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

Science.gov (United States)

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

2014-09-01

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

Minimal clinically important difference in the fibromyalgia impact questionnaire.

Science.gov (United States)

Bennett, Robert M; Bushmakin, Andrew G; Cappelleri, Joseph C; Zlateva, Gergana; Sadosky, Alesia B

2009-06-01

The Fibromyalgia Impact Questionnaire (FIQ) is a disease-specific composite instrument that measures the effect of problems experienced by patients with fibromyalgia (FM). Utilization of the FIQ in measuring changes due to interventions in FM requires derivation of a clinically meaningful change for that instrument. Analyses were conducted to estimate the minimal clinically important difference (MCID), and to propose FIQ severity categories. Data from 3 similarly designed, 3-month placebo-controlled, clinical treatment trials of pregabalin 300, 450, and 600 mg/day in patients with FM were modeled to estimate the change in the mean FIQ total and stiffness items corresponding to each category on the Patient Global Impression of Change. FIQ severity categories were modeled and determined using established pain severity cutpoints as an anchor. A total of 2228 patients, mean age 49 years, 93% women, with a mean baseline FIQ total score of 62 were treated in the 3 studies. Estimated MCID on a given measure were similar across the studies. In a pooled analysis the estimated MCID (95% confidence interval) was 14% (13; 15) and for FIQ stiffness it was 13% (12; 14). In the severity analysis a FIQ total score from 0 to or= 39 to or=59 to 100 a severe effect. The analysis indicates that a 14% change in the FIQ total score is clinically relevant, and results of these analyses should enhance the clinical utility of the FIQ in research and practice.

Minimally invasive unicompartmental knee replacement: Midterm clinical outcome.

Science.gov (United States)

Tian, Shaoqi; Liu, Jiangjun; Yuan, Wanqing; Wang, Yuanhe; Ha, Chengzhi; Liu, Lun; Li, Qicai; Yang, Xu; Sun, Kang

2017-01-01

The purpose of this study was to explore the midterm clinical outcomes of unicompartmental knee replacement (UKR) for medial knee arthropathy through a minimally invasive approach (MIA). From January 2006 to June 2010, 442 consecutive patients (485 knees) were included in the study. All patients underwent MIA-UKR with the mobile bearing Oxford phrase III prosthesis. The incision was made starting 1 cm medial to the medial pole of the patella and extending distally to the tibial tubercle. Radiographic evaluations include femorotibial angle (FTA) from coronal x-rays and rectified varus deformity angle, while clinical evaluations included Knee Society Score (KSS, clinical score and function score), the Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis index and visual analog scale (VAS) for pain. Patients followed-up at 1, 3, 6, 12 months after surgery and each year thereafter. Four hundreds and two patients completed the entire follow-up, 40 patients (45 knees) were lost to follow-up. The average follow-up time was 73.0 ± 1.9 months. The mean length of the incisions was 5.0 ± 0.2 cm. The average FTA decreased from 183.6° ± 5.1° preoperatively to 174.3° ± 4.2° postoperatively, and the mean rectified varus deformity angle was 9.3° ± 1.2°. The KSS clinical score improved from 42.4 ± 2.9 to 92.9 ± 3.8, and the function score improved from 53.5 ± 3.8 to 93.5 ± 4.0. The WOMAC score improved from 47.5 ± 3.1 preoperatively to 12.3 ± 1.5 at the last evaluation. The VAS dropped from 7.8 ± 1.9 preoperatively to 1.6 ± 0.2 postoperatively. All clinical evaluations (KSS, WOMAC, VAS) were significantly different (p clinical outcomes of MIA-UKR are satisfactory in a Chinese patient population, which is a good surgical option for patients with medial arthropathy of the knee. However, longer-term follow-up studies should be performed in these patients.

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

Science.gov (United States)

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

2014-01-01

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

Minimally invasive unicompartmental knee replacement: Midterm clinical outcome.

Directory of Open Access Journals (Sweden)

Shaoqi Tian

Full Text Available The purpose of this study was to explore the midterm clinical outcomes of unicompartmental knee replacement (UKR for medial knee arthropathy through a minimally invasive approach (MIA.From January 2006 to June 2010, 442 consecutive patients (485 knees were included in the study. All patients underwent MIA-UKR with the mobile bearing Oxford phrase III prosthesis. The incision was made starting 1 cm medial to the medial pole of the patella and extending distally to the tibial tubercle. Radiographic evaluations include femorotibial angle (FTA from coronal x-rays and rectified varus deformity angle, while clinical evaluations included Knee Society Score (KSS, clinical score and function score, the Western Ontario and McMaster Universities Arthritis Index (WOMAC osteoarthritis index and visual analog scale (VAS for pain. Patients followed-up at 1, 3, 6, 12 months after surgery and each year thereafter.Four hundreds and two patients completed the entire follow-up, 40 patients (45 knees were lost to follow-up. The average follow-up time was 73.0 ± 1.9 months. The mean length of the incisions was 5.0 ± 0.2 cm. The average FTA decreased from 183.6° ± 5.1° preoperatively to 174.3° ± 4.2° postoperatively, and the mean rectified varus deformity angle was 9.3° ± 1.2°. The KSS clinical score improved from 42.4 ± 2.9 to 92.9 ± 3.8, and the function score improved from 53.5 ± 3.8 to 93.5 ± 4.0. The WOMAC score improved from 47.5 ± 3.1 preoperatively to 12.3 ± 1.5 at the last evaluation. The VAS dropped from 7.8 ± 1.9 preoperatively to 1.6 ± 0.2 postoperatively. All clinical evaluations (KSS, WOMAC, VAS were significantly different (p < 0.05 from pre and post-operative evaluations. The survival rate was 99.1% at 73 months, and the revision rate was 0.9%.The midterm clinical outcomes of MIA-UKR are satisfactory in a Chinese patient population, which is a good surgical option for patients with medial arthropathy of the knee. However, longer

Assessing the stroke-specific quality of life for outcome measurement in stroke rehabilitation: minimal detectable change and clinically important difference.

Science.gov (United States)

Lin, Keh-chung; Fu, Tiffany; Wu, Ching-yi; Hsieh, Ching-ju

2011-01-19

This study was conducted to establish the minimal detectable change (MDC) and clinically important differences (CIDs) of the physical category of the Stroke-Specific Quality of Life Scale in patients with stroke. MDC and CIDs scores were calculated from the data of 74 participants enrolled in randomized controlled trials investigating the effects of two rehabilitation programs in patients with stroke. These participants received treatments for 3 weeks and underwent clinical assessment before and after treatment. To obtain test-retest reliability for calculating MDC, another 25 patients with chronic stroke were recruited. The MDC was calculated from the standard error of measurement (SEM) to indicate a real change with 95% confidence for individual patients (MDC95). Distribution-based and anchor-based methods were adopted to triangulate the ranges of minimal CIDs. The percentage of scale width was calculated by dividing the MDC and CIDs by the total score range of each physical category. The percentage of patients exceeding MDC95 and minimal CIDs was also reported. The MDC95 of the mobility, self-care, and upper extremity (UE) function subscales were 5.9, 4.0, and 5.3 respectively. The minimal CID ranges for these 3 subscales were 1.5 to 2.4, 1.2 to 1.9, and 1.2 to 1.8. The percentage of patients exceeding MDC95 and minimal CIDs of the mobility, self-care, and UE function subscales were 9.5% to 28.4%, 6.8% to 28.4%, and 12.2% to 33.8%, respectively. The change score of an individual patient has to reach 5.9, 4.0, and 5.3 on the 3 subscales to indicate a true change. The mean change scores of a group of patients with stroke on these subscales should reach the lower bound of CID ranges of 1.5 (6.3% scale width), 1.2 (6.0% scale width), and 1.2 (6.0% scale width) to be regarded as clinically important change. This information may facilitate interpretations of patient-reported outcomes after stroke rehabilitation. Future research is warranted to validate these findings.

Of Minima and Maxima: The Social Significance of Minimal Competency Testing and the Search for Educational Excellence.

Science.gov (United States)

Ericson, David P.

1984-01-01

Explores the many meanings of the minimal competency testing movement and the more recent mobilization for educational excellence in the schools. Argues that increasing the value of the diploma by setting performance standards on minimal competency tests and by elevating academic graduation standards may strongly conflict with policies encouraging…

The Minimal Clinically Important Difference for the Mayo-Portland Adaptability Inventory.

Science.gov (United States)

Malec, James F; Kean, Jacob; Monahan, Patrick O

To determine the Minimal Clinically Important Difference (MCID) and Robust Clinically Important Difference (RCID) of the Mayo-Portland Adaptability Inventory-4 (MPAI-4) as measures of response to intervention. Retrospective analysis of existing data. Both distribution- and anchor-based methods were used to triangulate on the MCID and to identify a moderate, that is, more robust, level of change (RCID) for the MPAI-4. These were further evaluated with respect to clinical provider ratings. Data for individuals with acquired brain injury in rehabilitation programs throughout the United States in the OutcomeInfo Database (n = 3087) with 2 MPAI-4 ratings. MPAI-4, Supervision Rating Scale, Clinician Rating of Global Clinical Improvement. Initial analyses suggested 5 T-score points (5T) as the MCID and 9T as the RCID. Eighty-one percent to 87% of clinical raters considered a 5T change and 99% considered a 9T change to indicate meaningful improvement. 5T represents the MCID for the MPAI-4 and 9T, the RCID. Both values are notably less than the Reliable Change Index (RCI). While the RCI indicates change with a high level of statistical confidence, it may be insensitive to change that is considered meaningful by providers and participants as indicated by the MCID.

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

Science.gov (United States)

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

2017-12-08

The d2 Test of Attention (D2) is a commonly used measure of selective attention for patients with schizophrenia. However, its test-retest reliability and minimal detectable change (MDC) are unknown in patients with schizophrenia, limiting its utility in both clinical and research settings. The aim of the present study was to examine the test-retest reliability and MDC of the D2 in patients with schizophrenia. A rater administered the D2 on 108 patients with schizophrenia twice at a 1-month interval. Test-retest reliability was determined through the calculation of the intra-class correlation coefficient (ICC). We also carried out Bland-Altman analysis, which included a scatter plot of the differences between test and retest against their mean. Systematic biases were evaluated by use of a paired t-test. The ICCs for the D2 ranged from 0.78 to 0.94. The MDCs (MDC%) of the seven subscores were 102.3 (29.7), 19.4 (85.0), 7.2 (94.6), 21.0 (69.0), 104.0 (33.1), 105.0 (35.8), and 7.8 (47.8), which represented limited-to-acceptable random measurement error. Trends in the Bland-Altman plots of the omissions (E1), commissions (E2), and errors (E) were noted, presenting that the data had heteroscedasticity. According to the results, the D2 had good test-retest reliability, especially in the scores of TN, TN-E, and CP. For the further research, finding a way to improve the administration procedure to reduce random measurement error would be important for the E1, E2, E, and FR subscores. © The Author(s) 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

New trends in minimally invasive urological surgery

Directory of Open Access Journals (Sweden)

Prabhakar Rajan

2009-10-01

Full Text Available Purpose: The perceived benefits of minimally-invasive surgery include less postoperative pain, shorter hospitalization, reduced morbidity and better cosmesis while maintaining diagnostic accuracy and therapeutic outcome. We review the new trends in minimally-invasive urological surgery. Materials and method: We reviewed the English language literature using the National Library of Medicine database to identify the latest technological advances in minimally-invasive surgery with particular reference to urology. Results: Amongst other advances, studies incorporating needlescopic surgery, laparoendoscopic single-site surgery , magnetic anchoring and guidance systems, natural orifice transluminal endoscopic surgery and flexible robots were considered of interest. The results from initial animal and human studies are also outlined. Conclusion: Minimally-invasive surgery continues to evolve to meet the demands of the operators and patients. Many novel technologies are still in the testing phase, whilst others have entered clinical practice. Further evaluation is required to confirm the safety and efficacy of these techniques and validate the published reports.

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

Directory of Open Access Journals (Sweden)

Antonio Giorgio

2017-11-01

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

Sacroiliac Joint Fusion: One Year Clinical and Radiographic Results Following Minimally Invasive Sacroiliac Joint Fusion Surgery.

Science.gov (United States)

Kube, Richard A; Muir, Jeffrey M

2016-01-01

Recalcitrant sacroiliac joint pain responds well to minimally-invasive surgical (MIS) techniques, although long-term radiographic and fusion data are limited. To evaluate the one-year clinical results from a cohort of patients with chronic sacroiliac (SI) joint pain unresponsive to conservative therapies who have undergone minimally invasive SI joint fusion. SI joint fusion was performed between May 2011 and January 2014. Outcomes included radiographic assessment of fusion status, leg and back pain severity via visual analog scale (VAS), disability via Oswestry Disability Index (ODI) and complication rate. Outcomes were measured at baseline and at follow-up appointments 6 months and 12 months post-procedure. Twenty minimally invasive SI joint fusion procedures were performed on 18 patients (mean age: 47.2 (14.2), mean BMI: 29.4 (5.3), 56% female). At 12 months, the overall fusion rate was 88%. Back and leg pain improved from 81.7 to 44.1 points (p<0.001) and from 63.6 to 27.7 points (p=0.001), respectively. Disability scores improved from 61.0 to 40.5 (p=0.009). Despite a cohort containing patients with multiple comorbidities and work-related injuries, eight patients (50%) achieved the minimal clinically important difference (MCID) in back pain at 12 months, with 9 (69%) patients realizing this improvement in leg pain and 8 (57%) realizing the MCID in ODI scores at 12 months. No major complications were reported. Minimally invasive SI joint surgery is a safe and effective procedure, with a high fusion rate, a satisfactory safety profile and significant improvements in pain severity and disability reported through 12 months post-procedure.

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

International Nuclear Information System (INIS)

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

2003-01-01

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

Health status measurement in COPD: the minimal clinically important difference of the clinical COPD questionnaire

Directory of Open Access Journals (Sweden)

van den Berg JWK

2006-04-01

Full Text Available Abstract Background Patient-reported outcomes (PRO questionnaires are being increasingly used in COPD clinical studies. The challenge facing investigators is to determine what change is significant, ie what is the minimal clinically important difference (MCID. This study aimed to identify the MCID for the clinical COPD questionnaire (CCQ in terms of patient referencing, criterion referencing, and by the standard error of measurement (SEM. Methods Patients were ≥40 years of age, diagnosed with COPD, had a smoking history of >10 pack-years, and were participating in a randomized, controlled clinical trial comparing intravenous and oral prednisolone in patients admitted with an acute exacerbation of COPD. The CCQ was completed on Days 1–7 and 42. A Global Rating of Change (GRC assessment was taken to establish the MCID by patient referencing. For criterion referencing, health events during a period of 1 year after Day 42 were included in this analysis. Results 210 patients were recruited, 168 completed the CCQ questionnaire on Day42. The MCID of the CCQ total score, as indicated by patient referencing in terms of the GRC, was 0.44. The MCID of the CCQ in terms of criterion referencing for the major outcomes was 0.39, and calculation of the SEM resulted in a value of 0.21. Conclusion This investigation, which is the first to determine the MCID of a PRO questionnaire via more than one approach, indicates that the MCID of the CCQ total score is 0.4.

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

Energy Technology Data Exchange (ETDEWEB)

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

2017-08-15

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

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

Directory of Open Access Journals (Sweden)

Mark D. Allen

2011-01-01

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

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

Science.gov (United States)

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

2017-09-01

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

Minimally invasive unicompartmental knee replacement: retrospective clinical and radiographic evaluation of 83 patients.

Science.gov (United States)

Bruni, Danilo; Iacono, Francesco; Russo, Alessandro; Zaffagnini, Stefano; Marcheggiani Muccioli, Giulio Maria; Bignozzi, Simone; Bragonzoni, Laura; Marcacci, Maurilio

2010-06-01

We performed a retrospective clinical and radiographic evaluation of 83 nonconsecutive patients operated in our institute between February 1996 and March 2003 with a mean follow-up of 60 months to assess the efficiency of unicompartmental knee replacement (UKR) performed with a minimally invasive technique. The aim of this study was to correlate the clinical outcome with the pre- and post-operative alignment and with implant positioning on coronal and sagittal plane. Eighty-three nonconsecutive patients (60 males, 23 females) underwent cemented UKR (De Puy Preservation Uni with all-poly tibial component), for both medial OA (80 patients) and AVN of the medial femoral condyle (3 patients). All patients were available at final follow-up evaluation, and they all presented an evident varus alignment at pre-operative clinical and radiographic evaluation. At radiographic measurement, we considered a knee with femoro-tibial angle (FTA) > 175 degrees as varus knee, 170 degrees FTA FTA 90 degrees for valgus knee and a TPA clinical result presented a mean varus deformity of 7.2 degrees (3.6 degrees-10.8 degrees) pre-operatively. According to literature, we demonstrated that a small amount of undercorrection with a small amount of residual varus deformity of 3 degrees-5 degrees is the goal to be reached in order to avoid both rapid degeneration of the nonreplaced compartment and the premature loosening of the replaced compartment. We performed a mean axial correction of 5 degrees (SD 3.9 degrees), leaving a mean axial varus deformity of 2.2 degrees in the excellent group. In our series, the group with excellent results also showed a post-operative PTS of 7 degrees (2.4 degrees-11.6 degrees), while mean pre-operative PTS was 6.5 degrees (2.7 degrees-10.3 degrees). In this study, results have shown that minimally invasive UKR producing a small amount of varus undercorrection in selected patients with medial tibio-femoral osteoarthritis or moderate avascular necrosis of the

The minimal ice water caloric test compared with established vestibular caloric test procedures.

Science.gov (United States)

Schmäl, Frank; Lübben, Björn; Weiberg, Kerstin; Stoll, Wolfgang

2005-01-01

Caloric testing of the vestibular labyrinth is usually performed by classical caloric test procedures (CCTP) using water warmed to 30 degrees C and 44 degrees C. Ice water irrigation (4 degrees C) is usually not performed, although it might be useful as a bedside test. To verify the validity of the Minimal Ice Water Caloric Test (MIWCT), comparative video-oculographic investigations were performed in 22 healthy subjects using ice water (0.5 ml, 1.0 ml, 2 ml), CCTP, and cold air (27 degrees C). Frequency, amplitude, slow phase velocity (SPV), the onset, and the duration of nystagmus were documented. After addition of three ice cubes, the temperature of conventional tap water (16 degrees C) fell within 13 min to 4 degrees C. In pessimum position the subjects demonstrated no nystagmus response. Compared to CCTP, MIWCT was associated with a significantly later onset of nystagmus and a significant prolongation of the nystagmus reaction. In contrast to air stimulation (27 degrees C), a significant Spearman's correlation was noted between MIWCT (1 and 2 ml) and established CCTP in respect of essential nystagmus parameters (frequency, amplitude and SPV). Furthermore, MIWCT (0.5 and 1 ml) showed a higher sensitivity and specificity with regard to the detection of canal paresis based on Jongkees' formula compared to stimulation with air 27 degrees C. Thus, MIWCT appears to be a suitable procedure for bedside investigation of vestibular function outside the vestibular laboratory, e.g. in a hospital ward, where bedridden patients with vertigo occasionally require vestibular testing.

Clinical study of treatment of cerebral hemorrhage: remove the intracranial hematoma with a minimal invasive procedure

International Nuclear Information System (INIS)

Ke Dongfeng; He Yunguang; Hu Wen; Lin Yang; Yang Danyang; Chen Shaokai; Ma Shaobing

2004-01-01

Objective: To study the feasibility and factors of minimal invasive intracranial hematoma removing procedure as a treatment of cerebral hemorrhage. Methods: From May, 2000 to September, 2003, 33 patients with intracerebral hemorrhage underwent minimal invasive intracranial hematoma removing procedure and from May, 1997 to September, 2000, 27 patients with cerebral hemorrhage received conservative treatments. Two groups were compared and analyzed. The quantity of hemorrhage and the indication of procedure were also studied. Results: State of an illness has no significant difference between the two groups (P<0.05). The rate of recovery were higher in the group undergoing the procedure (57.6%) than in the control group (14.8%) (P<0.05). The rate of handicap were lower in the procedure group (24.0%) than in the control group (60.0%) (P<0.05). The mortality were also lower in the procedure group (24.2%) than in the control group (63.0%) (P<0.01). In the control group no patient with a hematoma larger than 70 ml survived. In the procedure group patients with hematoma larger than 70 ml had less chance of survival than the other patients (P<0.01). The mortality rate were respectively 50%, 5.6%, 33.3% when the procedure was done in super early, early, delayed stage. The mortality rate was higher in the super early stage than in early stage (P<0.05). Conclusion: The minimal invasive intracranial hematoma removing procedure has a better clinical outcome than the conservative treatment. The procedure reduces obviously mortality rate and increase the quality of survival. Multiple puncturing and draining or craniotomy are recommended to remove huge hematoma. The earlier treatment brings better clinical effects. This technique is simple, less invasive and provides good clinical outcome, which is worth recommendation

Statistical Primer for Athletic Trainers: The Essentials of Understanding Measures of Reliability and Minimal Important Change.

Science.gov (United States)

Riemann, Bryan L; Lininger, Monica R

2018-01-01

  To describe the concepts of measurement reliability and minimal important change.   All measurements have some magnitude of error. Because clinical practice involves measurement, clinicians need to understand measurement reliability. The reliability of an instrument is integral in determining if a change in patient status is meaningful.   Measurement reliability is the extent to which a test result is consistent and free of error. Three perspectives of reliability-relative reliability, systematic bias, and absolute reliability-are often reported. However, absolute reliability statistics, such as the minimal detectable difference, are most relevant to clinicians because they provide an expected error estimate. The minimal important difference is the smallest change in a treatment outcome that the patient would identify as important.   Clinicians should use absolute reliability characteristics, preferably the minimal detectable difference, to determine the extent of error around a patient's measurement. The minimal detectable difference, coupled with an appropriately estimated minimal important difference, can assist the practitioner in identifying clinically meaningful changes in patients.

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

Science.gov (United States)

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

2018-05-02

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

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

Science.gov (United States)

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

2015-01-01

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

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

Directory of Open Access Journals (Sweden)

Hye Mi Yoo

2015-05-01

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

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

Directory of Open Access Journals (Sweden)

Bin Chet Toh

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

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

Science.gov (United States)

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

2007-11-30

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

Consensus guidelines on plasma cell myeloma minimal residual disease analysis and reporting.

Science.gov (United States)

Arroz, Maria; Came, Neil; Lin, Pei; Chen, Weina; Yuan, Constance; Lagoo, Anand; Monreal, Mariela; de Tute, Ruth; Vergilio, Jo-Anne; Rawstron, Andy C; Paiva, Bruno

2016-01-01

Major heterogeneity between laboratories in flow cytometry (FC) minimal residual disease (MRD) testing in multiple myeloma (MM) must be overcome. Cytometry societies such as the International Clinical Cytometry Society and the European Society for Clinical Cell Analysis recognize a strong need to establish minimally acceptable requirements and recommendations to perform such complex testing. A group of 11 flow cytometrists currently performing FC testing in MM using different instrumentation, panel designs (≥ 6-color) and analysis software compared the procedures between their respective laboratories and reviewed the literature to propose a consensus guideline on flow-MRD analysis and reporting in MM. Consensus guidelines support i) the use of minimum of five initial gating parameters (CD38, CD138, CD45, forward, and sideward light scatter) within the same aliquot for accurate identification of the total plasma cell compartment; ii) the analysis of potentially aberrant phenotypic markers and to report the antigen expression pattern on neoplastic plasma cells as being reduced, normal or increased, when compared to a normal reference plasma cell immunophenotype (obtained using the same instrument and parameters); and iii) the percentage of total bone marrow plasma cells plus the percentages of both normal and neoplastic plasma cells within the total bone marrow plasma cell compartment, and over total bone marrow cells. Consensus guidelines on minimal current and future MRD analyses should target a lower limit of detection of 0.001%, and ideally a limit of quantification of 0.001%, which requires at least 3 × 10(6) and 5 × 10(6) bone marrow cells to be measured, respectively. © 2015 International Clinical Cytometry Society.

Clinical implications of using the arm motor ability test in stroke rehabilitation.

Science.gov (United States)

O'Dell, Michael W; Kim, Grace; Finnen, Lisa Rivera; Polistena, Caitlin

2011-05-01

To identify all published studies using the Arm Motor Ability Test (AMAT), a standardized, laboratory-based measure for selected upper extremity activities of daily living (ADLs); and to summarize its current uses and provide recommendations for its future use. An Ovid online search was performed using the terms "Arm Motor Ability Test" and "AMAT." The reference lists of all articles obtained were reviewed for additional studies not appearing in the literature search. In addition, the original manual for the use and administration of the AMAT was reviewed. All studies examining the psychometric properties of the AMAT or using the AMAT as an outcome measure were identified. Articles simply mentioning the AMAT without providing data and case reports or abstracts (other than those addressing a specific aspect of the scale of interest) were excluded. Studies were reviewed by the primary author. No formal system of quality review was used. The AMAT has been used as an outcome measure in stroke rehabilitation research examining upper extremity robotics, functional electrical stimulation, and cortical stimulation. The most recent version contains 10 ADL tasks, each of which is composed of 1 to 3 subtasks. Of the 3 domains originally proposed, only the "functional ability" domain is routinely assessed. Psychometric studies have demonstrated good reliability and at least reasonable construct validity. The instrument's sensitivity to change over time is less well established, and no recommendation can be made regarding a minimal clinically important difference. We recommend that the 10-item version of the AMAT and assessment of only the functional ability domain be adopted as standard going forward. Further research should include examination of sensitivity over time, minimal clinically important change, reliability and validity in the mid and lower range of scores, and in neurologic diagnoses other than stroke. Copyright © 2011 American Congress of Rehabilitation Medicine

Defining patient-based minimal clinically important effect sizes: a study in palliative radiotherapy for painful unresectable pelvic recurrences from rectal cancer

International Nuclear Information System (INIS)

Wong, Rebecca K.S.; Gafni, Amiram; Whelan, Tim; Franssen, Edmee; Fung, Karen

2002-01-01

Purpose: To measure patient-based minimal clinically important effect sizes (minimal incremental benefit that an individual would require to accept one treatment option over another) for pain relief between two contrasting palliative radiotherapy regimens for painful pelvic recurrences from rectal cancer. Methods and Materials: Forty-three patients with a history of cancer pain without prior pelvic radiotherapy participated in decision aid-facilitated trade-off exercises. The clinical scenario and treatment options of a 5-day vs. a 20-day course of radiotherapy were described. The duration of pain relief for the 20-day regimen was increased until the respondents' preferences switched to the 20-day regimen. The exercises were repeated for different probabilities of benefit and pain intensity at the time of decision making. Results: When the probability of pain relief was unchanged, the median switch point for the duration of pain relief was 6.7 and 7.2 months for severe and mild pain, respectively. The cumulative percentage frequency curve for the switch points approximated a sigmoid distribution. Conclusion: Determining the minimal clinically important effect sizes for symptom relief for palliative therapies is feasible. This type of information can be used to incorporate patient values into clinical trial designs. Modification of this method can be used to improve our understanding of shared (physician and patient) decision making

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

Science.gov (United States)

Wade, Christopher H; Wilfond, Benjamin S

2006-11-15

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

Survey of clinical infant lung function testing practices.

