commutability of commercial control materials and human serum pools and to investigate the suitability of the materials for the external quality assessment (EQA) of serum apolipoprotein A-I (apo A-I) measurement. The Clinical and Laboratory Standards Institute (CLSI) EP14-A3 protocol was used for the commutability study. Apo A-I concentrations in two levels of commercial control materials used in EQA program, two fresh-frozen human serum pools (FSPs) and two frozen human serum pools prepared from residual clinical specimens (RSPs) were measured along with 50 individual samples using nine commercial assays. Measurement results of the 50 individual samples obtained with different assays were pairwise analyzed by Deming regression, and 95% prediction intervals (PIs) were calculated. The commutability of the processed materials was evaluated by comparing the measurement results of the materials with the limits of the PIs. The FSP-1 was commutable for all the 36 assay pairs, and FSP-2 was commutable for 30 pairs; RSP-1 and RSP-2 showed commutability for 27/36 and 22/36 assay pairs, respectively, whereas the two EQA materials were commutable only for 4/36 and 5/36 assay pairs, respectively. Non-commutability of the tested EQA materials has been observed among current apo A-I assays. EQA programs need either to take into account the commutability-related biases in the interpretation of the EQA results or to use more commutable materials. Frozen human serum pools were commutable for most of the assays.

Validation of the iHealth BP3 upper-arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Chen, Can; Shang, Fujun; Wang, Jiepin; Chen, Jianghong; Ji, Na; Wan, Yi

2012-12-01

This study aimed to evaluate the performance of the iHealth BP3 upper-arm blood pressure monitor, which is designed for clinic use and self-measurement of blood pressure using Apple touch devices as an interface. The European Society of Hypertension International Protocol (ESH-IP) revision 2010 for the validation of blood pressure measuring devices in adults was followed precisely. Ninty-nine couples of test device and reference blood pressure measurements were obtained during the study (three pairs for each of the 33 participants). The 33 participants, age 47.1±12.3 years (age range 27-69 years) and arm circumference 30.0±4.4 cm, had a mean systolic blood pressure (SBP) of 143.9±27.4 mmHg and a mean diastolic blood pressure (DBP) of 90.1±18.3 mmHg. The device passed all of the requirements fulfilling the standards of the protocol, and the mean±SD device-observer difference was 2.8±4.2 mmHg for SBP and -0.4±3.5 mmHg for DBP. According to the results of the validation study on the basis of the ESH-IP revision 2010, the iHealth BP3 can be recommended for clinic use and self-measurement in an adult population. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Examples for the importance of radiophysical measurements in clinical phototherapy.

PubMed

Schneider, Lars Alexander; Wlaschek, Meinhard; Dissemond, Joachim; Scharffetter-Kochanek, Karin

2007-05-01

Optimal UV therapy requires regular surveillance of the variables that influence therapeutic success. In daily practice, phototherapy equipment is often operated with an attitude of "autocontrol." This implies that thorough control measurements of the emission spectra and calibration of UV fluences are not routinely performed. For both quality control and patient safety, it is essential to regularly check whether a UV source is providing the right target spectrum with the correct dose to the skin. We have exemplarily taken three UV sources currently used in clinical practice and performed radiophysical measurements, i. e. determined emission spectra, radiation output and correctness of dose calculation. All three sources revealed either a largely inhomogeneous distribution pattern of radiation intensity, variation of radiation intensity over time or insufficient filtering of the UV lamp emission spectrum. Furthermore the dose calculation procedures had to be revised because of significant differences between the estimated and the administered UV doses. Radiophysical measurement of all UV-equipment in clinical use is a simple and effective way to improve the safety and reliability of phototherapy. Such measurements help to uncover technical flaws in radiation sources and prevent unnecessary side effects and UV exposure risks for the patient.

Critical dosimetry measures and surrogate tools that can facilitate clinical success in PDT (Conference Presentation)

NASA Astrophysics Data System (ADS)

Pogue, Brian W.; Davis, Scott C.; Kanick, Stephen C.; Maytin, Edward V.; Pereira, Stephen P.; Palanisami, Akilan; Hasan, Tayyaba

2016-03-01

Photodynamic therapy can be a highly complex treatment with more than one parameter to control, or in some cases it is easily implemented with little control other than prescribed drug and light values. The role of measured dosimetry as related to clinical adoption has not been as successful as it could have been, and part of this may be from the conflicting goals of advocating for as many measurements as possible for accurate control, versus companies and clinical adopters advocating for as few measurements as possible, to keep it simple. An organized approach to dosimetry selection is required, which shifts from mechanistic measurements in pre-clinical and early phase I trials, towards just those essential dose limiting measurements and a focus on possible surrogate measures in phase II/III trials. This essential and surrogate approach to dosimetry should help successful adoption of clinical PDT if successful. The examples of essential dosimetry points and surrogate dosimetry tools which might be implemented in phase II and higher trials are discussed for solid tissue PDT with verteporfin and skin lesion treatment with aminolevulinc acid.

Clinically relevant response and remission outcomes in cariprazine-treated patients with bipolar I disorder.

PubMed

Earley, Willie; Durgam, Suresh; Lu, Kaifeng; Ruth, Adam; Németh, György; Laszlovszky, István; Yatham, Lakshmi N

2018-01-15

Rates of response and remission are measures that endorse the clinical significance of treatment. Cariprazine is FDA approved for the acute treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adults. Post hoc analyses of pooled data from 3 pivotal trials of cariprazine in manic/mixed episodes associated with bipolar I disorder were conducted to investigate the effect of cariprazine on various criteria of response and remission. The constituent studies were 3-week randomized, double-blind, placebo-controlled, multicenter, parallel-group phase II/III studies in adult patients (age 18-65 years) with bipolar I disorder (NCT00488618, NCT01058096, NCT01058668). Post hoc analyses included Young Mania Rating Scale (YMRS) outcomes for response (≥50% decrease in score), remission (total score ≤12 and ≤8), cumulative remission, and global improvement. Additionally, composite remission (YMRS total score ≤12 plus Montgomery-Åsberg Depression Rating Scale total score ≤12) and worsening/switch to depression (MADRS total score ≥15) by week were investigated. Rates of response and remission were significantly greater for cariprazine versus placebo on every measure evaluated (P < .01 all analyses); the estimated number needed to treat for each measure was ≤10. There was no evidence of worsening/switch to depression. Post hoc analyses, short treatment duration, no active comparator. Cariprazine-treated patients with bipolar I disorder attained clinically significant improvement in manic symptoms as shown by significantly greater rates of response and remission versus placebo; improvement in manic symptoms did not induce depressive symptoms. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

An international dosimetry exchange for boron neutron capture therapy. Part I: Absorbed dose measurements.

PubMed

Binns, P J; Riley, K J; Harling, O K; Kiger, W S; Munck af Rosenschöld, P M; Giusti, V; Capala, J; Sköld, K; Auterinen, I; Serén, T; Kotiluoto, P; Uusi-Simola, J; Marek, M; Viererbl, L; Spurny, F

2005-12-01

An international collaboration was organized to undertake a dosimetry exchange to enable the future combination of clinical data from different centers conducting neutron capture therapy trials. As a first step (Part I) the dosimetry group from the Americas, represented by MIT, visited the clinical centers at Studsvik (Sweden), VTT Espoo (Finland), and the Nuclear Research Institute (NRI) at Rez (Czech Republic). A combined VTT/NRI group reciprocated with a visit to MIT. Each participant performed a series of dosimetry measurements under equivalent irradiation conditions using methods appropriate to their clinical protocols. This entailed in-air measurements and dose versus depth measurements in a large water phantom. Thermal neutron flux as well as fast neutron and photon absorbed dose rates were measured. Satisfactory agreement in determining absorbed dose within the experimental uncertainties was obtained between the different groups although the measurement uncertainties are large, ranging between 3% and 30% depending upon the dose component and the depth of measurement. To improve the precision in the specification of absorbed dose amongst the participants, the individually measured dose components were normalized to the results from a single method. Assuming a boron concentration of 15 microg g(-1) that is typical of concentrations realized clinically with the boron delivery compound boronophenylalanine-fructose, systematic discrepancies in the specification of the total biologically weighted dose of up to 10% were apparent between the different groups. The results from these measurements will be used in future to normalize treatment plan calculations between the different clinical dosimetry protocols as Part II of this study.

Predicting clinical concussion measures at baseline based on motivation and academic profile.

PubMed

Trinidad, Katrina J; Schmidt, Julianne D; Register-Mihalik, Johna K; Groff, Diane; Goto, Shiho; Guskiewicz, Kevin M

2013-11-01

The purpose of this study was to predict baseline neurocognitive and postural control performance using a measure of motivation, high school grade point average (hsGPA), and Scholastic Aptitude Test (SAT) score. Cross-sectional. Clinical research center. Eighty-eight National Collegiate Athletic Association Division I incoming student-athletes (freshman and transfers). Participants completed baseline clinical concussion measures, including a neurocognitive test battery (CNS Vital Signs), a balance assessment [Sensory Organization Test (SOT)], and motivation testing (Rey Dot Counting). Participants granted permission to access hsGPA and SAT total score. Standard scores for each CNS Vital Signs domain and SOT composite score. Baseline motivation, hsGPA, and SAT explained a small percentage of the variance of complex attention (11%), processing speed (12%), and composite SOT score (20%). Motivation, hsGPA, and total SAT score do not explain a significant amount of the variance in neurocognitive and postural control measures but may still be valuable to consider when interpreting neurocognitive and postural control measures.

Metadata-driven Clinical Data Loading into i2b2 for Clinical and Translational Science Institutes.

PubMed

Post, Andrew R; Pai, Akshatha K; Willard, Richard; May, Bradley J; West, Andrew C; Agravat, Sanjay; Granite, Stephen J; Winslow, Raimond L; Stephens, David S

2016-01-01

Clinical and Translational Science Award (CTSA) recipients have a need to create research data marts from their clinical data warehouses, through research data networks and the use of i2b2 and SHRINE technologies. These data marts may have different data requirements and representations, thus necessitating separate extract, transform and load (ETL) processes for populating each mart. Maintaining duplicative procedural logic for each ETL process is onerous. We have created an entirely metadata-driven ETL process that can be customized for different data marts through separate configurations, each stored in an extension of i2b2 's ontology database schema. We extended our previously reported and open source Eureka! Clinical Analytics software with this capability. The same software has created i2b2 data marts for several projects, the largest being the nascent Accrual for Clinical Trials (ACT) network, for which it has loaded over 147 million facts about 1.2 million patients.

Metadata-driven Clinical Data Loading into i2b2 for Clinical and Translational Science Institutes

PubMed Central

Post, Andrew R.; Pai, Akshatha K.; Willard, Richard; May, Bradley J.; West, Andrew C.; Agravat, Sanjay; Granite, Stephen J.; Winslow, Raimond L.; Stephens, David S.

2016-01-01

Clinical and Translational Science Award (CTSA) recipients have a need to create research data marts from their clinical data warehouses, through research data networks and the use of i2b2 and SHRINE technologies. These data marts may have different data requirements and representations, thus necessitating separate extract, transform and load (ETL) processes for populating each mart. Maintaining duplicative procedural logic for each ETL process is onerous. We have created an entirely metadata-driven ETL process that can be customized for different data marts through separate configurations, each stored in an extension of i2b2 ‘s ontology database schema. We extended our previously reported and open source Eureka! Clinical Analytics software with this capability. The same software has created i2b2 data marts for several projects, the largest being the nascent Accrual for Clinical Trials (ACT) network, for which it has loaded over 147 million facts about 1.2 million patients. PMID:27570667

New calibration method for I-scan sensors to enable the precise measurement of pressures delivered by 'pressure garments'.

PubMed

Macintyre, Lisa

2011-11-01

Accurate measurement of the pressure delivered by medical compression products is highly desirable both in monitoring treatment and in developing new pressure inducing garments or products. There are several complications in measuring pressure at the garment/body interface and at present no ideal pressure measurement tool exists for this purpose. This paper summarises a thorough evaluation of the accuracy and reproducibility of measurements taken following both of Tekscan Inc.'s recommended calibration procedures for I-scan sensors; and presents an improved method for calibrating and using I-scan pressure sensors. The proposed calibration method enables accurate (±2.1 mmHg) measurement of pressures delivered by pressure garments to body parts with a circumference ≥30 cm. This method is too cumbersome for routine clinical use but is very useful, accurate and reproducible for product development or clinical evaluation purposes. Copyright © 2011 Elsevier Ltd and ISBI. All rights reserved.

Verification measurements and clinical evaluation of the iPlan RT Monte Carlo dose algorithm for 6 MV photon energy

NASA Astrophysics Data System (ADS)

Petoukhova, A. L.; van Wingerden, K.; Wiggenraad, R. G. J.; van de Vaart, P. J. M.; van Egmond, J.; Franken, E. M.; van Santvoort, J. P. C.

2010-08-01

This study presents data for verification of the iPlan RT Monte Carlo (MC) dose algorithm (BrainLAB, Feldkirchen, Germany). MC calculations were compared with pencil beam (PB) calculations and verification measurements in phantoms with lung-equivalent material, air cavities or bone-equivalent material to mimic head and neck and thorax and in an Alderson anthropomorphic phantom. Dosimetric accuracy of MC for the micro-multileaf collimator (MLC) simulation was tested in a homogeneous phantom. All measurements were performed using an ionization chamber and Kodak EDR2 films with Novalis 6 MV photon beams. Dose distributions measured with film and calculated with MC in the homogeneous phantom are in excellent agreement for oval, C and squiggle-shaped fields and for a clinical IMRT plan. For a field with completely closed MLC, MC is much closer to the experimental result than the PB calculations. For fields larger than the dimensions of the inhomogeneities the MC calculations show excellent agreement (within 3%/1 mm) with the experimental data. MC calculations in the anthropomorphic phantom show good agreement with measurements for conformal beam plans and reasonable agreement for dynamic conformal arc and IMRT plans. For 6 head and neck and 15 lung patients a comparison of the MC plan with the PB plan was performed. Our results demonstrate that MC is able to accurately predict the dose in the presence of inhomogeneities typical for head and neck and thorax regions with reasonable calculation times (5-20 min). Lateral electron transport was well reproduced in MC calculations. We are planning to implement MC calculations for head and neck and lung cancer patients.

Validity of the Digital Inclinometer and iPhone When Measuring Thoracic Spine Rotation.

PubMed

Bucke, Jonathan; Spencer, Simon; Fawcett, Louise; Sonvico, Lawrence; Rushton, Alison; Heneghan, Nicola R

2017-09-01

  Spinal axial rotation is required for many functional and sporting activities. Eighty percent of axial rotation occurs in the thoracic spine. Existing measures of thoracic spine rotation commonly involve laboratory equipment, use a seated position, and include lumbar motion. A simple performance-based outcome measure would allow clinicians to evaluate isolated thoracic spine rotation. Currently, no valid measure exists.   To explore the criterion and concurrent validity of a digital inclinometer (DI) and iPhone Clinometer app (iPhone) for measuring thoracic spine rotation using the heel-sit position.   Controlled laboratory study.   University laboratory.   A total of 23 asymptomatic healthy participants (14 men, 9 women; age = 25.82 ± 4.28 years, height = 170.26 ± 8.01 cm, mass = 67.50 ± 9.46 kg, body mass index = 23.26 ± 2.79) were recruited from a student population.   We took DI and iPhone measurements of thoracic spine rotation in the heel-sit position concurrently with dual-motion analysis (laboratory measure) and ultrasound imaging of the underlying bony tissue motion (reference standard). To determine the criterion and concurrent validity, we used the Pearson product moment correlation coefficient (r, 2 tailed) and Bland-Altman plots.   The DI (r = 0.88, P < .001) and iPhone (r = 0.88, P < .001) demonstrated strong criterion validity. Both also had strong concurrent validity (r = 0.98, P < .001). Bland-Altman plots illustrated mean differences of 5.82° (95% confidence interval [CI] = 20.37°, -8.73°) and 4.94° (95% CI = 19.23°, -9.35°) between the DI and iPhone, respectively, and the reference standard and 0.87° (95% CI = 6.79°, -5.05°) between the DI and iPhone.   The DI and iPhone provided valid measures of thoracic spine rotation in the heel-sit position. Both can be used in clinical practice to assess thoracic spine rotation, which may be valuable when evaluating thoracic dysfunction.

[Clinical research=design*measurements*statistical analyses].

PubMed

Furukawa, Toshiaki

2012-06-01

A clinical study must address true endpoints that matter for the patients and the doctors. A good clinical study starts with a good clinical question. Formulating a clinical question in the form of PECO can sharpen one's original question. In order to perform a good clinical study one must have a knowledge of study design, measurements and statistical analyses: The first is taught by epidemiology, the second by psychometrics and the third by biostatistics.

Clinical height measurements are unreliable: a call for improvement.

PubMed

Mikula, A L; Hetzel, S J; Binkley, N; Anderson, P A

2016-10-01

Height measurements are currently used to guide imaging decisions that assist in osteoporosis care, but their clinical reliability is largely unknown. We found both clinical height measurements and electronic health record height data to be unreliable. Improvement in height measurement is needed to improve osteoporosis care. The aim of this study is to assess the accuracy and reliability of clinical height measurement in a university healthcare clinical setting. Electronic health record (EHR) review, direct measurement of clinical stadiometer accuracy, and observation of staff height measurement technique at outpatient facilities of the University of Wisconsin Hospital and Clinics. We examined 32 clinical stadiometers for reliability and observed 34 clinic staff perform height measurements at 12 outpatient primary care and specialty clinics. An EHR search identified 4711 men and women age 43 to 89 with no known metabolic bone disease who had more than one height measurement over 3 months. The short study period and exclusion were selected to evaluate change in recorded height not due to pathologic processes. Mean EHR recorded height change (first to last measurement) was -0.02 cm (SD 1.88 cm). Eighteen percent of patients had height measurement differences noted in the EHR of ≥2 cm over 3 months. The technical error of measurement (TEM) was 1.77 cm with a relative TEM of 1.04 %. None of the staff observed performing height measurements followed all recommended height measurement guidelines. Fifty percent of clinic staff reported they on occasion enter patient reported height into the EHR rather than performing a measurement. When performing direct measurements on stadiometers, the mean difference from a gold standard length was 0.24 cm (SD 0.80). Nine percent of stadiometers examined had an error of >1.5 cm. Clinical height measurements and EHR recorded height results are unreliable. Improvement in this measure is needed as an adjunct to improve

Measuring health-related quality of life in drug clinical trials: is it given due importance?

PubMed

Miguel, Ramón San; López-González, Ana María; Sanchez-Iriso, Eduardo; Mar, Javier; Cabasés, Juan M

2008-04-01

Efficacy estimations of drug clinical trials have been based on clinical measurements and survival rates. However, advances in psychometric techniques have allowed to incorporate a new dimension based on quality of life. Questionnaires aimed at measuring patients' health status outlook, now enable us to quantify the loss of quality of life caused by disease and the improvement that can be achieved by pharmacological treatments. The Aim of this study is to make a quantitative evaluation of the use of health related quality of life (HRQL) measures in drug clinical trials. A systematic review was performed, in duplicate, of the five journals with highest contribution to the ACP Journal Club, i.e. New England Journal of Medicine, JAMA, The Lancet, Annals of Internal Medicine and the British Medical Journal. HRQL measures were evaluated in published articles referring to drug clinical trials. We identified 193 articles that reported the results of clinical trials, of which 28 included QOL measures as secondary end points and two as primary end points: in total, these comprised 16% of the articles analysed. Discussion Without considering the relevance of HRQL measures as a tool in the allocation of resources, it should be included as a health outcome dimension in drug clinical trials. The absence of this evaluation in studies about chronic diseases that affects patients' daily life activities would not be justified. HRQL measures are not used on a regular basis in drug clinical trials that are reported in the relevant literature. Systematic incorporation of QOL measures into clinical trials would make it possible to measure the benefit obtained from drug treatments taking into account the patients' perceptions. Moreover, it would encourage the development of prospective cost-effectiveness studies with patient recorded data in the context of clinical trials. Our findings have a direct impact on practice. Being conscious of the low use of HRQL in clinical trials, it could

Contingent negative variation in patients with deficit schizophrenia or bipolar I disorder with psychotic features: measurement and correlation with clinical characteristics.

PubMed

Li, Zhe; Deng, Wei; Liu, Xiang; Zheng, Zhong; Li, Mingli; Li, Yinfei; Han, Yuanyuan; Ma, Xiaohong; Wang, Qiang; Liu, Xiehe; Li, Tao

2015-04-01

Schizophrenia is a highly heterogeneous disease. Event-related potentials have been regarded to establish intermediate phenotypes of schizophrenia. Our previous study found that patients with deficit schizophrenia (DS) are relatively homogeneous and show a significantly longer onset latency of contingent negative variation (CNV) expectancy wave. To further examine CNV in patients with first-episode and drug-naïve DS or bipolar I disorder (BP I) with psychotic features, and also investigate correlations between CNV and clinical characteristics in DS and BP I. We elicited a CNV using an alarm (S1)-imperative (S2) paradigm in 30 DS patients or 33 BP I with psychotic features as well as 40 healthy controls. CNV amplitude was significantly smaller and reaction time significantly longer in the DS and BP I groups than in healthy controls. Post-imperative negative variation (PINV) interval was significantly shorter in the DS group than in healthy controls. The onset latency of CNV expectancy wave was significantly longer and PINV area significantly smaller in the DS group than in the other groups. In the DS group, CNV amplitude and PINV interval correlated negatively with the subscale of negative symptoms on the Positive and Negative Syndrome Scale (PANSS); CNV amplitude also correlated negatively with disease duration. In the BP I group, CNV amplitude and reaction time showed no correlation with clinical features. CNV amplitude is a common trait marker for psychosis. The onset latency of CNV expectancy wave appears to be a specific trait marker and may be used to identify candidate genes for DS.

Cortisol levels in fingernails, neurocognitive performance and clinical variables in euthymic bipolar I disorder.

PubMed

Herane-Vives, Andres; Cleare, Anthony J; Chang, Chin-Kuo; de Angel, Valeria; Papadopoulos, Andrew; Fischer, Susanne; Halari, Rozmin; Cheung, Eric Y W; Young, Allan H

2017-03-27

Neurocognitive impairment has been found in bipolar patients. Hypercortisolemia is one possible cause but there has been no agreement on this. Previous sampling methods assessed only acute cortisol levels, whereas the association between cortisol and psychopathology might be better understood by investigating chronic levels. Fingernails are a novel method for measuring chronic cortisol concentration (CCC). Here, we measured CCC in euthymic bipolar disorder I (BD-I) patients and healthy controls using fingernails to investigate whether differences in CCC influenced neurocognitive performance. We also investigated whether differences in clinical illness variables influenced CCC in euthymic BD-I patients. A previous study demonstrated neurocognitive impairment in euthymic BD-I patients. The current study included a portion of this sample: 40 BD-I versus 42 matched controls who provided fingernail samples. There was no statistically significant difference in CCC between controls and BD-I (P = .09). Logistic regression analyses revealed that euthymic bipolar I subjects with more than five years of current euthymia had decreased odds of having higher fingernail cortisol concentration (>71.2 pg/mg) compared to those with less than 1.5 years (P = .04). There was no association between CCC and cognitive impairment in all domains before and after adjustment for age and sex. The current evidence suggests CCC is not a trait biomarker in euthymic BD-I (BD-I). Longer periods of stability in affective disorders are associated with lower CCC. Fingernail cortisol does not seem to be implicated in neurocognitive impairment and BD-I. Future studies may investigate CCC in different illness phases of BD-I.

Lack of transferability between two automated immunoassays for serum IGF-I measurement.

PubMed

Gomez-Gomez, Carolina; Iglesias, Eva M; Barallat, Jaume; Moreno, Fernando; Biosca, Carme; Pastor, Mari-Cruz; Granada, Maria-Luisa

2014-01-01

IGF-I is a clinically relevant protein in the diagnosis and monitoring of treatment of growth disor- ders. The Growth Hormone Research Society and the International IGF Research Society have encouraged the adoption of a universal calibration for immunoassays to improve standardization of IGF-I measurements, but currently commercial assays are calibrated either against the old WHO IRR 87/518 or the new WHO 02/254. We compared two IGF-I immunochemiluminescent assays: IMMULITE® 2000 (Siemens) and LIAISON® (DiaSorin), which differ in their standardization, and verified their precision according to quality specifications based on biological variation and their linear range. 62 patient serum samples were analyzed for both assays and compared according to standards of the Clinical and Laboratory Standards Institute (CLSI), EP9-A2-IR. Precision was verified according to CLSI EP15- A2. Optimal coefficient of variation (CVo) and desirable coefficient of variation (CVd) for IGF-I assays were calculated as quality specifications based on the biological variability, in order to assess if the interassay analytical CV (CVa1) in the two methods were appropriate. Two dilution series using the 1st WHO International Standard (WHO IS) for IGF-I 02/254 were used to verify and compare the linearity range. The regression analysis showed constant and proportional differences for serum samples (slope b = 0.8115 (CI 95% CI; 0.7575-0.8556); intercept a = 33.6873 (95% CI: 23.3613-44.0133) between assays and similar pro- portional differences for WHO IS 02/254 standard dilutions series (slope b = 0.8024 (CI 95% CI; 0.7560-0.8616); intercept a = 6.9623 (95% CI: -2.0819-18.4383) between assays. Within-laboratory coefficients of variation for low and high levels were 2.82% and 3.80% for IMMULITE® 2000 and 3.58% and 2.14% for LIAISON®, respecttively. IGF-I concentrations measured by both assays are not transferable. The results emphasize the need to express IGF-I concentrations in standard

Assessment of Minimum 124I Activity Required in Uptake Measurements Before Radioiodine Therapy for Benign Thyroid Diseases.

PubMed

Gabler, Anja S; Kühnel, Christian; Winkens, Thomas; Freesmeyer, Martin

2016-08-01

This study aimed to assess a hypothetical minimum administered activity of (124)I required to achieve comparability between pretherapeutic radioiodine uptake (RAIU) measurements by (124)I PET/CT and by (131)I RAIU probe, the clinical standard. In addition, the impact of different reconstruction algorithms on (124)I RAIU and the evaluation of pixel noise as a parameter for image quality were investigated. Different scan durations were simulated by different reconstruction intervals of 600-s list-mode PET datasets (including 15 intervals up to 600 s and 5 different reconstruction algorithms: filtered-backprojection and 4 iterative techniques) acquired 30 h after administration of 1 MBq of (124)I. The Bland-Altman method was used to compare mean (124)I RAIU levels versus mean 3-MBq (131)I RAIU levels (clinical standard). The data of 37 patients with benign thyroid diseases were assessed. The impact of different reconstruction lengths on pixel noise was investigated for all 5 of the (124)I PET reconstruction algorithms. A hypothetical minimum activity was sought by means of a proportion equation, considering that the length of a reconstruction interval equates to a hypothetical activity. Mean (124)I RAIU and (131)I RAIU already showed high levels of agreement for reconstruction intervals of as short as 10 s, corresponding to a hypothetical minimum activity of 0.017 MBq of (124)I. The iterative algorithms proved generally superior to the filtered-backprojection algorithm. (124)I RAIU showed a trend toward higher levels than (131)I RAIU if the influence of retrosternal tissue was not considered, which was proven to be the cause of a slight overestimation by (124)I RAIU measurement. A hypothetical minimum activity of 0.5 MBq of (124)I obtained with iterative reconstruction appeared sufficient both visually and with regard to pixel noise. This study confirms the potential of (124)I RAIU measurement as an alternative method for (131)I RAIU measurement in benign thyroid

Interchangeability of Procalcitonin Measurements Using the Point of Care Testing i-CHROMATM Reader and the Automated Liaison XL.

PubMed

Stenner, Elisabetta; Barbati, Giulia; West, Nicole; Ben, Fabia Del; Martin, Francesca; Ruscio, Maurizio

2018-06-01

Our aim was to verify if procalcitonin (PCT) measurements using the new point-of-care testing i-CHROMATM are interchangeable with those of Liaison XL. One hundred seventeen serum samples were processed sequentially on a Liaison XL and i-CHROMATM. Statistical analysis was done using the Passing-Bablok regression, Bland-Altman test, and Cohen's Kappa statistic. Proportional and constant differences were observed between i-CHROMATM and Liaison XL. The 95% CI of the mean bias% was very large, exceeding the maximum allowable TE% and the clinical reference change value. However, the concordance between methods at the clinical relevant cutoffs was strong, with the exception of the 0.25 ng/mL cutoff which was moderate. Our data suggest that i-CHROMATM is not interchangeable with Liaison XL. However, while the strong concordance at the clinical relevant cutoffs allows us to consider i-CHROMATM a suitable option to Liaison XL to support clinicians' decision-making; nevertheless, the moderate agreement at the 0.25 ng/mL cutoff recommends caution in interpreting the data around this cutoff.

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

PubMed Central

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

2014-01-01

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

Late 124I PET/CT Uptake Measurement-Assessment of Appropriate Examination Protocol in Benign Thyroid Diseases.

PubMed

Freesmeyer, Martin; Gabler, Anja S; Kühnel, Christian; Winkens, Thomas

2017-07-01

This study aimed at investigating the performance of late I PET/CT for radioiodine uptake (RAIU) measurement at 336 hours after administration in patients with benign thyroid diseases requiring radioiodine therapy. Special attention was paid to the comparability of I uptake (I-RAIU) to the clinical standard (I-RAIU, probe measurement). Considering cost aspects, we sought to establish an economically reasonable examination protocol based on scan duration and administered activity. List-mode PET data sets of 40-minute acquisition time were acquired 336 hours after administration of 1 MBq I in 18 patients. Different scan durations were simulated by different reconstruction intervals (RIs) ranging from 5 seconds to 40 minutes, and total thyroid activity was measured. Mean I-RAIU levels of each RI were compared with mean I-RAIU levels (3 MBq). A hypothetical scan duration or hypothetical activity, respectively, was sought by means of a proportion equation, considering that the length of an RI is equitable to a hypothetical activity. After 336 hours, the mean total thyroid activity was 254 ± 7.7 kBq for I and 26.9 ± 8.7 kBq for I. The mean I-RAIU and I-RAIU showed high levels of agreement for RI from 2 minutes to 40 minutes. Reconstruction interval shorter than 2 minutes did not result in sufficient agreement. The present study confirmed the feasibility of late I PET/CT as alternative method for RAIU measurement in patients with benign thyroid diseases; 1 MBq I PET/CT scans as short as 2 minutes resulted in RAIU levels comparable to those of standard I-RAIU. The parameter "appropriate scan-duration activity product" is proposed to enable an economically reasonable examination protocol.

Clinical and laboratory analysis of late-onset glutaric aciduria type I (GA-I) in Uighur: A report of two cases.

PubMed

Zhang, Xiaoying; Luo, Qiong

2017-02-01

The aim of the present study was to investigate the clinical, biochemical and genetic mutation characteristics of two cases of late-onset glutaric aciduria type I (GA-I) in Uighur. The clinical data and glutaryl-CoA dehydrogenase (GCDH) genetic test results of two cases of late-onset GA-I in Uighur were collected and analyzed, and reviewed with relevant literature. One patient with late-onset GA-I primarily exhibited clinical intermittent headache, while the other patient was asymptomatic. The urinary organic acid analysis detected a large number of glutaric acid and 3-hydroxy glutaric acid, 3-hydroxy-propionic acid. One patient exhibited white matter degeneration in cranial magnetic resonance imaging (MRI) and the other patient showed no abnormality. The two patients both exhibited c. 1204C >T, p.R402W, heterozygous mutation, and c. 532G >A, p.G178R, heterozygous mutation. Besides central nervous system infectious diseases, patients with clinical headache, cranial MRI-suggested bilateral temporal lobe arachnoid cyst and abnormal signals in the basal ganglia should be highly suspected as late-onset GA-I. Early diagnosis and correct treatment are key to improve its prognosis.

Clinical and laboratory analysis of late-onset glutaric aciduria type I (GA-I) in Uighur: A report of two cases

PubMed Central

Zhang, Xiaoying; Luo, Qiong

2017-01-01

The aim of the present study was to investigate the clinical, biochemical and genetic mutation characteristics of two cases of late-onset glutaric aciduria type I (GA-I) in Uighur. The clinical data and glutaryl-CoA dehydrogenase (GCDH) genetic test results of two cases of late-onset GA-I in Uighur were collected and analyzed, and reviewed with relevant literature. One patient with late-onset GA-I primarily exhibited clinical intermittent headache, while the other patient was asymptomatic. The urinary organic acid analysis detected a large number of glutaric acid and 3-hydroxy glutaric acid, 3-hydroxy-propionic acid. One patient exhibited white matter degeneration in cranial magnetic resonance imaging (MRI) and the other patient showed no abnormality. The two patients both exhibited c. 1204C >T, p.R402W, heterozygous mutation, and c. 532G >A, p.G178R, heterozygous mutation. Besides central nervous system infectious diseases, patients with clinical headache, cranial MRI-suggested bilateral temporal lobe arachnoid cyst and abnormal signals in the basal ganglia should be highly suspected as late-onset GA-I. Early diagnosis and correct treatment are key to improve its prognosis. PMID:28352331

Sensation seeking amongst healthy volunteers participating in phase I clinical trials.

PubMed Central

Farré, M; Lamas, X; Camí, J

1995-01-01

1. Phase I clinical trials are usually carried out in healthy volunteers. In addition to economic gain, factors that may influence willingness to participate include scientific interest, curiosity and choice for risky activities. 2. We assessed the relationship between personality variables and volunteering for clinical pharmacology research. Two personality questionnaires, the Sensation Seeking Scale (SSS, form V) and the Eysenck Personality Questionnaire (EPQ), were administered to 48 male healthy university students who volunteered to participate in a phase I clinical trial and to 43 male university students who were not willing to participate in phase I clinical trials. General norm data were also used for the comparison of results. 3. When healthy volunteers were compared with unwilling subjects, significant differences were found in thrill-and-adventure seeking (7.9 vs 6.7, P = 0.0034), experience seeking (6.4 vs 5.2, P = 0.0012), disinhibition (6.2 vs 4.3, P < 0.0001), boredom susceptibility (3.9 vs 2.8, P = 0.0073), total sensation seeking trait (24.3 vs 19.0, P < 0.0001), extraversion (15.1 vs 13.3, P = 0.0490), and psychoticism (4.4 vs 3.5, P = 0.0086). When healthy volunteers were compared with general norm data similar statistically significant differences were found in all these scales, except for boredom susceptibility and psychoticism. 4. The personality profile of healthy volunteers was characterized by a higher sensation seeking trait and extraversion as compared with individuals who were not willing to participate in phase I clinical trials and general norm data. PMID:7640147

EVALUATION OF THE I-STAT PORTABLE CLINICAL ANALYZER FOR MEASUREMENT OF IONIZED CALCIUM AND SELECTED BLOOD CHEMISTRY VALUES IN ASIAN ELEPHANTS (ELEPHAS MAXIMUS).

PubMed

Tarbert, Danielle K; Behling-Kelly, Erica; Priest, Heather; Childs-Sanford, Sara

2017-06-01

Thei-STAT® portable clinical analyzer (PCA) provides patient-side results for hematologic, biochemical, and blood gas values when immediate results are desired. This analyzer is commonly used in nondomestic animals; however, validation of this method in comparison with traditional benchtop methods should be performed for each species. In this study, the i-STAT PCA was compared with the Radiometer ABL 800 Flex benchtop analyzer using 24 heparinized whole blood samples obtained from healthy E. maximus . In addition, the effect of sample storage was evaluated on the i-STAT PCA. Analytes evaluated were hydrogen ion concentration (pH), glucose, potassium (K + ), sodium (Na + ), bicarbonate (HCO 3 - ), total carbon dioxide (TCO 2 ), partial pressure of carbon dioxide (PCO 2 ), and ionized calcium (iCa 2+ ). Statistical analysis using correlation coefficients, Passing-Bablok regression analysis, and Bland-Altman plots found good agreement between results from samples run immediately after phlebotomy and 4 hr postsampling on the i-STAT PCA with the exception of K + , which is known to change with sample storage. Comparison of the results from the two analyzers at 4 hr postsampling found very strong or strong correlation in all values except K + , with statistically significant bias in all values except glucose and PCO 2 . Despite bias, mean differences assessed via Bland-Altman plots were clinically acceptable for all analytes excluding K + . Within the reference range for iCa 2+ , the iCa 2+ values obtained by the i-STAT PCA and Radiometer ABL 800 Flex were close in value, however in light of the constant and proportionate biases detected, overestimation at higher values and underestimation at lower values of iCa 2+ by the i-STAT PCA would be of potential concern. This study supports the use of the i-STAT PCA for the evaluation of these analytes, with the exception of K + , in the Asian elephant.

[Do you measure gait speed in your daily clinical practice? A review].

PubMed

Inzitari, Marco; Calle, Alicia; Esteve, Anna; Casas, Álvaro; Torrents, Núria; Martínez, Nicolás

Gait speed (GS), measured at usual pace, is an easy, quick, reliable, non-expensive and informative measurement. With a standard chronometer, like those that currently found in mobile phones, and with two marks on the floor, trained health professionals obtain a more objective and quick measurement compared with many geriatric scales used in daily practice. GS is one of the pillars of the frailty phenotype, and is closely related to sarcopenia. It is a powerful marker of falls incidence, disability and death, mostly useful in the screening of older adults that live in the community. In recent years, the evidence is reinforcing the usefulness of GS in acute care and post-surgical patients. Its use in patients with cognitive impairment is suggested, due to the strong link between cognitive and physical function. Although GS meets the criteria for a good geriatric screening tool, it is not much used in clinical practice. Why? This review has different aims: (i)disentangling the relationship between GS and frailty; (ii)reviewing the protocols to measure GS and the reference values; (iii)reviewing the evidence in different clinical groups (older adults with frailty, with cognitive impairment, with cancer or other pathologies), and in different settings (community, acute care, rehabilitation), and (iv)speculating about the reasons for its poor use in clinical practice and about the gaps to be filled. Copyright © 2016 SEGG. Publicado por Elsevier España, S.L.U. All rights reserved.

Nanoscale Structure of Type I Collagen Fibrils: Quantitative Measurement of D-spacing

PubMed Central

Erickson, Blake; Fang, Ming; Wallace, Joseph M.; Orr, Bradford G.; Les, Clifford M.; Holl, Mark M. Banaszak

2012-01-01

This paper details a quantitative method to measure the D-periodic spacing of Type I collagen fibrils using Atomic Force Microscopy coupled with analysis using a 2D Fast Fourier Transform approach. Instrument calibration, data sampling and data analysis are all discussed and comparisons of the data to the complementary methods of electron microscopy and X-ray scattering are made. Examples of the application of this new approach to the analysis of Type I collagen morphology in disease models of estrogen depletion and Osteogenesis Imperfecta are provided. We demonstrate that it is the D-spacing distribution, not the D-spacing mean, that showed statistically significant differences in estrogen depletion associated with early stage Osteoporosis and Osteogenesis Imperfecta. The ability to quantitatively characterize nanoscale morphological features of Type I collagen fibrils will provide important structural information regarding Type I collagen in many research areas, including tissue aging and disease, tissue engineering, and gene knock out studies. Furthermore, we also envision potential clinical applications including evaluation of tissue collagen integrity under the impact of diseases or drug treatments. PMID:23027700

Clinical and laboratory features of HTLV-I asymptomatic carriers and patients with HTLV-I-associated myelopathy/tropical spastic paraparesis from the Brazilian Amazon

PubMed Central

Takatani, Massanobu; Crispim, Myuki Esashika; Fraiji, Nelson; Stefani, Mariane Martins Araujo; Kiesslich, Dagmar

2017-01-01

ABSTRACT Clinical and laboratory parameters including blood and cerebrospinal fluid (CSF) neopterin were investigated in human-T-lymphotropic-virus-type-I associated-myelopathy/tropical-spastic-paraparesis-HAM/TSP and in HTLV-I carriers. HAM/TSP (n = 11, 2 males/9 females, median age = 48 years), recently diagnosed HTLV-I carriers (n = 21, 15 females/6 males, median age = 44 years), healthy individuals (n = 20, 10 males/10 females, median age = 34.6 years) from the Brazilian Amazon (Manaus, Amazonas State) were investigated. Neopterin was measured (IBL ELISA Neopterin, Germany) in serum samples of all the participants, in CSF of 9 HAM/TSP patients as well as in 6 carriers. In HAM/TSP patients, CSF cell counts, protein and glucose were measured, the Osame’s motor-disability-score/OMDS was determined, and brain/spinal cord magnetic-resonance-imaging (MRI) was performed. HAM/TSP patients had normal CSF glucose, leukocyte counts; and normal protein levels predominated. Brain-MRI showed white-matter lesions in 7 out of 11 HAM/TSP patients. OMDS varied from 2-8: 9 were able to walk, 2 were wheel-chair-users. The median serum neopterin concentration in HAM/TSP patients was 6.6 nmol/ L; min. 2.8- max. 12.5 nmol/ L); was lower in carriers (4.3 nmol/L; min. 2.7- max. 7.2 nmol/ L) as well as in healthy participants (4.7 nmol/ L; min. 2.7- max. 8.0 nmol/ L) (p < 0.05). CSF neopterin concentrations in HAM/TSP patients were higher than in serum samples, and higher compared to carriers (p < 0.05). Carriers had similar serum-CSF neopterin concentrations compared to healthy participants. Variable clinical and laboratory profiles were seen in HAM/TSP patients, however our results support the neopterin measurement as a potential biomarker of disease activity. PMID:28380116

Ten years of iPSC: clinical potential and advances in vitro hematopoietic differentiation.

PubMed

Paes, Bárbara Cristina Martins Fernandes; Moço, Pablo Diego; Pereira, Cristiano Gonçalves; Porto, Geciane Silveira; de Sousa Russo, Elisa Maria; Reis, Luiza Cunha Junqueira; Covas, Dimas Tadeu; Picanço-Castro, Virginia

2017-06-01

Ten years have passed since the first publication announcing the generation of induced pluripotent stem cells (iPSCs). Issues related to ethics, immune rejection, and cell availability seemed to be solved following this breakthrough. The development of iPSC technology allows advances in in vitro cell differentiation for cell therapy purpose and other clinical applications. This review provides a perspective on the iPSC potential for cell therapies, particularly for hematological applications. We discuss the advances in in vitro hematopoietic differentiation, the possibilities to employ iPSC in hematology studies, and their potential clinical application in hematologic diseases. The generation of red blood cells and functional T cells and the genome editing technology applied to mutation correction are also covered. We highlight some of the requirements and obstacles to be overcome before translating these cells from research to the clinic, for instance, iPSC variability, genotoxicity, the differentiation process, and engraftment. Also, we evaluate the patent landscape and compile the clinical trials in the field of pluripotent stem cells. Currently, we know much more about iPSC than in 2006, but there are still challenges that must be solved. A greater understanding of molecular mechanisms underlying the generation of hematopoietic stem cells is necessary to produce suitable and transplantable hematopoietic stem progenitor cells from iPSC.

Safety of phase I clinical trials with monoclonal antibodies in Germany--the regulatory requirements viewed in the aftermath of the TGN1412 disaster.

PubMed

Liedert, B; Bassus, S; Schneider, C K; Kalinke, U; Löwer, J

2007-01-01

This review summarizes scientific, ethical and regulatory aspects of Phase I clinical trials with monoclonal antibodies. The current standard requirements for pre-clinical testing and for clinical study design are presented. The scientific considerations discussed herein are generally applicable, the view on legal requirements for clinical trials refer to the German jurisdiction only. The adverse effects associated with the TGN1412 Phase I trial indicate that the predictive value of pre-clinical animal models requires reevaluation and that, in certain cases, some issues of clinical trial protocols such as dose fixing may need refinement or redesign. Concrete safety measures, which have been proposed as a consequence of the TGN1412 event include introduction of criteria for high-risk antibodies, sequential inclusion of trial participants and implementation of pre-Phase I studies where dose calculation is based on the pre-clinical No Effect Level instead of the No Observed Adverse Effect Level. The recently established European clinical trials database (EUDRACT Database) is a further safety tool to expedite the sharing of relevant information between scientific authorities.

Neurocognitive function in clinically stable individuals with long-term bipolar I disorder: Comparisons with schizophrenia patients and controls.

PubMed

Lin, Pei-Yun; Wang, Peng-Wei; Chen, Cheng-Sheng; Yen, Cheng-Fang

2017-05-01

This study compared the levels of the five domains of neurocognitive function-executive function, attention, memory, verbal comprehension, and perceptual organization-among clinically stable individuals with long-term bipolar I disorder, individuals with long-term schizophrenia, and a group of controls. We recruited a total of 93 clinically stable individuals with bipolar I disorder, 94 individuals with schizophrenia, and 106 controls in this study. Their neurocognitive function was measured using a series of neurocognitive function tests: the Wechsler Adult Intelligence Scale-Third Edition (WAIS-III), Line Cancellation Test, Visual Form Discrimination, Controlled Oral Word Association Test, Wisconsin Card Sorting Test, Continuous Performance Task, and Wechsler Memory Scale-Third Edition. Neurocognitive function was compared among the three groups through a multivariate analysis of variance. The results indicated that when the effect of age was controlled, clinically stable individuals with bipolar I disorder and those with schizophrenia demonstrated poor neurocognitive function on all tests except for the WAIS-III Similarity and Information and the Line Cancellation Test. The individuals with bipolar I disorder had similar levels of neurocognitive function compared with the schizophrenia group, but higher levels of neurocognitive function on the WAIS-III Comprehension, Controlled Oral Word Association Test, and Wechsler Memory Scale-Third Edition Auditory Immediate and Delayed Index and Visual Immediate and Delayed Index. The conclusions of this study suggest that compared with controls, individuals with long-term bipolar I disorder and those with long-term schizophrenia have poorer neurocognitive function, even when clinically stable. Individuals with long-term bipolar I disorder and those with long-term schizophrenia have similar levels of deficits in several domains of neurocognitive function. Copyright © 2017. Published by Elsevier Taiwan.

Recommendations for Self-Report Outcome Measures in Vulvodynia Clinical Trials.

PubMed

Pukall, Caroline F; Bergeron, Sophie; Brown, Candace; Bachmann, Gloria; Wesselmann, Ursula

2017-08-01

Vulvodynia (idiopathic chronic vulvar pain) is a prevalent condition associated with significant and negative impacts in many areas of function. Despite the increased research interest in vulvodynia in recent years, recommendations for outcome measures for use in clinical trials are missing. The purpose of this paper, therefore, was to provide recommendations for outcome measures for vulvodynia clinical trials so that consistent measures are used across trials to facilitate between-study comparisons and the conduct of large multicenter trials, and to improve measurement of the multiple dimensions of vulvodynia. Given that provoked vestibulodynia (PVD)-characterized by provoked pain localized to the vaginal opening-is the most common subtype of vulvodynia and the current main focus of clinical trials, this paper focused on recommended outcome measures in PVD clinical trials. The framework used to guide the selection of outcome measures was based on the one proposed by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). The IMMPACT framework provided a well-suited guideline for outcome measure recommendations in PVD clinical trials. However, given the provoked presentation of PVD and the significant impact it has on sexuality, modifications to some of the IMMPACT recommendations were made and specific additional measures were suggested. Measures that are specific to vulvovaginal pain are ideal for adoption in PVD clinical trials, and many such measures currently exist that allow the relevant IMMPACT domains to be captured.

Use of outcome measures in pulmonary hypertension clinical trials.

PubMed

Parikh, Kishan S; Rajagopal, Sudarshan; Arges, Kristine; Ahmad, Tariq; Sivak, Joseph; Kaul, Prashant; Shah, Svati H; Tapson, Victor; Velazquez, Eric J; Douglas, Pamela S; Samad, Zainab

2015-09-01

To evaluate the use of surrogate measures in pulmonary hypertension (PH) clinical trials and how it relates to clinical practice. Studies of pulmonary arterial hypertension (PAH) employ a variety of surrogate measures in addition to clinical events because of a small patient population, participant burden, and costs. The use of these measures in PH drug trials is poorly defined. We searched PubMed/MEDLINE/Embase for randomized or prospective cohort PAH clinical treatment trials from 1985 to 2013. Extracted data included intervention, trial duration, study design, patient characteristics, and primary and secondary outcome measures. To compare with clinical practice, we assessed the use of surrogate measures in a clinical sample of patients on PH medications at Duke University Medical Center between 2003 and 2014. Between 1985 and 2013, 126 PAH trials were identified and analyzed. Surrogate measures served as primary endpoints in 119 trials (94.0%). Inclusion of invasive hemodynamics decreased over time (78.6%, 75.0%, 52.2%; P for trend = .02), while functional testing (7.1%, 60.0%, 81.5%; P for trend < .0001) and functional status or quality of life (0%, 47.6%, 62.8%; P for trend < .0001) increased in PAH trials over the same time periods. Echocardiography data were reported as a primary or secondary outcome in 32 trials (25.4%) with increased use from 1985-1994 to 1995-2004 (7.1% vs 35.0%, P = .04), but the trend did not continue to 2005-2013 (25.0%). In comparison, among 450 patients on PAH therapies at our institution between 2003 and 2013, clinical assessments regularly incorporated serial echocardiography and 6-minute walk distance tests (92% and 95% of patients, respectively) and repeat measurement of invasive hemodynamics (46% of patients). The majority of PAH trials have utilized surrogate measures as primary endpoints. The use of these surrogate endpoints has evolved significantly over time with increasing use of patient-centered endpoints and decreasing or

The clinical applicability of a daily summary of patients' self-reported postoperative pain-A repeated measure analysis.

PubMed

Wikström, Lotta; Eriksson, Kerstin; Fridlund, Bengt; Nilsson, Mats; Årestedt, Kristofer; Broström, Anders

2017-12-01

(i) To determine whether a central tendency, median, based on patients' self-rated pain is a clinically applicable daily measure to show patients' postoperative pain on the first day after major surgery (ii) and to determine the number of self-ratings required for the calculation of this measure. Perioperative pain traits in medical records are difficult to overview. The clinical applicability of a daily documented summarising measure of patients' self-rated pain scores is little explored. A repeated measure design was carried out at three Swedish country hospitals. Associations between the measures were analysed with nonparametric statistical methods; systematic and individual group changes were analysed separately. Measure I: pain scores at rest and activity postoperative day 1; measure II: retrospective average pain from postoperative day 1. The sample consisted of 190 general surgery patients and 289 orthopaedic surgery patients with a mean age of 65; 56% were men. Forty-four percent had a pre-operative daily intake of analgesia, and 77% used postoperative opioids. A range of 4-9 pain scores seem to be eligible for the calculation of the daily measures of pain. Rank correlations for individual median scores, based on four ratings, vs. retrospective self-rated average pain, were moderate and strengthened with increased numbers of ratings. A systematic group change towards a higher level of reported retrospective pain was significant. The median values were clinically applicable daily measures. The risk of obtaining a higher value than was recalled by patients seemed to be low. Applicability increased with increased frequency of self-rated pain scores and with high-quality pain assessments. The documenting of daily median pain scores at rest and during activity could constitute the basis for obtaining patients' experiences by showing their pain severity trajectories. The measures could also be an important key to predicting postoperative health

Preliminary Vibration Measurements on Mark I Vehicle

DOT National Transportation Integrated Search

1971-01-01

Preliminary measurements have been made on the acceleration and vibration environment of the Mark I vehicle while operating on the New York City Transit System. Measurements at the journal box indicated shor period high acceleration pulses as lage as...

Semi-spontaneous oral text production: measurements in clinical practice.

PubMed

Lind, Marianne; Kristoffersen, Kristian Emil; Moen, Inger; Simonsen, Hanne Gram

2009-12-01

Functionally relevant assessment of the language production of speakers with aphasia should include assessment of connected speech production. Despite the ecological validity of everyday conversations, more controlled and monological types of texts may be easier to obtain and analyse in clinical practice. This article discusses some simple measurements for the analysis of semi-spontaneous oral text production by speakers with aphasia. Specifically, the measurements are related to the production of verbs and nouns, and the realization of different sentence types. The proposed measurements should be clinically relevant, easily applicable, and linguistically meaningful. The measurements have been applied to oral descriptions of the 'Cookie Theft' picture by eight monolingual Norwegian speakers, four with an anomic type of aphasia and four without any type of language impairment. Despite individual differences in both the clinical and the non-clinical group, most of the measurements seem to distinguish between speakers with and without aphasia.

Pragmatic characteristics of patient-reported outcome measures are important for use in clinical practice.

PubMed

Kroenke, Kurt; Monahan, Patrick O; Kean, Jacob

2015-09-01

Measures for assessing patient-reported outcomes (PROs) that may have initially been developed for research are increasingly being recommended for use in clinical practice as well. Although psychometric rigor is essential, this article focuses on pragmatic characteristics of PROs that may enhance uptake into clinical practice. Three sources were drawn on in identifying pragmatic criteria for PROs: (1) selected literature review including recommendations by other expert groups; (2) key features of several model public domain PROs; and (3) the authors' experience in developing practical PROs. Eight characteristics of a practical PRO include: (1) actionability (i.e., scores guide diagnostic or therapeutic actions/decision making); (2) appropriateness for the relevant clinical setting; (3) universality (i.e., for screening, severity assessment, and monitoring across multiple conditions); (4) self-administration; (5) item features (number of items and bundling issues); (6) response options (option number and dimensions, uniform vs. varying options, time frame, intervals between options); (7) scoring (simplicity and interpretability); and (8) accessibility (nonproprietary, downloadable, available in different languages and for vulnerable groups, and incorporated into electronic health records). Balancing psychometric and pragmatic factors in the development of PROs is important for accelerating the incorporation of PROs into clinical practice. Published by Elsevier Inc.

Clinimetrics: the science of clinical measurements.

PubMed

Fava, G A; Tomba, E; Sonino, N

2012-01-01

'Clinimetrics' is the term introduced by Alvan R. Feinstein in the early 1980s to indicate a domain concerned with indexes, rating scales and other expressions that are used to describe or measure symptoms, physical signs and other clinical phenomena. Clinimetrics has a set of rules that govern the structure of indexes, the choice of component variables, the evaluation of consistency, validity and responsiveness. This review illustrates how clinimetrics may help expanding the narrow range of information that is currently used in clinical science. It will focus on characteristics and types of clinimetric indexes and their current use. The clinimetric perspective provides an intellectual home for clinical judgment, whose implementation is likely to improve outcomes both in clinical research and practice. © 2011 Blackwell Publishing Ltd.

Noninvasive iPhone Measurement of Left Ventricular Ejection Fraction Using Intrinsic Frequency Methodology.

PubMed

Pahlevan, Niema M; Rinderknecht, Derek G; Tavallali, Peyman; Razavi, Marianne; Tran, Thao T; Fong, Michael W; Kloner, Robert A; Csete, Marie; Gharib, Morteza

2017-07-01

The study is based on previously reported mathematical analysis of arterial waveform that extracts hidden oscillations in the waveform that we called intrinsic frequencies. The goal of this clinical study was to compare the accuracy of left ventricular ejection fraction derived from intrinsic frequencies noninvasively versus left ventricular ejection fraction obtained with cardiac MRI, the most accurate method for left ventricular ejection fraction measurement. After informed consent, in one visit, subjects underwent cardiac MRI examination and noninvasive capture of a carotid waveform using an iPhone camera (The waveform is captured using a custom app that constructs the waveform from skin displacement images during the cardiac cycle.). The waveform was analyzed using intrinsic frequency algorithm. Outpatient MRI facility. Adults able to undergo MRI were referred by local physicians or self-referred in response to local advertisement and included patients with heart failure with reduced ejection fraction diagnosed by a cardiologist. Standard cardiac MRI sequences were used, with periodic breath holding for image stabilization. To minimize motion artifact, the iPhone camera was held in a cradle over the carotid artery during iPhone measurements. Regardless of neck morphology, carotid waveforms were captured in all subjects, within seconds to minutes. Seventy-two patients were studied, ranging in age from 20 to 92 years old. The main endpoint of analysis was left ventricular ejection fraction; overall, the correlation between ejection fraction-iPhone and ejection fraction-MRI was 0.74 (r = 0.74; p < 0.0001; ejection fraction-MRI = 0.93 × [ejection fraction-iPhone] + 1.9). Analysis of carotid waveforms using intrinsic frequency methods can be used to document left ventricular ejection fraction with accuracy comparable with that of MRI. The measurements require no training to perform or interpret, no calibration, and can be repeated at the bedside to generate almost

Teaching concepts of clinical measurement variation to medical students.

PubMed

Hodder, R A; Longfield, J N; Cruess, D F; Horton, J A

1982-09-01

An exercise in clinical epidemiology was developed for medical students to demonstrate the process and limitations of scientific measurement using models that simulate common clinical experiences. All scales of measurement (nominal, ordinal and interval) were used to illustrate concepts of intra- and interobserver variation, systematic error, recording error, and procedural error. In a laboratory, students a) determined blood pressures on six videotaped subjects, b) graded sugar content of unknown solutions from 0 to 4+ using Clinitest tablets, c) measured papules that simulated PPD reactions, d) measured heart and kidney size on X-rays and, e) described a model skin lesion (melanoma). Traditionally, measurement variation is taught in biostatistics or epidemiology courses using previously collected data. Use of these models enables students to produce their own data using measurements commonly employed by the clinician. The exercise provided material for a meaningful discussion of the implications of measurement error in clinical decision-making.

Saccharomyces boulardii CNCM I-745 in different clinical conditions.

PubMed

Dinleyici, Ener Cagri; Kara, Ates; Ozen, Metehan; Vandenplas, Yvan

2014-11-01

Saccharomyces boulardii is a well-known probiotic worldwide, and there are numerous studies including experimental and clinical trials in children and adults by the use of S. boulardii. The objective of the present report is to provide an update on the evidence for the efficacy of S. boulardii CNCM I-745 in different clinical conditions. Saccharomyces boulardii is one of the best-studied probiotics in acute gastroenteritis (AGE) and is shown to be safe and to reduce the duration of diarrhea and hospitalization by about 1 day. Saccharomyces boulardii is one of the recommended probiotics for AGE in children by European Society of Paediatric Infectious Diseases and European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN). Saccharomyces boulardii is also a recommended probiotic for the prevention of antibiotic-associated diarrhea (AAD), and a recent study showed promising results for the treatment of AAD in children. There is insufficient evidence to recommend the long-term use of S. boulardii in patients with irritable bowel syndrome. Although some clinical studies showed positive effects of S. boulardii on inflammation, there is no clinical evidence that S. boulardii is useful in inflammatory bowel disease. Saccharomyces boulardii could be used in patients needing Helicobacter pylori eradication because the S. boulardii improves compliance, decreases the side effects and moderately increases the eradication rate. There are new promising results (improving feeding tolerance, shorten the course of hyperbilirubinemia), but we do still not recommend the routine use of S. boulardii in newborns. Saccharomyces boulardii CNCM I-745 is a good example for the statement that each probiotic needs to be taxonomically characterized and its efficacy and safety should be documented individually in different clinical settings.

AXAF VETA-I mirror ring focus measurements

NASA Technical Reports Server (NTRS)

Tananbaum, H. D.; Zhao, P.

1994-01-01

The AXAF VETA-I mirror ring focus measurements were made with an HRI (microchannel plate) X-ray detector. The ring focus is a sharply focused ring formed by X-rays before they reach the VEAT-I focal plane. It is caused by spherical aberrations due to the finite source distance and the despace in the VETA-I test. The ring focus test reveals some aspects fo the test system distortions and the mirror surface figure which are difficult or impossible to detect at the focal plane. The test results show periodic modulations of the ring radius and width which could be caused by gravity, thermal, and/or epoxy shrinkage distortions. The strongest component of the modulation had a 12-fold symmetry, because these distortions were exerted on the mirror through 12 flexures of the VETA-I mount. Ring focus models were developed to simulate the ring image. The models were compared with the data to understand the test system distortions and the mirror glass imperfection. Further studies will be done to complete this work. The ring focus measurement is a very powerful test. We expect that a similar test for the finally assembled mirror of AXAD-I will be highly valuable.

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

PubMed

Williams, Leanne M; Rush, A John; Koslow, Stephen H; Wisniewski, Stephen R; Cooper, Nicholas J; Nemeroff, Charles B; Schatzberg, Alan F; Gordon, Evian

2011-01-05

Clinically useful treatment moderators of Major Depressive Disorder (MDD) have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine; and develop a model that incorporates multiple predictors and moderators. The International Study to Predict Optimized Treatment - in Depression (iSPOT-D) is a multi-centre, international, randomized, prospective, open-label trial. It is enrolling 2016 MDD outpatients (ages 18-65) from primary or specialty care practices (672 per treatment arm; 672 age-, sex- and education-matched healthy controls). Study-eligible patients are antidepressant medication (ADM) naïve or willing to undergo a one-week wash-out of any non-protocol ADM, and cannot have had an inadequate response to protocol ADM. Baseline assessments include symptoms; distress; daily function; cognitive performance; electroencephalogram and event-related potentials; heart rate and genetic measures. A subset of these baseline assessments are repeated after eight weeks of treatment. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary) and self-reported depressive symptoms, social functioning, quality of life, emotional regulation, and side-effect burden (secondary). Participants may then enter a naturalistic telephone follow-up at weeks 12, 16, 24 and 52. The first half of the sample will be used to identify potential predictors and moderators, and the second half to replicate and confirm. First enrolment was in December 2008, and is ongoing. iSPOT-D evaluates clinical and biological predictors of treatment response in the largest known sample of MDD collected worldwide. International Study to Predict Optimised Treatment - in Depression (iSPOT-D) ClinicalTrials.gov Identifier: NCT00693849. URL: http://clinicaltrials.gov/ct2/show/NCT00693849?term

A virtual clinical trial comparing static versus dynamic PET imaging in measuring response to breast cancer therapy

NASA Astrophysics Data System (ADS)

Wangerin, Kristen A.; Muzi, Mark; Peterson, Lanell M.; Linden, Hannah M.; Novakova, Alena; Mankoff, David A.; E Kinahan, Paul

2017-05-01

We developed a method to evaluate variations in the PET imaging process in order to characterize the relative ability of static and dynamic metrics to measure breast cancer response to therapy in a clinical trial setting. We performed a virtual clinical trial by generating 540 independent and identically distributed PET imaging study realizations for each of 22 original dynamic fluorodeoxyglucose (18F-FDG) breast cancer patient studies pre- and post-therapy. Each noise realization accounted for known sources of uncertainty in the imaging process, such as biological variability and SUV uptake time. Four definitions of SUV were analyzed, which were SUVmax, SUVmean, SUVpeak, and SUV50%. We performed a ROC analysis on the resulting SUV and kinetic parameter uncertainty distributions to assess the impact of the variability on the measurement capabilities of each metric. The kinetic macro parameter, K i , showed more variability than SUV (mean CV K i   =  17%, SUV  =  13%), but K i pre- and post-therapy distributions also showed increased separation compared to the SUV pre- and post-therapy distributions (mean normalized difference K i   =  0.54, SUV  =  0.27). For the patients who did not show perfect separation between the pre- and post-therapy parameter uncertainty distributions (ROC AUC  <  1), dynamic imaging outperformed SUV in distinguishing metabolic change in response to therapy, ranging from 12 to 14 of 16 patients over all SUV definitions and uptake time scenarios (p  <  0.05). For the patient cohort in this study, which is comprised of non-high-grade ER+  tumors, K i outperformed SUV in an ROC analysis of the parameter uncertainty distributions pre- and post-therapy. This methodology can be applied to different scenarios with the ability to inform the design of clinical trials using PET imaging.

Measuring urgency in clinical practice.

PubMed

Dmochowski, Roger R; FitzGerald, Mary P; Wyndaele, Jean-Jacques

2009-12-01

The study of urinary urgency is challenging for a number of reasons, including our lack of understanding of the normal physiology of urinary sensation and the pathophysiology of abnormal sensation. Issues with nomenclature and lack of agreement about the nature of the experience of normal and abnormal urinary sensation add to this difficulty. Review of published literature and critique. Currently available tools for measurement of urgency include validated questionnaires that describe the severity of urgency and its impact on quality of life, modified bladder diaries, body maps of urgency, and measures of urinary sensation during filling cystometry. All these provide some information about the experience of urinary urgency, but no single measure currently captures its multidimensional nature. Measurement of urgency in clinical practice and indeed the optimal treatment strategy has yet to come of age.

Predicting academic performance and clinical competency for international dental students: seeking the most efficient and effective measures.

PubMed

Stacey, D Graham; Whittaker, John M

2005-02-01

Measures used in the selection of international dental students to a U.S. D.D.S. program were examined to identify the grouping that most effectively and efficiently predicted academic performance and clinical competency. Archival records from the International Dental Program (IDP) at Loma Linda University provided data on 171 students who had trained in countries outside the United States. The students sought admission to the D.D.S. degree program, successful completion of which qualified them to sit for U.S. licensure. As with most dental schools, competition is high for admission to the D.D.S. program. The study's goal was to identify what measures contributed to a fair and accurate selection process for dental school applicants from other nations. Multiple regression analyses identified National Board Part II and dexterity measures as significant predictors of academic performance and clinical competency. National Board Part I, TOEFL, and faculty interviews added no significant additional help in predicting eventual academic performance and clinical competency.

Measurement of cardiac troponin I utilizing a point of care analyzer in healthy alpacas.

PubMed

Blass, Keith A; Kraus, Marc S; Rishniw, Mark; Mann, Sabine; Mitchell, Lisa M; Divers, Thomas J

2011-12-01

Myocardial disease in camelids is poorly characterized. Nutritional (selenium deficiency) and toxic (ionophore toxicity) myocardial disease have been reported in camelids. Diagnosis and management of these and other myocardial diseases might be enhanced by evaluating cardiac troponin I (cTnI) concentrations. No information about cTnI reference intervals in camelids is currently available. (A) To determine cTnI concentrations obtained using a point of care i-STAT(®)1 analyzer (Heska Corporation) in healthy alpacas; (B) to compare alpaca cTnI concentrations between heparinized whole blood and plasma samples and between 2 different storage conditions (4 °C for 24 h or -80 °C for 30 days); (C) to examine assay reproducibility using the i-STAT(®)1. 23 healthy alpacas were evaluated. Blood and plasma samples were analyzed by the i-STAT(®)1 within 1 h of collection. Aliquots of plasma were stored at either 4 °C for 24 h or -80 °C for 30 days, and then analyzed. Assay reproducibility was determined by comparing 2 plasma or whole blood cTnI concentrations measured on the same sample over a 10 min period. Analyzer-specific plasma cTnI concentrations in clinically normal alpacas had a median of <0.02 ng/mL (range: <0.02 ng/mL to 0.07 ng/mL). Plasma and whole blood concentrations showed good agreement. Storage did not affect cTnI concentrations (p > 0.75). Plasma cTnI concentrations had coefficient of repeatability of 0.02 ng/mL. The i-STAT(®)1 can measure cTnI in alpacas on both plasma and whole blood and provides similar values for both samples. Storage at 4 °C for 24 h or -80 °C for 30 days does not affect estimates of plasma cTnI. Evaluation of cTnI might be of value in assessing cardiac disease in this species. Copyright © 2011 Elsevier B.V. All rights reserved.

Choice Impulsivity: Definitions, Measurement Issues, and Clinical Implications

PubMed Central

Hamilton, Kristen R.; Mitchell, Marci R.; Wing, Victoria C.; Balodis, Iris M.; Bickel, Warren K.; Fillmore, Mark; Lane, Scott D.; Lejuez, C. W.; Littlefield, Andrew K.; Luijten, Maartje; Mathias, Charles W.; Mitchell, Suzanne H.; Napier, T. Celeste; Reynolds, Brady; Schütz, Christian G.; Setlow, Barry; Sher, Kenneth J.; Swann, Alan C.; Tedford, Stephanie E.; White, Melanie J.; Winstanley, Catharine A.; Yi, Richard; Potenza, Marc N.; Moeller, F. Gerard

2015-01-01

Background Impulsivity critically relates to many psychiatric disorders. Given the multi-faceted construct that impulsivity represents, defining core aspects of impulsivity is vital for the assessment and understanding of clinical conditions. Choice impulsivity (CI), involving the preferential selection of smaller sooner rewards over larger later rewards, represents one important type of impulsivity. Method The International Society for Research on Impulsivity (InSRI) convened to discuss the definition and assessment of CI and provide recommendations regarding measurement across species. Results Commonly used preclinical and clinical CI behavioral tasks are described, and considerations for each task are provided to guide CI task selection. Differences in assessment of CI (self-report, behavioral) and calculating CI indices (e.g., area-under-the-curve, indifference point, steepness of discounting curve) are discussed along with properties of specific behavioral tasks used in preclinical and clinical settings. Conclusions The InSRI group recommends inclusion of measures of CI in human studies examining impulsivity. Animal studies examining impulsivity should also include assessments of CI and these measures should be harmonized in accordance with human studies of the disorders being modeled in the preclinical investigations. The choice of specific CI measures to be included should be based on the goals of the study and existing preclinical and clinical literature using established CI measures. PMID:25867841

Seeking informed consent to Phase I cancer clinical trials: identifying oncologists' communication strategies.

PubMed

Brown, Richard; Bylund, Carma L; Siminoff, Laura A; Slovin, Susan F

2011-04-01

Phase I clinical trials are the gateway to effective new cancer treatments. Many physicians have difficulty when discussing Phase I clinical trials. Research demonstrates evidence of suboptimal communication. Little is known about communication strategies used by oncologists when recruiting patients for Phase I trials. We analyzed audio recorded Phase I consultations to identify oncologists' communication strategies. Subjects were consecutive cancer patients from six medical oncologists attending one of three outpatient clinics at a major Cancer Center in the United States. Sixteen patients signed informed consent for audio recording of their consultations in which a Phase I study was discussed. These were transcribed in full and analyzed to identify communication strategies. Six communication themes emerged from the analysis: (1) orienting, (2) educating patients, (3) describing uncertainty and prognosis, (4) persuading, (5) decision making, and (6) making a treatment recommendation. As expected, although there was some common ground between communication in Phase I and the Phase II and III settings, there were distinct differences. Oncologists used persuasive communication, made explicit recommendations, or implicitly expressed a treatment preference and were choice limiting. This highlights the complexity of discussing Phase I trials and the need to develop strategies to aid oncologists and patients in these difficult conversations. Patient centered communication that values patient preferences while preserving the oncologist's agenda can be a helpful approach to these discussions. Copyright © 2010 John Wiley & Sons, Ltd.

Outcome Measures for Clinical Trials in Down Syndrome

PubMed Central

Esbensen, Anna J.; Hooper, Stephen R.; Fidler, Deborah; Hartley, Sigan; Edgin, Jamie; d’Ardhuy, Xavier Liogier; Capone, George; Conners, Frances; Mervis, Carolyn B.; Abbeduto, Leonard; Rafii, Michael; Krinsky-McHale, Sharon J.; Urv, Tiina

2017-01-01

Increasingly individuals with intellectual and developmental disabilities, including Down syndrome, are being targeted for clinical trials. However, a challenge exists in effectively evaluating the outcomes of these new pharmacological interventions. Few empirically evaluated, psychometrically sound outcome measures appropriate for use in clinical trials with individuals with Down syndrome have been identified. To address this challenge, the NIH assembled leading clinicians and scientists to review existing measures and identify those that currently are appropriate for trials; those that may be appropriate after expansion of age range addition of easier items, and/or downward extension of psychometric norms; and areas where new measures need to be developed. This paper focuses on measures in the areas of cognition and behavior. PMID:28452584

The I-V Measurement System for Solar Cells Based on MCU

NASA Astrophysics Data System (ADS)

Fengxiang, Chen; Yu, Ai; Jiafu, Wang; Lisheng, Wang

2011-02-01

In this paper, an I-V measurement system for solar cells based on Single-chip Microcomputer (MCU) is presented. According to the test principles of solar cells, this measurement system mainly comprises of two parts—data collecting, data processing and displaying. The MCU mainly used as to acquire data, then the collecting results is sent to the computer by serial port. The I-V measurement results of our test system are shown in the human-computer interaction interface based on our hardware circuit. By comparing the test results of our I-V tester and the results of other commercial I-V tester, we found errors for most parameters are less than 5%, which shows our I-V test result is reliable. Because the MCU can be applied in many fields, this I-V measurement system offers a simple prototype for portable I-V tester for solar cells.

Applicability of self-activation of an NaI scintillator for measurement of photo-neutrons around a high-energy X-ray radiotherapy machine.

PubMed

Wakabayashi, Genichiro; Nohtomi, Akihiro; Yahiro, Eriko; Fujibuchi, Toshioh; Fukunaga, Junichi; Umezu, Yoshiyuki; Nakamura, Yasuhiko; Nakamura, Katsumasa; Hosono, Makoto; Itoh, Tetsuo

2015-01-01

The applicability of the activation of an NaI scintillator for neutron monitoring at a clinical linac was investigated experimentally. Thermal neutron fluence rates are derived by measurement of the I-128 activity generated in an NaI scintillator irradiated by neutrons; β-rays from I-128 are detected efficiently by the NaI scintillator. In order to verify the validity of this method for neutron measurement, we irradiated an NaI scintillator at a research reactor, and the neutron fluence rate was estimated. The method was then applied to neutron measurement at a 10-MV linac (Varian Clinac 21EX), and the neutron fluence rate was estimated at the isocenter and at 30 cm from the isocenter. When the scintillator was irradiated directly by high-energy X-rays, the production of I-126 was observed due to photo-nuclear reactions, in addition to the generation of I-128 and Na-24. From the results obtained by these measurements, it was found that the neutron measurement by activation of an NaI scintillator has a great advantage in estimates of a low neutron fluence rate by use of a quick measurement following a short-time irradiation. Also, the future application of this method to quasi real-time monitoring of neutrons during patient treatments at a radiotherapy facility is discussed, as well as the method of evaluation of the neutron dose.

Reference values and repeatability of the Schirmer tear tests I and II in domesticated, clinically normal dromedary camels (Camelus dromedarius).

PubMed

Marzok, Mohamed A; Badawy, Adel M; El-Khodery, Sabry A

2017-05-01

To determine the normal values and repeatability for Schirmer tear test (STT) in clinically normal dromedary camels and to analyze the influence of the age and gender on these values. Thirty clinically normal dromedary camels of different ages (calves, immature, and mature). Schirmer tear tests I and II were performed using commercial STT strips. Three measurements were obtained from each eye over three consecutive weeks, and the variance of these measurements was determined. Mean values and coefficient of variation of STT I and STT II for the right and left eyes varied significantly among camel groups (P < 0.05). For STT I, the most frequently recorded values were >14-18, > 22-26, and >30-34 mm/min in calves, immature camels, and mature camels, respectively. For STT II, however, the most frequently recorded values were 7-14, >10-18, and >26-30 mm/min, respectively. The interassay coefficients of variation were 1.7-14.4% and were significantly lower in mature camels than in calves and immature camels (P < 0.05). Age was positively correlated with STT I (r = 0.81) and STT II values (r = 0.88). No significant variations were found between genders. This preliminary study reports STT I and II values and repeatability in normal dromedary camels. This information may assist veterinary practitioners in complete ophthalmic examinations and in accurate diagnosis of ocular surface diseases affecting the tear film in this species. © 2016 American College of Veterinary Ophthalmologists.

Outcome Measures for Clinical Trials in Down Syndrome.

PubMed

Esbensen, Anna J; Hooper, Stephen R; Fidler, Deborah; Hartley, Sigan L; Edgin, Jamie; d'Ardhuy, Xavier Liogier; Capone, George; Conners, Frances A; Mervis, Carolyn B; Abbeduto, Leonard; Rafii, Michael; Krinsky-McHale, Sharon J; Urv, Tiina

2017-05-01

Increasingly individuals with intellectual and developmental disabilities, including Down syndrome, are being targeted for clinical trials. However, a challenge exists in effectively evaluating the outcomes of these new pharmacological interventions. Few empirically evaluated, psychometrically sound outcome measures appropriate for use in clinical trials with individuals with Down syndrome have been identified. To address this challenge, the National Institutes of Health (NIH) assembled leading clinicians and scientists to review existing measures and identify those that currently are appropriate for trials; those that may be appropriate after expansion of age range addition of easier items, and/or downward extension of psychometric norms; and areas where new measures need to be developed. This article focuses on measures in the areas of cognition and behavior.

Clinical features of Mexican patients with Mucopolysaccharidosis type I.

PubMed

Alonzo-Rojo, A; García-Ortiz, J E; Ortiz-Aranda, M; Gallegos-Arreola, M P; Figuera-Villanueva, L E

2017-09-21

Mucopolysaccharidosis type I (MPS-I) is an autosomal recessive lysosomal storage disorder caused by a deficiency or absence of α--iduronidase, which is involved in the catabolism of glycosaminoglycans (GAGs). This deficiency leads to the accumulation of GAGs in several organs. Given the wide spectrum of the disease, MPS-I has historically been classified into 3 clinical subtypes - severe (Hurler syndrome), intermediate (Hurler-Scheie syndrome), and mild (Scheie syndrome) - none of which is determined by residual enzyme activity. Eleven Mexican patients with MPS-I from northwestern México were evaluated. Diagnoses were confirmed through quantification of GAGs in urine and enzyme assay for α--iduronidase. Regardless of phenotype, all patients had various degrees of infiltrated facies, short stature, dysostosis multiplex, joint contractures, and corneal opacity typical of the disease. A better understanding of the spectrum of this disease can assist in diagnosis, treatment, and improvement in the quality of life for these patients.

Evaluating clinical periodontal measures as surrogates for bacterial exposure: The Oral Infections and Vascular Disease Epidemiology Study (INVEST)

PubMed Central

2010-01-01

Background Epidemiologic studies of periodontal infection as a risk factor for cardiovascular disease often use clinical periodontal measures as a surrogate for the underlying bacterial exposure of interest. There are currently no methodological studies evaluating which clinical periodontal measures best reflect the levels of subgingival bacterial colonization in population-based settings. We investigated the characteristics of clinical periodontal definitions that were most representative of exposure to bacterial species that are believed to be either markers, or themselves etiologic, of periodontal disease. Methods 706 men and women aged ≥ 55 years, residing in northern Manhattan were enrolled. Using DNA-DNA checkerboard hybridization in subgingival biofilms, standardized values for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Treponema denticola and Tannerella forsythia were averaged within mouth and summed to define "bacterial burden". Correlations of bacterial burden with clinical periodontal constructs defined by the severity and extent of attachment loss (AL), pocket depth (PD) and bleeding on probing (BOP) were assessed. Results Clinical periodontal constructs demonstrating the highest correlations with bacterial burden were: i) percent of sites with BOP (r = 0.62); ii) percent of sites with PD ≥ 3 mm (r = 0.61); and iii) number of sites with BOP (r = 0.59). Increasing PD or AL severity thresholds consistently attenuated correlations, i.e., the correlation of bacterial burden with the percent of sites with PD ≥ 8 mm was only r = 0.16. Conclusions Clinical exposure definitions of periodontal disease should incorporate relatively shallow pockets to best reflect whole mouth exposure to bacterial burden. PMID:20056008

Activation of Type I Interferon Pathway in Systemic Lupus Erythematosus: Association with Distinct Clinical Phenotypes

PubMed Central

Karageorgas, Theophanis P.; Tseronis, Dimitrios D.; Mavragani, Clio P.

2011-01-01

Growing evidence over the last few years suggests a central role of type I IFN pathway in the pathogenesis of systemic autoimmune disorders. Data from clinical and genetic studies in patients with systemic lupus erythematosus (SLE) and lupus-prone mouse models, indicates that the type I interferon system may play a pivotal role in the pathogenesis of several lupus and associated clinical features, such as nephritis, neuropsychiatric and cutaneous lupus, premature atherosclerosis as well as lupus-specific autoantibodies particularly against ribonucleoproteins. In the current paper, our aim is to summarize the latest findings supporting the association of type I IFN pathway with specific clinical manifestations in the setting of SLE providing insights on the potential use of type I IFN as a therapeutic target. PMID:22162633

Measuring pacemaker dose: A clinical perspective

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

Studenski, Matthew T., E-mail: matthew.studenski@jeffersonhospital.org; Xiao Ying; Harrison, Amy S.

2012-07-01

Recently in our clinic, we have seen an increased number of patients presenting with pacemakers and defibrillators. Precautions are taken to develop a treatment plan that minimizes the dose to the pacemaker because of the adverse effects of radiation on the electronics. Here we analyze different dosimeters to determine which is the most accurate in measuring pacemaker or defibrillator dose while at the same time not requiring a significant investment in time to maintain an efficient workflow in the clinic. The dosimeters analyzed here were ion chambers, diodes, metal-oxide-semiconductor field effect transistor (MOSFETs), and optically stimulated luminescence (OSL) dosimeters. Amore » simple phantom was used to quantify the angular and energy dependence of each dosimeter. Next, 8 patients plans were delivered to a Rando phantom with all the dosimeters located where the pacemaker would be, and the measurements were compared with the predicted dose. A cone beam computed tomography (CBCT) image was obtained to determine the dosimeter response in the kilovoltage energy range. In terms of the angular and energy dependence of the dosimeters, the ion chamber and diode were the most stable. For the clinical cases, all the dosimeters match relatively well with the predicted dose, although the ideal dosimeter to use is case dependent. The dosimeters, especially the MOSFETS, tend to be less accurate for the plans, with many lateral beams. Because of their efficiency, we recommend using a MOSFET or a diode to measure the dose. If a discrepancy is observed between the measured and expected dose (especially when the pacemaker to field edge is <10 cm), we recommend analyzing the treatment plan to see whether there are many lateral beams. Follow-up with another dosimeter rather than repeating multiple times with the same type of dosimeter. All dosimeters should be placed after the CBCT has been acquired.« less

Patient-reported outcomes (PROs): the significance of using humanistic measures in clinical trial and clinical practice.

PubMed

Refolo, P; Minacori, R; Mele, V; Sacchini, D; Spagnolo, A G

2012-10-01

Patient-reported outcome (PRO) is an "umbrella term" that covers a whole range of potential types of measurement but it is used specifically to refer to all measures quantifying the state of health through the evaluation of outcomes reported by the patient himself/herself. PROs are increasingly seen as complementary to biomedical measures and they are being incorporated more frequently into clinical trials and clinical practice. After considering the cultural background of PROs - that is the well known patient-centered model of medicine -, their historical profile (since 1914, the year of the first outcome measure) and typologies, the paper aims at debating their methodological complexity and implementation into practice. Some clinical trials and therapeutic managements utilizing patient-centered measures will be also analyzed.

Value-based HR practices, i-deals and clinical error control with CSR as a moderator.

PubMed

Luu, Tuan; Rowley, Chris; Siengthai, Sununta; Thanh Thao, Vo

2017-05-08

Purpose Notwithstanding the rising magnitude of system factors in patient safety improvement, "human factors" such as idiosyncratic deals (i-deals) which also contribute to the adjustment of system deficiencies should not be neglected. The purpose of this paper is to investigate the role of value-based HR practices in catalyzing i-deals, which then influence clinical error control. The research further examines the moderating role of corporate social responsibility (CSR) on the effect of value-based HR practices on i-deals. Design/methodology/approach The data were collected from middle-level clinicians from hospitals in the Vietnam context. Findings The research results confirmed the effect chain from value-based HR practices through i-deals to clinical error control with CSR as a moderator. Originality/value The HRM literature is expanded through enlisting i-deals and clinical error control as the outcomes of HR practices.

Rapid Rule-Out of Acute Myocardial Injury Using a Single High-Sensitivity Cardiac Troponin I Measurement.

PubMed

Sandoval, Yader; Smith, Stephen W; Shah, Anoop S V; Anand, Atul; Chapman, Andrew R; Love, Sara A; Schulz, Karen; Cao, Jing; Mills, Nicholas L; Apple, Fred S

2017-01-01

Rapid rule-out strategies using high-sensitivity cardiac troponin assays are largely supported by studies performed outside the US in selected cohorts of patients with chest pain that are atypical of US practice, and focused exclusively on ruling out acute myocardial infarction (AMI), rather than acute myocardial injury, which is more common and associated with a poor prognosis. Prospective, observational study of consecutive patients presenting to emergency departments [derivation (n = 1647) and validation (n = 2198) cohorts], where high-sensitivity cardiac troponin I (hs-cTnI) was measured on clinical indication. The negative predictive value (NPV) and diagnostic sensitivity of an hs-cTnI concentration I concentrations <99th percentile at presentation, acute myocardial injury occurred in 8.3% and 11.0% in the derivation and validation cohorts, respectively. In the derivation cohort, 27% had hs-cTnI < LoD, with NPV and diagnostic sensitivity for acute myocardial injury of 99.1% (95% CI, 97.7-99.8) and 99.0% (97.5-99.7) and an NPV for AMI or cardiac death at 30 days of 99.6% (98.4-100). In the validation cohort, 22% had hs-cTnI I concentration ClinicalTrials.gov Identifier: NCT02060760. © 2016 American Association for Clinical Chemistry.

Standards for Clinical Trials in Male and Female Sexual Dysfunction: II. Patient-Reported Outcome Measures.

PubMed

Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio

2016-12-01

The second article in this series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, focuses on measurement of patient-reported outcomes (PROs). Together with the design of appropriate phase I to phase IV clinical trials, the development, validation, choice, and implementation of valid PRO measurements-the focus of the present article-form the foundation of research on treatments for male and female sexual dysfunctions. PRO measurements are assessments of any aspect of a patient's health status that come directly from the patient (ie, without the interpretation of the patient's responses by a physician or anyone else). PROs are essential for assessing male and female sexual dysfunction and treatment response, including symptom frequency and severity, personal distress, satisfaction, and other measurements of sexual and general health-related quality of life. Although there are some relatively objective measurements of sexual dysfunction (ie, intravaginal ejaculatory latency time, frequency of sexual activity, etc), these measurements do not comprehensively assess the occurrence and extent of sexual dysfunction or treatment on the patient's symptoms, functioning, and well-being. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient's perspective. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Rapid-Response Impulsivity: Definitions, Measurement Issues, and Clinical Implications

PubMed Central

Hamilton, Kristen R.; Littlefield, Andrew K.; Anastasio, Noelle C.; Cunningham, Kathryn A.; Fink, Latham H.; Wing, Victoria C.; Mathias, Charles W.; Lane, Scott D.; Schutz, Christian; Swann, Alan C.; Lejuez, C.W.; Clark, Luke; Moeller, F. Gerard; Potenza, Marc N.

2015-01-01

Impulsivity is a multi-faceted construct that is a core feature of multiple psychiatric conditions and personality disorders. However, progress in understanding and treating impulsivity in the context of these conditions is limited by a lack of precision and consistency in its definition and assessment. Rapid-response-impulsivity (RRI) represents a tendency toward immediate action that occurs with diminished forethought and is out of context with the present demands of the environment. Experts from the International Society for Research on Impulsivity (InSRI) met to discuss and evaluate RRI-measures in terms of reliability, sensitivity, and validity with the goal of helping researchers and clinicians make informed decisions about the use and interpretation of findings from RRI-measures. Their recommendations are described in this manuscript. Commonly-used clinical and preclinical RRI-tasks are described, and considerations are provided to guide task selection. Tasks measuring two conceptually and neurobiologically distinct types of RRI, “refraining from action initiation” (RAI) and “stopping an ongoing action” (SOA) are described. RAI and SOA-tasks capture distinct aspects of RRI that may relate to distinct clinical outcomes. The InSRI group recommends that: 1) selection of RRI-measures should be informed by careful consideration of the strengths, limitations, and practical considerations of the available measures; 2) researchers use both RAI and SOA tasks in RRI studies to allow for direct comparison of RRI types and examination of their associations with clinically relevant measures; and, 3) similar considerations should be made for human and non-human studies in an effort to harmonize and integrate pre-clinical and clinical research. PMID:25867840

Clinical, radiological, and genetic similarities between patients with Chiari Type I and Type 0 malformations.

PubMed

Markunas, Christina A; Tubbs, R Shane; Moftakhar, Roham; Ashley-Koch, Allison E; Gregory, Simon G; Oakes, W Jerry; Speer, Marcy C; Iskandar, Bermans J

2012-04-01

Although Chiari Type I (CM-I) and Type 0 (CM-0) malformations have been previously characterized clinically and radiologically, there have been no studies focusing on the possible genetic link between these disorders. The goal of this study was to identify families in whom CM-0 and CM-I co-occurred and to further assess the similarities between these disorders. Families were ascertained through a proband with CM-I. Detailed family histories were obtained to identify first-degree relatives diagnosed with CM-0. Several criteria were used to exclude individuals with acquired forms of CM-I and/or syringomyelia. Individuals were excluded with syndromic, traumatic, infectious, or tumor-related syringomyelia, as well as CM-I due to a supratentorial mass, hydrocephalus, history of cervical or cranial surgery unrelated to CM-I, or development of symptoms following placement of a lumbar shunt. Medical records and MR images were used to characterize CM-I and CM-0 individuals clinically and radiologically. Five families were identified in which the CM-I proband had a first-degree relative with CM-0. Further assessment of affected individuals showed similar clinical and radiological features between CM-0 and CM-I individuals, although CM-I patients in general had more severe symptoms and skull base abnormalities than their CM-0 relatives. Overall, both groups showed improvement in symptoms and/or syrinx size following craniocervical decompression surgery. There is accumulating evidence suggesting that CM-0 and CM-I may be caused by a common underlying developmental mechanism. The data in this study are consistent with this hypothesis, showing similar clinical and radiological features between CM-0 and CM-I individuals, as well as the occurrence of both disorders within families. Familial clustering of CM-0 and CM-I suggests that these disorders may share an underlying genetic basis, although additional epigenetic and/or environmental factors are likely to play an important role

Clinical, radiological, and genetic similarities between patients with Chiari Type I and Type 0 malformations

PubMed Central

Markunas, Christina A.; Tubbs, R. Shane; Moftakhar, Roham; Ashley-Koch, Allison E.; Gregory, Simon G.; Oakes, W. Jerry; Speer, Marcy C.; Iskandar, Bermans J.

2012-01-01

Object Although Chiari Type I (CM-I) and Type 0 (CM-0) malformations have been previously characterized clinically and radiologically, there have been no studies focusing on the possible genetic link between these disorders. The goal of this study was to identify families in whom CM-0 and CM-I co-occurred and to further assess the similarities between these disorders. Methods Families were ascertained through a proband with CM-I. Detailed family histories were obtained to identify first-degree relatives diagnosed with CM-0. Several criteria were used to exclude individuals with acquired forms of CM-I and/or syringomyelia. Individuals were excluded with syndromic, traumatic, infectious, or tumor-related syringomyelia, as well as CM-I due to a supratentorial mass, hydrocephalus, history of cervical or cranial surgery unrelated to CM-I, or development of symptoms following placement of a lumbar shunt. Medical records and MR images were used to characterize CM-I and CM-0 individuals clinically and radiologically. Results Five families were identified in which the CM-I proband had a first-degree relative with CM-0. Further assessment of affected individuals showed similar clinical and radiological features between CM-0 and CM-I individuals, although CM-I patients in general had more severe symptoms and skull base abnormalities than their CM-0 relatives. Overall, both groups showed improvement in symptoms and/or syrinx size following craniocervical decompression surgery. Conclusions There is accumulating evidence suggesting that CM-0 and CM-I may be caused by a common underlying developmental mechanism. The data in this study are consistent with this hypothesis, showing similar clinical and radiological features between CM-0 and CM-I individuals, as well as the occurrence of both disorders within families. Familial clustering of CM-0 and CM-I suggests that these disorders may share an underlying genetic basis, although additional epigenetic and/or environmental factors

Clinical skills development in student-run free clinic volunteers: a multi-trait, multi-measure study.

PubMed

Nakamura, Mio; Altshuler, David; Chadwell, Margit; Binienda, Juliann

2014-12-12

At Wayne State University School of Medicine (WSU SOM), the Robert R. Frank Student Run Free Clinic (SRFC) is one place preclinical students can gain clinical experience. There have been no published studies to date measuring the impact of student-run free clinic (SRFC) volunteerism on clinical skills development in preclinical medical students. Surveys were given to first year medical students at WSU SOM at the beginning and end of Year 1 to assess perception of clinical skills, including self-confidence, self-reflection, and professionalism. Scores of the Year 1 Objective Structured Clinical Exam (OSCE) were compared between SRFC volunteers and non-volunteers. There were a total of 206 (68.2%) and 80 (26.5%) survey responses at the beginning and end of Year 1, respectively. Of the 80 students, 31 (38.7%) volunteered at SRFC during Year 1. Statistically significant differences were found between time points in self-confidence (p < 0.001) in both groups. When looking at self-confidence in skills pertaining to SRFC, the difference between groups was statistically significant (p = 0.032) at both time points. A total of 302 students participated in the Year 1 OSCE, 27 (9%) of which were SRFC volunteers. No statistically significant differences were found between groups for mean score (p = 0.888) and established level of rapport (p = 0.394). While this study indicated no significant differences in clinical skills in students who volunteer at the SRFC, it is a first step in attempting to measure clinical skill development outside of the structured medical school setting. The findings lend themselves to development of research designs, clinical surveys, and future studies to measure the impact of clinical volunteer opportunities on clinical skills development in future physicians.

Effects of Different Containers on Radioactivity Measurements using a Dose Calibrator with Special Reference to 111In and 123I.

PubMed

Inoue, Yusuke; Abe, Yutaka; Kikuchi, Kei; Miyatake, Hiroki; Watanabe, Atsushi

2017-01-01

Low-energy characteristic x-rays emitted by 111 In and 123 I sources are easily absorbed by the containers of the sources, affecting radioactivity measurements using a dose calibrator. We examined the effects of different containers on the estimated activities. The radioactivities of 111 In, 123 I, 201 Tl, and 99m Tc were measured in containers frequently employed in clinical practice in Japan. The 111 In measurements were performed in the vials A and B of the 111 In-pentetreotide preparation kit and in the plastic syringe. The activities of 123 I-metaiodobenzylguanidine and 201 Tl chloride were measured in the prefilled glass syringes and plastic syringes. The milking vial, vial A, vial B, and plastic syringe were used to assay 99m Tc. For 111 In and 123 I, measurements were performed with and without a copper filter. The filter was inserted into the well of the dose calibrator to absorb low-energy x-rays. The relative estimate was defined as the ratio of the activity estimated with the dose calibrator to the standard activity. The estimated activities varied greatly depending on the container when 111 In and 123 I sources were assayed without the copper filter. The relative estimates of 111 In were 0.908, 1.072, and 1.373 in the vial A, vial B, and plastic syringe, respectively. The relative estimates of 123 I were 1.052 and 1.352 in the glass syringe and plastic syringe, respectively. Use of the copper filter eliminated the container-dependence in 111 In and 123 I measurements. Container-dependence was demonstrated in neither 201 Tl nor 99m Tc measurements. The activities of 111 In and 123 I estimated with a dose calibrator differ greatly among the containers. Accurate estimation may be attained using the container-specific correction factor or using the copper filter.

Development of CER-001: Preclinical Dose Selection Through to Phase I Clinical Findings.

PubMed

Keyserling, Constance H; Barbaras, Ronald; Benghozi, Renee; Dasseux, Jean-Louis

2017-05-01

CER-001 comprises recombinant human apolipoprotein A-I complexed with phospholipids that mimics natural, nascent, pre-β high-density lipoprotein (HDL). We present animal model data showing dose-dependent increases in cholesterol efflux with CER-001 and its subsequent elimination by reverse lipid transport, together with inhibition of atherosclerotic plaque progression. We report the first phase I study results with CER-001 in humans, starting at 0.25 mg/kg, which is 1/80th of the safe dose (20 mg/kg) established in 4-week multiple-dose animal studies dosed every second day. Healthy volunteers, 18-55 years old with a low-density lipoprotein-cholesterol:HDL-cholesterol ratio greater than 3.0, received single intravenous escalating doses of CER-001 (0.25-45.0 mg/kg) and placebo in a double-blind randomised cross-over fashion. Subjects were followed up for 3 weeks post-dose. Assessments included adverse event monitoring, blood sampling, and clinical laboratory measurements. Thirty-two subjects were enrolled. All CER-001 doses (0.25-45 mg/kg) were safe and well tolerated, with an adverse event profile similar to placebo. Effects on clinical chemistry, haematology and coagulation parameters were comparable to placebo. No adverse effects of CER-001 on electrocardiograms were observed. No antibodies to apolipoprotein A-I were detected following single-dose administration of CER-001. Plasma apolipoprotein A-I levels increased in a dose-related manner and returned to baseline by 24 h post-dose for doses up to 10 mg/kg but remained in circulation for >72 h post-dose for doses >10 mg/kg. CER-001 caused elevations in plasma cholesterol and total and unesterified cholesterol in the HDL fraction. Mobilisation of unesterified cholesterol in the HDL fraction was seen with CER-001 at doses as low as 2 mg/kg. CER-001 is well tolerated when administered to humans as single doses up to 45 mg/kg and mobilises and eliminates cholesterol via reverse lipid transport.

Measuring pacemaker dose: a clinical perspective.

PubMed

Studenski, Matthew T; Xiao, Ying; Harrison, Amy S

2012-01-01

Recently in our clinic, we have seen an increased number of patients presenting with pacemakers and defibrillators. Precautions are taken to develop a treatment plan that minimizes the dose to the pacemaker because of the adverse effects of radiation on the electronics. Here we analyze different dosimeters to determine which is the most accurate in measuring pacemaker or defibrillator dose while at the same time not requiring a significant investment in time to maintain an efficient workflow in the clinic. The dosimeters analyzed here were ion chambers, diodes, metal-oxide-semiconductor field effect transistor (MOSFETs), and optically stimulated luminescence (OSL) dosimeters. A simple phantom was used to quantify the angular and energy dependence of each dosimeter. Next, 8 patients plans were delivered to a Rando phantom with all the dosimeters located where the pacemaker would be, and the measurements were compared with the predicted dose. A cone beam computed tomography (CBCT) image was obtained to determine the dosimeter response in the kilovoltage energy range. In terms of the angular and energy dependence of the dosimeters, the ion chamber and diode were the most stable. For the clinical cases, all the dosimeters match relatively well with the predicted dose, although the ideal dosimeter to use is case dependent. The dosimeters, especially the MOSFETS, tend to be less accurate for the plans, with many lateral beams. Because of their efficiency, we recommend using a MOSFET or a diode to measure the dose. If a discrepancy is observed between the measured and expected dose (especially when the pacemaker to field edge is <10 cm), we recommend analyzing the treatment plan to see whether there are many lateral beams. Follow-up with another dosimeter rather than repeating multiple times with the same type of dosimeter. All dosimeters should be placed after the CBCT has been acquired. Copyright © 2012 American Association of Medical Dosimetrists. Published by

Clinical use of three-dimensional video measurements of eye movements

NASA Technical Reports Server (NTRS)

Merfeld, D. M.; Black, F. O.; Wade, S.; Paloski, W. H. (Principal Investigator)

1998-01-01

Noninvasive measurements of three-dimensional eye position can be accurately achieved with video methods. A case study showing the potential clinical benefit of these enhanced measurements is presented along with some thoughts about technological advances, essential for clinical application, that are likely to occur in the next several years.

Analysis of the causes of discrepancies in troponin I concentrations as measured by ARCHITECT High-Sensitive Troponin I ST and STACIA CLEIA cTnI.

PubMed

Kondo, Takashi; Kobayashi, Daisuke; Mochizuki, Maki; Asanuma, Kouichi; Takahashi, Satoshi

2017-01-01

Background Recently developed reagents for the highly sensitive measurement of cardiac troponin I are useful for early diagnosis of acute coronary syndrome. However, differences in measured values between these new reagents and previously used reagents have not been well studied. In this study, we aimed to compare the values between ARCHITECT High-Sensitive Troponin I ST (newly developed reagents), ARCHITECT Troponin I ST and STACIA CLEIA cardiac troponin I (two previously developed reagent kits). Methods Gel filtration high-performance liquid chromatography was used to analyse the causes of differences in measured values. Results The measured values differed between ARCHITECT High-Sensitive Troponin I ST and STACIA CLEIA cardiac troponin I reagents (r = 0.82). Cross-reactivity tests using plasma with added skeletal-muscle troponin I resulted in higher reactivity (2.17-3.03%) for the STACIA CLEIA cardiac troponin I reagents compared with that for the ARCHITECT High-Sensitive Troponin I ST reagents (less than 0.014%). In addition, analysis of three representative samples using gel filtration high-performance liquid chromatography revealed reagent-specific differences in the reactivity against each cardiac troponin I complex; this could explain the differences in values observed for some of the samples. Conclusion The newly developed ARCHITECT High-Sensitive Troponin I ST reagents were not affected by the presence of skeletal-muscle troponin I in the blood and may be useful for routine examinations.

Use of ultrasound measurement of the inferior vena cava diameter as an objective tool in the assessment of children with clinical dehydration.

PubMed

Chen, Lei; Kim, Yunie; Santucci, Karen A

2007-10-01

Bedside ultrasonography (US) measurement of the inferior vena cava (IVC) and aorta (Ao) may be useful in objectively assessing children with dehydration. The objectives of this study were 1) to compare the IVC and Ao diameters (IVC/Ao) ratio of dehydrated children with controls and 2) to compare the IVC/Ao ratio before and after intravenous (i.v.) rehydration in children with dehydration. This prospective observational study was performed in an urban pediatric emergency department. Children between 6 months and 16 years of age with clinical evidence of dehydration were enrolled. Bedside US measurements of the IVC and Ao were taken before and immediately after i.v. fluids were administered. An age-, gender-, and weight-matched control without dehydration was enrolled for each subject. The IVC/Ao ratios of subjects and controls were compared using Wilcoxon signed rank test, as were the ratios before and after i.v. hydration for each subject. Thirty-six pairs of subjects and matched controls were enrolled. The IVC/Ao ratios in the subjects were lower as compared with controls (mean of 0.75 vs. 1.01), with a mean difference of 0.26 (95% confidence interval = 0.18 to 0.35). In subjects, the IVC/Ao ratios were significantly lower before i.v. hydration (mean of 0.75 vs. 1.09), with a mean difference of 0.34 (95% confidence interval = 0.29 to 0.39). As measured by bedside US measurement, the IVC/Ao ratio is lower in children clinically assessed to be dehydrated. Furthermore, it increases with administration of i.v. fluid boluses.

i3b3: Infobuttons for i2b2 as a Mechanism for Investigating the Information Needs of Clinical Researchers.

PubMed

Kennell, Timothy; Dempsey, Donald M; Cimino, James J

2016-01-01

The information needs of clinicians, as they interact with the EHR, are well-studied. Clinical researchers also interact with the EHR and, while they might be expected to have some similar needs, the unique needs that arise due to nature of their work remain largely unstudied. For clinicians, infobuttons (context-aware hyperlinks) provide a mechanism of studying these information needs. Here we describe the integration of infobuttons into i2b2, a popular data warehouse commonly used by clinical researchers, using a plugin. A preliminary survey of i2b2 developers suggests a general interest in infobuttons for i2b2 and indicates good likelihood for their deployment, where they may be used as a tool for further studying these needs in greater detail.

Clinical performance of a new point-of-care cardiac troponin I test.

PubMed

Christ, Michael; Geier, Felicitas; Blaschke, Sabine; Giannitsis, Evangelos; Khellaf, Mehdi; Mair, Johannes; Pariente, David; Scharnhorst, Volkher; Semjonow, Veronique; Hausfater, Pierre

2018-04-09

We evaluated the clinical performance of the Minicare cardiac troponin-I (cTnI), a new point-of-care (POC) cTnI test for the diagnosis of acute myocardial infarction (AMI) in a prospective, multicentre study (ISRCTN77371338). Of 474 patients (≥18 years) admitted to an emergency department (ED) or chest pain unit (CPU) with symptoms suggestive of acute coronary syndrome (ACS; ≤12 h from symptom onset), 465 were eligible. Minicare cTnI was tested immediately, 3 h and 6 h after presentation. AMI diagnoses were adjudicated independently based on current guidelines. The diagnostic performance of the Minicare cTnI test at 3 h was similar for whole blood and in plasma: sensitivity 0.92 vs. 0.90; specificity 0.91 vs. 0.90; positive predictive value (PPV) 0.68 vs. 0.66; negative predictive value (NPV) 0.98 vs. 0.98; positive likelihood ratio (LR+) 10.18 vs. 9.41; negative likelihood ratio (LR-) 0.09 vs. 0.11. The optimal diagnostic performance was obtained at 3 h using cut-offs cTnI >43 ng/L plus cTnI change from admission ≥18.5 ng/L: sensitivity 0.90, specificity 0.96, PPV 0.81, NPV 0.98, and LR+ 21.54. The area under the receiver operating characteristics (ROC) curve for cTnI whole blood baseline value and absolute change after 3 h curve was 0.93. These data support the clinical usefulness of Minicare cTnI within a 0 h/3 h-blood sampling protocol supported by current guidelines for the evaluation of suspected ACS.

Challenges in Measuring Benefit of Clinical Research Training Programs--the ASH Clinical Research Training Institute Example.

PubMed

Sung, Lillian; Crowther, Mark; Byrd, John; Gitlin, Scott D; Basso, Joe; Burns, Linda

2015-12-01

The American Society of Hematology developed the Clinical Research Training Institute (CRTI) to address the lack of training in patient-oriented research among hematologists. As the program continues, we need to consider metrics for measuring the benefits of such a training program. This article addresses the benefits of clinical research training programs. The fundamental and key components are education and mentorship. However, there are several other benefits including promotion of collaboration, job and advancement opportunities, and promotion of work-life balance. The benefits of clinical research training programs need to be measured so that funders and society can judge if they are worth the investment in time and resources. Identification of elements that are important to program benefit is essential to measuring the benefit of the program as well as program planning. Future work should focus on the constructs which contribute to benefits of clinical research training programs such as CRTI.

Four new type I restriction enzymes identified in Escherichia coli clinical isolates

PubMed Central

Kasarjian, Julie K. A.; Kodama, Yoshiaki; Iida, Masatake; Matsuda, Katsura; Ryu, Junichi

2005-01-01

Using a plasmid transformation method and the RM search computer program, four type I restriction enzymes with new recognition sites and two isoschizomers (EcoBI and Eco377I) were identified in a collection of clinical Escherichia coli isolates. These new enzymes were designated Eco394I, Eco826I, Eco851I and Eco912I. Their recognition sequences were determined to be GAC(5N)RTAAY, GCA(6N)CTGA, GTCA(6N)TGAY and CAC(5N)TGGC, respectively. A methylation sensitivity assay, using various synthetic oligonucleotides, was used to identify the adenines that prevent cleavage when methylated (underlined). These results suggest that type I enzymes are abundant in E.coli and many other bacteria, as has been inferred from bacterial genome sequencing projects. PMID:16040596

Comparison of cardiac troponins I and T measured with high-sensitivity methods for evaluation of prognosis in atrial fibrillation: an ARISTOTLE substudy.

PubMed

Hijazi, Ziad; Siegbahn, Agneta; Andersson, Ulrika; Lindahl, Bertil; Granger, Christopher B; Alexander, John H; Atar, Dan; Gersh, Bernard J; Hanna, Michael; Harjola, Veli-Pekka; Horowitz, John; Husted, Steen; Hylek, Elaine M; Lopes, Renato D; McMurray, John J V; Wallentin, Lars

2015-02-01

Although cardiac troponin is associated with outcomes in atrial fibrillation (AF), the complementary prognostic information provided by cardiac troponin I (cTnI) and cTnT is unknown. This study investigated the distribution, determinants, and prognostic value of cTnI and cTnT concentrations in patients with AF. Samples were collected. At the time of randomization, we analyzed cTnI and cTnT concentrations of 14806 AF patients in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial using high-sensitivity assays. Correlations (Spearman), determinants (multivariable linear regression), and outcomes (adjusted Cox models and c-statistics) were investigated. Concentrations of cTnI and cTnT were correlated (r = 0.70) and measurable in most participants [cTnI 98.5% (median 5.4 ng/L, ≥99th percentile in 9.2%) and cTnT 93.5% (median 10.9 ng/L, ≥99th percentile in 34.4%)]. Renal impairment was the most important factor affecting the concentrations of both troponins. cTnI increase was more associated with heart failure, vascular disease, and persistent/permanent AF, and cTnT with age, male sex, and diabetes. Over a median 1.9 years of follow-up, patients with both troponins above the median had significantly higher risk for stroke/systemic embolism [hazard ratio (HR) 1.72 (95% CI 1.31-2.27)], cardiac death [3.14 (2.35-4.20)], and myocardial infarction [2.99 (1.78-5.03)] than those with both troponins below median (all P < 0.005). Intermediate risks were observed when only 1 troponin was above the median. When combined with clinical information, each marker provided similar prognostication and had comparable c-index. cTnI and cTnT concentrations are moderately correlated and measurable in plasma of most AF patients. The risk of stroke and cardiovascular events is highest when both troponins are above median concentrations. Each troponin provides comparable prognostic information when combined with clinical risk factors

I PREPARE: development and clinical utility of an environmental exposure history mnemonic.

PubMed

Paranzino, Grace K; Butterfield, Patricia; Nastoff, Teresa; Ranger, Cherryll

2005-01-01

The I PREPARE environmental exposure history mnemonic is a quick reference tool created for primary care providers. Health care providers (N = 159) were asked to evaluate a prototype mnemonic, to suggest new health history questions, and to propose the deletion of less relevant questions. The goal of this evaluation was to create a practical and clinically relevant mnemonic, rather than to obtain quantitative estimates of validity. The final I PREPARE mnemonic cues the provider to "Investigate potential exposures;" ask questions related to "Present work," "Residence," "Environmental concerns," "Past work," and "Activities;" provide "Referrals and resources;" and "Educate" the patient by reviewing a checklist of strategies to prevent or minimize exposures. The sequence of I PREPARE makes intuitive sense by cueing the provider to ask specific questions and provide educational materials to the patient. National improvements in the quality of environmental exposure history data are predicated in part on the creation of simple and convenient tools for use in clinical practice.

Utilizing measure-based feedback in control-mastery theory: A clinical error.

PubMed

Snyder, John; Aafjes-van Doorn, Katie

2016-09-01

Clinical errors and ruptures are an inevitable part of clinical practice. Often times, therapists are unaware that a clinical error or rupture has occurred, leaving no space for repair, and potentially leading to patient dropout and/or less effective treatment. One way to overcome our blind spots is by frequently and systematically collecting measure-based feedback from the patient. Patient feedback measures that focus on the process of psychotherapy such as the Patient's Experience of Attunement and Responsiveness scale (PEAR) can be used in conjunction with treatment outcome measures such as the Outcome Questionnaire 45.2 (OQ-45.2) to monitor the patient's therapeutic experience and progress. The regular use of these types of measures can aid clinicians in the identification of clinical errors and the associated patient deterioration that might otherwise go unnoticed and unaddressed. The current case study describes an instance of clinical error that occurred during the 2-year treatment of a highly traumatized young woman. The clinical error was identified using measure-based feedback and subsequently understood and addressed from the theoretical standpoint of the control-mastery theory of psychotherapy. An alternative hypothetical response is also presented and explained using control-mastery theory. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

An Electronic Adherence Measurement Intervention to Reduce Clinical Inertia in the Treatment of Uncontrolled Hypertension: The MATCH Cluster Randomized Clinical Trial.