Science.gov (United States)

Peterson-Carmichael, Stacey L; Rosenfeld, Margaret; Ascher, Simon B; Hornik, Christoph P; Arets, H G M; Davis, Stephanie D; Hall, Graham L

2014-02-01

Data supporting the clinical use of infant lung function (ILF) tests are limited making the interpretation of clinical ILF measures difficult. To evaluate current ILF testing practices and to survey users regarding the indications, limitations and perceived clinical benefits of ILF testing. We created a 26-item survey hosted on the European Respiratory Society (ERS) website between January and May 2010. Notifications were sent to members of the ERS, American Thoracic Society and the Asian Pacific Society of Respirology. Responses were sought from ILF laboratory directors and pediatric respirologists. The survey assessed the clinical indications, patient populations, equipment and reference data used, and perceived limitations of ILF testing. We received 148 responses with 98 respondents having ILF equipment and performing testing in a clinical capacity. Centers in North America were less likely to perform ≥50 studies/year than centers in Europe or other continents (13% vs. 41%). Most respondents used ILF data to either "start a new therapy" (78%) or "help decide about initiation of further diagnostic workup such as bronchoscopy, chest CT or serological testing" (69%). Factors reported as limiting clinical ILF testing were need for sedation, uncertainty regarding clinical impact of study results and time intensive nature of the study. Clinical practices associated with ILF testing vary significantly; centers that perform more studies are more likely to use the results for clinical purposes and decision making. The future of ILF testing is uncertain in the face of the limitations perceived by the survey respondents. © 2013 Wiley Periodicals, Inc.

Fault Sample Generation for Virtual Testability Demonstration Test Subject to Minimal Maintenance and Scheduled Replacement

Directory of Open Access Journals (Sweden)

Yong Zhang

2015-01-01

Full Text Available Virtual testability demonstration test brings new requirements to the fault sample generation. First, fault occurrence process is described by stochastic process theory. It is discussed that fault occurrence process subject to minimal repair is nonhomogeneous Poisson process (NHPP. Second, the interarrival time distribution function of the next fault event is proposed and three typical kinds of parameterized NHPP are discussed. Third, the procedure of fault sample generation is put forward with the assumptions of minimal maintenance and scheduled replacement. The fault modes and their occurrence time subject to specified conditions and time period can be obtained. Finally, an antenna driving subsystem in automatic pointing and tracking platform is taken as a case to illustrate the proposed method. Results indicate that both the size and structure of the fault samples generated by the proposed method are reasonable and effective. The proposed method can be applied to virtual testability demonstration test well.

Correlates of minimal dating.

Science.gov (United States)

Leck, Kira

2006-10-01

Researchers have associated minimal dating with numerous factors. The present author tested shyness, introversion, physical attractiveness, performance evaluation, anxiety, social skill, social self-esteem, and loneliness to determine the nature of their relationships with 2 measures of self-reported minimal dating in a sample of 175 college students. For women, shyness, introversion, physical attractiveness, self-rated anxiety, social self-esteem, and loneliness correlated with 1 or both measures of minimal dating. For men, physical attractiveness, observer-rated social skill, social self-esteem, and loneliness correlated with 1 or both measures of minimal dating. The patterns of relationships were not identical for the 2 indicators of minimal dating, indicating the possibility that minimal dating is not a single construct as researchers previously believed. The present author discussed implications and suggestions for future researchers.

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

Science.gov (United States)

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

2011-08-01

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

Strategies to Minimize Antibiotic Resistance

Directory of Open Access Journals (Sweden)

Sang Hee Lee

2013-09-01

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

[Clinical Tests Testing New Therapies for Stargardt Disease].

Science.gov (United States)

Kousal, B; Ďuďáková, Ľ; Hlavatá, L; Lišková, P

2016-02-01

To provide information on currently ongoing clinical trials for Stargardt disease. We have searched the clinical trial register (www.clinicaltrials.gov) for the keyword "Stargardt" and list active ongoing studies. There are currently eight registered clinical trials enrolling patients with Stargardt disease; all in phase I or II aiming at four mechanisms of action: inhibition of the production of vitamin A toxic dimers, gene therapy restoring wild type transcription of the ABCA4 gene, neuroprotection preventing retinal cells from oxidative damage, and replacement of the damaged retinal pigment epithelium using stem cell therapy. The basic prerequisite for enrolment in the vast majority of clinical trials is confirmation of the clinical diagnosis by mutational analysis. The wide variety of therapies that are registered as clinical trials for Stargardt disease significantly raises the possibility that effective treatments will be available in the near future for this currently incurable condition and that molecular genetic testing should be increasingly considered. Stargardt disease, clinical trial, ABCA4, mutation.

Comparative effectiveness of open versus minimally invasive sacroiliac joint fusion.

Science.gov (United States)

Ledonio, Charles Gt; Polly, David W; Swiontkowski, Marc F; Cummings, John T

2014-01-01

The mainstay of sacroiliac joint disruption/degenerative sacroiliitis therapy has been nonoperative management. This nonoperative management often includes a regimen of physical therapy, chiropractic treatment, therapeutic injections, and possibly radiofrequency ablation at the discretion of the treating physician. When these clinical treatments fail, sacroiliac joint fusion has been recommended as the standard treatment. Open and minimally invasive (MIS) surgical techniques are typical procedures. This study aims to compare the perioperative measures and Oswestry Disability Index (ODI) outcomes associated with each of these techniques. A comparative retrospective chart review of patients with sacroiliac joint fusion and a minimum of 1 year of follow-up was performed. Perioperative measures and ODI scores were compared using the Fisher's exact test and two nonparametric tests, ie, the Mann-Whitney U test and the Wilcoxon signed-rank test. The results are presented as percent or median with range, as appropriate. Forty-nine patients from two institutions underwent sacroiliac joint fusion between 2006 and 2012. Ten patients were excluded because of incomplete data, leaving 39 evaluable patients, of whom 22 underwent open and 17 underwent MIS sacroiliac joint fusion. The MIS group was significantly older (median age 66 [39-82] years) than the open group (median age 51 [34-74] years). Surgical time and hospital stay were significantly shorter in the MIS group than in the open group. Preoperative ODI was significantly greater in the open group (median 64 [44-78]) than in the MIS group (median 53 [14-84]). Postoperative improvement in ODI was statistically significant within and between groups, with MIS resulting in greater improvement. The open and MIS sacroiliac joint fusion techniques resulted in statistically and clinically significant improvement for patients with degenerative sacroiliitis refractory to nonoperative management. However, the number of patients

Oligonucleotide-based pharmaceuticals: Non-clinical and clinical safety signals and non-clinical testing strategies.

Science.gov (United States)

Mustonen, Enni-Kaisa; Palomäki, Tiina; Pasanen, Markku

2017-11-01

Antisense oligonucleotides, short interfering RNAs (siRNAs) and aptamers are oligonucleotide-based pharmaceuticals with a promising role in targeted therapies. Currently, five oligonucleotide-based pharmaceuticals have achieved marketing authorization in Europe or USA and many more are undergoing clinical testing. However, several safety concerns have been raised in non-clinical and clinical studies. Oligonucleotides share properties with both chemical and biological pharmaceuticals and therefore they pose challenges also from the regulatory point of view. We have analyzed the safety data of oligonucleotides and evaluated the applicability of current non-clinical toxicological guidelines for assessing the safety of oligonucleotide-based pharmaceuticals. Oligonucleotide-based pharmaceuticals display a similar toxicological profile, exerting adverse effects on liver and kidney, evoking hematological alterations, as well as causing immunostimulation and prolonging the coagulation time. It is possible to extrapolate some of these effects from non-clinical studies to humans. However, evaluation strategies for genotoxicity testing of "non-natural" oligonucleotides should be revised. Additionally, the selective use of surrogates and prediction of clinical endpoints for non-clinically observed immunostimulation is complicated by its multiple potential manifestations, demanding improvements in the testing strategies. Utilizing more relevant and mechanistic-based approaches and taking better account of species differences, could possibly improve the prediction of relevant immunological/proinflammatory effects in humans. Copyright © 2017 Elsevier Inc. All rights reserved.

Minimal clinically important improvement (MCII) and patient-acceptable symptom state (PASS) in total hip arthroplasty (THA) patients 1 year postoperatively

DEFF Research Database (Denmark)

Paulsen, Aksel; Roos, Ewa M.; Pedersen, Alma Becic

2014-01-01

-55% improvement from mean baseline PRO score and PASSs corresponded to absolute follow-up scores of 57-91% of the maximum score in THA patients 1 year after surgery. Interpretation - This study improves the interpretability of PRO scores. The different estimation approaches presented may serve as a guide......Background and purpose - The increased use of patient-reported outcomes (PROs) in orthopedics requires data on estimated minimal clinically important improvements (MCIIs) and patient-acceptable symptom states (PASSs). We wanted to find cut-points corresponding to minimal clinically important PRO...... change score and the acceptable postoperative PRO score, by estimating MCII and PASS 1 year after total hip arthroplasty (THA) for the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) and the EQ-5D. Patients and methods - THA patients from 16 different departments received 2 PROs and additional...

Responsiveness of clinical tests for people with neck pain

DEFF Research Database (Denmark)

Jørgensen, René; Ris, Inge; Juhl, Carsten

2017-01-01

of four clinical tests which are low cost and easy to perform in a clinical setting, including the craniocervical flexion test, cervical active range of movement, test for the cervical extensors and pressure pain threshold testing. METHODS: This study is a secondary analysis of data collected......BACKGROUND: Responsiveness of a clinical test is highly relevant in order to evaluate the effect of a given intervention. However, the responsiveness of clinical tests for people with neck pain has not been adequately evaluated. The objective of the present study was to examine the responsiveness...... in a previously published randomised controlled trial. Participants were randomized to either physical training, exercises and pain education combined or pain education only. Participants were tested on the clinical tests at baseline and at 4-month follow-up. An anchor-based approach using Receiver Operator...

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

Directory of Open Access Journals (Sweden)

Juan Antonio Castro Flores

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

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

DEFF Research Database (Denmark)

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

2000-01-01

influence on lower urinary tract function. More than half of the patients had urge or mixed incontinence. Most of the patients were managed with conservative treatment. Fifteen percent were referred to in-hospital treatment, with 5% to incontinence surgery. In total 44% felt cured or very much improved......Our objective was to evaluate a new concept for assessment and treatment of urinary incontinence in an open-access, interdisciplinary incontinence clinic. A standardized program for investigation and treatment of incontinence was based on minimal relevant investigations, primarily non......-surgical treatment with a limited consumption of resources ("minimal care"). This was a prospective observational study of 408 consecutive women examined and treated in the clinic. The main characteristics of the women were a high median age and a high prevalence of severe concomitant diseases with possible...

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

Energy Technology Data Exchange (ETDEWEB)

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

2009-07-01

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

The REVAMP trial to evaluate HIV resistance testing in sub-Saharan Africa: a case study in clinical trial design in resource limited settings to optimize effectiveness and cost effectiveness estimates.

Science.gov (United States)

Siedner, Mark J; Bwana, Mwebesa B; Moosa, Mahomed-Yunus S; Paul, Michelle; Pillay, Selvan; McCluskey, Suzanne; Aturinda, Isaac; Ard, Kevin; Muyindike, Winnie; Moodley, Pravikrishnen; Brijkumar, Jaysingh; Rautenberg, Tamlyn; George, Gavin; Johnson, Brent; Gandhi, Rajesh T; Sunpath, Henry; Marconi, Vincent C

2017-07-01

In sub-Saharan Africa, rates of sustained HIV virologic suppression remain below international goals. HIV resistance testing, while common in resource-rich settings, has not gained traction due to concerns about cost and sustainability. We designed a randomized clinical trial to determine the feasibility, effectiveness, and cost-effectiveness of routine HIV resistance testing in sub-Saharan Africa. We describe challenges common to intervention studies in resource-limited settings, and strategies used to address them, including: (1) optimizing generalizability and cost-effectiveness estimates to promote transition from study results to policy; (2) minimizing bias due to patient attrition; and (3) addressing ethical issues related to enrollment of pregnant women. The study randomizes people in Uganda and South Africa with virologic failure on first-line therapy to standard of care virologic monitoring or immediate resistance testing. To strengthen external validity, study procedures are conducted within publicly supported laboratory and clinical facilities using local staff. To optimize cost estimates, we collect primary data on quality of life and medical resource utilization. To minimize losses from observation, we collect locally relevant contact information, including Whatsapp account details, for field-based tracking of missing participants. Finally, pregnant women are followed with an adapted protocol which includes an increased visit frequency to minimize risk to them and their fetuses. REVAMP is a pragammatic randomized clinical trial designed to test the effectiveness and cost-effectiveness of HIV resistance testing versus standard of care in sub-Saharan Africa. We anticipate the results will directly inform HIV policy in sub-Saharan Africa to optimize care for HIV-infected patients.

Human papilloma virus testing knowledge and attitudes among women attending colposcopy clinic with ASCUS/LGSIL pap smears.

Science.gov (United States)

Le, T; Hicks, W; Menard, C; Boyd, D; Hewson, T; Hopkins, L; Kee Fung, M Fung

2004-09-01

To study women's knowledge regarding the role of human papilloma virus (HPV) in cervical intraepithelial neoplasia and their attitudes toward the integration of HPV testing as part of routine follow-up of atypical squamous cell of uncertain significance/low-grade squamous intraepithelial lesion (ASCUS/LGSIL) abnormalities. Over a 12-month period, all women attending the University of Ottawa colposcopy clinic for evaluation and follow-up of ASCUS/LGSIL Pap smears were recruited. Demographic data included age, nature of the Pap smear abnormality, gravidity, parity, occupation and education level, smoking history, previous history of abnormal smears, colposcopic examination and treatment, and current method of contraception. The women were asked to rate their level of concern over their Pap smear abnormality, from 0 (not concerned) to 10 (very concerned). Women's knowledge regarding the role of HPV in cervical intraepithelial neoplasia and the rationale behind the use of HPV testing was assessed by the clinic nurse as being minimal, moderate, or good, as defined by pre-specified criteria. Upon explanation by the nurses of the results of the recent ALTS (ASCUS/LGSIL Triage Study) trial, the women were asked to state whether they preferred to continue with regular colposcopic surveillance every 6 months, or to use the results of the HPV test, if negative, to reduce the number of colposcopy examinations to one annually. Descriptive statistics and logistic regression analysis were used to identify significant demographic factors associated with the women's preference for incorporation of HPV testing in their follow-up. All P values less than.10 were considered to be statistically significant, due to the exploratory nature of the study. Of the 100 women who participated in the study, 42% presented with ASCUS. The mean age (+/- SD) of the women was 33.63 +/- 11.25 years (range, 18-75 years); 66% were office workers with at least a community college degree, 86% reported

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

Science.gov (United States)

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

2015-09-10

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

Minimizing off-Target Mutagenesis Risks Caused by Programmable Nucleases.

Science.gov (United States)

Ishida, Kentaro; Gee, Peter; Hotta, Akitsu

2015-10-16

Programmable nucleases, such as zinc finger nucleases (ZFNs), transcription activator like effector nucleases (TALENs), and clustered regularly interspersed short palindromic repeats associated protein-9 (CRISPR-Cas9), hold tremendous potential for applications in the clinical setting to treat genetic diseases or prevent infectious diseases. However, because the accuracy of DNA recognition by these nucleases is not always perfect, off-target mutagenesis may result in undesirable adverse events in treated patients such as cellular toxicity or tumorigenesis. Therefore, designing nucleases and analyzing their activity must be carefully evaluated to minimize off-target mutagenesis. Furthermore, rigorous genomic testing will be important to ensure the integrity of nuclease modified cells. In this review, we provide an overview of available nuclease designing platforms, nuclease engineering approaches to minimize off-target activity, and methods to evaluate both on- and off-target cleavage of CRISPR-Cas9.

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

Science.gov (United States)

Evans, Barbara J.

2014-01-01

Recent recommendations by the American College of Medical Genetics and Genomics (ACMG) for reporting incidental findings present novel ethical and legal issues. This article expresses no views on the ethical aspects of these recommendations and focuses strictly on liability risks and how to minimize them. The recommendations place labs and clinicians in a new liability environment that exposes them to intentional tort lawsuits as well to traditional suits for negligence. Intentional tort suits are especially troubling because of their potential to inflict ruinous personal financial losses on individual clinicians and laboratory personnel. This article surveys this new liability landscape and describes analytical approaches for minimizing tort liabilities. To a considerable degree, liability risks can be controlled by structuring activities in ways that make future lawsuits nonviable before the suits ever arise. Proactive liability analysis is an effective tool for minimizing tort liabilities in connection with the testing and reporting activities that the ACMG recommends. PMID:24030435

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

Science.gov (United States)

Evans, Barbara J

2013-12-01

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

[Manufacture method and clinical application of minimally invasive dental implant guide template based on registration technology].

Science.gov (United States)

Lin, Zeming; He, Bingwei; Chen, Jiang; D u, Zhibin; Zheng, Jingyi; Li, Yanqin

2012-08-01

To guide doctors in precisely positioning surgical operation, a new production method of minimally invasive implant guide template was presented. The mandible of patient was scanned by CT scanner, and three-dimensional jaw bone model was constructed based on CT images data The professional dental implant software Simplant was used to simulate the plant based on the three-dimensional CT model to determine the location and depth of implants. In the same time, the dental plaster models were scanned by stereo vision system to build the oral mucosa model. Next, curvature registration technology was used to fuse the oral mucosa model and the CT model, then the designed position of implant in the oral mucosa could be determined. The minimally invasive implant guide template was designed in 3-Matic software according to the design position of implant and the oral mucosa model. Finally, the template was produced by rapid prototyping. The three-dimensional registration technology was useful to fuse the CT data and the dental plaster data, and the template was accurate that could provide the doctors a guidance in the actual planting without cut-off mucosa. The guide template which fabricated by comprehensive utilization of three-dimensional registration, Simplant simulation and rapid prototyping positioning are accurate and can achieve the minimally invasive and accuracy implant surgery, this technique is worthy of clinical use.

Optimum sample size allocation to minimize cost or maximize power for the two-sample trimmed mean test.

Science.gov (United States)

Guo, Jiin-Huarng; Luh, Wei-Ming

2009-05-01

When planning a study, sample size determination is one of the most important tasks facing the researcher. The size will depend on the purpose of the study, the cost limitations, and the nature of the data. By specifying the standard deviation ratio and/or the sample size ratio, the present study considers the problem of heterogeneous variances and non-normality for Yuen's two-group test and develops sample size formulas to minimize the total cost or maximize the power of the test. For a given power, the sample size allocation ratio can be manipulated so that the proposed formulas can minimize the total cost, the total sample size, or the sum of total sample size and total cost. On the other hand, for a given total cost, the optimum sample size allocation ratio can maximize the statistical power of the test. After the sample size is determined, the present simulation applies Yuen's test to the sample generated, and then the procedure is validated in terms of Type I errors and power. Simulation results show that the proposed formulas can control Type I errors and achieve the desired power under the various conditions specified. Finally, the implications for determining sample sizes in experimental studies and future research are discussed.

Erythema-index of clinical patch test reactions

DEFF Research Database (Denmark)

Jemec, G B; Johansen, J D

1995-01-01

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

Six-year success rates of occlusal amalgam and glass-ionomer restorations placed using three minimal intervention approaches.

NARCIS (Netherlands)

Mandari, G.J.; Frencken, J.E.F.M.; Hof, M.A. van 't

2003-01-01

The present randomised clinical trial was aimed at comparing three minimally invasive restorative treatment approaches for managing dental caries in occlusal surfaces using a non-gamma-2 amalgam and a low-viscosity glass-ionomer as the restorative material. The treatment approaches tested in

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

Directory of Open Access Journals (Sweden)

Freedberg Kenneth A

2007-11-01

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

Puzzle test: A tool for non-analytical clinical reasoning assessment.

Science.gov (United States)

Monajemi, Alireza; Yaghmaei, Minoo

2016-01-01

Most contemporary clinical reasoning tests typically assess non-automatic thinking. Therefore, a test is needed to measure automatic reasoning or pattern recognition, which has been largely neglected in clinical reasoning tests. The Puzzle Test (PT) is dedicated to assess automatic clinical reasoning in routine situations. This test has been introduced first in 2009 by Monajemi et al in the Olympiad for Medical Sciences Students.PT is an item format that has gained acceptance in medical education, but no detailed guidelines exist for this test's format, construction and scoring. In this article, a format is described and the steps to prepare and administer valid and reliable PTs are presented. PT examines a specific clinical reasoning task: Pattern recognition. PT does not replace other clinical reasoning assessment tools. However, it complements them in strategies for assessing comprehensive clinical reasoning.

Minimal Flavour Violation and Beyond

CERN Document Server

Isidori, Gino

2012-01-01

We review the formulation of the Minimal Flavour Violation (MFV) hypothesis in the quark sector, as well as some "variations on a theme" based on smaller flavour symmetry groups and/or less minimal breaking terms. We also review how these hypotheses can be tested in B decays and by means of other flavour-physics observables. The phenomenological consequences of MFV are discussed both in general terms, employing a general effective theory approach, and in the specific context of the Minimal Supersymmetric extension of the SM.

Clinical Application Of Serological Tests For Syphilis

OpenAIRE

Lawee, David

1980-01-01

This article differentiates and describes the serological tests for syphilis— antitreponemal antibody tests (TPI, FTA-ABS, TPHA), non-treponemal antigen test (VDRL)—their clinical and serological correlation, the responses to therapy and the biologically false positive syndrome.

Clinical investigation of radioallergosorbent test (RAST)

International Nuclear Information System (INIS)

Okuda, Minoru; Usami, Atsushi

1974-01-01

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

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

Science.gov (United States)

Schoenberg, Mike R; Rum, Ruba S

2017-11-01

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

Responsiveness, minimal detectable change, and minimal clinically important difference of the Nottingham Extended Activities of Daily Living Scale in patients with improved performance after stroke rehabilitation.

Science.gov (United States)

Wu, Ching-yi; Chuang, Li-ling; Lin, Keh-chung; Lee, Shin-da; Hong, Wei-hsien

2011-08-01

To determine the responsiveness, minimal detectable change (MDC), and minimal clinically important differences (MCIDs) of the Nottingham Extended Activities of Daily Living (NEADL) scale and to assess percentages of patients' change scores exceeding the MDC and MCID after stroke rehabilitation. Secondary analyses of patients who received stroke rehabilitation therapy. Medical centers. Patients with stroke (N=78). Secondary analyses of patients who received 1 of 4 rehabilitation interventions. Responsiveness (standardized response mean [SRM]), 90% confidence that a change score at this threshold or higher is true and reliable rather than measurement error (MDC(90)), and MCID on the NEADL score and percentages of patients exceeding the MDC(90) and MCID. The SRM of the total NEADL scale was 1.3. The MDC(90) value for the total NEADL scale was 4.9, whereas minima and maxima of the MCID for total NEADL score were 2.4 and 6.1 points, respectively. Percentages of patients exceeding the MDC(90) and MCID of the total NEADL score were 50.0%, 73.1%, and 32.1%, respectively. The NEADL is a responsive instrument relevant for measuring change in instrumental activities of daily living after stroke rehabilitation. A patient's change score has to reach 4.9 points on the total to indicate a true change. The mean change score of a stroke group on the total NEADL scale should achieve 6.1 points to be regarded as clinically important. Our findings are based on patients with improved NEADL performance after they received specific interventions. Future research with larger sample sizes is warranted to validate these estimates. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Clinical applications of preimplantation genetic testing.

Science.gov (United States)

Brezina, Paul R; Kutteh, William H

2015-02-19

Genetic diagnostic technologies are rapidly changing the way medicine is practiced. Preimplantation genetic testing is a well established application of genetic testing within the context of in vitro fertilization cycles. It involves obtaining a cell(s) from a developing embryo in culture, which is then subjected to genetic diagnostic analysis; the resulting information is used to guide which embryos are transferred into the uterus. The potential applications and use of this technology have increased in recent years. Experts agree that preimplantation genetic diagnosis is clinically appropriate for many known genetic disorders. However, some applications of such testing, such as preimplantation genetic screening for aneuploidy, remain controversial. Clinical data suggest that preimplantation genetic screening may be useful, but further studies are needed to quantify the size of the effect and who would benefit most. © BMJ Publishing Group Ltd 2015.

A videoscope for use in minimally invasive periodontal surgery.

Science.gov (United States)

Harrel, Stephen K; Wilson, Thomas G; Rivera-Hidalgo, Francisco

2013-09-01

Minimally invasive periodontal procedures have been reported to produce excellent clinical results. Visualization during minimally invasive procedures has traditionally been obtained by the use of surgical telescopes, surgical microscopes, glass fibre endoscopes or a combination of these devices. All of these methods for visualization are less than fully satisfactory due to problems with access, magnification and blurred imaging. A videoscope for use with minimally invasive periodontal procedures has been developed to overcome some of the difficulties that exist with current visualization approaches. This videoscope incorporates a gas shielding technology that eliminates the problems of fogging and fouling of the optics of the videoscope that has previously prevented the successful application of endoscopic visualization to periodontal surgery. In addition, as part of the gas shielding technology the videoscope also includes a moveable retractor specifically adapted for minimally invasive surgery. The clinical use of the videoscope during minimally invasive periodontal surgery is demonstrated and discussed. The videoscope with gas shielding alleviates many of the difficulties associated with visualization during minimally invasive periodontal surgery. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

Science.gov (United States)

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

2018-01-01

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

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

Directory of Open Access Journals (Sweden)

Michael G. Mauk

2018-02-01

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

Sensitivity and Specificity of Clinical and Laboratory Otolith Function Tests.

Science.gov (United States)

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

2017-10-01

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

SPORT AND EXERCISE PHYSIOLOGY TESTING Volume one: Sport Testing Volume two: Exercise and Clinical Testing

Directory of Open Access Journals (Sweden)

Edward M. Winter

2007-03-01

Full Text Available DESCRIPTION The objective of the book is to discuss the theoretical and practical aspects of physiological testing in exercise and sports which is essential to evaluate and monitor developing exercise performance for athletes and public health, and improving quality of life for patients.A board of leading sport and exercise physiologists and scientists are gathered to discuss physiological assessments that have proven validity and reliability, both in sport and health relevant issues. Incidentally, it updates the reader about the current subjects of physiological exertion testing in both research and clinical procedures. Both volumes individually cover the increasing number of available research and review publications, and theoretical explanations are supported by practical examples. A step-by-step and/or checklist method is used in appropriate sections which make the guides more user-friendly than most. PURPOSE The first volume is designed to help readers develop an understanding of the essential concepts of sport specific testing whereas the second volume aims at making the exercise and clinical specific testing comprehensible, dealing with both technical terms and the theories underlying the importance of these tests. AUDIENCE As Guidelines books of the British Association of Sport and Exercise Sciences, it will be of interest to a wide range of students, researchers and practitioners in the sport and exercise disciplines whether they work in the laboratory or in the field. FEATURES The first volume features immediate practical requirements particularly in sport testing. It is composed of five parts with detailed sub-sections in all of them. The topics of the parts are: i general principles, ii methodological issues, iii general procedures, iv sport specific procedures, v special populations.The second volume is also presented in five parts, again with sub-sections in all of them, but considering the requirements in clinical and exercise

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

Science.gov (United States)

Tian, Yonghao; Liu, Xinyu

2016-10-01

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

Model-based decision making in early clinical development: minimizing the impact of a blood pressure adverse event.