PubMed

Kronish, Ian M; Moise, Nathalie; McGinn, Thomas; Quan, Yan; Chaplin, William; Gallagher, Benjamin D; Davidson, Karina W

2016-11-01

To appropriately manage uncontrolled hypertension, clinicians must decide whether blood pressure (BP) is above goal due to a need for additional medication or to medication nonadherence. Yet, clinicians are poor judges of adherence, and uncertainty about adherence may promote inertia with respect to medication modification. We aimed to determine the effect of sharing electronically-measured adherence data with clinicians on the management of uncontrolled hypertension. This was a cluster randomized trial. Twenty-four primary care providers (12 intervention, 12 usual care; cluster units) and 100 patients with uncontrolled hypertension (65 intervention, 35 usual care) were included in the study. At one visit per patient, clinicians in the intervention group received a report summarizing electronically measured adherence to the BP regimen and recommended clinical actions. Clinicians in the control group did not receive a report. The primary outcome was the proportion of visits with appropriate clinical management (i.e., treatment intensification among adherent patients and adherence counseling among nonadherent patients). Secondary outcomes included patient-rated quality of care and communication during the visit. The proportion of visits with appropriate clinical management was higher in the intervention group than the control group (45 out of 65; 69 %) versus (12 out of 35; 34 %; p = 0.001). A higher proportion of adherent patients in the intervention group had their regimen intensified (p = 0.01), and a higher proportion of nonadherent patients in the intervention group received adherence counseling (p = 0.005). Patients in the intervention group were more likely to give their clinician high ratings on quality of care (p = 0.05), and on measures of patient-centered (p = 0.001) and collaborative communication (p = 0.02). Providing clinicians with electronically-measured antihypertensive adherence reports reduces inertia in the management of

Outcome measures for oral health based on clinical assessments and claims data: feasibility evaluation in practice.

PubMed

Hummel, Riët; Bruers, Josef; van der Galiën, Onno; van der Sanden, Wil; van der Heijden, Geert

2017-10-05

It is well known that treatment variation exists in oral healthcare, but the consequences for oral health are unknown as the development of outcome measures is still in its infancy. The aim of this study was to identify and develop outcome measures for oral health and explore their performance using health insurance claims records and clinical data from general dental practices. The Dutch healthcare insurance company Achmea collaborated with researchers, oral health experts, and general dental practitioners (GDPs) in a proof of practice study to test the feasibility of measures in general dental practices. A literature search identified previously described outcome measures for oral healthcare. Using a structured approach, identified measures were (i) prioritized, adjusted and added to after discussion and then (ii) tested for feasibility of data collection, their face validity and discriminative validity. Data sources were claims records from Achmea, clinical records from dental practices, and prospective, pre-determined clinical assessment data obtained during routine consultations. In total eight measures (four on dental caries, one on tooth wear, two on periodontal health, one on retreatment) were identified, prioritized and tested. The retreatment measure and three measures for dental caries were found promising as data collection was feasible, they had face validity and discriminative validity. Deployment of these measures demonstrated variation in clinical practices of GDPs. Feedback of this data to GDPs led to vivid discussions on best practices and quality of care. The measure 'tooth wear' was not considered sufficiently responsive; 'changes in periodontal health score' was considered a controversial measure. The available data for the measures 'percentage of 18-year-olds with no tooth decay' and 'improvement in gingival bleeding index at reassessment' was too limited to provide accurate estimates per dental practice. The evaluated measures 'time to first

Dose escalation methods in phase I cancer clinical trials.

PubMed

Le Tourneau, Christophe; Lee, J Jack; Siu, Lillian L

2009-05-20

Phase I clinical trials are an essential step in the development of anticancer drugs. The main goal of these studies is to establish the recommended dose and/or schedule of new drugs or drug combinations for phase II trials. The guiding principle for dose escalation in phase I trials is to avoid exposing too many patients to subtherapeutic doses while preserving safety and maintaining rapid accrual. Here we review dose escalation methods for phase I trials, including the rule-based and model-based dose escalation methods that have been developed to evaluate new anticancer agents. Toxicity has traditionally been the primary endpoint for phase I trials involving cytotoxic agents. However, with the emergence of molecularly targeted anticancer agents, potential alternative endpoints to delineate optimal biological activity, such as plasma drug concentration and target inhibition in tumor or surrogate tissues, have been proposed along with new trial designs. We also describe specific methods for drug combinations as well as methods that use a time-to-event endpoint or both toxicity and efficacy as endpoints. Finally, we present the advantages and drawbacks of the various dose escalation methods and discuss specific applications of the methods in developmental oncotherapeutics.

Impact of Glucose Measurement Processing Delays on Clinical Accuracy and Relevance

PubMed Central

Jangam, Sujit R.; Hayter, Gary; Dunn, Timothy C.

2013-01-01

Background In a hospital setting, glucose is often measured from venous blood in the clinical laboratory. However, laboratory glucose measurements are typically not available in real time. In practice, turn-around times for laboratory measurements can be minutes to hours. This analysis assesses the impact of turn-around time on the effective clinical accuracy of laboratory measurements. Methods Data obtained from an earlier study with 58 subjects with type 1 diabetes mellitus (T1DM) were used for this analysis. In the study, glucose measurements using a YSI glucose analyzer were obtained from venous blood samples every 15 min while the subjects were at the health care facility. To simulate delayed laboratory results, each YSI glucose value from a subject was paired with one from a later time point (from the same subject) separated by 15, 30, 45, and 60 min. To assess the clinical accuracy of a delayed YSI result relative to a real-time result, the percentage of YSI pairs that meet the International Organization for Standardization (ISO) 15197:2003(E) standard for glucose measurement accuracy (±15 mg/dl for blood glucose < 75 mg/dl, ±20% for blood glucose ≥ 75 mg/dl) was calculated. Results It was observed that delays of 15 min or more reduce clinical accuracy below the ISO 15197:2003(E) recommendation of 95%. The accuracy was less than 65% for delays of 60 min. Conclusion This analysis suggests that processing delays in glucose measurements reduce the clinical relevance of results in patients with T1DM and may similarly degrade the clinical value of measurements in other patient populations. PMID:23759399

Impact of glucose measurement processing delays on clinical accuracy and relevance.

PubMed

Jangam, Sujit R; Hayter, Gary; Dunn, Timothy C

2013-05-01

In a hospital setting, glucose is often measured from venous blood in the clinical laboratory. However, laboratory glucose measurements are typically not available in real time. In practice, turn-around times for laboratory measurements can be minutes to hours. This analysis assesses the impact of turn-around time on the effective clinical accuracy of laboratory measurements. Data obtained from an earlier study with 58 subjects with type 1 diabetes mellitus (T1DM) were used for this analysis. In the study, glucose measurements using a YSI glucose analyzer were obtained from venous blood samples every 15 min while the subjects were at the health care facility. To simulate delayed laboratory results, each YSI glucose value from a subject was paired with one from a later time point (from the same subject) separated by 15, 30, 45, and 60 min. To assess the clinical accuracy of a delayed YSI result relative to a real-time result, the percentage of YSI pairs that meet the International Organization for Standardization (ISO) 15197:2003(E) standard for glucose measurement accuracy (±15 mg/dl for blood glucose < 75 mg/dl, ±20% for blood glucose ≥ 75 mg/dl) was calculated. It was observed that delays of 15 min or more reduce clinical accuracy below the ISO 15197:2003(E) recommendation of 95%. The accuracy was less than 65% for delays of 60 min. This analysis suggests that processing delays in glucose measurements reduce the clinical relevance of results in patients with T1DM and may similarly degrade the clinical value of measurements in other patient populations. © 2013 Diabetes Technology Society.

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

PubMed

Nottingham, Sara; Henning, Jolene

2014-01-01

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

An iPhone application for upper arm posture and movement measurements.

PubMed

Yang, Liyun; Grooten, Wilhelmus J A; Forsman, Mikael

2017-11-01

There is a need for objective methods for upper arm elevation measurements for accurate and convenient risk assessments. The aims of this study were (i) to compare a newly developed iOS application (iOS) for measuring upper arm elevation and angular velocity with a reference optical tracking system (OTS), and (ii) to compare the accuracy of the iOS incorporating a gyroscope and an accelerometer with using only an accelerometer, which is standard for inclinometry. The iOS-OTS limits of agreement for static postures (9 subjects) were -4.6° and 4.8°. All root mean square differences in arm swings and two simulated work tasks were <6.0°, and all mean correlation coefficients were >0.98. The mean absolute iOS-OTS difference of median angular velocity was <13.1°/s, which was significantly lower than only using an accelerometer (<43.5°/s). The accuracy of this iOS application compares well to that of today's research methods and it can be useful for practical upper arm measurements. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

[History of Clinical Psychiatry of Sapienza University of Rome in Policlinico Umberto I].

PubMed

Coccanari de' Fornari, Maria Antonietta; Iannitelli, Angela; Biondi, Massimo

2017-01-01

The present article intends to go over the history of the Psychiatric Clinic of the Sapienza University of Rome, starting from the beginning of the teaching of Psychiatry at Santa Maria della Pietà mental hospital, back in 1871, to the eventual founding, at the University "La Sapienza" and the Umberto I general hospital, of the Institute of Psychiatric Clinic and next of the Nervous and Mental Diseases' Clinic with the enclosed specialization school in Psychiatry. A detailed overview is supplied on the characters of the eminent scientists who have succeeded over time at the head of the Clinic and on the description of its different organization, conceived by each of them because of their educational and cultural roots. In this humus is born, in 1966, the journal Rivista di Psichiatria, still alive. To follow, a brief description of what the academic Psychiatry of the Umberto I nowadays represents, and indeed point of contact of different psychiatric thinking roots, with an organic, pharmacological, phenomenological, and psychotherapeutic orientation, this latter in the psychodynamic, cognitive-behavioral, and family-related approaches.

Instruments measuring spirituality in clinical research: a systematic review.

PubMed

Monod, Stéfanie; Brennan, Mark; Rochat, Etienne; Martin, Estelle; Rochat, Stéphane; Büla, Christophe J

2011-11-01

Numerous instruments have been developed to assess spirituality and measure its association with health outcomes. This study's aims were to identify instruments used in clinical research that measure spirituality; to propose a classification of these instruments; and to identify those instruments that could provide information on the need for spiritual intervention. A systematic literature search in MEDLINE, CINHAL, PsycINFO, ATLA, and EMBASE databases, using the terms "spirituality" and "adult$," and limited to journal articles was performed to identify clinical studies that used a spiritual assessment instrument. For each instrument identified, measured constructs, intended goals, and data on psychometric properties were retrieved. A conceptual and a functional classification of instruments were developed. Thirty-five instruments were retrieved and classified into measures of general spirituality (N = 22), spiritual well-being (N = 5), spiritual coping (N = 4), and spiritual needs (N = 4) according to the conceptual classification. Instruments most frequently used in clinical research were the FACIT-Sp and the Spiritual Well-Being Scale. Data on psychometric properties were mostly limited to content validity and inter-item reliability. According to the functional classification, 16 instruments were identified that included at least one item measuring a current spiritual state, but only three of those appeared suitable to address the need for spiritual intervention. Instruments identified in this systematic review assess multiple dimensions of spirituality, and the proposed classifications should help clinical researchers interested in investigating the complex relationship between spirituality and health. Findings underscore the scarcity of instruments specifically designed to measure a patient's current spiritual state. Moreover, the relatively limited data available on psychometric properties of these instruments highlight the need for additional research to

A clinically guided approach for improving performance measurement for hypertension.

PubMed

Steinman, Michael A; Lee, Sei J; Peterson, Carolyn A; Fung, Kathy Z; Goldstein, Mary K

2012-05-01

Performance measures often fail to account for legitimate reasons why patients do not achieve recommended treatment targets. We tested a novel performance measurement system for blood pressure (BP) control that was designed to mimic clinical reasoning. This clinically guided approach focuses on (1) exempting patients for whom tight BP control may not be appropriate or feasible and (2) assessing BP over time. Trained abstractors conducted structured chart reviews of 201 adults with hypertension in 2 VA health care systems. Results were compared with traditional methods of performance measurement. Among 201 veterans, 183 (91%) were male, and the mean age was 71±11 years. Using the clinically guided approach, 61 patients (30%) were exempted from performance measurement. The most common reasons for exemption were inadequate opportunity to manage BP (35 patients, 17%) and the use of 4 or more antihypertensive medications (19 patients, 9%). Among patients eligible for performance measurement, there was little agreement on the presence of controlled versus uncontrolled BP when comparing the most recent BP (the traditional approach) with an integrated assessment of BP control (κ 0.14). After accounting for clinically guided exemptions and methods of BP assessment, only 15 of 72 patients (21%) whose last BP was ≥140/90 mm Hg were classified as problematic by the clinically guided approach. Many patients have legitimate reasons for not achieving tight BP control, and the methods used for BP assessment have marked effects on whether a patient is classified as having adequate or inadequate BP control.

Atmospheric water vapour over oceans from SSM/I measurements

NASA Technical Reports Server (NTRS)

Schluessel, Peter; Emery, William J.

1990-01-01

A statistical retrieval technique is developed to derive the atmospheric water vapor column content from the Special Sensor Microwave/Imager (SSM/I) measurements. The radiometer signals are simulated by means of radiative-transfer calculations for a large set of atmospheric/oceanic situations. These simulated responses are subsequently summarized by multivariate analyses, giving water-vapor coefficients and error estimates. Radiative-transfer calculations show that the SSM/I microwave imager can detect atmospheric water vapor structures with an accuracy from 0.145 to 0.17 g/sq cm. The accuracy of the method is confirmed by globally distributed match-ups with radiosonde measurements.

Magnetogate: using an iPhone magnetometer for measuring kinematic variables

NASA Astrophysics Data System (ADS)

Kağan Temiz, Burak; Yavuz, Ahmet

2016-01-01

This paper presents a method to measure the movement of an object from specific locations on a straight line using an iPhone’s magnetometer. In this method, called ‘magnetogate’, an iPhone is placed on a moving object (in this case a toy car) and small neodymium magnets are arranged at equal intervals on one side of a straight line. The magnetometer sensor of the iPhone is switched on and then the car starts moving. The iPhone’s magnetometer is stimulated throughout its movement along a straight line. A ‘sensor Kinetics’ application on the iPhone saves the magnetic stimulations and produces a graph of the changing magnetic field near the iPhone. At the end of motion, data from the magnetometer is interpreted and peaks on the graph are detected. Thus, position-time changes can be analysed and comments about the motion of the object can be made. The position, velocity and acceleration of the object can be easily measured with this method.

Intravenous iron in clinical concentrations does not impair haemoglobin measurement.

PubMed

O'Loughlin, Edmond; Garnett, Peter Bj; Falkner, Nathalie M; Williams, Robin

2016-03-01

Intravenous iron is commonly administered to anaemic patients to treat iron deficiency, but due to its ferric colouration, it may interfere with the spectrophotometric assessment of haemoglobin concentrations. This paper investigates the potential interference of three clinically used intravenous iron preparations on the measurement of haemoglobin. Haemoglobin concentration was measured for neat and Hartmann's solution-diluted iron polymaltose, carboxymaltose and sucrose solutions using bedside (Radiometer HemoCue®), point-of-care (Radiometer ABL800 Flex) and laboratory (Abbott CellDyne Sapphire™) devices. Haemoglobin concentration was then assessed with the same devices utilizing anaemic whole blood with the iron solutions added. Neat iron preparations registered clinically significant haemoglobin concentrations on bedside and laboratory measurements. When intravenous iron preparations were diluted to clinical concentrations, their effect on haemoglobin measurements, either in isolation or mixed with anaemic blood, was negligible. Although neat preparations of intravenous iron do interfere with spectrophotometric analysis of haemoglobin, concentrations likely to be seen post iron infusion do not significantly interfere with haemoglobin measurement. © The Author(s) 2015.

Measures to Improve Diagnostic Safety in Clinical Practice

PubMed Central

Singh, Hardeep; Graber, Mark L; Hofer, Timothy P

2016-01-01

Timely and accurate diagnosis is foundational to good clinical practice and an essential first step to achieving optimal patient outcomes. However, a recent Institute of Medicine report concluded that most of us will experience at least one diagnostic error in our lifetime. The report argues for efforts to improve the reliability of the diagnostic process through better measurement of diagnostic performance. The diagnostic process is a dynamic team-based activity that involves uncertainty, plays out over time, and requires effective communication and collaboration among multiple clinicians, diagnostic services, and the patient. Thus, it poses special challenges for measurement. In this paper, we discuss how the need to develop measures to improve diagnostic performance could move forward at a time when the scientific foundation needed to inform measurement is still evolving. We highlight challenges and opportunities for developing potential measures of “diagnostic safety” related to clinical diagnostic errors and associated preventable diagnostic harm. In doing so, we propose a starter set of measurement concepts for initial consideration that seem reasonably related to diagnostic safety, and call for these to be studied and further refined. This would enable safe diagnosis to become an organizational priority and facilitate quality improvement. Health care systems should consider measurement and evaluation of diagnostic performance as essential to timely and accurate diagnosis and to the reduction of preventable diagnostic harm. PMID:27768655

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

PubMed Central

Nottingham, Sara; Henning, Jolene

2014-01-01

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

PEGylated carboxyhemoglobin bovine (SANGUINATE): results of a phase I clinical trial.

PubMed

Misra, Hemant; Lickliter, Jason; Kazo, Friedericke; Abuchowski, Abraham

2014-08-01

PEGylated carboxyhemoglobin bovine (SANGUINATE) is a dual action carbon monoxide releasing (CO)/oxygen (O2 ) transfer agent for the treatment of hypoxia. Its components inhibit vasoconstriction, decrease extravasation, limit reactive oxygen species production, enhance blood rheology, and deliver oxygen to the tissues. Animal models of cerebral ischemia, peripheral ischemia, and myocardial ischemia demonstrated SANGUINATE's efficacy in reducing myocardial infarct size, limiting necrosis from cerebral ischemia, and promoting more rapid recovery from hind limb ischemia. In a Phase I trial, three cohorts of eight healthy volunteers received single ascending doses of 80, 120, or 160 mg/kg of SANGUINATE. Two volunteers within each cohort served as a saline control. There were no serious adverse events. Serum haptoglobin decreased, but did not appear to be dose related. The T1/2 was dose dependent and ranged from 7.9 to 13.8 h. In addition to the Phase I trial, SANGUINATE was used under an expanded access emergency Investigational New Drug. SANGUINATE was found to be safe and well tolerated in a Phase I clinical trial, and therefore it will advance into further clinical trials in patients. © 2014 The Authors. Artificial Organs published by Wiley Periodicals, Inc. on behalf of International Center for Artificial Organs and Transplantation (ICAOT).

Detecting interferences with iOS applications to measure speed of sound

NASA Astrophysics Data System (ADS)

Yavuz, Ahmet; Kağan Temiz, Burak

2016-01-01

Traditional experiments measuring the speed of sound consist of studying harmonics by changing the length of a glass tube closed at one end. In these experiments, the sound source and observer are outside of the tube. In this paper, we propose the modification of this old experiment by studying destructive interference in a pipe using a headset, iPhone and iPad. The iPhone is used as an emitter with signal generator application and the iPad is used as the receiver with a spectrogram application. Two experiments are carried out for measures: the emitter inside of the tube with the receiver outside, and vice versa. We conclude that it is even possible to adequately and easily measure the speed of sound using a cup or a can of coke with the method described in this paper.

Analysis of repeated measurement data in the clinical trials

PubMed Central

Singh, Vineeta; Rana, Rakesh Kumar; Singhal, Richa

2013-01-01

Statistics is an integral part of Clinical Trials. Elements of statistics span Clinical Trial design, data monitoring, analyses and reporting. A solid understanding of statistical concepts by clinicians improves the comprehension and the resulting quality of Clinical Trials. In biomedical research it has been seen that researcher frequently use t-test and ANOVA to compare means between the groups of interest irrespective of the nature of the data. In Clinical Trials we record the data on the patients more than two times. In such a situation using the standard ANOVA procedures is not appropriate as it does not consider dependencies between observations within subjects in the analysis. To deal with such types of study data Repeated Measure ANOVA should be used. In this article the application of One-way Repeated Measure ANOVA has been demonstrated by using the software SPSS (Statistical Package for Social Sciences) Version 15.0 on the data collected at four time points 0 day, 15th day, 30th day, and 45th day of multicentre clinical trial conducted on Pandu Roga (~Iron Deficiency Anemia) with an Ayurvedic formulation Dhatrilauha. PMID:23930038

Ragweed sublingual tablet immunotherapy: part I - evidence-based clinical efficacy and safety.

PubMed

Creticos, Peter Socrates; Pfaar, Oliver

2018-06-01

Sublingual tablet immunotherapy provides an attractive alternative approach to allergen immunotherapy, as the allergen is administered as a rapidly dissolving sublingual tablet. Part I of this two-part series on the ragweed sublingual tablet describes the dose-ranging clinical work, the safety studies and the clinical outcomes from the pivotal trials which provide clear evidence for statistically significant and clinically meaningful benefit in the treatment of patients suffering from ragweed-induced seasonal allergic rhinitis-conjunctivitis with or without milder asthma. The robust results observed in the clinical trials performed with the ragweed sublingual tablet are defined by the quality of their study design, their use of a standardized allergen extract, their consistent reproducibility in demonstrating therapeutic efficacy and their properly quantified and graded safety data.

Reliable jitter and shimmer measurements in voice clinics: the relevance of vowel, gender, vocal intensity, and fundamental frequency effects in a typical clinical task.

PubMed

Brockmann, Meike; Drinnan, Michael J; Storck, Claudio; Carding, Paul N

2011-01-01

The aims of this study were to examine vowel and gender effects on jitter and shimmer in a typical clinical voice task while correcting for the confounding effects of voice sound pressure level (SPL) and fundamental frequency (F(0)). Furthermore the relative effect sizes of vowel, gender, voice SPL, and F(0) were assessed, and recommendations for clinical measurements were derived. With this cross-sectional single cohort study, 57 healthy adults (28 women, 29 men) aged 20-40 years were investigated. Three phonations of /a/, /o/, and /i/ at "normal" voice loudness were analyzed using Praat (software). The effects of vowel, gender, voice SPL, and F(0) on jitter and shimmer were assessed using descriptive and inferential (analysis of covariance) statistics. The effect sizes were determined with the eta-squared statistic. Vowels, gender, voice SPL, and F(0), each had significant effects either on jitter or on shimmer, or both. Voice SPL was the most important factor, whereas vowel, gender, and F(0) effects were comparatively small. Because men had systematically higher voice SPL, the gender effects on jitter and shimmer were smaller when correcting for SPL and F(0). Surprisingly, in clinical assessments, voice SPL has the single biggest impact on jitter and shimmer. Vowel and gender effects were clinically important, whereas fundamental frequency had a relatively small influence. Phonations at a predefined voice SPL (80 dB minimum) and vowel (/a/) would enhance measurement reliability. Furthermore, gender-specific thresholds applying these guidelines should be established. However, the efficiency of these measures should be verified and tested with patients. Copyright © 2011 The Voice Foundation. All rights reserved.

The development and validation of a questionnaire to measure the clinical learning environment for undergraduate dental students (DECLEI).

PubMed

Kossioni, A E; Lyrakos, G; Ntinalexi, I; Varela, R; Economu, I

2014-05-01

The aim of this study was to develop and validate according to psychometric standards a self-administered instrument to measure the students' self-perceptions of the undergraduate clinical dental environment (DECLEI). The initial questionnaire was developed using feedback from dental students, experts' opinion and an extensive literature review. Critical incident technique (CIT) analysis was used to generate items and identify domains. Thirty clinical dental students participated in a pilot validation that generated a 67-item questionnaire. To develop a shorter and more practical version of the instrument, DECLEI-67 was distributed to 153 clinical students at the University of Athens and its English version to 51 students from various dental schools, attending the 2012 European Dental Students Association meeting. This final procedure aimed to select items, identify subscales and measure internal consistency and discriminant validity. A total of 202 students returned the questionnaires (response rate 99%). The final instrument included 24 items divided into three subscales: (i) organisation and learning opportunities, (ii) professionalism and communication and (iii) satisfaction and commitment to the dental studies. Cronbach's α for the total questionnaire was 0.89. The interscale correlations ranged from 0.39 to 0.48. The instrument identified differences related to school of origin, age and duration of clinical experience. An interpretation of the scores (range 0–100) has been proposed. The 24-item DECLEI seemed to be a practical and valid instrument to measure a dental school's undergraduate clinical learning environment.

PhotoExam: adoption of an iOS-based clinical image capture application at Mayo Clinic.

PubMed

Wyatt, Kirk D; Willaert, Brian N; Pallagi, Peter J; Uribe, Richard A; Yiannias, James A; Hellmich, Thomas R

2017-12-01

Mayo Clinic developed an internal iOS-based, point-of-care clinical image capture application for clinicians. We aimed to assess the adoption and utilization of the application at Mayo Clinic. Metadata of 22,784 photos of 6417 patients taken by 606 users over 8040 clinical encounters between 3/1/2015 and 10/31/2015 were analyzed. A random sample of photos from 100 clinical encounters was assessed for quality using a five-item rubric. Use of traditional medical photography services before and after application launch were compared. The largest group of users was residents/fellows, accounting for 31% of users but only 18% of all photos. Attending physicians accounted for 29% of users and 30% of photos. Nurses accounted for 14% of users and 28% of photos. Surgical specialties had the most users (36% of users), followed by dermatology (14% of users); however, dermatology accounted for 54% of all photos, and surgery accounted for 26% of photos. Images received an average of 91% of possible points on the quality scoring rubric. Most frequent reasons for missing points were the location on the body not clearly being demonstrated (19% of encounters) and the perspective/scale not being clearly demonstrated (12% of encounters). There was no discernible pre-post effect of the application's launch on use of traditional medical photography services. Point-of-care clinical photography is a growing phenomenon with potential to become the new standard of care. Patient and provider attitudes and the impact on patient outcomes remain unclear. © 2017 The International Society of Dermatology.

Relationship between Clinic and Ambulatory Blood-Pressure Measurements and Mortality.

PubMed

Banegas, José R; Ruilope, Luis M; de la Sierra, Alejandro; Vinyoles, Ernest; Gorostidi, Manuel; de la Cruz, Juan J; Ruiz-Hurtado, Gema; Segura, Julián; Rodríguez-Artalejo, Fernando; Williams, Bryan

2018-04-19

Evidence for the influence of ambulatory blood pressure on prognosis derives mainly from population-based studies and a few relatively small clinical investigations. This study examined the associations of blood pressure measured in the clinic (clinic blood pressure) and 24-hour ambulatory blood pressure with all-cause and cardiovascular mortality in a large cohort of patients in primary care. We analyzed data from a registry-based, multicenter, national cohort that included 63,910 adults recruited from 2004 through 2014 in Spain. Clinic and 24-hour ambulatory blood-pressure data were examined in the following categories: sustained hypertension (elevated clinic and elevated 24-hour ambulatory blood pressure), "white-coat" hypertension (elevated clinic and normal 24-hour ambulatory blood pressure), masked hypertension (normal clinic and elevated 24-hour ambulatory blood pressure), and normotension (normal clinic and normal 24-hour ambulatory blood pressure). Analyses were conducted with Cox regression models, adjusted for clinic and 24-hour ambulatory blood pressures and for confounders. During a median follow-up of 4.7 years, 3808 patients died from any cause, and 1295 of these patients died from cardiovascular causes. In a model that included both 24-hour and clinic measurements, 24-hour systolic pressure was more strongly associated with all-cause mortality (hazard ratio, 1.58 per 1-SD increase in pressure; 95% confidence interval [CI], 1.56 to 1.60, after adjustment for clinic blood pressure) than the clinic systolic pressure (hazard ratio, 1.02; 95% CI, 1.00 to 1.04, after adjustment for 24-hour blood pressure). Corresponding hazard ratios per 1-SD increase in pressure were 1.55 (95% CI, 1.53 to 1.57, after adjustment for clinic and daytime blood pressures) for nighttime ambulatory systolic pressure and 1.54 (95% CI, 1.52 to 1.56, after adjustment for clinic and nighttime blood pressures) for daytime ambulatory systolic pressure. These relationships were

Ambulatory measurement of ankle kinetics for clinical applications.

PubMed

Rouhani, H; Favre, J; Crevoisier, X; Aminian, K

2011-10-13

This study aimed to design and validate the measurement of ankle kinetics (force, moment, and power) during consecutive gait cycles and in the field using an ambulatory system. An ambulatory system consisting of plantar pressure insole and inertial sensors (3D gyroscopes and 3D accelerometers) on foot and shank was used. To test this system, 12 patients and 10 healthy elderly subjects wore shoes embedding this system and walked many times across a gait lab including a force-plate surrounded by seven cameras considered as the reference system. Then, the participants walked two 50-meter trials where only the ambulatory system was used. Ankle force components and sagittal moment of ankle measured by ambulatory system showed correlation coefficient (R) and normalized RMS error (NRMSE) of more than 0.94 and less than 13% in comparison with the references system for both patients and healthy subjects. Transverse moment of ankle and ankle power showed R>0.85 and NRMSE<23%. These parameters also showed high repeatability (CMC>0.7). In contrast, the ankle coronal moment of ankle demonstrated high error and lower repeatability. Except for ankle coronal moment, the kinetic features obtained by the ambulatory system could distinguish the patients with ankle osteoarthritis from healthy subjects when measured in 50-meter trials. The proposed ambulatory system can be easily accessible in most clinics and could assess main ankle kinetics quantities with acceptable error and repeatability for clinical evaluations. This system is therefore suggested for field measurement in clinical applications. Copyright © 2011 Elsevier Ltd. All rights reserved.

Normalized Movement Quality Measures for Therapeutic Robots Strongly Correlate With Clinical Motor Impairment Measures

PubMed Central

Celik, Ozkan; O’Malley, Marcia K.; Boake, Corwin; Levin, Harvey S.; Yozbatiran, Nuray; Reistetter, Timothy A.

2016-01-01

In this paper, we analyze the correlations between four clinical measures (Fugl–Meyer upper extremity scale, Motor Activity Log, Action Research Arm Test, and Jebsen-Taylor Hand Function Test) and four robotic measures (smoothness of movement, trajectory error, average number of target hits per minute, and mean tangential speed), used to assess motor recovery. Data were gathered as part of a hybrid robotic and traditional upper extremity rehabilitation program for nine stroke patients. Smoothness of movement and trajectory error, temporally and spatially normalized measures of movement quality defined for point-to-point movements, were found to have significant moderate to strong correlations with all four of the clinical measures. The strong correlations suggest that smoothness of movement and trajectory error may be used to compare outcomes of different rehabilitation protocols and devices effectively, provide improved resolution for tracking patient progress compared to only pre-and post-treatment measurements, enable accurate adaptation of therapy based on patient progress, and deliver immediate and useful feedback to the patient and therapist. PMID:20388607

Acute Respiratory Distress Syndrome Measurement Error. Potential Effect on Clinical Study Results

PubMed Central

Cooke, Colin R.; Iwashyna, Theodore J.; Hofer, Timothy P.

2016-01-01

Rationale: Identifying patients with acute respiratory distress syndrome (ARDS) is a recognized challenge. Experts often have only moderate agreement when applying the clinical definition of ARDS to patients. However, no study has fully examined the implications of low reliability measurement of ARDS on clinical studies. Objectives: To investigate how the degree of variability in ARDS measurement commonly reported in clinical studies affects study power, the accuracy of treatment effect estimates, and the measured strength of risk factor associations. Methods: We examined the effect of ARDS measurement error in randomized clinical trials (RCTs) of ARDS-specific treatments and cohort studies using simulations. We varied the reliability of ARDS diagnosis, quantified as the interobserver reliability (κ-statistic) between two reviewers. In RCT simulations, patients identified as having ARDS were enrolled, and when measurement error was present, patients without ARDS could be enrolled. In cohort studies, risk factors as potential predictors were analyzed using reviewer-identified ARDS as the outcome variable. Measurements and Main Results: Lower reliability measurement of ARDS during patient enrollment in RCTs seriously degraded study power. Holding effect size constant, the sample size necessary to attain adequate statistical power increased by more than 50% as reliability declined, although the result was sensitive to ARDS prevalence. In a 1,400-patient clinical trial, the sample size necessary to maintain similar statistical power increased to over 1,900 when reliability declined from perfect to substantial (κ = 0.72). Lower reliability measurement diminished the apparent effectiveness of an ARDS-specific treatment from a 15.2% (95% confidence interval, 9.4–20.9%) absolute risk reduction in mortality to 10.9% (95% confidence interval, 4.7–16.2%) when reliability declined to moderate (κ = 0.51). In cohort studies, the effect on risk factor associations

Clinical Complexity in Medicine: A Measurement Model of Task and Patient Complexity.

PubMed

Islam, R; Weir, C; Del Fiol, G

2016-01-01

Complexity in medicine needs to be reduced to simple components in a way that is comprehensible to researchers and clinicians. Few studies in the current literature propose a measurement model that addresses both task and patient complexity in medicine. The objective of this paper is to develop an integrated approach to understand and measure clinical complexity by incorporating both task and patient complexity components focusing on the infectious disease domain. The measurement model was adapted and modified for the healthcare domain. Three clinical infectious disease teams were observed, audio-recorded and transcribed. Each team included an infectious diseases expert, one infectious diseases fellow, one physician assistant and one pharmacy resident fellow. The transcripts were parsed and the authors independently coded complexity attributes. This baseline measurement model of clinical complexity was modified in an initial set of coding processes and further validated in a consensus-based iterative process that included several meetings and email discussions by three clinical experts from diverse backgrounds from the Department of Biomedical Informatics at the University of Utah. Inter-rater reliability was calculated using Cohen's kappa. The proposed clinical complexity model consists of two separate components. The first is a clinical task complexity model with 13 clinical complexity-contributing factors and 7 dimensions. The second is the patient complexity model with 11 complexity-contributing factors and 5 dimensions. The measurement model for complexity encompassing both task and patient complexity will be a valuable resource for future researchers and industry to measure and understand complexity in healthcare.

MICRODOSIMETRIC MEASUREMENT OF SECONDARY RADIATION IN THE PASSIVE SCATTERED PROTON THERAPY ROOM OF iTHEMBA LABS USING A TISSUE-EQUIVALENT PROPORTIONAL COUNTER.

PubMed

Chiriotti, S; Parisi, A; Vanhavere, F; De Saint-Hubert, M; Vandevoorde, C; Slabbert, J; Beukes, P; de Kock, E; Symons, J

2018-04-13

Measurements of the dose equivalent at different distances from the isocenter of the proton therapy center at iThemba LABS were previously performed with a tissue-equivalent proportional counter (TEPC). These measurements showed that the scattered radiation levels were one or two orders of magnitude higher in comparison to other passive scattering delivery systems. In order to reduce these radiation levels, additional shielding was installed shortly after the measurements were done. Therefore, the aim of this work is to quantify and assess the reduction of the secondary doses delivered in the proton therapy room at iThemba LABS after the installation of the additional shielding. This has been performed by measuring microdosimetric spectra with a TEPC at 11 locations around the isocenter when a clinical modulated beam of 200 MeV proton was impinging onto a water phantom placed at the isocenter.

Do clinical data and human papilloma virus genotype influence spontaneous regression in grade I cervical intraepithelial neoplasia?

PubMed

Cortés-Alaguero, Caterina; González-Mirasol, Esteban; Morales-Roselló, José; Poblet-Martinez, Enrique

2017-03-15

To determine whether medical history, clinical examination and human papilloma virus (HPV) genotype influence spontaneous regression in cervical intraepithelial neoplasia grade I (CIN-I). We retrospectively evaluated 232 women who were histologically diagnosed as have CIN-I by means of Kaplan-Meier curves, the pattern of spontaneous regression according to the medical history, clinical examination, and HPV genotype. Spontaneous regression occurred in most patients and was influenced by the presence of multiple HPV genotypes but not by the HPV genotype itself. In addition, regression frequency was diminished when more than 50% of the cervix surface was affected or when an abnormal cytology was present at the beginning of follow-up. The frequency of regression in CIN-I is high, making long-term follow-up and conservative management advisable. Data from clinical examination and HPV genotyping might help to anticipate which lesions will regress.

Amotivation in Schizophrenia: Integrated Assessment With Behavioral, Clinical, and Imaging Measures

PubMed Central

Wolf, Daniel H.; Satterthwaite, Theodore D.; Kantrowitz, Jacob J.; Katchmar, Natalie; Vandekar, Lillie; Elliott, Mark A.; Ruparel, Kosha

2014-01-01

Motivational deficits play a central role in disability caused by schizophrenia and constitute a major unmet therapeutic need. Negative symptoms have previously been linked to hypofunction in ventral striatum (VS), a core component of brain motivation circuitry. However, it remains unclear to what extent this relationship holds for specific negative symptoms such as amotivation, and this question has not been addressed with integrated behavioral, clinical, and imaging measures. Here, 41 individuals with schizophrenia and 37 controls performed a brief, computerized progressive ratio task (PRT) that quantifies effort exerted in pursuit of monetary reward. Clinical amotivation was assessed using the recently validated Clinical Assessment Interview for Negative Symptoms (CAINS). VS function was probed during functional magnetic resonance imaging using a monetary guessing paradigm. We found that individuals with schizophrenia had diminished motivation as measured by the PRT, which significantly and selectively related to clinical amotivation as measured by the CAINS. Critically, lower PRT motivation in schizophrenia was also dimensionally related to VS hypofunction. Our results demonstrate robust dimensional associations between behavioral amotivation, clinical amotivation, and VS hypofunction in schizophrenia. Integrating behavioral measures such as the PRT will facilitate translational efforts to identify biomarkers of amotivation and to assess response to novel therapeutic interventions. PMID:24657876

Kinematic measures for upper limb robot-assisted therapy following stroke and correlations with clinical outcome measures: A review.

PubMed

Tran, Vi Do; Dario, Paolo; Mazzoleni, Stefano

2018-03-01

This review classifies the kinematic measures used to evaluate post-stroke motor impairment following upper limb robot-assisted rehabilitation and investigates their correlations with clinical outcome measures. An online literature search was carried out in PubMed, MEDLINE, Scopus and IEEE-Xplore databases. Kinematic parameters mentioned in the studies included were categorized into the International Classification of Functioning, Disability and Health (ICF) domains. The correlations between these parameters and the clinical scales were summarized. Forty-nine kinematic parameters were identified from 67 articles involving 1750 patients. The most frequently used parameters were: movement speed, movement accuracy, peak speed, number of speed peaks, and movement distance and duration. According to the ICF domains, 44 kinematic parameters were categorized into Body Functions and Structure, 5 into Activities and no parameters were categorized into Participation and Personal and Environmental Factors. Thirteen articles investigated the correlations between kinematic parameters and clinical outcome measures. Some kinematic measures showed a significant correlation coefficient with clinical scores, but most were weak or moderate. The proposed classification of kinematic measures into ICF domains and their correlations with clinical scales could contribute to identifying the most relevant ones for an integrated assessment of upper limb robot-assisted rehabilitation treatments following stroke. Increasing the assessment frequency by means of kinematic parameters could optimize clinical assessment procedures and enhance the effectiveness of rehabilitation treatments. Copyright © 2018 IPEM. Published by Elsevier Ltd. All rights reserved.

Measuring Workplace Climate in Community Clinics and Health Centers.

PubMed

Friedberg, Mark W; Rodriguez, Hector P; Martsolf, Grant R; Edelen, Maria O; Vargas Bustamante, Arturo

2016-10-01

The effectiveness of community clinics and health centers' efforts to improve the quality of care might be modified by clinics' workplace climates. Several surveys to measure workplace climate exist, but their relationships to each other and to distinguishable dimensions of workplace climate are unknown. To assess the psychometric properties of a survey instrument combining items from several existing surveys of workplace climate and to generate a shorter instrument for future use. We fielded a 106-item survey, which included items from 9 existing instruments, to all clinicians and staff members (n=781) working in 30 California community clinics and health centers, receiving 628 responses (80% response rate). We performed exploratory factor analysis of survey responses, followed by confirmatory factor analysis of 200 reserved survey responses. We generated a new, shorter survey instrument of items with strong factor loadings. Six factors, including 44 survey items, emerged from the exploratory analysis. Two factors (Clinic Workload and Teamwork) were independent from the others. The remaining 4 factors (staff relationships, quality improvement orientation, managerial readiness for change, and staff readiness for change) were highly correlated, indicating that these represented dimensions of a higher-order factor we called "Clinic Functionality." This 2-level, 6-factor model fit the data well in the exploratory and confirmatory samples. For all but 1 factor, fewer than 20 survey responses were needed to achieve clinic-level reliability >0.7. Survey instruments designed to measure workplace climate have substantial overlap. The relatively parsimonious item set we identified might help target and tailor clinics' quality improvement efforts.

An overview af SAGE I and II ozone measurements

NASA Technical Reports Server (NTRS)

Mccormick, M. P.; Zawodny, J. M.; Veiga, R. E.; Larsen, J. C.; Wang, P. H.

1989-01-01

The stratospheric Aerosol and Gas Experiments (SAGE) I and II measure Mie, Rayleigh, and gaseous extinction profiles using the solar occultation technique. These global measurements yield ozone profiles with a vertical resolution of 1 km which have been routinely obtained for the periods from February 1979 to November 1981 (SAGE I) and October 1984 to the present (SAGE II). The long-term periodic behavior of the measured ozone is presented as well as case studies of the observed short-term spatial and temporal variability. A linear regression shows annual, semiannual, and quasi-biennial oscillation features at various altitudes and latitudes which, in general, agree with past work. Also, ozone, aerosol, and water vapor data are described for the Antarctic springtime, showing large variation relative to the vortex. Cross-sections in latitude and altitude and polar plots at various altitudes clearly delineate the ozone hole vertically and areally.

Using Clinical Data Standards to Measure Quality: A New Approach.

PubMed

D'Amore, John D; Li, Chun; McCrary, Laura; Niloff, Jonathan M; Sittig, Dean F; McCoy, Allison B; Wright, Adam

2018-04-01

 Value-based payment for care requires the consistent, objective calculation of care quality. Previous initiatives to calculate ambulatory quality measures have relied on billing data or individual electronic health records (EHRs) to calculate and report performance. New methods for quality measure calculation promoted by federal regulations allow qualified clinical data registries to report quality outcomes based on data aggregated across facilities and EHRs using interoperability standards.  This research evaluates the use of clinical document interchange standards as the basis for quality measurement.  Using data on 1,100 patients from 11 ambulatory care facilities and 5 different EHRs, challenges to quality measurement are identified and addressed for 17 certified quality measures.  Iterative solutions were identified for 14 measures that improved patient inclusion and measure calculation accuracy. Findings validate this approach to improving measure accuracy while maintaining measure certification.  Organizations that report care quality should be aware of how identified issues affect quality measure selection and calculation. Quality measure authors should consider increasing real-world validation and the consistency of measure logic in respect to issues identified in this research. Schattauer GmbH Stuttgart.

Clinical balance assessment: perceptions of commonly-used standardized measures and current practices among physiotherapists in Ontario, Canada

PubMed Central

2013-01-01

Background Balance impairment is common in multiple clinical populations, and comprehensive assessment is important for identifying impairments, planning individualized treatment programs, and evaluating change over time. However, little information is available regarding whether clinicians who treat balance are satisfied with existing assessment tools. In 2010 we conducted a cross-sectional survey of balance assessment practices among physiotherapists in Ontario, Canada, and reported on the use of standardized balance measures (Sibley et al. 2011 Physical Therapy; 91: 1583-91). The purpose of this study was to analyse additional survey data and i) evaluate satisfaction with current balance assessment practices and standardized measures among physiotherapists who treat adult or geriatric populations with balance impairment, and ii) identify factors associated with satisfaction. Methods The questionnaire was distributed to 1000 practicing physiotherapists. This analysis focuses on questions in which respondents were asked to rate their general perceptions about balance assessment, the perceived utility of individual standardized balance measures, whether they wanted to improve balance assessment practices, and why. Data were summarized with descriptive statistics and utility of individual measures was compared across clinical practice areas (orthopaedic, neurological, geriatric or general rehabilitation). Results The questionnaire was completed by 369 respondents, of which 43.4% of respondents agreed that existing standardized measures of balance meet their needs. In ratings of individual measures, the Single Leg Stance test and Berg Balance Scale were perceived as useful for clinical decision-making and evaluating change over time by over 70% of respondents, and the Timed Up-and-Go test was perceived as useful for decision-making by 56.9% of respondents and useful for evaluating change over time by 62.9% of respondents, but there were significant differences across

Clinical balance assessment: perceptions of commonly-used standardized measures and current practices among physiotherapists in Ontario, Canada.

PubMed

Sibley, Kathryn M; Straus, Sharon E; Inness, Elizabeth L; Salbach, Nancy M; Jaglal, Susan B

2013-03-20

Balance impairment is common in multiple clinical populations, and comprehensive assessment is important for identifying impairments, planning individualized treatment programs, and evaluating change over time. However, little information is available regarding whether clinicians who treat balance are satisfied with existing assessment tools. In 2010 we conducted a cross-sectional survey of balance assessment practices among physiotherapists in Ontario, Canada, and reported on the use of standardized balance measures (Sibley et al. 2011 Physical Therapy; 91: 1583-91). The purpose of this study was to analyse additional survey data and i) evaluate satisfaction with current balance assessment practices and standardized measures among physiotherapists who treat adult or geriatric populations with balance impairment, and ii) identify factors associated with satisfaction. The questionnaire was distributed to 1000 practicing physiotherapists. This analysis focuses on questions in which respondents were asked to rate their general perceptions about balance assessment, the perceived utility of individual standardized balance measures, whether they wanted to improve balance assessment practices, and why. Data were summarized with descriptive statistics and utility of individual measures was compared across clinical practice areas (orthopaedic, neurological, geriatric or general rehabilitation). The questionnaire was completed by 369 respondents, of which 43.4% of respondents agreed that existing standardized measures of balance meet their needs. In ratings of individual measures, the Single Leg Stance test and Berg Balance Scale were perceived as useful for clinical decision-making and evaluating change over time by over 70% of respondents, and the Timed Up-and-Go test was perceived as useful for decision-making by 56.9% of respondents and useful for evaluating change over time by 62.9% of respondents, but there were significant differences across practice groups. Seventy

QNOTE: an instrument for measuring the quality of EHR clinical notes.

PubMed

Burke, Harry B; Hoang, Albert; Becher, Dorothy; Fontelo, Paul; Liu, Fang; Stephens, Mark; Pangaro, Louis N; Sessums, Laura L; O'Malley, Patrick; Baxi, Nancy S; Bunt, Christopher W; Capaldi, Vincent F; Chen, Julie M; Cooper, Barbara A; Djuric, David A; Hodge, Joshua A; Kane, Shawn; Magee, Charles; Makary, Zizette R; Mallory, Renee M; Miller, Thomas; Saperstein, Adam; Servey, Jessica; Gimbel, Ronald W

2014-01-01

The outpatient clinical note documents the clinician's information collection, problem assessment, and patient management, yet there is currently no validated instrument to measure the quality of the electronic clinical note. This study evaluated the validity of the QNOTE instrument, which assesses 12 elements in the clinical note, for measuring the quality of clinical notes. It also compared its performance with a global instrument that assesses the clinical note as a whole. Retrospective multicenter blinded study of the clinical notes of 100 outpatients with type 2 diabetes mellitus who had been seen in clinic on at least three occasions. The 300 notes were rated by eight general internal medicine and eight family medicine practicing physicians. The QNOTE instrument scored the quality of the note as the sum of a set of 12 note element scores, and its inter-rater agreement was measured by the intraclass correlation coefficient. The Global instrument scored the note in its entirety, and its inter-rater agreement was measured by the Fleiss κ. The overall QNOTE inter-rater agreement was 0.82 (CI 0.80 to 0.84), and its note quality score was 65 (CI 64 to 66). The Global inter-rater agreement was 0.24 (CI 0.19 to 0.29), and its note quality score was 52 (CI 49 to 55). The QNOTE quality scores were consistent, and the overall QNOTE score was significantly higher than the overall Global score (p=0.04). We found the QNOTE to be a valid instrument for evaluating the quality of electronic clinical notes, and its performance was superior to that of the Global instrument. 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.

Measuring and improving student engagement in clinical training.

PubMed

Lee, Simin; Valtis, Yannis K; Jun, Tomi; Wang, David; Zhang, Biqi; Chung, Esther H; Yu, Amy; Williams, Rachael; Cohen, Marya J

2018-01-01

Volunteer service learning activities, including Student Run Clinics (SRCs), are becoming an increasingly popular extracurricular component of medical education. While there are reports that student clinicians generally enjoy their educational experiences at SRCs, it is not understood how to optimize and measure student engagement in them. To identify key drivers of student engagement a tool was created to measure volunteer experience at the Crimson Care Collaborative (CCC), a primary care SRC. CCC volunteers were asked to complete an online engagement survey. Cross-sectional survey data were collected for 149 CCC volunteers (53% response rate). Multivariate linear regression showed that overall 'likelihood to recommend CCC to a friend' was significantly associated with students' perception of the clarity of their role within the clinic, frequency of interprofessional interactions, and overall quality of medical education. Students who volunteer more frequently and for longer periods of time had higher engagement scores. Measuring engagement is feasible in volunteer settings. Engagement appears to be dependent on both structural and experiential components. Easily modifiable components of job design (role definition, expected frequency of volunteering), are key drivers of volunteer engagement.

Normal plasma levels of cardiac troponin I measured by the high-sensitivity cardiac troponin I access prototype assay and the impact on the diagnosis of myocardial ischemia.

PubMed

Venge, Per; Johnston, Nina; Lindahl, Bertil; James, Stefan

2009-09-22

This study sought to evaluate the analytical and clinical performance of the novel hypersensitive cardiac troponin I (cTnI) prototype assay from Beckman Coulter (Fullerton, California). Studies on patients with acute coronary syndromes and on seemingly healthy subjects have shown that even very minor elevations of cardiac troponins are associated with an increased risk of death. However, the normal plasma levels of cardiac troponins are still not known. cTnI plasma levels were measured in 542 healthy subjects, 319 men (age 59.9 +/- 11.8 years) and 213 women (age 59.8 +/- 13.1 years), and in 1,503 randomly selected patients of the GUSTO IV (Global Utilization of Strategies To open Occluded arteries IV) cohort with unstable angina and non-ST-segment elevation myocardial infarctions (MIs). The cTnI levels at 10% coefficient of variation and 20% coefficient of variation imprecision were 0.0033 and 0.0016 microg/l, respectively. The cTnI levels were measurable in >95% of the healthy subjects. The median level of healthy subjects <60 years of age was 0.0032 microg/l (range 0.0011 to 0.0079 microg/l) with the 99th percentile being 0.010 microg/l. No sex differences were observed. A receiver-operator characteristic curve analysis showed an optimal discrimination between healthy subjects and patients at 0.0064 microg/l with a sensitivity of 84.8% (95% confidence interval: 82.8% to 86.6%) and specificity of 89.7% (95% confidence interval: 86.8% to 92.2%). Outcomes as to death and/or MI were significantly different at this level (p < 0.01) in the GUSTO IV cohort. The novel high-sensitivity cTnI prototype assay from Beckman Coulter allows for the first time the measurement of cTnI levels in almost all healthy subjects. Our data indicate that the assay may be a powerful aid in the diagnosis and outcome prediction of patients with suspected myocardial ischemia and question any definition of myocardial infarction.

A study on the measurement of wrist motion range using the iPhone 4 gyroscope application.

PubMed

Kim, Tae Seob; Park, David Dae Hwan; Lee, Young Bae; Han, Dong Gil; Shim, Jeong Su; Lee, Young Jig; Kim, Peter Chan Woo

2014-08-01

Measuring the range of motion (ROM) of the wrist is an important physical examination conducted in the Department of Hand Surgery for the purpose of evaluation, diagnosis, prognosis, and treatment of patients. The most common method for performing this task is by using a universal goniometer. This study was performed using 52 healthy participants to compare wrist ROM measurement using a universal goniometer and the iPhone 4 Gyroscope application. Participants did not have previous wrist illnesses and their measured values for wrist motion were compared in each direction. Normal values for wrist ROM are 73 degrees of flexion, 71 degrees of extension, 19 degrees of radial deviation, 33 degrees of ulnar deviation, 140 degrees of supination, and 60 degrees of pronation.The average measurement values obtained using the goniometer were 74.2 (5.1) degrees for flexion, 71.1 (4.9) degrees for extension, 19.7 (3.0) degrees for radial deviation, 34.0 (3.7) degrees for ulnar deviation, 140.8 (5.6) degrees for supination, and 61.1 (4.7) degrees for pronation. The average measurement values obtained using the iPhone 4 Gyroscope application were 73.7 (5.5) degrees for flexion, 70.8 (5.1) degrees for extension, 19.5 (3.0) degrees for radial deviation, 33.7 (3.9) degrees for ulnar deviation, 140.4 (5.7) degrees for supination, and 60.8 (4.9) degrees for pronation. The differences between the measurement values by the Gyroscope application and average value were 0.7 degrees for flexion, -0.2 degrees for extension, 0.5 degrees for radial deviation, 0.7 degrees for ulnar deviation, 0.4 degrees for supination, and 0.8 degrees for pronation. The differences in average value were not statistically significant. The authors introduced a new method of measuring the range of wrist motion using the iPhone 4 Gyroscope application that is simpler to use and can be performed by the patient outside a clinical setting.

New standard measures for clinical voice analysis include high speed films

NASA Astrophysics Data System (ADS)

Pedersen, Mette; Munch, Kasper

2012-02-01

In the clinical work with patients in a medical voice clinic it is important to have a normal updated reference for the data used. Several new parameters have to be correlated to older traditional measures. The older ones are stroboscopy, eventually coordinated with electroglottography (EGG), the Multi- Dimensional-Voice Program and airflow rates. Long Time Averaged Spectrograms (LTAS) and phonetograms (voice profiles) are calculating the range and dynamics of tones of the patients. High-speed films, updated airflow measures as well as area calculations of phonotograms add information to the understanding of the glottis closure in single movements of the vocal cords. A multivariate analysis was made to study the connection between the measures. This information can be used in many connections, also in the otolaryngological clinic.

Measuring the Cobb angle with the iPhone in kyphoses: a reliability study.

PubMed

Jacquot, Frederic; Charpentier, Axelle; Khelifi, Sofiane; Gastambide, Daniel; Rigal, Regis; Sautet, Alain

2012-08-01

Smartphones have gained widespread use in the healthcare field to fulfill a variety of tasks. We developed a small iPhone application to take advantage of the built-in position sensor to measure angles in a variety of spinal deformities. We present a reliability study of this tool in measuring kyphotic angles. Radiographs taken from 20 different patients' charts were presented to a panel of six operators at two different times. Radiographs were measured with the protractor and the iPhone application and statistical analysis was applied to measure intraclass correlation coefficients between both measurement methods, and to measure intra- and interobserver reliability The intraclass correlation coefficient calculated between methods (i.e. CobbMeter application on the iPhone versus standard method with the protractor) was 0.963 for all measures, indicating excellent correlation was obtained between the CobbMeter application and the standard method. The interobserver correlation coefficient was 0.965. The intraobserver ICC was 0.977, indicating excellent reproductibility of measurements at different times for all operators. The interobserver ICC between fellowship trained senior surgeons and general orthopaedic residents was 0.989. Consistently, the ICC for intraobserver and interobserver correlations was higher with the CobbMeter application than with the regular protractor method. This difference was not statistically significant. Measuring kyphotic angles with the iPhone application appears to be a valid procedure and is in no way inferior to the standard way of measuring the Cobb angle in kyphotic deformities.

Development of a Cost-Effective Modular Pixelated NaI(Tl) Detector for Clinical SPECT Applications

PubMed Central

Rozler, Mike; Liang, Haoning; Chang, Wei

2013-01-01

A new pixelated detector for high-resolution clinical SPECT applications was designed and tested. The modular detector is based on a scintillator block comprised of 2.75×2.75×10 mm3 NaI(Tl) pixels and decoded by an array of 51 mm diameter single-anode PMTs. Several configurations, utilizing two types of PMTs, were evaluated using a collimated beam source to measure positioning accuracy directly. Good pixel separation was observed, with correct pixel identification ranging from 60 to 72% averaged over the entire area of the modules, depending on the PMT type and configuration. This translates to a significant improvement in positioning accuracy compared to continuous slab detectors of the same thickness, along with effective reduction of “dead” space at the edges. The observed 10% average energy resolution compares well to continuous slab detectors. The combined performance demonstrates the suitability of pixelated detectors decoded with a relatively small number of medium-sized PMTs as a cost-effective approach for high resolution clinical SPECT applications, in particular those involving curved detector geometries. PMID:24146436

Amotivation in schizophrenia: integrated assessment with behavioral, clinical, and imaging measures.