Science.gov (United States)

Stroh, Mark; Addy, Carol; Wu, Yunhui; Stoch, S Aubrey; Pourkavoos, Nazaneen; Groff, Michelle; Xu, Yang; Wagner, John; Gottesdiener, Keith; Shadle, Craig; Wang, Hong; Manser, Kimberly; Winchell, Gregory A; Stone, Julie A

2009-03-01

We describe how modeling and simulation guided program decisions following a randomized placebo-controlled single-rising oral dose first-in-man trial of compound A where an undesired transient blood pressure (BP) elevation occurred in fasted healthy young adult males. We proposed a lumped-parameter pharmacokinetic-pharmacodynamic (PK/PD) model that captured important aspects of the BP homeostasis mechanism. Four conceptual units characterized the feedback PD model: a sinusoidal BP set point, an effect compartment, a linear effect model, and a system response. To explore approaches for minimizing the BP increase, we coupled the PD model to a modified PK model to guide oral controlled-release (CR) development. The proposed PK/PD model captured the central tendency of the observed data. The simulated BP response obtained with theoretical release rate profiles suggested some amelioration of the peak BP response with CR. This triggered subsequent CR formulation development; we used actual dissolution data from these candidate CR formulations in the PK/PD model to confirm a potential benefit in the peak BP response. Though this paradigm has yet to be tested in the clinic, our model-based approach provided a common rational framework to more fully utilize the limited available information for advancing the program.

Clinical Laboratory Tests in Some Acute Exogenous Poisonings.

Science.gov (United States)

Tufkova, Stoilka G; Yankov, Ivan V; Paskaleva, Diana A

2017-09-01

There is no specific toxicological screening of clinical laboratory parameters in clinical toxicology when it comes to acute exogenous poisoning. To determine routine clinical laboratory parameters and indicators for assessment of vital functions in patients with acute intoxications. One hundred and fifty-three patients were included in the present study. They were hospitalized in the Department of Clinical Toxicology at St. George University Hospital, Plovdiv for cerebral toxicity inducing medication (n = 45), alcohol (n = 40), heroin abuse (n = 33). The controls were 35. The laboratory tests were conducted in compliance with the standards of the clinical laboratory. We used the following statistical analyses: analysis of variance (the ucriterion of normal distribution, the Student's t-test, dispersion analysis based on ANOVA) and non-parametric analysis. Based on the routine hematological parameters with statistically significant changes in three groups of poisoning are: red blood cells, hematocrit, hemoglobin (except alcohol intoxication) and leukocytes. We found statistically significant changes in serum total protein, sodium and bilirubin. The highest statistical significance is the increased activity of AST and ALT. We present a model for selection of clinical laboratory tests for severe acute poisoning with modern equipment under standardized conditions. The results of the study suggest that the clinical laboratory constellation we used can be used as a mandatory element in the diagnosis of moderate and severe intoxication with the mentioned toxic substances.

Diagnostic accuracy of the gravity stress test and clinical signs in cases of isolated supination-external rotation-type lateral malleolar fractures.

Science.gov (United States)

Nortunen, S; Flinkkilä, T; Lantto, I; Kortekangas, T; Niinimäki, J; Ohtonen, P; Pakarinen, H

2015-08-01

We prospectively assessed the diagnostic accuracy of the gravity stress test and clinical findings to evaluate the stability of the ankle mortise in patients with supination-external rotation-type fractures of the lateral malleolus without widening of the medial clear space. The cohort included 79 patients with a mean age of 44 years (16 to 82). Two surgeons assessed medial tenderness, swelling and ecchymosis and performed the external rotation (ER) stress test (a reference standard). A diagnostic radiographer performed the gravity stress test. For the gravity stress test, the positive likelihood ratio (LR) was 5.80 with a 95% confidence interval (CI) of 2.75 to 12.27, and the negative LR was 0.15 (95% CI 0.07 to 0.35), suggesting a moderate change from the pre-test probability. Medial tenderness, both alone and in combination with swelling and/or ecchymosis, indicated a small change (positive LR, 2.74 to 3.25; negative LR, 0.38 to 0.47), whereas swelling and ecchymosis indicated only minimal changes (positive LR, 1.41 to 1.65; negative LR, 0.38 to 0.47). In conclusion, when gravity stress test results are in agreement with clinical findings, the result is likely to predict stability of the ankle mortise with an accuracy equivalent to ER stress test results. When clinical examination suggests a medial-side injury, however, the gravity stress test may give a false negative result. ©2015 The British Editorial Society of Bone & Joint Surgery.

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

Science.gov (United States)

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

2014-09-07

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

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

Science.gov (United States)

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

2013-02-01

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

Validity of a new assessment rubric for a short-answer test of clinical reasoning.

Science.gov (United States)

Yeung, Euson; Kulasagarem, Kulamakan; Woods, Nicole; Dubrowski, Adam; Hodges, Brian; Carnahan, Heather

2016-07-26

The validity of high-stakes decisions derived from assessment results is of primary concern to candidates and certifying institutions in the health professions. In the field of orthopaedic manual physical therapy (OMPT), there is a dearth of documented validity evidence to support the certification process particularly for short-answer tests. To address this need, we examined the internal structure of the Case History Assessment Tool (CHAT); this is a new assessment rubric developed to appraise written responses to a short-answer test of clinical reasoning in post-graduate OMPT certification in Canada. Fourteen physical therapy students (novices) and 16 physical therapists (PT) with minimal and substantial OMPT training respectively completed a mock examination. Four pairs of examiners (n = 8) participated in appraising written responses using the CHAT. We conducted separate generalizability studies (G studies) for all participants and also by level of OMPT training. Internal consistency was calculated for test questions with more than 2 assessment items. Decision studies were also conducted to determine optimal application of the CHAT for OMPT certification. The overall reliability of CHAT scores was found to be moderate; however, reliability estimates for the novice group suggest that the scale was incapable of accommodating for scores of novices. Internal consistency estimates indicate item redundancies for several test questions which will require further investigation. Future validity studies should consider discriminating the clinical reasoning competence of OMPT trainees strictly at the post-graduate level. Although rater variance was low, the large variance attributed to error sources not incorporated in our G studies warrant further investigations into other threats to validity. Future examination of examiner stringency is also warranted.

A Prospective Randomized Study on Operative Treatment for Simple Distal Tibial Fractures-Minimally Invasive Plate Osteosynthesis Versus Minimal Open Reduction and Internal Fixation.

Science.gov (United States)

Kim, Ji Wan; Kim, Hyun Uk; Oh, Chang-Wug; Kim, Joon-Woo; Park, Ki Chul

2018-01-01

To compare the radiologic and clinical results of minimally invasive plate osteosynthesis (MIPO) and minimal open reduction and internal fixation (ORIF) for simple distal tibial fractures. Randomized prospective study. Three level 1 trauma centers. Fifty-eight patients with simple and distal tibial fractures were randomized into a MIPO group (treatment with MIPO; n = 29) or a minimal group (treatment with minimal ORIF; n = 29). These numbers were designed to define the rate of soft tissue complication; therefore, validation of superiority in union time or determination of differences in rates of delayed union was limited in this study. Simple distal tibial fractures treated with MIPO or minimal ORIF. The clinical outcome measurements included operative time, radiation exposure time, and soft tissue complications. To evaluate a patient's function, the American Orthopedic Foot and Ankle Society ankle score (AOFAS) was used. Radiologic measurements included fracture alignment, delayed union, and union time. All patients acquired bone union without any secondary intervention. The mean union time was 17.4 weeks and 16.3 weeks in the MIPO and minimal groups, respectively. There was 1 case of delayed union and 1 case of superficial infection in each group. The radiation exposure time was shorter in the minimal group than in the MIPO group. Coronal angulation showed a difference between both groups. The American Orthopedic Foot and Ankle Society ankle scores were 86.0 and 86.7 in the MIPO and minimal groups, respectively. Minimal ORIF resulted in similar outcomes, with no increased rate of soft tissue problems compared to MIPO. Both MIPO and minimal ORIF have high union rates and good functional outcomes for simple distal tibial fractures. Minimal ORIF did not result in increased rates of infection and wound dehiscence. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Comparative effectiveness of open versus minimally invasive sacroiliac joint fusion

Directory of Open Access Journals (Sweden)

Ledonio CGT

2014-06-01

Full Text Available Charles GT Ledonio,1 David W Polly Jr,1 Marc F Swiontkowski,1 John T Cummings Jr2 1Department of Orthopaedic Surgery, University of Minnesota, Twin Cities, MN, 2Community Neurosurgical Care, Indianapolis, IN, USA Background: The mainstay of sacroiliac joint disruption/degenerative sacroiliitis therapy has been nonoperative management. This nonoperative management often includes a regimen of physical therapy, chiropractic treatment, therapeutic injections, and possibly radiofrequency ablation at the discretion of the treating physician. When these clinical treatments fail, sacroiliac joint fusion has been recommended as the standard treatment. Open and minimally invasive (MIS surgical techniques are typical procedures. This study aims to compare the perioperative measures and Oswestry Disability Index (ODI outcomes associated with each of these techniques. Methods: A comparative retrospective chart review of patients with sacroiliac joint fusion and a minimum of 1 year of follow-up was performed. Perioperative measures and ODI scores were compared using the Fisher's exact test and two nonparametric tests, ie, the Mann–Whitney U test and the Wilcoxon signed-rank test. The results are presented as percent or median with range, as appropriate. Results: Forty-nine patients from two institutions underwent sacroiliac joint fusion between 2006 and 2012. Ten patients were excluded because of incomplete data, leaving 39 evaluable patients, of whom 22 underwent open and 17 underwent MIS sacroiliac joint fusion. The MIS group was significantly older (median age 66 [39–82] years than the open group (median age 51 [34–74] years. Surgical time and hospital stay were significantly shorter in the MIS group than in the open group. Preoperative ODI was significantly greater in the open group (median 64 [44–78] than in the MIS group (median 53 [14–84]. Postoperative improvement in ODI was statistically significant within and between groups, with MIS

MRD Testing in Multiple Myeloma: From a Surrogate Marker of Clinical Outcomes to an Every-Day Clinical Tool.

Science.gov (United States)

Landgren, Ola

2018-01-01

Minimal residual disease (MRD) testing in multiple myeloma is here to stay. Studies show that MRD negativity is consistently associated with longer progression-free survival (PFS). It is just a matter of time until MRD negativity will become a regulatory endpoint for drug approval. Until that can happen, more analysis will be required to define the exact details of MRD in the regulatory setting. For example, for randomized studies there is need to define the amount of improvement in MRD negativity between the experimental arm and the control arm at a given time-point for a drug to obtain regulatory accelerated approval. Such efforts are underway. For the multiple myeloma field as a whole, important tasks for the (near) coming future are as follows: (1) to conduct or finalize the expanded analysis to define the exact details of MRD in the regulatory setting, (2) to develop new and better MRD assays-both more sensitive MRD assays for bone marrow aspirates and nonbone marrow aspirate-based assays (eg, blood-based and imaging-based MRD assays), and (3) to design novel clinical studies to formally assess the effect of MRD negativity in clinical decision making. The aim with this issue of the Journal is to provide a deep and comprehensive summary of the latest MRD knowledge in the field, and to outline future directions. Copyright © 2018 Elsevier Inc. All rights reserved.

Stable-label intravenous glucose tolerance test minimal model

International Nuclear Information System (INIS)

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

1989-01-01

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

Using generalizability theory to develop clinical assessment protocols.

Science.gov (United States)

Preuss, Richard A

2013-04-01

Clinical assessment protocols must produce data that are reliable, with a clinically attainable minimal detectable change (MDC). In a reliability study, generalizability theory has 2 advantages over classical test theory. These advantages provide information that allows assessment protocols to be adjusted to match individual patient profiles. First, generalizability theory allows the user to simultaneously consider multiple sources of measurement error variance (facets). Second, it allows the user to generalize the findings of the main study across the different study facets and to recalculate the reliability and MDC based on different combinations of facet conditions. In doing so, clinical assessment protocols can be chosen based on minimizing the number of measures that must be taken to achieve a realistic MDC, using repeated measures to minimize the MDC, or simply based on the combination that best allows the clinician to monitor an individual patient's progress over a specified period of time.

Minimally invasive treatments of uterine fibroids

NARCIS (Netherlands)

Voogt, M.J.

2012-01-01

This thesis assesses clinical results and technical developments of two minimally invasive treatments for symptomatic uterine fibroids: uterine artery embolization (UAE) and magnetic resonance-guided high intensity focused ultrasound (MR-HIFU). Part I: Uterine artery embolization The results of a

Critical flicker frequency and continuous reaction times for the diagnosis of minimal hepatic encephalopathy

DEFF Research Database (Denmark)

Lauridsen, Mette Enok Munk; Jepsen, Peter; Vilstrup, Hendrik

2011-01-01

Abstract Minimal hepatic encephalopathy (MHE) is intermittently present in up to 2/3 of patients with chronic liver disease. It impairs their daily living and can be treated. However, there is no consensus on diagnostic criteria except that psychometric methods are required. We compared two easy...... appropriately to a sensory stimulus. The choice of test depends on the information needed in the clinical and scientific care and study of the patients....

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

Science.gov (United States)

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

2013-01-01

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

[Static posturography versus clinical tests in elderly people with vestibular pathology].

Science.gov (United States)

Ortuño-Cortés, Miguel A; Martín-Sanz, Eduardo; Barona-de Guzmán, Rafael

2008-01-01

Balance can be quantified by clinical tests and through instrumental studies. The objective of this paper is to determine the correlation between static posturography and 4 clinical tests of balance in elderly people with vestibular disorders and to identify its capability to discriminate the groups studied. 60 patients with vestibular disorders and 60 healthy subjects performed 4 clinical tests (one leg standing with opened eyes, Timed Up and Go, Tinetti and Berg tests) and a static posturography analysis (NedSVE/IBV system) under 4 conditions: Romberg Test, Eyes Open (REO), Romberg Test, Eyes Closed (REC), Romberg Test on Foam with Eyes Open (RFEO), and Romberg Test on Foam with Eyes Closed (RFEC). RFEO correlated best with the clinical tests and RFEC was the worst. RFEO distinguished between healthy individuals and decompensated patients. RFEO gave the best information about postural balance in the elderly. RFEC was not useful. Static posturography can be useful to distinguish vestibular compensation status.

Graded Cycling Test Combined With the Talk Test Is Responsive in Cardiac Rehabilitation

DEFF Research Database (Denmark)

Nielsen, Susanne Grøn; Vinther, Anders

2016-01-01

PURPOSE: To evaluate clinical assessment outcome of cardiac rehabilitation, a simple and reliable submaximal exercise test, not based on heart rate, is warranted. The Talk Test (TT) has been found to correlate well with the ventilatory threshold, and excellent reliability was observed for TT...... combined with the Graded Cycling Test (GCT-TT) in cardiac patients. The purpose was to investigate responsiveness of GCT-TT in cardiac rehabilitation patients. METHODS: Patients (n = 93) referred to 8 weeks of cardiac rehabilitation were included. Pre- and posttests were performed using GCT-TT. Mean test...... changes in watts (W) were compared with the standard error of measurement (SEM95) for groups and the smallest real difference (SRD) for individuals. Minimal clinically important difference was assessed by comparing patient perceived changes in physical fitness with the test changes. RESULTS...

The minimally important difference for the health assessment questionnaire in rheumatoid arthritis clinical practice is smaller than in randomized controlled trials.

Science.gov (United States)

Pope, Janet E; Khanna, Dinesh; Norrie, Deborah; Ouimet, Janine M

2009-02-01

Patient-reported outcomes are used in clinical practice and trials. We studied a large clinical practice to determine the minimally important difference (MID) estimates for (1) the Health Assessment Questionnaire-Damage Index (HAQ-DI): improvement and worsening using patient global assessment anchor; and (2) pain using a patient-reported pain anchor. Patients with rheumatoid arthritis (RA; N = 225) had clinic visits at 2 timepoints within 1 year, completed the HAQ-DI and pain visual analog scale (VAS; 0-100 mm), and answered the question, "How would you describe your overall status/overall pain since the last visit?", as much worsened, somewhat worsened, the same, somewhat improved, or much improved. If rated as somewhat improved or worsened, they were defined as the minimally changed subgroups. Eighty-three percent were women, mean age 60 years, with disease duration 11.7 +/- 10.7 years. The baseline HAQ-DI was 0.97 +/- SD 0.76, and at followup 1.0 +/- 0.77 (mean change +0.03 +/- 0.40). The baseline pain VAS was 42.3 +/- 28.8, and at followup 38.5 +/- 27.9 (mean change -2.8 +/- 25.9). The mean (SD) HAQ-DI change score was -0.09 (0.42) for somewhat improved and 0.15 (0.33) for somewhat worsened. The HAQ-DI change for somewhat/much better was -0.20 +/- 0.52, and for somewhat/much worse +0.21 +/- 0.33. For pain, somewhat improved changed by -11.9 mm on the VAS, and somewhat worsened by 6.8 mm. Estimates for HAQ-DI and pain were larger than the for no-change group, 0.03 (0.32) and -3.2 (20.9). The MID for HAQ-DI in clinical practice is smaller than it is in trials. This may have implications for observational studies and clinical care.

Minimal Dark Matter in the sky

International Nuclear Information System (INIS)

Panci, P.

2016-01-01

We discuss some theoretical and phenomenological aspects of the Minimal Dark Matter (MDM) model proposed in 2006, which is a theoretical framework highly appreciated for its minimality and yet its predictivity. We first critically review the theoretical requirements of MDM pointing out generalizations of this framework. Then we review the phenomenology of the originally proposed fermionic hyperchargeless electroweak quintuplet showing its main γ-ray tests.

Clinical and biomechanical outcome of minimal invasive and open repair of the Achilles tendon

Directory of Open Access Journals (Sweden)

Chan Alexander

2011-12-01

Full Text Available Abstract Introduction With evolutions in surgical techniques, minimally invasive surgical (MIS repair with Achillon applicator has been introduced. However, there is still a lack of literature to investigate into the clinical merits of MIS over open surgery. This study aims to investigate the correlation between clinical outcome, gait analysis and biomechanical properties comparing both surgical methods. Materials and methods A single centre retrospective review on all the consecutive operated patients between January 2004 and December 2008 was performed. Twenty-six patients (19 male and 7 female; age 40.4 ± 9.2 years had experienced a complete Achilles tendon rupture with operative repair. Nineteen of the patients, 10 MIS versus 9 open repairs (13 men with a mean age of 40.54 ± 10.43 (range 23-62 yrs and 6 women with a mean age of 45.33 ± 7.71 (range 35-57 yrs were further invited to attend a thorough clinical assessment using Holz's scale and biomechanical evaluation at a mean of 25.3 months after operation. This study utilized the Cybex II isokinetic dynamometer to assess the isokinetic peak force of plantar-flexion and dorsiflexion of both ankles. The patients were also invited to return to our Gait Laboratory for analysis. The eight-infrared camera motion capture system (VICON, UK was utilized for the acquisition of kinematic variables. Their anthropometric data was measured according to the Davis and coworkers' standard. Results The mean operative time and length of hospital stay were shorter in the MIS group. The operative time was 54.55 ± 15.15 minutes versus 68.80 ± 18.23 minutes of the MIS group and Open group respectively (p = 0.045, whereas length of stay was 3.36 ± 1.21 days versus 6.40 ± 3.70 days respectively (p = 0.039. There is statistically significant decrease (p = 0.005 in incision length in MIS group than the open surgery group, 3.23 ± 1.10 cm versus 9.64 ± 2.55 cm respectively. Both groups attained similar Holz

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

NARCIS (Netherlands)

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

2005-01-01

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

The minimally tuned minimal supersymmetric standard model

International Nuclear Information System (INIS)

Essig, Rouven; Fortin, Jean-Francois

2008-01-01

The regions in the Minimal Supersymmetric Standard Model with the minimal amount of fine-tuning of electroweak symmetry breaking are presented for general messenger scale. No a priori relations among the soft supersymmetry breaking parameters are assumed and fine-tuning is minimized with respect to all the important parameters which affect electroweak symmetry breaking. The superpartner spectra in the minimally tuned region of parameter space are quite distinctive with large stop mixing at the low scale and negative squark soft masses at the high scale. The minimal amount of tuning increases enormously for a Higgs mass beyond roughly 120 GeV

Quality of Life After Cardiac Surgery Based on the Minimal Clinically Important Difference Concept.

Science.gov (United States)

Grand, Nathalie; Bouchet, Jean Baptiste; Zufferey, Paul; Beraud, Anne Marie; Awad, Sahar; Sandri, Fabricio; Campisi, Salvator; Fuzellier, Jean François; Molliex, Serge; Vola, Marco; Morel, Jerome

2018-03-23

Health-related quality of life (HRQOL) is an increasingly important issue in assessing the consequences of any surgical or medical intervention. Our study aimed to evaluate change in HRQOL 6 months after elective cardiac surgery and to identify specific predictors of poor HRQOL. In this prospective, single-center study, HRQOL was evaluated before and 6 months after surgery using the SF-36 questionnaire and its two components: the physical component summary (PCS) and the mental component summary (MCS). We distinguished patients with worsening of HRQOL according to the minimal clinically important difference. All consecutive adult patients undergoing cardiac surgery were included. 326 patients completed the preoperative and postoperative SF-36 questionnaires and 24 patients died before completing follow-up questionnaires. Based on the definition used, clinically significant deterioration of HRQOL was observed in 93 patients (26.6%) for PCS and 99 patients (28.2%) for MCS. Renal replacement for acute renal failure and mechanical ventilation for longer than 48 hours were independent risk factors for PCS and MCS worsening or death. Although our study showed overall improvement of QOL after cardiac surgery, over a quarter of the patients manifested deterioration of HRQOL at 6 months post-surgery. The findings from this study should help clinicians to inform patients about their likely postoperative functional status and quality of life. Copyright © 2018. Published by Elsevier Inc.

The minimal non-minimal standard model

International Nuclear Information System (INIS)

Bij, J.J. van der

2006-01-01

In this Letter I discuss a class of extensions of the standard model that have a minimal number of possible parameters, but can in principle explain dark matter and inflation. It is pointed out that the so-called new minimal standard model contains a large number of parameters that can be put to zero, without affecting the renormalizability of the model. With the extra restrictions one might call it the minimal (new) non-minimal standard model (MNMSM). A few hidden discrete variables are present. It is argued that the inflaton should be higher-dimensional. Experimental consequences for the LHC and the ILC are discussed

Fall risk screening in the elderly: A comparison of the minimal chair height standing ability test and 5-repetition sit-to-stand test.

Science.gov (United States)

Reider, Nadia; Gaul, Catherine

2016-01-01

Successfully identifying older adults with a high risk of falling can be complicated, time consuming and not feasible in daily medical practice. This study compared the effectiveness of the Minimal Chair Height Standing Ability Test (MCHSAT) and 5-repetition sit-to-stand tst (5R-STS) as fall risk-screening instruments for the elderly. 167 community-dwelling older adults (mean age=83.6±7.3years) were interviewed for demographics, fall history, cognition, and mobility status. MCHSAT performance was assessed using a chair whose seat height was modifiable by increments of 5cm, starting at 47cm and lowering after each successful attempt. 5R-STS performance was assessed by recording the time it took to rise and sit back down five consecutive times from a chair of 47cm high. Operating Receiving Characteristic (ROC) curves and Area under the Curve (AUC) were calculated for each test as well as for sub-groups of participants classified based on medical comorbidities (e.g. cardiac disease/stroke, lower limb arthritis). The MCHSAT and 5R-STS were equally effective fall-risk screening instruments for the overall population (AUC (95% CI)=0.72 (0.63-0.82) and 0.73(0.64-0.81) respectively). The 5R-STS was more effective than the MCHSAT for participants suffering from lower limb arthritis (AUC (95% CI)=0.81(0.70-0.92) and 0.71(0.58-0.85) respectively) while the opposite was true for participants with a history of cardiac disease or stroke (AUC (95% CI)=0.59 (0.44-0.80) and 0.65 (0.47-0.84) respectively). Due to their simplicity and quick administration time, the MCHSAT and 5R-STS are equally suitable for implementation in clinical settings. Copyright © 2016. Published by Elsevier Ireland Ltd.

Chances of cryosurgery in the minimal invasive therapy; Chancen der Kryochirurgie in der Minimal Invasiven Therapie

Energy Technology Data Exchange (ETDEWEB)

Haensgen, H. [Institut fuer Luft- und Kaeltetechnik GmbH, Dresden (Germany). Fachbereich Klimatechnik; Binneberg, A. [Institut fuer Luft- und Kaeltetechnik GmbH, Dresden (Germany). Fachbereich Klimatechnik; Herzog, R. [Institut fuer Luft- und Kaeltetechnik GmbH, Dresden (Germany). Fachbereich Klimatechnik; Schumann, B. [Institut fuer Luft- und Kaeltetechnik GmbH, Dresden (Germany). Fachbereich Klimatechnik

1995-01-01

Object in view of the minimal invasive therapy is to substitute the traditional open and therefore invasive surgically interventions through fewer invasive surgery. Additional to preponderantly in MIT used microsurgery and laser-therapy also cryotherapy may be used. Clinical results in therapy of trigeminalneuralgia are present. Application of endoscopic cryotip are possible. (orig.)

Limited access atrial septal defect closure and the evolution of minimally invasive surgery.

Science.gov (United States)

Izzat, M B; Yim, A P; El-Zufari, M H

1998-04-01

While minimizing the "invasiveness" in general surgery has been equated with minimizing "access", what constitutes minimally invasive intra-cardiac surgery remains controversial. Many surgeons doubt the benefits of minimizing access when the need for cardiopulmonary bypass cannot be waived. Recognizing that median sternotomy itself does entail significant morbidity, we investigated the value of alternative approaches to median sternotomy using atrial septal defect closure as our investigative model. We believe that some, but not all minimal access approaches are associated with reduced postoperative morbidity and enhanced recovery. Our current strategy is to use a mini-sternotomy approach in adult patients, whereas conventional median sternotomy remains our standard approach in the pediatric population. Considerable clinical experiences coupled with documented clinical benefits are fundamental before a certain approach is adopted in routine practice.

Cost Minimization Analysis of Different Strategies of Management of Clinically Significant Scorpion Envenomation Among Pediatric Patients.

Science.gov (United States)

Sinha, Madhumita; Quan, Dan; McDonald, Fred W; Valdez, André

2016-12-01

Scorpion antivenom was recently approved for use in patients with clinically significant scorpion envenomation in the United States; no formal economic analysis on its impact on cost of management has been performed. Three different strategies of management of scorpion envenomation with systemic neurotoxic symptoms in children were compared for cost minimization from a societal perspective. In strategy I, patients were managed with supportive care only without antivenom. In strategy II, an aggressive strategy of full-dose antivenom (initial dose of 3 vials with the use of additional vials administered 1 vial at a time) was considered. In strategy III, a single-vial serial antivenom dosing strategy titrated to clinical response was considered. Clinical probabilities for the different strategies were obtained from retrospective review of medical records of patients with scorpion envenomation over a 10-year period at our institution. Baseline cost values were obtained from patient reimbursement data from our institution. In baseline analysis, strategy I of supportive care only with no antivenom was least costly at US $3466.50/patient. Strategy III of single-vial serial dosing was intermediate but less expensive than strategy II of full-dose antivenom, with an incremental cost of US $3171.08 per patient. In a 1-way sensitivity analysis, at a threshold antivenom cost of US $1577.87, strategy III of single-vial serial dosing became the least costly strategy. For children with scorpion envenomation, use of a management strategy based on serial dosing of antivenom titrated to clinical response is less costly than a strategy of initial use of full-dose antivenom.