PubMed

Wolf, Daniel H; Satterthwaite, Theodore D; Kantrowitz, Jacob J; Katchmar, Natalie; Vandekar, Lillie; Elliott, Mark A; Ruparel, Kosha

2014-11-01

Motivational deficits play a central role in disability caused by schizophrenia and constitute a major unmet therapeutic need. Negative symptoms have previously been linked to hypofunction in ventral striatum (VS), a core component of brain motivation circuitry. However, it remains unclear to what extent this relationship holds for specific negative symptoms such as amotivation, and this question has not been addressed with integrated behavioral, clinical, and imaging measures. Here, 41 individuals with schizophrenia and 37 controls performed a brief, computerized progressive ratio task (PRT) that quantifies effort exerted in pursuit of monetary reward. Clinical amotivation was assessed using the recently validated Clinical Assessment Interview for Negative Symptoms (CAINS). VS function was probed during functional magnetic resonance imaging using a monetary guessing paradigm. We found that individuals with schizophrenia had diminished motivation as measured by the PRT, which significantly and selectively related to clinical amotivation as measured by the CAINS. Critically, lower PRT motivation in schizophrenia was also dimensionally related to VS hypofunction. Our results demonstrate robust dimensional associations between behavioral amotivation, clinical amotivation, and VS hypofunction in schizophrenia. Integrating behavioral measures such as the PRT will facilitate translational efforts to identify biomarkers of amotivation and to assess response to novel therapeutic interventions. © The Author 2014. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Magnetic resonance imaging-based measures predictive of short-term surgical outcome in patients with Chiari malformation Type I: a pilot study.

PubMed

Alperin, Noam; Loftus, James Ryan; Bagci, Ahmet M; Lee, Sang H; Oliu, Carlos J; Shah, Ashish H; Green, Barth A

2017-01-01

OBJECTIVE This study identifies quantitative imaging-based measures in patients with Chiari malformation Type I (CM-I) that are associated with positive outcomes after suboccipital decompression with duraplasty. METHODS Fifteen patients in whom CM-I was newly diagnosed underwent MRI preoperatively and 3 months postoperatively. More than 20 previously described morphological and physiological parameters were derived to assess quantitatively the impact of surgery. Postsurgical clinical outcomes were assessed in 2 ways, based on resolution of the patient's chief complaint and using a modified Chicago Chiari Outcome Scale (CCOS). Statistical analyses were performed to identify measures that were different between the unfavorable- and favorable-outcome cohorts. Multivariate analysis was used to identify the strongest predictors of outcome. RESULTS The strongest physiological parameter predictive of outcome was the preoperative maximal cord displacement in the upper cervical region during the cardiac cycle, which was significantly larger in the favorable-outcome subcohorts for both outcome types (p < 0.05). Several hydrodynamic measures revealed significantly larger preoperative-to-postoperative changes in the favorable-outcome subcohort. Predictor sets for the chief-complaint classification included the cord displacement, percent venous drainage through the jugular veins, and normalized cerebral blood flow with 93.3% accuracy. Maximal cord displacement combined with intracranial volume change predicted outcome based on the modified CCOS classification with similar accuracy. CONCLUSIONS Tested physiological measures were stronger predictors of outcome than the morphological measures in patients with CM-I. Maximal cord displacement and intracranial volume change during the cardiac cycle together with a measure that reflects the cerebral venous drainage pathway emerged as likely predictors of decompression outcome in patients with CM-I.

Clinical validation of the NANDA-I diagnosis of impaired memory in elderly patients.

PubMed

Montoril, Michelle H; Lopes, Marcos Venícios O; Santana, Rosimere F; Sousa, Vanessa Emille C; Carvalho, Priscilla Magalhães O; Diniz, Camila M; Alves, Naiana P; Ferreira, Gabriele L; Fróes, Nathaly Bianka M; Menezes, Angélica P

2016-05-01

The aim of this study was to perform a clinical validation of the defining characteristics of impaired memory (IM) in elderly patients at a long-term care institution. A sample of 123 elderly patients was evaluated with a questionnaire designed to identify IM according to the NANDA-I taxonomy. Accuracy measures were calculated for the total sample and for males and females separately. Sensitivity and specificity values indicated that: (1) inability to learn new skills is useful in screening IM, and (2) forgets to perform a behavior at a scheduled time, forgetfulness, inability to learn new information, inability to recall events, and inability to recall factual information are confirmatory indicators. Specific factors can affect the manifestation of IM by elderly patients. The results may be useful in improving diagnostic accuracy and efficiency of the IM nursing diagnosis. Copyright © 2015 Elsevier Inc. All rights reserved.

American tertiary clinic-referred bipolar II disorder versus bipolar I disorder associated with hastened depressive recurrence.

PubMed

Dell'Osso, Bernardo; Shah, Saloni; Do, Dennis; Yuen, Laura D; Hooshmand, Farnaz; Wang, Po W; Miller, Shefali; Ketter, Terence A

2017-12-01

Bipolar disorder (BD) is a chronic, frequently comorbid condition characterized by high rates of mood episode recurrence and suicidality. Little is known about prospective longitudinal characterization of BD type II (BD II) versus type I (BD I) in relation to time to depressive recurrence and recovery from major depressive episode. We therefore assessed times to depressive recurrence/recovery in tertiary clinic-referred BD II versus I patients. Outpatients referred to Stanford BD Clinic during 2000-2011 were assessed with Systematic Treatment Enhancement Program for BD (STEP-BD) Affective Disorders Evaluation and with Clinical Monitoring Form during up to 2 years of naturalistic treatment. Prevalence and clinical correlates of bipolar subtype in recovered (euthymic ≥8 weeks) and depressed patients were assessed. Kaplan-Meier analyses assessed the relationships between bipolar subtype and longitudinal depressive severity, and Cox proportional hazard analyses assessed the potential mediators. BD II versus BD I was less common among 105 recovered (39.0 vs. 61.0%, p = 0.03) and more common among 153 depressed (61.4 vs. 38.6%, p = 0.006) patients. Among recovered patients, BD II was associated with 6/25 (24.0%) baseline unfavorable illness characteristics/mood symptoms/psychotropics and hastened depressive recurrence (p = 0.015). Among depressed patients, BD II was associated with 8/25 (33.0%) baseline unfavorable illness characteristics/mood symptoms/psychotropics, but only non-significantly associated with delayed depressive recovery. BD II versus BD I was significantly associated with current depression and hastened depressive recurrence, but only non-significantly associated with delayed depressive recovery. Research on bipolar subtype relationships with depressive recurrence/recovery is warranted to enhance clinical management of BD patients.

Xenogenous Collagen Matrix and/or Enamel Matrix Derivative for Treatment of Localized Gingival Recessions: A Randomized Clinical Trial. Part I: Clinical Outcomes.

PubMed

Sangiorgio, João Paulo Menck; Neves, Felipe Lucas da Silva; Rocha Dos Santos, Manuela; França-Grohmann, Isabela Lima; Casarin, Renato Corrêa Viana; Casati, Márcio Zaffalon; Santamaria, Mauro Pedrine; Sallum, Enilson Antonio

2017-12-01

Considering xenogeneic collagen matrix (CM) and enamel matrix derivative (EMD) characteristics, it is suggested that their combination could promote superior clinical outcomes in root coverage procedures. Thus, the aim of this parallel, double-masked, dual-center, randomized clinical trial is to evaluate clinical outcomes after treatment of localized gingival recession (GR) by a coronally advanced flap (CAF) combined with CM and/or EMD. Sixty-eight patients presenting one Miller Class I or II GRs were randomly assigned to receive either CAF (n = 17); CAF + CM (n = 17); CAF + EMD (n = 17), or CAF + CM + EMD (n = 17). Recession height, probing depth, clinical attachment level, and keratinized tissue width and thickness were measured at baseline and 90 days and 6 months after surgery. The obtained root coverage was 68.04% ± 24.11% for CAF; 87.20% ± 15.01% for CAF + CM; 88.77% ± 20.66% for CAF + EMD; and 91.59% ± 11.08% for CAF + CM + EMD after 6 months. Groups that received biomaterials showed greater values (P <0.05). Complete root coverage (CRC) for CAF + EMD was 70.59%, significantly superior to CAF alone (23.53%); CAF + CM (52.94%), and CAF + CM + EMD (51.47%) (P <0.05). Keratinized tissue thickness gain was significant only in CM-treated groups (P <0.05). The three approaches are superior to CAF alone for root coverage. EMD provides highest levels of CRC; however, the addition of CM increases gingival thickness. The combination approach does not seem justified.

Orofacial clinical features in Arnold Chiari type I malformation: A case series.

PubMed

de Arruda, José-Alcides; Figueiredo, Eugênia; Monteiro, João-Luiz; Barbosa, Livia-Mirelle; Rodrigues, Cleomar; Vasconcelos, Belmiro

2018-04-01

Arnold Chiari malformation (ACM) is characterized by an anatomical defect at the base of the skull where the cerebellum and the spinal cord herniate through the foramen magnum into the cervical spinal canal. Among the subtypes of the condition, ACM type I (ACM-I) is particularly outstanding because of the severity of symptoms. This study aimed to analyze the orofacial clinical manifestations of patients with ACM-I, and discuss their demographic distribution and clinical features in light of the literature. A case series with patients with ACM-I treated between 2012 and 2015 was described. The sample consisted of patients who were referred by the Department of Neurosurgery to the Oral and Maxillofacial Surgery Service of Hospital da Restauração in Brazil for the assessment of facial symptomatology. A questionnaire was applied to evaluate the presence of painful orofacial findings. Data are reported using descriptive statistical methods. Mean patient age was 39.3 years and the sample consisted mostly of male patients. A high prevalence of headache (50%) and pain in the neck (66.7%) and masticatory muscles (50%) was found. Only one patient reported difficulty in performing mandibular movements and two reported jaw clicking sounds. Mean mouth opening was 40.83 mm. ACM-I patients may exhibit orofacial symptoms which may mimic temporomandibular joint disorders. This study brings interesting information that could help clinicians and oral and maxillofacial surgeons to understand this uncommon condition and also help with the diagnosis of patients with similar physical characteristics by referring them to a neurosurgeon. Key words: Arnold-Chiari malformation, facial pain, diagnosis, orofacial.

Clinical and molecular investigation in Chinese patients with glutaric aciduria type I.

PubMed

Zhang, Yanghui; Li, Haoxian; Ma, Ruiyu; Mei, Libin; Wei, Xianda; Liang, Desheng; Wu, Lingqian

2016-01-30

Glutaric aciduria type I (GA-I) is a rare autosomal recessive metabolic disorder caused by deficiency of glutaryl-CoA dehydrogenase (GCDH), leading to an abnormal metabolism of lysine, hydroxylysine and tryptophan. It results in accumulations of glutaric acid, 3-hydroxyglutaric acid and glutaconic acid. Clinical features include the sudden onset of encephalopathy, hypotonia and macrocephaly usually before age 18months. Here we report five cases of GA-I confirmed with mutation analysis. GCDH gene mutations were identified in all five probands with GA-I. Three of them had compound heterozygous mutations and two had homozygous mutations. Mutations of two alleles (c.334G>T and IVS11-11A>G) were novel and both of them were confirmed to be splice site mutations by reverse transcription PCR. Copyright © 2015 Elsevier B.V. All rights reserved.

Measurement of leukocyte rheology in vascular disease: clinical rationale and methodology. International Society of Clinical Hemorheology.

PubMed

Wautier, J L; Schmid-Schönbein, G W; Nash, G B

1999-01-01

The measurement of leukocyte rheology in vascular disease is a recent development with a wide range of new opportunities. The International Society of Clinical Hemorheology has asked an expert panel to propose guidelines for the investigation of leukocyte rheology in clinical situations. This article first discusses the mechanical, adhesive and related functional properties of leukocytes (especially neutrophils) which influence their circulation, and establishes the rationale for clinically-related measurements of parameters which describe them. It is concluded that quantitation of leukocyte adhesion molecules, and of their endothelial receptors may assist understanding of leukocyte behaviour in vascular disease, along with measurements of flow resistance of leukocytes, free radical production, degranulation and gene expression. For instance, vascular cell adhesion molecule (VCAM-1) is abnormally present on endothelial cells in atherosclerosis, diabetes mellitus and inflammatory conditions. Soluble forms of intercellular adhesion molecule (ICAM-1) or VCAM can be found elevated in the blood of patients with rheumatoid arthritis or infections disease. In the second part of the article, possible technical approaches are presented and possible avenues for leukocyte rheological investigations are discussed.

Lung volumes: measurement, clinical use, and coding.

PubMed

Flesch, Judd D; Dine, C Jessica

2012-08-01

Measurement of lung volumes is an integral part of complete pulmonary function testing. Some lung volumes can be measured during spirometry; however, measurement of the residual volume (RV), functional residual capacity (FRC), and total lung capacity (TLC) requires special techniques. FRC is typically measured by one of three methods. Body plethysmography uses Boyle's Law to determine lung volumes, whereas inert gas dilution and nitrogen washout use dilution properties of gases. After determination of FRC, expiratory reserve volume and inspiratory vital capacity are measured, which allows the calculation of the RV and TLC. Lung volumes are commonly used for the diagnosis of restriction. In obstructive lung disease, they are used to assess for hyperinflation. Changes in lung volumes can also be seen in a number of other clinical conditions. Reimbursement for measurement of lung volumes requires knowledge of current procedural terminology (CPT) codes, relevant indications, and an appropriate level of physician supervision. Because of recent efforts to eliminate payment inefficiencies, the 10 previous CPT codes for lung volumes, airway resistance, and diffusing capacity have been bundled into four new CPT codes.

Measures to Improve Diagnostic Safety in Clinical Practice.

PubMed

Singh, Hardeep; Graber, Mark L; Hofer, Timothy P

2016-10-20

Timely and accurate diagnosis is foundational to good clinical practice and an essential first step to achieving optimal patient outcomes. However, a recent Institute of Medicine report concluded that most of us will experience at least one diagnostic error in our lifetime. The report argues for efforts to improve the reliability of the diagnostic process through better measurement of diagnostic performance. The diagnostic process is a dynamic team-based activity that involves uncertainty, plays out over time, and requires effective communication and collaboration among multiple clinicians, diagnostic services, and the patient. Thus, it poses special challenges for measurement. In this paper, we discuss how the need to develop measures to improve diagnostic performance could move forward at a time when the scientific foundation needed to inform measurement is still evolving. We highlight challenges and opportunities for developing potential measures of "diagnostic safety" related to clinical diagnostic errors and associated preventable diagnostic harm. In doing so, we propose a starter set of measurement concepts for initial consideration that seem reasonably related to diagnostic safety and call for these to be studied and further refined. This would enable safe diagnosis to become an organizational priority and facilitate quality improvement. Health-care systems should consider measurement and evaluation of diagnostic performance as essential to timely and accurate diagnosis and to the reduction of preventable diagnostic harm.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Clinical workflow for spinal curvature measurement with portable ultrasound

NASA Astrophysics Data System (ADS)

Tabanfar, Reza; Yan, Christina; Kempston, Michael; Borschneck, Daniel; Ungi, Tamas; Fichtinger, Gabor

2016-03-01

PURPOSE: Spinal curvature monitoring is essential in making treatment decisions in scoliosis. Monitoring entails radiographic examinations, however repeated ionizing radiation exposure has been shown to increase cancer risk. Ultrasound does not emit ionizing radiation and is safer for spinal curvature monitoring. We investigated a clinical sonography protocol and challenges associated with position-tracked ultrasound in spinal curvature measurement in scoliosis. METHODS: Transverse processes were landmarked along each vertebra using tracked ultrasound snapshots. The transverse process angle was used to determine the orientation of each vertebra. We tested our methodology on five patients in a local pediatric scoliosis clinic, comparing ultrasound to radiographic curvature measurements. RESULTS: Despite strong correlation between radiographic and ultrasound curvature angles in phantom studies, we encountered new challenges in the clinical setting. Our main challenge was differentiating transverse processes from ribs and other structures during landmarking. We observed up to 13° angle variability for a single vertebra and a 9.85° +/- 10.81° difference between ultrasound and radiographic Cobb angles for thoracic curvatures. Additionally, we were unable to visualize anatomical landmarks in the lumbar region where soft tissue depth was 25-35mm. In volunteers with large Cobb angles (greater than 40° thoracic and 60° lumbar), we observed spinal protrusions resulting in incomplete probe-skin contact and partial ultrasound images not suitable for landmarking. CONCLUSION: Spinal curvature measurement using tracked ultrasound is viable on phantom spine models. In the clinic, new challenges were encountered which must be resolved before a universal sonography protocol can be developed.

Effects of room environment and nursing experience on clinical blood pressure measurement: an observational study.

PubMed

Zhang, Meng; Zhang, Xuemei; Chen, Fei; Dong, Birong; Chen, Aiqing; Zheng, Dingchang

2017-04-01

This study aimed to examine the effects of measurement room environment and nursing experience on the accuracy of manual auscultatory blood pressure (BP) measurement. A training database with 32 Korotkoff sounds recordings from the British Hypertension Society was played randomly to 20 observers who were divided into four groups according to the years of their nursing experience (i.e. ≥10 years, 1-9 years, nursing students with frequent training, and those without any medical background; five observers in each group). All the observers were asked to determine manual auscultatory systolic blood pressure (SBP) and diastolic blood pressure (DBP) both in a quiet clinical assessment room and in a noisy nurse station area. This procedure was repeated on another day, yielding a total of four measurements from each observer (i.e. two room environments and two repeated determinations on 2 separate days) for each Korotkoff sound. The measurement error was then calculated against the reference answer, with the effects of room environment and nursing experience of the observer investigated. Our results showed that there was no statistically significant difference for BPs measured under both quiet and noisy environments (P>0.80 for both SBP and DBP). However, there was a significant effect on the measurement accuracy between the observer groups (P<0.001 for both SBP and DBP). The nursing students performed best with overall SBP and DBP errors of -0.8±2.4 and 0.1±1.8 mmHg, respectively. The SBP measurement error from the nursing students was significantly smaller than that for each of the other three groups (all P<0.001). Our results indicate that frequent nursing trainings are important for nurses to achieve accurate manual auscultatory BP measurement.

Spinal Muscular Atrophy Type I: Is It Ethical to Standardize Supportive Care Intervention in Clinical Trials?

PubMed

Finkel, Richard S; Bishop, Kathie M; Nelson, Robert M

2017-02-01

The natural history of spinal muscular atrophy type I (SMA-I) has changed as improved medical support has become available. With investigational drugs for spinal muscular atrophy now in clinical trials, efficient trial design focuses on enrolling recently diagnosed infants, providing best available supportive care, and minimizing subject variation. The quandary has arisen whether it is ethically appropriate to specify a predefined level of nutritional and/or ventilation support for spinal muscular atrophy type I subjects while participating in these studies. We conducted a survey at 2 spinal muscular atrophy investigator meetings involving physician investigators, clinical evaluators, and study coordinators from North America, Europe, and Asia-Pacific. Each group endorsed the concept that having a predefined degree of nutritional and ventilation support was warranted in this context. We discuss how autonomy, beneficence/non-maleficence, noncoercion, social benefit, and equipoise can be maintained when a predefined level of supportive care is proposed, for participation in a clinical trial.

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

PubMed Central

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

2017-01-01

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

[Prescribed drug use for bipolar disorder type I and II in clinical practice].

PubMed

Persson, Charlotte; Kardell, Mathias; Karanti, Alina; Isgren, Anniella; Annerbrink, Kristina; Landen, Mikael

2017-01-10

Prescribed drug use for bipolar disorder type I and II in clinical practice Practice guidelines based on available evidence and clinical consensus are available for the treatment of bipolar disorder. We surveyed to which extent those guidelines are implemented in clinical practice in Sweden. We analysed pharmacological treatment in patients with bipolar disorder in 2015 using the national quality register for bipolar disorder (BipoläR). We compared bipolar disorder type I (BDI) with type bipolar disorder type II (BDII). The vast majority of patients were prescribed a mood stabilizer either as monotherapy or as a part of combination therapy (BDI 87%, BDII 83%, p<0.001). Whereas lithium was the most common mood stabilizer in type I (BDI 65%, BDII 40%, p<0.001), lamotrigine was the most common mood stabilizer in type II (BDI 18%, BDII 42%, p<0.001). Antidepressants were less common in BDI than BDII (35% vs. 53%, p<0.001). Antipsychotic drugs (first or second generation) were more frequently used in BDI than BDII (49% vs 35%, p<0.001). Central stimulants were rarely used (BDI 3.1%, BDII 6.6%, p<0.001). Combining a mood stabilizer with an antipsychotic drug was more common in BDI than BDII (27% vs. 12%, p<0.001), whereas combining a mood stabilizer with an antidepressant was less common in BDI than BDII (16% vs 28%, p<0.001). We conclude that most patients are prescribed mood stabilizers and that the differences between BDI and BDII are rational given the differences in clinical manifestations. The use of antidepressants is surprisingly high given the long-standing debate about the risk and effectiveness of this class in bipolar disorder.

Targeting delta opioid receptors for pain treatment: drugs in phase I and II clinical development.

PubMed

Spahn, Viola; Stein, Christoph

2017-02-01

Opioids are widely used to treat severe pain. Most clinically used opioids activate µ-opioid receptors (MOR). Their ligands induce potent analgesia but also adverse effects. The δ-opioid receptor (DOR) is another member of the opioid receptor family that has been under intense investigation with the aim to avoid MOR-induced side effects. Areas covered: This article reviews DOR ligands which appeared to be promising after preclinical evaluation. A literature search using Pubmed, Cochrane library, ClinicalTrials.gov, EudraCT, AdisInsight database and EBSCO Online Library was conducted. Out of numerous newly synthesized molecules, only few candidates entered phase I and/or II clinical investigation. The publicly accessible results are presented here. Expert opinion: Many compounds showed potent DOR-specific pain inhibition in preclinical studies. ADL5859 and ADL5747 entered clinical trials and successfully passed phase I. However, in phase II studies the primary endpoint (pain reduction) was not met and further investigation was terminated. A third compound, NP2, is in phase II clinical evaluation and results are pending. These findings suggest a potential of DOR ligands according to preclinical studies. Further clinical research and secondary analysis of unpublished data is needed to identify molecules which are useful in humans.

Usher syndrome clinical types I and II: could ocular symptoms and signs differentiate between the two types?

PubMed

Tsilou, Ekaterini T; Rubin, Benjamin I; Caruso, Rafael C; Reed, George F; Pikus, Anita; Hejtmancik, James F; Iwata, Fumino; Redman, Joy B; Kaiser-Kupfer, Muriel I

2002-04-01

Usher syndrome types I and II are clinical syndromes with substantial genetic and clinical heterogeneity. We undertook the current study in order to identify ocular symptoms and signs that could differentiate between the two types. Sixty-seven patients with Usher syndrome were evaluated. Based on audiologic and vestibular findings, patients were classified as either Usher type I or II. The severity of the ocular signs and symptoms present in each type were compared. Visual acuity, visual field area, electroretinographic amplitude, incidence of cataract and macular lesions were not significantly different between Usher types I and II. However, the ages when night blindness was perceived and retinitis pigmentosa was diagnosed differed significantly between the two types. There seems to be some overlap between types I and II of Usher syndrome in regard to the ophthalmologic findings. However, night blindness appears earlier in Usher type I (although the difference in age of appearance appears to be less dramatic than previously assumed). Molecular elucidation of Usher syndrome may serve as a key to understanding these differences and, perhaps, provide a better tool for use in clinical diagnosis, prognosis and genetic counseling.

Measures that identify prescription medication misuse, abuse, and related events in clinical trials: ACTTION critique and recommended considerations

PubMed Central

Smith, Shannon M.; Jones, Judith K.; Katz, Nathaniel P.; Roland, Carl L.; Setnik, Beatrice; Trudeau, Jeremiah J.; Wright, Stephen; Burke, Laurie B.; Comer, Sandra D.; Dart, Richard C.; Dionne, Raymond; Haddox, J. David; Jaffe, Jerome H.; Kopecky, Ernest A.; Martell, Bridget A.; Montoya, Ivan D.; Stanton, Marsha; Wasan, Ajay D.; Turk, Dennis C.; Dworkin, Robert H.

2017-01-01

Accurate assessment of inappropriate medication use events (i.e., misuse, abuse, and related events [MAREs]) occurring in clinical trials is an important component in evaluating a medication’s abuse potential. A meeting was convened to review all instruments measuring such events in clinical trials according to previously published standardized terminology and definitions [27]. Only 2 approaches have been reported that are specifically designed to identify and classify MAREs occurring in clinical trials, rather than to measure an individual’s risk of using a medication inappropriately: the Self-Reported Misuse, Abuse, and Diversion [SR-MAD] instrument and the Misuse, Abuse, and Diversion Drug Event Reporting System [MADDERS]. The conceptual basis, strengths, and limitations of these methods are discussed. To our knowledge, MADDERS is the only system available to comprehensively evaluate inappropriate medication use events prospectively in order to determine the underlying intent. MADDERS can also be applied retrospectively to completed trial data. SR-MAD can be used prospectively; additional development may be required to standardize its implementation and fully appraise the intent of inappropriate use events. Additional research is needed to further demonstrate the validity and utility of both MADDERS and SR-MAD. PMID:28479207

SU-E-I-51: Quantitative Assessment of X-Ray Imaging Detector Performance in a Clinical Setting - a Simple Approach Using a Commercial Instrument

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

Sjoeberg, J; Bujila, R; Omar, A

2015-06-15

Purpose: To measure and compare the performance of X-ray imaging detectors in a clinical setting using a dedicated instrument for the quantitative determination of detector performance. Methods: The DQEPro (DQE Instruments Inc., London, Ontario Canada) was used to determine the MTF, NPS and DQE using an IEC compliant methodology for three different imaging modalities: conventional radiography (CsI-based detector), general-purpose radioscopy (CsI-based detector), and mammography (a-Se based detector). The radiation qualities (IEC) RQA-5 and RQA-M-2 were used for the CsI-based and a-Se-based detectors, respectively. The DQEPro alleviates some of the difficulties associated with DQE measurements by automatically positioning test devices overmore » the detector, guiding the user through the image acquisition process and providing software for calculations. Results: A comparison of the NPS showed that the image noise of the a-Se detector was less correlated than the CsI detectors. A consistently higher performance was observed for the a-Se detector at all spatial frequencies (MTF: 0.97@0.25 cy/mm, DQE: 0.72@0.25 cy/mm) and the DQE drops off slower than for the CsI detectors. The CsI detector used for conventional radiography displayed a higher performance at low spatial frequencies compared to the CsI detector used for radioscopy (DQE: 0.65 vs 0.60@0.25 cy/mm). However, at spatial frequencies above 1.3 cy/mm, the radioscopy detector displayed better performance than the conventional radiography detector (DQE: 0.35 vs 0.24@2.00 cy/mm). Conclusion: The difference in the MTF, NPS and DQE that was observed for the two different CsI detectors and the a-Se detector reflect the imaging tasks that the different detector types are intended for. The DQEPro has made the determination and calculation of quantitative metrics of X-ray imaging detector performance substantially more convenient and accessible to undertake in a clinical setting.« less

Magnetogate: Using an iPhone Magnetometer for Measuring Kinematic Variables

ERIC Educational Resources Information Center

Temiz, Burak Kagan; Yavuz, Ahmet

2016-01-01

This paper presents a method to measure the movement of an object from specific locations on a straight line using an iPhone's magnetometer. In this method, called "magnetogate," an iPhone is placed on a moving object (in this case a toy car) and small neodymium magnets are arranged at equal intervals on one side of a straight line. The…

Does measuring BHR add to guideline derived clinical measures in determining treatment for patients with persistent asthma?

PubMed

Koenig, Steven M; Murray, John J; Wolfe, James; Andersen, Leslie; Yancey, Steve; Prillaman, Barbara; Stauffer, John; Dorinsky, Paul

2008-05-01

Little is known about the use of biomarkers in guiding treatment decisions in routine asthma management. The objective of this study was to determine whether adding a LABA to an ICS would control bronchial hyperresponsiveness (BHR) at an overall lower dose of ICS when titration of medication was based upon the assessment of routine clinical measures with or without the measurement of BHR. After a 2-week run-in period, subjects (> or = 12 years) were randomized to one of three treatment groups. Two groups followed a BHR treatment strategy (based on clinical parameters [lung function, asthma symptoms, and bronchodilator use] and BHR) and were treated with either fluticasone propionate/salmeterol (FSC(BHR) group) or fluticasone propionate (FP(BHR) group) (n=156 each). The third group followed a clinical treatment algorithm (based on clinical parameters alone) and were treated with fluticasone propionate (FP(REF) group; n=154). All treatments were administered via Diskus. Treatment doses were adjusted as needed every 8 weeks for 40 weeks according to the subject's derived severity class, which was based on clinical measures of asthma control with or without BHR. The mean total daily inhaled corticosteroids (ICS) dose during the double-blind treatment period was lower, although not statistically significant, in the FSC(BHR) group compared with the FP(BHR) group (a difference of -42.9 mcg; p=0.07). Compared with the FP(REF) group, the mean total daily ICS dose was higher in the FSC(BHR) group (a difference of 85.2 mcg) and was significantly higher in the FP(BHR) group (a difference of 131.2 mcg, p=0.037). This study demonstrated that for most subjects, control of BHR was maintained when treatment was directed toward control of clinical parameters. In addition, there was a trend towards control of BHR and clinical measures at a lower dose of ICS when used concurrently with salmeterol.

The number needed to treat: a clinically useful measure of treatment effect.

PubMed Central

Cook, R. J.; Sackett, D. L.

1995-01-01

The relative benefit of an active treatment over a control is usually expressed as the relative risk, the relative risk reduction, or the odds ratio. These measures are used extensively in both clinical and epidemiological investigations. For clinical decision making, however, it is more meaningful to use the measure "number needed to treat." This measure is calculated on the inverse of the absolute risk reduction. It has the advantage that it conveys both statistical and clinical significance to the doctor. Furthermore, it can be used to extrapolate published findings to a patient at an arbitrary specified baseline risk when the relative risk reduction associated with treatment is constant for all levels of risk. PMID:7873954

Clinical and serologic parallels to APS-I in patients with thymomas, and autoantigen transcripts in their tumors1

PubMed Central

Wolff, Anette S. B.; Kärner, Jaanika; Owe, Jone F.; Oftedal, Bergithe E.V.; Gilhus, Nils Erik; Erichsen, Martina M.; Kämpe, Olle; Meager, Anthony; Peterson, Pärt; Kisand, Kai; Willcox, Nick; Husebye, Eystein S.

2014-01-01

Patients with the autoimmune polyendocrine syndrome type I (APS-I), caused by mutations in the autoimmune regulator (AIRE) gene, and myasthenia gravis (MG) with thymoma, show intriguing but unexplained parallels. They include uncommon manifestations like autoimmune adrenal insufficiency (AI), hypoparathyroidism (HP), and chronic mucocutaneous candidiasis (CMC) plus autoantibodies neutralizing IL-17, IL-22 and type I interferons. Thymopoiesis in the absence of AIRE is implicated in both syndromes. To test whether these parallels extend further, we screened 247 patients with MG and/or thymoma for clinical features and organ-specific autoantibodies characteristic of APS-I patients, and assayed 26 thymoma samples for transcripts for AIRE and 16 peripheral tissue-specific autoantigens (TSAgs) by quantitative PCR. We found APS-I-typical autoantibodies and clinical manifestations, including CMC, AI and asplenia, respectively in 49/121 (40%) and 10/121 (8%) thymoma patients, but clinical features seldom co-occurred with the corresponding autoantibodies. Both were rare in other MG subgroups (N=126). In 38 APS-I patients, by contrast, we observed neither autoantibodies against muscle antigens nor any neuromuscular disorders. Whereas relative transcript levels for AIRE and 7 of 16 TSAgs showed the expected under-expression in thymomas, levels were increased for 4 of the 5 TSAgs most frequently targeted by these patients’ autoAbs. Hence the clinical and serologic parallels to APS-I in patients with thymomas are not explained purely by deficient TSAg transcription in these aberrant AIRE-deficient tumors. We therefore propose additional explanations for the unusual autoimmune biases they provoke. Thymoma patients should be monitored for potentially life-threatening APS-I manifestations such as AI and HP. PMID:25230752

Development of the Computerized Model of Performance-Based Measurement System to Measure Nurses' Clinical Competence.

PubMed

Liou, Shwu-Ru; Liu, Hsiu-Chen; Tsai, Shu-Ling; Cheng, Ching-Yu; Yu, Wei-Chieh; Chu, Tsui-Ping

2016-04-01

Critical thinking skills and clinical competence are for providing quality patient care. The purpose of this study is to develop the Computerized Model of Performance-Based Measurement system based on the Clinical Reasoning Model. The system can evaluate and identify learning needs for clinical competency and be used as a learning tool to increase clinical competency by using computers. The system includes 10 high-risk, high-volume clinical case scenarios coupled with questions testing clinical reasoning, interpersonal, and technical skills. Questions were sequenced to reflect patients' changing condition and arranged by following the process of collecting and managing information, diagnosing and differentiating urgency of problems, and solving problems. The content validity and known-groups validity was established. The Kuder-Richardson Formula 20 was 0.90 and test-retest reliability was supported (r = 0.78). Nursing educators can use the system to understand students' needs for achieving clinical competence, and therefore, educational plans can be made to better prepare students and facilitate their smooth transition to a future clinical environment. Clinical nurses can use the system to evaluate their performance-based abilities and weakness in clinical reasoning. Appropriate training programs can be designed and implemented to practically promote nurses' clinical competence and quality of patient care.

The discrepancy between patients and informants on clinician-rated measures in major depressive disorder: implications for clinical trials and clinical practice.

PubMed

Peselow, Eric D; Karamians, Reneh; Lord, Marie; Tobia, Gabriel; IsHak, Waguih William

2014-03-01

Clinician-rated measures are used in clinical trials and measurement-based clinical care settings to assess baseline symptoms and treatment outcomes of major depressive disorder (MDD), with a widely held dictum that they are sufficient in assessing the patient's clinical status. In this study, we examined clinician-rated measures of depressive and global symptom severity, obtained by interviewing patients as well as informants in an attempt to examine the potential difference or similarity between these two sources of information. The sample consisted of 89 treatment seeking, DSM-IV diagnosed MDD outpatients treated between 1995 and 2004. The clinician-rated measures used included the Montgomery Åsberg Depression Rating Scale (MADRS), and the Clinical Global Impression Scale (CGI) for Severity. The scores of the clinician-rated measures collected from patients' interviews were compared with those collected from informants' interviews. Clinician-rated scores, collected by interviewing patients, were significantly higher and indicative of greater symptom severity when compared with those collected by interviewing informants. This was true for both the MADRS before (P<0.0001) and after treatment scores (P<0.0001), as well as the CGI before (P<0.0001) and after treatment scores (P<0.0001). Consistently involving informants and the time/burden it takes for them to participate might not be practical in MDD clinical trials or everyday clinical care. The discrepancies observed between the clinician-rated scores obtained from patients and informants emphasize the importance of incorporating collateral information during the assessment and rating of depressive symptom severity in both clinical trials as well as in clinical practice.

The measure of treatment agreement between portable and laboratory blood gas measurements in guiding protocol-driven ventilator management.

PubMed

Thomas, Frank O; Hoffman, Terri L; Handrahan, Diana L; Crapo, Robert O; Snow, Greg

2009-08-01

Portable blood gas analyzer and monitor devices are increasingly being used to direct ventilator therapy. The purpose of this study was to evaluate the "measure of treatment agreement" between portable and laboratory blood gas measurements used in guiding protocol-driven ventilator management. Using National Institutes of Health Acute Respiratory Distress Syndrome network ventilator management guidelines to manage patient care, measurements taken from the Nonin 8500 M pulse oximeter (SpO2), the Novametrix-610 end-tidal CO2 (ETCO2) detector, and the i-STAT 1 (SaO2, PO2, pH, PCO2) were compared with the recommended treatment from paired laboratory ABL-725 (SaCO2, PO2, pH, PCO2) measurements. Four hundred forty-six intubated adult intensive care unit patients were studied prospectively. Except for the ETCO2 (R2 = 0.460), correlation coefficients between portable and laboratory measurements were high (R2 > or = 0.755). Testing for equivalence, the Nonin-SpO2, iSTAT-PO2, iSTAT-pH, and iSTAT-PCO2 were deemed "equivalent" surrogates to paired ABL measurements. Testing for the limits of agreement found only the iSTAT-PCO2 to be an acceptable surrogate measurement. The measure of treatment agreement between the portable and paired laboratory blood gas measurements were Nonin-SpO2 (68%), iSTAT-SaO2 (73%), iSTAT-PO2 (97%), iSTAT-pH (88%), iSTAT-PCO2 (95%), and Novametrix-ETCO2 (60%). Only the iSTAT-PO2 and the iSTAT-PCO2 achieved the > or =95% treatment agreement threshold to be considered as acceptable surrogates to laboratory measurements. : The iSTAT-PO2 and -PCO2 were portable device measurements acceptable as surrogates to standard clinical laboratory blood gas measurements in guiding protocol-directed ventilator management. The "measure of treatment agreement," based on standardized decisions and measurement thresholds of a protocol, provides a simple method for assessing clinical validity of surrogate measurements.

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

PubMed

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

2018-02-01

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

A Clinical Data Warehouse Based on OMOP and i2b2 for Austrian Health Claims Data.

PubMed

Rinner, Christoph; Gezgin, Deniz; Wendl, Christopher; Gall, Walter

2018-01-01

To develop simulation models for healthcare related questions clinical data can be reused. Develop a clinical data warehouse to harmonize different data sources in a standardized manner and get a reproducible interface for clinical data reuse. The Kimball life cycle for the development of data warehouse was used. The development is split into the technical, the data and the business intelligence pathway. Sample data was persisted in the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). The i2b2 clinical data warehouse tools were used to query the OMOP CDM by applying the new i2b2 multi-fact table feature. A clinical data warehouse was set up and sample data, data dimensions and ontologies for Austrian health claims data were created. The ability of the standardized data access layer to create and apply simulation models will be evaluated next.

KiDS-i-800: Comparing weak gravitational lensing measurements from same-sky surveys

NASA Astrophysics Data System (ADS)

Amon, A.; Heymans, C.; Klaes, D.; Erben, T.; Blake, C.; Hildebrandt, H.; Hoekstra, H.; Kuijken, K.; Miller, L.; Morrison, C. B.; Choi, A.; de Jong, J. T. A.; Glazebrook, K.; Irisarri, N.; Joachimi, B.; Joudaki, S.; Kannawadi, A.; Lidman, C.; Napolitano, N.; Parkinson, D.; Schneider, P.; van Uitert, E.; Viola, M.; Wolf, C.

2018-04-01

We present a weak gravitational lensing analysis of 815deg2 of i-band imaging from the Kilo-Degree Survey (KiDS-i-800). In contrast to the deep r-band observations, which take priority during excellent seeing conditions and form the primary KiDS dataset (KiDS-r-450), the complementary yet shallower KiDS-i-800 spans a wide range of observing conditions. The overlapping KiDS-i-800 and KiDS-r-450 imaging therefore provides a unique opportunity to assess the robustness of weak lensing measurements. In our analysis we introduce two new `null' tests. The `nulled' two-point shear correlation function uses a matched catalogue to show that the calibrated KiDS-i-800 and KiDS-r-450 shear measurements agree at the level of 1 ± 4%. We use five galaxy lens samples to determine a `nulled' galaxy-galaxy lensing signal from the full KiDS-i-800 and KiDS-r-450 surveys and find that the measurements agree to 7 ± 5% when the KiDS-i-800 source redshift distribution is calibrated using either spectroscopic redshifts, or the 30-band photometric redshifts from the COSMOS survey.

Clinical chemistry through Clinical Chemistry: a journal timeline.

PubMed

Rej, Robert

2004-12-01

The establishment of the modern discipline of clinical chemistry was concurrent with the foundation of the journal Clinical Chemistry and that of the American Association for Clinical Chemistry in the late 1940s and early 1950s. To mark the 50th volume of this Journal, I chronicle and highlight scientific milestones, and those within the discipline, as documented in the pages of Clinical Chemistry. Amazing progress has been made in the field of laboratory diagnostics over these five decades, in many cases paralleling-as well as being bolstered by-the rapid pace in the development of computer technologies. Specific areas of laboratory medicine particularly well represented in Clinical Chemistry include lipids, endocrinology, protein markers, quality of laboratory measurements, molecular diagnostics, and general advances in methodology and instrumentation.

Measuring quality of life in evaluating clinical interventions: an overview.

PubMed

Kind, P

2001-07-01

Health professionals provide care with some purpose in mind. It is reasonable to assume that they are therefore interested in observing and measuring health outcomes. In the recent past, it has become fashionable to describe health outcomes in terms of their impact on 'quality of life', a widely used term that is usually left undefined. Measures of health-related quality of life (HRQoL) are now in common usage in clinical studies. The construction of both generic and condition-specific measures of HRQoL relies heavily on the choice of descriptive domains, a process that often reflects the personal values of the developer of the instrument. Subjective valuation is a recurring phenomenon in the construction and application of HRQoL measures. These values should not be restricted to the private judgement of the clinician alone. The challenge for those evaluating clinical interventions is to make such values explicit and to extend the franchise to society as a whole.

Clinical Application Of The Direct Measurement Of Human Shape

NASA Astrophysics Data System (ADS)

Anderson, J.; Vincent, R.; Marks, P.; English, M. J.

1980-07-01

A system is described for the recording and measurement of human body shape by a series of circular ultrasound scans. Computer manipulation of the echo data provides a graphic display of body contour, and a measurement of total body surface area and volume. The theoretical resolution for distance measurements using this device is 2.5 mm, a figure achieved in practical calibration experiments using a metal test object. Measurements from the body surface, although less precise, are sufficiently accurate and reproducible to enable useful clinical information to be obtained, particularly in recording the morphological changes associated with obesity and malnutrition.

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

PubMed

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

2013-10-21

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

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

PubMed Central

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

2013-01-01

Static whole body PET/CT, employing the standardized uptake value (SUV), is considered the standard clinical approach to diagnosis and treatment response monitoring for a wide range of oncologic malignancies. Alternative PET protocols involving dynamic acquisition of temporal images have been implemented in the research setting, allowing quantification of tracer dynamics, an important capability for tumor characterization and treatment response monitoring. Nonetheless, dynamic protocols have been confined to single bed-coverage limiting the axial field-of-view to ~15–20 cm, and have not been translated to the routine clinical context of whole-body PET imaging for the inspection of disseminated disease. Here, we pursue a transition to dynamic whole body PET parametric imaging, by presenting, within a unified framework, clinically feasible multi-bed dynamic PET acquisition protocols and parametric imaging methods. We investigate solutions to address the challenges of: (i) long acquisitions, (ii) small number of dynamic frames per bed, and (iii) non-invasive quantification of kinetics in the plasma. In the present study, a novel dynamic (4D) whole body PET acquisition protocol of ~45min total length is presented, composed of (i) an initial 6-min dynamic PET scan (24 frames) over the heart, followed by (ii) a sequence of multi-pass multi-bed PET scans (6 passes x 7 bed positions, each scanned for 45sec). Standard Patlak linear graphical analysis modeling was employed, coupled with image-derived plasma input function measurements. Ordinary least squares (OLS) Patlak estimation was used as the baseline regression method to quantify the physiological parameters of tracer uptake rate Ki and total blood distribution volume V on an individual voxel basis. Extensive Monte Carlo simulation studies, using a wide set of published kinetic FDG parameters and GATE and XCAT platforms, were conducted to optimize the acquisition protocol from a range of 10 different clinically

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

NASA Astrophysics Data System (ADS)

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

2013-10-01

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

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

PubMed

Edelblute, Heather B; Fisher, Jill A

2015-02-01

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

Clinical tooth preparations and associated measuring methods: a systematic review.

PubMed

Tiu, Janine; Al-Amleh, Basil; Waddell, J Neil; Duncan, Warwick J

2015-03-01

The geometries of tooth preparations are important features that aid in the retention and resistance of cemented complete crowns. The clinically relevant values and the methods used to measure these are not clear. The purpose of this systematic review was to retrieve, organize, and critically appraise studies measuring clinical tooth preparation parameters, specifically the methodology used to measure the preparation geometry. A database search was performed in Scopus, PubMed, and ScienceDirect with an additional hand search on December 5, 2013. The articles were screened for inclusion and exclusion criteria and information regarding the total occlusal convergence (TOC) angle, margin design, and associated measuring methods were extracted. The values and associated measuring methods were tabulated. A total of 1006 publications were initially retrieved. After removing duplicates and filtering by using exclusion and inclusion criteria, 983 articles were excluded. Twenty-three articles reported clinical tooth preparation values. Twenty articles reported the TOC, 4 articles reported margin designs, 4 articles reported margin angles, and 3 articles reported the abutment height of preparations. A variety of methods were used to measure these parameters. TOC values seem to be the most important preparation parameter. Recommended TOC values have increased over the past 4 decades from an unachievable 2- to 5-degree taper to a more realistic 10 to 22 degrees. Recommended values are more likely to be achieved under experimental conditions if crown preparations are performed outside of the mouth. We recommend that a standardized measurement method based on the cross sections of crown preparations and standardized reporting be developed for future studies analyzing preparation geometry. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Goniometric reliability in a clinical setting. Shoulder measurements.

PubMed

Riddle, D L; Rothstein, J M; Lamb, R L

1987-05-01

The purpose of this study was to examine the intratester and intertester reliabilities for clinical goniometric measurements of shoulder passive range of motion (PROM) using two different sizes of universal goniometers. Patients were measured without controlling therapist goniometric placement technique or patient position during measurements. Repeated PROM measurements of shoulder flexion, extension, abduction, shoulder horizontal abduction, horizontal adduction, lateral (external) rotation, and medial (internal) rotation were taken of two groups of 50 subjects each. The intratester intraclass correlation coefficients (ICCs) for all motions ranged from .87 to .99. The ICCs for the intertester reliability of PROM measurements of horizontal abduction, horizontal adduction, extension, and medial rotation ranged from .26 to .55. The intertester ICCs for PROM measurements of flexion, abduction, and lateral rotation ranged from .84 to .90. Goniometric PROM measurements for the shoulder appear to be highly reliable when taken by the same physical therapist, regardless of the size of the goniometer used. The degree of intertester reliability for these measurements appears to be range-of-motion specific.

Tablet Computing in Clinical Training of Pediatric Residents.

PubMed

Howard, David J; Coovert, Sally A; Coovert, Michael D; Nelson, Robert M

2015-07-01

Medical residents receive both medical education and clinical skills training. New technologies and pedagogies are being developed to address each of these phases. Our research focuses on the efficacy of an iPad(®) (Apple, Cupertino, CA) for clinical skills training. For a period of 3 years, the University of South Florida provided incoming pediatric residents (n=94) with an iPad. At the end of the 3-year program, we surveyed the residents, measuring perceptions and satisfaction of iPad use in clinical training. Sixty percent of the residents responded to the survey. Ninety-three percent reported at least some iPad usage per day on clinical activities. We classified 13 facets of clinical training into three conceptual areas and provided figures detailing iPad use for each facet relative to other facets in the same cluster. The obtaining, management, and display of information are primary uses of iPad applications in clinical training. Finally, we provide information relative to perceived obstacles in clinical training, with weight of the device being the most frequently cited. The role of graduate medical education is changing with the introduction of new technologies. These technologies can differentially impact the various aspects of residency education and training. Residents reported using an iPad extensively in their clinical training. We argue that in addition to impacting traditional educational strategies, iPads can successfully facilitate aspects of clinical training in medical education.

Does sensitivity measured from screening test-sets predict clinical performance?

NASA Astrophysics Data System (ADS)

Soh, BaoLin P.; Lee, Warwick B.; Mello-Thoms, Claudia R.; Tapia, Kriscia A.; Ryan, John; Hung, Wai Tak; Thompson, Graham J.; Heard, Rob; Brennan, Patrick C.

2014-03-01

Aim: To examine the relationship between sensitivity measured from the BREAST test-set and clinical performance. Background: Although the UK and Australia national breast screening programs have regarded PERFORMS and BREAST test-set strategies as possible methods of estimating readers' clinical efficacy, the relationship between test-set and real life performance results has never been satisfactorily understood. Methods: Forty-one radiologists from BreastScreen New South Wales participated in this study. Each reader interpreted a BREAST test-set which comprised sixty de-identified mammographic examinations sourced from the BreastScreen Digital Imaging Library. Spearman's rank correlation coefficient was used to compare the sensitivity measured from the BREAST test-set with screen readers' clinical audit data. Results: Results shown statistically significant positive moderate correlations between test-set sensitivity and each of the following metrics: rate of invasive cancer per 10 000 reads (r=0.495; p < 0.01); rate of small invasive cancer per 10 000 reads (r=0.546; p < 0.001); detection rate of all invasive cancers and DCIS per 10 000 reads (r=0.444; p < 0.01). Conclusion: Comparison between sensitivity measured from the BREAST test-set and real life detection rate demonstrated statistically significant positive moderate correlations which validated that such test-set strategies can reflect readers' clinical performance and be used as a quality assurance tool. The strength of correlation demonstrated in this study was higher than previously found by others.

Reliability of Performance-Based Clinical Measurements to Assess Shoulder Girdle Kinematics and Positioning: Systematic Review.

PubMed

D'hondt, Norman E; Kiers, Henri; Pool, Jan J M; Hacquebord, Sijmen T; Terwee, Caroline B; Veeger, Dirkjan H E J

2017-01-01

Deviant shoulder girdle movement is suggested as an eminent factor in the etiology of shoulder pain. Reliable measurements of shoulder girdle kinematics are a prerequisite for optimizing clinical management strategies. The purpose of this study was to evaluate the reliability, measurement error, and internal consistency of measurements with performance-based clinical tests for shoulder girdle kinematics and positioning in patients with shoulder pain. The MEDLINE, Embase, CINAHL, and SPORTDiscus databases were systematically searched from inception to August 2015. Articles published in Dutch, English, or German were included if they involved the evaluation of at least one of the measurement properties of interest. Two reviewers independently evaluated the methodological quality per studied measurement property with the 4-point-rating scale of the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) checklist, extracted data, and assessed the adequacy of the measurement properties. Forty studies comprising more than 30 clinical tests were included. Actual reported measurements of the tests were categorized into: (1) positional measurement methods, (2) measurement methods to determine dynamic characteristics, and (3) tests to diagnose impairments of shoulder girdle function. Best evidence synthesis of the tests was performed per measurement for each measurement property. All studies had significant limitations, including incongruence between test description and actual reported measurements and a lack of reporting on minimal important change. In general, the methodological quality of the selected studies was fair to poor. High-quality evidence indicates that measurements obtained with the Modified Scapular Assistance Test are not reliable for clinical use. Sound recommendations for the use of other tests could not be made due to inadequate evidence. Across studies, diversity in description, performance, and interpretation of similar

21 CFR 862.2730 - Osmometer for clinical use.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862... to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent... device are used in the diagnosis and treatment of body fluid disorders. (b) Classification. Class I...

21 CFR 862.2730 - Osmometer for clinical use.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862... to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent... device are used in the diagnosis and treatment of body fluid disorders. (b) Classification. Class I...

21 CFR 862.2730 - Osmometer for clinical use.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862... to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent... device are used in the diagnosis and treatment of body fluid disorders. (b) Classification. Class I...

21 CFR 862.2730 - Osmometer for clinical use.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862... to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent... device are used in the diagnosis and treatment of body fluid disorders. (b) Classification. Class I...

Measuring Cutaneous Lesions: Trends in Clinical Practice.

PubMed

Zhang, Shali; Blalock, Travis W

2018-03-01

Knowing the size of a cutaneous lesion can be important for tracking its progression over time, selecting the proper treatment modality, surgical planning, determining prognosis, and accurate billing. However, providers vary in their consistency, accuracy, and methods of measuring cutaneous lesions. To investigate the clinical practices of US dermatologists and dermatologic surgeons regarding how they determine the size of cutaneous lesions. A survey was electronically distributed to members of the American Society for Dermatologic Surgery. Four hundred twenty-six dermatologists completed the online survey. When a lesion is suspected to be malignant, 85% of respondents obtained exact measurements most, if not all, of the time; however, only 8% did for benign lesions. Most providers determined lesion sizes themselves rather than delegating to staff. When performing visual estimation, approximately three-quarters believed that they were accurate to within 1 to 2 mm. The top reasons for obtaining exact measurements were for tracking atypical pigmented lesions, determining treatment pathways, and accurate billing. The majority of respondents believed that lesion size affected management decisions; however, the need for exact measurement remains controversial, particularly for benign lesions. Future studies may investigate whether taking exact versus estimated measurements has an effect on outcomes.

Augment clinical measurement using a constraint-based esophageal model

NASA Astrophysics Data System (ADS)

Kou, Wenjun; Acharya, Shashank; Kahrilas, Peter; Patankar, Neelesh; Pandolfino, John

2017-11-01

Quantifying the mechanical properties of the esophageal wall is crucial to understanding impairments of trans-esophageal flow characteristic of several esophageal diseases. However, these data are unavailable owing to technological limitations of current clinical diagnostic instruments that instead display esophageal luminal cross sectional area based on intraluminal impedance change. In this work, we developed an esophageal model to predict bolus flow and the wall property based on clinical measurements. The model used the constraint-based immersed-boundary method developed previously by our group. Specifically, we first approximate the time-dependent wall geometry based on impedance planimetry data on luminal cross sectional area. We then fed these along with pressure data into the model and computed wall tension based on simulated pressure and flow fields, and the material property based on the strain-stress relationship. As examples, we applied this model to augment FLIP (Functional Luminal Imaging Probe) measurements in three clinical cases: a normal subject, achalasia, and eosinophilic esophagitis (EoE). Our findings suggest that the wall stiffness was greatest in the EoE case, followed by the achalasia case, and then the normal. This is supported by NIH Grant R01 DK56033 and R01 DK079902.

Recommendation for measuring clinical outcome in distal radius fractures: a core set of domains for standardized reporting in clinical practice and research.

PubMed

Goldhahn, Jörg; Beaton, Dorcas; Ladd, Amy; Macdermid, Joy; Hoang-Kim, Amy

2014-02-01

Lack of standardization of outcome measurement has hampered an evidence-based approach to clinical practice and research. We adopted a process of reviewing evidence on current use of measures and appropriate theoretical frameworks for health and disability to inform a consensus process that was focused on deriving the minimal set of core domains in distal radius fracture. We agreed on the following seven core recommendations: (1) pain and function were regarded as the primary domains, (2) very brief measures were needed for routine administration in clinical practice, (3) these brief measures could be augmented by additional measures that provide more detail or address additional domains for clinical research, (4) measurement of pain should include measures of both intensity and frequency as core attributes, (5) a numeric pain scale, e.g. visual analogue scale or visual numeric scale or the pain subscale of the patient-reported wrist evaluation (PRWE) questionnaires were identified as reliable, valid and feasible measures to measure these concepts, (6) for function, either the Quick Disability of the arm, shoulder and hand questionnaire or PRWE-function subscale was identified as reliable, valid and feasible measures, and (7) a measure of participation and treatment complications should be considered core outcomes for both clinical practice and research. We used a sound methodological approach to form a comprehensive foundation of content for outcomes in the area of distal radius fractures. We recommend the use of symptom and function as separate domains in the ICF core set in clinical research or practice for patients with wrist fracture. Further research is needed to provide more definitive measurement properties of measures across all domains.

Validation of clinic weights from electronic health records against standardized weight measurements in weight loss trials.