Minimalism

CERN Document Server

Obendorf, Hartmut

2009-01-01

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

Platelet function testing: methods of assessment and clinical utility.

LENUS (Irish Health Repository)

Mylotte, Darren

2012-02-01

Platelets play a central role in the regulation of both thrombosis and haemostasis yet tests of platelet function have, until recently, been exclusively used in the diagnosis and management of bleeding disorders. Recent advances have demonstrated the clinical utility of platelet function testing in patients with cardiovascular disease. The ex vivo measurement of response to antiplatelet therapies (aspirin and clopidogrel), by an ever-increasing array of platelet function tests, is with some assays, predictive of adverse clinical events and thus, represents an emerging area of interest for both the clinician and basic scientist. This review article will describe the advantages and disadvantages of the currently available methods of measuring platelet function and discuss both the limitations and emerging data supporting the role of platelet function studies in clinical practice.

Platelet function testing: methods of assessment and clinical utility.

LENUS (Irish Health Repository)

Mylotte, Darren

2011-01-01

Platelets play a central role in the regulation of both thrombosis and haemostasis yet tests of platelet function have, until recently, been exclusively used in the diagnosis and management of bleeding disorders. Recent advances have demonstrated the clinical utility of platelet function testing in patients with cardiovascular disease. The ex vivo measurement of response to antiplatelet therapies (aspirin and clopidogrel), by an ever-increasing array of platelet function tests, is with some assays, predictive of adverse clinical events and thus, represents an emerging area of interest for both the clinician and basic scientist. This review article will describe the advantages and disadvantages of the currently available methods of measuring platelet function and discuss both the limitations and emerging data supporting the role of platelet function studies in clinical practice.

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

Directory of Open Access Journals (Sweden)

A R Prabhakar

2015-01-01

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

Natural history of minimal anterior displacements of the temporomandibular joint meniscus

International Nuclear Information System (INIS)

Drace, J.E.

1988-01-01

Magnetic resonance (MR) imaging of the temporomandibular joint (TMJ) often provides more precise localization of the meniscus than other imaging modalities. Previous study of the distribution of meniscus position in a control population showed that anterior displacements of more than 10 0 were more than 2 standard deviations from the mean, but the clinical significance and natural history of minimal displacements remained uncertain. Twenty follow-up MR studies were performed after 1-2 years in subjects with minimal meniscus displacements drawn from an original series of 125 symptomatic patients and 50 asymptomatic volunteers. These were correlated with repeated clinical histories and clinical examinations. A significant increase in the amount of anterior displacement was found in 55% of the originally asymptomatic volunteers with minimal displacements, which was accompanied by new symptoms in 40%. This was seen exclusively among those with a history of orthodontia. Worsening anterior displacements were seen in 50% of the patient population, and 25% had associated worsening symptoms. These findings indicate that detection of even minimal displacements of the TMJ meniscus is necessary and warrants follow-up MR examinations. Routine follow-up MR images should be obtained following malocclusion treatment and after major dental procedures

Minimally Invasive Technique for PMMA Augmentation of Fenestrated Screws

Directory of Open Access Journals (Sweden)

Jan-Helge Klingler

2015-01-01

Full Text Available Purpose. To describe the minimally invasive technique for cement augmentation of cannulated and fenestrated screws using an injection cannula as well as to report its safety and efficacy. Methods. A total of 157 cannulated and fenestrated pedicle screws had been cement-augmented during minimally invasive posterior screw-rod spondylodesis in 35 patients from January to December 2012. Retrospective evaluation of cement extravasation and screw loosening was carried out in postoperative plain radiographs and thin-sliced triplanar computed tomography scans. Results. Twenty-seven, largely prevertebral cement extravasations were detected in 157 screws (17.2%. None of the cement extravasations was causing a clinical sequela like a new neurological deficit. One screw loosening was noted (0.6% after a mean follow-up of 12.8 months. We observed no cementation-associated complication like pulmonary embolism or hemodynamic insufficiency. Conclusions. The presented minimally invasive cement augmentation technique using an injection cannula facilitates convenient and safe cement delivery through polyaxial cannulated and fenestrated screws during minimally invasive screw-rod spondylodesis. Nevertheless, the optimal injection technique and design of fenestrated screws have yet to be identified. This trial is registered with German Clinical Trials DRKS00006726.

Evaluation of clinical methods for peroneal muscle testing.

Science.gov (United States)

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

2013-03-01

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

Effect of home testing of international normalized ratio on clinical events.

Science.gov (United States)

Matchar, David B; Jacobson, Alan; Dolor, Rowena; Edson, Robert; Uyeda, Lauren; Phibbs, Ciaran S; Vertrees, Julia E; Shih, Mei-Chiung; Holodniy, Mark; Lavori, Philip

2010-10-21

Warfarin anticoagulation reduces thromboembolic complications in patients with atrial fibrillation or mechanical heart valves, but effective management is complex, and the international normalized ratio (INR) is often outside the target range. As compared with venous plasma testing, point-of-care INR measuring devices allow greater testing frequency and patient involvement and may improve clinical outcomes. We randomly assigned 2922 patients who were taking warfarin because of mechanical heart valves or atrial fibrillation and who were competent in the use of point-of-care INR devices to either weekly self-testing at home or monthly high-quality testing in a clinic. The primary end point was the time to a first major event (stroke, major bleeding episode, or death). The patients were followed for 2.0 to 4.75 years, for a total of 8730 patient-years of follow-up. The time to the first primary event was not significantly longer in the self-testing group than in the clinic-testing group (hazard ratio, 0.88; 95% confidence interval, 0.75 to 1.04; P=0.14). The two groups had similar rates of clinical outcomes except that the self-testing group reported more minor bleeding episodes. Over the entire follow-up period, the self-testing group had a small but significant improvement in the percentage of time during which the INR was within the target range (absolute difference between groups, 3.8 percentage points; P<0.001). At 2 years of follow-up, the self-testing group also had a small but significant improvement in patient satisfaction with anticoagulation therapy (P=0.002) and quality of life (P<0.001). As compared with monthly high-quality clinic testing, weekly self-testing did not delay the time to a first stroke, major bleeding episode, or death to the extent suggested by prior studies. These results do not support the superiority of self-testing over clinic testing in reducing the risk of stroke, major bleeding episode, and death among patients taking warfarin

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

Directory of Open Access Journals (Sweden)

Alexander A. Weinreb

2009-10-01

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

Syndromic Panel-Based Testing in Clinical Microbiology.

Science.gov (United States)

Ramanan, Poornima; Bryson, Alexandra L; Binnicker, Matthew J; Pritt, Bobbi S; Patel, Robin

2018-01-01

The recent development of commercial panel-based molecular diagnostics for the rapid detection of pathogens in positive blood culture bottles, respiratory specimens, stool, and cerebrospinal fluid has resulted in a paradigm shift in clinical microbiology and clinical practice. This review focuses on U.S. Food and Drug Administration (FDA)-approved/cleared multiplex molecular panels with more than five targets designed to assist in the diagnosis of bloodstream, respiratory tract, gastrointestinal, or central nervous system infections. While these panel-based assays have the clear advantages of a rapid turnaround time and the detection of a large number of microorganisms and promise to improve health care, they present certain challenges, including cost and the definition of ideal test utilization strategies (i.e., optimal ordering) and test interpretation. Copyright © 2017 American Society for Microbiology.

Clinical investigation of 14C-urea breath test

International Nuclear Information System (INIS)

Yu Yongli; Zhu Ruisen; Ji Hong; Luo Quanyong

2000-01-01

To investigate clinical value of 14 C-urea breath test ( 14 C-UBT) for the diagnosis of Helicobacter pylori(Hp), 70 patients were both performed gastroscopy (taking gastric mucosae biopsy for rapid urease test and histology) and 14 C-UBT (some patients by Hp-IgG or DNAHp test also) within two days. The positive cases of both rapid urease test and histology was defined as 'gold standard' of Hp-positive, whereas the negative cases of both rapid urease test and histology as 'gold standard' of Hp-negative. The sensitivity of 14 C-UBT was 93.2%, the specificity 73.1%, and the diagnostic accuracy 85.7%. The difference (comparing with 'gold standard') was not marked (x 2 = 0.9 0.05(1) 2 = 3.84, P>0.05). But the diagnostic accuracy of 14 C-UBT (85.7%) and Hp-IgG (50%) had a marked difference (x 2 13.80>x 0.01(1) 2 = 6.64, P 14 C-UBT was easy to operate, reliable and suitable for clinical application

[Clinical investigation of basophil activation test as a complementary test for house dust mite allergen].

Science.gov (United States)

Ren, H L; Li, J D; Miao, Y H; Xu, T

2018-03-01

Objective: To investigate the clinical application of glass micro fiber basophil activation test (BAT) used as a complementary test for house dust mite allergen. Method: Forty patients with clinical diagnosed allergic rhinitis was test by three methods for house dust mite allergen, skin prick test(SPT),Immuno CAP sIgE, and BAT in vitro. The sensitivity and specificity of glass micro fiber were accessed, and the consistency between BAT, SPT, and Immuno sIgE was analyzed. As in vivo provocation was not performed, gold standard is regarded as the combination of medical history and positive reports of SPT and/or ImmunoCAP sIgE test. Result: Twentythree patients are diagnosed as house dust mite allergic rhinitis by gold standard. The sensitivity and specificity of glass micro fiber BAT were 60.9% and 88.2%, the sensitivity of SPT and sIgE was 87.0% and sIgE 73.9%. The correlation rates between BAT with SPT is 0.67( P house dust mite allergic rhinitis, BAT have a good consistency with SPT and sIgE, while as it has only moderate consistency with "gold standard", further studies are needed to prove its clinical significance. Copyright© by the Editorial Department of Journal of Clinical Otorhinolaryngology Head and Neck Surgery.

Minimal changes in health status questionnaires: distinction between minimally detectable change and minimally important change

Directory of Open Access Journals (Sweden)

Knol Dirk L

2006-08-01

Full Text Available Abstract Changes in scores on health status questionnaires are difficult to interpret. Several methods to determine minimally important changes (MICs have been proposed which can broadly be divided in distribution-based and anchor-based methods. Comparisons of these methods have led to insight into essential differences between these approaches. Some authors have tried to come to a uniform measure for the MIC, such as 0.5 standard deviation and the value of one standard error of measurement (SEM. Others have emphasized the diversity of MIC values, depending on the type of anchor, the definition of minimal importance on the anchor, and characteristics of the disease under study. A closer look makes clear that some distribution-based methods have been merely focused on minimally detectable changes. For assessing minimally important changes, anchor-based methods are preferred, as they include a definition of what is minimally important. Acknowledging the distinction between minimally detectable and minimally important changes is useful, not only to avoid confusion among MIC methods, but also to gain information on two important benchmarks on the scale of a health status measurement instrument. Appreciating the distinction, it becomes possible to judge whether the minimally detectable change of a measurement instrument is sufficiently small to detect minimally important changes.

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

Science.gov (United States)

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

2015-09-08

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

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

Science.gov (United States)

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

2009-08-01

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

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

Science.gov (United States)

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

2013-03-01

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

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

Science.gov (United States)

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

2018-06-01

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

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

Science.gov (United States)

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

2015-01-01

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

Minimally modified theories of gravity: a playground for testing the uniqueness of general relativity

Science.gov (United States)

Carballo-Rubio, Ra{úl; Di Filippo, Francesco; Liberati, Stefano

2018-06-01

In a recent paper [1], it was introduced a new class of gravitational theories with two local degrees of freedom. The existence of these theories apparently challenges the distinctive role of general relativity as the unique non-linear theory of massless spin-2 particles. Here we perform a comprehensive analysis of these theories with the aim of (i) understanding whether or not these are actually equivalent to general relativity, and (ii) finding the root of the variance in case these are not. We have found that a broad set of seemingly different theories actually pass all the possible tests of equivalence to general relativity (in vacuum) that we were able to devise, including the analysis of scattering amplitudes using on-shell techniques. These results are complemented with the observation that the only examples which are manifestly not equivalent to general relativity either do not contain gravitons in their spectrum, or are not guaranteed to include only two local degrees of freedom once radiative corrections are taken into account. Coupling to matter is also considered: we show that coupling these theories to matter in a consistent way is not as straightforward as one could expect. Minimal coupling, as well as the most straightforward non-minimal couplings, cannot be used. Therefore, before being able to address any issues in the presence of matter, it would be necessary to find a consistent (and in any case rather peculiar) coupling scheme.

Minimal surfaces

CERN Document Server

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

2010-01-01

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

Testing non-minimally coupled inflation with CMB data: a Bayesian analysis

International Nuclear Information System (INIS)

Campista, Marcela; Benetti, Micol; Alcaniz, Jailson

2017-01-01

We use the most recent cosmic microwave background (CMB) data to perform a Bayesian statistical analysis and discuss the observational viability of inflationary models with a non-minimal coupling, ξ, between the inflaton field and the Ricci scalar. We particularize our analysis to two examples of small and large field inflationary models, namely, the Coleman-Weinberg and the chaotic quartic potentials. We find that ( i ) the ξ parameter is closely correlated with the primordial amplitude ; ( ii ) although improving the agreement with the CMB data in the r − n s plane, where r is the tensor-to-scalar ratio and n s the primordial spectral index, a non-null coupling is strongly disfavoured with respect to the minimally coupled standard ΛCDM model, since the upper bounds of the Bayes factor (odds) for ξ parameter are greater than 150:1.

Testing non-minimally coupled inflation with CMB data: a Bayesian analysis

Energy Technology Data Exchange (ETDEWEB)

Campista, Marcela; Benetti, Micol; Alcaniz, Jailson, E-mail: campista@on.br, E-mail: micolbenetti@on.br, E-mail: alcaniz@on.br [Observatório Nacional, Rua General José Cristino 77, Rio de Janeiro, RJ, 20921-400 Brazil (Brazil)

2017-09-01

We use the most recent cosmic microwave background (CMB) data to perform a Bayesian statistical analysis and discuss the observational viability of inflationary models with a non-minimal coupling, ξ, between the inflaton field and the Ricci scalar. We particularize our analysis to two examples of small and large field inflationary models, namely, the Coleman-Weinberg and the chaotic quartic potentials. We find that ( i ) the ξ parameter is closely correlated with the primordial amplitude ; ( ii ) although improving the agreement with the CMB data in the r − n {sub s} plane, where r is the tensor-to-scalar ratio and n {sub s} the primordial spectral index, a non-null coupling is strongly disfavoured with respect to the minimally coupled standard ΛCDM model, since the upper bounds of the Bayes factor (odds) for ξ parameter are greater than 150:1.

Minimally invasive radical pancreatectomy for left-sided pancreatic cancer: Current status and future perspectives

Science.gov (United States)

Kang, Chang Moo; Lee, Sung Hwan; Lee, Woo Jung

2014-01-01

Minimally invasive distal pancreatectomy with splenectomy has been regarded as a safe and effective treatment for benign and borderline malignant pancreatic lesions. However, its application for left-sided pancreatic cancer is still being debated. The clinical evidence for radical antegrade modular pancreatosplenectomy (RAMPS)-based minimally invasive approaches for left-sided pancreatic cancer was reviewed. Potential indications and surgical concepts for minimally invasive RAMPS were suggested. Despite the limited clinical evidence for minimally invasive distal pancreatectomy in left-sided pancreatic cancer, the currently available clinical evidence supports the use of laparoscopic distal pancreatectomy under oncologic principles in well-selected left sided pancreatic cancers. A pancreas-confined tumor with an intact fascia layer between the pancreas and left adrenal gland/kidney positioned more than 1 or 2 cm away from the celiac axis is thought to constitute a good condition for the use of margin-negative minimally invasive RAMPS. The use of minimally invasive (laparoscopic or robotic) anterior RAMPS is feasible and safe for margin-negative resection in well-selected left-sided pancreatic cancer. The oncologic feasibility of the procedure remains to be determined; however, the currently available interim results indicate that even oncologic outcomes will not be inferior to those of open radical distal pancreatosplenectomy. PMID:24605031

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

Science.gov (United States)

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

2013-01-01

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

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

Science.gov (United States)

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

2013-03-01

Mixed reality environments for medical applications have been explored and developed over the past three decades in an effort to enhance the clinician's view of anatomy and facilitate the performance of minimally invasive procedures. These environments must faithfully represent the real surgical field and require seamless integration of pre- and intra-operative imaging, surgical instrument tracking, and display technology into a common framework centered around and registered to the patient. However, in spite of their reported benefits, few mixed reality environments have been successfully translated into clinical use. Several challenges that contribute to the difficulty in integrating such environments into clinical practice are presented here and discussed in terms of both technical and clinical limitations. This article should raise awareness among both developers and end-users toward facilitating a greater application of such environments in the surgical practice of the future. Copyright © 2013 Elsevier Ltd. All rights reserved.

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

Science.gov (United States)

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

2017-10-01

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

Comparing minimally supervised home-based and closely supervised gym-based exercise programs in weight reduction and insulin resistance after bariatric surgery: A randomized clinical trial.

Science.gov (United States)

Kaviani, Sara; Dadgostar, Haleh; Mazaherinezhad, Ali; Adib, Hanie; Solaymani-Dodaran, Masoud; Soheilipour, Fahimeh; Hakiminezhad, Mahdi

2017-01-01

Background: Effectiveness of various exercise protocols in weight reduction after bariatric surgery has not been sufficiently explored in the literature. Thus, in the present study, we aimed at comparing the effect of minimally supervised home-based and closely supervised gym-based exercise programs on weight reduction and insulin resistance after bariatric surgery. Methods: Females undergoing gastric bypass surgery were invited to participate in an exercise program and were randomly allocated into 2 groups using a random number generator in Excel. They were either offered a minimally supervised home-based (MSHB) or closely supervised gym-based (CSGB) exercise program. The CSGB protocol constitutes 2 weekly training sessions under ACSM guidelines. In the MSHB protocol, the participants received a notebook containing a list of recommended aerobic and resistance exercises, a log to record their activity, and a schedule of follow-up phone calls and clinic visits. Both groups received a pedometer. We measured their weight, BMI, lipid profile, FBS, and insulin level at baseline and at 20 weeks after the exercises, the results of which were compared using t test or Mann-Whitney U test at the end of the study. All the processes were observed by 1 senior resident in sport medicine. Results: A total of 80 patients were recruited who were all able to complete our study (MSHB= 38 and CSGB= 42). The baseline comparison revealed that the 2 groups were similar. The mean change (reduction) in BMI was slightly better in CSGB (8.61 95% CI 7.76-9.45) compared with the MSHB (5.18 95% CI 3.91-6.46); p< 0.01. However, the 2 groups did not have a statistically significant difference in the amount of change in the other factors including FBS and Homa.ir. Conclusion: As we expected a non-inferiority result, our results showed that both MSHB and CSGB exercise methods are somewhat equally effective in improving lipid profile and insulin resistance in the 2 groups, but a slightly better

Minimizing time for test in integrated circuit

OpenAIRE

Andonova, A. S.; Dimitrov, D. G.; Atanasova, N. G.

2004-01-01

The cost for testing integrated circuits represents a growing percentage of the total cost for their production. The former strictly depends on the length of the test session, and its reduction has been the target of many efforts in the past. This paper proposes a new method for reducing the test length by adopting a new architecture and exploiting an evolutionary optimisation algorithm. A prototype of the proposed approach was tested on 1SCAS standard benchmarks and theexperimental results s...

Evaluating Diagnostic Point-of-Care Tests in Resource-Limited Settings

Science.gov (United States)

Drain, Paul K; Hyle, Emily P; Noubary, Farzad; Freedberg, Kenneth A; Wilson, Douglas; Bishai, William; Rodriguez, William; Bassett, Ingrid V

2014-01-01

Diagnostic point-of-care (POC) testing is intended to minimize the time to obtain a test result, thereby allowing clinicians and patients to make an expeditious clinical decision. As POC tests expand into resource-limited settings (RLS), the benefits must outweigh the costs. To optimize POC testing in RLS, diagnostic POC tests need rigorous evaluations focused on relevant clinical outcomes and operational costs, which differ from evaluations of conventional diagnostic tests. Here, we reviewed published studies on POC testing in RLS, and found no clearly defined metric for the clinical utility of POC testing. Therefore, we propose a framework for evaluating POC tests, and suggest and define the term “test efficacy” to describe a diagnostic test’s capacity to support a clinical decision within its operational context. We also proposed revised criteria for an ideal diagnostic POC test in resource-limited settings. Through systematic evaluations, comparisons between centralized diagnostic testing and novel POC technologies can be more formalized, and health officials can better determine which POC technologies represent valuable additions to their clinical programs. PMID:24332389

Testing for Chronic Diarrhea.

Science.gov (United States)

Raman, M

Chronic diarrhea is a frequently encountered symptom in clinical practice. The etiologies for chronic diarrhea are diverse and broad with varying clinical implications. A useful method of categorizing chronic diarrhea to guide a diagnostic work-up is a pathophysiology-based framework. Chronic diarrhea may be categorized as malabsorptive, secretory, osmotic, and inflammatory or motility related. Frequently, overlap between categories may exist for any given diarrhea etiology and diagnostic testing must occur with an understanding of the differential diagnosis. Investigations to achieve a diagnosis for chronic diarrhea range from screening blood and stool tests to more directed testing such as diagnostic imaging, and endoscopic and histological evaluation. The pathophysiology-based framework proposed in this chapter will allow the clinician to select screening tests followed by targeted tests to minimize cost and complications to the patient, while providing a highly effective method to achieve an accurate diagnosis. © 2017 Elsevier Inc. All rights reserved.

Minimally-aggressive gestational trophoblastic neoplasms.

Science.gov (United States)

Cole, Laurence A

2012-04-01

We have previously defined a new syndrome "Minimally-aggressive gestational trophoblastic neoplasms" in which choriocarcinoma or persistent hydatidiform mole has a minimal growth rate and becomes chemorefractory. Previously we described a new treatment protocol, waiting for hCG rise to >3000 mIU/ml and disease becomes more advanced, then using combination chemotherapy. Initially we found this treatment successful in 8 of 8 cases, here we find this protocol appropriate in a further 16 cases. Initially we used hyperglycosylated hCG, a limited availability test, to identify this syndrome. Here we propose also using hCG doubling rate to detect this syndrome. Minimally aggressive gestational trophoblastic disease can be detected by chemotherapy resistance or low hyperglycosylated hCG, disease by hyperglycosylated hCG and by hCG doubling test. All were recommended to hold off further chemotherapy until hCG >3000mIU/ml. One case died prior to the start of the study, one case withdrew because of a lung nodule and one withdrew refusing the suggested combination chemotherapy. The remaining 16 women were all successfully treated. A total of 8 plus 16 or 24 of 24 women were successfully treated using the proposed protocol, holding back on chemotherapy until hCG >3000mIU/ml. Copyright © 2011 Elsevier Inc. All rights reserved.

Minimally invasive approaches for gastric cancer-Korean experience.

Science.gov (United States)

Yang, Han-Kwang; Suh, Yun-Suhk; Lee, Hyuk-Joon

2013-03-01

Laparoscopic surgery in Korea increased rapidly because of the early detection of gastric cancer by the development of diagnostic tools and nationwide screening. The Korean Laparoscopic Gastrointestinal Surgery Study Group (KLASS group) played a leading role in various projects related with minimally invasive surgery. The justification of minimally invasive procedures including robotic surgery, sentinel-node biopsy, or single-port surgery/Natural Orifice Transluminal Endoscopic Surgery (NOTES) must be predetermined by the clinical trial before a wide application, and the medical industry as well as surgeons should have great responsibility. Copyright © 2012 Wiley Periodicals, Inc.

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

Directory of Open Access Journals (Sweden)

Nicholas L. DePace

2014-12-01

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

Current clinical trials testing combinations of immunotherapy and radiation.

Science.gov (United States)

Crittenden, Marka; Kohrt, Holbrook; Levy, Ronald; Jones, Jennifer; Camphausen, Kevin; Dicker, Adam; Demaria, Sandra; Formenti, Silvia

2015-01-01

Preclinical evidence of successful combinations of ionizing radiation with immunotherapy has inspired testing the translation of these results to the clinic. Interestingly, the preclinical work has consistently predicted the responses encountered in clinical trials. The first example came from a proof-of-principle trial started in 2001 that tested the concept that growth factors acting on antigen-presenting cells improve presentation of tumor antigens released by radiation and induce an abscopal effect. Granulocyte-macrophage colony-stimulating factor was administered during radiotherapy to a metastatic site in patients with metastatic solid tumors to translate evidence obtained in a murine model of syngeneic mammary carcinoma treated with cytokine FLT-3L and radiation. Subsequent clinical availability of vaccines and immune checkpoint inhibitors has triggered a wave of enthusiasm for testing them in combination with radiotherapy. Examples of ongoing clinical trials are described in this report. Importantly, most of these trials include careful immune monitoring of the patients enrolled and will generate important data about the proimmunogenic effects of radiation in combination with a variety of immune modulators, in different disease settings. Results of these studies are building a platform of evidence for radiotherapy as an adjuvant to immunotherapy and encourage the growth of this novel field of radiation oncology. Copyright © 2015 Elsevier Inc. All rights reserved.

Test-retest reliability and minimal detectable change of two simplified 3-point balance measures in patients with stroke.

Science.gov (United States)

Chen, Yi-Miau; Huang, Yi-Jing; Huang, Chien-Yu; Lin, Gong-Hong; Liaw, Lih-Jiun; Lee, Shih-Chieh; Hsieh, Ching-Lin

2017-10-01

The 3-point Berg Balance Scale (BBS-3P) and 3-point Postural Assessment Scale for Stroke Patients (PASS-3P) were simplified from the BBS and PASS to overcome the complex scoring systems. The BBS-3P and PASS-3P were more feasible in busy clinical practice and showed similarly sound validity and responsiveness to the original measures. However, the reliability of the BBS-3P and PASS-3P is unknown limiting their utility and the interpretability of scores. We aimed to examine the test-retest reliability and minimal detectable change (MDC) of the BBS-3P and PASS-3P in patients with stroke. Cross-sectional study. The rehabilitation departments of a medical center and a community hospital. A total of 51 chronic stroke patients (64.7% male). Both balance measures were administered twice 7 days apart. The test-retest reliability of both the BBS-3P and PASS-3P were examined by intraclass correlation coefficients (ICC). The MDC and its percentage over the total score (MDC%) of each measure was calculated for examining the random measurement errors. The ICC values of the BBS-3P and PASS-3P were 0.99 and 0.97, respectively. The MDC% (MDC) of the BBS-3P and PASS-3P were 9.1% (5.1 points) and 8.4% (3.0 points), respectively, indicating that both measures had small and acceptable random measurement errors. Our results showed that both the BBS-3P and the PASS-3P had good test-retest reliability, with small and acceptable random measurement error. These two simplified 3-level balance measures can provide reliable results over time. Our findings support the repeated administration of the BBS-3P and PASS-3P to monitor the balance of patients with stroke. The MDC values can help clinicians and researchers interpret the change scores more precisely.

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

Science.gov (United States)

Wang-Hsu, Elizabeth; Smith, Susan S

2017-01-10

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

Minimally Invasive Sacroiliac Joint Fusion Using a Novel Hydroxyapatite-Coated Screw: Preliminary 1-Year Clinical and Radiographic Results of a 2-Year Prospective Study.

Science.gov (United States)

Rappoport, Louis H; Luna, Ingrid Y; Joshua, Gita

2017-05-01

Proper diagnosis and treatment of sacroiliac joint (SIJ) pain remains a clinical challenge. Dysfunction of the SIJ can produce pain in the lower back, buttocks, and extremities. Triangular titanium implants for minimally invasive surgical arthrodesis have been available for several years, with reputed high levels of success and patient satisfaction. This study reports on a novel hydroxyapatite-coated screw for surgical treatment of SIJ pain. Data were prospectively collected on 32 consecutive patients who underwent minimally invasive SIJ fusion with a novel hydroxyapatite-coated screw. Clinical assessments and radiographs were collected and evaluated at 3, 6, and 12 months postoperatively. Mean (standard deviation) patient age was 55.2 ± 10.7 years, and 62.5% were female. More patients (53.1%) underwent left versus right SIJ treatment, mean operative time was 42.6 ± 20.4 minutes, and estimated blood loss did not exceed 50 mL. Overnight hospital stay was required for 84% of patients, and the remaining patients needed a 2-day stay (16%). Mean preoperative visual analog scale back and leg pain scores decreased significantly by 12 months postoperatively (P sacroiliac joint pain. Future clinical studies with larger samples are warranted to assess long-term patient outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

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

Science.gov (United States)

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

2017-11-01

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

Aspergillus Polymerase Chain Reaction: Systematic Review of Evidence for Clinical Use in Comparison With Antigen Testing

Science.gov (United States)

White, P. Lewis; Wingard, John R.; Bretagne, Stéphane; Löffler, Jürgen; Patterson, Thomas F.; Slavin, Monica A.; Barnes, Rosemary A.; Pappas, Peter G.; Donnelly, J. Peter

2015-01-01

Background. Aspergillus polymerase chain reaction (PCR) was excluded from the European Organisation for the Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) definitions of invasive fungal disease because of limited standardization and validation. The definitions are being revised. Methods. A systematic literature review was performed to identify analytical and clinical information available on inclusion of galactomannan enzyme immunoassay (GM-EIA) (2002) and β-d-glucan (2008), providing a minimal threshold when considering PCR. Categorical parameters and statistical performance were compared. Results. When incorporated, GM-EIA and β-d-glucan sensitivities and specificities for diagnosing invasive aspergillosis were 81.6% and 91.6%, and 76.9% and 89.4%, respectively. Aspergillus PCR has similar sensitivity and specificity (76.8%–88.0% and 75.0%–94.5%, respectively) and comparable utility. Methodological recommendations and commercial PCR assays assist standardization. Although all tests have limitations, currently, PCR is the only test with independent quality control. Conclusions. We propose that there is sufficient evidence that is at least equivalent to that used to include GM-EIA and β-d-glucan testing, and that PCR is now mature enough for inclusion in the EORTC/MSG definitions. PMID:26113653

Minimal Residual Disease Assessment in Lymphoma: Methods and Applications.

Science.gov (United States)

Herrera, Alex F; Armand, Philippe

2017-12-01

Standard methods for disease response assessment in patients with lymphoma, including positron emission tomography and computed tomography scans, are imperfect. In other hematologic malignancies, particularly leukemias, the ability to detect minimal residual disease (MRD) is increasingly influencing treatment paradigms. However, in many subtypes of lymphoma, the application of MRD assessment techniques, like flow cytometry or polymerase chain reaction-based methods, has been challenging because of the absence of readily detected circulating disease or canonic chromosomal translocations. Newer MRD detection methods that use next-generation sequencing have yielded promising results in a number of lymphoma subtypes, fueling the hope that MRD detection may soon be applicable in clinical practice for most patients with lymphoma. MRD assessment can provide real-time information about tumor burden and response to therapy, noninvasive genomic profiling, and monitoring of clonal dynamics, allowing for many possible applications that could significantly affect the care of patients with lymphoma. Further validation of MRD assessment methods, including the incorporation of MRD assessment into clinical trials in patients with lymphoma, will be critical to determine how best to deploy MRD testing in routine practice and whether MRD assessment can ultimately bring us closer to the goal of personalized lymphoma care. In this review article, we describe the methods available for detecting MRD in patients with lymphoma and their relative advantages and disadvantages. We discuss preliminary results supporting the potential applications for MRD testing in the care of patients with lymphoma and strategies for including MRD assessment in lymphoma clinical trials.

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

Science.gov (United States)

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

2013-05-01

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

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

Science.gov (United States)

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

2017-05-01

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

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

Science.gov (United States)

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

2015-01-01

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

The Minimally Important Difference for the Fatigue Visual Analog Scale in Patients with Rheumatoid Arthritis followed in an Academic Clinical Practice

Science.gov (United States)

Khanna, Dinesh; Pope, Janet; Khanna, Puja P.; Maloney, Michelle; Samedi, Nooshin; Norrie, Debbie; Ouimet, Gillian; Hays, Ron D

2011-01-01

Introduction Fatigue is a common symptom in RA and used as an outcome measure in RA clinical trials. We studied a large academic clinical practice to estimate the minimally important difference (MID) for a fatigue visual analog scale using patient-reported anchors (fatigue, pain and overall health). Methods RA patients (N=307) had clinic visits at 2 time points at a median of 5.9 months apart. They completed fatigue visual analog scale (VAS; 0–10) and retrospective anchor items, “How would you describe your overall fatigue/pain/overall health since the last visit?” Much worsened, Somewhat worsened, Same, Somewhat better, or Much better. The fatigue anchor was used for primary analysis and the pain/ overall health anchors for sensitivity analyses. The minimally changed group was defined by those reporting they were somewhat better or somewhat worsened. Results The mean (SD) age was 59.4 (13.2) years, disease duration was 14.1 (11.5) years, and 83% of patients were women. The baseline mean (SD) HAQ-DI score was 0.84 (0.75). The baseline fatigue VAS score was 4.2 (2.9) and at follow up was 4.3 (2.8) (mean change of −0.07 [2.5], p=NS). The fatigue change score (0–10 scale) for somewhat better and somewhat worsened for fatigue anchor averaged −1.12 and 1.26, respectively. Using pain anchor, the fatigue changed score for somewhat better and somewhat worsened averaged −0.87 and 1.13 and using global anchor, the fatigue changed score for somewhat better and somewhat worsened averaged −0.82 and 1.17, respectively. Effect size (ES) estimates using 3 anchors were small for somewhat better (range: 0.27 to 0.39) and somewhat worsened (range: 0.40 to 0.44) groups but larger than the no-change group (range: 0.03 to 0.08). Conclusions The MID for fatigue VAS is between −0.82 to −1.12 for improvement and 1.13 to 1.26 for worsening on 0–10 scale in a large RA clinical practice and similar to that seen in RA clinical trials. This information can aid in

15N liver function tests - concept, validity, clinical use

International Nuclear Information System (INIS)

Faust, H.; Jung, K.; Krumbiegel, P.; Hirschberg, K.; Reinhardt, R.; Junghans, P.

1987-01-01

Several liver function tests using the oral application of a nitrogen compound labelled with 15 N and the subsequent determination of 15 N in a certain fraction of urine by emission spectrometry are described. Because of the key position of the liver in the metabolism of nitrogen compounds the results of these tests allow conclusions concerning disturbances of special liver functions. Instructions for the clinical use of the '[ 15 N]Ammonium Test', '[ 15 N]Hippurate Test' the '[ 15 N]Methacetin Test', and the '[ 15 N]Glycine Test' are given. (author)

[Description of clinical thinking by the dual-process theory].

Science.gov (United States)

Peña G, Luis

2012-06-01

Clinical thinking is a very complex process that can be described by the dual-process theory, it has an intuitive part (that recognizes patterns) and an analytical part (that tests hypotheses). It is vulnerable to cognitive bias that professionals must be aware of, to minimize diagnostic errors.

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

Science.gov (United States)

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

2017-09-01

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

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

Directory of Open Access Journals (Sweden)

Melissa E. Stauffer

2011-01-01

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

Responsiveness of Clinical Outcome Measures

DEFF Research Database (Denmark)

Lauridsen, Henrik Hein

Background The Oswestry Disability Index (ODI) is one of two standardised functional health measurement scales (HMS) recommended. Despite extensive psychometric testing, little is known about HMS behaviour and the minimal clinically important difference (MCID) in subgroups of LBP patients. Moreover...... obtainable by a certain treatment. Chronic LBP patients seem to have a reasonable idea of an acceptable change in pain but overestimate change in functional and psychological /affective domains....

Approximate k-NN delta test minimization method using genetic algorithms: Application to time series

CERN Document Server

Mateo, F; Gadea, Rafael; Sovilj, Dusan

2010-01-01

In many real world problems, the existence of irrelevant input variables (features) hinders the predictive quality of the models used to estimate the output variables. In particular, time series prediction often involves building large regressors of artificial variables that can contain irrelevant or misleading information. Many techniques have arisen to confront the problem of accurate variable selection, including both local and global search strategies. This paper presents a method based on genetic algorithms that intends to find a global optimum set of input variables that minimize the Delta Test criterion. The execution speed has been enhanced by substituting the exact nearest neighbor computation by its approximate version. The problems of scaling and projection of variables have been addressed. The developed method works in conjunction with MATLAB's Genetic Algorithm and Direct Search Toolbox. The goodness of the proposed methodology has been evaluated on several popular time series examples, and also ...

Minimally Invasive Cardiac Surgery: Transapical Aortic Valve Replacement

Directory of Open Access Journals (Sweden)

Ming Li

2012-01-01

Full Text Available Minimally invasive cardiac surgery is less traumatic and therefore leads to quicker recovery. With the assistance of engineering technologies on devices, imaging, and robotics, in conjunction with surgical technique, minimally invasive cardiac surgery will improve clinical outcomes and expand the cohort of patients that can be treated. We used transapical aortic valve implantation as an example to demonstrate that minimally invasive cardiac surgery can be implemented with the integration of surgical techniques and engineering technologies. Feasibility studies and long-term evaluation results prove that transapical aortic valve implantation under MRI guidance is feasible and practical. We are investigating an MRI compatible robotic surgical system to further assist the surgeon to precisely deliver aortic valve prostheses via a transapical approach. Ex vivo experimentation results indicate that a robotic system can also be employed in in vivo models.

[Clinical research of minimal extracorporeal circulation in perioperative blood conservation of coronary artery bypass graft].

Science.gov (United States)

Liu, Yan; Cui, Hu-jun; Tao, Liang; Chen, Xu-fa

2011-04-01

To analyze the clinical effect of minimal extracorporeal circulation (MECC) in blood conservation perioperatively coronary artery bypass graft (CABG). The data of 120 cases received simple CABG since August 2006 to October 2009 was analyzed retrospectively. All the patients were divided to three groups according to the mode of circulation support in-operation: MECC, conventional extracorporeal circulation (cECC) or off-pump, 40 cases in each group. Jostra MECC system with normal temperature was used in MECC group, and common membrane oxygenator with moderate hypo-temperature was used in cECC group. Collect the data of coagulation and the blood cytological examination perioperatively, the draining volume during the first 24 h after operation, and consumption of blood products perioperatively. Standard and logistic EuroSCORE were higher in MECC group than the others (P blood products in cECC group, but no difference among the three groups. MECC could reduce the ruin to blood cell and interfere to coagulation function during the conventional ECC procedure, decrease the postoperative draining volume and requirement of blood products.

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

DEFF Research Database (Denmark)

Andersen, J T; Sander, P

1996-01-01

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

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

Science.gov (United States)

2010-10-01

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

EMG of the hip adductor muscles in six clinical examination tests.

Science.gov (United States)

Lovell, Gregory A; Blanch, Peter D; Barnes, Christopher J

2012-08-01

To assess activation of muscles of hip adduction using EMG and force analysis during standard clinical tests, and compare athletes with and without a prior history of groin pain. Controlled laboratory study. 21 male athletes from an elite junior soccer program. Bilateral surface EMG recordings of the adductor magnus, adductor longus, gracilis and pectineus as well as a unilateral fine-wire EMG of the pectineus were made during isometric holds in six clinical examination tests. A load cell was used to measure force data. Test type was a significant factor in the EMG output for all four muscles (all muscles p stronger than Hips 45, Hips 90 and Side lay. BMI (body mass index) was a significant factor (p Muscle EMG varied significantly with clinical test position. Athletes with previous groin injury had a significant fall in some EMG outputs. Copyright © 2011 Elsevier Ltd. All rights reserved.

[Quality Management and Quality Specifications of Laboratory Tests in Clinical Studies--Challenges in Pre-Analytical Processes in Clinical Laboratories].

Science.gov (United States)

Ishibashi, Midori

2015-01-01

The cost, speed, and quality are the three important factors recently indicated by the Ministry of Health, Labour and Welfare (MHLW) for the purpose of accelerating clinical studies. Based on this background, the importance of laboratory tests is increasing, especially in the evaluation of clinical study participants' entry and safety, and drug efficacy. To assure the quality of laboratory tests, providing high-quality laboratory tests is mandatory. For providing adequate quality assurance in laboratory tests, quality control in the three fields of pre-analytical, analytical, and post-analytical processes is extremely important. There are, however, no detailed written requirements concerning specimen collection, handling, preparation, storage, and shipping. Most laboratory tests for clinical studies are performed onsite in a local laboratory; however, a part of laboratory tests is done in offsite central laboratories after specimen shipping. As factors affecting laboratory tests, individual and inter-individual variations are well-known. Besides these factors, standardizing the factors of specimen collection, handling, preparation, storage, and shipping, may improve and maintain the high quality of clinical studies in general. Furthermore, the analytical method, units, and reference interval are also important factors. It is concluded that, to overcome the problems derived from pre-analytical processes, it is necessary to standardize specimen handling in a broad sense.

Minimal Invasive Urologic Surgery and Postoperative Ileus

Directory of Open Access Journals (Sweden)

Fouad Aoun

2015-07-01

Full Text Available Postoperative ileus (POI is the most common cause of prolonged length of hospital stays (LOS and associated healthcare costs. The advent of minimal invasive technique was a major breakthrough in the urologic landscape with great potential to progress in the future. In the field of gastrointestinal surgery, several studies had reported lower incidence rates for POI following minimal invasive surgery compared to conventional open procedures. In contrast, little is known about the effect of minimal invasive approach on the recovery of bowel motility after urologic surgery. We performed an overview of the potential benefit of minimal invasive approach on POI for urologic procedures. The mechanisms and risk factors responsible for the onset of POI are discussed with emphasis on the advantages of minimal invasive approach. In the urologic field, POI is the main complication following radical cystectomy but it is rarely of clinical significance for other minimal invasive interventions. Laparoscopy or robotic assisted laparoscopic techniques when studied individually may reduce to their own the duration and prevent the onset of POI in a subset of procedures. The potential influence of age and urinary diversion type on postoperative ileus is contradictory in the literature. There is some evidence suggesting that BMI, blood loss, urinary extravasation, existence of a major complication, bowel resection, operative time and transperitoneal approach are independent risk factors for POI. Treatment of POI remains elusive. One of the most important and effective management strategies for patients undergoing radical cystectomy has been the development and use of enhanced recovery programs. An optimal rational strategy to shorten the duration of POI should incorporate minimal invasive approach when appropriate into multimodal fast track programs designed to reduce POI and shorten LOS.

Clinical implementation of KRAS testing in metastatic colorectal carcinoma: the pathologist's perspective.

Science.gov (United States)

Ross, Jeffrey S

2012-10-01

Mutation status of the KRAS gene identifies a distinct disease subtype of metastatic colorectal carcinoma that does not respond to antibody therapeutics targeting the epidermal growth factor receptor. This is currently the only validated marker in metastatic colorectal carcinoma with a clear implication in treatment selection. KRAS testing is widely accepted in clinical practice to guide metastatic colorectal carcinoma therapeutic decisions, and there are many commercially available platforms to perform the test. To evaluate the critical role of pathologists in the full implementation of KRAS testing by optimizing tumor tissue collection and fixation procedures and by choosing testing technologies and reliable Clinical Laboratory Improvement Amendments of 1988-certified laboratories to perform the tests. Prospective clinical trials, retrospective studies, and quality assessment and survey reports were identified in the following databases: PubMed, American Society of Clinical Oncology Proceedings (American Society of Clinical Oncology Annual Meeting and Gastrointestinal Cancer Symposium) and European Society for Medical Oncology Proceedings (Annals of Oncology European Society for Medical Oncology Congress and Annals of Oncology World Congress on Gastrointestinal Cancers). More bona fide standards are needed to address the variety of available test methods, which have different performance characteristics including speed, sensitivity to detect rare mutations, and technical requirements. Refined standards addressing timing of KRAS testing, laboratory performance and accuracy, quality assurance and control, proper tissue collection, and appropriate result reporting would also be greatly beneficial. Pathologists should be aware that the amount of information they need to manage will increase, because future trends and technological advances will enhance the predictive power of diagnostic tests or the scope of the biomarker panels tested routinely across tumor types.

Minimal disease activity for rheumatoid arthritis: a preliminary definition

NARCIS (Netherlands)

Wells, George A.; Boers, Maarten; Shea, Beverley; Brooks, Peter M.; Simon, Lee S.; Strand, C. Vibeke; Aletaha, Daniel; Anderson, Jennifer J.; Bombardier, Claire; Dougados, Maxime; Emery, Paul; Felson, David T.; Fransen, Jaap; Furst, Dan E.; Hazes, Johanna M. W.; Johnson, Kent R.; Kirwan, John R.; Landewé, Robert B. M.; Lassere, Marissa N. D.; Michaud, Kaleb; Suarez-Almazor, Maria; Silman, Alan J.; Smolen, Josef S.; van der Heijde, Desiree M. F. M.; van Riel, Piet L. C. M.; Wolfe, Fred; Tugwell, Peter S.

2005-01-01

Agreement on response criteria in rheumatoid arthritis (RA) has allowed better standardization and interpretation of clinical trial reports. With recent advances in therapy, the proportion of patients achieving a satisfactory state of minimal disease activity (MDA) is becoming a more important

Minimal disease activity for rheumatoid arthritis: a preliminary definition.

NARCIS (Netherlands)

Wells, G.A.; Boers, M.; Shea, B.; Brooks, P.M.; Simon, L.S.; Strand, C.V.; Aletaha, D.; Anderson, J.; Bombardier, C.; Dougados, M.; Emery, P.; Felson, D.T.; Fransen, J.; Furst, D.E.; Hazes, J.M.W.; Johnson, K.; Kirwan, J.; Landewe, R.B.; Lassere, M.N.; Michaud, K.; Suarez-Almazor, M.; Silman, A.J.; Smolen, J.S.; Heijde, D.M.F.M. van der; Riel, P.L.C.M. van; Wolfe, F.; Tugwell, P.S.

2005-01-01

Agreement on response criteria in rheumatoid arthritis (RA) has allowed better standardization and interpretation of clinical trial reports. With recent advances in therapy, the proportion of patients achieving a satisfactory state of minimal disease activity (MDA) is becoming a more important

Clinical Applications of CO2 and H2 Breath Test

Directory of Open Access Journals (Sweden)

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

2016-08-01

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

[Clinical research XVII. χ(2) test, from the expected to the observed].

Science.gov (United States)

Rivas-Ruiz, Rodolfo; Castelán-Martínez, Osvaldo D; Pérez, Marcela; Talavera, Juan O

2013-01-01

When you want to show if there is a statistical association or differences between categorical variables, it is recommended to use the χ(2) test. This nonparametric test is one of the most used in clinical research; it contrasts nominal or ordinal qualitative variables that are observed in clinical practice. This test calculates the p value that determines whether differences between groups are real or due to chance. The χ(2) test is the basis of other tests to analyze qualitative ordinal variables as χ(2) for linear trend, which compares three groups with two outcomes or McNemar test, which contrasts two related samples (a before and afterward comparison) or Mantel-Haenszel χ(2), which controls for potential confounding variables. When using small samples, where the expected results are less than 5, Fisher's exact test should be used. These tests are the most widely used in the medical literature; however, they do not give us the magnitude or the direction of the event and a proper interpretation that requires clinical judgment is needed.

Case Report: Diagnosis of hypogeusia after oral exposure to commercial cleaning agent and considerations for clinical taste testing [version 2; referees: 2 approved, 1 not approved

Directory of Open Access Journals (Sweden)

Marie Jetté

2017-06-01

Full Text Available Few reports in the literature document acute taste disturbance following exposure to toxic chemicals. We describe the case of a 54-year-old man who presented with primary complaint of tongue numbness and persistent problems with taste 1.5 years following oral exposure to a commercial cleaning agent. A test of olfaction revealed normosmia for age and gender. Lingual tactile two-point discrimination testing showed reduced somatosensation. Taste threshold testing using a 3-drop method demonstrated severe hypogeusia, though the patient was able to discriminate tastants at lower concentrations with a whole mouth swish and spit test. We conclude that clinical evaluation of dysgeusia can be performed using a number of previously published testing methods, however, determining causative factors may be confounded by duration since exposure, lack of knowledge of baseline taste function, and medications. Although many testing options exist, basic taste testing can be performed with minimal expertise or specialized equipment, depending on the patient history and goals of evaluation.

B-ALL minimal residual disease flow cytometry: an application of a novel method for optimization of a single-tube model.

Science.gov (United States)

Shaver, Aaron C; Greig, Bruce W; Mosse, Claudio A; Seegmiller, Adam C

2015-05-01

Optimizing a clinical flow cytometry panel can be a subjective process dependent on experience. We develop a quantitative method to make this process more rigorous and apply it to B lymphoblastic leukemia/lymphoma (B-ALL) minimal residual disease (MRD) testing. We retrospectively analyzed our existing three-tube, seven-color B-ALL MRD panel and used our novel method to develop an optimized one-tube, eight-color panel, which was tested prospectively. The optimized one-tube, eight-color panel resulted in greater efficiency of time and resources with no loss in diagnostic power. Constructing a flow cytometry panel using a rigorous, objective, quantitative method permits optimization and avoids problems of interdependence and redundancy in a large, multiantigen panel. Copyright© by the American Society for Clinical Pathology.

A new condition for assessing the clinical efficiency of a diagnostic test.

Science.gov (United States)

Bokhari, Ehsan; Hubert, Lawrence

2015-09-01

When prediction using a diagnostic test outperforms simple prediction using base rates, the test is said to be "clinically efficient," a term first introduced into the literature by Meehl and Rosen (1955) in Psychological Bulletin. This article provides three equivalent conditions for determining the clinical efficiency of a diagnostic test: (a) Meehl-Rosen (Meehl & Rosen, 1955); (b) Dawes (Dawes, 1962); and (c) the Bokhari-Hubert condition, introduced here for the first time. Clinical efficiency is then generalized to situations where misclassification costs are considered unequal (for example, false negatives are more costly than false positives). As an illustration, the clinical efficiency of an actuarial device for predicting violent and dangerous behavior is examined that was developed as part of the MacArthur Violence Risk Assessment Study. (c) 2015 APA, all rights reserved.

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

Science.gov (United States)

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

2014-09-01

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

Clinical tests to diagnose lumbar spondylolysis and spondylolisthesis: A systematic review.

Science.gov (United States)

Alqarni, Abdullah M; Schneiders, Anthony G; Cook, Chad E; Hendrick, Paul A

2015-08-01

The aim of this paper was to systematically review the diagnostic ability of clinical tests to detect lumbar spondylolysis and spondylolisthesis. A systematic literature search of six databases, with no language restrictions, from 1950 to 2014 was concluded on February 1, 2014. Clinical tests were required to be compared against imaging reference standards and report, or allow computation, of common diagnostic values. The systematic search yielded a total of 5164 articles with 57 retained for full-text examination, from which 4 met the full inclusion criteria for the review. Study heterogeneity precluded a meta-analysis of included studies. Fifteen different clinical tests were evaluated for their ability to diagnose lumbar spondylolisthesis and one test for its ability to diagnose lumbar spondylolysis. The one-legged hyperextension test demonstrated low to moderate sensitivity (50%-73%) and low specificity (17%-32%) to diagnose lumbar spondylolysis, while the lumbar spinous process palpation test was the optimal diagnostic test for lumbar spondylolisthesis; returning high specificity (87%-100%) and moderate to high sensitivity (60-88) values. Lumbar spondylolysis and spondylolisthesis are identifiable causes of LBP in athletes. There appears to be utility to lumbar spinous process palpation for the diagnosis of lumbar spondylolisthesis, however the one-legged hyperextension test has virtually no value in diagnosing patients with spondylolysis. Copyright © 2015 Elsevier Ltd. All rights reserved.

Limits of clinical tests to screen autonomic function in diabetes type 1.

Science.gov (United States)

Ducher, M; Bertram, D; Sagnol, I; Cerutti, C; Thivolet, C; Fauvel, J P

2001-11-01

A precocious detection of cardiac autonomic dysfunction is of major clinical interest that could lead to a more intensive supervision of diabetic patients. However, classical clinical exploration of cardiac autonomic function is not easy to undertake in a reproducible way. Thus, respective interests of autonomic nervous parameters provided by both clinical tests and computerized analysis of resting blood pressure were checked in type 1 diabetic patients without orthostatic hypotension and microalbuminuria. Thirteen diabetic subjects matched for age and gender to thirteen healthy subjects volunteered to participate to the study. From clinical tests (standing up, deep breathing, Valsalva maneuver, handgrip test), autonomic function was scored according to Ewing's methodology. Analysis of resting beat to beat blood pressure provided autonomic indices of the cardiac function (spectral analysis or Z analysis). 5 of the 13 diabetic patients exhibited a pathological score (more than one pathological response) suggesting the presence of cardiovascular autonomic dysfunction. The most discriminative test was the deep breathing test. However, spectral indices of BP recordings and baro-reflex sensitivity (BRS) of these 5 subjects were similar to those of healthy subjects and of remaining diabetic subjects. Alteration in Ewing's score given by clinical tests may not reflect an alteration of cardiac autonomic function in asymptomatic type 1 diabetic patients, because spectral indices of sympathetic and parasympathetic (including BRS) function were within normal range. Our results strongly suggest to confront results provided by both methodologies before concluding to an autonomic cardiac impairment in asymptomatic diabetic patients.

Clinical balance tests, proprioceptive system and adolescent idiopathic scoliosis.

Science.gov (United States)

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

2017-06-01

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

Trichomonas vaginalis Nucleic Acid Amplification Testing at an Urban HIV Clinic.

Science.gov (United States)

Muzny, Christina A; Burkholder, Greer A; Fry, Karen R; Austin, Erika L; Schwebke, Jane R

2016-08-01

Trichomonas vaginalis is the most common nonviral sexually transmitted infection. T. vaginalis nucleic acid amplification testing (NAAT) recently became available at the University of Alabama at Birmingham human immunodeficiency virus (HIV) clinic. The objective of this study was to determine the uptake of T. vaginalis NAAT testing among clinic providers during the first year of test availability in addition to T. vaginalis prevalence and predictors based on NAAT results. This was a retrospective review of HIV+ women and men ages ≥16 years at the University of Alabama at Birmingham HIV Clinic, including those receiving a T. vaginalis NAAT on a genitourinary specimen. Between August 2014 and August 2015, 3163 HIV+ patients were seen (768 women, 2395 men), of whom 861 (27.3%) received a T. vaginalis NAAT; 402 women (52.3%) and 459 men (19.2%). Among those with T. vaginalis NAAT results, 70 (17.4%) of 402 women and 12 (2.6%) of 459 men (9 men who have sex with women, 1 man who has sex with men, 2 unknown) tested positive. In adjusted analyses for women, age ≤40 years (odds ratio [OR], 2.93; 95% confidence interval [CI], 1.23-6.96), current cocaine use (OR, 4.86; 95% CI, 1.57-15.06), and CD4 vaginalis NAAT. For those with a positive T. vaginalis NAAT, treatment was prescribed for 65 (92.9%) of 70 women and 10 (83.3%) of 12 men. Initial uptake of T. vaginalis NAAT testing was modest at this HIV clinic yet identified a high prevalence among women tested. Emphasis on the need for testing in HIV+ women is necessary.