PubMed

Xiao, Lan; Lv, Nan; Rosas, Lisa G; Au, David; Ma, Jun

2017-02-01

To validate clinic weights in electronic health records against researcher-measured weights for outcome assessment in weight loss trials. Clinic and researcher-measured weights from a published trial (BE WELL) were compared using Lin's concordance correlation coefficient, Bland and Altman's limits of agreement, and polynomial regression model. Changes in clinic and researcher-measured weights in BE WELL and another trial, E-LITE, were analyzed using growth curve modeling. Among BE WELL (n = 330) and E-LITE (n = 241) participants, 96% and 90% had clinic weights (mean [SD] of 5.8 [6.1] and 3.7 [3.9] records) over 12 and 15 months of follow-up, respectively. The concordance correlation coefficient was 0.99, and limits of agreement plots showed no pattern between or within treatment groups, suggesting overall good agreement between researcher-measured and nearest-in-time clinic weights up to 3 months. The 95% confidence intervals for predicted percent differences fell within ±3% for clinic weights within 3 months of the researcher-measured weights. Furthermore, the growth curve slopes for clinic and researcher-measured weights by treatment group did not differ significantly, suggesting similar inferences about treatment effects over time, in both trials. Compared with researcher-measured weights, close-in-time clinic weights showed high agreement and inference validity. Clinic weights could be a valid pragmatic outcome measure in weight loss studies. © 2017 The Obesity Society.

Clinical response of the novel activating ALK-I1171T mutation in neuroblastoma to the ALK inhibitor ceritinib.

PubMed

Guan, Jikui; Fransson, Susanne; Siaw, Joachim Tetteh T; Treis, Diana; Van den Eynden, Jimmy; Chand, Damini; Umapathy, Ganesh; Svenberg, Petter; Ruuth, Kristina; Wessman, Sandra; Shamikh, Alia; Jacobsson, Hans; Gordon, Lena; Stenman, Jakob; Larsson, Erik; Svensson, Par-Johan; Hansson, Magnus; Martinsson, Tommy; Kogner, Per; Palmer, Ruth H; Hallberg, Bengt

2018-06-15

Tumors with Anaplastic Lymphoma Kinase (ALK) fusion rearrangements, including non-small cell lung cancer and anaplastic large cell lymphoma, are highly sensitive to ALK tyrosine kinase inhibitors (TKIs), underscoring the notion that such cancers are addicted to ALK activity. While mutations in ALK are heavily implicated in childhood neuroblastoma, response to the ALK TKI crizotinib has been disappointing. Embryonal tumors in patients with DNA repair defects such as Fanconi anemia (FA) often have a poor prognosis, due to lack of therapeutic options. Here we report a child with underlying FA and ALK mutant high-risk neuroblastoma responding strongly to precision therapy with the ALK TKI ceritinib. Conventional chemotherapy treatment caused severe, life-threatening toxicity. Genomic analysis of the initial biopsy identified germ-line FANCA mutations as well as a novel ALK-I1171T variant. ALK-I1171T generates a potent gain-of-function mutant, as measured in PC12 cell neurite outgrowth and NIH3T3 transformation. Pharmacological inhibition profiling of ALK-I1171T in response to various ALK TKIs identified an 11-fold improved inhibition of ALK-I1171T with ceritinib when compared with crizotinib. Immunoaffinity-coupled LC-MS/MS phosphoproteomics analysis indicated a decrease in ALK signaling in response to ceritinib. Ceritinib was therefore selected for treatment in this child. Mono-therapy with ceritinib was well tolerated and resulted in normalized catecholamine markers and tumor shrinkage. After 7.5 months treatment, residual primary tumor was surgically removed and exhibited hallmarks of differentiation together with reduced Ki67 levels. Clinical follow-up after 21 months treatment revealed complete clinical remission including all metastatic sites. Therefore, ceritinib presents a viable therapeutic option for ALK-positive neuroblastoma. Cold Spring Harbor Laboratory Press.

KiDS-i-800: comparing weak gravitational lensing measurements from same-sky surveys

NASA Astrophysics Data System (ADS)

Amon, A.; Heymans, C.; Klaes, D.; Erben, T.; Blake, C.; Hildebrandt, H.; Hoekstra, H.; Kuijken, K.; Miller, L.; Morrison, C. B.; Choi, A.; de Jong, J. T. A.; Glazebrook, K.; Irisarri, N.; Joachimi, B.; Joudaki, S.; Kannawadi, A.; Lidman, C.; Napolitano, N.; Parkinson, D.; Schneider, P.; van Uitert, E.; Viola, M.; Wolf, C.

2018-07-01

We present a weak gravitational lensing analysis of 815 deg2 of i-band imaging from the Kilo-Degree Survey (KiDS-i-800). In contrast to the deep r-band observations, which take priority during excellent seeing conditions and form the primary KiDS data set (KiDS-r-450), the complementary yet shallower KiDS-i-800 spans a wide range of observing conditions. The overlapping KiDS-i-800 and KiDS-r-450 imaging therefore provides a unique opportunity to assess the robustness of weak lensing measurements. In our analysis we introduce two new `null' tests. The `nulled' two-point shear correlation function uses a matched catalogue to show that the calibrated KiDS-i-800 and KiDS-r-450 shear measurements agree at the level of 1 ± 4 per cent. We use five galaxy lens samples to determine a `nulled' galaxy-galaxy lensing signal from the full KiDS-i-800 and KiDS-r-450 surveys and find that the measurements agree to 7 ± 5 per cent when the KiDS-i-800 source redshift distribution is calibrated using either spectroscopic redshifts, or the 30-band photometric redshifts from the COSMOS survey.

Identification of V122I (Val122Ile) transthyretin cardiac amyloidosis (ATTR) using serum retinol-binding protein 4 (RBP4) and a clinical prediction model

PubMed Central

Arvanitis, Marios; Koch, Clarissa M; Chan, Gloria G.; Arancivia, Celia M.T.; LaValley, Michael; Jacobson, Daniel; Berk, John L.; Connors, Lawreen H.; Ruberg, Frederick L.

2017-01-01

Importance Transthyretin amyloid cardiomyopathy (ATTR) is an under-recognized cause of heart failure (HF) in the elderly, owing in part to difficulty in diagnosis. ATTR can result from mutant TTR protein with one of the most common mutations in the United States, V122I, present in 3.43% of African Americans. Objective To determine whether serum retinol-binding protein 4 (RBP4), an endogenous TTR ligand, could be used as a diagnostic test for ATTR V122I amyloidosis. Design Combined prospective and retrospective cohort study Setting Tertiary care referral center Participants Fifty prospectively genotyped African American patients over age 60 years with non-amyloid HF and cardiac wall thickening, and a comparator cohort of biopsy proven ATTR V122I amyloidosis patients (n=25) comprised the development cohort. Twenty-seven prospectively genotyped African American patients and 9 ATTR V122I amyloidosis patients comprised the validation cohort. Main Outcomes and Measures Circulating RBP4, TTR, B-type natriuretic peptide (BNP) and troponin I (TnI) concentrations, electrocardiography (ECG), echocardiography, and clinical characteristics were assessed in all patients. Receiver operating characteristic (ROC) analysis was performed to identify optimal thresholds for ATTR V122I amyloidosis identification. A clinical prediction rule was developed using penalized logistic regression, evaluated using ROC analysis and validated in an independent cohort of cases and controls. Results Age, gender, BNP and TnI were similar between ATTR V122I amyloidosis patients and controls. Serum RBP4 concentration was lower in patients with ATTR V122I amyloidosis compared to non-amyloid controls (31.5 vs. 49.4 ug/ml, p < 0.001) and the difference persisted after controlling for potential confounding parameters. Left ventricular ejection fraction (LVEF) was lower in ATTR V122I amyloidosis (40% vs. 57%, p<0.001), while interventricular septal diameter (IVSd) was higher (16 vs. 14 mm, p<0.001). ROC

Measuring Workplace Climate in Community Clinics and Health Centers

PubMed Central

Friedberg, Mark W.; Rodriguez, Hector P.; Martsolf, Grant; Edelen, Maria Orlando; Vargas-Bustamante, Arturo

2018-01-01

Background The effectiveness of community clinics and health centers’ efforts to improve the quality of care might be modified by clinics’ workplace climates. Several surveys to measure workplace climate exist, but their relationships to each other and to distinguishable dimensions of workplace climate are unknown. Objective To assess the psychometric properties of a survey instrument combining items from several existing surveys of workplace climate and to generate a shorter instrument for future use. Methods We fielded a 106-item survey, which included items from 9 existing instruments, to all clinicians and staff members (n=781) working in 30 California community clinics and health centers, receiving 628 responses (80% response rate). We performed exploratory factor analysis of survey responses, followed by confirmatory factor analysis of 200 reserved survey responses. We generated a new, shorter survey instrument of items with strong factor loadings. Results Six factors, including 44 survey items, emerged from the exploratory analysis. Two factors (Clinic Workload and Teamwork) were independent from the others. The remaining 4 factors (Staff Relationships, Quality Improvement Orientation, Managerial Readiness for Change, and Staff Readiness for Change) were highly correlated, indicating that these represented dimensions of a higher-order factor we called “Clinic Functionality.” This two-level, six-factor model fit the data well in the exploratory and confirmatory samples. For all but one factor, fewer than 20 survey responses were needed to achieve clinic-level reliability >0.7. Conclusion Survey instruments designed to measure workplace climate have substantial overlap. The relatively parsimonious item set we identified might help target and tailor clinics’ quality improvement efforts. PMID:27326549

Preclinical study and phase I clinical safety evaluation of recombinant Mycobacterium tuberculosis ESAT6 protein.

PubMed

Du, Wei-Xin; Chen, Bao-Wen; Lu, Jin-Biao; Gao, Meng-Qiu; Shen, Xiao-Bing; Yang, Lei; Su, Cheng; Wang, Guo-Zhi; Sun, Qing-feng; Xu, Miao

2013-05-15

To investigate the ability of rESAT6 to identify different mycobacteria-sensitized guinea pigs and its safety in preclinical and phase I clinical study. Guinea pigs were sensitized with different Mycobacteria. After sensitization, all animals were intradermally injected with rESAT6 and either PPD or PPD-B. At 24 h after the injection, the erythema of the injection sites were measured using a double-blind method. For the preclinical safety study, different doses of rESAT6 and BSA were given 3 times intramuscularly to guinea pigs. On day 14 after the final immunization, the guinea pigs were intravenously injected with the same reagents in the hind legs and the allergic reactions were observed. A single-center, randomized, open phase I clinical trial was employed. The skin test was conducted in 32 healthy volunteers aged 19-65 years with 0.1 µg, 0.5 µg, and 1 µg rESAT6. Physical examination and laboratory tests were performed before and after the skin test and adverse reactions were monitored. The volunteers' local and systemic adverse reactions and adverse events were recorded for 7 days. Positive PPD or PPD-B skin tests were observed in all Mycobacteria-sensitized guinea pigs; the diameters of erythema were all >10 mm. The rESAT6 protein induced a positive skin test result in the guinea pigs sensitized with MTB, M. bovis, M. africanum and M. kansasii; the diameters of erythema were 14.7±2.0, 9.3±3.8, 18.7±2.4, and 14.8±4.2 mm, respectively. A negative skin test result was detected in BCG-vaccinated and other NTM-sensitized guinea pigs. The rESAT6 caused no allergic symptoms, but many allergic reactions, such as cough, dyspnea, and even death, were observed in the guinea pigs who were administered BSA. During the phase I clinical trial, no adverse reactions were found in the 0.1 µg rESAT6 group, but in the 0.5 µg rESAT6 group 2 volunteers reported pain and 1 reported itching, and in the 1 µg rESAT6 group there was 1 case of pain, 1 case of itching, and 1

Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures.

PubMed

Jammer, Ib; Wickboldt, Nadine; Sander, Michael; Smith, Andrew; Schultz, Marcus J; Pelosi, Paolo; Leva, Brigitte; Rhodes, Andrew; Hoeft, Andreas; Walder, Bernhard; Chew, Michelle S; Pearse, Rupert M

2015-02-01

There is a need for large trials that test the clinical effectiveness of interventions in the field of perioperative medicine. Clinical outcome measures used in such trials must be robust, clearly defined and patient-relevant. Our objective was to develop standards for the use of clinical outcome measures to strengthen the methodological quality of perioperative medicine research. A literature search was conducted using PubMed and opinion leaders worldwide were invited to nominate papers that they believed the group should consider. The full texts of relevant articles were reviewed by the taskforce members and then discussed to reach a consensus on the required standards. The report was then circulated to opinion leaders for comment and review. This report describes definitions for 22 individual adverse events with a system of severity grading for each. In addition, four composite outcome measures were identified, which were designed to evaluate postoperative outcomes. The group also agreed on standards for four outcome measures for the evaluation of healthcare resource use and quality of life. Guidance for use of these outcome measures is provided, with particular emphasis on appropriate duration of follow-up. This report provides clearly defined and patient-relevant outcome measures for large clinical trials in perioperative medicine. These outcome measures may also be of use in clinical audit. This report is intended to complement and not replace other related work to improve assessment of clinical outcomes following specific surgical procedures.

30 CFR 250.406 - What additional safety measures must I take when I conduct drilling operations on a platform that...

Code of Federal Regulations, 2010 CFR

2010-07-01

... OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations General Requirements § 250.406 What additional safety measures must I take when I conduct drilling... when I conduct drilling operations on a platform that has producing wells or has other hydrocarbon flow...

Pooling of cross-cultural PRO data in multinational clinical trials: how much can poor measurement affect statistical power?

PubMed

Regnault, Antoine; Hamel, Jean-François; Patrick, Donald L

2015-02-01

Cultural differences and/or poor linguistic validation of patient-reported outcome (PRO) instruments may result in differences in the assessment of the targeted concept across languages. In the context of multinational clinical trials, these measurement differences may add noise and potentially measurement bias to treatment effect estimation. Our objective was to explore the potential effect on treatment effect estimation of the "contamination" of a cultural subgroup by a flawed PRO measurement. We ran a simulation exercise in which the distribution of the score in the overall sample was considered a mixture of two normal distributions: a standard normal distribution was assumed in a "main" subgroup and a normal distribution which differed either in mean (bias) or in variance (noise) in a "contaminated" subgroup (the subgroup with potential flaws in the PRO measurement). The observed power was compared to the expected power (i.e., the power that would have been observed if the subgroup had not been contaminated). Even if differences between the expected and observed power were small, some substantial differences were obtained (up to a 0.375 point drop in power). No situation was systematically protected against loss of power. The impact of poor PRO measurement in a cultural subgroup may induce a notable drop in the study power and consequently reduce the chance of showing an actual treatment effect. These results illustrate the importance of the efforts to optimize conceptual and linguistic equivalence of PRO measures when pooling data in international clinical trials.

Clinical measurements analysis of multi-spectral photoplethysmograph biosensors

NASA Astrophysics Data System (ADS)

Asare, Lasma; Kviesis-Kipge, Edgars; Spigulis, Janis

2014-05-01

The developed portable multi-spectral photoplethysmograph (MS-PPG) optical biosensor device, intended for analysis of peripheral blood volume pulsations at different vascular depths, has been clinically verified. Multi-spectral monitoring was performed by means of a four - wavelengths (454 nm, 519 nm, 632 nm and 888 nm) light emitted diodes and photodiode with multi-channel signal output processing. Two such sensors can be operated in parallel and imposed on the patient's skin. The clinical measurements confirmed ability to detect PPG signals at four wavelengths simultaneously and to record temporal differences in the signal shapes (corresponding to different penetration depths) in normal and pathological skin. This study analyzed wavelengths relations between systole and diastole peak difference at various tissue depths in normal and pathological skin. The difference between parameters of healthy and pathological skin at various skin depths could be explain by oxy- and deoxyhemoglobin dominance at different wavelengths operated in sensor. The proposed methodology and potential clinical applications in dermatology for skin assessment are discussed.

An official American thoracic society workshop report: developing performance measures from clinical practice guidelines.

PubMed

Kahn, Jeremy M; Gould, Michael K; Krishnan, Jerry A; Wilson, Kevin C; Au, David H; Cooke, Colin R; Douglas, Ivor S; Feemster, Laura C; Mularski, Richard A; Slatore, Christopher G; Wiener, Renda Soylemez

2014-05-01

Many health care performance measures are either not based on high-quality clinical evidence or not tightly linked to patient-centered outcomes, limiting their usefulness in quality improvement. In this report we summarize the proceedings of an American Thoracic Society workshop convened to address this problem by reviewing current approaches to performance measure development and creating a framework for developing high-quality performance measures by basing them directly on recommendations from well-constructed clinical practice guidelines. Workshop participants concluded that ideally performance measures addressing care processes should be linked to clinical practice guidelines that explicitly rate the quality of evidence and the strength of recommendations, such as the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process. Under this framework, process-based performance measures would only be developed from strong recommendations based on high- or moderate-quality evidence. This approach would help ensure that clinical processes specified in performance measures are both of clear benefit to patients and supported by strong evidence. Although this approach may result in fewer performance measures, it would substantially increase the likelihood that quality-improvement programs based on these measures actually improve patient care.

40 CFR 63.5395 - How do I measure the density of a finish?

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 13 2013-07-01 2012-07-01 true How do I measure the density of a... and Initial Compliance Requirements § 63.5395 How do I measure the density of a finish? (a) To determine the density of a finish, the reference method is EPA Method 24 of appendix A of 40 CFR part 60...

40 CFR 63.5395 - How do I measure the density of a finish?

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 13 2014-07-01 2014-07-01 false How do I measure the density of a... and Initial Compliance Requirements § 63.5395 How do I measure the density of a finish? (a) To determine the density of a finish, the reference method is EPA Method 24 of appendix A of 40 CFR part 60...

40 CFR 63.5395 - How do I measure the density of a finish?

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 13 2012-07-01 2012-07-01 false How do I measure the density of a... and Initial Compliance Requirements § 63.5395 How do I measure the density of a finish? (a) To determine the density of a finish, the reference method is EPA Method 24 of appendix A of 40 CFR part 60...

Clinical implementation of photon beam flatness measurements to verify beam quality.

PubMed

Goodall, Simon; Harding, Nicholas; Simpson, Jake; Alexander, Louise; Morgan, Steve

2015-11-08

This work describes the replacement of Tissue Phantom Ratio (TPR) measurements with beam profile flatness measurements to determine photon beam quality during routine quality assurance (QA) measurements. To achieve this, a relationship was derived between the existing TPR15/5 energy metric and beam flatness, to provide baseline values and clinically relevant tolerances. The beam quality was varied around two nominal beam energy values for four matched Elekta linear accelerators (linacs) by varying the bending magnet currents and reoptimizing the beam. For each adjusted beam quality the TPR15/5 was measured using an ionization chamber and Solid Water phantom. Two metrics of beam flatness were evaluated using two identical commercial ionization chamber arrays. A linear relationship was found between TPR15/5 and both metrics of flatness, for both nominal energies and on all linacs. Baseline diagonal flatness (FDN) values were measured to be 103.0% (ranging from 102.5% to 103.8%) for 6 MV and 102.7% (ranging from 102.6% to 102.8%) for 10 MV across all four linacs. Clinically acceptable tolerances of ± 2% for 6 MV, and ± 3% for 10 MV, were derived to equate to the current TPR15/5 clinical tolerance of ± 0.5%. Small variations in the baseline diagonal flatness values were observed between ionization chamber arrays; however, the rate of change of TPR15/5 with diagonal flatness was found to remain within experimental uncertainty. Measurements of beam flatness were shown to display an increased sensitivity to variations in the beam quality when compared to TPR measurements. This effect is amplified for higher nominal energy photons. The derivation of clinical baselines and associated tolerances has allowed this method to be incorporated into routine QA, streamlining the process whilst also increasing versatility. In addition, the effect of beam adjustment can be observed in real time, allowing increased practicality during corrective and preventive maintenance

Perspectives on human clinical trials of therapies using iPS cells in Japan: reaching the forefront of stem-cell therapies.

PubMed

Song, Peipei; Inagaki, Yoshinori; Sugawara, Yasuhiko; Kokudo, Norihiro

2013-06-01

A research project involving sheets of retinal pigment epithelium constructed from iPS cells derived from patients with age-related maculopathy is one step closer to being approved for clinical trials by the Japanese Government. Now is the time to make therapies using iPS cells clinically available.

A Novel Method for Assessing Task Complexity in Outpatient Clinical-Performance Measures.

PubMed

Hysong, Sylvia J; Amspoker, Amber B; Petersen, Laura A

2016-04-01

Clinical-performance measurement has helped improve the quality of health-care; yet success in attaining high levels of quality across multiple domains simultaneously still varies considerably. Although many sources of variability in care quality have been studied, the difficulty required to complete the clinical work itself has received little attention. We present a task-based methodology for evaluating the difficulty of clinical-performance measures (CPMs) by assessing the complexity of their component requisite tasks. Using Functional Job Analysis (FJA), subject-matter experts (SMEs) generated task lists for 17 CPMs; task lists were rated on ten dimensions of complexity, and then aggregated into difficulty composites. Eleven outpatient work SMEs; 133 VA Medical Centers nationwide. Clinical Performance: 17 outpatient CPMs (2000-2008) at 133 VA Medical Centers nationwide. Measure Difficulty: for each CPM, the number of component requisite tasks and the average rating across ten FJA complexity scales for the set of tasks comprising the measure. Measures varied considerably in the number of component tasks (M = 10.56, SD = 6.25, min = 5, max = 25). Measures of chronic care following acute myocardial infarction exhibited significantly higher measure difficulty ratings compared to diabetes or screening measures, but not to immunization measures ([Formula: see text] = 0.45, -0.04, -0.05, and -0.06 respectively; F (3, 186) = 3.57, p = 0.015). Measure difficulty ratings were not significantly correlated with the number of component tasks (r = -0.30, p = 0.23). Evaluating the difficulty of achieving recommended CPM performance levels requires more than simply counting the tasks involved; using FJA to assess the complexity of CPMs' component tasks presents an alternate means of assessing the difficulty of primary-care CPMs and accounting for performance variation among measures and performers. This in turn could be used in designing

Conditional Risk of Relapse in Surveillance for Clinical Stage I Testicular Cancer.

PubMed

Nayan, Madhur; Jewett, Michael A S; Hosni, Ali; Anson-Cartwright, Lynn; Bedard, Philippe L; Moore, Malcolm; Hansen, Aaron R; Chung, Peter; Warde, Padraig; Sweet, Joan; O'Malley, Martin; Atenafu, Eshetu G; Hamilton, Robert J

2017-01-01

Patients on surveillance for clinical stage I (CSI) testicular cancer are counseled regarding their baseline risk of relapse. The conditional risk of relapse (cRR), which provides prognostic information on patients who have survived for a period of time without relapse, have not been determined for CSI testicular cancer. To determine cRR in CSI testicular cancer. We reviewed 1239 patients with CSI testicular cancer managed with surveillance at a tertiary academic centre between 1980 and 2014. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: cRR estimates were calculated using the Kaplan-Meier method. We stratified patients according to validated risk factors for relapse. We used linear regression to determine cRR trends over time. At orchiectomy, the risk of relapse within 5 yr was 42.4%, 17.3%, 20.3%, and 12.2% among patients with high-risk nonseminomatous germ cell tumor (NSGCT), low-risk NSGCT, seminoma with tumor size ≥3cm, and seminoma with tumor size <3cm, respectively. However, for patients without relapse within the first 2 yr of follow-up, the corresponding risk of relapse within the next 5 yr in the groups was 0.0%, 1.0% (95% confidence interval [CI] 0.3-1.7%), 5.6% (95% CI 3.1-8.2%), and 3.9% (95% CI 1.4-6.4%). Over time, cRR decreased (p≤0.021) in all models. Limitations include changes to surveillance protocols over time and few late relapses. After 2 yr, the risk of relapse on surveillance for CSI testicular cancer is very low. Consideration should be given to adapting surveillance protocols to individualized risk of relapse based on cRR as opposed to static protocols based on baseline factors. This strategy could reduce the intensity of follow-up for the majority of patients. Our study is the first to provide data on the future risk of relapse during surveillance for clinical stage I testicular cancer, given a patient has been without relapse for a specified period of time. Copyright © 2016 European Association of Urology. Published by Elsevier B

[Incidence of exercise-induced bronchospasm (E.I.B.) and its correlation with clinical history in children with allergic asthma].

PubMed

Novembre, E; Dini, L; Veneruso, G; Lombardi, E; Bernardini, R; Vierucci, A

1993-01-01

In this study, 65 allergic asthmatic children were evaluated for the presence of exercise induced bronchospasm (E.I.B.). Pulmonary function (volume at 1 second of forced expiration--FEV1; maximal mid-expiratory flow--FEF 25-75; peak expiratory flow--PEF) was assessed before and serially for 20' following treadmill exercise. Only 18 children (27.6%) presented a fall in FEV1 > or = 20%. There was a relationship between severity of asthma and incidence of E.I.B., as children with episodic, frequent and chronic asthma presented respectively 13/55 (23.4%), 2/6 (33.3%) and 3/4 (75%) of positive responses. The presence of E.I.B. cannot be predicted by clinical history, as 15/36 (41.7%) of subjects with positive clinical history had E.I.B., against 3/29 (10.3%) of subjects with negative clinical history (p = n.s.). E.I.B. in asthmatic children is less frequent as reported, correlates with severity of asthma and cannot be accurately predicted from the history.

Using an evidence-based approach to measure outcomes in clinical practice.

PubMed

MacDermid, Joy C; Grewal, Ruby; MacIntyre, Norma J

2009-02-01

Evaluation of the outcome of evidence-based practice decisions in individual patients or patient groups is step five in the evidence-based practice approach. Outcome measures are any measures that reflect patient status. Status or outcome measures can be used to detect change over time (eg, treatment effects), to discriminate among clinical groups, or to predict future outcomes (eg, return to work). A variety of reliable and valid physical impairment and disability measures are available to assess treatment outcomes in hand surgery and therapy. Evidence from research studies that includes normative data, standard error of measurement, or comparative scores for important clinical subgroups can be used to set treatment goals, monitor recovery, and compare individual patient outcomes to those reported in the literature. Clinicians tend to rely on impairment measures, such as radiographic measures, grip strength, and range of motion, although self-report measures are known to be equally reliable and more related to global effects, such as return-to-work. The process of selecting and implementing outcome measures is crucial. This process works best when team members are involved and willing to trial new measures. In this way, the team can develop customized outcome assessment procedures that meet their needs for assessing individual patients and providing data for program evaluation.

Effect of Sport Related Concussion on Clinically Measured Simple Reaction Time

PubMed Central

Eckner, James T.; Kutcher, Jeffrey S.; Broglio, Steven P.; Richardson, James K.

2013-01-01

Background Reaction time (RT) is a valuable component of the sport concussion assessment battery. RT is typically measured using computers running specialized software, which limits its applicability in some athletic settings and populations. To address this, we developed a simple clinical test of RT (RTclin) that involves grasping a falling measuring stick. Purpose To determine the effect of concussion on RTclin and its sensitivity and specificity for concussion. Materials and methods Concussed athletes (n=28) and non-concussed control teammates (n=28) completed RTclin assessments at baseline and within 48 hours of injury. Repeated measures ANOVA compared mean baseline and follow-up RTclin values between groups. Sensitivity and specificity were calculated over a range of reliable change confidence levels. Results RTclin differed significantly between groups (p < .001): there was significant prolongation from baseline to post-injury in the concussed group (p= .003), with a trend toward improvement in the control group (p = .058). Sensitivity and specificity were maximized when a critical change value of 0 ms was applied (i.e., any increase in RTclin from baseline was interpreted as abnormal), which corresponded to a sensitivity of 75%, specificity of 68%, and a 65% reliable change confidence level. Conclusions RTclin appears sensitive to the effects of concussion and distinguished concussed and non-concussed athletes with similar sensitivity and specificity to other commonly used concussion assessment tools. Given its simplicity, low cost, and minimal time requirement, RTclin should be considered a viable component of the sports medicine provider’s multifaceted concussion assessment battery. PMID:23314889

Streptococcus pyogenes collagen type I-binding Cpa surface protein. Expression profile, binding characteristics, biological functions, and potential clinical impact.

PubMed

Kreikemeyer, Bernd; Nakata, Masanobu; Oehmcke, Sonja; Gschwendtner, Caroline; Normann, Jana; Podbielski, Andreas

2005-09-30

The Streptococcus pyogenes collagen type I-binding protein Cpa (collagen-binding protein of group A streptococci) expressed by 28 serotypes of group A streptococci has been extensively characterized at the gene and protein levels. Evidence for three distinct families of cpa genes was found, all of which shared a common sequence encoding a 60-amino acid domain that accounted for selective binding to type I collagen. Surface plasmon resonance-based affinity measurements and functional studies indicated that the expression of Cpa was consistent with an attachment role for bacteria to tissue containing collagen type I. A cpa mutant displayed a significantly decreased internalization rate when incubated with HEp-2 cells but had no effect on the host cell viability. By utilizing serum from patients with a positive titer for streptolysin/DNase antibody, an increased anti-Cpa antibody titer was noted for patients with a clinical history of arthritis or osteomyelitis. Taken together, these results suggest Cpa may be a relevant matrix adhesin contributing to the pathogenesis of S. pyogenes infection of bones and joints.

MiDAS I (mild Decompression Alternative to Open Surgery): a preliminary report of a prospective, multi-center clinical study.

PubMed

Chopko, Bohdan; Caraway, David L

2010-01-01

Neurogenic claudication due to lumbar spinal stenosis is a common problem that can be caused by many factors including hypertrophic ligamentum flavum, facet hypertrophy, and disc protrusion. When standard medical therapies such as pain medication, epidural steroid injections, and physical therapy fail, or when the patient is unwilling, unable, or not severe enough to advance to more invasive surgical procedures, both physicians and patients are often left with a treatment dilemma. Patients in this study were treated with mild, an ultra-minimally invasive lumbar decompression procedure using a dorsal approach. The mild procedure is performed under fluoroscopic imaging to resect bone adjacent to, and achieve partial resection of, the hypertrophic ligamentum flavum with minimal disruption of surrounding muscular and skeletal structure. To assess the clinical application and patient safety and functional outcomes of the mild lumbar decompression procedure in the treatment of symptomatic central canal spinal stenosis. Multi-center, non-blinded, prospective clinical study. Fourteen US spine specialist practices. Between July 2008 and January 2010, 78 patients were enrolled in the MiDAS I Study and treated with the mild procedure for lumbar decompression. Of these patients, 6-week follow-up was available for 75 patients. Visual Analog Score (VAS), Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and SF-12v2 Health Survey. Outcomes were assessed at baseline and 6 weeks post-treatment. There were no major device or procedure-related complications reported in this patient cohort. At 6 weeks, the MiDAS I Study showed statistically and clinically significant reduction of pain as measured by VAS, ZCQ, and SF-12v2. In addition, improvement in physical function and mobility as measured by ODI, ZCQ, and SF-12v2 was statistically and clinically significant in this study. This is a preliminary report encompassing 6-week follow-up. There was no control group

Anti-troponin I antibodies in renal transplant patients.

PubMed

Nunes, José Pedro L; Sampaio, Susana; Cerqueira, Ana; Kaya, Ziya; Oliveira, Nuno Pardal

2015-02-01

To characterize the prevalence and clinical correlates of anti-troponin I antibodies in renal transplant patients. A group of 48 consecutive renal transplant patients under immunosuppressive therapy were studied. Anti-troponin I antibodies were measured and clinical data were retrieved. An anti-troponin I antibody titer <1:40 was seen in most patients (30). IgG antibody titers ≥1:80 were seen in eight patients, with a single value of 1:160. Regarding IgM antibodies, in six cases titers ≥1:80 were seen, with one value of 1:320. In only one patient were both anti-troponin I antibody IgG and IgM titers 1:80 or higher. Clinical cardiac disease was seen in nine patients. The presence of an anti-troponin I antibody titer ≥1:80 was not associated with the presence of clinical cardiac disease (p=0.232), but was associated with statin therapy status (p=0.008), being less frequent in patients under statin therapy. Anti-troponin I antibodies are seen in a minority of renal transplant patients, and are not associated with the presence of clinical heart disease, but are associated with lack of statin therapy. Copyright © 2014 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

Whole Brain Radiotherapy and RRx-001: Two Partial Responses in Radioresistant Melanoma Brain Metastases from a Phase I/II Clinical Trial: A TITE-CRM Phase I/II Clinical Trial.

PubMed

Kim, Michelle M; Parmar, Hemant; Cao, Yue; Pramanik, Priyanka; Schipper, Matthew; Hayman, James; Junck, Larry; Mammoser, Aaron; Heth, Jason; Carter, Corey A; Oronsky, Arnold; Knox, Susan J; Caroen, Scott; Oronsky, Bryan; Scicinski, Jan; Lawrence, Theodore S; Lao, Christopher D

2016-04-01

Kim et al. report two patients with melanoma metastases to the brain that responded to treatment with RRx-001 and whole brain radiotherapy (WBRT) without neurologic or systemic toxicity in the context of a phase I/II clinical trial. RRx-001 is an reactive oxygen and reactive nitrogen species (ROS/RNS)-dependent systemically nontoxic hypoxic cell radiosensitizer with vascular normalizing properties under investigation in patients with various solid tumors including those with brain metastases. Metastatic melanoma to the brain is historically associated with poor outcomes and a median survival of 4 to 5 months. WBRT is a mainstay of treatment for patients with multiple brain metastases, but no significant therapeutic advances for these patients have been described in the literature. To date, candidate radiosensitizing agents have failed to demonstrate a survival benefit in patients with brain metastases, and in particular, no agent has demonstrated improved outcome in patients with metastatic melanoma. Kim et al. report two patients with melanoma metastases to the brain that responded to treatment with novel radiosensitizing agent RRx-001 and WBRT without neurologic or systemic toxicity in the context of a phase I/II clinical trial. Published by Elsevier Inc.

40 CFR 63.5395 - How do I measure the density of a finish?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 12 2010-07-01 2010-07-01 true How do I measure the density of a... Initial Compliance Requirements § 63.5395 How do I measure the density of a finish? (a) To determine the density of a finish, the reference method is EPA Method 24 of appendix A of 40 CFR part 60. You may use...

40 CFR 63.5395 - How do I measure the density of a finish?

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 12 2011-07-01 2009-07-01 true How do I measure the density of a... Initial Compliance Requirements § 63.5395 How do I measure the density of a finish? (a) To determine the density of a finish, the reference method is EPA Method 24 of appendix A of 40 CFR part 60. You may use...

30 CFR 260.116 - How do I measure natural gas production on my eligible lease?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 2 2010-07-01 2010-07-01 false How do I measure natural gas production on my... do I measure natural gas production on my eligible lease? You must measure natural gas production on... natural gas, measured according to part 250, subpart L of this title, equals one barrel of oil equivalent...

Targeting radioimmunotherapy of hepatocellular carcinoma with iodine ({sup 131}I) metuximab injection: Clinical Phase I/II trials

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

Chen Zhinan; Mi Li; Xu Jing

2006-06-01

Purpose: HAb18G/CD147 is a hepatocellular carcinoma (HCC)-associated antigen. We developed iodine ({sup 131}I) metuximab injection (Licartin), a novel {sup 131}I-labeled HAb18G/CD147-specific monoclonal antibody F(ab'){sub 2} fragment, and evaluated its safety, pharmacokinetics, and clinical efficacy on HCC in Phase I/II trials. Methods and Materials: In a Phase I trial, 28 patients were randomly assigned to receive the injection in 9.25-, 18.5-, 27.75-, or 37-MBq/kg doses by hepatic artery infusion. In a multicenter Phase II trial, 106 patients received the injection (27.75 MBq/kg) on Day 1 of a 28-day cycle. Response rate and survival rate were the endpoints. Results: No life-threatening toxicmore » effects were found. The safe dosage was 27.75 MBq/kg. The blood clearance fitted a biphasic model, and its half-life was 90.56-63.93 h. In the Phase II trial, the injection was found to be targeted and concentrated to tumor tissues. Of the 73 patients completing two cycles, 6 (8.22%) had a partial response, 14 (19.18%) minor response, and 43 (58.90%) stable disease. The 21-month survival rate was 44.54%. The survival rate of progression-free patients was significantly higher than that of patients with progressive disease after either one or two cycles (p < 0.0001 or p 0.0019). Conclusion: Iodine ({sup 131}I) metuximab injection is safe and active for HCC patients.« less

iSPEX: everybody can measure atmospheric aerosols with a smartphone spectropolarimeter

NASA Astrophysics Data System (ADS)

Snik, F.; Heikamp, S.; de Boer, J.; Keller, C. U.; van Harten, G.; Smit, J. M.; Rietjens, J. H. H.; Hasekamp, O.; Stam, D. M.; Volten, H.; iSPEX Team

2012-04-01

An increasing amount people carry a mobile phone with internet connection, camera and large computing power. iSPEX, a spectropolarimetric add-on with complementary app, instantly turns a smartphone into a scientific instrument to measure dust and other aerosols in our atmosphere. A measurement involves scanning the blue sky, which yields the angular behavior of the degree of linear polarization as a function of wavelength, which can unambiguously be interpreted in terms of size, shape and chemical composition of the aerosols in the sky directly above. The measurements are tagged with location and pointing information, and submitted to a central database where they will be interpreted and compiled into an aerosol map. Through crowdsourcing, many people will thus be able to contribute to a better assessment of health risks of particulate matter and of whether or not volcanic ash clouds are dangerous for air traffic. It can also contribute to the understanding of the relationship between atmospheric aerosols and climate change. We will give a live presentation of the first iSPEX prototype. Furthermore, we will present the design and the plans for producing the iSPEX add-on, app and website. We aim to distribute thousands of iSPEX units, such that a unique network of aerosol measurement equipment is created. Many people will thus contribute to the solution of several urgent social and scientific problems, and learn about the nature of light, remote sensing and the issues regarding atmospheric aerosols in the process. In particular we focus on school classes where smartphones are usually considered a nuisance, whereas now they can be a crucial part of various educational programs in science class.

Phase I-II clinical trial of hyaluronan-cisplatin nanoconjugate in dogs with naturally occurring malignant tumors.

PubMed

Cai, Shuang; Zhang, Ti; Forrest, W C; Yang, Qiuhong; Groer, Chad; Mohr, Eva; Aires, Daniel J; Axiak-Bechtel, Sandra M; Flesner, Brian K; Henry, Carolyn J; Selting, Kimberly A; Tate, Deborah; Swarz, Jeffrey A; Bryan, Jeffrey N; Forrest, M Laird

2016-09-01

OBJECTIVE To conduct a phase I-II clinical trial of hyaluronan-cisplatin nanoconjugate (HA-Pt) in dogs with naturally occurring malignant tumors. ANIMALS 18 healthy rats, 9 healthy mice, and 16 dogs with cancer. PROCEDURES HA-Pt was prepared and tested by inductively coupled plasma mass spectrometry; DNA-platinum adduct formation and antiproliferation effects of cisplatin and HA-Pt were compared in vitro. Effects of cisplatin (IV) and HA-Pt (SC) in rodents were tested by clinicopathologic assays. In the clinical trial, dogs with cancer received 1 to 4 injections of HA-Pt (10 to 30 mg/m(2), intratumoral or peritumoral, q 3 wk). Blood samples were collected for pharmacokinetic analysis; CBC, serum BUN and creatinine concentration measurement, and urinalysis were conducted before and 1 week after each treatment. Some dogs underwent hepatic enzyme testing. Tumors were measured before the first treatment and 3 weeks after each treatment to assess response. RESULTS No adverse drug effects were detected in pretrial assessments in rodents. Seven of 16 dogs completed the study; 3 had complete tumor responses, 3 had stable disease, and 1 had progressive disease. Three of 7 dogs with oral and nasal squamous cell carcinoma (SCC) that completed the study had complete responses. Myelosuppression and cardiotoxicosis were identified in 6 and 2 dogs, respectively; none had nephrotoxicosis. Four of 5 dogs with hepatic enzymes assessed had increased ALT activities, attributed to diaquated cisplatin products in the HA-Pt. Pharmacokinetic data fit a 3-compartment model. CONCLUSIONS AND CLINICAL RELEVANCE HA-Pt treatment resulted in positive tumor responses in some dogs, primarily those with SCC. The adverse effect rate was high. IMPACT FOR HUMAN MEDICINE Oral SCC in dogs has characteristics similar to human head and neck SCC; these results could be useful in developing human treatments.

Establishment of a Method for Measuring Antioxidant Capacity in Urine, Based on Oxidation Reduction Potential and Redox Couple I2/KI

PubMed Central

Cao, Tinghui; He, Min; Bai, Tianyu

2016-01-01

Objectives. To establish a new method for determination of antioxidant capacity of human urine based on the redox couple I2/KI and to evaluate the redox status of healthy and diseased individuals. Methods. The method was based on the linear relationship between oxidation reduction potential (ORP) and logarithm of concentration ratio of I2/KI. ORP of a solution with a known concentration ratio of I2/KI will change when reacted with urine. To determine the accuracy of the method, both vitamin C and urine were reacted separately with I2/KI solution. The new method was compared with the traditional method of iodine titration and then used to measure the antioxidant capacity of urine samples from 30 diabetic patients and 30 healthy subjects. Results. A linear relationship was found between logarithm of concentration ratio of I2/KI and ORP (R 2 = 0.998). Both vitamin C and urine concentration showed a linear relationship with ORP (R 2 = 0.994 and 0.986, resp.). The precision of the method was in the acceptable range and results of two methods had a linear correlation (R 2 = 0.987). Differences in ORP values between diabetic group and control group were statistically significant (P < 0.05). Conclusions. A new method for measuring the antioxidant capacity of clinical urine has been established. PMID:28115919

Effects of performance measure implementation on clinical manager and provider motivation.

PubMed

Damschroder, Laura J; Robinson, Claire H; Francis, Joseph; Bentley, Douglas R; Krein, Sarah L; Rosland, Ann-Marie; Hofer, Timothy P; Kerr, Eve A

2014-12-01

Clinical performance measurement has been a key element of efforts to transform the Veterans Health Administration (VHA). However, there are a number of signs that current performance measurement systems used within and outside the VHA may be reaching the point of maximum benefit to care and in some settings, may be resulting in negative consequences to care, including overtreatment and diminished attention to patient needs and preferences. Our research group has been involved in a long-standing partnership with the office responsible for clinical performance measurement in the VHA to understand and develop potential strategies to mitigate the unintended consequences of measurement. Our aim was to understand how the implementation of diabetes performance measures (PMs) influences management actions and day-to-day clinical practice. This is a mixed methods study design based on quantitative administrative data to select study facilities and quantitative data from semi-structured interviews. Sixty-two network-level and facility-level executives, managers, front-line providers and staff participated in the study. Qualitative content analyses were guided by a team-based consensus approach using verbatim interview transcripts. A published interpretive motivation theory framework is used to describe potential contributions of local implementation strategies to unintended consequences of PMs. Implementation strategies used by management affect providers' response to PMs, which in turn potentially undermines provision of high-quality patient-centered care. These include: 1) feedback reports to providers that are dissociated from a realistic capability to address performance gaps; 2) evaluative criteria set by managers that are at odds with patient-centered care; and 3) pressure created by managers' narrow focus on gaps in PMs that is viewed as more punitive than motivating. Next steps include working with VHA leaders to develop and test implementation approaches to help

Clinical outcome measurement: Models, theory, psychometrics and practice.

PubMed

McClimans, Leah; Browne, John; Cano, Stefan

In the last decade much has been made of the role that models play in the epistemology of measurement. Specifically, philosophers have been interested in the role of models in producing measurement outcomes. This discussion has proceeded largely within the context of the physical sciences, with notable exceptions considering measurement in economics. However, models also play a central role in the methods used to develop instruments that purport to quantify psychological phenomena. These methods fall under the umbrella term 'psychometrics'. In this paper, we focus on Clinical Outcome Assessments (COAs) and discuss two measurement theories and their associated models: Classical Test Theory (CTT) and Rasch Measurement Theory. We argue that models have an important role to play in coordinating theoretical terms with empirical content, but to do so they must serve: 1) as a representation of the measurement interaction; and 2) in conjunction with a theory of the attribute in which we are interested. We conclude that Rasch Measurement Theory is a more promising approach than CTT in these regards despite the latter's popularity with health outcomes researchers. Copyright © 2017. Published by Elsevier Ltd.

Change in plasma lactate concentration during arctigenin administration in a phase I clinical trial in patients with gemcitabine-refractory pancreatic cancer

PubMed Central

Fujioka, Rumi; Mochizuki, Nobuo; Ikeda, Masafumi; Sato, Akihiro; Nomura, Shogo; Owada, Satoshi; Yomoda, Satoshi; Tsuchihara, Katsuya; Kishino, Satoshi

2018-01-01

Arctigenin is evaluated for antitumor efficacy in patients with pancreatic cancer. It has an inhibitory activity on mitochondrial complex I.Therefore, plasma lactate level of patients after arctigenin administration was evaluated for biomarker of clinical response and/or adverse effect. Plasma lactate level in 15 patients enrolled in a Phase I clinical trial of GBS-01 rich in arctigenin was analyzed by colorimetric assay. Statistical analyses for association of plasma lactate and clinical responses, pharmacokinetics of arctigenin, and background factors of each patient by multivariate and univariate analyses.In about half of the patients, transient increase of lactate was observed. Correlation between plasma lactate level and pharmacokinetic parameters of arctigenin and its glucuronide conjugate, and clinical outcome was not detected. Regarding to the determinant of lactate level, only slight association with liver function test was detected. Plasma lactate level is primary determined by reutilization rather than production for antitumor effect and dose not serve as a biomarker. Arctigenin, inhibition of mitochondrial complex I, plasma lactate concentration, phase I clinical trial of GBS-01, Cori cycle. PMID:29856804

Change in plasma lactate concentration during arctigenin administration in a phase I clinical trial in patients with gemcitabine-refractory pancreatic cancer.

PubMed

Fujioka, Rumi; Mochizuki, Nobuo; Ikeda, Masafumi; Sato, Akihiro; Nomura, Shogo; Owada, Satoshi; Yomoda, Satoshi; Tsuchihara, Katsuya; Kishino, Satoshi; Esumi, Hiroyasu

2018-01-01

Arctigenin is evaluated for antitumor efficacy in patients with pancreatic cancer. It has an inhibitory activity on mitochondrial complex I.Therefore, plasma lactate level of patients after arctigenin administration was evaluated for biomarker of clinical response and/or adverse effect. Plasma lactate level in 15 patients enrolled in a Phase I clinical trial of GBS-01 rich in arctigenin was analyzed by colorimetric assay. Statistical analyses for association of plasma lactate and clinical responses, pharmacokinetics of arctigenin, and background factors of each patient by multivariate and univariate analyses.In about half of the patients, transient increase of lactate was observed. Correlation between plasma lactate level and pharmacokinetic parameters of arctigenin and its glucuronide conjugate, and clinical outcome was not detected. Regarding to the determinant of lactate level, only slight association with liver function test was detected. Plasma lactate level is primary determined by reutilization rather than production for antitumor effect and dose not serve as a biomarker. Arctigenin, inhibition of mitochondrial complex I, plasma lactate concentration, phase I clinical trial of GBS-01, Cori cycle.

Intra- and Interobserver Variability of Cochlear Length Measurements in Clinical CT.

PubMed

Iyaniwura, John E; Elfarnawany, Mai; Riyahi-Alam, Sadegh; Sharma, Manas; Kassam, Zahra; Bureau, Yves; Parnes, Lorne S; Ladak, Hanif M; Agrawal, Sumit K

2017-07-01

The cochlear A-value measurement exhibits significant inter- and intraobserver variability, and its accuracy is dependent on the visualization method in clinical computed tomography (CT) images of the cochlea. An accurate estimate of the cochlear duct length (CDL) can be used to determine electrode choice, and frequency map the cochlea based on the Greenwood equation. Studies have described estimating the CDL using a single A-value measurement, however the observer variability has not been assessed. Clinical and micro-CT images of 20 cadaveric cochleae were acquired. Four specialists measured A-values on clinical CT images using both standard views and multiplanar reconstructed (MPR) views. Measurements were repeated to assess for intraobserver variability. Observer variabilities were evaluated using intra-class correlation and absolute differences. Accuracy was evaluated by comparison to the gold standard micro-CT images of the same specimens. Interobserver variability was good (average absolute difference: 0.77 ± 0.42 mm) using standard views and fair (average absolute difference: 0.90 ± 0.31 mm) using MPR views. Intraobserver variability had an average absolute difference of 0.31 ± 0.09 mm for the standard views and 0.38 ± 0.17 mm for the MPR views. MPR view measurements were more accurate than standard views, with average relative errors of 9.5 and 14.5%, respectively. There was significant observer variability in A-value measurements using both the standard and MPR views. Creating the MPR views increased variability between experts, however MPR views yielded more accurate results. Automated A-value measurement algorithms may help to reduce variability and increase accuracy in the future.

Reliability and criterion validity of two applications of the iPhone™ to measure cervical range of motion in healthy participants

PubMed Central

2013-01-01

Summary of background data Recent smartphones, such as the iPhone, are often equipped with an accelerometer and magnetometer, which, through software applications, can perform various inclinometric functions. Although these applications are intended for recreational use, they have the potential to measure and quantify range of motion. The purpose of this study was to estimate the intra and inter-rater reliability as well as the criterion validity of the clinometer and compass applications of the iPhone in the assessment cervical range of motion in healthy participants. Methods The sample consisted of 28 healthy participants. Two examiners measured cervical range of motion of each participant twice using the iPhone (for the estimation of intra and inter-reliability) and once with the CROM (for the estimation of criterion validity). Estimates of reliability and validity were then established using the intraclass correlation coefficient (ICC). Results We observed a moderate intra-rater reliability for each movement (ICC = 0.65-0.85) but a poor inter-rater reliability (ICC < 0.60). For the criterion validity, the ICCs are moderate (>0.50) to good (>0.65) for movements of flexion, extension, lateral flexions and right rotation, but poor (<0.50) for the movement left rotation. Conclusion We found good intra-rater reliability and lower inter-rater reliability. When compared to the gold standard, these applications showed moderate to good validity. However, before using the iPhone as an outcome measure in clinical settings, studies should be done on patients presenting with cervical problems. PMID:23829201

Using iRT, a normalized retention time for more targeted measurement of peptides

PubMed Central

Escher, Claudia; Reiter, Lukas; MacLean, Brendan; Ossola, Reto; Herzog, Franz; Chilton, John; MacCoss, Michael J.; Rinner, Oliver

2014-01-01

Multiple reaction monitoring (MRM) has recently become the method of choice for targeted quantitative measurement of proteins using mass spectrometry. The method, however, is limited in the number of peptides that can be measured in one run. This number can be markedly increased by scheduling the acquisition if the accurate retention time (RT) of each peptide is known. Here we present iRT, an empirically derived dimensionless peptide-specific value that allows for highly accurate RT prediction. The iRT of a peptide is a fixed number relative to a standard set of reference iRT-peptides that can be transferred across laboratories and chromatographic systems. We show that iRT facilitates the setup of multiplexed experiments with acquisition windows more than 4 times smaller compared to in silico RT predictions resulting in improved quantification accuracy. iRTs can be determined by any laboratory and shared transparently. The iRT concept has been implemented in Skyline, the most widely used software for MRM experiments. PMID:22577012

Automating Performance Measures and Clinical Practice Guidelines: Differences and Complementarities.

PubMed

Tu, Samson W; Martins, Susana; Oshiro, Connie; Yuen, Kaeli; Wang, Dan; Robinson, Amy; Ashcraft, Michael; Heidenreich, Paul A; Goldstein, Mary K

2016-01-01

Through close analysis of two pairs of systems that implement the automated evaluation of performance measures (PMs) and guideline-based clinical decision support (CDS), we contrast differences in their knowledge encoding and necessary changes to a CDS system that provides management recommendations for patients failing performance measures. We trace the sources of differences to the implementation environments and goals of PMs and CDS.

Combining clinical and genomics queries using i2b2 – Three methods

PubMed Central

Murphy, Shawn N.; Avillach, Paul; Bellazzi, Riccardo; Phillips, Lori; Gabetta, Matteo; Eran, Alal; McDuffie, Michael T.; Kohane, Isaac S.

2017-01-01

We are fortunate to be living in an era of twin biomedical data surges: a burgeoning representation of human phenotypes in the medical records of our healthcare systems, and high-throughput sequencing making rapid technological advances. The difficulty representing genomic data and its annotations has almost by itself led to the recognition of a biomedical “Big Data” challenge, and the complexity of healthcare data only compounds the problem to the point that coherent representation of both systems on the same platform seems insuperably difficult. We investigated the capability for complex, integrative genomic and clinical queries to be supported in the Informatics for Integrating Biology and the Bedside (i2b2) translational software package. Three different data integration approaches were developed: The first is based on Sequence Ontology, the second is based on the tranSMART engine, and the third on CouchDB. These novel methods for representing and querying complex genomic and clinical data on the i2b2 platform are available today for advancing precision medicine. PMID:28388645

Absolute Calibration of Si iRMs used for Measurements of Si Paleo-nutrient proxies

NASA Astrophysics Data System (ADS)

Vocke, R. D., Jr.; Rabb, S. A.

2016-12-01

Silicon isotope variations (reported as δ30Si and δ29Si, relative to NBS28) in silicic acid dissolved in ocean waters, in biogenic silica and in diatoms are extremely informative paleo-nutrient proxies. The resolution and comparability of such measurements depend on the quality of the isotopic Reference Materials (iRMs) defining the delta scale. We report new absolute Si isotopic measurements on the iRMs NBS28 (RM 8546 - Silica Sand), Diatomite, and Big Batch using the Avogadro measurement approach and comparing them with prior assessments of these iRMs. The Avogadro Si measurement technique was developed by the German Physikalish-Technische Bundesanstalt (PTB) to provide a precise and highly accurate method to measure absolute isotopic ratios in highly enriched 28Si (99.996%) material. These measurements are part of an international effort to redefine the kg and mole based on the Planck constant h and the Avogadro constant NA, respectively (Vocke et al., 2014 Metrologia 51, 361, Azuma et al., 2015 Metrologia 52 360). This approach produces absolute Si isotope ratio data with lower levels of uncertainty when compared to the traditional "Atomic Weights" method of absolute isotope ratio measurement calibration. This is illustrated in Fig. 1 where absolute Si isotopic measurements on SRM 990, separated by 40+ years of advances in instrumentation, are compared. The availability of this new technique does not say that absolute Si isotopic ratios are or ever will be better for normal Si isotopic measurements when seeking isotopic variations in nature, because they are not. However, by determining the absolute isotopic ratios of all the Si iRM scale artifacts, such iRMs become traceable to the metric system (SI); thereby automatically conferring on all the artifact-based δ30Si and δ29Si measurements traceability to the base SI unit, the mole. Such traceability should help reduce the potential of bias between different iRMs and facilitate the replacement of delta

Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice.

PubMed

Anderson, Jaclyn; Caplan, Liron; Yazdany, Jinoos; Robbins, Mark L; Neogi, Tuhina; Michaud, Kaleb; Saag, Kenneth G; O'Dell, James R; Kazi, Salahuddin

2012-05-01

Although the systematic measurement of disease activity facilitates clinical decision making in rheumatoid arthritis (RA), no recommendations currently exist on which measures should be applied in clinical practice in the US. The American College of Rheumatology (ACR) convened a Working Group (WG) to comprehensively evaluate the validity, feasibility, and acceptability of available RA disease activity measures and derive recommendations for their use in clinical practice. The Rheumatoid Arthritis Clinical Disease Activity Measures Working Group conducted a systematic review of the literature to identify RA disease activity measures. Using exclusion criteria, input from an Expert Advisory Panel (EAP), and psychometric analysis, a list of potential measures was created. A survey was administered to rheumatologists soliciting input. The WG used these survey results in conjunction with the psychometric analyses to derive final recommendations. Systematic review of the literature resulted in identification of 63 RA disease activity measures. Application of exclusion criteria and ratings by the EAP narrowed the list to 14 measures for further evaluation. Practicing rheumatologists rated 9 of these 14 measures as most useful and feasible. From these 9 measures, the WG selected 6 with the best psychometric properties for inclusion in the final set of ACR-recommended RA disease activity measures. We recommend the Clinical Disease Activity Index, Disease Activity Score with 28-joint counts (erythrocyte sedimentation rate or C-reactive protein), Patient Activity Scale (PAS), PAS-II, Routine Assessment of Patient Index Data with 3 measures, and Simplified Disease Activity Index because they are accurate reflections of disease activity; are sensitive to change; discriminate well between low, moderate, and high disease activity states; have remission criteria; and are feasible to perform in clinical settings. Copyright © 2012 by the American College of Rheumatology.

Comparison of posterior fossa volumes and clinical outcomes after decompression of Chiari malformation Type I.

PubMed

Khalsa, Siri Sahib S; Siu, Alan; DeFreitas, Tiffani A; Cappuzzo, Justin M; Myseros, John S; Magge, Suresh N; Oluigbo, Chima O; Keating, Robert F

2017-05-01

OBJECTIVE Previous studies have indicated an association of Chiari malformation Type I (CM-I) and a small posterior fossa. Most of these studies have been limited by 2D quantitative methods, and more recent studies utilizing 3D methodologies are time-intensive with manual segmentation. The authors sought to develop a more automated tool to calculate the 3D posterior fossa volume, and correlate its changes after decompression with surgical outcomes. METHODS A semiautomated segmentation program was developed, and used to compare the pre- and postoperative volumes of the posterior cranial fossa (PCF) and the CSF spaces (cisterna magna, prepontine cistern, and fourth ventricle) in a cohort of pediatric patients with CM-I. Volume changes were correlated with postoperative symptomatic improvements in headache, syrinx, tonsillar descent, cervicomedullary kinking, and overall surgical success. RESULTS Forty-two pediatric patients were included in this study. The mean percentage increase in PCF volume was significantly greater in patients who showed clinical improvement versus no improvement in headache (5.89% vs 1.54%, p < 0.05) and tonsillar descent (6.52% vs 2.57%, p < 0.05). Overall clinical success was associated with a larger postoperative PCF volume increase (p < 0.05). These clinical improvements were also significantly associated with a larger increase in the volume of the cisterna magna (p < 0.05). The increase in the caudal portion of the posterior fossa volume was also larger in patients who showed improvement in syrinx (6.63% vs 2.58%, p < 0.05) and cervicomedullary kinking (9.24% vs 3.79%, p < 0.05). CONCLUSIONS A greater increase in the postoperative PCF volume, and specifically an increase in the cisterna magna volume, was associated with a greater likelihood of clinical improvements in headache and tonsillar descent in patients with CM-I. Larger increases in the caudal portion of the posterior fossa volume were also associated with a greater likelihood of

Relationship between Clinical and Polysomnography Measures Corrected for CPAP Use.

PubMed

Kirkham, Erin M; Heckbert, Susan R; Weaver, Edward M

2015-11-15

The changes in patient-reported measures of obstructive sleep apnea (OSA) burden are largely discordant with the change in apnea-hypopnea index (AHI) and other polysomnography measures before and after treatment. For patients treated with continuous positive airway pressure (CPAP), some investigators have theorized that this discordance is due in part to the variability in CPAP use. We aim to test the hypothesis that patient-reported outcomes of CPAP treatment have stronger correlations with AHI when it is corrected for mean nightly CPAP use. This was a cross-sectional study of 459 adults treated with CPAP for OSA. Five patient-reported measures of OSA burden were collected at baseline and after 6 months of CPAP therapy. The correlations between the change in each patient-reported measure and the change in AHI as well as mean nightly AHI (corrected for CPAP use with a weighted average formula) were measured after 6 months of treatment. The same analysis was repeated for 4 additional polysomnography measures, including apnea index, arousal index, lowest oxyhemoglobin saturation, and desaturation index. The change in AHI was weakly but significantly correlated with change in 2 of the 5 clinical measures. The change in mean nightly AHI demonstrated statistically significant correlations with 4 out of 5 clinical measures, though each with coefficients less than 0.3. Similar results were seen for apnea index, arousal index, lowest oxyhemoglobin saturation, and desaturation index. Correction for CPAP use yielded overall small but significant improvements in the correlations between patient-reported measures of sleep apnea burden and polysomnography measures after 6 months of treatment. © 2015 American Academy of Sleep Medicine.

Circulating intestinal fatty acid-binding protein (I-FABP) levels in acute decompensated heart failure.

PubMed

Kitai, Takeshi; Kim, Yong-Hyun; Kiefer, Kathryn; Morales, Rommel; Borowski, Allen G; Grodin, Justin L; Tang, W H Wilson

2017-06-01

Venous congestion has become increasingly recognized as a potential contributor to end-organ dysfunction in heart failure. Elevated I-FABP, which is excreted specifically from damaged intestinal epithelial cells, has been found in patients with abdominal hypertension and intestinal ischemia. We hypothesize that elevated intestinal fatty acid-binding protein (I-FABP) levels would identify patients with more advanced heart failure who have venous and intestinal congestion. Baseline serum I-FABP levels were measured in 69 acute decompensated heart failure (ADHF) patients admitted to the intensive care unit for invasive hemodynamic monitoring and tailored medical therapy. Comprehensive echocardiography examinations were performed in all study patients, and clinical outcomes (death, cardiac transplant or left ventricular assist device placement) were assessed. The median circulating I-FABP level was 853pg/ml (interquartile range: 533 to 1448pg/ml). Age, gender, race, and baseline comorbidities were comparable between patients with low and high I-FABP levels. Although there were no significant correlations between I-FABP levels and invasively-measured hemodynamic parameters nor echocardiographic parameters, patients with higher I-FABP levels (≥853g/ml) had significantly worse clinical outcomes compared to those with lower I-FABP levels (<853pg/ml, P=0.025). Circulating I-FABP levels had no association with invasively-measured hemodynamic parameters, but were associated with adverse clinical outcomes in patients with ADHF with systolic dysfunction. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Magnetic field measurements of a clinical MR imager at 1.5 tesla

NASA Astrophysics Data System (ADS)

Muhech, A.; Tellez, I.; Esteva, M.; Marrufo, O.; Jimenez, L.; Vazquez, F.; Taboada, J.; Rodriguez, A. O.

2012-10-01

In the clinical environment is mandatory to run periodically measurements of uniformity of the magnetic field produced by the magnet to assure good image quality. The phase difference method was used to measure the magnetic field uniformity of the 1.5 T scanner of the Instituto Nacional de Neurologia y Neurocirugia MVS. The uniformity field values showed that the imager performance is reasonably good for clinical imaging. Some concern was raised since results may not be good enough for magnetic resonance spectroscopy runs.

Comparing i-Tree modeled ozone deposition with field measurements in a periurban Mediterranean forest

Treesearch

A. Morani; D. Nowak; S. Hirabayashi; G. Guidolotti; M. Medori; V. Muzzini; S. Fares; G. Scarascia Mugnozza; C. Calfapietra

2014-01-01

Ozone flux estimates from the i-Tree model were compared with ozone flux measurements using the Eddy Covariance technique in a periurban Mediterranean forest near Rome (Castelporziano). For the first time i-Tree model outputs were compared with field measurements in relation to dry deposition estimates. Results showed generally a...

Validation of the Italian version of the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM).

PubMed

Palmieri, Gaspare; Evans, Chris; Hansen, Vidje; Brancaleoni, Greta; Ferrari, Silvia; Porcelli, Piero; Reitano, Francesco; Rigatelli, Marco

2009-01-01

The Clinical Outcomes in Routine Evaluation--Outcome Measure (CORE-OM) was translated into Italian and tested in non-clinical (n = 263) and clinical (n = 647) samples. The translation showed good acceptability, internal consistency and convergent validity in both samples. There were large and statistically significant differences between clinical and non-clinical datasets on all scores. The reliable change criteria were similar to those for the UK referential data. Some of the clinically significant change criteria, particularly for the men, were moderately different from the UK cutting points. The Italian version of the CORE-OM showed respectable psychometric parameters. However, it seemed plausible that non-clinical and clinical distributions of self-report scores on psychopathology and functioning measures may differ by language and culture. *A good quality Italian translation of the CORE-OM, and hence the GP-CORE, CORE-10 and CORE-5 measures also, is now available for use by practitioners and anyone surveying or exploring general psychological state. The measures can be obtained from CORE-IMS or yourself and practitioners are encouraged to share anonymised data so that good clinical and non-clinical referential databases can be established for Italy.

Use of continuous glucose monitoring as an outcome measure in clinical trials.

PubMed

Beck, Roy W; Calhoun, Peter; Kollman, Craig

2012-10-01

Although developed to be a management tool for individuals with diabetes, continuous glucose monitoring (CGM) also has potential value for the assessment of outcomes in clinical studies. We evaluated using CGM as such an outcome measure. Data were analyzed from six previously completed inpatient studies in which both CGM (Freestyle Navigator™ [Abbott Diabetes Care, Alameda, CA] or Guardian(®) [Medtronic, Northridge, CA]) and reference glucose measurements were available. The analyses included 97 days of data from 93 participants with type 1 diabetes (age range, 5-57 years; mean, 18 ± 12 years). Mean glucose levels per day were similar for the CGM and reference measurements (median, 148 mg/dL vs. 143 mg/dL, respectively; P = 0.92), and the correlation of the two was high (r = 0.89). Similarly, most glycemia metrics showed no significant differences comparing CGM and reference values, except that the nadir glucose tended to be slightly lower and peak glucose slightly higher with reference measurements than CGM measurements (respective median, 59 mg/dL vs. 66 mg/dL [P = 0.05] and 262 mg/dL vs. 257 mg/dL [P = 0.003]) and glucose variability as measured with the coefficient of variation was slightly lower with CGM than reference measurements (respective median, 31% vs. 35%; P<0.001). A reasonably high degree of concordance exists when comparing outcomes based on CGM measurements with outcomes based on reference blood glucose measurements. CGM inaccuracy and underestimation of the extremes of hyperglycemia and hypoglycemia can be accounted for in a clinical trial's study design. Thus, in appropriate settings, CGM can be a very meaningful and feasible outcome measure for clinical trials.

The impact of an educational DVD on cancer patients considering participation in a phase I clinical trial.

PubMed

Strevel, Elizabeth L; Newman, Colin; Pond, Gregory R; MacLean, Martha; Siu, Lillian L

2007-07-01

The quality of informed consent in phase I trials is controversial, partially due to gaps in patient understanding. We assessed an educational DVD's impact on knowledge and satisfaction in cancer patients newly referred to a phase I clinic. Forty-nine patients were randomly assigned to view an educational DVD (n = 22) which explained phase I trials or a placebo DVD (n = 27). Patients completed a questionnaire assessing knowledge of phase I studies and satisfaction with the DVD. The blinded interviewing physician (n = 8) rated the patient's understanding of phase I trials. The mean patient age was 56; 61% were male. Patients who viewed the educational DVD were less likely to believe that phase I trials determine drug efficacy (p = 0.019), more likely to know that phase I drugs have not been thoroughly studied in humans (p = 0.003), and less likely to believe that these agents have proven activity against human cancers (p = 0.008). More patients who viewed the educational DVD agreed/strongly agreed that the DVD provided useful information (p < 0.001), were confident in their knowledge of phase I trials (p = 0.031), felt aided in their decision to enter a phase I study (p = 0.011), and would have more questions for their physicians because of the DVD (p = 0.017). No statistically significant difference in physician perception of patient understanding or phase I trial accrual was observed between the educational and placebo DVD groups. An educational DVD increased patient knowledge and satisfaction regarding participation in phase I clinical trials.

Respiratory muscle function in infants with spinal muscular atrophy type I.

PubMed

Finkel, Richard S; Weiner, Daniel J; Mayer, Oscar H; McDonough, Joseph M; Panitch, Howard B

2014-12-01

To determine the feasibility and safety of respiratory muscle function testing in weak infants with a progressive neuromuscular disorder. Respiratory insufficiency is the major cause of morbidity and mortality in infants with spinal muscular atrophy type I (SMA-I). Tests of respiratory muscle strength, endurance, and breathing patterns can be performed safely in SMA-I infants. Useful data can be collected which parallels the clinical course of pulmonary function in SMA-I. An exploratory study of respiratory muscle function testing and breathing patterns in seven infants with SMA-I seen in our neuromuscular clinic. Measurements were made at initial study visit and, where possible, longitudinally over time. We measured maximal inspiratory (MIP) and transdiaphragmatic pressures, mean transdiaphragmatic pressure, airway occlusion pressure at 100 msec of inspiration, inspiratory and total respiratory cycle time, and aspects of relative thoracoabdominal motion using respiratory inductive plethysmography (RIP). The tension time index of the diaphragm and of the respiratory muscles, phase angle (Φ), phase relation during the total breath, and labored breathing index were calculated. Age at baseline study was 54-237 (median 131) days. Reliable data were obtained safely for MIP, phase angle, labored breathing index, and the invasive and non-invasive tension time indices, even in very weak infants. Data obtained corresponded to the clinical estimate of severity and predicted the need for respiratory support. The testing employed was both safe and feasible. Measurements of MIP and RIP are easily performed tests that are well tolerated and provide clinically useful information for infants with SMA-I. © 2014 Wiley Periodicals, Inc.

From clinical to tissue-based dual TIA: Validation and refinement of ABCD3-I score.

PubMed

Dai, Qiliang; Sun, Wen; Xiong, Yunyun; Hankey, Graeme J; Xiao, Lulu; Zhu, Wusheng; Ma, Minmin; Liu, Wenhua; Liu, Dezhi; Cai, Qiankun; Han, Yunfei; Duan, Lihui; Chen, Xiangliang; Xu, Gelin; Liu, Xinfeng

2015-04-07

To investigate whether dual tissue-defined ischemic attacks, defined as multiple diffusion-weighted imaging lesions of different age and/or arterial territory (dual DWI), are an independent and stronger predictor of 90-day stroke than dual clinical TIAs (dual TIA). Consecutive patients with clinically defined TIA were enrolled and assessed clinically and by MRI within 3 days. The predictive ability of the ABCD clinical factors, dual TIA, and dual DWI was evaluated by means of multivariate logistic regression. Among 658 patients who were included in the study and completed 90 days of follow-up, a total of 70 patients (10.6%) experienced subsequent stroke by 90 days. Multivariate logistic regression indicated that dual DWI was an independent predictor for subsequent stroke (odds ratio 4.64, 95% confidence interval 2.15-10.01), while dual TIA was not (odds ratio 1.18, 95% confidence interval 0.69-2.01). C statistics was higher when the item of dual TIA in ABCD3-I score was replaced by dual DWI (0.759 vs 0.729, p = 0.035). The net reclassification value for 90-day stroke risk was also improved (continuous net reclassification improvement 0.301, p = 0.017). Dual DWI independently predicted future stroke in patients with TIA. A new ABCD3-I score with dual DWI instead of dual clinical TIA may improve risk stratification for early stroke risk after TIA. © 2015 American Academy of Neurology.

30 CFR 260.116 - How do I measure natural gas production on my eligible lease?

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 2 2011-07-01 2011-07-01 false How do I measure natural gas production on my... Bidding Systems Eligible Leases § 260.116 How do I measure natural gas production on my eligible lease? You must measure natural gas production on your eligible lease subject to the royalty suspension...

Measuring clinical management by physicians and nurses in European hospitals: development and validation of two scales.

PubMed

Plochg, Thomas; Arah, Onyebuchi A; Botje, Daan; Thompson, Caroline A; Klazinga, Niek S; Wagner, Cordula; Mannion, Russell; Lombarts, Kiki

2014-04-01

Clinical management is hypothesized to be critical for hospital management and hospital performance. The aims of this study were to develop and validate professional involvement scales for measuring the level of clinical management by physicians and nurses in European hospitals. Testing of validity and reliability of scales derived from a questionnaire of 21 items was developed on the basis of a previous study and expert opinion and administered in a cross-sectional seven-country research project 'Deepening our Understanding of Quality improvement in Europe' (DUQuE). A sample of 3386 leading physicians and nurses working in 188 hospitals located in Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey. Validity and reliability of professional involvement scales and subscales. Psychometric analysis yielded four subscales for leading physicians: (i) Administration and budgeting, (ii) Managing medical practice, (iii) Strategic management and (iv) Managing nursing practice. Only the first three factors applied well to the nurses. Cronbach's alpha for internal consistency ranged from 0.74 to 0.86 for the physicians, and from 0.61 to 0.81 for the nurses. Except for the 0.74 correlation between 'Administration and budgeting' and 'Managing medical practice' among physicians, all inter-scale correlations were <0.70 (range 0.43-0.61). Under testing for construct validity, the subscales were positively correlated with 'formal management roles' of physicians and nurses. The professional involvement scales appear to yield reliable and valid data in European hospital settings, but the scale 'Managing medical practice' for nurses needs further exploration. The measurement instrument can be used for international research on clinical management.

Comparison of the performance of four different tools in diagnosing disease-associated anorexia and their relationship with nutritional, functional and clinical outcome measures in hospitalized patients.

PubMed

Arezzo di Trifiletti, Adriana; Misino, Paola; Giannantoni, Patrizia; Giannantoni, Barbara; Cascino, Antonia; Fazi, Lucia; Rossi Fanelli, Filippo; Laviano, Alessandro

2013-08-01

impaired nutritional and functional variables. However, only the Anorexia Questionnaire identifies patients with longer hospital stay. Our results suggest that in clinical practice, modification of appetite reflects different underlying mechanisms whose impacts on clinical outcome measures may differ. Therefore, an ideal anorexia assessment tool does not appear to exist, but it should be chosen according to the outcome measures to be assessed (i.e., Anorexia Questionnaire to predict length of stay). Copyright © 2012 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Measuring impedance in congestive heart failure: Current options and clinical applications

PubMed Central

Tang, W. H. Wilson; Tong, Wilson

2011-01-01

Measurement of impedance is becoming increasingly available in the clinical setting as a tool for assessing hemodynamics and volume status in patients with heart failure. The 2 major categories of impedance assessment are the band electrode method and the implanted device lead method. The exact sources of the impedance signal are complex and can be influenced by physiologic effects such as blood volume, fluid, and positioning. This article provides a critical review of our current understanding and promises of impedance measurements, the techniques that have evolved, as well as the evidence and limitations regarding their clinical applications in the setting of heart failure management. PMID:19249408

Dynamic [Cl-]i measurement with chloride sensing quantum dots nanosensor in epithelial cells

NASA Astrophysics Data System (ADS)

Wang, Yuchi; Mao, Hua; Wong, Lid B.

2010-02-01

We have synthesized a chloride sensing quantum dots (QD) nanosensor, Cl-QD, for the dynamic measurements of chloride ion concentration in the millimolar range, a sensitivity that is applicable to most physiological intracellular chloride ion concentration ([Cl-]i) measurements in epithelial cells. The Cl-QD is synthesized by conjugating an anion receptor, 1-(2-mercapto-ethyl)-3-phenyl-thiourea (MEPTU) to a water soluble CdSe/ZnS QD at an emission wavelength of 620 nm. Upon binding of chloride ions to the Cl-QD, a photo-induced electron transfer mechanism caused the fluorescence of the QD to quench. This resulted in an inversely proportional relationship between the chloride ion concentration and the fluorescence intensity of the Cl-QD. We have utilized this Cl-QD to measure [Cl-]i in T84 and CF-PAC cultured cells, with either the C1C-2 or CFTR chloride channels being manipulated by pharmacological chloride channel activators and inhibitors. Activations of C1C-2 and CFTR chloride channels in T84 by the respective lubiprostone and genistein caused predictive increases in the fluorescence of the Cl-QD, i.e., a decrease of [Cl-]i. Conversely, glibenclamide, a chloride channel inhibitor, applied to the CF-PAC cells caused a predictable decrease in the fluorescence of Cl-QD due to the increase of [Cl-]i. These are the first data in using QD-based chloride ion sensors for dynamic measurements of intracellular chloride ion concentrations in epithelial cells.

Measuring performance improvement: total organizational commitment or clinical specialization.

PubMed

Caron, Aleece; Jones, Paul; Neuhauser, Duncan; Aron, David C

2004-01-01

Resources for hospitals are limited when they are faced with multiple publicly reported performance measures as tools to assess quality. The leadership in these organizations may choose to focus on 1 or 2 of these outcomes. An alternative approach is that the leadership may commit resources or create conditions that result in improved quality over a broad range of measures. We used aggregated data on mortality, length of stay, and obstetrical outcomes from Greater Cleveland Health Quality Choice data to test these theories. We used Pearson correlation analysis to determine of outcomes were correlated with one another. We used repeated-measures ANOVA to determine if an association existed between outcome and time and outcome and hospital. All of the outcomes across all hospitals demonstrate a trend of overall improvement. Both the Pearson and ANOVA result support the hypothesis for the organization-wide approach to quality improvement. Hospital that make improvements in one clinical area trend to make improvements in others. Hospitals that produce improvements in limited clinical or administrative areas may not have completely adopted CQI into their culture or may not have yet realized the benefits of their organizational commitments, but use some of the concepts to improve quality outcomes.

The predictive effect of insight on adverse clinical outcomes in bipolar I disorder: a two-year prospective study.

PubMed

Yen, Cheng-Fang; Chen, Cheng-Sheng; Yen, Ju-Yu; Ko, Chih-Hung

2008-05-01

Research has revealed that a lack of insight is associated with poorer clinical outcomes in schizophrenia; however, the predictive value of insight on adverse clinical outcomes among bipolar patients is quite understudied. The aim of this prospective study was to examine the impact of insight on adverse clinical outcomes among the patients with bipolar I disorder over a 2-year period. Sixty-five remitted bipolar I disorder patients received follow-up assessments at 3, 6, 9, 12, 18, and 24 months to detect the adverse clinical outcomes defined by the incidence of bipolar-related psychiatric hospitalization, emergency room visits, violent or suicidal behavior. The Schedule of Assessment of Insight was used to provide a baseline insight score. Cox regression analysis was used to examine the predictive value of insight on the adverse clinical outcomes. Impaired insight into treatment and a greater number of previous hospitalizations significantly increased the risk of adverse clinical outcomes with bipolar disorder in the 2-year period. However, insight into recognition of the illness and re-labeling of psychotic phenomena did not have any significant effect on adverse clinical outcomes. Bipolar patients' insight into treatment is an independent predictor of adverse clinical outcomes. Improving insight into treatment might be a promising target for a better outcome.

Quality control and assurance for validation of DOS/I measurements

NASA Astrophysics Data System (ADS)

Cerussi, Albert; Durkin, Amanda; Kwong, Richard; Quang, Timothy; Hill, Brian; Tromberg, Bruce J.; MacKinnon, Nick; Mantulin, William W.

2010-02-01

Ongoing multi-center clinical trials are crucial for Biophotonics to gain acceptance in medical imaging. In these trials, quality control (QC) and assurance (QA) are key to success and provide "data insurance". Quality control and assurance deal with standardization, validation, and compliance of procedures, materials and instrumentation. Specifically, QC/QA involves systematic assessment of testing materials, instrumentation performance, standard operating procedures, data logging, analysis, and reporting. QC and QA are important for FDA accreditation and acceptance by the clinical community. Our Biophotonics research in the Network for Translational Research in Optical Imaging (NTROI) program for breast cancer characterization focuses on QA/QC issues primarily related to the broadband Diffuse Optical Spectroscopy and Imaging (DOS/I) instrumentation, because this is an emerging technology with limited standardized QC/QA in place. In the multi-center trial environment, we implement QA/QC procedures: 1. Standardize and validate calibration standards and procedures. (DOS/I technology requires both frequency domain and spectral calibration procedures using tissue simulating phantoms and reflectance standards, respectively.) 2. Standardize and validate data acquisition, processing and visualization (optimize instrument software-EZDOS; centralize data processing) 3. Monitor, catalog and maintain instrument performance (document performance; modularize maintenance; integrate new technology) 4. Standardize and coordinate trial data entry (from individual sites) into centralized database 5. Monitor, audit and communicate all research procedures (database, teleconferences, training sessions) between participants ensuring "calibration". This manuscript describes our ongoing efforts, successes and challenges implementing these strategies.

Clinical measures of balance in people with type two diabetes: A systematic literature review.

PubMed

Dixon, C J; Knight, T; Binns, E; Ihaka, B; O'Brien, D

2017-10-01

Approximately 422 million people have diabetes mellitus worldwide, with the majority diagnosed with type 2 diabetes mellitus (T2DM). The complications of diabetes mellitus include diabetic peripheral neuropathy (DPN) and retinopathy, both of which can lead to balance impairments. Balance assessment is therefore an integral component of the clinical assessment of a person with T2DM. Although there are a variety of balance measures available, it is uncertain which measures are the most appropriate for this population. Therefore, the aim of this study was to conduct a systematic review on clinical balance measures used with people with T2DM and DPN. Databases searched included: CINAHL plus, MEDLINE, SPORTDiscus, Dentistry and Oral Sciences source, and SCOPUS. Key terms, inclusion and exclusion criteria were used to identify appropriate studies. Identified studies were critiqued using the Downs and Black appraisal tool. Eight studies were included, these studies incorporated a total of ten different clinical balance measures. The balance measures identified included the Dynamic Balance Test, balance walk, tandem and unipedal stance, Functional Reach Test, Clinical Test of Sensory Interaction and Balance, Berg Balance Scale, Tinetti Performance-Oriented Mobility Assessment, Activity-Specific Balance Confidence Scale, Timed Up and Go test, and the Dynamic Gait Index. Numerous clinical balance measures were used for people with T2DM. However, the identified balance measures did not assess all of the systems of balance, and most had not been validated in a T2DM population. Therefore, future research is needed to identify the validity of a balance measure that assesses these systems in people with T2DM. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Effectiveness of an i-PTH Measurement in Predicting Post Thyroidectomy Hypocalcemia: Prospective Controlled Study

PubMed Central

Kim, Jin Pyeong; Park, Jung Je; Son, Hee Young; Kim, Rock Bum; Kim, Ho Youp

2013-01-01

Purpose Hypocalcemia is the most common complication after total thyroidectomy. The purpose of this study was to determine whether measurement of intact parathyroid hormone (i-PTH) level in thyroidectomy patients could predict hypocalcemia. Materials and Methods We performed a prospective study of patients undergoing total thyroidectomy. Serum concentration of i-PTH, total calcium (Ca), ionized calcium (Ca2+), phosphate (P), magnesium (Mg), and albumin were measured preoperatively and at 0 hour, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours postoperatively. Results 108 patients were recruited to the study. A total of 50 patients (46%) experienced hypocalcemia. The serum i-PTH concentration was linearly related to the time of measurement, while concentrations of P, Mg, albumin, Ca, and Ca2+ were not. We compared odds ratios, and found that the concentration of i-PTH at 6 hours post operation was the most closely related to the occurrence of hypocalcemic symptom. On ROC analysis using i-PTH level at 6 hours, an i-PTH level of 10.6 mg/dL was found to maximize both sensitivity and specificity at the same time point. Conclusion We found that i-PTH was a predictor of hypocalcemia, and that the earliest predictor of hypocalcemic symptoms was an i-PTH concentration lower than 10.6 mg/dL obtained 6 hours after total thyroidectomy. PMID:23549808

Measurements of [C I] Emission from Comet Hale-Bopp

NASA Astrophysics Data System (ADS)

Oliversen, R. J.; Doane, N.; Scherb, F.; Harris, W. M.; Morgenthaler, J. P.

2002-12-01

We present quantitative measurements of cometary [C I] 9850 Å emission obtained during observations of comet Hale-Bopp (C/1995 O1) in 1997 March and April. The observations were carried out using a high-resolution (λ/Δλ~40,000) Fabry-Pérot/CCD spectrometer at the McMath-Pierce Solar telescope on Kitt Peak. This forbidden line, the carbon analog of [O I] 6300 Å, is emitted in the radiative decay of C(1D) atoms. In the absence of other sources and sinks, [C I] 9850 Å emission can be used as a direct tracer of CO photodissociation in comets. However, in Hale-Bopp's large, dense coma, other processes, such as collisional excitation of ground-state C(3P), dissociative recombination of CO+, and collisional dissociation of CO and CO2 may produce significant amounts of C(1D). The long C(1D) radiative lifetime (~4000 s) makes collisional deexcitation (quenching) the primary loss mechanism in the inner coma. Thus, a detailed, self-consistent global model of collisional and photochemical interactions is necessary to fully account for [C I] 9850 Å emission in comet Hale-Bopp.

Density Measurements in Air by Optically Exciting the Cordes Bands of I2

NASA Technical Reports Server (NTRS)

Balla, R. Jeffrey; Exton, Reginald J.

2000-01-01

We describe an optical method based on laser-induced fluorescence for obtaining instantaneous measurements of density along a line in low-density air seeded with I2. The Cordes bands of I2 (D(sup 1)sigma(sup +, sub u)) left arrow X(sup 1)sigma(sup +, sub g)) are excited with a tunable ArF excimer laser. air densities in the range (0.1-6.5) x 10(exp 17) cm(exp -3) are measured over 295-583 K using the density-dependent emission ratio of two emission bands of I2; the 340 nm bands and the diffuse-structured McLennan bands near 320 nm.

Assessment of Heparin Anticoagulation Measured Using i-STAT and Hemochron Activated Clotting Time.

PubMed

Maslow, Andrew; Chambers, Alison; Cheves, Tracey; Sweeney, Joseph

2018-01-31

Adequate anticoagulation, measured using activated clotting time (ACT), is important during vascular and cardiac surgeries. Unfractionated heparin is the most common anticoagulant used. The purpose of this analysis was to compare the i-STAT ACT (iACT) to the Hemochron ACT (hACT), both of which were then compared to anti-factor Xa (anti-Xa) assay, a representation of heparin level and activity. Prospective study. Tertiary care cardiovascular center. Eleven consecutive elective adult cardiac surgical patients. Prior to cardiopulmonary bypass, ACTs were measured using i-STAT and Hemochron technologies and compared to each other and to anti-Xa assay prior to and during a cumulative administration of heparin. Data were compared using bias analyses. Heparin (300 U/kg) was administered in quarterly doses. Coagulation labs were collected prior to and 3 minutes after each quarterly dose of heparin. The baseline ACTs for i-STAT and Hemochron were 147 and 142 seconds, respectively. A significant association was found between iACT and hACT (p = 0.002). The iACT measurements underestimated hACT at ACT levels >180 seconds or anti-Xa levels >0.75 U/mL. No significant difference was found between ACT data at anti-Xa levels <0.5 U/mL. There was a good association between the iACT and hACT; however, the 2 tests are not equivalent. Overall, the iACT underestimated the hACT. Agreement between the ACT technologies was good at lower ACTs and anti-Xa levels, but declined with an anti-Xa >0.75 U/mL. Copyright © 2018 Elsevier Inc. All rights reserved.

Developing a Workflow Composite Score to Measure Clinical Information Logistics. A Top-down Approach.

PubMed

Liebe, J D; Hübner, U; Straede, M C; Thye, J

2015-01-01

Availability and usage of individual IT applications have been studied intensively in the past years. Recently, IT support of clinical processes is attaining increasing attention. The underlying construct that describes the IT support of clinical workflows is clinical information logistics. This construct needs to be better understood, operationalised and measured. It is therefore the aim of this study to propose and develop a workflow composite score (WCS) for measuring clinical information logistics and to examine its quality based on reliability and validity analyses. We largely followed the procedural model of MacKenzie and colleagues (2011) for defining and conceptualising the construct domain, for developing the measurement instrument, assessing the content validity, pretesting the instrument, specifying the model, capturing the data and computing the WCS and testing the reliability and validity. Clinical information logistics was decomposed into the descriptors data and information, function, integration and distribution, which embraced the framework validated by an analysis of the international literature. This framework was refined selecting representative clinical processes. We chose ward rounds, pre- and post-surgery processes and discharge as sample processes that served as concrete instances for the measurements. They are sufficiently complex, represent core clinical processes and involve different professions, departments and settings. The score was computed on the basis of data from 183 hospitals of different size, ownership, location and teaching status. Testing the reliability and validity yielded encouraging results: the reliability was high with r(split-half) = 0.89, the WCS discriminated between groups; the WCS correlated significantly and moderately with two EHR models and the WCS received good evaluation results by a sample of chief information officers (n = 67). These findings suggest the further utilisation of the WCS. As the WCS does not

Using iRT, a normalized retention time for more targeted measurement of peptides.

PubMed

Escher, Claudia; Reiter, Lukas; MacLean, Brendan; Ossola, Reto; Herzog, Franz; Chilton, John; MacCoss, Michael J; Rinner, Oliver

2012-04-01

Multiple reaction monitoring (MRM) has recently become the method of choice for targeted quantitative measurement of proteins using mass spectrometry. The method, however, is limited in the number of peptides that can be measured in one run. This number can be markedly increased by scheduling the acquisition if the accurate retention time (RT) of each peptide is known. Here we present iRT, an empirically derived dimensionless peptide-specific value that allows for highly accurate RT prediction. The iRT of a peptide is a fixed number relative to a standard set of reference iRT-peptides that can be transferred across laboratories and chromatographic systems. We show that iRT facilitates the setup of multiplexed experiments with acquisition windows more than four times smaller compared to in silico RT predictions resulting in improved quantification accuracy. iRTs can be determined by any laboratory and shared transparently. The iRT concept has been implemented in Skyline, the most widely used software for MRM experiments. © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

What is the impact of a clinically related readmission measure on the assessment of hospital performance?

PubMed

Khouri, Roger K; Hou, Hechuan; Dhir, Apoorv; Andino, Juan J; Dupree, James M; Miller, David C; Ellimoottil, Chad

2017-11-28

The Hospital Readmission Reduction Program (HRRP) penalizes hospitals for high all-cause unplanned readmission rates. Many have expressed concern that hospitals serving patient populations with more comorbidities, lower incomes, and worse self-reported health status may be disproportionately penalized by readmissions that are not clinically related to the index admission. The impact of including clinically unrelated readmissions on hospital performance is largely unknown. We sought to determine if a clinically related readmission measure would significantly alter the assessment of hospital performance. We analyzed Medicare claims for beneficiaries in Michigan admitted for pneumonia and joint replacement from 2011 to 2013. We compared each hospital's 30-day readmission rate using specifications from the HRRP's all-cause unplanned readmission measure to values calculated using a clinically related readmission measure. We found that the mean 30-day readmission rates were lower when calculated using the clinically related readmission measure (joint replacement: all-cause 5.8%, clinically related 4.9%, p < 0.001; pneumonia: all cause 12.5%, clinically related 11.3%, p < 0.001)). The correlation of hospital ranks using both methods was strong (joint replacement: 0.95 (p < 0.001), pneumonia: 0.90 (p < 0.001)). Our findings suggest that, while greater specificity may be achieved with a clinically related measure, clinically unrelated readmissions may not impact hospital performance in the HRRP.

Management of clinical stage I testicular pure seminoma. Report on 42 patients and review of the literature.

PubMed

Porcaro, Antonio B; Antoniolli, Stefano Zecchini; Schiavone, Dionisio; Maffei, Nicola; Bassetto, Maria A; Curti, Pierpaolo

2002-06-01

Testis cancer is the most common tumor detected in men aged from 20 to 35 years accounting for 1-2%. About 20-30% of patients presenting with clinical stage I pure seminoma of the testis, which accounts for 45-50% of all germ cell tumors, present with occult metastases in the retroperitoneal lymph nodes. Currently, treatment options for clinical stage I seminoma include adjuvant radiotherapy (RT) as well as surveillance and adjuvant single agent chemotherapy. Herein, we review our experience in the management of 42 patients with clinical stage I pure seminoma of the testis and review the literature concerning this topic. Between January 1977 and December 2000, of 56 patients with pure seminoma of the testis 42 (75%) were assessed as clinical stage I disease. Adjuvant RT was performed in 41 patients and surveillance in 1. Radiations fields included the para-aortic and ipsilateral pelvic lymph nodes. A radiation dose of 25 Gy in 20 daily fractions was given. All patients were followed up. Average age was 41.2 years (range 24-67). Mean follow-up was 85.3 months (range 12-279). Histopathology assessed classic seminoma in 41 cases (98%) and spermatocytic seminoma in 1 (2%). Small vessel invasion was detected in 8 cases (19%). Overall relapse rate was 4.7%. Overall survival rate resulted 97%. Adjuvant radiotherapy (RT) is a safe standard of care in controlling microscopic retroperitoneal disease in patients with clinical stage I seminoma. About 3 to 5% of patients undergo relapses, mostly after the first 18 months after orchiectomy. Overall cause-specific survival rates range between 96% to 100%. An alternative optional treatment for compliant patients presenting with low risk factors for relapse is surveillance with recurrences rates ranging between 15% to 20%. Surveillance avoids unnecessary treatment in about 80% of patients, thus it could be offered as a safe alternative option to adjuvant RT since imaging detects relapses at their early stages. Adjuvant chemotherapy

Chiari I malformation presenting as downbeat nystagmus: clinical presentation, diagnosis, and management.

PubMed

Goodwin, Denise; Halvorson, Ami R

2012-02-15

Chiari I malformation is a congenital, neurological condition that is characterized by defects of the skull base resulting in herniation of the cerebellum through the foramen magnum into the cervical spinal canal. Because the condition can result in visual symptoms, patients will often search for answers from their eye care providers; A 28-year-old Hispanic diabetic male with a 10-year history of nystagmus was referred to the neuro-ophthalmic disease clinic following the initiation of oscillopsia 1 year previous. Downbeat nystagmus, which worsened in right and down gaze, was evident. Cranial nerve testing was unremarkable, but the patient did report trouble with choking on food and drink. Neuroimaging revealed Chiari I malformation. The patient underwent a suboccipital craniectomy which resulted in lessened nystagmus and improved symptoms; The majority of patients with Chiari I malformation have an onset of symptoms in the second or third decade of life. Most commonly, a suboccipital headache that worsens with Valsalva maneuver is present. Visual symptoms include retro-orbital pain, flashing lights or floaters, blurred vision, photophobia, diplopia, transient vision loss, and peripheral vision loss. Objective evidence is often lacking in these patients; however, horizontal or vertical nystagmus is present in up to 45% of those with Chiari I malformation. Surgery has proven to be an effective and safe method to treat symptomatic Chiari I malformation. American Optometric Association.

Clinical features and axis I comorbidity of Australian adolescent pathological Internet and video game users.

PubMed

King, Daniel L; Delfabbro, Paul H; Zwaans, Tara; Kaptsis, Dean

2013-11-01

Although there is growing international recognition of pathological technology use (PTU) in adolescence, there has been a paucity of empirical research conducted in Australia. This study was designed to assess the clinical features of pathological video gaming (PVG) and pathological Internet use (PIU) in a normative Australian adolescent population. A secondary objective was to investigate the axis I comorbidities associated with PIU and video gaming. A total of 1287 South Australian secondary school students aged 12-18 years were recruited. Participants were assessed using the PTU checklist, Revised Children's Anxiety and Depression Scale, Social Anxiety Scale for Adolescents, revised UCLA Loneliness Scale, and Teenage Inventory of Social Skills. Adolescents who met the criteria for PVG or PIU or both were compared to normal adolescents in terms of axis I comorbidity. The prevalence rates of PIU and PVG were 6.4% and 1.8%, respectively. A subgroup with co-occurring PIU and PVG was identified (3.3%). The most distinguishing clinical features of PTU were withdrawal, tolerance, lies and secrecy, and conflict. Symptoms of preoccupation, inability to self-limit, and using technology as an escape were commonly reported by adolescents without PTU, and therefore may be less useful as clinical indicators. Depression, panic disorder, and separation anxiety were most prevalent among adolescents with PIU. PTU among Australian adolescents remains an issue warranting clinical concern. These results suggest an emerging trend towards the greater uptake and use of the Internet among female adolescents, with associated PIU. Although there exists an overlap of PTU disorders, adolescents with PIU appear to be at greater risk of axis I comorbidity than adolescents with PVG alone. Further research with an emphasis on validation techniques, such as verified identification of harm, may enable an informed consensus on the definition and diagnosis of PTU.

Use of Continuous Glucose Monitoring as an Outcome Measure in Clinical Trials

PubMed Central

Calhoun, Peter; Kollman, Craig

2012-01-01

Abstract Objective Although developed to be a management tool for individuals with diabetes, continuous glucose monitoring (CGM) also has potential value for the assessment of outcomes in clinical studies. We evaluated using CGM as such an outcome measure. Research Design and Methods Data were analyzed from six previously completed inpatient studies in which both CGM (Freestyle Navigator™ [Abbott Diabetes Care, Alameda, CA] or Guardian® [Medtronic, Northridge, CA]) and reference glucose measurements were available. The analyses included 97 days of data from 93 participants with type 1 diabetes (age range, 5–57 years; mean, 18±12 years). Results Mean glucose levels per day were similar for the CGM and reference measurements (median, 148 mg/dL vs. 143 mg/dL, respectively; P=0.92), and the correlation of the two was high (r=0.89). Similarly, most glycemia metrics showed no significant differences comparing CGM and reference values, except that the nadir glucose tended to be slightly lower and peak glucose slightly higher with reference measurements than CGM measurements (respective median, 59 mg/dL vs. 66 mg/dL [P=0.05] and 262 mg/dL vs. 257 mg/dL [P=0.003]) and glucose variability as measured with the coefficient of variation was slightly lower with CGM than reference measurements (respective median, 31% vs. 35%; P<0.001). Conclusions A reasonably high degree of concordance exists when comparing outcomes based on CGM measurements with outcomes based on reference blood glucose measurements. CGM inaccuracy and underestimation of the extremes of hyperglycemia and hypoglycemia can be accounted for in a clinical trial's study design. Thus, in appropriate settings, CGM can be a very meaningful and feasible outcome measure for clinical trials. PMID:23013201

Ares I Scale Model Acoustic Tests Instrumentation for Acoustic and Pressure Measurements

NASA Technical Reports Server (NTRS)

Vargas, Magda B.; Counter, Douglas D.

2011-01-01

The Ares I Scale Model Acoustic Test (ASMAT) was a development test performed at the Marshall Space Flight Center (MSFC) East Test Area (ETA) Test Stand 116. The test article included a 5% scale Ares I vehicle model and tower mounted on the Mobile Launcher. Acoustic and pressure data were measured by approximately 200 instruments located throughout the test article. There were four primary ASMAT instrument suites: ignition overpressure (IOP), lift-off acoustics (LOA), ground acoustics (GA), and spatial correlation (SC). Each instrumentation suite incorporated different sensor models which were selected based upon measurement requirements. These requirements included the type of measurement, exposure to the environment, instrumentation check-outs and data acquisition. The sensors were attached to the test article using different mounts and brackets dependent upon the location of the sensor. This presentation addresses the observed effect of the sensors and mounts on the acoustic and pressure measurements.

Integration of technology-based outcome measures in clinical trials of Parkinson and other neurodegenerative diseases.

PubMed

Artusi, Carlo Alberto; Mishra, Murli; Latimer, Patricia; Vizcarra, Joaquin A; Lopiano, Leonardo; Maetzler, Walter; Merola, Aristide; Espay, Alberto J

2018-01-01

We sought to review the landscape of past, present, and future use of technology-based outcome measures (TOMs) in clinical trials of neurodegenerative disorders. We systematically reviewed PubMed and ClinicalTrials.gov for published and ongoing clinical trials in neurodegenerative disorders employing TOMs. In addition, medical directors of selected pharmaceutical companies were surveyed on their companies' ongoing efforts and future plans to integrate TOMs in clinical trials as primary, secondary, or exploratory endpoints. We identified 164 published clinical trials indexed in PubMed that used TOMs as outcome measures in Parkinson disease (n = 132) or other neurodegenerative disorders (n = 32). The ClinicalTrials.gov search yielded 42 clinical trials using TOMs, representing 2.7% of ongoing trials. Sensor-based technology accounted for over 75% of TOMs applied. Gait and physical activity were the most common targeted domains. Within the next 5 years, 83% of surveyed pharmaceutical companies engaged in neurodegenerative disorders plan to deploy TOMs in clinical trials. Although promising, TOMs are underutilized in clinical trials of neurodegenerative disorders. Validating relevant endpoints, standardizing measures and procedures, establishing a single platform for integration of data and algorithms from different devices, and facilitating regulatory approvals should advance TOMs integration into clinical trials. Copyright © 2017 Elsevier Ltd. All rights reserved.

30 CFR 250.406 - What additional safety measures must I take when I conduct drilling operations on a platform that...

Code of Federal Regulations, 2014 CFR

2014-07-01

... when I conduct drilling operations on a platform that has producing wells or has other hydrocarbon flow... OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations General Requirements § 250.406 What additional safety measures must I take...

30 CFR 250.406 - What additional safety measures must I take when I conduct drilling operations on a platform that...

Code of Federal Regulations, 2013 CFR

2013-07-01

... when I conduct drilling operations on a platform that has producing wells or has other hydrocarbon flow... OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations General Requirements § 250.406 What additional safety measures must I take...

30 CFR 250.406 - What additional safety measures must I take when I conduct drilling operations on a platform that...

Code of Federal Regulations, 2012 CFR

2012-07-01

... when I conduct drilling operations on a platform that has producing wells or has other hydrocarbon flow... OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations General Requirements § 250.406 What additional safety measures must I take...

A Phase I clinical trial of lodenafil carbonate, a new phosphodiesterase Type 5 (PDE5) inhibitor, in healthy male volunteers.

PubMed

Mendes, Gustavo D; dos Santos Filho, Hilton Oliveira; dos Santos Pereira, Alberto; Mendes, Fabiana D; Ilha, Jaime O; Alkharfy, Khalid M; De Nucci, Gilberto

2012-12-01

Lodenafil carbonate is a new phosphodiesterase Type 5 (PDE5) inhibitor used in treatment of erectile dysfunction. The present study was conducted to evaluate the safety, tolerability, and pharmacokinetics of lodenafil carbonate after administering ascending (1 - 100 mg) single oral doses to healthy male volunteers (n = 33). The study was an open label, dose-escalation, Phase I clinical trial involving the administration of single oral doses of lodenafil carbonate. Lodenafil carbonate was administered sequentially, escalating in single doses of 1 mg - 100 mg with a washout period of at least 1 week between each dose. The progression to the next dose was allowed after clinical and laboratory exams, Ambulatory Monitoring of Arterial Pressure (AMAP) without relevant clinical modifications and adverse events without clinical relevancy. Blood samples were collected at pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 14, 16, 20 and 24 h post-dosing. Plasma samples for measurement of lodenafil carbonate and lodenafil were analyzed by liquid chromatography coupled to tandem mass spectrometry. No serious adverse events were observed, and none of the subjects discontinued the study due to intolerance. The AMAP measurements, clinical and laboratory exams and ECG revealed no significant changes even at higher doses. Lodenafil carbonate was not detected in any samples, indicating that it acts as a prodrug. The mean lodenafil pharmacokinetic parameters for tmax and t1/2 were 1.6 ( ± 0.4) h and 3.3 ( ± 1.1) h, respectively. This study demonstrated that lodenafil carbonate was well tolerated and showed a good safety profile in healthy male volunteers.

Clinical and economic effects of iNO in premature newborns with respiratory failure at 1 year.

PubMed

Watson, R Scott; Clermont, Gilles; Kinsella, John P; Kong, Lan; Arendt, Robert E; Cutter, Gary; Linde-Zwirble, Walter T; Abman, Steven H; Angus, Derek C

2009-11-01

The long-term consequences of inhaled nitric oxide (iNO) use in premature newborns with respiratory failure are unknown. We therefore studied the clinical and economic outcomes to 1 year of corrected age after a randomized controlled trial of prophylactic iNO. Premature newborns (gestational age iNO or placebo within 48 h of birth until 21 d or extubation. We assessed clinical outcomes via in-person neurodevelopmental evaluation at 1 y corrected age and telephone interviews every 3 m. We estimated costs from detailed hospital bills and interviews, converting all costs to 2008 US$. Of 793 trial subjects, 631 (79.6%) contributed economic data, and 455 (77.1% of survivors) underwent neurodevelopmental evaluation. At 1 y corrected age, survival was not different by treatment arm (79.2% iNO vs. 74.5% placebo, P = .12), nor were other post-discharge outcomes. For subjects weighing 750-999 g, those receiving iNO had greater survival free from neurodevelopmental impairment (67.9% vs. 55.6%, P = .04). However, in subjects weighing 500-749 g, iNO led to greater oxygen dependency (11.7% vs. 4.0%, P = .04). Median total costs were similar ($235,800 iNO vs. $198,300 placebo, P = .19). Quality-adjusted survival was marginally better with iNO (by 0.011 quality-adjusted life-years/subject). The incremental cost-effectiveness ratio was $2.25 million/quality-adjusted life-year. Subjects in both arms commonly experienced neurodevelopmental and pulmonary morbidity, consuming substantial health care resources. Prophylactic iNO beginning in the first days of life did not lower costs and had a poor cost-effectiveness profile.

Statistical Validation for Clinical Measures: Repeatability and Agreement of Kinect™-Based Software

PubMed Central

Tello, Emanuel; Rodrigo, Alejandro; Valentinuzzi, Max E.

2018-01-01

Background The rehabilitation process is a fundamental stage for recovery of people's capabilities. However, the evaluation of the process is performed by physiatrists and medical doctors, mostly based on their observations, that is, a subjective appreciation of the patient's evolution. This paper proposes a tracking platform of the movement made by an individual's upper limb using Kinect sensor(s) to be applied for the patient during the rehabilitation process. The main contribution is the development of quantifying software and the statistical validation of its performance, repeatability, and clinical use in the rehabilitation process. Methods The software determines joint angles and upper limb trajectories for the construction of a specific rehabilitation protocol and quantifies the treatment evolution. In turn, the information is presented via a graphical interface that allows the recording, storage, and report of the patient's data. For clinical purposes, the software information is statistically validated with three different methodologies, comparing the measures with a goniometer in terms of agreement and repeatability. Results The agreement of joint angles measured with the proposed software and goniometer is evaluated with Bland-Altman plots; all measurements fell well within the limits of agreement, meaning interchangeability of both techniques. Additionally, the results of Bland-Altman analysis of repeatability show 95% confidence. Finally, the physiotherapists' qualitative assessment shows encouraging results for the clinical use. Conclusion The main conclusion is that the software is capable of offering a clinical history of the patient and is useful for quantification of the rehabilitation success. The simplicity, low cost, and visualization possibilities enhance the use of the software Kinect for rehabilitation and other applications, and the expert's opinion endorses the choice of our approach for clinical practice. Comparison of the new measurement

Statistical Validation for Clinical Measures: Repeatability and Agreement of Kinect™-Based Software.

PubMed

Lopez, Natalia; Perez, Elisa; Tello, Emanuel; Rodrigo, Alejandro; Valentinuzzi, Max E

2018-01-01

The rehabilitation process is a fundamental stage for recovery of people's capabilities. However, the evaluation of the process is performed by physiatrists and medical doctors, mostly based on their observations, that is, a subjective appreciation of the patient's evolution. This paper proposes a tracking platform of the movement made by an individual's upper limb using Kinect sensor(s) to be applied for the patient during the rehabilitation process. The main contribution is the development of quantifying software and the statistical validation of its performance, repeatability, and clinical use in the rehabilitation process. The software determines joint angles and upper limb trajectories for the construction of a specific rehabilitation protocol and quantifies the treatment evolution. In turn, the information is presented via a graphical interface that allows the recording, storage, and report of the patient's data. For clinical purposes, the software information is statistically validated with three different methodologies, comparing the measures with a goniometer in terms of agreement and repeatability. The agreement of joint angles measured with the proposed software and goniometer is evaluated with Bland-Altman plots; all measurements fell well within the limits of agreement, meaning interchangeability of both techniques. Additionally, the results of Bland-Altman analysis of repeatability show 95% confidence. Finally, the physiotherapists' qualitative assessment shows encouraging results for the clinical use. The main conclusion is that the software is capable of offering a clinical history of the patient and is useful for quantification of the rehabilitation success. The simplicity, low cost, and visualization possibilities enhance the use of the software Kinect for rehabilitation and other applications, and the expert's opinion endorses the choice of our approach for clinical practice. Comparison of the new measurement technique with established

Clinical measurement of tooth wear: Tooth wear indices

PubMed Central

López-Frías, Francisco J.; Castellanos-Cosano, Lizett; Martín-González, Jenifer; Llamas-Carreras, José M.

2012-01-01

Attrition, erosion, and abrasion result in alterations to the tooth and manifest as tooth wear. Each classification corresponds to a different process with specific clinical features. Classifications made so far have no accurate prevalence data because the indexes do not necessarily measure a specific etiology, or because the study populations can be diverse in age and characteristics. Tooth wears (attrition, erosion and abrasion) is perceived internationally as a growing problem. However, the interpretation and comparison of clinical and epidemiological studies, it is increasingly difficult because of differences in terminology and the large number of indicators/indices that have been developed for the diagnosis, classification and monitoring of the loss of dental hard tissue. These indices have been designed to identify increasing severity and are usually numerical, none have universal acceptance, complicating the evaluation of the true increase in prevalence reported. This article considers the ideal requirements for an erosion index. A literature review is conducted with the aim of analyzing the evolution of the indices used today and discuss whether they meet the clinical needs and research in dentistry. Key words:Tooth wear, tooth wear indices, attrition, erosion, abrasion, abfraction. PMID:24558525

Treatment and outcomes of an Australian cohort of outpatients with bipolar I or schizoaffective disorder over twenty-four months: implications for clinical practice

PubMed Central

2012-01-01

Background The Bipolar Comprehensive Outcomes Study (BCOS) is a 2-year, prospective, non-interventional, observational study designed to explore the clinical and functional outcomes associated with ‘real-world’ treatment of participants with bipolar I or schizoaffective disorder. All participants received treatment as usual. There was no study medication. Methods Participants prescribed either conventional mood stabilizers (CMS; n = 155) alone, or olanzapine with, or without, CMS (olanzapine ± CMS; n = 84) were assessed every 3 months using several measures, including the Young Mania Rating Scale, 21-item Hamilton Depression Rating Scale, Clinical Global Impressions Scale – Bipolar Version, and the EuroQol Instrument. This paper reports 24-month longitudinal clinical, pharmacological, functional, and socioeconomic data. Results On average, participants were 42 (range 18 to 79) years of age, 58%; were female, and 73%; had a diagnosis of bipolar I. Polypharmacy was the usual approach to pharmacological treatment; participants took a median of 5 different psychotropic medications over the course of the study, and spent a median proportion of time of 100%; of the study on mood stabilizers, 90%; on antipsychotics, 9%; on antidepressants, and 5%; on benzodiazepines/hypnotics. By 24 months, the majority of participants had achieved both symptomatic and syndromal remission of both mania and depression. Symptomatic relapse rates were similar for both the CMS alone (65%;) and the olanzapine ± CMS (61%;) cohorts. Conclusions Participants with bipolar I or schizoaffective disorder in this study were receiving complex medication treatments that were often discordant with recommendations made in contemporary major treatment guidelines. The majority of study participants demonstrated some clinical and functional improvements, but not all achieved remission of symptoms or syndrome. PMID:23244301

Predicting dynamic knee joint load with clinical measures in people with medial knee osteoarthritis.