The minimally important difference for the fatigue visual analog scale in patients with rheumatoid arthritis followed in an academic clinical practice.

Science.gov (United States)

Khanna, Dinesh; Pope, Janet E; Khanna, Puja P; Maloney, Michelle; Samedi, Nooshin; Norrie, Debbie; Ouimet, Gillian; Hays, Ron D

2008-12-01

To estimate the minimally important difference (MID) for a fatigue visual analog scale (VAS) using patient-reported anchors (fatigue, pain, and overall health). Patients with rheumatoid arthritis (RA; n = 307) had 2 clinic visits at a median of 5.9 months apart. They completed a fatigue VAS (0-10 scale) and the retrospective anchor items, "How would you describe your overall fatigue/pain/overall health since the last visit?" with response options: Much worsened, Somewhat worsened, Same, Somewhat better, or Much better. The fatigue anchor was used for primary analysis and the pain/overall health anchors for sensitivity analyses. The minimally changed group was defined by those reporting they were somewhat better or somewhat worsened. The mean [standard deviation (SD)] age was 59.4 (13.2) years, disease duration was 14.1 (11.5) years, and 83% of patients were women. The baseline mean (SD) Health Assessment Questionnaire-Disability Index score was 0.84 (0.75). The baseline fatigue VAS score was 4.2 (2.9) and at followup was 4.3 (2.8) [mean change of -0.07 (2.5); p = not significant]. The fatigue change score (0-10 scale) for Somewhat better and Somewhat worsened for the fatigue anchor averaged -1.12 and 1.26, respectively. Using the pain anchor, the fatigue change score for Somewhat better and Somewhat worsened averaged -0.87 and 1.13; and using the global anchor, the fatigue change score for Somewhat better and Somewhat worsened averaged -0.82 and 1.17, respectively. Effect size estimates using 3 anchors were small for the Somewhat better (range 0.27-0.39) and Somewhat worsened (0.40-0.44) groups, but larger than for the no-change group (0.03-0.08). The MID for fatigue VAS is between -0.82 for -1.12 for improvement and is 1.13 to 1.26 for worsening on a 0-10 scale in a large RA clinical practice, and is similar to that seen in RA clinical trials. This information can aid in interpreting fatigue VAS in day-to-day care in clinical practice.

Testing devices or experimental systems? Cancer clinical trials take the genomic turn.

Science.gov (United States)

Nelson, Nicole C; Keating, Peter; Cambrosio, Alberto; Aguilar-Mahecha, Adriana; Basik, Mark

2014-06-01

Clinical trials are often described as machine-like systems for generating specific information concerning drug safety and efficacy, and are understood as a component of the industrial drug development processes. This paper argues that contemporary clinical trials in oncology are not reducible to mere drug testing. Drawing on ethnographic fieldwork and interviews with researchers in the field of oncology from 2010 to 2013, we introduce a conceptual contrast between trials as testing machines and trials as clinical experimental systems to draw attention to the ways trials are increasingly being used to ask open-ended scientific questions. When viewed as testing machines, clinical trials are seen as a means to produce answers to straightforward questions and deviations from the protocol are seen as bugs in the system; but practitioners can also treat trials as clinical experimental systems to investigate as yet undefined problems and where heterogeneity becomes a means to produce novel biological or clinical insights. The rise of "biomarker-driven" clinical trials in oncology, which link measurable biological characteristics such as genetic mutations to clinical features such as a patient's response to a particular drug, exemplifies a trend towards more experimental styles of clinical work. These transformations are congruent with changes in the institutional structure of clinical research in oncology, including a movement towards more flexible, networked research arrangements, and towards using individual patients as model systems for asking biological questions. Copyright © 2014 Elsevier Ltd. All rights reserved.

ANTIFUNGAL SUSCEPTIBILITY TESTING: CURRENT ROLE FROM THE CLINICAL LABORATORY PERSPECTIVE

Directory of Open Access Journals (Sweden)

Brunella Posteraro

2014-04-01

Full Text Available Despite availability of many antifungal agents, antifungal clinical resistance occurs, perhaps as a result of an infecting organism found to be resistant in vitro to one or more antifungals tested. Thus, antifungal susceptibility testing (AFST results, if timely generated by the clinical microbiology and communicated to clinicians, can aid them in the therapeutic decision making, especially for difficult-to-treat invasive candidiasis and aspergillosis. Although recently refined AFST methods are commercially available to allow a close antifungal resistance surveillance in many clinical setting, novel assays, relying on short-time antifungal drug exposure of fungal isolates, are upcoming tools for AFST. Based on emerging technologies such as flow cytometry, MALDI-TOF mass spectrometry, and isothermal microcalorimetry, these assays could provide a reliable means for quicker and sensitive assessment of AFST.

The Effect of Microneedle Thickness on Pain During Minimally Invasive Facial Procedures: A Clinical Study.

Science.gov (United States)

Sezgin, Billur; Ozel, Bora; Bulam, Hakan; Guney, Kirdar; Tuncer, Serhan; Cenetoglu, Seyhan

2014-07-01

Minimally invasive procedures are becoming increasingly popular because they require minimal downtime and are effective for achieving a more youthful appearance. The choice of needle for minimally invasive procedures can be a major factor in the patient's comfort level, which in turn affects the physician's comfort level. In this comparative study, the authors assessed levels of pain and bruising after participants were injected with 30-gauge or 33-gauge (G) microneedles, which are commonly used for minimally invasive injection procedures. Twenty healthy volunteers were recruited for this prospective study. Eight injection points (4 on each side of the face) were determined for each patient. All participants received injections of saline with both microneedles in a randomized, blinded fashion. Levels of pain and bruising were assessed and analyzed for significance. The highest level of pain was in the malar region, and the lowest level was in the glabella. Although all pain scores were lower for the 33-G microneedle, the difference was significant only for the forehead. Because most minimally invasive procedures require multiple injections during the same sitting, the overall procedure was evaluated as well. Assessment of the multiple-injection process demonstrated a significant difference in pain level, favoring the 33-G needle. Although the difference in bruising was not statistically significant between the 2 needles, the degree of bruising was lower with the 33-G needle. For procedures that involve multiple injections to the face (such as mesotherapy and injection of botulinum toxin A), thinner needles result in less pain, making the overall experience more comfortable for the patient and the physician. 3. © 2014 The American Society for Aesthetic Plastic Surgery, Inc.

Evaluating a mobile application for improving clinical laboratory test ordering and diagnosis.

Science.gov (United States)

Meyer, Ashley N D; Thompson, Pamela J; Khanna, Arushi; Desai, Samir; Mathews, Benji K; Yousef, Elham; Kusnoor, Anita V; Singh, Hardeep

2018-04-20

Mobile applications for improving diagnostic decision making often lack clinical evaluation. We evaluated if a mobile application improves generalist physicians' appropriate laboratory test ordering and diagnosis decisions and assessed if physicians perceive it as useful for learning. In an experimental, vignette study, physicians diagnosed 8 patient vignettes with normal prothrombin times (PT) and abnormal partial thromboplastin times (PTT). Physicians made test ordering and diagnosis decisions for 4 vignettes using each resource: a mobile app, PTT Advisor, developed by the Centers for Disease Control and Prevention (CDC)'s Clinical Laboratory Integration into Healthcare Collaborative (CLIHC); and usual clinical decision support. Then, physicians answered questions regarding their perceptions of the app's usefulness for diagnostic decision making and learning using a modified Kirkpatrick Training Evaluation Framework. Data from 368 vignettes solved by 46 physicians at 7 US health care institutions show advantages for using PTT Advisor over usual clinical decision support on test ordering and diagnostic decision accuracy (82.6 vs 70.2% correct; P < .001), confidence in decisions (7.5 vs 6.3 out of 10; P < .001), and vignette completion time (3:02 vs 3:53 min.; P = .06). Physicians reported positive perceptions of the app's potential for improved clinical decision making, and recommended it be used to address broader diagnostic challenges. A mobile app, PTT Advisor, may contribute to better test ordering and diagnosis, serve as a learning tool for diagnostic evaluation of certain clinical disorders, and improve patient outcomes. Similar methods could be useful for evaluating apps aimed at improving testing and diagnosis for other conditions.

A comprehensive test of clinical reasoning for medical students: An olympiad experience in Iran.

Science.gov (United States)

Monajemi, Alireza; Arabshahi, Kamran Soltani; Soltani, Akbar; Arbabi, Farshid; Akbari, Roghieh; Custers, Eugene; Hadadgar, Arash; Hadizadeh, Fatemeh; Changiz, Tahereh; Adibi, Peyman

2012-01-01

Although some tests for clinical reasoning assessment are now available, the theories of medical expertise have not played a major role in this filed. In this paper, illness script theory was chose as a theoretical framework and contemporary clinical reasoning tests were put together based on this theoretical model. This paper is a qualitative study performed with an action research approach. This style of research is performed in a context where authorities focus on promoting their organizations' performance and is carried out in the form of teamwork called participatory research. Results are presented in four parts as basic concepts, clinical reasoning assessment, test framework, and scoring. we concluded that no single test could thoroughly assess clinical reasoning competency, and therefore a battery of clinical reasoning tests is needed. This battery should cover all three parts of clinical reasoning process: script activation, selection and verification. In addition, not only both analytical and non-analytical reasoning, but also both diagnostic and management reasoning should evenly take into consideration in this battery. This paper explains the process of designing and implementing the battery of clinical reasoning in the Olympiad for medical sciences students through an action research.

A Generalized Random Regret Minimization Model

NARCIS (Netherlands)

Chorus, C.G.

2013-01-01

This paper presents, discusses and tests a generalized Random Regret Minimization (G-RRM) model. The G-RRM model is created by replacing a fixed constant in the attribute-specific regret functions of the RRM model, by a regret-weight variable. Depending on the value of the regret-weights, the G-RRM

The quality of veterinary in-clinic and reference laboratory biochemical testing.

Science.gov (United States)

Rishniw, Mark; Pion, Paul D; Maher, Tammy

2012-03-01

Although evaluation of biochemical analytes in blood is common in veterinary practice, studies assessing the global quality of veterinary in-clinic and reference laboratory testing have not been reported. The aim of this study was to assess the quality of biochemical testing in veterinary laboratories using results obtained from analyses of 3 levels of assayed quality control materials over 5 days. Quality was assessed by comparison of calculated total error with quality requirements, determination of sigma metrics, use of a quality goal index to determine factors contributing to poor performance, and agreement between in-clinic and reference laboratory mean results. The suitability of in-clinic and reference laboratory instruments for statistical quality control was determined using adaptations from the computerized program, EZRules3. Reference laboratories were able to achieve desirable quality requirements more frequently than in-clinic laboratories. Across all 3 materials, > 50% of in-clinic analyzers achieved a sigma metric ≥ 6.0 for measurement of 2 analytes, whereas > 50% of reference laboratory analyzers achieved a sigma metric ≥ 6.0 for measurement of 6 analytes. Expanded uncertainty of measurement and ± total allowable error resulted in the highest mean percentages of analytes demonstrating agreement between in-clinic and reference laboratories. Owing to marked variation in bias and coefficient of variation between analyzers of the same and different types, the percentages of analytes suitable for statistical quality control varied widely. These findings reflect the current state-of-the-art with regard to in-clinic and reference laboratory analyzer performance and provide a baseline for future evaluations of the quality of veterinary laboratory testing. © 2012 American Society for Veterinary Clinical Pathology.

National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for use of tumor markers in clinical practice

DEFF Research Database (Denmark)

Sturgeon, Catharine M; Hoffman, Barry R; Chan, Daniel W

2008-01-01

BACKGROUND: This report presents updated National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines summarizing quality requirements for the use of tumor markers. METHODS: One subcommittee developed guidelines for analytical quality relevant to serum and tissue-based tumor...... questions to ensure selection of the appropriate test, adherence to good clinical and laboratory practices (e.g., minimization of the risk of incorrect patient and/or specimen identification, tube type, or timing), use of internationally standardized and well-characterized methods, careful adherence...... records. Also mandatory is extensive validation encompassing all stages of analysis before introduction of new technologies such as microarrays and mass spectrometry. Provision of high-quality tumor marker services is facilitated by dialogue involving researchers, diagnostic companies, clinical...

Cost-effectiveness of minimally invasive sacroiliac joint fusion.

Science.gov (United States)

Cher, Daniel J; Frasco, Melissa A; Arnold, Renée Jg; Polly, David W

2016-01-01

Sacroiliac joint (SIJ) disorders are common in patients with chronic lower back pain. Minimally invasive surgical options have been shown to be effective for the treatment of chronic SIJ dysfunction. To determine the cost-effectiveness of minimally invasive SIJ fusion. Data from two prospective, multicenter, clinical trials were used to inform a Markov process cost-utility model to evaluate cumulative 5-year health quality and costs after minimally invasive SIJ fusion using triangular titanium implants or non-surgical treatment. The analysis was performed from a third-party perspective. The model specifically incorporated variation in resource utilization observed in the randomized trial. Multiple one-way and probabilistic sensitivity analyses were performed. SIJ fusion was associated with a gain of approximately 0.74 quality-adjusted life years (QALYs) at a cost of US$13,313 per QALY gained. In multiple one-way sensitivity analyses all scenarios resulted in an incremental cost-effectiveness ratio (ICER) dysfunction due to degenerative sacroiliitis or SIJ disruption.

Minimal Residual Disease in Acute Myeloid Leukemia: Still a Work in Progress?

Directory of Open Access Journals (Sweden)

Federico Mosna

2017-06-01

Full Text Available Minimal residual disease evaluation refers to a series of molecular and immunophenotypical techniques aimed at detecting submicroscopic disease after therapy. As such, its application in acute myeloid leukemia has greatly increased our ability to quantify treatment response, and to determine the chemosensitivity of the disease, as the final product of the drug schedule, dose intensity, biodistribution, and the pharmakogenetic profile of the patient. There is now consistent evidence for the prognostic power of minimal residual disease evaluation in acute myeloid leukemia, which is complementary to the baseline prognostic assessment of the disease. The focus for its use is therefore shifting to individualize treatment based on a deeper evaluation of chemosensitivity and residual tumor burden. In this review, we will summarize the results of the major clinical studies evaluating minimal residual disease in acute myeloid leukemia in adults in recent years and address the technical and practical issues still hampering the spread of these techniques outside controlled clinical trials. We will also briefly speculate on future developments and offer our point of view, and a word of caution, on the present use of minimal residual disease measurements in “real-life” practice. Still, as final standardization and diffusion of the methods are sorted out, we believe that minimal residual disease will soon become the new standard for evaluating response in the treatment of acute myeloid leukemia.

A critique of statistical hypothesis testing in clinical research

Directory of Open Access Journals (Sweden)

Somik Raha

2011-01-01

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

Development of standardized approaches to reporting of minimal residual disease data using a reporting software package designed within the European LeukemiaNet

DEFF Research Database (Denmark)

Ostergaard, M; Nyvold, Charlotte Guldborg; Jovanovic, J V

2011-01-01

Quantitative PCR (qPCR) for detection of fusion transcripts and overexpressed genes is a promising tool for following minimal residual disease (MRD) in patients with hematological malignancies. Its widespread clinical use has to some extent been hampered by differences in data analysis and presen......Quantitative PCR (qPCR) for detection of fusion transcripts and overexpressed genes is a promising tool for following minimal residual disease (MRD) in patients with hematological malignancies. Its widespread clinical use has to some extent been hampered by differences in data analysis...... and presentation that complicate multicenter clinical trials. To address these issues, we designed a highly flexible MRD-reporting software program, in which data from various qPCR platforms can be imported, processed, and presented in a uniform manner to generate intuitively understandable reports. The software...... was tested in a two-step quality control (QC) study; the first step involved eight centers, whose previous experience with the software ranged from none to extensive. The participants received cDNA from consecutive samples from a BCR-ABL+ chronic myeloid leukemia (CML) patient and an acute myeloid leukemia...

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

Science.gov (United States)

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

2015-01-01

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

Advances in the use of inhalation provocation tests in clinical evaluation

NARCIS (Netherlands)

Hargreave, F. E.; Ramsdale, E. H.; Sterk, P. J.; Juniper, E. F.

1985-01-01

Recent advances in the use of inhalation provocation tests in the clinical evaluation of asthma have been made with methacholine and histamine tests. The tests can be better standardized and the results more accurately interpreted. The ease of stimulation of bronchoconstriction by methacholine and

Routine use of point-of-care tests: usefulness and application in clinical microbiology.

Science.gov (United States)

Clerc, O; Greub, G

2010-08-01

Point-of-care (POC) tests offer potentially substantial benefits for the management of infectious diseases, mainly by shortening the time to result and by making the test available at the bedside or at remote care centres. Commercial POC tests are already widely available for the diagnosis of bacterial and viral infections and for parasitic diseases, including malaria. Infectious diseases specialists and clinical microbiologists should be aware of the indications and limitations of each rapid test, so that they can use them appropriately and correctly interpret their results. The clinical applications and performance of the most relevant and commonly used POC tests are reviewed. Some of these tests exhibit insufficient sensitivity, and should therefore be coupled to confirmatory tests when the results are negative (e.g. Streptococcus pyogenes rapid antigen detection test), whereas the results of others need to be confirmed when positive (e.g. malaria). New molecular-based tests exhibit better sensitivity and specificity than former immunochromatographic assays (e.g. Streptococcus agalactiae detection). In the coming years, further evolution of POC tests may lead to new diagnostic approaches, such as panel testing, targeting not just a single pathogen, but all possible agents suspected in a specific clinical setting. To reach this goal, the development of serology-based and/or molecular-based microarrays/multiplexed tests will be needed. The availability of modern technology and new microfluidic devices will provide clinical microbiologists with the opportunity to be back at the bedside, proposing a large variety of POC tests that will allow quicker diagnosis and improved patient care.

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

Science.gov (United States)

Kawano, Seiji

2014-12-01

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

Clinic flow for STI, HIV, and TB patients in an urban infectious disease clinic offering point-of-care testing services in Durban, South Africa.

Science.gov (United States)

Stime, Katrina J; Garrett, Nigel; Sookrajh, Yukteshwar; Dorward, Jienchi; Dlamini, Ntuthu; Olowolagba, Ayo; Sharma, Monisha; Barnabas, Ruanne V; Drain, Paul K

2018-05-11

Many clinics in Southern Africa have long waiting times. The implementation of point-of-care (POC) tests to accelerate diagnosis and improve clinical management in resource-limited settings may improve or worsen clinic flow and waiting times. The objective of this study was to describe clinic flow with special emphasis on the impact of POC testing at a large urban public healthcare clinic in Durban, South Africa. We used time and motion methods to directly observe patients and practitioners. We created patient flow maps and recorded individual patient waiting and consultation times for patients seeking STI, TB, or HIV care. We conducted semi-structured interviews with 20 clinic staff to ascertain staff opinions on clinic flow and POC test implementation. Among 121 observed patients, the total number of queues ranged from 4 to 7 and total visit times ranged from 0:14 (hours:minutes) to 7:38. Patients waited a mean of 2:05 for standard-of-care STI management, and approximately 4:56 for STI POC diagnostic testing. Stable HIV patients who collected antiretroviral therapy refills waited a mean of 2:42 in the standard queue and 2:26 in the fast-track queue. A rapid TB test on a small sample of patients with the Xpert MTB/RIF assay and treatment initiation took a mean of 6:56, and 40% of patients presenting with TB-related symptoms were asked to return for an additional clinic visit to obtain test results. For all groups, the mean clinical assessment time with a nurse or physician was 7 to 9 min, which accounted for 2 to 6% of total visit time. Staff identified poor clinic flow and personnel shortages as areas of concern that may pose challenges to expanding POC tests in the current clinic environment. This busy urban clinic had multiple patient queues, long clinical visits, and short clinical encounters. Although POC testing ensured patients received a diagnosis sooner, it more than doubled the time STI patients spent at the clinic and did not result in same

Panel-Based Clinical Genetic Testing in 85 Children with Inherited Retinal Disease.

Science.gov (United States)

Taylor, Rachel L; Parry, Neil R A; Barton, Stephanie J; Campbell, Christopher; Delaney, Claire M; Ellingford, Jamie M; Hall, Georgina; Hardcastle, Claire; Morarji, Jiten; Nichol, Elisabeth J; Williams, Lindsi C; Douzgou, Sofia; Clayton-Smith, Jill; Ramsden, Simon C; Sharma, Vinod; Biswas, Susmito; Lloyd, I Chris; Ashworth, Jane L; Black, Graeme C; Sergouniotis, Panagiotis I

2017-07-01

To assess the clinical usefulness of genetic testing in a pediatric population with inherited retinal disease (IRD). Single-center retrospective case series. Eighty-five unrelated children with a diagnosis of isolated or syndromic IRD who were referred for clinical genetic testing between January 2014 and July 2016. Participants underwent a detailed ophthalmic examination, accompanied by electrodiagnostic testing (EDT) and dysmorphologic assessment where appropriate. Ocular and extraocular features were recorded using Human Phenotype Ontology terms. Subsequently, multigene panel testing (105 or 177 IRD-associated genes) was performed in an accredited diagnostic laboratory, followed by clinical variant interpretation. Diagnostic yield and clinical usefulness of genetic testing. Overall, 78.8% of patients (n = 67) received a probable molecular diagnosis; 7.5% (n = 5) of these had autosomal dominant disease, 25.4% (n = 17) had X-linked disease, and 67.2% (n = 45) had autosomal recessive disease. In a further 5.9% of patients (n = 5), a single heterozygous ABCA4 variant was identified; all these participants had a spectrum of clinical features consistent with ABCA4 retinopathy. Most participants (84.7%; n = 72) had undergone EDT and 81.9% (n = 59) of these patients received a probable molecular diagnosis. The genes most frequently mutated in the present cohort were CACNA1F and ABCA4, accounting for 14.9% (n = 10) and 11.9% (n = 8) of diagnoses respectively. Notably, in many cases, genetic testing helped to distinguish stationary from progressive IRD subtypes and to establish a precise diagnosis in a timely fashion. Multigene panel testing pointed to a molecular diagnosis in 84.7% of children with IRD. The diagnostic yield in the study population was significantly higher compared with that in previously reported unselected IRD cohorts. Approaches similar to the one described herein are expected to become a standard component of care in pediatric ophthalmology

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

Directory of Open Access Journals (Sweden)

Warrington RJ

2006-06-01

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

Clinical acceptance testing and scanner comparison of ultrasound shear wave elastography.

Science.gov (United States)

Long, Zaiyang; Tradup, Donald J; Song, Pengfei; Stekel, Scott F; Chen, Shigao; Glazebrook, Katrina N; Hangiandreou, Nicholas J

2018-03-15

Because of the rapidly growing use of ultrasound shear wave elastography (SWE) in clinical practices, there is a significant need for development of clinical physics performance assessment methods for this technology. This study aims to report two clinical medical physicists' tasks: (a) acceptance testing (AT) of SWE function on ten commercial ultrasound systems for clinical liver application and (b) comparison of SWE measurements of targets across vendors for clinical musculoskeletal application. For AT, ten GE LOGIQ E9 XDclear 2.0 scanners with ten C1-6-D and ten 9L-D transducers were studied using two commercial homogenous phantoms. Five measurements were acquired at two depths for each scanner/transducer pair by two operators. Additional tests were performed to access effects of different coupling media, phantom locations and operators. System deviations were less than 5% of group mean or three times standard deviation; therefore, all systems passed AT. A test protocol was provided based on results that no statistically significant difference was observed between using ultrasound gel and salt water for coupling, among different phantom locations, and that interoperator and intraoperator coefficient of variation was less than 3%. For SWE target measurements, two systems were compared - a Supersonic Aixplorer scanner with a SL10-2 and a SL15-4 transducer, and an abovementioned GE scanner with 9L-D transducer. Two stepped cylinders with diameters of 4.05-10.40 mm were measured both longitudinally and transaxially. Target shear wave speed quantification was performed using an in-house MATLAB program. Using the target shear wave speed deduced from phantom specs as a reference, SL15-4 performed the best at the measured depth. However, it was challenging to reliably measure a 4.05 mm target for either system. The reported test methods and results could provide important information when dealing with SWE-related tasks in the clinical environment. © 2018 The Authors

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

Science.gov (United States)

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

2016-03-01

This study aimed to examine the validity of the Naturalistic Action Test in differentiating Mild Cognitive Impairment from early dementia compared to clinical diagnosis and ascertain Naturalistic Action Test cut-off points. This was a cross-sectional study of 70 consecutive patients diagnosed with Mild Cognitive Impairment attending the memory clinic in St James's Hospital, Dublin, Ireland. Patients with a diagnosis of Mild Cognitive Impairment who attended for routine annual assessment were asked to participate in the study. The Naturalistic Action Test was carried out after the patient had completed their routine assessment in the clinic. The Area under the Curve, AUC ± SE was 0.808 ± 0.058, p Cognitive Impairment in our study (PPV 50%, NPV 91%, sensitivity 78%, specificity 73% and accuracy of 74%). There was discrepancy in 18 patients using the new cut-off point (≥11 for Mild Cognitive Impairment vs ≤10 for dementia). The Naturalistic Action Test is a useful tool that can increase diagnostic accuracy in differentiating Mild Cognitive Impairment from early dementia. Copyright © 2015 John Wiley & Sons, Ltd.

Compatibility of Clinical Manifestation with Skin Prick Test Result and Food Provocation Test in Food Cross Reaction

OpenAIRE

Lubis, Azwin; Barlianto, Wisnu; Endaryanto, Anang; Harsono, Ariyanto

2017-01-01

Background: Subjective diagnostic test of food allergy is hugely biased, resulting in irrational diet avoidance. Additional objective tools by skin prick test following food provocation test resulting more accurate cause and prevalence on population. Purpose: To evaluate the compatibility of clinical symptoms with skin prick test and provocation test for imunoglobulin E (IgE) mediated food allergy in Dr. Soetomo Hospital Surabaya. Methods: Cross sectional observational analytic study. Patient...

The clinical testing of male gonad shields. Technical report

International Nuclear Information System (INIS)

Church, W.W.; Burnett, B.M.

1975-11-01

Two types of male gonad shields, designed for use with support garments, were tested in a number of hospitals and clinics throughout the United States. The clinical evaluation consisted of: (1) measuring dose reduction with thermoluminescent dosimeters; and (2) determining acceptability of the shields for routine use in x-ray facilities, through the use of survey forms completed by patients, technologists, and facilities. The shields proved to provide a basis for a very satisfactory male gonad shield program

The clinical testing of male gonad shields. Technical report

Energy Technology Data Exchange (ETDEWEB)

Church, W.W.; Burnett, B.M.