PubMed

Hunt, Michael A; Bennell, Kim L

2011-08-01

Knee joint loading, as measured by the knee adduction moment (KAM), has been implicated in the pathogenesis of knee osteoarthritis (OA). Given that the KAM can only currently be accurately measured in the laboratory setting with sophisticated and expensive equipment, its utility in the clinical setting is limited. This study aimed to determine the ability of a combination of four clinical measures to predict KAM values. Three-dimensional motion analysis was used to calculate the peak KAM at a self-selected walking speed in 47 consecutive individuals with medial compartment knee OA and varus malalignment. Clinical predictors included: body mass; tibial angle measured using an inclinometer; walking speed; and visually observed trunk lean toward the affected limb during the stance phase of walking. Multiple linear regression was performed to predict KAM magnitudes using the four clinical measures. A regression model including body mass (41% explained variance), tibial angle (17% explained variance), and walking speed (9% explained variance) explained a total of 67% of variance in the peak KAM. Our study demonstrates that a set of measures easily obtained in the clinical setting (body mass, tibial alignment, and walking speed) can help predict the KAM in people with medial knee OA. Identifying those patients who are more likely to experience high medial knee loads could assist clinicians in deciding whether load-modifying interventions may be appropriate for patients, whilst repeated assessment of joint load could provide a mechanism to monitor disease progression or success of treatment. Copyright © 2010 Elsevier B.V. All rights reserved.

Patient-Oriented Eczema Measure (POEM), a core instrument to measure symptoms in clinical trials: a Harmonising Outcome Measures for Eczema (HOME) statement.

PubMed

Spuls, P I; Gerbens, L A A; Simpson, E; Apfelbacher, C J; Chalmers, J R; Thomas, K S; Prinsen, C A C; von Kobyletzki, L B; Singh, J A; Williams, H C; Schmitt, J

2017-04-01

The Harmonising Outcome Measures for Eczema (HOME) initiative has defined four core outcome domains for a core outcome set (COS) to be measured in all atopic eczema (AE) trials to ensure cross-trial comparison: clinical signs, symptoms, quality of life and long-term control. The aim of this paper is to report on the consensus process that was used to select the core instrument to consistently assess symptoms in all future AE trials. Following the HOME roadmap, two systematic reviews were performed which identified three instruments that had sufficient evidence of validity, reliability and feasibility to be considered for the final COS. At the fourth international HOME meeting, there was broad consensus among all stakeholders that the Patient-Oriented Eczema Measure (POEM) should be used as the core instrument (87·5% agreed, 9·4% unsure, 3·1% disagreed). All relevant stakeholders are encouraged to use POEM as the chosen instrument to measure the core domain of symptoms in all future AE clinical trials. Other instruments of interest can be used in addition to POEM. © 2016 British Association of Dermatologists.

A comprehensive clinical research database based on CDISC ODM and i2b2.

PubMed

Meineke, Frank A; Stäubert, Sebastian; Löbe, Matthias; Winter, Alfred

2014-01-01

We present a working approach for a clinical research database as part of an archival information system. The CDISC ODM standard is target for clinical study and research relevant routine data, thus decoupling the data ingest process from the access layer. The presented research database is comprehensive as it covers annotating, mapping and curation of poorly annotated source data. Besides a conventional relational database the medical data warehouse i2b2 serves as main frontend for end-users. The system we developed is suitable to support patient recruitment, cohort identification and quality assurance in daily routine.

Lymphatic vessel invasion and lymph node metastasis in patients with clinical stage I non-small cell lung cancer.

PubMed

Kang, Du-Young; Lee, Sungsoo

2014-09-01

The aim of this study was to investigate the association between the presence of lymphatic vessel invasion (LVI) in primary tumors and lymph node (LN) metastasis in clinical stage I non-small cell lung cancer (NSCLC) patients. A total of 76 patients who underwent complete resection for clinical stage I adenocarcinoma and squamous cell carcinoma were retrospectively examined. Tumors consisted of 51 cases of adenocarcinoma and 25 cases of squamous cell carcinoma as determined by histology. LN metastasis was detected in 24.4% (19/76) of patients. Factors associated with LN metastasis on univariate analysis included LVI (p < 0.001) and increased tumor dimensions (p < 0.05). Binary logistic regression analysis showed that the presence of LVI (p < 0.001) was the only predictor of LN metastasis. LVI is significantly associated with LN metastasis in patients with clinical stage I NSCLC. These findings may be helpful in determining the most appropriate operative strategy for patients if preoperative detection of LVI becomes feasible. Georg Thieme Verlag KG Stuttgart · New York.

Anorectal physiology measurements are of no value in clinical practice. True or false?

PubMed Central

Carty, N. J.; Moran, B.; Johnson, C. D.

1994-01-01

This article examines whether there is any clinical value in anorectal physiology measurements. The function of the human rectum is poorly understood and the factors which affect function of the anal sphincters are complex. Several laboratories have reported results of anorectal physiology measurements, but there is extensive variation between normal values in different laboratories. It is argued that anorectal physiology measurements fail to meet the criteria of a useful clinical test: 1. It is not widely available to clinicians; 2. It is not possible to establish a reproducible normal range; 3. Abnormal measurements do not correlate with disease entities or explain symptoms; 4. The results are often unhelpful in diagnosis and management; 5. Clinical outcome after intervention does not correlate with alteration in the measurements obtained. On the other hand it can be argued that anorectal physiology measurements do provide information that assists in the management of conditions such as constipation, anismus, Hirschsprung's disease, faecal incontinence and tenesmus. Management based on biofeedback modification of physiological responses requires these techniques as part of the biofeedback system. There is evidence that this may be appropriate in anismus and solitary rectal ulcer syndrome. However, the assessment of these difficult conditions and the interpretation of the results are probably at present best confined to specialist units. PMID:8074392

A combination of clinical balance measures and FRAX® to improve identification of high-risk fallers.

PubMed

Najafi, David A; Dahlberg, Leif E; Hansson, Eva Ekvall

2016-05-03

The FRAX® algorithm quantifies a patient's 10-year probability of a hip or major osteoporotic fracture without taking an individual's balance into account. Balance measures assess the functional ability of an individual and the FRAX® algorithm is a model that integrates the individual patients clinical risk factors [not balance] and bone mineral density. Thus, clinical balance measures capture aspects that the FRAX® algorithm does not, and vice versa. It is therefore possible that combining FRAX® and clinical balance measures can improve the identification of patients at high fall risk and thereby high fracture risk. Our study aim was to explore whether there is an association between clinical balance measures and fracture prediction obtained from FRAX®. A cross-sectional study design was used where post hoc was performed on a dataset of 82 participants (54 to 89 years of age, mean age 71.4, 77 female), with a fall-related wrist-fracture between 2008 and 2012. Balance was measured by tandem stance, standing one leg, walking in the figure of eight, walking heel to toe on a line, walking as fast as possible for 30 m and five times sit to stand balance measures [tandem stance and standing one leg measured first with open and then with closed eyes] and each one analyzed for bivariate relations with the 10-year probability values for hip and major osteoporotic fractures as calculated by FRAX® using Spearman's rank correlation test. Individuals with high FRAX® values had poor outcome in balance measures; however the significance level of the correlation differed between tests. Standing one leg eyes closed had strongest correlation to FRAX® (0.610 p = < 0.01) and Five times sit to stand was the only test that did not correlate with FRAX® (0.013). This study showed that there is an association between clinical balance measures and FRAX®. Hence, the use of clinical balance measures and FRAX® in combination, might improve the identification of individuals with

A focused exercise regimen improves clinical measures of balance in patients with peripheral neuropathy.

PubMed

Richardson, J K; Sandman, D; Vela, S

2001-02-01

To determine the effect of a specific exercise regimen on clinical measures of postural stability and confidence in a population with peripheral neuropathy (PN). Prospective, controlled, single blind study. Outpatient clinic of a university hospital. Twenty subjects with diabetes mellitus and electrodiagnostically confirmed PN. Ten subjects underwent a 3-week intervention exercise regimen designed to increase rapidly available distal strength and balance. The other 10 subjects performed a control exercise regimen. Unipedal stance time, functional reach, tandem stance time, and score on the activities-specific balance and confidence (ABC) scale. The intervention subjects, but not the control subjects, showed significant improvement in all 3 clinical measures of balance and nonsignificant improvement on the ABC scale. A brief, specific exercise regimen improved clinical measures of balance in patients with diabetic PN. Further studies are needed to determine if this result translates into a lower fall frequency in this high-risk population.

Measuring patient activation in Italy: Translation, adaptation and validation of the Italian version of the patient activation measure 13 (PAM13-I).

PubMed

Graffigna, Guendalina; Barello, Serena; Bonanomi, Andrea; Lozza, Edoardo; Hibbard, Judith

2015-12-23

The Patient Activation Measure (PAM13) is an instrument that assesses patient knowledge, skills, and confidence for disease self-management. This cross-sectional study was aimed to validate a culturally-adapted Italian Patient Activation Measure (PAM13-I) for patients with chronic conditions. 519 chronic patients were involved in the Italian validation study and responded to PAM13-I. The PAM 13 was translated into Italian by a standardized forward-backward translation. Data quality was assessed by mean, median, item response, missing values, floor and ceiling effects, internal consistency (Cronbach's alpha and average inter-item correlation), item-rest correlations. Rasch Model and differential item functioning assessed scale properties. Mean PAM13-I score was 66.2. Rasch analysis showed that the PAM13-I is a good measure of patient activation. The level of internal consistency was good (α = 0.88). For all items, the distribution of answers was left-skewed, with a small floor effect (range 1.7-4.5 %) and a moderate ceiling effect (range 27.6-55.0 %). The Italian version formed a unidimensional, probabilistic Guttman-like scale explaining 41 % of the variance. The PAM13-I has been demonstrated to be a valid and reliable measure of patient activation and the present study suggests its applicability to the Italian-speaking chronic patient population. The measure has good psychometric properties and appears to be consistent with the developmental nature of the patient activation phenomenon, although it presents a different ranking order of the items comparing to the American version. PAM13-I can be a useful assessment tool to evaluate interventions aimed at improving patient engagement in healthcare and to train doctors in attuning their communication to the level of patients' activation. Future research could be conducted to further confirm the validity of the PAM13-I.

Lifetime Measurement in the Yrast Band of 119I

NASA Astrophysics Data System (ADS)

Lobach, Yu. N.; Pasternak, A. A.; Srebrny, J.; Droste, Ch.; Hagemann, G. B.; Juutinen, S.; Morek, T.; Piiparinen, M.; Podsvirova, E. O.; Toermaenen, S.; Starosta, K.; Virtanen, A.; Wasilewski, A. A.

1999-05-01

The lifetime of levels in the yrast band of 119I were measured by DSAM and RDM using the 109Ag (13C,3n) reaction at E=54 MeV. The detailed description of data analysis including the stopping power determination and estimation of side feeding time is given. A modified method of RDM data analysis --- Recoil Distance Doppler Shape Attenuation (RDDSA) is used.

Ares I Scale Model Acoustic Test Instrumentation for Acoustic and Pressure Measurements

NASA Technical Reports Server (NTRS)

Vargas, Magda B.; Counter, Douglas

2011-01-01

Ares I Scale Model Acoustic Test (ASMAT) is a 5% scale model test of the Ares I vehicle, launch pad and support structures conducted at MSFC to verify acoustic and ignition environments and evaluate water suppression systems Test design considerations 5% measurements must be scaled to full scale requiring high frequency measurements Users had different frequencies of interest Acoustics: 200 - 2,000 Hz full scale equals 4,000 - 40,000 Hz model scale Ignition Transient: 0 - 100 Hz full scale equals 0 - 2,000 Hz model scale Environment exposure Weather exposure: heat, humidity, thunderstorms, rain, cold and snow Test environments: Plume impingement heat and pressure, and water deluge impingement Several types of sensors were used to measure the environments Different instrument mounts were used according to the location and exposure to the environment This presentation addresses the observed effects of the selected sensors and mount design on the acoustic and pressure measurements

Automated realtime data import for the i2b2 clinical data warehouse: introducing the HL7 ETL cell.

PubMed

Majeed, Raphael W; Röhrig, Rainer

2012-01-01

Clinical data warehouses are used to consolidate all available clinical data from one or multiple organizations. They represent an important source for clinical research, quality management and controlling. Since its introduction, the data warehouse i2b2 gathered a large user base in the research community. Yet, little work has been done on the process of importing clinical data into data warehouses using existing standards. In this article, we present a novel approach of utilizing the clinical integration server as data source, commonly available in most hospitals. As information is transmitted through the integration server, the standardized HL7 message is immediately parsed and inserted into the data warehouse. Evaluation of import speeds suggest feasibility of the provided solution for real-time processing of HL7 messages. By using the presented approach of standardized data import, i2b2 can be used as a plug and play data warehouse, without the hurdle of customized import for every clinical information system or electronic medical record. The provided solution is available for download at http://sourceforge.net/projects/histream/.

Patient-Reported Outcome Measures for Use in Clinical Trials and Clinical Practice in Inflammatory Bowel Diseases: A Systematic Review.

PubMed

de Jong, Marin J; Huibregtse, Roxanne; Masclee, Ad A M; Jonkers, Daisy M A E; Pierik, Marie J

2018-05-01

Mucosal inflammation must be carefully monitored to improve the long-term outcomes of patients with inflammatory bowel diseases (IBD). Patient-reported outcome measures (PROMs) are used increasingly to monitor disease activity in clinical practice and as endpoints in clinical trials. We performed a systematic review to provide an overview of the available PROMs on IBD activity and to evaluate their diagnostic value. A systematic search of the PubMed, Medline, Cochrane library, and Embase databases using defined keywords, identified 973 articles. These were screened by 2 independent reviewers, and 37 articles on development or validation of PROMs to assess IBD activity were identified for further analysis. Based on the recommendations of the Food and Drug Administration (FDA), the following measurement properties were evaluated: content, construct, and criterion validity; reliability; and responsiveness to change. In addition, data on ease of use in clinical practice were collected. Seventeen articles presenting 20 different PROMs were included the final analysis, although none met all the FDA-recommended criteria. Only 2 PROMs (patient-reported Harvey Bradshaw Index and Simple Clinical Colitis Activity Index scores) reported patient involvement during its development. Only 6 PROMs (patient-reported global assessment, patient assessment of disease activity, mobile health index for Crohn's disease, mobile health index for ulcerative colitis, patient-reported outcome derived from the Mayo score, and the 6-point Mayo score) were validated as markers of IBD activity, using findings from endoscopy as the reference standard; these PROMs identified patients with mucosal inflammation with area under the curve values of 0.63-0.82. The mobile health index for CD and UC scores had the best measurement properties for use in clinical practice and in clinical trials. In a systematic review, we identified more than 20 PROMS that have been developed and tested for their ability to

Measurement-based care for refractory depression: a clinical decision support model for clinical research and practice.

PubMed

Trivedi, Madhukar H; Daly, Ella J

2007-05-01

Despite years of antidepressant drug development and patient and provider education, suboptimal medication dosing and duration of exposure resulting in incomplete remission of symptoms remains the norm in the treatment of depression. Additionally, since no one treatment is effective for all patients, optimal implementation focusing on the measurement of symptoms, side effects, and function is essential to determine effective sequential treatment approaches. There is a need for a paradigm shift in how clinical decision making is incorporated into clinical practice and for a move away from the trial-and-error approach that currently determines the "next best" treatment. This paper describes how our experience with the Texas Medication Algorithm Project (TMAP) and the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial has confirmed the need for easy-to-use clinical support systems to ensure fidelity to guidelines. To further enhance guideline fidelity, we have developed an electronic decision support system that provides critical feedback and guidance at the point of patient care. We believe that a measurement-based care (MBC) approach is essential to any decision support system, allowing physicians to individualize and adapt decisions about patient care based on symptom progress, tolerability of medication, and dose optimization. We also believe that successful integration of sequential algorithms with MBC into real-world clinics will facilitate change that will endure and improve patient outcomes. Although we use major depression to illustrate our approach, the issues addressed are applicable to other chronic psychiatric conditions including comorbid depression and substance use disorder as well as other medical illnesses.

Measurement-Based Care for Refractory Depression: A Clinical Decision Support Model for Clinical Research and Practice

PubMed Central

Trivedi, Madhukar H.; Daly, Ella J.

2009-01-01

Despite years of antidepressant drug development and patient and provider education, suboptimal medication dosing and duration of exposure resulting in incomplete remission of symptoms remains the norm in the treatment of depression. Additionally, since no one treatment is effective for all patients, optimal implementation focusing on the measurement of symptoms, side effects, and function is essential to determine effective sequential treatment approaches. There is a need for a paradigm shift in how clinical decision making is incorporated into clinical practice and for a move away from the trial-and-error approach that currently determines the “next best” treatment. This paper describes how our experience with the Texas Medication Algorithm Project (TMAP) and the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial has confirmed the need for easy-to-use clinical support systems to ensure fidelity to guidelines. To further enhance guideline fidelity, we have developed an electronic decision support system that provides critical feedback and guidance at the point of patient care. We believe that a measurement-based care (MBC) approach is essential to any decision support system, allowing physicians to individualize and adapt decisions about patient care based on symptom progress, tolerability of medication, and dose optimization. We also believe that successful integration of sequential algorithms with MBC into real-world clinics will facilitate change that will endure and improve patient outcomes. Although we use major depression to illustrate our approach, the issues addressed are applicable to other chronic psychiatric conditions including comorbid depression and substance use disorder as well as other medical illnesses. PMID:17320312

Strategic performance management: development of a performance measurement system at the Mayo Clinic.

PubMed

Curtright, J W; Stolp-Smith, S C; Edell, E S

2000-01-01

Managing and measuring performance become exceedingly complex as healthcare institutions evolve into integrated health systems comprised of hospitals, outpatient clinics and surgery centers, nursing homes, and home health services. Leaders of integrated health systems need to develop a methodology and system that align organizational strategies with performance measurement and management. To meet this end, multiple healthcare organizations embrace the performance-indicators reporting system known as a "balanced scorecard" or a "dashboard report." This discrete set of macrolevel indicators gives senior management a fast but comprehensive glimpse of the organization's performance in meeting its quality, operational, and financial goals. The leadership of outpatient operations for Mayo Clinic in Rochester, Minnesota built on this concept by creating a performance management and measurement system that monitors and reports how well the organization achieves its performance goals. Internal stakeholders identified metrics to measure performance in each key category. Through these metrics, the organization links Mayo Clinic's vision, primary value, core principles, and day-to-day operations by monitoring key performance indicators on a weekly, monthly, or quarterly basis.

Phase I Clinical Trial Results of Auranofin, a Novel Antiparasitic Agent

PubMed Central

Capparelli, Edmund V.; Bricker-Ford, Robin; Rogers, M. John; McKerrow, James H.

2016-01-01

ABSTRACT Under an NIH priority to identify new drugs to treat class B parasitic agents, we performed high-throughput screens, which identified the activity of auranofin (Ridaura) against Entamoeba histolytica and Giardia intestinalis, major causes of water- and foodborne outbreaks. Auranofin, an orally administered, gold (Au)-containing compound that was approved by the FDA in 1985 for treatment of rheumatoid arthritis, was effective in vitro and in vivo against E. histolytica and both metronidazole-sensitive and -resistant strains of Giardia. We now report the results of an NIH-sponsored phase I trial to characterize the pharmacokinetics (PK) and safety of auranofin in healthy volunteers using modern techniques to measure gold levels. Subjects received orally 6 mg (p.o.) of auranofin daily, the recommended dose for rheumatoid arthritis, for 7 days and were followed for 126 days. Treatment-associated adverse events were reported by 47% of the subjects, but all were mild and resolved without treatment. The mean gold maximum concentration in plasma (Cmax) at day 7 was 0.312 μg/ml and the half-life (t1/2) 35 days, so steady-state blood levels would not be reached in short-term therapy. The highest concentration of gold, 13 μM (auranofin equivalent), or more than 25× the 50% inhibitory concentration (IC50) for E. histolytica and 4× that for Giardia, was in feces at 7 days. Modeling of higher doses (9 and 21 mg/day) was performed for systemic parasitic infections, and plasma gold levels of 0.4 to 1.0 μg/ml were reached after 14 days of treatment at 21 mg/day. This phase I trial supports the idea of the safety of auranofin and provides important PK data to support its potential use as a broad-spectrum antiparasitic drug. (This study has been registered at ClinicalTrials.gov under identifier NCT02089048.) PMID:27821451

Capturing Key NANDA-I Nursing Diagnoses From Actual Clinical Data for Patients With Heart Failure.

PubMed

Park, Hyejin; Tucker, Denise A

2017-01-01

The purpose of the study was to identify key nursing diagnoses with related factors and signs/symptoms using NANDA-I for patients with heart failure (HF). A retrospective descriptive design was used to address the research questions. Data were obtained from the records of patients discharged for 1 year with the medical diagnoses of HF from a Midwestern community hospital. A total of 272 inpatient records were analyzed to describe the frequency and percentage of NANDA-I diagnosis with related factors and signs/symptoms. The top 10 NANDA-I diagnoses associated with related factors and signs/symptoms were identified. Further research related to standardized nursing terminologies such as NANDA-I using large clinical databases from health information systems is needed to support evidence-based nursing diagnosis decision making. © 2015 NANDA International, Inc.

Clinical relevance of findings in trials of CBT for depression.

PubMed

Lepping, P; Whittington, R; Sambhi, R S; Lane, S; Poole, R; Leucht, S; Cuijpers, P; McCabe, R; Waheed, W

2017-09-01

Cognitive behavioural therapy (CBT) is beneficial in depression. Symptom scores can be translated into Clinical Global Impression (CGI) scale scores to indicate clinical relevance. We aimed to assess the clinical relevance of findings of randomised controlled trials (RCTs) of CBT in depression. We identified RCTs of CBT that used the Hamilton Rating Scale for Depression (HAMD). HAMD scores were translated into Clinical Global Impression - Change scale (CGI-I) scores to measure clinical relevance. One hundred and seventy datasets from 82 studies were included. The mean percentage HAMD change for treatment arms was 53.66%, and 29.81% for control arms, a statistically significant difference. Combined active therapies showed the biggest improvement on CGI-I score, followed by CBT alone. All active treatments had better than expected HAMD percentage reduction and CGI-I scores. CBT has a clinically relevant effect in depression, with a notional CGI-I score of 2.2, indicating a significant clinical response. The non-specific or placebo effect of being in a psychotherapy trial was a 29% reduction of HAMD. Copyright © 2017. Published by Elsevier Masson SAS.

Introduction to the special issue: toward implementing physiological measures in clinical child and adolescent assessments.

PubMed

De Los Reyes, Andres; Aldao, Amelia

2015-01-01

The National Institute of Mental Health recently launched the Research Domain Criteria (RDoC). The RDoC is an initiative to improve classification of mental health concerns by promoting research on the brain mechanisms underlying these concerns, with the ultimate goal of developing interventions that target these brain mechanisms. A key focus of RDoC involves opening new lines of research examining patients' responses on biological measures. The RDoC presents unique challenges to mental health professionals who work with children and adolescents. Indeed, mental health professionals rarely integrate biological measures into clinical assessments. Thus, RDoC's ability to improve patient care rests, in part, on the development of strategies for implementing biological measures within mental health assessments. Further, mental health professionals already carry out comprehensive assessments that frequently yield inconsistent findings. These inconsistencies have historically posed challenges to interpreting research findings as well as assessment outcomes in practice settings. In this introductory article, we review key issues that informed the development of a special issue of articles demonstrating methods for implementing low-cost measures of physiological functioning in clinical child and adolescent assessments. We also outline a conceptual framework, informed by theoretical work on using and interpreting multiple informants' clinical reports (De Los Reyes, Thomas, Goodman, & Kundey, 2013 ), to guide hypothesis testing when using physiological measures within clinical child and adolescent assessments. This special issue and the conceptual model described in this article may open up new lines of research testing paradigms for implementing clinically feasible physiological measures in clinical child and adolescent assessments.

Does adding clinical data to administrative data improve agreement among hospital quality measures?

PubMed

Hanchate, Amresh D; Stolzmann, Kelly L; Rosen, Amy K; Fink, Aaron S; Shwartz, Michael; Ash, Arlene S; Abdulkerim, Hassen; Pugh, Mary Jo V; Shokeen, Priti; Borzecki, Ann

2017-09-01

Hospital performance measures based on patient mortality and readmission have indicated modest rates of agreement. We examined if combining clinical data on laboratory tests and vital signs with administrative data leads to improved agreement with each other, and with other measures of hospital performance in the nation's largest integrated health care system. We used patient-level administrative and clinical data, and hospital-level data on quality indicators, for 2007-2010 from the Veterans Health Administration (VA). For patients admitted for acute myocardial infarction (AMI), heart failure (HF) and pneumonia we examined changes in hospital performance on 30-d mortality and 30-d readmission rates as a result of adding clinical data to administrative data. We evaluated whether this enhancement yielded improved measures of hospital quality, based on concordance with other hospital quality indicators. For 30-d mortality, data enhancement improved model performance, and significantly changed hospital performance profiles; for 30-d readmission, the impact was modest. Concordance between enhanced measures of both outcomes, and with other hospital quality measures - including Joint Commission process measures, VA Surgical Quality Improvement Program (VASQIP) mortality and morbidity, and case volume - remained poor. Adding laboratory tests and vital signs to measure hospital performance on mortality and readmission did not improve the poor rates of agreement across hospital quality indicators in the VA. Efforts to improve risk adjustment models should continue; however, evidence of validation should precede their use as reliable measures of quality. Published by Elsevier Inc.

How to measure kyphosis in everyday clinical practice: a reliability study on different methods.

PubMed

Zaina, Fabio; Donzelli, Sabrina; Lusini, Monia; Negrini, Stefano

2012-01-01

The sagittal plane measures have a relevant role both in Idiopathic Scoliosis (AIS) and in Hyperkyphosis (HK) management. Nevertheless, clinical tools for everyday use are scarce and not adequately studied. To assess the repeatability of different methods for the collection of the sagittal profile of patients with spinal deformities during everyday clinics. We performed 4 different studies in 4 different populations of AIS and HK patients. In the first study we reported the normative data and measurement error of the plumbline measures in a general population of 180 adolescents. In the second study we compared the sagittal distances from the plumbline of C7, T12, L3, and Sagittal Index (SI = C7+L3) with the measures of the Video Rasterstereography at the same levels and the angles of kyphosis and lordosis in 100 AIS patients. In the third study we evaluated the intra and inter-rater repeatability and the measurement error of kyphosis and lordosis angles measured with the Inclimed in 100 AIS patients. In the last study we evaluated the repeatability of the sagittal distances from the plumbline, by using a 1 mm change instead of 5 mm in a population of 40 patients. repeatability has been evaluated according to Bland and Altman, to identify the limits of variation that are clinically significant. Results. Study 1: the normative data were: females: 34 ± 11 mm for C7; 34 ± 15 mm for L3, males: 34 ± 10 mm for C7; 48 ± 10 mm for L3;. Study 2: a coefficient of correlation was calculated in order to compare measures. Study 3: the k value for Inclimed varied from fair to good. Study 4: the repeatability was fair for this measure. Some clinical instruments are now available for sagittal plane assessment in AIS and hyperkyphosis. The results of the present study report the limits during measurements in a clinical setting of parameters that are routinely collected by some clinicians.

The factor structure and psychometric properties of the Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM) in Norwegian clinical and non-clinical samples

PubMed Central

2013-01-01

Background The Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) is a 34-item instrument developed to monitor clinically significant change in out-patients. The CORE-OM covers four domains: well-being, problems/symptoms, functioning and risk, and sums up in two total scores: the mean of All items, and the mean of All non-risk items. The aim of this study was to examine the psychometric properties of the Norwegian translation of the CORE-OM. Methods A clinical sample of 527 out-patients from North Norwegian specialist psychiatric services, and a non-clinical sample of 464 persons were obtained. The non-clinical sample was a convenience sample consisting of friends and family of health personnel, and of students of medicine and clinical psychology. Students also reported psychological stress. Exploratory factor analysis (EFA) was employed in half the clinical sample. Confirmatory (CFA) factor analyses modelling the theoretical sub-domains were performed in the remaining half of the clinical sample. Internal consistency, means, and gender and age differences were studied by comparing the clinical and non-clinical samples. Stability, effect of language (Norwegian versus English), and of psychological stress was studied in the sub-sample of students. Finally, cut-off scores were calculated, and distributions of scores were compared between clinical and non-clinical samples, and between students reporting stress or no stress. Results The results indicate that the CORE-OM both measures general (g) psychological distress and sub-domains, of which risk of harm separates most clearly from the g factor. Internal consistency, stability and cut-off scores compared well with the original English version. No, or only negligible, language effects were found. Gender differences were only found for the well-being domain in the non-clinical sample and for the risk domain in the clinical sample. Current patient status explained differences between clinical and non-clinical

International Expert Consensus Document on Takotsubo Syndrome (Part I): Clinical Characteristics, Diagnostic Criteria, and Pathophysiology.

PubMed

Ghadri, Jelena-Rima; Wittstein, Ilan Shor; Prasad, Abhiram; Sharkey, Scott; Dote, Keigo; Akashi, Yoshihiro John; Cammann, Victoria Lucia; Crea, Filippo; Galiuto, Leonarda; Desmet, Walter; Yoshida, Tetsuro; Manfredini, Roberto; Eitel, Ingo; Kosuge, Masami; Nef, Holger M; Deshmukh, Abhishek; Lerman, Amir; Bossone, Eduardo; Citro, Rodolfo; Ueyama, Takashi; Corrado, Domenico; Kurisu, Satoshi; Ruschitzka, Frank; Winchester, David; Lyon, Alexander R; Omerovic, Elmir; Bax, Jeroen J; Meimoun, Patrick; Tarantini, Guiseppe; Rihal, Charanjit; Y-Hassan, Shams; Migliore, Federico; Horowitz, John D; Shimokawa, Hiroaki; Lüscher, Thomas Felix; Templin, Christian

2018-06-07

Takotsubo syndrome (TTS) is a poorly recognized heart disease that was initially regarded as a benign condition. Recently, it has been shown that TTS may be associated with severe clinical complications including death and that its prevalence is probably underestimated. Since current guidelines on TTS are lacking, it appears timely and important to provide an expert consensus statement on TTS. The clinical expert consensus document part I summarizes the current state of knowledge on clinical presentation and characteristics of TTS and agrees on controversies surrounding TTS such as nomenclature, different TTS types, role of coronary artery disease, and etiology. This consensus also proposes new diagnostic criteria based on current knowledge to improve diagnostic accuracy.

International Expert Consensus Document on Takotsubo Syndrome (Part I): Clinical Characteristics, Diagnostic Criteria, and Pathophysiology

PubMed Central

Ghadri, Jelena-Rima; Wittstein, Ilan Shor; Prasad, Abhiram; Sharkey, Scott; Dote, Keigo; Akashi, Yoshihiro John; Cammann, Victoria Lucia; Crea, Filippo; Galiuto, Leonarda; Desmet, Walter; Yoshida, Tetsuro; Manfredini, Roberto; Eitel, Ingo; Kosuge, Masami; Nef, Holger M; Deshmukh, Abhishek; Lerman, Amir; Bossone, Eduardo; Citro, Rodolfo; Ueyama, Takashi; Corrado, Domenico; Kurisu, Satoshi; Ruschitzka, Frank; Winchester, David; Lyon, Alexander R; Omerovic, Elmir; Bax, Jeroen J; Meimoun, Patrick; Tarantini, Guiseppe; Rihal, Charanjit; Y.-Hassan, Shams; Migliore, Federico; Horowitz, John D; Shimokawa, Hiroaki; Lüscher, Thomas Felix; Templin, Christian

2018-01-01

Abstract Takotsubo syndrome (TTS) is a poorly recognized heart disease that was initially regarded as a benign condition. Recently, it has been shown that TTS may be associated with severe clinical complications including death and that its prevalence is probably underestimated. Since current guidelines on TTS are lacking, it appears timely and important to provide an expert consensus statement on TTS. The clinical expert consensus document part I summarizes the current state of knowledge on clinical presentation and characteristics of TTS and agrees on controversies surrounding TTS such as nomenclature, different TTS types, role of coronary artery disease, and etiology. This consensus also proposes new diagnostic criteria based on current knowledge to improve diagnostic accuracy. PMID:29850871

Assessing mental imagery in clinical psychology: A review of imagery measures and a guiding framework

PubMed Central

Pearson, David G.; Deeprose, Catherine; Wallace-Hadrill, Sophie M.A.; Heyes, Stephanie Burnett; Holmes, Emily A.

2013-01-01

Mental imagery is an under-explored field in clinical psychology research but presents a topic of potential interest and relevance across many clinical disorders, including social phobia, schizophrenia, depression, and post-traumatic stress disorder. There is currently a lack of a guiding framework from which clinicians may select the domains or associated measures most likely to be of appropriate use in mental imagery research. We adopt an interdisciplinary approach and present a review of studies across experimental psychology and clinical psychology in order to highlight the key domains and measures most likely to be of relevance. This includes a consideration of methods for experimentally assessing the generation, maintenance, inspection and transformation of mental images; as well as subjective measures of characteristics such as image vividness and clarity. We present a guiding framework in which we propose that cognitive, subjective and clinical aspects of imagery should be explored in future research. The guiding framework aims to assist researchers in the selection of measures for assessing those aspects of mental imagery that are of most relevance to clinical psychology. We propose that a greater understanding of the role of mental imagery in clinical disorders will help drive forward advances in both theory and treatment. PMID:23123567

The Genomic Landscape and Clinical Relevance of A-to-I RNA Editing in Human Cancers | Office of Cancer Genomics

Cancer.gov

Adenosine-to-inosine (A-to-I) RNA editing is a widespread post-transcriptional mechanism, but its genomic landscape and clinical relevance in cancer have not been investigated systematically. We characterized the global A-to-I RNA editing profiles of 6,236 patient samples of 17 cancer types from The Cancer Genome Atlas and revealed a striking diversity of altered RNA-editing patterns in tumors relative to normal tissues. We identified an appreciable number of clinically relevant editing events, many of which are in noncoding regions.

Serial Liver Stiffness Measurements and Monitoring of Liver-Transplanted Patients in a Real-Life Clinical Practice

PubMed Central

Rinaldi, Luca; Valente, Giovanna; Piai, Guido

2016-01-01

Background Liver transplanted patients need close surveillance for early signs of graft disease. Objectives Transient elastography can safely be repeated over time, offering serial liver stiffness measurement values. Serial stiffness measurements were compared to single baseline stiffness measurements in predicting the appearance of liver-related clinical events and guiding subsequent clinical decisions. Methods One hundred and sixty liver transplanted patients were observed for three years in our real-life practice. Results Liver stiffness measurements were stable in 75% of patients, decreased in 4% of patients, and increased in 21% of patients. The pattern of increased stiffness measurements was associated with both HCV-RNA positive status and the presence of an active biliary complication of liver transplantation and was more predictive of a clinically significant event resulting from any disease of the transplanted liver when compared to a stable pattern or to a single liver stiffness measurement. The procedures that were consequently performed were often diagnostic for unexpected situations, both in HCV-RNA positive and HCV-RNA negative patients. Conclusions The pattern of longitudinally increased liver stiffness measurements efficiently supported clinical decisions for individualized management strategies. Repeated transient elastography in real-life clinical practice appears to have a practical role in monitoring liver transplanted patients. PMID:28123442

Outcome measurement in clinical trials for Ulcerative Colitis: towards standardisation

PubMed Central

Cooney, Rachel M; Warren, Bryan F; Altman, Douglas G; Abreu, Maria T; Travis, Simon PL

2007-01-01

Clinical trials on novel drug therapies require clear criteria for patient selection and agreed definitions of disease remission. This principle has been successfully applied in the field of rheumatology where agreed disease scoring systems have allowed multi-centre collaborations and facilitated audit across treatment centres. Unfortunately in ulcerative colitis this consensus is lacking. Thirteen scoring systems have been developed but none have been properly validated. Most trials choose different endpoints and activity indices, making comparison of results from different trials extremely difficult. International consensus on endoscopic, clinical and histological scoring systems is essential as these are the key components used to determine entry criteria and outcome measurements in clinical trials on ulcerative colitis. With multiple new therapies under development, there is a pressing need for consensus to be reached. PMID:17592647

Natural language processing and the representation of clinical data.

PubMed Central

Sager, N; Lyman, M; Bucknall, C; Nhan, N; Tick, L J

1994-01-01

OBJECTIVE: Develop a representation of clinical observations and actions and a method of processing free-text patient documents to facilitate applications such as quality assurance. DESIGN: The Linguistic String Project (LSP) system of New York University utilizes syntactic analysis, augmented by a sublanguage grammar and an information structure that are specific to the clinical narrative, to map free-text documents into a database for querying. MEASUREMENTS: Information precision (I-P) and information recall (I-R) were measured for queries for the presence of 13 asthma-health-care quality assurance criteria in a database generated from 59 discharge letters. RESULTS: I-P, using counts of major errors only, was 95.7% for the 28-letter training set and 98.6% for the 31-letter test set. I-R, using counts of major omissions only, was 93.9% for the training set and 92.5% for the test set. PMID:7719796

Absolute activity measurements with the windowless 4π-CsI(Tl)-sandwich spectrometer

NASA Astrophysics Data System (ADS)

Denecke, B.

1994-01-01

The windowless 4π-CsI(Tl)-sandwich spectrometer consists of two scintillation crystals sandwiching radioactive sources deposited on thin plastic foils. This configuration has a solid angle very close to 4π sr. The detectors are sensitive to charged particles with energies > 15 keV and measure photons of 15-200 keV with a probability > 98%. Disintegration rates of samples of radionuclides with complex decay modes can be determined directly from the measured count rates with uncertainties below 0.3%. Radionuclide solutions of 57Co, 109Cd, 125I, 152Eu and 192Ir were standardised, partly in the framework of international comparisons. A detailed description of the spectrometer and the measurement procedure is given.

Clinical benefit of metaphase I oocytes

PubMed Central

Vanhoutte, Leen; De Sutter, Petra; Van der Elst, Josiane; Dhont, Marc

2005-01-01

Background We studied the benefit of using in vitro matured metaphase I (MI) oocytes for ICSI in patients with a maximum of 6 mature metaphase II (MII) oocytes at retrieval. Methods In 2004, 187 ICSI cycles were selected in which maximum 6 MII oocytes and at least one MI oocyte were retrieved. MI oocytes were put in culture to mature until the moment of ICSI, which was performed between 2 to 11 hours after oocyte retrieval (day 0). In exceptional cases, when the patient did not have any mature oocyte at the scheduled time of ICSI, MI oocytes were left to mature overnight and were injected between 19 to 26 hours after retrieval (day 1). Embryos from MI oocytes were chosen for transfer only when no other good quality embryos from MII oocytes were available. Outcome parameters were time period of in vitro maturation (IVM), IVM and fertilization rates, embryo development, clinical pregnancy rates, implantation rates and total MI oocyte utilization rate. Results The overall IVM rate was 43%. IVM oocytes had lower fertilization rates compared to in vivo matured sibling oocytes (52% versus 68%, P < 0.05). The proportion of poor quality embryos was significantly higher in IVM derived oocytes. One pregnancy and live birth was obtained out of 13 transfers of embryos exclusively derived from IVM oocytes. This baby originated from an oocyte that was injected after 22 hrs of IVM. Conclusion Fertilization of in vitro matured MI oocytes can result in normal embryos and pregnancy, making IVM worthwhile, particularly when few MII oocytes are obtained at retrieval. PMID:16356175

Integrated passive flux measurement in groundwater: design and performance of iFLUX samplers

NASA Astrophysics Data System (ADS)

Verreydt, Goedele; Razaei, Meisam; Meire, Patrick; Van Keer, Ilse; Bronders, Jan; Seuntjens, Piet

2017-04-01

The monitoring and management of soil and groundwater is a challenge. Current methods for the determination of movement or flux of pollution in groundwater use no direct measurements but only simulations based on concentration measurements and Darcy velocity estimations. This entails large uncertainties which cause remediation failures and higher costs for contaminated site owners. On top of that, the lack of useful data makes it difficult to get approval for a risk-based management approach which completely avoids costly remedial actions. The iFLUX technology is a key development of Dr. Goedele Verreydt at the University of Antwerp and VITO. It is supported by the passive flux measurement technology as invented by Prof. Mike Annable and his team at the University of Florida. The iFLUX technology includes an in situ measurement device for capturing dynamic groundwater quality and quantity, the iFLUX sampler, and an associated interpretation and visualization method. The iFLUX sampler is a modular passive sampler that provides simultaneous in situ point determinations of a time-averaged target compound mass flux and water flux. The sampler is typically installed in a monitoring well where it intercepts the groundwater flow and captures the compounds of interest. The sampler consists of permeable cartridges which are each packed with a specific sorbent matrix. The sorbent matrix of the water flux cartridge is impregnated with known amounts of water soluble resident tracers. These tracers are leached from the matrix at rates proportional to the groundwater flux. The measurements of the contaminants and the remaining resident tracer are used to determine groundwater and target compound fluxes. Exposure times range from 1 week to 6 months, depending on the expected concentration and groundwater flow velocity. The iFLUX sampler technology has been validated and tested at several field projects. Currently, 4 cartridges are tested and available: 1 waterflux cartridge to

Evaluation of Beckman Coulter DxI 800 immunoassay system using clinically oriented performance goals.

PubMed

Akbas, Neval; Schryver, Patricia G; Algeciras-Schimnich, Alicia; Baumann, Nikola A; Block, Darci R; Budd, Jeffrey R; Gaston, S J Stephen; Klee, George G

2014-11-01

We evaluated the analytical performance of 24 immunoassays using the Beckman Coulter DxI 800 immunoassay systems at Mayo Clinic, Rochester, MN for trueness, precision, detection limits, linearity, and consistency (across instruments and reagent lots). Clinically oriented performance goals were defined using the following methods: trueness-published desirable accuracy limits, precision-published desirable biologic variation; detection limits - 0.1 percentile of patient test values, linearity - 50% of total error, and consistency-percentage test values crossing key decision points. Local data were collected for precision, linearity, and consistency. Data were provided by Beckman Coulter, Inc. for trueness and detection limits. All evaluated assays except total thyroxine were within the proposed goals for trueness. Most of the assays met the proposed goals for precision (86% of intra-assay results and 75% of inter-assay results). Five assays had more than 15% of the test results below the minimum detection limits. Carcinoembryonic antigen, total thyroxine and free triiodothyronine exceeded the proposed goals of ±6.3%, ±5% and ±5.7% for dilution linearity. All evaluated assays were within the proposed goals for instrument consistency. Lot-to-lot consistency results for cortisol, ferritin and total thyroxine exceeded the proposed goals of 3.3%, 11.4% and 7% at one medical decision level, while vitamin B12 exceeded the proposed goals of 5.2% and 3.8% at two decision levels. The Beckman Coulter DxI 800 immunoassay system meets most of these proposed goals, even though these clinically focused performance goals represent relatively stringent limits. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

A novel, non-invasive transdermal fluid sampling methodology: IGF-I measurement following exercise

USDA-ARS?s Scientific Manuscript database

This study tested the hypothesis that transdermal fluid (TDF) provides a more sensitive and accurate measure of exercise-induced increases in insulin-like growth factor-I (IGF-I) than serum, and that these increases are detectable proximal, but not distal, to the exercising muscle. A novel, noninvas...

Exploring Patient Activation in the Clinic: Measurement from Three Perspectives

ERIC Educational Resources Information Center

Ledford, Christy J. W.; Ledford, Christopher C.; Childress, Marc A.

2013-01-01

Objective. To further conceptualize and operationalize patient activation (PA), using measures from patient, physician, and researcher perspectives. Data Source/Study Setting. Multimethod observation in 2010 within a family medicine clinic. Study Design. Part of an intervention with 130 patients with type 2 diabetes, this observational study…

Clinical study using novel endoscopic system for measuring size of gastrointestinal lesion

PubMed Central

Oka, Kiyoshi; Seki, Takeshi; Akatsu, Tomohiro; Wakabayashi, Takao; Inui, Kazuo; Yoshino, Junji

2014-01-01

AIM: To verify the performance of a lesion size measurement system through a clinical study. METHODS: Our proposed system, which consists of a conventional endoscope, an optical device, an optical probe, and a personal computer, generates a grid scale to measure the lesion size from an endoscopic image. The width of the grid scale is constantly adjusted according to the distance between the tip of the endoscope and lesion because the lesion size on an endoscopic image changes according to the distance. The shape of the grid scale was corrected to match the distortion of the endoscopic image. The distance was calculated using the amount of laser light reflected from the lesion through an optical probe inserted into the instrument channel of the endoscope. The endoscopist can thus measure the lesion size without contact by comparing the lesion with the size of the grid scale on the endoscopic image. (1) A basic test was performed to verify the relationship between the measurement error eM and the tilt angle of the endoscope; and (2) The sizes of three colon polyps were measured using our system during endoscopy. These sizes were immediately measured by scale after their removal. RESULTS: There was no error at α = 0°. In addition, the values of eM (mean ± SD) were 0.24 ± 0.11 mm (α = 10°), 0.90 ± 0.58 mm (α = 20°) and 2.31 ± 1.41 mm (α = 30°). According to these results, our system has been confirmed to measure accurately when the tilt angle is less than 20°. The measurement error was approximately 1 mm in the clinical study. Therefore, it was concluded that our proposed measurement system was also effective in clinical examinations. CONCLUSION: By combining simple optical equipment with a conventional endoscope, a quick and accurate system for measuring lesion size was established. PMID:24744595

Measuring energy expenditure in clinical populations: rewards and challenges

PubMed Central

Psota, T; Chen, KY

2013-01-01

The measurement of energy expenditure (EE) is recommended as an important component of comprehensive clinical nutrition assessments in patients with altered metabolic states, who failed to respond to nutrition support and with critical illness that require individualized nutrition support. There is evidence that EE is variable in patients with metabolic diseases, such as chronic renal disease, cirrhosis, HIV, cancer cachexia, cystic fibrosis and patients under intensive care. By using appropriate techniques and interpretations of basal or resting EE, clinicians can facilitate the adequate nutrition support with minimum negative impacts from under- or overfeeding in these patients. This review is based on our current understanding of the different components of EE and the techniques to measure them, and to re-examine advances and challenges to determine energy needs in clinical populations with more focuses on the obese, pediatric and elderly patients. In addition, technological advances have expanded the choices of market-available equipments for assessing EE, which also bring specific challenges and rewards in selecting the right equipment with specific performance criteria. Lastly, analytical considerations of interpreting the results of EE in the context of changing body composition are presented and discussed. PMID:23443826

The assessment of sympathetic activity using iPPG based inter-limb coherence measurements

NASA Astrophysics Data System (ADS)

Tsoy, Maria O.; Rogatina, Kristina V.; Stiukhina, Elena S.; Postnov, Dmitry E.

2017-04-01

Photoplethysmography is an optical technique that can be used to detect blood volume changes and to measure important physiological parameters. This is low cost and non-invasive technique. However, one has to apply sensor directly to the skin. In this regard, the development on remote mothods receives the growing attention, such as imaging photoplethysmography (iPPG). Note, most of public-available iPPG systems are based on smartphone-embedded cameras, and thus have a sample frequency about 30-60 frames per second, which is enough for heart rate measurements, but may be too low for some more advanced usages of this technique. In our work, we describe the attempt to use smartphone-based iPPG technique aimed to measure the tiny mismatch in RR interval data series recorded from left and right arms. We use the transmission mode iPPG, in which the light transmitted through the medium of finger is detected by a web-camera opposite the LED source. The computational scheme by processing and analysis of the received signal was implemented using MATLAB language (MathWork Inc. in the United States). We believe that further development of our approach may lead to fast and low cost method to access the state of the sympathetic nervous system.

Reaching clinically relevant outcome measures for new pharmacotherapy and immunotherapy of atopic eczema.

PubMed

Chalmers, Joanne; Deckert, Stefanie; Schmitt, Jochen

2015-06-01

This article describes the core outcome set (COS) for atopic eczema trials. COS describe a minimum set of outcomes to be assessed in a defined situation. COS are required to overcome the current situation of different trials using different endpoints with unclear/insufficient measurement properties resulting in incomparable trials. The global multi-stakeholder Harmonising Outcomes Measures for Eczema initiative developed the Harmonising Outcomes Measures for Eczema roadmap as a generic framework for COS development. Following the establishment of a panel representing all stakeholders, a core set of outcome domains need to be selected based on systematic reviews and consensus methods. Outcome measurement instruments to assess these core domains need to be valid, reliable, and feasible. There is broad global consensus that clinical signs, quality of life, symptoms, and long-term control of flares form the COS for atopic eczema trials. The Eczema Area and Severity Index is recommended to assess clinical signs in atopic eczema trials. Systematic reviews to identify adequate outcome measurement instruments for the other core outcome domains are underway. Clinical signs should be assessed in all atopic eczema trials by at least the Eczema Area and Severity Index. Quality of life, symptoms, and flares should also be assessed in all atopic eczema trials by a valid, reliable, and feasible instrument.

Fat-Soluble Vitamins: Clinical Indications and Current Challenges for Chromatographic Measurement

PubMed Central

Albahrani, Ali A.; Greaves, Ronda F.

2016-01-01

Fat-soluble vitamins, including vitamins A, D and E, are required for a wide variety of physiological functions. Over the past two decades, deficiencies of these vitamins have been associated with increased risk of cancer, type II diabetes mellitus and a number of immune system disorders. In addition, there is increasing evidence of interactions between these vitamins, especially between vitamins A and D. As a result of this enhanced clinical association with disease, translational clinical research and laboratory requests for vitamin measurements have significantly increased. These laboratory requests include measurement of 25-OHD (vitamin D), retinol (vitamin A) and α-tocopherol (vitamin E); the most accepted blood indicators for the assessment of body fat-soluble vitamin (FSV) status. There are significant obstacles to precise FSV measurement in blood. These obstacles include their physical and chemical properties, incomplete standardisation of measurement and limitations in the techniques that are currently used for quantification. The aim of this review is to briefly outline the metabolism and interactions of FSV as a prelude to identifying the current challenges for the quantification of blood vitamins A, D and E. PMID:27057076

Fat-Soluble Vitamins: Clinical Indications and Current Challenges for Chromatographic Measurement.

PubMed

Albahrani, Ali A; Greaves, Ronda F

2016-02-01

Fat-soluble vitamins, including vitamins A, D and E, are required for a wide variety of physiological functions. Over the past two decades, deficiencies of these vitamins have been associated with increased risk of cancer, type II diabetes mellitus and a number of immune system disorders. In addition, there is increasing evidence of interactions between these vitamins, especially between vitamins A and D. As a result of this enhanced clinical association with disease, translational clinical research and laboratory requests for vitamin measurements have significantly increased. These laboratory requests include measurement of 25-OHD (vitamin D), retinol (vitamin A) and α-tocopherol (vitamin E); the most accepted blood indicators for the assessment of body fat-soluble vitamin (FSV) status. There are significant obstacles to precise FSV measurement in blood. These obstacles include their physical and chemical properties, incomplete standardisation of measurement and limitations in the techniques that are currently used for quantification. The aim of this review is to briefly outline the metabolism and interactions of FSV as a prelude to identifying the current challenges for the quantification of blood vitamins A, D and E.

Alzheimer Disease Biomarkers as Outcome Measures for Clinical Trials in MCI.

PubMed

Caroli, Anna; Prestia, Annapaola; Wade, Sara; Chen, Kewei; Ayutyanont, Napatkamon; Landau, Susan M; Madison, Cindee M; Haense, Cathleen; Herholz, Karl; Reiman, Eric M; Jagust, William J; Frisoni, Giovanni B

2015-01-01

The aim of this study was to compare the performance and power of the best-established diagnostic biological markers as outcome measures for clinical trials in patients with mild cognitive impairment (MCI). Magnetic resonance imaging, F-18 fluorodeoxyglucose positron emission tomography markers, and Alzheimer's Disease Assessment Scale-cognitive subscale were compared in terms of effect size and statistical power over different follow-up periods in 2 MCI groups, selected from Alzheimer's Disease Neuroimaging Initiative data set based on cerebrospinal fluid (abnormal cerebrospinal fluid Aβ1-42 concentration-ABETA+) or magnetic resonance imaging evidence of Alzheimer disease (positivity to hippocampal atrophy-HIPPO+). Biomarkers progression was modeled through mixed effect models. Scaled slope was chosen as measure of effect size. Biomarkers power was estimated using simulation algorithms. Seventy-four ABETA+ and 51 HIPPO+ MCI patients were included in the study. Imaging biomarkers of neurodegeneration, especially MR measurements, showed highest performance. For all biomarkers and both MCI groups, power increased with increasing follow-up time, irrespective of biomarker assessment frequency. These findings provide information about biomarker enrichment and outcome measurements that could be employed to reduce MCI patient samples and treatment duration in future clinical trials.

Prosthetists' perceptions and use of outcome measures in clinical practice: Long-term effects of focused continuing education.

PubMed

Hafner, Brian J; Spaulding, Susan E; Salem, Rana; Morgan, Sara J; Gaunaurd, Ignacio; Gailey, Robert

2017-06-01

Continuing education is intended to facilitate clinicians' skills and knowledge in areas of practice, such as administration and interpretation of outcome measures. To evaluate the long-term effect of continuing education on prosthetists' confidence in administering outcome measures and their perceptions of outcomes measurement in clinical practice. Pretest-posttest survey methods. A total of 66 prosthetists were surveyed before, immediately after, and 2 years after outcomes measurement education and training. Prosthetists were grouped as routine or non-routine outcome measures users, based on experience reported prior to training. On average, prosthetists were just as confident administering measures 1-2 years after continuing education as they were immediately after continuing education. In all, 20% of prosthetists, initially classified as non-routine users, were subsequently classified as routine users at follow-up. Routine and non-routine users' opinions differed on whether outcome measures contributed to efficient patient evaluations (79.3% and 32.4%, respectively). Both routine and non-routine users reported challenges integrating outcome measures into normal clinical routines (20.7% and 45.9%, respectively). Continuing education had a long-term impact on prosthetists' confidence in administering outcome measures and may influence their clinical practices. However, remaining barriers to using standardized measures need to be addressed to keep practitioners current with evolving practice expectations. Clinical relevance Continuing education (CE) had a significant long-term impact on prosthetists' confidence in administering outcome measures and influenced their clinical practices. In all, approximately 20% of prosthetists, who previously were non-routine outcome measure users, became routine users after CE. There remains a need to develop strategies to integrate outcome measurement into routine clinical practice.

Statistical controversies in clinical research: requiem for the 3 + 3 design for phase I trials.

PubMed

Paoletti, X; Ezzalfani, M; Le Tourneau, C

2015-09-01

More than 95% of published phase I trials have used the 3 + 3 design to identify the dose to be recommended for phase II trials. However, the statistical community agrees on the limitations of the 3 + 3 design compared with model-based approaches. Moreover, the mechanisms of action of targeted agents strongly challenge the hypothesis that the maximum tolerated dose constitutes the optimal dose, and more outcomes including clinical and biological activity increasingly need to be taken into account to identify the optimal dose. We review key elements from clinical publications and from the statistical literature to show that the 3 + 3 design lacks the necessary flexibility to address the challenges of targeted agents. The design issues raised by expansion cohorts, new definitions of dose-limiting toxicity and trials of combinations are not easily addressed by the 3 + 3 design or its extensions. Alternative statistical proposals have been developed to make a better use of the complex data generated by phase I trials. Their applications require a close collaboration between all actors of early phase clinical trials. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Reliability and concurrent validity of the iPhone® Compass application to measure thoracic rotation range of motion (ROM) in healthy participants

PubMed Central

Schram, Ben; Cox, Alistair J.; Anderson, Sarah L.; Keogh, Justin

2018-01-01

Background Several water-based sports (swimming, surfing and stand up paddle boarding) require adequate thoracic mobility (specifically rotation) in order to perform the appropriate activity requirements. The measurement of thoracic spine rotation is problematic for clinicians due to a lack of convenient and reliable measurement techniques. More recently, smartphones have been used to quantify movement in various joints in the body; however, there appears to be a paucity of research using smartphones to assess thoracic spine movement. Therefore, the aim of this study is to determine the reliability (intra and inter rater) and validity of the iPhone® app (Compass) when assessing thoracic spine rotation ROM in healthy individuals. Methods A total of thirty participants were recruited for this study. Thoracic spine rotation ROM was measured using both the current clinical gold standard, a universal goniometer (UG) and the Smart Phone Compass app. Intra-rater and inter-rater reliability was determined with a Intraclass Correlation Coefficient (ICC) and associated 95% confidence intervals (CI). Validation of the Compass app in comparison to the UG was measured using Pearson’s correlation coefficient and levels of agreement were identified with Bland–Altman plots and 95% limits of agreement. Results Both the UG and Compass app measurements both had excellent reproducibility for intra-rater (ICC 0.94–0.98) and inter-rater reliability (ICC 0.72–0.89). However, the Compass app measurements had higher intra-rater reliability (ICC = 0.96 − 0.98; 95% CI [0.93–0.99]; vs. ICC = 0.94 − 0.98; 95% CI [0.88–0.99]) and inter-rater reliability (ICC = 0.87 − 0.89; 95% CI [0.74–0.95] vs. ICC = 0.72 − 0.82; 95% CI [0.21–0.94]). A strong and significant correlation was found between the UG and the Compass app, demonstrating good concurrent validity (r = 0.835, p < 0.001). Levels of agreement between the two devices were 24.8° (LoA –9.5�

Reliability and concurrent validity of the iPhone® Compass application to measure thoracic rotation range of motion (ROM) in healthy participants.