1975-11-01

Two types of male gonad shields, designed for use with support garments, were tested in a number of hospitals and clinics throughout the United States. The clinical evaluation consisted of: (1) measuring dose reduction with thermoluminescent dosimeters; and (2) determining acceptability of the shields for routine use in x-ray facilities, through the use of survey forms completed by patients, technologists, and facilities. The shields proved to provide a basis for a very satisfactory male gonad shield program. (GRA)

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

Directory of Open Access Journals (Sweden)

Chmielewski Mariusz

2017-01-01

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

CLINICAL TESTS FOR THE ASSESSMENT OF THE PELVIC GIRDLE PAIN IN PREGNANCY AND POSTPARTUM

Directory of Open Access Journals (Sweden)

Darija Šćepanović

2018-02-01

Full Text Available Background: Pregnancy-related pelvic girdle pain (PGP refers to the pain in the lumbosacral region, the sacroiliac joints and the symphysis pubis joint. The results of the high methodological quality studies indicate that the point prevalence of pregnant women suffering from PGP is about 20 %. Pregnancy-related PGP requires a comprehensive physiotherapy assessment in order to make or confirm a diagnosis, plan the treatment and evaluate the patient’s condi- tion. Physiotherapy assessment includes clinical diagnostic tests which should satisfy the criteria of safety, feasibility, reliability, sensitivity, specificity and validity. The aim of the present paper was to systematically review the literature on clinical diagnostic tests of PGP in order to determine which clinical tests meet the necessary criteria and are appropriate for clinical examination of PGP in pregnancy and postpartum. Methods: PubMed, Cinahl, Embase, Index Medicus databases and the Cochrane controlled trials reg- ister from 1980 to 2008 were searched using the key words, pregnancy/pelvic girdle pain, pregnancy/clinical tests/sacroiliac joint/symphysis pubis. Only the articles/texts in English and Slovene were reviewed unless translated abstract was available. Additional manual searches of the reference lists in books and review articles were undertaken. Along with the randomized clinical studies the literature search encompassed also the basic studies. Results: Nine studies evaluating the tests for clinical examination of the pregnancy-related PGP met the criteria for inclusion in this review. The studies evaluated and analysed six provocation tests for the sacroiliac joint, namely, the Posterior pelvic pain provocation test (P4, Patrick’s Faber test, palpation of the long dorsal ligament, compression test, separation test, Menell’s test as well as two provocation tests for the symphysis pubis joint (pain palpation and a modified Trendelenburg test and one functional

Assessing clinical reasoning in optometry using the script concordance test.

Science.gov (United States)

Faucher, Caroline; Dufour-Guindon, Marie-Pier; Lapointe, Gabrielle; Gagnon, Robert; Charlin, Bernard

2016-05-01

Clinical reasoning is central to any health profession but its development among learners is difficult to assess. Over the last few decades, the script concordance test (SCT) has been developed to solve this dilemma and has been used in many health professions; however, no study has been published on the use of the script concordance test in optometry. The purpose of this study was to develop and validate a script concordance test for the field of optometry. A 101-question script concordance test (27 short clinical scenarios) was developed and administered online to a convenience sample of 23 second-year and 19 fourth-year students of optometry. It was also administered to a reference panel of 12 experienced optometrists to develop the scoring key. An item-total correlation was calculated for each question. Cronbach's alpha coefficient was used to evaluate the script concordance test reliability and a t-test compared the two groups. A final 77-question script concordance test was created by eliminating questions with low item-total correlation. Cronbach's alpha for this optimised 77-question script concordance test was 0.80. A group comparison revealed that the second-year students' scores (n = 23; mean score = 66.4 ± 7.87 per cent) were statistically lower (t = -4.141; p Optometry © 2016 Optometry Australia.

Obtaining patient test results from clinical laboratories: a survey of state law for pharmacists.

Science.gov (United States)

Witry, Matthew J; Doucette, William R

2009-01-01

To identify states with laws that restrict to whom clinical laboratories may release copies of laboratory test results and to describe how these laws may affect pharmacists' ability to obtain patient laboratory test results. Researchers examined state statutes and administrative codes for all 50 states and the District of Columbia at the University of Iowa Law Library between June and July 2007. Researchers also consulted with lawyers, state Clinical Laboratory Improvement Amendments officers, and law librarians. Laws relating to the study objective were analyzed. 34 jurisdictions do not restrict the release of laboratory test results, while 17 states have laws that restrict to whom clinical laboratories can send copies of test results. In these states, pharmacists will have to use alternative sources, such as physician offices, to obtain test results. Pharmacists must consider state law before requesting copies of laboratory test results from clinical laboratories. This may be an issue that state pharmacy associations can address to increase pharmacist access to important patient information.

Application of Minimally Invasive Treatment of Locking Compression Plate in Schatzker Ⅰ-Ⅲ Tibial Plateau Fracture

OpenAIRE

Guohui Zhao

2014-01-01

Objective: To investigate the clinical effect of minimally invasive treatment of locking compression plate (LCP) in Schatzker Ⅰ-Ⅲ tibial plateau fracture. Methods: Thirty-eight patients with Schatzker Ⅰ-Ⅲ tibial plateau fracture in our hospital were given minimally invasive treatment of LCP, and the artificial bone was transplanted to the depressed bone. Adverse responses, wound healing time and clinical efficacy were observed. Results: All patients were followed-up for 14- 20 months, and the...

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

Directory of Open Access Journals (Sweden)

Ali Habib

2012-01-01

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

PSA testing without clinical indication for prostate cancer in relation to socio-demographic and clinical characteristics in the Danish Diet, Cancer and Health Study

DEFF Research Database (Denmark)

Karlsen, Randi V; Larsen, Signe B; Christensen, Jane

2013-01-01

Background. Social differences in prostate cancer (PC) incidence and mortality might be related to testing for prostate-specific antigen (PSA). Although routine PSA screening is not recommended in Denmark, testing without clinical indication increased during the past decade. We evaluated...... associations between socio-demographic or clinical characteristics and PSA testing without clinical indication. Material and methods. In the Danish Diet, Cancer and Health Cohort, we identified 1051 men with PC diagnosed in 1993-2008. Diagnostic and clinical characteristics were obtained from medical records......, and socio-demographic information was retrieved from administrative registers. We used general logistic regression analysis to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for associations between socio-demographic or clinical characteristics and PSA testing without clinical indication. Cox...

Lentivector Iterations and Pre-Clinical Scale-Up/Toxicity Testing: Targeting Mobilized CD34+ Cells for Correction of Fabry Disease

Directory of Open Access Journals (Sweden)

Ju Huang

2017-06-01

Full Text Available Fabry disease is a rare lysosomal storage disorder (LSD. We designed multiple recombinant lentivirus vectors (LVs and tested their ability to engineer expression of human α-galactosidase A (α-gal A in transduced Fabry patient CD34+ hematopoietic cells. We further investigated the safety and efficacy of a clinically directed vector, LV/AGA, in both ex vivo cell culture studies and animal models. Fabry mice transplanted with LV/AGA-transduced hematopoietic cells demonstrated α-gal A activity increases and lipid reductions in multiple tissues at 6 months after transplantation. Next we found that LV/AGA-transduced Fabry patient CD34+ hematopoietic cells produced even higher levels of α-gal A activity than normal CD34+ hematopoietic cells. We successfully transduced Fabry patient CD34+ hematopoietic cells with “near-clinical grade” LV/AGA in small-scale cultures and then validated a clinically directed scale-up transduction process in a GMP-compliant cell processing facility. LV-transduced Fabry patient CD34+ hematopoietic cells were subsequently infused into NOD/SCID/Fabry (NSF mice; α-gal A activity corrections and lipid reductions were observed in several tissues 12 weeks after the xenotransplantation. Additional toxicology studies employing NSF mice xenotransplanted with the therapeutic cell product demonstrated minimal untoward effects. These data supported our successful clinical trial application (CTA to Health Canada and opening of a “first-in-the-world” gene therapy trial for Fabry disease.

Genetic counselors' (GC) knowledge, awareness, understanding of clinical next-generation sequencing (NGS) genomic testing.

Science.gov (United States)

Boland, P M; Ruth, K; Matro, J M; Rainey, K L; Fang, C Y; Wong, Y N; Daly, M B; Hall, M J

2015-12-01

Genomic tests are increasingly complex, less expensive, and more widely available with the advent of next-generation sequencing (NGS). We assessed knowledge and perceptions among genetic counselors pertaining to NGS genomic testing via an online survey. Associations between selected characteristics and perceptions were examined. Recent education on NGS testing was common, but practical experience limited. Perceived understanding of clinical NGS was modest, specifically concerning tumor testing. Greater perceived understanding of clinical NGS testing correlated with more time spent in cancer-related counseling, exposure to NGS testing, and NGS-focused education. Substantial disagreement about the role of counseling for tumor-based testing was seen. Finally, a majority of counselors agreed with the need for more education about clinical NGS testing, supporting this approach to optimizing implementation. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Pattern Of Skin Prick Allergy Test Results In Enugu | Mgbor ...

African Journals Online (AJOL)

In this study we report on pattern of allergy prick skin test results found among atopic patients attending the department of otorhinolargngology of the University of Nigeria Teaching Hospital Enugu and Hansa Clinics, Enugu and propose ways of minimizing the exposure of the population to allergens. Material and method

Evolutions in clinical reasoning assessment: The Evolving Script Concordance Test.

Science.gov (United States)

Cooke, Suzette; Lemay, Jean-François; Beran, Tanya

2017-08-01

Script concordance testing (SCT) is a method of assessment of clinical reasoning. We developed a new type of SCT case design, the evolving SCT (E-SCT), whereby the patient's clinical story is "evolving" and with thoughtful integration of new information at each stage, decisions related to clinical decision-making become increasingly clear. We aimed to: (1) determine whether an E-SCT could differentiate clinical reasoning ability among junior residents (JR), senior residents (SR), and pediatricians, (2) evaluate the reliability of an E-SCT, and (3) obtain qualitative feedback from participants to help inform the potential acceptability of the E-SCT. A 12-case E-SCT, embedded within a 24-case pediatric SCT (PaedSCT), was administered to 91 pediatric residents (JR: n = 50; SR: n = 41). A total of 21 pediatricians served on the panel of experts (POE). A one-way analysis of variance (ANOVA) was conducted across the levels of experience. Participants' feedback on the E-SCT was obtained with a post-test survey and analyzed using two methods: percentage preference and thematic analysis. Statistical differences existed across levels of training: F = 19.31 (df = 2); p decision-making process. The E-SCT demonstrated very good reliability and was effective in distinguishing clinical reasoning ability across three levels of experience. Participants found the E-SCT engaging and representative of real-life clinical reasoning and decision-making processes. We suggest that further refinement and utilization of the evolving style case will enhance SCT as a robust, engaging, and relevant method for the assessment of clinical reasoning.

Feline genetics: clinical applications and genetic testing.

Science.gov (United States)

Lyons, Leslie A

2010-11-01

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

Minimal clinically important difference and the effect of clinical variables on the ankle osteoarthritis scale in surgically treated end-stage ankle arthritis.

Science.gov (United States)

Coe, Marcus P; Sutherland, Jason M; Penner, Murray J; Younger, Alastair; Wing, Kevin J

2015-05-20

There is much debate regarding the best outcome tool for use in foot and ankle surgery, specifically in patients with ankle arthritis. The Ankle Osteoarthritis Scale (AOS) is a validated, disease-specific score. The goals of this study were to investigate the clinical performance of the AOS and to determine a minimal clinically important difference (MCID) for it, using a large cohort of 238 patients undergoing surgery for end-stage ankle arthritis. Patients treated with total ankle arthroplasty or ankle arthrodesis were prospectively followed for a minimum of two years at a single site. Data on demographics, comorbidities, AOS score, Short Form-36 results, and the relationship between expectations and satisfaction were collected at baseline (preoperatively), at six and twelve months, and then yearly thereafter. A linear regression analysis examined the variables affecting the change in AOS scores between baseline and the two-year follow-up. An MCID in the AOS change score was then determined by employing an anchor question, which asked patients to rate their relief from symptoms after surgery. Surgical treatment of end-stage ankle arthritis resulted in a mean improvement (and standard deviation) of 31.2 ± 22.7 points in the AOS score two years after surgery. The MCID of the AOS change score was a mean of 28.0 ± 17.9 points. The change in AOS score was significantly affected by the preoperative AOS score, smoking, back pain, and age. Patients undergoing arthroplasty or arthrodesis for end-stage ankle arthritis experienced a mean improvement in AOS score that was greater than the estimated MCID (31.2 versus 28.0 points). Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

The Use of the Bilingual Aphasia Test for Assessment and Transcranial Direct Current Stimulation to Modulate Language Acquisition in Minimally Verbal Children with Autism

Science.gov (United States)

Schneider, Harry D.; Hopp, Jenna P.

2011-01-01

Minimally verbal children with autism commonly demonstrate language dysfunction, including immature syntax acquisition. We hypothesised that transcranial direct current stimulation (tDCS) should facilitate language acquisition in a cohort (n = 10) of children with immature syntax. We modified the English version of the Bilingual Aphasia Test (BAT)…

How to start a minimal access mitral valve program.

Science.gov (United States)

Hunter, Steven

2013-11-01

The seven pillars of governance established by the National Health Service in the United Kingdom provide a useful framework for the process of introducing new procedures to a hospital. Drawing from local experience, the author present guidance for institutions considering establishing a minimal access mitral valve program. The seven pillars of governance apply to the practice of minimally invasive mitral valve surgery, based on the principle of patient-centred practice. The author delineate the benefits of minimally invasive mitral valve surgery in terms of: "clinical effectiveness", including reduced length of hospital stay, "risk management effectiveness", including conversion to sternotomy and aortic dissection, "patient experience" including improved cosmesis and quicker recovery, and the effectiveness of communication, resources and strategies in the implementation of minimally invasive mitral valve surgery. Finally, the author have identified seven learning curves experienced by surgeons involved in introducing a minimal access mitral valve program. The learning curves are defined as: techniques of mitral valve repair, Transoesophageal Echocardiography-guided cannulation, incisions, instruments, visualization, aortic occlusion and cardiopulmonary bypass strategies. From local experience, the author provide advice on how to reduce the learning curves, such as practising with the specialised instruments and visualization techniques during sternotomy cases. Underpinning the NHS pillars are the principles of systems awareness, teamwork, communication, ownership and leadership, all of which are paramount to performing any surgery but more so with minimal access surgery, as will be highlighted throughout this paper.

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

Science.gov (United States)

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

2009-02-01

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

"Look at my classifier's result": Disentangling unresponsive from (minimally) conscious patients.

Science.gov (United States)

Noirhomme, Quentin; Brecheisen, Ralph; Lesenfants, Damien; Antonopoulos, Georgios; Laureys, Steven

2017-01-15

Given the fact that clinical bedside examinations can have a high rate of misdiagnosis, machine learning techniques based on neuroimaging and electrophysiological measurements are increasingly being considered for comatose patients and patients with unresponsive wakefulness syndrome, a minimally conscious state or locked-in syndrome. Machine learning techniques have the potential to move from group-level statistical results to personalized predictions in a clinical setting. They have been applied for the purpose of (1) detecting changes in brain activation during functional tasks, equivalent to a behavioral command-following test and (2) estimating signs of consciousness by analyzing measurement data obtained from multiple subjects in resting state. In this review, we provide a comprehensive overview of the literature on both approaches and discuss the translation of present findings to clinical practice. We found that most studies struggle with the difficulty of establishing a reliable behavioral assessment and fluctuations in the patient's levels of arousal. Both these factors affect the training and validation of machine learning methods to a considerable degree. In studies involving more than 50 patients, small to moderate evidence was found for the presence of signs of consciousness or good outcome, where one study even showed strong evidence for good outcome. Copyright © 2015 Elsevier Inc. All rights reserved.

Hip Arthroscopy Outcomes With Respect to Patient Acceptable Symptomatic State and Minimal Clinically Important Difference.

Science.gov (United States)

Levy, David M; Kuhns, Benjamin D; Chahal, Jaskarndip; Philippon, Marc J; Kelly, Bryan T; Nho, Shane J

2016-09-01

To determine whether the hip arthroscopy literature to date has shown outcomes consistent with published patient acceptable symptomatic state (PASS) and minimal clinically important difference (MCID) estimates. All clinical investigations of hip arthroscopy using modified Harris Hip Score (mHHS) and/or Hip Outcome Score (HOS) outcomes with at least 1 year of follow-up were reviewed. Ninety-one studies (9,746 hips) were included for review. Eighty-one studies (9,317 hips) contained only primary hip arthroscopies and were the primary focus of this review. The remaining studies (429 hips) did not exclude patients with prior surgical history and were thus considered separately. Mean mHHS, HOS-ADL (Activities of Daily Living) and HOS-SS (Sports-Specific) scores were compared with previously published PASS and MCID values. After 31 ± 20 months, 5.8% of study populations required revision arthroscopy and 5.5% total hip arthroplasty. A total of 88%, 25%, and 30% of study populations met PASS for mHHS, HOS-ADL, and HOS-SS, respectively, and 97%, 90%, and 93% met MCID. On bivariate analysis, increasing age was associated with significantly worse postoperative mHHS (P arthroscopy, we have found that more than 90% of study populations meet MCID standards for the most commonly used patient-reported outcomes measures in hip arthroscopy literature, mHHS and HOS. Eighty-eight percent meet PASS standards for the mHHS, but PASS standards are far more difficult to achieve for HOS-ADL (25%) and HOS-SS (30%) subscales. Differences in psychometric properties of the mHHS and HOS likely account for the discrepancies in PASS. Level IV, systematic review of Level I to IV studies. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

The burden of minimal hepatic encephalopathy: from diagnosis to therapeutic strategies

Science.gov (United States)

Ridola, Lorenzo; Cardinale, Vincenzo; Riggio, Oliviero

2018-01-01

Minimal hepatic encephalopathy (MHE) is the mildest form of hepatic encephalopathy (HE). It affects the performance of psychometric tests focused on attention, working memory, psychomotor speed, and visuospatial ability, as well as electrophysiological and other functional brain measures. MHE is a frequent complication of liver disease, affecting up to 80% of tested patients. By being related to falls, an impairment in fitness to drive and the development of overt HE, MHE severely affects the lives of patients and caregivers by altering their quality of life and their socioeconomic status. MHE is detected in clinically asymptomatic patients using appropriate psychometric tests and neurophysiological methods that highlight neuropsychological alterations, such as video-spatial orientation deficits, attention disorders, memory, reaction times, electroencephalogram slowing, prolongation of latency-evoked cognitive potentials, and reduction in the critical flicker frequency. Several treatments have been proposed for MHE treatment, including non-absorbable disaccharides, poorly absorbable antibiotics such as rifaximin, probiotics and branched-chain amino acids. However, because of the multiple diagnosis methods, the various endpoints of treatment trials and the variety of agents used in trials, the treatment of MHE is not currently recommended as routine, but only on a case-by-case basis. PMID:29507462

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

Science.gov (United States)

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

2012-11-01

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

Molecular identification and amphotericin B susceptibility testing of clinical isolates of Aspergillus from 11 hospitals in Korea.

Science.gov (United States)

Heo, Min Seok; Shin, Jong Hee; Choi, Min Ji; Park, Yeon Joon; Lee, Hye Soo; Koo, Sun Hoe; Lee, Won Gil; Kim, Soo Hyun; Shin, Myung Geun; Suh, Soon Pal; Ryang, Dong Wook

2015-11-01

We investigated the species distribution and amphotericin B (AMB) susceptibility of Korean clinical Aspergillus isolates by using two Etests and the CLSI broth microdilution method. A total of 136 Aspergillus isolates obtained from 11 university hospitals were identified by sequencing the internal transcribed spacer (ITS) and β-tubulin genomic regions. Minimal inhibitory concentrations (MICs) of AMB were determined in Etests using Mueller-Hinton agar (Etest-MH) and RPMI agar (Etest-RPG), and categorical agreement with the CLSI method was assessed by using epidemiological cutoff values. ITS sequencing identified the following six Aspergillus species complexes: Aspergillus fumigatus (42.6% of the isolates), A. niger (23.5%), A. flavus (17.6%), A. terreus (11.0%), A. versicolor (4.4%), and A. ustus (0.7%). Cryptic species identifiable by β-tubulin sequencing accounted for 25.7% (35/136) of the isolates. Of all 136 isolates, 36 (26.5%) had AMB MICs of ≥2 μg/mL by the CLSI method. The categorical agreement of Etest-RPG with the CLSI method was 98% for the A. fumigatus, A. niger, and A. versicolor complexes, 87% for the A. terreus complex, and 37.5% for the A. flavus complex. That of Etest-MH was ≤75% for the A. niger, A. flavus, A. terreus, and A. versicolor complexes but was higher for the A. fumigatus complex (98.3%). Aspergillus species other than A. fumigatus constitute about 60% of clinical Aspergillus isolates, and reduced AMB susceptibility is common among clinical isolates of Aspergillus in Korea. Molecular identification and AMB susceptibility testing by Etest-RPG may be useful for characterizing Aspergillus isolates of clinical relevance.

Reducing duplicate testing: a comparison of two clinical decision support tools.

Science.gov (United States)

Procop, Gary W; Keating, Catherine; Stagno, Paul; Kottke-Marchant, Kandice; Partin, Mary; Tuttle, Robert; Wyllie, Robert

2015-05-01

Unnecessary duplicate laboratory testing is common and costly. Systems-based means to avert unnecessary testing should be investigated and employed. We compared the effectiveness and cost savings associated with two clinical decision support tools to stop duplicate testing. The Hard Stop required telephone contact with the laboratory and justification to have the duplicate test performed, whereas the Smart Alert allowed the provider to bypass the alert at the point of order entry without justification. The Hard Stop alert was significantly more effective than the Smart Alert (92.3% vs 42.6%, respectively; P < .0001). The cost savings realized per alert activation was $16.08/alert for the Hard Stop alert vs $3.52/alert for the Smart Alert. Structural and process changes that require laboratory contact and justification for duplicate testing are more effective than interventions that allow providers to bypass alerts without justification at point of computerized physician order entry. Copyright© by the American Society for Clinical Pathology.

Minimally Invasive and Open Distal Chevron Osteotomy for Mild to Moderate Hallux Valgus.

Science.gov (United States)

Brogan, Kit; Lindisfarne, Edward; Akehurst, Harold; Farook, Usama; Shrier, Will; Palmer, Simon

2016-11-01

Minimally invasive surgical (MIS) techniques are increasingly being used in foot and ankle surgery but it is important that they are adopted only once they have been shown to be equivalent or superior to open techniques. We believe that the main advantages of MIS are found in the early postoperative period, but in order to adopt it as a technique longer-term studies are required. The aim of this study was to compare the 2-year outcomes of a third-generation MIS distal chevron osteotomy with a comparable traditional open distal chevron osteotomy for mild-moderate hallux valgus. Our null hypothesis was that the 2 techniques would yield equivalent clinical and radiographic results at 2 years. This was a retrospective cohort study. Eighty-one consecutive feet (49 MIS and 32 open distal chevron osteotomies) were followed up for a minimum 24 months (range 24-58). All patients were clinically assessed using the Manchester-Oxford Foot Questionnaire. Radiographic measures included hallux valgus angle, the intermetatarsal angle, hallux interphalangeal angle, metatarsal phalangeal joint angle, distal metatarsal articular angle, tibial sesamoid position, shape of the first metatarsal head, and plantar offset. Statistical analysis was done using Student t test or Wilcoxon rank-sum test for continuous data and Pearson chi-square test for categorical data. Clinical and radiologic postoperative scores in all domains were substantially improved in both groups (P .05). There were no significant differences in complications between the 2 groups ( > .5). The midterm results of this third-generation technique show that it was a safe procedure with good clinical outcomes and comparable to traditional open techniques for symptomatic mild-moderate hallux valgus. Level III, retrospective comparative study. © The Author(s) 2016.

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

Directory of Open Access Journals (Sweden)

S. Sarubbo

2012-01-01

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

Clinical evaluation of serum bile acids as a new liver function test

Energy Technology Data Exchange (ETDEWEB)

Biffl, H; Pristautz, H; Parsche, P; Passath, A; Leb, G [Graz Univ. (Austria). Medizinische Klinik

1980-01-01

In a randomized patient material, with various histologically verified hepatobiliary diseases, the serum levels of Cholyl glycine (CG) and Sulfolithocholyl glycine (SLCG) were compared with each other. SLCG levels are a more sensitive parameter and permit a more significant differentiation between fatty and normal livers and between cases with and without portal hypertension in liver cirrhosis. There were poor correlations between the hitherto routinely performed laboratory tests and the SLCG levels, but good correlations between SLCG and defined parenchymal liver diseases. The publication ends with the presentation of a newly developed SLCG-stimulation test, which provides a staging of parenchymal liver diseases without unnecessary requirements of time and material and with minimal stress to the patients.

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

Directory of Open Access Journals (Sweden)

Robert A. Hauser

2014-01-01

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

Precision electroweak tests of the minimal and flipped SU(5) supergravity models

Energy Technology Data Exchange (ETDEWEB)

Lopez, J.L.; Nanopoulos, D.V.; Park, G.T.; Pois, H.; Yuan, K. (Center for Theoretical Physics, Department of Physics, Texas A M University, College Station, Texas 77843-4242 (United States) Astroparticle Physics Group, Houston Advanced Research Center (HARC), The Woodlands, Texas 77381 (United States))

1993-10-01

We explore the one-loop electroweak radiative corrections in the minimal SU(5) and the no-scale flipped SU(5) supergravity models via explicit calculation of vacuum polarization contributions to the [epsilon][sub 1,2,3] parameters. Experimentally, [epsilon][sub 1,2,3] are obtained from a global fit to the CERN LEP observables, and [ital M][sub [ital W

Use of Minimally Invasive Distal Metatarsal Osteotomy for Correction of Hallux Valgus

Directory of Open Access Journals (Sweden)

Chun-Kit Tong

2012-06-01

Conclusion: Good clinical and radiographic results have been achieved with minimally invasive techniques for treatment of hallux valgus. This is an acceptable alternative operation for mild-to-moderate hallux valgus.

Japanese Society of Medical Oncology Clinical Guidelines: Molecular Testing for Colorectal Cancer Treatment, Third Edition.

Science.gov (United States)

Yamazaki, Kentaro; Taniguchi, Hiroya; Yoshino, Takayuki; Akagi, Kiwamu; Ishida, Hideyuki; Ebi, Hiromichi; Nakatani, Kaname; Muro, Kei; Yatabe, Yasushi; Yamaguchi, Kensei; Tsuchihara, Katsuya

2018-06-01

The Japanese Society of Medical Oncology (JSMO) previously published 2 editions of the clinical guidelines: "Japanese guidelines for testing of KRAS gene mutation in colorectal cancer" in 2008 and "Japanese Society of Medical Oncology Clinical Guidelines: RAS (KRAS/NRAS) mutation testing in colorectal cancer patients" in 2014. These guidelines have contributed to the proper use of KRAS and RAS mutation testing, respectively. Recently, clinical utility, particularly for colorectal cancer (CRC) patients with BRAF V600E mutation or DNA mismatch-repair (MMR) deficiency, has been established. Therefore, the guideline members decided these genetic alterations should also be involved. The aim of this revision is to properly carry out testing for BRAF V600E mutation and MMR deficiency in addition to RAS mutation. The revised guidelines include the basic requirements for testing for these genetic alterations based on recent scientific evidence. Furthermore, because clinical utility of comprehensive genetic testing using next-generation sequencing and somatic gene testing of analyzing circulating tumor DNA has increasingly evolved with recent advancements in testing technology, we noted the current situation and prospects for these testing technologies and their clinical implementation in the revised guidelines. © 2018 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

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

Science.gov (United States)

2010-04-01

... minimal risk but presenting the prospect of direct benefit to individual subjects. 50.52 Section 50.52... investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual... prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to...