PubMed

Furness, James; Schram, Ben; Cox, Alistair J; Anderson, Sarah L; Keogh, Justin

2018-01-01

Several water-based sports (swimming, surfing and stand up paddle boarding) require adequate thoracic mobility (specifically rotation) in order to perform the appropriate activity requirements. The measurement of thoracic spine rotation is problematic for clinicians due to a lack of convenient and reliable measurement techniques. More recently, smartphones have been used to quantify movement in various joints in the body; however, there appears to be a paucity of research using smartphones to assess thoracic spine movement. Therefore, the aim of this study is to determine the reliability (intra and inter rater) and validity of the iPhone ® app (Compass) when assessing thoracic spine rotation ROM in healthy individuals. A total of thirty participants were recruited for this study. Thoracic spine rotation ROM was measured using both the current clinical gold standard, a universal goniometer (UG) and the Smart Phone Compass app. Intra-rater and inter-rater reliability was determined with a Intraclass Correlation Coefficient (ICC) and associated 95% confidence intervals (CI). Validation of the Compass app in comparison to the UG was measured using Pearson's correlation coefficient and levels of agreement were identified with Bland-Altman plots and 95% limits of agreement. Both the UG and Compass app measurements both had excellent reproducibility for intra-rater (ICC 0.94-0.98) and inter-rater reliability (ICC 0.72-0.89). However, the Compass app measurements had higher intra-rater reliability ( ICC  = 0.96 - 0.98; 95% CI [0.93-0.99]; vs. ICC  = 0.94 - 0.98; 95% CI [0.88-0.99]) and inter-rater reliability ( ICC  = 0.87 - 0.89; 95% CI [0.74-0.95] vs. ICC  = 0.72 - 0.82; 95% CI [0.21-0.94]). A strong and significant correlation was found between the UG and the Compass app, demonstrating good concurrent validity ( r  = 0.835, p  < 0.001). Levels of agreement between the two devices were 24.8° (LoA -9.5°, +15.3°). The UG was found to consistently

Taking the iPad's Measure

ERIC Educational Resources Information Center

Raths, David

2012-01-01

Soon after the iPad's release in 2010, several universities decided to issue the devices to all incoming freshmen. At the time, critics scoffed at the moves as little more than marketing gimmicks designed to attract students. In truth, few of the schools required instructors to design curriculum around the iPad or had specific plans to measure…

Relationship between HRV measurements and demographic and clinical variables in a population of patients with atrial fibrillation.

PubMed

Buttà, Carmelo; Tuttolomondo, Antonino; Casuccio, Alessandra; Petrantoni, Rossella; Miceli, Giuseppe; Cuttitta, Francesco; Pinto, Antonio

2016-12-01

Little is known about the role of HRV in atrial fibrillation (AF) patients. Aim of our study was to assess the relationship between HRV measurements and demographic and clinical variables in a population of 274 AF patients. We selected all consecutive patients with persistent/permanent AF among whom had performed a Holter ECG in our Department from April 2010 to April 2015. Time-domain analysis of HRV was evaluated. Demographic and clinical variables were collected for each patient. At multivariable logistic regression, a higher pNN50 was associated with ACE inhibitors/ARBs (p = 0.016) and a lower pNN50 with obesity (p = 0.037) and higher heart rate (HR) (p < 0.0005). A higher RMSSD was associated with ACE inhibitors/ARBs (p = 0.001), digitalis (p < 0.0005) and beta-blockers (p = 0.002) and a lower RMSSD with a higher HR (p < 0.0005). A higher SDNN i was associated with ACE inhibitors/ARBs (p < 0.0005), digitalis (p < 0.0005) and beta-blockers (p = 0.002) and a lower SDNN i with dysthyroidism (p = 0.048) and higher HR (p < 0.0005). A higher SDANN was associated with non-dihydropyiridine calcium-channel-blockers (p = 0.002) and ACE inhibitors/ARBs (p = 0.002) and a lower SDANN with hypertension (p = 0.034), obesity (p = 0.011), stroke (p = 0.031), pneumonia (p = 0.005) and higher HR (p < 0.0005). A higher SDNN was associated with ACE inhibitors/ARBs (p < 0.0005), digitalis (p < 0.0005) and beta-blockers (p = 0.022) and a lower SDNN with obesity (p = 0.012), pneumonia (p = 0.049) and higher HR (p < 0.0005). Our study showed that, in AF patients, there is a direct relationship between some clinical variables and HRV measurements; as for patients with sinus rhythm, even in AF patients this relationship seemed to reflect the autonomic nervous system activity.

Treatment and Prognosis of Isolated Local Relapse after Stereotactic Body Radiotherapy for Clinical Stage I Non-Small-Cell Lung Cancer: Importance of Salvage Surgery.

PubMed

Hamaji, Masatsugu; Chen, Fengshi; Matsuo, Yukinori; Ueki, Nami; Hiraoka, Masahiro; Date, Hiroshi

2015-11-01

Many efforts have been made to detect local relapse (LR) in the follow-up after stereotactic body radiotherapy (SBRT) for non-small-cell lung cancer (NSCLC) although limited data are available on its treatment and prognosis. We aimed to characterize treatment options and clarify long-term outcomes of isolated LR after SBRT for patients with clinical stage I NSCLC. We reviewed our institutional database in search of patients with isolated LR after SBRT for clinical stage I NSCLC at our institution between 1999 and 2013. Patient characteristics were compared with Mann-Whitney U test, χ2 test, or Fisher's exact test as appropriate. Survival outcomes were estimated with Kaplan-Meier method. Potential prognostic factors were investigated using Cox proportional hazard model. Of 308 patients undergoing SBRT for clinical stage I NSCLC, 49 patients were identified to have isolated LR. Twelve patients underwent salvage surgery, none underwent radiotherapy, and eight patients received chemotherapy, whereas 29 patients received best supportive care. No patient characteristic except operability was significantly related with patient selection for LR treatments. Five-year overall survival (OS) rate of the whole cohort was 47.9% from SBRT and 25.7% from LR. Salvage surgery was associated with improved OS after LR (p = 0.014), and 5-year OS for patients undergoing salvage surgery was 79.5% from LR. It was confirmed that our patient selection for salvage surgery for isolated LR was associated with favorable survival outcomes. Operability based on multidisciplinary conferences, rather than measurable patient characteristics, is essential for appropriate patient selection for salvage surgery.

Prevalence of melanocortin receptor 4 (MC4R) V103I gene variant and its association with obesity among the Kampar Health Clinic cohort, Perak, Malaysia.

PubMed

Chua, H N; Fan, S H; Say, Y H

2012-04-01

This study investigated the prevalence of the Melanocortin receptor 4 (MC4R) V1031 gene variant and its association with obesity among a cohort of 254 patients (101 males; 118 obese) attending the Kampar Health Clinic. Genotyping revealed the mutated I allele frequency of 0.02, no homozygous mutated (II), and similar distribution of V and I alleles across BMI groups, genders and ethnic groups. No significant difference was found for the means of anthropometric measurements between alleles. Prevalence of this gene variant among the Malaysian cohort was similar with previous populations (2-4% of mutated allele carrier), but was not associated with obesity.

Electromagnetic semi-implantable hearing device: phase I. Clinical trials.

PubMed

McGee, T M; Kartush, J M; Heide, J C; Bojrab, D I; Clemis, J D; Kulick, K C

1991-04-01

Conventional hearing aids have improved significantly in recent years; however, amplification of sound within the external auditory canal creates a number of intrinsic problems, including acoustic feedback and the need for a tight ear mold to increase usable gain. Nonacoustic alternatives which could obviate these encumbrances have not become practical due to inefficient coupling (piezoelectric techniques) or unfeasible power requirements (electromagnetic techniques). Recent technical advances, however, prompted a major clinical investigation of a new electromagnetic, semi-implantable hearing device. This study presents the details of clinical phase I, in which an electromagnetic driver was coupled with a target magnet temporarily affixed onto the lateral surface of the malleus of six hearing aid users with sensorineural losses. The results indicate that the electromagnetic hearing device provides sufficient gain and output characteristics to benefit individuals with sensorineural hearing loss. Significant improvements compared to conventional hearing aids were noted in pure-tone testing and, to a lesser degree, in speech discrimination. Subjective responses were quite favorable, indicating that the electromagnetic hearing device 1. produces no acoustic feedback; 2. works well in noisy environments; and 3. provides a more quiet, natural sound than patients' conventional hearing aids. These favorable results led to phase II of the project, in which patients with surgically amendable mixed hearing losses were implanted with the target magnet incorporated within a hydroxyapatite ossicular prosthesis. The results of this second-stage investigation were also encouraging and will be reported separately.

Apoptosis of keratinocytes and serum DNase I activity in patients with cutaneous lupus erythematosus: relationship with clinical and immunoserological parameters.

PubMed

Skiljevic, D; Bonaci-Nikolic, B; Brasanac, D; Nikolic, M

2017-03-01

Dysregulation of apoptosis has an important role in the induction of autoimmunity. To evaluate the influence of keratinocyte apoptosis and deoxyribonuclease I (DNase I) activity on the clinical and immunoserological parameters of cutaneous lupus erythematosus (CLE). We studied 69 CLE patients (39 with discoid LE (DLE), 12 with subacute CLE (SCLE), 12 with acute and 6 with intermittent CLE). Thirty of sixty-nine patients fulfilled criteria for systemic LE (SLE). Apoptotic index (AI) was evaluated immunohistochemically in lesional and non-lesional, photoprotected skin. Serum DNase I activity, antichromatin and anti-ENA antibodies were measured by ELISA. Disease activity was determined by SLEDAI-2K, SLICC/ACR, CLASI and RCLASI. AI in lesions was higher than in non-lesional skin (P < 0.001). There was no difference in AI between CLE and SLE patients. Patients with SCLE had higher lesional AI than patients with DLE (P < 0.05). We found a positive correlation between the lesional AI with CLASI A (P < 0.05) and RCLASI D (P < 0.05). CLE and SLE patients had significantly lower DNase I activity than healthy controls (P < 0.001). Patients with normal DNase I activity and low AI had significantly lower CLASI A than patients with decreased DNase I activity and/or elevated AI (P < 0.05). Increased keratinocyte apoptosis characterizes lesions of all CLE forms, especially of SCLE. AI correlates with CLE markers of acute and chronic inflammation. Normal level of apoptosis and DNase I activity simultaneously reduce the level of acute inflammation in CLE. Serum DNase I activity and AI might be important biomarkers in the evaluation of CLE patients. © 2016 European Academy of Dermatology and Venereology.

Automated population of an i2b2 clinical data warehouse from an openEHR-based data repository.

PubMed

Haarbrandt, Birger; Tute, Erik; Marschollek, Michael

2016-10-01

Detailed Clinical Model (DCM) approaches have recently seen wider adoption. More specifically, openEHR-based application systems are now used in production in several countries, serving diverse fields of application such as health information exchange, clinical registries and electronic medical record systems. However, approaches to efficiently provide openEHR data to researchers for secondary use have not yet been investigated or established. We developed an approach to automatically load openEHR data instances into the open source clinical data warehouse i2b2. We evaluated query capabilities and the performance of this approach in the context of the Hanover Medical School Translational Research Framework (HaMSTR), an openEHR-based data repository. Automated creation of i2b2 ontologies from archetypes and templates and the integration of openEHR data instances from 903 patients of a paediatric intensive care unit has been achieved. In total, it took an average of ∼2527s to create 2.311.624 facts from 141.917 XML documents. Using the imported data, we conducted sample queries to compare the performance with two openEHR systems and to investigate if this representation of data is feasible to support cohort identification and record level data extraction. We found the automated population of an i2b2 clinical data warehouse to be a feasible approach to make openEHR data instances available for secondary use. Such an approach can facilitate timely provision of clinical data to researchers. It complements analytics based on the Archetype Query Language by allowing querying on both, legacy clinical data sources and openEHR data instances at the same time and by providing an easy-to-use query interface. However, due to different levels of expressiveness in the data models, not all semantics could be preserved during the ETL process. Copyright © 2016 Elsevier Inc. All rights reserved.

Linking quality indicators to clinical trials: an automated approach

PubMed Central

Coiera, Enrico; Choong, Miew Keen; Tsafnat, Guy; Hibbert, Peter; Runciman, William B.

2017-01-01

Abstract Objective Quality improvement of health care requires robust measurable indicators to track performance. However identifying which indicators are supported by strong clinical evidence, typically from clinical trials, is often laborious. This study tests a novel method for automatically linking indicators to clinical trial registrations. Design A set of 522 quality of care indicators for 22 common conditions drawn from the CareTrack study were automatically mapped to outcome measures reported in 13 971 trials from ClinicalTrials.gov. Intervention Text mining methods extracted phrases mentioning indicators and outcome phrases, and these were compared using the Levenshtein edit distance ratio to measure similarity. Main Outcome Measure Number of care indicators that mapped to outcome measures in clinical trials. Results While only 13% of the 522 CareTrack indicators were thought to have Level I or II evidence behind them, 353 (68%) could be directly linked to randomized controlled trials. Within these 522, 50 of 70 (71%) Level I and II evidence-based indicators, and 268 of 370 (72%) Level V (consensus-based) indicators could be linked to evidence. Of the indicators known to have evidence behind them, only 5.7% (4 of 70) were mentioned in the trial reports but were missed by our method. Conclusions We automatically linked indicators to clinical trial registrations with high precision. Whilst the majority of quality indicators studied could be directly linked to research evidence, a small portion could not and these require closer scrutiny. It is feasible to support the process of indicator development using automated methods to identify research evidence. PMID:28651340

Photoinhibition of Photosystems I and II Using Chlorophyll Fluorescence Measurements

ERIC Educational Resources Information Center

Quiles, Maria Jose

2005-01-01

In this study the photoinhibition of photosystems (PS) I and II caused by exposure to high intensity light in oat ("Avena sativa," var Prevision) is measured by the emission of chlorophyll fluorescence in intact leaves adapted to darkness. The maximal quantum yield of PS II was lower in plants grown under high light intensity than in plants grown…

Webcam delivery of the Lidcombe program for early stuttering: a phase I clinical trial.

PubMed

O'Brian, Sue; Smith, Kylie; Onslow, Mark

2014-06-01

The Lidcombe Program is an operant treatment for early stuttering shown with meta-analysis to have a favorable odds ratio. However, many clients are unable to access the treatment because of distance and lifestyle factors. In this Phase I trial, we explored the potential efficacy, practicality, and viability of an Internet webcam Lidcombe Program service delivery model. Participants were 3 preschool children who stuttered and their parents, all of whom received assessment and treatment using webcam in their homes with no clinic attendance. At 6 months post-Stage 1 completion, all children were stuttering below 1.0% syllables stuttered. The webcam intervention was acceptable to the parents and appeared to be practical and viable, with only occasional audiovisual problems. At present, there is no reason to doubt that a webcam-delivered Lidcombe Program will be shown with clinical trials to have comparable efficacy with the clinic version. Webcam-delivered Lidcombe Program intervention is potentially efficacious, is practical and viable, and requires further exploration with comparative clinical trials and a qualitative study of parent and caregiver experiences.

Measurement of funny current (I(f)) channel mRNA in human atrial tissue: correlation with left atrial filling pressure and atrial fibrillation.

PubMed

Lai, L P; Su, M J; Lin, J L; Tsai, C H; Lin, F Y; Chen, Y S; Hwang, J J; Huang, S K; Tseng, Y Z; Lien, W P

1999-07-01

The funny current (I(f)) contributes to phase IV spontaneous depolarization in cardiac pacemaker tissue. Enhanced I(f) activity in myocardial tissue may lead to increased automaticity and therefore tachyarrhythmia. We measured the amount of I(f) activity in the messenger ribonucleic acid (mRNA) in human atrial tissue and correlated the mRNA amount to left atrial filling pressure and atrial fibrillation (AF). A total of 34 patients undergoing open heart surgery were included (15 men and 19 women, aged 55+/-10 years). Atrial tissue was obtained from the right atrial free wall, the right atrial appendage, the left atrial free wall, and the left atrial appendage, respectively. The mRNA amount of the I(f) channel was measured by reverse transcription polymerase chain reaction and was normalized to the mRNA levels of glyceraldehyde 3-phosphate dehydrogenase. We found that the I(f) channel mRNA was present at all the atrial sampling sites. A higher left atrial filling pressure, an indicator of congestive heart failure, was associated with a higher I(f) mRNA level (r2 = 0.446, P < 0.01 by linear regression). We also found that the mRNA amount was significantly higher in patients with AF than in patients without AF (1.68+/-0.49 vs 1.27+/-0.43; P < 0.05). Age, sex, right atrial filling pressure, left atrial dimension, and left ventricular ejection fraction had no significant effect on the mRNA level. The mRNA of the I(f) channel is present in the free-wall area and appendage area from both atria. Increased left atrial filling pressure and clinical AF are associated with increased I(f) mRNA level.

Infant lung function tests as endpoints in the ISIS multicenter clinical trial in cystic fibrosis.

PubMed

Davis, Stephanie D; Ratjen, Felix; Brumback, Lyndia C; Johnson, Robin C; Filbrun, Amy G; Kerby, Gwendolyn S; Panitch, Howard B; Donaldson, Scott H; Rosenfeld, Margaret

2016-05-01

The Infant Study of Inhaled Saline (ISIS) in CF was the first multicenter clinical trial to utilize infant pulmonary function tests (iPFTs) as an endpoint. Secondary analysis of ISIS data was conducted in order to assess feasibility of iPFT measures and their associations with respiratory symptoms. Standard deviations were calculated to aid in power calculations for future clinical trials. Seventy-three participants enrolled, 70 returned for the final visit; 62 (89%) and 45 (64%) had acceptable paired functional residual capacity (FRC) and raised volume measurements, respectively. Mean baseline FEV0.5, FEF75 and FRC z-scores were 0.3 (SD: 1.2), -0.2 (SD: 2.0), and 1.8 (SD: 2.0). iPFTs are not appropriate primary endpoints for multicenter clinical trials due to challenges of obtaining acceptable data and near-normal average raised volume measurements. Raised volume measures have potential to serve as secondary endpoints in future clinical CF trials. Copyright © 2015 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

'I'm still a hustler': entrepreneurial responses to precarity by participants in phase I clinical trials.

PubMed

Monahan, Torin; Fisher, Jill A

This paper questions the implications of entrepreneurial responses to conditions of employment precarity by 'healthy volunteers' in phase I clinical trials in the United States. Such individuals are typically serial participants who often identify as professional volunteers and seek out drug studies as their primary source of income. Drawing on extensive qualitative research, this paper illustrates how healthy volunteers selectively import the identity of 'hustler' from the street environment and reposition it as connoting a set of valuable creative skills that give them a competitive edge over other participants. An entrepreneurial ethos allows them to view personal sacrifice and exposure to potentially dangerous drugs as smart investments leading to financially stable futures. These discursive moves normalize extractive, and at times dehumanizing, labour relations that offload expenses and risks to workers.

Efficacy Outcome Measures for Procedural Sedation Clinical Trials in Adults: An ACTTION Systematic Review.

PubMed

Williams, Mark R; McKeown, Andrew; Dexter, Franklin; Miner, James R; Sessler, Daniel I; Vargo, John; Turk, Dennis C; Dworkin, Robert H

2016-01-01

Successful procedural sedation represents a spectrum of patient- and clinician-related goals. The absence of a gold-standard measure of the efficacy of procedural sedation has led to a variety of outcomes being used in clinical trials, with the consequent lack of consistency among measures, making comparisons among trials and meta-analyses challenging. We evaluated which existing measures have undergone psychometric analysis in a procedural sedation setting and whether the validity of any of these measures support their use across the range of procedures for which sedation is indicated. Numerous measures were found to have been used in clinical research on procedural sedation across a wide range of procedures. However, reliability and validity have been evaluated for only a limited number of sedation scales, observer-rated pain/discomfort scales, and satisfaction measures in only a few categories of procedures. Typically, studies only examined 1 or 2 aspects of scale validity. The results are likely unique to the specific clinical settings they were tested in. Certain scales, for example, those requiring motor stimulation, are unsuitable to evaluate sedation for procedures where movement is prohibited (e.g., magnetic resonance imaging scans). Further work is required to evaluate existing measures for procedures for which they were not developed. Depending on the outcomes of these efforts, it might ultimately be necessary to consider measures of sedation efficacy to be procedure specific.

Evaluating iPhone recordings for acoustic voice assessment.

PubMed

Lin, Emily; Hornibrook, Jeremy; Ormond, Tika

2012-01-01

This study examined the viability of using iPhone recordings for acoustic measurements of voice quality. Acoustic measures were compared between voice signals simultaneously recorded from 11 normal speakers (6 females and 5 males) through an iPhone (model A1303, Apple, USA) and a comparison recording system. Comparisons were also conducted between the pre- and post-operative voices recorded from 10 voice patients (4 females and 6 males) through the iPhone. Participants aged between 27 and 79 years. Measures from iPhone and comparison signals were found to be highly correlated. Findings of the effects of vowel type on the selected measures were consistent between the two recording systems and congruent with previous findings. Analysis of the patient data revealed that a selection of acoustic measures, such as vowel space area and voice perturbation measures, consistently demonstrated a positive change following phonosurgery. The present findings indicated that the iPhone device tested was useful for tracking voice changes for clinical management. Preliminary findings regarding factors such as gender and type of pathology suggest that intra-subject, instead of norm-referenced, comparisons of acoustic measures would be more useful in monitoring the progression of a voice disorder or tracking the treatment effect. Copyright © 2012 S. Karger AG, Basel.

Impact of imaging measurements on response assessment in glioblastoma clinical trials

PubMed Central

Reardon, David A.; Ballman, Karla V.; Buckner, Jan C.; Chang, Susan M.; Ellingson, Benjamin M.

2014-01-01

We provide historical and scientific guidance on imaging response assessment for incorporation into clinical trials to stimulate effective and expedited drug development for recurrent glioblastoma by addressing 3 fundamental questions: (i) What is the current validation status of imaging response assessment, and when are we confident assessing response using today's technology? (ii) What imaging technology and/or response assessment paradigms can be validated and implemented soon, and how will these technologies provide benefit? (iii) Which imaging technologies need extensive testing, and how can they be prospectively validated? Assessment of T1 +/− contrast, T2/FLAIR, diffusion, and perfusion-imaging sequences are routine and provide important insight into underlying tumor activity. Nonetheless, utility of these data within and across patients, as well as across institutions, are limited by challenges in quantifying measurements accurately and lack of consistent and standardized image acquisition parameters. Currently, there exists a critical need to generate guidelines optimizing and standardizing MRI sequences for neuro-oncology patients. Additionally, more accurate differentiation of confounding factors (pseudoprogression or pseudoresponse) may be valuable. Although promising, diffusion MRI, perfusion MRI, MR spectroscopy, and amino acid PET require extensive standardization and validation. Finally, additional techniques to enhance response assessment, such as digital T1 subtraction maps, warrant further investigation. PMID:25313236

Inertial Sensor Measurements of Upper-Limb Kinematics in Stroke Patients in Clinic and Home Environment.

PubMed

Held, Jeremia P O; Klaassen, Bart; Eenhoorn, Albert; van Beijnum, Bert-Jan F; Buurke, Jaap H; Veltink, Peter H; Luft, Andreas R

2018-01-01

Upper-limb impairments in stroke patients are usually measured in clinical setting using standard clinical assessment. In addition, kinematic analysis using opto-electronic systems has been used in the laboratory setting to map arm recovery. Such kinematic measurements cannot capture the actual function of the upper extremity in daily life. The aim of this study is to longitudinally explore the complementarity of post-stroke upper-limb recovery measured by standard clinical assessments and daily-life recorded kinematics. The study was designed as an observational, single-group study to evaluate rehabilitation progress in a clinical and home environment, with a full-body sensor system in stroke patients. Kinematic data were recorded with a full-body motion capture suit during clinical assessment and self-directed activities of daily living. The measurements were performed at three time points for 3 h: (1) 2 weeks before discharge of the rehabilitation clinic, (2) right after discharge, and (3) 4 weeks after discharge. The kinematic analysis of reaching movements uses the position and orientation of each body segment to derive the joint angles. Newly developed metrics for classifying activity and quality of upper extremity movement were applied. The data of four stroke patients (three mildly impaired, one sever impaired) were included in this study. The arm motor function assessment improved during the inpatient rehabilitation, but declined in the first 4 weeks after discharge. A change in the data (kinematics and new metrics) from the daily-life recording was seen in in all patients. Despite this worsening patients increased the number of reaches they performed during daily life in their home environment. It is feasible to measure arm kinematics using Inertial Measurement Unit sensors during daily life in stroke patients at the different stages of rehabilitation. Our results from the daily-life recordings complemented the data from the clinical assessments and

The Noninvasive Measurement of X-Ray Tube Potential.

NASA Astrophysics Data System (ADS)

Ranallo, Frank Nunzio

In this thesis I briefly describe the design of clinical x-ray imaging systems and also the various methods of measuring x-ray tube potential, both invasive and noninvasive. I also discuss the meaning and usage of the quantities tube potential (kV) and peak tube potential (kVp) with reference to x-ray systems used in medical imaging. I propose that there exist several quantities which describe different important aspects of the tube potential as a function of time. These quantities are measurable and can be well defined. I have developed a list of definitions of these quantities along with suggested names and symbols. I describe the development and physical principles of a superior noninvasive method of tube potential measurement along with the instrumentation used to implement this method. This thesis research resulted in the development of several commercial kVp test devices (or "kVp Meters") for which the actual measurement procedure is simple, rapid, and reliable compared to other methods, invasive or noninvasive. These kVp test devices provide measurements with a high level of accuracy and reliability over a wide range of test conditions. They provide results which are more reliable and clinically meaningful than many other, more primary and invasive methods. The errors inherent in these new kVp test devices were investigated and methods to minimize them are discussed.

Waardenburg syndrome: clinical differentiation between types I and II.

PubMed

Pardono, Eliete; van Bever, Yolande; van den Ende, Jenneke; Havrenne, Poti C; Iughetti, Paula; Maestrelli, Sylvia R P; Costa F, Orozimbo; Richieri-Costa, Antonio; Frota-Pessoa, Oswaldo; Otto, Paulo A

2003-03-15

Here we present the results of a study performed on 59 patients affected by Waardenburg syndrome (WS), 30 with the I variant, 21 having the type II, and 8 of them being isolated cases without telecanthus. These patients belong to 37 families; the main contributions and conclusions are based on the detailed study of 25 of these families, examined using standard procedures. All patients were examined as to the presence of eight cardinal signs important for the diagnosis of the condition; from each patient, from many of his/her normal relatives, and from a control sample of 300 normal individuals stratified by age and sex, 23 different craniofacial measurements were obtained. We also estimated, using our own data as well those collected from the literature, the frequencies of the cardinal signs, based on a total sample of 461 affected individuals with WSI and 121 with WSII. In order to originate discriminant functions to separate individuals affected by one of the two variants, both metric (from craniofacial measurements) as well as categoric data (based on the frequencies of the cardinal signs or symptoms) were used. Discriminant analysis based on the frequency of the eight cardinal signs can improve the separation of WSI patients without telecanthus from those presenting the variant II. We present also a Table with the conditional probabilities favoring the diagnosis of WSI for suspect subjects without telecanthus and any combination of the other seven signs/symptoms. The discriminant function based on the four ocular measurements (inner and outer intercanthal, interpupillary, and inferior lacrymal distances), on the other side, perfectly classifies patients affected by one of the variants of WS, the same taking place when the average values of the W index of all affected individuals per family are used. The discriminant function based solely in the individual W index values of patients correctly classifies 93% of WSII subjects, but only 60% of the patients with the

Wear measurement of dental tissues and materials in clinical studies: A systematic review.

PubMed

Wulfman, C; Koenig, V; Mainjot, A K

2018-06-01

This study aims to systematically review the different methods used for wear measurement of dental tissues and materials in clinical studies, their relevance and reliability in terms of accuracy and precision, and the performance of the different steps of the workflow taken independently. An exhaustive search of clinical studies related to wear of dental tissues and materials reporting a quantitative measurement method was conducted. MedLine, Embase, Scopus, Cochrane Library and Web of Science databases were used. Prospective studies, pilot studies and case series (>10 patients), as long as they contained a description of wear measurement methodology. Only studies published after 1995 were considered. After duplicates' removal, 495 studies were identified, and 41 remained for quantitative analysis. Thirty-four described wear-measurement protocols, using digital profilometry and superimposition, whereas 7 used alternative protocols. A specific form was designed to analyze the risk of bias. The methods were described in terms of material analyzed; study design; device used for surface acquisition; matching software details and settings; type of analysis (vertical height-loss measurement vs volume loss measurement); type of area investigated (entire occlusal area or selective areas); and results. There is a need of standardization of clinical wear measurement. Current methods exhibit accuracy, which is not sufficient to monitor wear of restorative materials and tooth tissues. Their performance could be improved, notably limiting the use of replicas, using standardized calibration procedures and positive controls, optimizing the settings of scanners and matching softwares, and taking into account unusable data. Copyright © 2018 The Academy of Dental Materials. Published by Elsevier Inc. All rights reserved.

Comparison of methodologies for calculating quality measures based on administrative data versus clinical data from an electronic health record system: implications for performance measures.

PubMed

Tang, Paul C; Ralston, Mary; Arrigotti, Michelle Fernandez; Qureshi, Lubna; Graham, Justin

2007-01-01

New reimbursement policies and pay-for-performance programs to reward providers for producing better outcomes are proliferating. Although electronic health record (EHR) systems could provide essential clinical data upon which to base quality measures, most metrics in use were derived from administrative claims data. We compared commonly used quality measures calculated from administrative data to those derived from clinical data in an EHR based on a random sample of 125 charts of Medicare patients with diabetes. Using standard definitions based on administrative data (which require two visits with an encounter diagnosis of diabetes during the measurement period), only 75% of diabetics determined by manually reviewing the EHR (the gold standard) were identified. In contrast, 97% of diabetics were identified using coded information in the EHR. The discrepancies in identified patients resulted in statistically significant differences in the quality measures for frequency of HbA1c testing, control of blood pressure, frequency of testing for urine protein, and frequency of eye exams for diabetic patients. New development of standardized quality measures should shift from claims-based measures to clinically based measures that can be derived from coded information in an EHR. Using data from EHRs will also leverage their clinical content without adding burden to the care process.

Measurement of atomic Stark parameters of many Mn I and Fe I spectral lines using GMAW process

NASA Astrophysics Data System (ADS)

Zielinska, S.; Pellerin, S.; Dzierzega, K.; Valensi, F.; Musiol, K.; Briand, F.

2010-11-01

The particular character of the welding arc working in pure argon, whose emission spectrum consists of many spectral lines strongly broadened by the Stark effect, has allowed measurement, sometimes for the first time, of the Stark parameters of 15 Mn I and 10 Fe I atomic spectral lines, and determination of the dependence on temperature of normalized Stark broadening in Ne = 1023 m-3 of the 542.4 nm atomic iron line. These results show that special properties of the MIG plasma may be useful in this domain because composition of the wire-electrode may be easily adapted to the needs of an experiment.

Correlations of Clinical and Laboratory Measures of Balance in Older Men and Women: The MOBILIZE Boston Study

PubMed Central

Nguyen, Uyen-Sa D.T.; Kiel, Douglas P.; Li, Wenjun; Galica, Andrew M.; Kang, Hyun Gu; Casey, Virginia A.; Hannan, Marian T.

2012-01-01

Objective Impaired balance is associated with falls in older adults. However, there is no accepted gold standard on how balance should be measured. Few studies have examined measures of postural sway and clinical balance concurrently in large samples of community-dwelling older adults. We examined the associations among four types of measures of laboratory- and clinic-based balance in a large population-based cohort of older adults. Methods We evaluated balance measures in the MOBILIZE Boston Study (276 men, 489 women, 64–97 years). Measures included: (1) laboratory-based anteroposterior (AP) path length and average sway speed, mediolateral (ML) average sway and root-mean-square, and area of ellipse postural sway; (2) Short Physical Performance Battery (SPPB); (3) Berg Balance Scale; and (4) one-leg stand. Spearman Rank Correlation Coefficients (r) were assessed among the balance measures. Results Area of ellipse sway was highly correlated with the ML sway measures (r >0.9, p < 0.0001), and sway speed was highly correlated with AP sway (r=0.97, p < 0.0001). The Berg Balance Scale was highly correlated with SPPB (r=0.7, p<0.001), and one-leg stand (r=0.8, p<0.001). Correlations between the laboratory- and clinic-based balance measures were low but statistically significant (0.2 < r < 0.3, p<0.0001). Conclusion Clinic-based balance measures, and laboratory-based measures comparing area of ellipse with ML sways or sway speed with AP sway, are highly correlated. Clinic- with laboratory-based measures are less correlated. As both laboratory- and clinic-based measures inform balance in older adults but are not highly correlated with each other, future work should investigate the differences. PMID:22745045

Fear of birth in clinical practice: A structured review of current measurement tools.

PubMed

Richens, Yana; Smith, Debbie M; Lavender, Dame Tina

2018-06-01

To identify measurement tools which screen for the presence of fear of birth (FOB) and to determine the most effective tool/s for use in clinical practice. Fear or birth (FOB) is internationally recognised as a cause for increasing concern, despite a lack of consensus on a definition or optimal measure of assessment. There is a wide array of FOB measurement tools, however little clarity on which tool should be used to screen for FOB in clinical practice. This review explores the use of tools that are used to screen for FOB and discusses the perceived effectiveness of such tools. A structured literature review was undertaken. Electronic databases were searched in July 2017 and manuscripts reviewed for quality. The review included 46 papers. The majority of studies were undertaken in Scandinavia (n = 29) and a range of tools were used to measure FOB. The most widely used tool was the Wijma Delivery Expectancy Experience Questionnaire' (W-DEQ). Inconsistencies were found in the way this tool was used, including variations in assessment cut-off points, implementation and use across a range of cultural settings and women of varying gestations. Moreover, the tool may be too lengthy to use in clinical practice. The Fear of Birth Scale (FOBS) has been shown to be as effective as W-DEQ but has the advantage of being short and easy to administer. The inconsistencies in tools reflect the difficulties in defining FOB. A clear consensus definition of FOB would aid comparisons across practice and research. The W-DEQ is not used in clinical practice; this may be due to its length and complexity. The FOBS is likely to be a more versatile tool that can be used in clinical practice. Copyright © 2018 Elsevier B.V. All rights reserved.

Biomechanical and clinical factors related to stage I posterior tibial tendon dysfunction.

PubMed

Rabbito, Melissa; Pohl, Michael B; Humble, Neil; Ferber, Reed

2011-10-01

Case control. To investigate differences in arch height, ankle muscle strength, and biomechanical factors in individuals with stage I posterior tibial tendon dysfunction (PTTD) in comparison to healthy individuals. PTTD is a progressive condition, so early recognition and treatment are essential to help delay or reverse the progression. However, no previous studies have investigated stage I PTTD, and no single study has measured static anatomical structure, muscle strength, and gait mechanics in this population. Twelve individuals with stage I PTTD and 12 healthy, age- and gender-matched control subjects, who were engaged in running-related activities, participated in this study. Measurements of arch height index, maximum voluntary ankle invertor muscle strength, and 3-dimensional rearfoot and medial longitudinal arch kinematics during walking were obtained. The runners with PTTD demonstrated significantly lower seated arch height index (P = .02) and greater (P = .03) and prolonged (P = .05) peak rearfoot eversion angle during gait, compared to the healthy runners. No differences were found in standing arch height index values (P = .28), arch rigidity index (P = .06), ankle invertor strength (P = .49), or peak medial longitudinal arch values (P = .49) between groups. The increased foot pronation is hypothesized to place greater strain on the posterior tibialis muscle, which may partially explain the progressive nature of this condition.

Uncertainty in Measurement: Procedures for Determining Uncertainty With Application to Clinical Laboratory Calculations.

PubMed

Frenkel, Robert B; Farrance, Ian

2018-01-01

The "Guide to the Expression of Uncertainty in Measurement" (GUM) is the foundational document of metrology. Its recommendations apply to all areas of metrology including metrology associated with the biomedical sciences. When the output of a measurement process depends on the measurement of several inputs through a measurement equation or functional relationship, the propagation of uncertainties in the inputs to the uncertainty in the output demands a level of understanding of the differential calculus. This review is intended as an elementary guide to the differential calculus and its application to uncertainty in measurement. The review is in two parts. In Part I, Section 3, we consider the case of a single input and introduce the concepts of error and uncertainty. Next we discuss, in the following sections in Part I, such notions as derivatives and differentials, and the sensitivity of an output to errors in the input. The derivatives of functions are obtained using very elementary mathematics. The overall purpose of this review, here in Part I and subsequently in Part II, is to present the differential calculus for those in the medical sciences who wish to gain a quick but accurate understanding of the propagation of uncertainties. © 2018 Elsevier Inc. All rights reserved.

Development of clinical process measures for pediatric burn care: Understanding variation in practice patterns.

PubMed

Kazis, Lewis E; Sheridan, Robert L; Shapiro, Gabriel D; Lee, Austin F; Liang, Matthew H; Ryan, Colleen M; Schneider, Jeffrey C; Lydon, Martha; Soley-Bori, Marina; Sonis, Lily A; Dore, Emily C; Palmieri, Tina; Herndon, David; Meyer, Walter; Warner, Petra; Kagan, Richard; Stoddard, Frederick J; Murphy, Michael; Tompkins, Ronald G

2018-04-01

There has been little systematic examination of variation in pediatric burn care clinical practices and its effect on outcomes. As a first step, current clinical care processes need to be operationally defined. The highly specialized burn care units of the Shriners Hospitals for Children system present an opportunity to describe the processes of care. The aim of this study was to develop a set of process-based measures for pediatric burn care and examine adherence to them by providers in a cohort of pediatric burn patients. We conducted a systematic literature review to compile a set of process-based indicators. These measures were refined by an expert panel of burn care providers, yielding 36 process-based indicators in four clinical areas: initial evaluation and resuscitation, acute excisional surgery and critical care, psychosocial and pain control, and reconstruction and aftercare. We assessed variability in adherence to the indicators in a cohort of 1,076 children with burns at four regional pediatric burn programs in the Shriners Hospital system. The percentages of the cohort at each of the four sites were as follows: Boston, 20.8%; Cincinnati, 21.1%; Galveston, 36.0%; and Sacramento, 22.1%. The cohort included children who received care between 2006 and 2010. Adherence to the process indicators varied both across sites and by clinical area. Adherence was lowest for the clinical areas of acute excisional surgery and critical care, with a range of 35% to 48% across sites, followed by initial evaluation and resuscitation (range, 34%-60%). In contrast, the clinical areas of psychosocial and pain control and reconstruction and aftercare had relatively high adherence across sites, with ranges of 62% to 93% and 71% to 87%, respectively. Of the 36 process indicators, 89% differed significantly in adherence between clinical sites (p < 0.05). Acute excisional surgery and critical care exhibited the most variability. The development of this set of process

Reliable clinical serum analysis with reusable electrochemical sensor: Toward point-of-care measurement of the antipsychotic medication clozapine.

PubMed

Kang, Mijeong; Kim, Eunkyoung; Winkler, Thomas E; Banis, George; Liu, Yi; Kitchen, Christopher A; Kelly, Deanna L; Ghodssi, Reza; Payne, Gregory F

2017-09-15

Clozapine is one of the most promising medications for managing schizophrenia but it is under-utilized because of the challenges of maintaining serum levels in a safe therapeutic range (1-3μM). Timely measurement of serum clozapine levels has been identified as a barrier to the broader use of clozapine, which is however challenging due to the complexity of serum samples. We demonstrate a robust and reusable electrochemical sensor with graphene-chitosan composite for rapidly measuring serum levels of clozapine. Our electrochemical measurements in clinical serum from clozapine-treated and clozapine-untreated schizophrenia groups are well correlated to centralized laboratory analysis for the readily detected uric acid and for the clozapine which is present at 100-fold lower concentration. The benefits of our electrochemical measurement approach for serum clozapine monitoring are: (i) rapid measurement (≈20min) without serum pretreatment; (ii) appropriate selectivity and sensitivity (limit of detection 0.7μM); (iii) reusability of an electrode over several weeks; and (iv) rapid reliability testing to detect common error-causing problems. This simple and rapid electrochemical approach for serum clozapine measurements should provide clinicians with the timely point-of-care information required to adjust dosages and personalize the management of schizophrenia. Copyright © 2017 Elsevier B.V. All rights reserved.

Reliability and validity of an iPhone(®) application for the measurement of lumbar spine flexion and extension range of motion.

PubMed

Pourahmadi, Mohammad Reza; Taghipour, Morteza; Jannati, Elham; Mohseni-Bandpei, Mohammad Ali; Ebrahimi Takamjani, Ismail; Rajabzadeh, Fatemeh

2016-01-01

Measurement of lumbar spine range of motion (ROM) is often considered to be an essential component of lumbar spine physiotherapy and orthopedic assessment. The measurement can be carried out through various instruments such as inclinometers, goniometers, and etc. Recent smartphones have been equipped with accelerometers and magnetometers, which, through specific software applications (apps) can be used for inclinometric functions. The main purpose was to investigate the reliability and validity of an iPhone(®) app (TiltMeter(©) -advanced level and inclinometer) for measuring standing lumbar spine flexion-extension ROM in asymptomatic subjects. A cross-sectional study was carried out. This study was conducted in a physiotherapy clinic located at School of Rehabilitation Sciences, Iran University of Medical Science and Health Services, Tehran, Iran. A convenience sample of 30 asymptomatic adults (15 males; 15 females; age range = 18-55 years) was recruited between August 2015 and December 2015. Following a 2-minute warm-up, the subjects were asked to stand in a relaxed position and their skin was marked at the T12-L1 and S1-S2 spinal levels. From this position, they were asked to perform maximum lumbar flexion followed by maximum lumbar extension with their knees straight. Two blinded raters each used an inclinometer and the iPhone (®) app to measure lumbar spine flexion-extension ROM. A third rater read the measured angles. To calculate total lumbar spine flexion-extension ROM, the measurement from S1-S2 was subtracted from T12-L1. The second (2 hours later) and third (48 hours later) sessions were carried out in the same manner as the first session. All of the measurements were conducted 3 times and the mean value of 3 repetitions for each measurement was used for analysis. Intraclass correlation coefficient (ICC) models (3, k) and (2, k) were used to determine the intra-rater and inter-rater reliability, respectively. The Pearson correlation coefficients were

The Association of Clinic-Based Mobility Tasks and Measures of Community Performance and Risk.

PubMed

Callisaya, Michele L; Verghese, Joe

2018-01-10

Gait speed is recognized as an important predictor of adverse outcomes in older people. However, it is unknown whether other more complex mobility tasks are better predictors of such outcomes. To examine a range of clinic-based mobility tests and determine which were most strongly associated with measures of community performance and risk (CP&R). Cross-sectional study. Central Control Mobility and Aging Study, Westchester County, New York. Aged ≥65 years (n = 424). Clinic-based mobility measures included gait speed measured during normal and dual-task conditions, the Floor Maze Immediate and Delay tasks, and stair ascending and descending. CP&R measures were self-reported by the use of standardized questionnaires and classified into measures of performance (distance walked, travel outside one's home [life space], activities of daily living, and participation in cognitive leisure activities) or risk (balance confidence, fear of falling, and past falls). Linear and logistic regression were used to examine associations between the clinic-based mobility measures and CP&R measures adjusting for covariates. The mean age of the sample was 77.8 (SD 6.4) years, and 55.2% (n = 234) were female. In final models, faster normal walking speed was most strongly associated with 5 of the 7 community measures (greater distance walked, greater life space, better activities of daily living function, higher balance confidence, and less fear of falling; all P < .05). More complex tasks (walking while talking and maze immediate) were associated with cognitive leisure activity (P < .05), and ascending stairs was the only measure associated with a history of falls (P < .05). Normal walking speed is a simple and inexpensive clinic-based mobility test that is associated with a wide range of CP&R measures. In addition, poorer performance ascending stairs may assist in identifying those at risk of falls. Poorer performance in more complex mobility tasks (walking while talking and maze

Effectiveness of a Therapeutic Summer Camp for Children with ADHD: Phase I Clinical Intervention Trial

ERIC Educational Resources Information Center

Hantson, Julie; Wang, Pan Pan; Grizenko-Vida, Michael; Ter-Stepanian, Marina; Harvey, William; Joober, Ridha; Grizenko, Natalie

2012-01-01

Objective: The objective of this study was to evaluate the effectiveness of a 2-week therapeutic summer day camp for children with ADHD, which included a social skills training program and parent psychoeducation and training program. This was an open-label, nonrandomized Phase I Clinical Intervention Trial. Method: Parents completed the Weiss…

The iSCREEN Electronic Diabetes Dashboard: A Tool to Improve Knowledge and Implementation of Pediatric Clinical Practice Guidelines.

PubMed

Zahanova, Stacy; Tsouka, Alexandra; Palmert, Mark R; Mahmud, Farid H

2017-12-01

Clinical practice guidelines (CPG) provide evidence-based recommendations for patient care but may not be optimally applied in clinical settings. As a pilot study, we evaluated the impact of a computerized, point-of-care decision support system (CDSS) on guideline knowledge and adherence in our diabetes clinic. iSCREEN, a CDSS, integrated with a province-wide electronic health record, was designed based on the Canadian Diabetes Association 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. Evaluation data were gathered by retrospective chart review and clinician questionnaire prior to and after implementation of iSCREEN. Records of patients with type 1 diabetes, 14 to 18 years of age, were assessed for appropriate screening for complications and comorbidities. To assess guideline adherence, 50 charts were reviewed at 2 time periods (25 before and 25 after launch of iSCREEN). Results revealed improved frequency of appropriate screening for diabetic nephropathy (p=0.03) and retinopathy (p=0.04), accompanied by a decrease in under- and overscreening for these outcomes. To assess guideline knowledge, 58 surveys were collected (31 prior to and 27 after the launch of iSCREEN) from care providers in the field of pediatric diabetes. There was a trend toward improved guideline knowledge in all team members (p=0.06). Implementation of a de novo CDSS was associated with improved rates of appropriate screening for diabetes-related complications. A trend toward improvement in health professionals' knowledge of the guidelines was also observed. Evaluation of this point-of-care computerized decision support tool suggests that it may facilitate diabetes care by optimizing complication screening and CPG knowledge, with the potential for broader implementation. Copyright © 2017 Diabetes Canada. Published by Elsevier Inc. All rights reserved.

Using the Clinical Interview and Curriculum Based Measurement to Examine Risk Levels

ERIC Educational Resources Information Center

Ginsburg, Herbert P.; Lee, Young-Sun; Pappas, Sandra

2016-01-01

This paper investigates the power of the computer guided clinical interview (CI) and new curriculum based measurement (CBM) measures to identify and help children at risk of low mathematics achievement. We use data from large numbers of children in Kindergarten through Grade 3 to investigate the construct validity of CBM risk categories. The basic…

Beyond Ryff's scale: Comprehensive measures of eudaimonic well-being in clinical populations. A systematic review.

PubMed

Brandel, Martina; Vescovelli, Francesca; Ruini, Chiara

2017-11-01

Eudaimonic well-being that protects mental and physical health has received increasing attention. This investigation aimed to review which comprehensive instruments for measuring eudaimonic well-being were applied with clinical populations (reporting mental or physical illnesses), beyond Ryff's Psychological Well-Being Scale. Articles citing at least 1 of the measures of eudaimonic well-being identified by previous theoretical work were extracted from medical and psychological electronic databases and screened. Only investigations involving clinical populations were included and reviewed. An initial screening identified 5,065 articles using eudaimonic well-being measures, out of which only 28 articles encompassed clinical populations and could be included. Sixteen involved patients with mental disorders and 12 populations with medical conditions. In these articles, only 4 measures of eudaimonic well-being were used (Mental Health Continuum, Flourishing Scale, General Causality Orientations Scale, and Orientations to Happiness Subscales), out of the 12 currently available in literature. The Mental Health Continuum was the most used instrument, particularly in adults with depression, whose levels of eudaimonic well-being are impaired, but may be improved by specific interventions. Autonomy appeared to influence patients' motivation to treatment, both in mental and physical disorders. The need for a larger consensus regarding specific measures of eudaimonic well-being for clinical populations emerged. The importance of including assessment of positive functioning as an indicator of recovery in clinical domains is discussed. Copyright © 2017 John Wiley & Sons, Ltd.

Adapting Social Neuroscience Measures for Schizophrenia Clinical Trials, Part 3: Fathoming External Validity

PubMed Central

Olbert, Charles M.

2013-01-01

It is unknown whether measures adapted from social neuroscience linked to specific neural systems will demonstrate relationships to external variables. Four paradigms adapted from social neuroscience were administered to 173 clinically stable outpatients with schizophrenia to determine their relationships to functionally meaningful variables and to investigate their incremental validity beyond standard measures of social and nonsocial cognition. The 4 paradigms included 2 that assess perception of nonverbal social and action cues (basic biological motion and emotion in biological motion) and 2 that involve higher level inferences about self and others’ mental states (self- referential memory and empathic accuracy). Overall, social neuroscience paradigms showed significant relationships to functional capacity but weak relationships to community functioning; the paradigms also showed weak correlations to clinical symptoms. Evidence for incremental validity beyond standard measures of social and nonsocial cognition was mixed with additional predictive power shown for functional capacity but not community functioning. Of the newly adapted paradigms, the empathic accuracy task had the broadest external validity. These results underscore the difficulty of translating developments from neuroscience into clinically useful tasks with functional significance. PMID:24072806

Adapting social neuroscience measures for schizophrenia clinical trials, part 3: fathoming external validity.

PubMed

Olbert, Charles M; Penn, David L; Kern, Robert S; Lee, Junghee; Horan, William P; Reise, Steven P; Ochsner, Kevin N; Marder, Stephen R; Green, Michael F

2013-11-01

It is unknown whether measures adapted from social neuroscience linked to specific neural systems will demonstrate relationships to external variables. Four paradigms adapted from social neuroscience were administered to 173 clinically stable outpatients with schizophrenia to determine their relationships to functionally meaningful variables and to investigate their incremental validity beyond standard measures of social and nonsocial cognition. The 4 paradigms included 2 that assess perception of nonverbal social and action cues (basic biological motion and emotion in biological motion) and 2 that involve higher level inferences about self and others' mental states (self-referential memory and empathic accuracy). Overall, social neuroscience paradigms showed significant relationships to functional capacity but weak relationships to community functioning; the paradigms also showed weak correlations to clinical symptoms. Evidence for incremental validity beyond standard measures of social and nonsocial cognition was mixed with additional predictive power shown for functional capacity but not community functioning. Of the newly adapted paradigms, the empathic accuracy task had the broadest external validity. These results underscore the difficulty of translating developments from neuroscience into clinically useful tasks with functional significance.

Effect of heterophoria measurement technique on the clinical accommodative convergence to accommodation ratio.

PubMed

Escalante, Jaime Bernal; Rosenfield, Mark

2006-05-01

Measurement of the stimulus accommodative convergence to accommodation (AC/A) ratio is a standard procedure in clinical optometric practice. Typically, heterophoria is assessed at several accommodative stimulus levels, and the gradient of the vergence to accommodation function computed. A number of procedures are available for the subjective measurement of heterophoria, but it is unclear whether the use of different vergence measurement techniques will alter the obtained AC/A value. Accordingly, the current study compared AC/A ratios measured using 3 clinical subjective heterophoria tests, namely the von Graefe (VG), Maddox Rod (MR), and Modified Thorington (MT) procedures. The AC/A ratio was measured in 60 visually normal subjects between 20 and 25 years of age using each of the 3 procedures listed above. The accommodative stimulus was varied by the introduction of +/-1.00 diopter (D) spherical lenses over the distance refractive correction while subjects viewed a target at a viewing distance of 40 cm. To examine the repeatability of each procedure, the AC/A ratio was measured on 2 separate occasions for each measurement technique, with the 2 sessions being separated by at least 24 hours. Mean values of stimulus AC/A ratio measured using the VG, MR, and MT procedures were 3.47, 2.99, and 2.46Delta/D, respectively. These differences were significant (p=0.0001). In addition, the coefficient of repeatability for the 3 techniques was 2.22, 1.99, and 1.20 Delta/D, respectively. Ratios obtained using the Modified Thorington technique with +/-1.00 D lenses showed the best repeatability, whereas the poorest repeatability was found with the von Graefe technique when only +1.00 D lenses were used to vary the accommodative stimulus. Accordingly, we recommend that that Modified Thorington procedure with +/-1.00 D lenses be used to quantify heterophoria during clinical measurement of the stimulus AC/A ratio.

Measurement of cardiac troponin I in healthy lactating dairy cows using a point of care analyzer (i-STAT-1).

PubMed

Labonté, Josiane; Roy, Jean-Philippe; Dubuc, Jocelyn; Buczinski, Sébastien

2015-06-01

Cardiac troponin I (cTnI) has been shown to be an accurate predictor of myocardial injury in cattle. The point-of-care i-STAT 1 immunoassay can be used to quantify blood cTnI in cattle. However, the cTnI reference interval in whole blood of healthy early lactating dairy cows remains unknown. To determine a blood cTnI reference interval in healthy early lactating Holstein dairy cows using the analyzer i-STAT 1. Forty healthy lactating dairy Holstein cows (0-60 days in milk) were conveniently selected from four commercial dairy farms. Each selected cow was examined by a veterinarian and transthoracic echocardiography was performed. A cow-side blood cTnI dosage was measured at the same time. A bootstrap statistical analysis method using unrestricted resampling was used to determine a reference interval for blood cTnI values. Forty healthy cows were recruited in the study. Median blood cTnI was 0.02 ng/mL (minimum: 0.00, maximum: 0.05). Based on the bootstrap analysis method with 40 cases, the 95th percentile of cTnI values in healthy cows was 0.036 ng/mL (90% CI: 0.02-0.05 ng/mL). A reference interval for blood cTnI values in healthy lactating cows was determined. Further research is needed to determine whether cTnI blood values could be used to diagnose and provide a prognosis for cardiac and noncardiac diseases in lactating dairy cows. Copyright © 2015 Elsevier B.V. All rights reserved.

Insulin-Like Growth Factor-I is a Marker for the Nutritional State

PubMed Central

Hawkes, Colin P; Grimberg, Adda

2017-01-01

Measurement of the serum concentration of insulin-like growth factor-1 (IGF-I) is generally used as a screening investigation for disorders of the growth hormone (GH)/IGF-I axis in children and adolescents with short stature. IGF-I concentration is sensitive to short-term and chronic alterations in the nutritional state, and the interpretation of IGF-I measurements requires knowledge of the child’s nutritional status. In this review, we summarize the effects of nutrition on the GH/IGF-I axis, and review the clinical implications of these interactions throughout childhood, both in under-nutrition and over-nutrition. PMID:26841638

Characterizing Quasar Outflows I: Sample, Spectral Measurements

NASA Astrophysics Data System (ADS)