A Window Into Clinical Next-Generation Sequencing-Based Oncology Testing Practices.

Science.gov (United States)

Nagarajan, Rakesh; Bartley, Angela N; Bridge, Julia A; Jennings, Lawrence J; Kamel-Reid, Suzanne; Kim, Annette; Lazar, Alexander J; Lindeman, Neal I; Moncur, Joel; Rai, Alex J; Routbort, Mark J; Vasalos, Patricia; Merker, Jason D

2017-12-01

- Detection of acquired variants in cancer is a paradigm of precision medicine, yet little has been reported about clinical laboratory practices across a broad range of laboratories. - To use College of American Pathologists proficiency testing survey results to report on the results from surveys on next-generation sequencing-based oncology testing practices. - College of American Pathologists proficiency testing survey results from more than 250 laboratories currently performing molecular oncology testing were used to determine laboratory trends in next-generation sequencing-based oncology testing. - These presented data provide key information about the number of laboratories that currently offer or are planning to offer next-generation sequencing-based oncology testing. Furthermore, we present data from 60 laboratories performing next-generation sequencing-based oncology testing regarding specimen requirements and assay characteristics. The findings indicate that most laboratories are performing tumor-only targeted sequencing to detect single-nucleotide variants and small insertions and deletions, using desktop sequencers and predesigned commercial kits. Despite these trends, a diversity of approaches to testing exists. - This information should be useful to further inform a variety of topics, including national discussions involving clinical laboratory quality systems, regulation and oversight of next-generation sequencing-based oncology testing, and precision oncology efforts in a data-driven manner.

Genetic counselors’ (GC) knowledge, awareness, and understanding of clinical next-generation sequencing (NGS) genomic testing

Science.gov (United States)

Boland, PM; Ruth, K; Matro, JM; Rainey, KL; Fang, CY; Wong, YN; Daly, MB; Hall, MJ

2014-01-01

Genomic tests are increasingly complex, less expensive, and more widely available with the advent of next-generation sequencing (NGS). We assessed knowledge and perceptions among genetic counselors pertaining to NGS genomic testing via an online survey. Associations between selected characteristics and perceptions were examined. Recent education on NGS testing was common, but practical experience limited. Perceived understanding of clinical NGS was modest, specifically concerning tumor testing. Greater perceived understanding of clinical NGS testing correlated with more time spent in cancer-related counseling, exposure to NGS testing, and NGS-focused education. Substantial disagreement about the role of counseling for tumor-based testing was seen. Finally, a majority of counselors agreed with the need for more education about clinical NGS testing, supporting this approach to optimizing implementation. PMID:25523111

Research progress of BOLD-fMRI in minimal hepatic encephalopathy

International Nuclear Information System (INIS)

Zhou Zhiming; Zhao Jiannong

2013-01-01

The minimal hepatic encephalopathy is the early stage of hepatic encephalopathy. It has few apparent clinical symptoms and specific manifestations, and is difficult to diagnose. In the recent years, BOLD-fMRI has been used to study hepatic encephalopathy gradually. Through detection of the brain neuron activities in different states, it can not only locate the abnormal activity of brain functional areas, but also can find the changes of brain functional connectivity. BOLD- fMRI combining with other MR technologies can explore the pathology and pathogenesis of minimal hepatic encephalopathy from micro to macro and from structure to function. (authors)

Validation of a clinical critical thinking skills test in nursing

OpenAIRE

Shin, Sujin; Jung, Dukyoo; Kim, Sungeun

2015-01-01

Purpose: The purpose of this study was to develop a revised version of the clinical critical thinking skills test (CCTS) and to subsequently validate its performance. Methods: This study is a secondary analysis of the CCTS. Data were obtained from a convenience sample of 284 college students in June 2011. Thirty items were analyzed using item response theory and test reliability was assessed. Test-retest reliability was measured using the results of 20 nursing college and graduate school stud...

Minimal Reducts with Grasp

Directory of Open Access Journals (Sweden)

Iris Iddaly Mendez Gurrola

2011-03-01

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

Minimally Invasive Surgical Treatment of Acute Epidural Hematoma: Case Series

Directory of Open Access Journals (Sweden)

Weijun Wang

2016-01-01

Full Text Available Background and Objective. Although minimally invasive surgical treatment of acute epidural hematoma attracts increasing attention, no generalized indications for the surgery have been adopted. This study aimed to evaluate the effects of minimally invasive surgery in acute epidural hematoma with various hematoma volumes. Methods. Minimally invasive puncture and aspiration surgery were performed in 59 cases of acute epidural hematoma with various hematoma volumes (13–145 mL; postoperative follow-up was 3 months. Clinical data, including surgical trauma, surgery time, complications, and outcome of hematoma drainage, recovery, and Barthel index scores, were assessed, as well as treatment outcome. Results. Surgical trauma was minimal and surgery time was short (10–20 minutes; no anesthesia accidents or surgical complications occurred. Two patients died. Drainage was completed within 7 days in the remaining 57 cases. Barthel index scores of ADL were ≤40 (n=1, 41–60 (n=1, and >60 (n=55; scores of 100 were obtained in 48 cases, with no dysfunctions. Conclusion. Satisfactory results can be achieved with minimally invasive surgery in treating acute epidural hematoma with hematoma volumes ranging from 13 to 145 mL. For patients with hematoma volume >50 mL and even cerebral herniation, flexible application of minimally invasive surgery would help improve treatment efficacy.

Prediction of clinical response to drugs in ovarian cancer using the chemotherapy resistance test (CTR-test).

Science.gov (United States)

Kischkel, Frank Christian; Meyer, Carina; Eich, Julia; Nassir, Mani; Mentze, Monika; Braicu, Ioana; Kopp-Schneider, Annette; Sehouli, Jalid

2017-10-27

In order to validate if the test result of the Chemotherapy Resistance Test (CTR-Test) is able to predict the resistances or sensitivities of tumors in ovarian cancer patients to drugs, the CTR-Test result and the corresponding clinical response of individual patients were correlated retrospectively. Results were compared to previous recorded correlations. The CTR-Test was performed on tumor samples from 52 ovarian cancer patients for specific chemotherapeutic drugs. Patients were treated with monotherapies or drug combinations. Resistances were classified as extreme (ER), medium (MR) or slight (SR) resistance in the CTR-Test. Combination treatment resistances were transformed by a scoring system into these classifications. Accurate sensitivity prediction was accomplished in 79% of the cases and accurate prediction of resistance in 100% of the cases in the total data set. The data set of single agent treatment and drug combination treatment were analyzed individually. Single agent treatment lead to an accurate sensitivity in 44% of the cases and the drug combination to 95% accuracy. The detection of resistances was in both cases to 100% correct. ROC curve analysis indicates that the CTR-Test result correlates with the clinical response, at least for the combination chemotherapy. Those values are similar or better than the values from a publication from 1990. Chemotherapy resistance testing in vitro via the CTR-Test is able to accurately detect resistances in ovarian cancer patients. These numbers confirm and even exceed results published in 1990. Better sensitivity detection might be caused by a higher percentage of drug combinations tested in 2012 compared to 1990. Our study confirms the functionality of the CTR-Test to plan an efficient chemotherapeutic treatment for ovarian cancer patients.

Minimally invasive orthognathic surgery.

Science.gov (United States)

Resnick, Cory M; Kaban, Leonard B; Troulis, Maria J

2009-02-01

Minimally invasive surgery is defined as the discipline in which operative procedures are performed in novel ways to diminish the sequelae of standard surgical dissections. The goals of minimally invasive surgery are to reduce tissue trauma and to minimize bleeding, edema, and injury, thereby improving the rate and quality of healing. In orthognathic surgery, there are two minimally invasive techniques that can be used separately or in combination: (1) endoscopic exposure and (2) distraction osteogenesis. This article describes the historical developments of the fields of orthognathic surgery and minimally invasive surgery, as well as the integration of the two disciplines. Indications, techniques, and the most current outcome data for specific minimally invasive orthognathic surgical procedures are presented.

Are traditional cognitive tests useful in predicting clinical success?

Science.gov (United States)

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

2002-11-01

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

Regularity of Minimal Surfaces

CERN Document Server

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

2010-01-01

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

Merits and pitfalls of genetic testing in a hypertrophic cardiomyopathy clinic.

Science.gov (United States)

Arad, Michael; Monserrat, Lorenzo; Haron-Khun, Shiraz; Seidman, Jonathan G; Seidman, Christine E; Arbustini, Eloisa; Glikson, Michael; Freimark, Dov

2014-11-01

Hypertrophic cardiomyopathy (HCM) is a familial disease with autosomal dominant inheritance and age-dependent penetrance, caused primarily by mutations of sarcomere genes. Because the clinical variability of HCM is related to its genetic heterogeneity, genetic studies may improve the diagnosis and prognostic evaluation in HCM. To analyze the impact of genetic diagnosis on the clinical management of HCM. Genetic studies were performed for either research or clinical reasons. Once the disease-causing mutation was identified, the management plan was reevaluated. Family members were invited to receive genetic counseling and encouraged to be tested for the mutation. Ten mutations in sarcomere protein genes were identified in 9 probands: 2 novel and 8 previously described. Advanced heart failure or sudden death in a young person prompted the genetic study in 8 of the 9 families. Of 98 relatives available for genotyping, only 53 (54%) agreed to be tested. The compliance was higher in families with sudden death and lower in what appeared to be sporadic HCM or elderly-onset disease. Among the healthy we identified 9 carriers and 19 non-carriers. In 6 individuals the test result resolved an uncertainty about "possible HCM." In several cases the genetic result was also used for family planning and played a role in decisions on cardioverter-defibrillator implantation. Recurrence of a same mutation in different families created an opportunity to apply the information from the literature for risk stratification of individual patients. We suggest that the clinical context determines the indication for genetic testing and interpretation of the results.

Assessment of clinical reasoning: A Script Concordance test designed for pre-clinical medical students.

Science.gov (United States)

Humbert, Aloysius J; Johnson, Mary T; Miech, Edward; Friedberg, Fred; Grackin, Janice A; Seidman, Peggy A

2011-01-01

The Script Concordance test (SCT) measures clinical reasoning in the context of uncertainty by comparing the responses of examinees and expert clinicians. It uses the level of agreement with a panel of experts to assign credit for the examinee's answers. This study describes the development and validation of a SCT for pre-clinical medical students. Faculty from two US medical schools developed SCT items in the domains of anatomy, biochemistry, physiology, and histology. Scoring procedures utilized data from a panel of 30 expert physicians. Validation focused on internal reliability and the ability of the SCT to distinguish between different cohorts. The SCT was administered to an aggregate of 411 second-year and 70 fourth-year students from both schools. Internal consistency for the 75 test items was satisfactory (Cronbach's alpha = 0.73). The SCT successfully differentiated second- from fourth-year students and both student groups from the expert panel in a one-way analysis of variance (F(2,508) = 120.4; p students from the two schools were not significantly different (p = 0.20). This SCT successfully differentiated pre-clinical medical students from fourth-year medical students and both cohorts of medical students from expert clinicians across different institutions and geographic areas. The SCT shows promise as an easy-to-administer measure of "problem-solving" performance in competency evaluation even in the beginning years of medical education.

Single and Combined Diagnostic Value of Clinical Features and Laboratory Tests in Acute Appendicitis

NARCIS (Netherlands)

Laméris, Wytze; van Randen, Adrienne; Go, Peter M. N. Y. H.; Bouma, Wim H.; Donkervoort, Sandra C.; Bossuyt, Patrick M. M.; Stoker, Jaap; Boermeester, Marja A.

2009-01-01

Objectives: The objective was to evaluate the diagnostic accuracy of clinical features and laboratory test results in detecting acute appendicitis. Methods: Clinical features and laboratory test results were prospectively recorded in a consecutive series of 1,101 patients presenting with abdominal

Consequences of "Minimal" Group Affiliations in Children

Science.gov (United States)

Dunham, Yarrow; Baron, Andrew Scott; Carey, Susan

2011-01-01

Three experiments (total N = 140) tested the hypothesis that 5-year-old children's membership in randomly assigned "minimal" groups would be sufficient to induce intergroup bias. Children were randomly assigned to groups and engaged in tasks involving judgments of unfamiliar in-group or out-group children. Despite an absence of information…

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

Science.gov (United States)

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

2017-10-01

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

Isothermal microcalorimetry for antifungal susceptibility testing of Mucorales, Fusarium spp., and Scedosporium spp.

NARCIS (Netherlands)

Furustrand Tafin, U.; Meis, J.F.G.M.; Trampuz, A.

2012-01-01

We evaluated isothermal microcalorimetry for real-time susceptibility testing of non-Aspergillus molds. MIC and minimal effective concentration (MEC) values of Mucorales (n = 4), Fusarium spp. (n = 4), and Scedosporium spp. (n = 4) were determined by microbroth dilution according to the Clinical

Minimal Poems Written in 1979 Minimal Poems Written in 1979

Directory of Open Access Journals (Sweden)

Sandra Sirangelo Maggio

2008-04-01

Full Text Available The reading of M. van der Slice's Minimal Poems Written in 1979 (the work, actually, has no title reminded me of a book I have seen a long time ago. called Truth, which had not even a single word printed inside. In either case we have a sample of how often excentricities can prove efficient means of artistic creativity, in this new literary trend known as Minimalism. The reading of M. van der Slice's Minimal Poems Written in 1979 (the work, actually, has no title reminded me of a book I have seen a long time ago. called Truth, which had not even a single word printed inside. In either case we have a sample of how often excentricities can prove efficient means of artistic creativity, in this new literary trend known as Minimalism.

Automated economic analysis model for hazardous waste minimization

International Nuclear Information System (INIS)

Dharmavaram, S.; Mount, J.B.; Donahue, B.A.

1990-01-01

The US Army has established a policy of achieving a 50 percent reduction in hazardous waste generation by the end of 1992. To assist the Army in reaching this goal, the Environmental Division of the US Army Construction Engineering Research Laboratory (USACERL) designed the Economic Analysis Model for Hazardous Waste Minimization (EAHWM). The EAHWM was designed to allow the user to evaluate the life cycle costs for various techniques used in hazardous waste minimization and to compare them to the life cycle costs of current operating practices. The program was developed in C language on an IBM compatible PC and is consistent with other pertinent models for performing economic analyses. The potential hierarchical minimization categories used in EAHWM include source reduction, recovery and/or reuse, and treatment. Although treatment is no longer an acceptable minimization option, its use is widespread and has therefore been addressed in the model. The model allows for economic analysis for minimization of the Army's six most important hazardous waste streams. These include, solvents, paint stripping wastes, metal plating wastes, industrial waste-sludges, used oils, and batteries and battery electrolytes. The EAHWM also includes a general application which can be used to calculate and compare the life cycle costs for minimization alternatives of any waste stream, hazardous or non-hazardous. The EAHWM has been fully tested and implemented in more than 60 Army installations in the United States

The sticky business of adhesion prevention in minimally invasive gynecologic surgery.

Science.gov (United States)

Han, Esther S; Scheib, Stacey A; Patzkowsky, Kristin E; Simpson, Khara; Wang, Karen C

2017-08-01

The negative impact of postoperative adhesions has long been recognized, but available options for prevention remain limited. Minimally invasive surgery is associated with decreased adhesion formation due to meticulous dissection with gentile tissue handling, improved hemostasis, and limiting exposure to reactive foreign material; however, there is conflicting evidence on the clinical significance of adhesion-related disease when compared to open surgery. Laparoscopic surgery does not guarantee the prevention of adhesions because longer operative times and high insufflation pressure can promote adhesion formation. Adhesion barriers have been available since the 1980s, but uptake among surgeons remains low and there is no clear evidence that they reduce clinically significant outcomes such as chronic pain or infertility. In this article, we review the ongoing magnitude of adhesion-related complications in gynecologic surgery, currently available interventions and new research toward more effective adhesion prevention. Recent literature provides updated epidemiologic data and estimates of healthcare costs associated with adhesion-related complications. There have been important advances in our understanding of normal peritoneal healing and the pathophysiology of adhesions. Adhesion barriers continue to be tested for safety and effectiveness and new agents have shown promise in clinical studies. Finally, there are many experimental studies of new materials and pharmacologic and biologic prevention agents. There is great interest in new adhesion prevention technologies, but new agents are unlikely to be available for clinical use for many years. High-quality effectiveness and outcomes-related research is still needed.

A New Clinical Pain Knowledge Test for Nurses: Development and Psychometric Evaluation.

Science.gov (United States)

Bernhofer, Esther I; St Marie, Barbara; Bena, James F

2017-08-01

All nurses care for patients with pain, and pain management knowledge and attitude surveys for nurses have been around since 1987. However, no validated knowledge test exists to measure postlicensure clinicians' knowledge of the core competencies of pain management in current complex patient populations. To develop and test the psychometric properties of an instrument designed to measure pain management knowledge of postlicensure nurses. Psychometric instrument validation. Four large Midwestern U.S. hospitals. Registered nurses employed full time and part time August 2015 to April 2016, aged M = 43.25 years; time as RN, M = 16.13 years. Prospective survey design using e-mail to invite nurses to take an electronic multiple choice pain knowledge test. Content validity of initial 36-item test "very good" (95.1% agreement). Completed tests that met analysis criteria, N = 747. Mean initial test score, 69.4% correct (range 27.8-97.2). After revision/removal of 13 unacceptable questions, mean test score was 50.4% correct (range 8.7-82.6). Initial test item percent difficulty range was 15.2%-98.1%; discrimination values range, 0.03-0.50; final test item percent difficulty range, 17.6%-91.1%, discrimination values range, -0.04 to 1.04. Split-half reliability final test was 0.66. A high decision consistency reliability was identified, with test cut-score of 75%. The final 23-item Clinical Pain Knowledge Test has acceptable discrimination, difficulty, decision consistency, reliability, and validity in the general clinical inpatient nurse population. This instrument will be useful in assessing pain management knowledge of clinical nurses to determine gaps in education, evaluate knowledge after pain management education, and measure research outcomes. Copyright © 2017 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

What is the role of clinical tests and ultrasound in acetabular labral tear diagnostics?

DEFF Research Database (Denmark)

Troelsen, Anders; Mechlenburg, Inger; Gelineck, John

2009-01-01

BACKGROUND AND PURPOSE: An acetabular labral tear is a diagnostic challenge. Various clinical tests have been described, but little is known about their diagnostic sensitivity and specificity. We investigated the diagnostic validity of clinical tests and ultrasound as compared with MR arthrography...... no or only slight signs of osteoarthritis (Tönnis grade 0-1). RESULTS: MR arthrography identified labral tears in 17 of the 18 hips. Ultrasound had a sensitivity of 94%, a positive predictive value of 94%, and was false negative in only 1 case compared to MR arthrography. The impingement test had the best...... diagnostic ability of the clinical tests, with a sensitivity of 59% and a specificity of 100%. The positive predictive value was 100% while the negative predictive value was 13%. INTERPRETATION: The impingement test is helpful in identifying acetabular labral tears. If this test is negative and if a labral...

Clinic research on the treatment for humeral shaft fracture with minimal invasive plate osteosynthesis: a retrospective study of 128 cases.

Science.gov (United States)

Chen, H; Hu, X; Yang, G; Xiang, M

2017-04-01

Minimal invasive plate osteosynthesis (MIPO) is one of the most important techniques in the treatment for humeral shaft fractures. This study was performed to evaluate the efficacy of MIPO technique for the treatment for humeral shaft fractures. We retrospectively evaluated 128 cases with humeral shaft fractures that were treated with MIPO technique from March 2005 to August 2008. All the patients were followed up by routine radiological imaging and clinical examinations. Constant-Murley score and HSS elbow joint score were used to evaluate the treatment outcome. The average duration of the surgery was 60 min (range 40-95 min) without blood transfusion. All fractures healed without infection. All cases recovered carrying angle except four cases with 10°-15° cubitus varus. After the average follow-up of 23 (13-38) months, satisfactory function was achieved according to Constant-Murley score and HSS elbow joint score. Constant-Murley score was 80 on average (range 68-91). According to HSS elbow joint score, there were 123 cases of excellent clinical outcome and five cases of effective outcome. It seems to be a safe and effective method for managing humeral shaft fractures with MIPO technique.

Current nonclinical testing paradigm enables safe entry to First-In-Human clinical trials: The IQ consortium nonclinical to clinical translational database.

Science.gov (United States)

Monticello, Thomas M; Jones, Thomas W; Dambach, Donna M; Potter, David M; Bolt, Michael W; Liu, Maggie; Keller, Douglas A; Hart, Timothy K; Kadambi, Vivek J

2017-11-01

The contribution of animal testing in drug development has been widely debated and challenged. An industry-wide nonclinical to clinical translational database was created to determine how safety assessments in animal models translate to First-In-Human clinical risk. The blinded database was composed of 182 molecules and contained animal toxicology data coupled with clinical observations from phase I human studies. Animal and clinical data were categorized by organ system and correlations determined. The 2×2 contingency table (true positive, false positive, true negative, false negative) was used for statistical analysis. Sensitivity was 48% with a 43% positive predictive value (PPV). The nonhuman primate had the strongest performance in predicting adverse effects, especially for gastrointestinal and nervous system categories. When the same target organ was identified in both the rodent and nonrodent, the PPV increased. Specificity was 84% with an 86% negative predictive value (NPV). The beagle dog had the strongest performance in predicting an absence of clinical adverse effects. If no target organ toxicity was observed in either test species, the NPV increased. While nonclinical studies can demonstrate great value in the PPV for certain species and organ categories, the NPV was the stronger predictive performance measure across test species and target organs indicating that an absence of toxicity in animal studies strongly predicts a similar outcome in the clinic. These results support the current regulatory paradigm of animal testing in supporting safe entry to clinical trials and provide context for emerging alternate models. Copyright © 2017 Elsevier Inc. All rights reserved.

Clinical diagnosis of Graves’ or non-Graves’ hyperthyroidism compared to TSH receptor antibody test

Directory of Open Access Journals (Sweden)

Lauren Bell

2018-04-01

Full Text Available Background: TSH receptor antibody (TRAb is considered the gold standard diagnostic test for the autoimmunity of Graves’ disease (GD, which is commonly diagnosed clinically. Aim: To evaluate the true positive (sensitivity and true negative (specificity rates of clinical diagnosis of GD or non-GD hyperthyroidism compared to the TRAb test. Setting: University teaching hospital in North West England. Participants: Patients in the Endocrinology service who had a TRAb measurement between December 2009 and October 2015. Methods: Electronic patient records were studied retrospectively for a pre-TRAb clinical diagnosis of GD or non-GD hyperthyroidism. We examined descriptive statistics and binary classification tests; Fisher exact test was used to analyse contingency tables. Results: We identified 316 patients with a mean age of 45 (range, 17–89 years; 247 (78% were women. Compared to the TRAb result, clinical diagnosis had a sensitivity of 88%, specificity 66%, positive predictive value 72%, negative predictive value 84%, false negative rate 12%, false positive rate 34%, positive likelihood ratio 2.6 and negative likelihood ratio 0.2 (P < 0.0001. Conclusions: Clinicians were liable to both over- and under-diagnose GD. The TRAb test can help reduce the number of incorrect or unknown diagnoses in the initial clinical assessment of patients presenting with hyperthyroidism.

Minimal Super Technicolor

DEFF Research Database (Denmark)

Antola, M.; Di Chiara, S.; Sannino, F.

2011-01-01

We introduce novel extensions of the Standard Model featuring a supersymmetric technicolor sector (supertechnicolor). As the first minimal conformal supertechnicolor model we consider N=4 Super Yang-Mills which breaks to N=1 via the electroweak interactions. This is a well defined, economical......, between unparticle physics and Minimal Walking Technicolor. We consider also other N =1 extensions of the Minimal Walking Technicolor model. The new models allow all the standard model matter fields to acquire a mass....

Clinical evaluation of a 51Cr-labeled red blood cell survival test for in vivo blood compatibility testing

International Nuclear Information System (INIS)

Pineda, A.A.; Dharkar, D.D.; Wahner, H.W.

1984-01-01

Modified red blood cell survival studies with use of 51Cr were performed in three groups of subjects. Group 1 consisted of normal subjects who were given labeled autologous blood, group 2 were subjects in need of blood transfusions and given labeled ABO and Rh crossmatch-compatible blood, and group 3 were patients in need of blood transfusion but in whom problems arose in finding compatible blood. The results of the studies suggest that for patients with blood compatibility problems, normal red blood cell survival values at 1 hour do not exclude the possibility of severe hemolysis 24 hours later. Thus, if a 1-hour test result is normal, the procedure should be extended routinely to 24 hours. Moreover, the test can be used to evaluate the clinical importance of antibodies. We showed that anti-Yka and anti-Lan were clinically significant, but high-titer, low-avidity antibodies, anti-Kna, anti-I, and anti-HI were clinically insignificant in the cases studied. This finding emphasizes the importance of an in vivo test for the final compatibility evaluation in complicated blood replacement problems

Evaluation of a clinic-based cholinesterase test kit for the Washington State Cholinesterase Monitoring Program.

Science.gov (United States)

Hofmann, Jonathan N; Carden, Angela; Fenske, Richard A; Ruark, Harold E; Keifer, Matthew C

2008-07-01

The Washington State Cholinesterase Monitoring Program for pesticide handlers requires blood draws at local clinics, with samples tested at a central laboratory. At present, workers with inhibited cholinesterase activity may be re-exposed before they can be removed from work. In this study we explored the option of on-site testing at local clinics using the EQM Test-mate Kittrade mark, a portable cholinesterase test kit. Test kit cholinesterase activity measurements were performed on 50 blood samples by our research staff, and compared to measurements on the same samples by the Washington State Public Health Laboratory. Another set of samples was also analyzed with the test kit by medical staff at an eastern Washington clinic. Triplicate measurements with the test kit had a 3.3% average coefficient of variation (CV) for plasma cholinesterase (PChE), and a 3.5% average CV for erythrocyte cholinesterase (AChE) measurements. The kit's PChE measurements were similar to PHL measurements (average ratio of 0.98) when performed in the laboratory, but had a tendency to underestimate activity when used in the clinic setting (average ratio of 0.87). The kit systematically overestimated AChE activity by 42-48% relative to the PHL measurements, regardless of where the samples were analyzed. This easy-to-use test kit appeared to be a viable method for clinic-based PChE measurements, but was less consistent for AChE measurements performed in the clinic. Absolute measurements with the kit need to be evaluated carefully relative to standardized methods. (c) 2008 Wiley-Liss, Inc.

Effects of an intensive clinical skills course on senior nursing students' self-confidence and clinical competence: A quasi-experimental post-test study.

Science.gov (United States)

Park, Soohyun

2018-02-01

To foster nursing professionals, nursing education requires the integration of knowledge and practice. Nursing students in their senior year experience considerable stress in performing the core nursing skills because, typically, they have limited opportunities to practice these skills in their clinical practicum. Therefore, nurse educators should revise the nursing curricula to focus on core nursing skills. To identify the effect of an intensive clinical skills course for senior nursing students on their self-confidence and clinical competence. A quasi-experimental post-test study. A university in South Korea during the 2015-2016 academic year. A convenience sample of 162 senior nursing students. The experimental group (n=79) underwent the intensive clinical skills course, whereas the control group (n=83) did not. During the course, students repeatedly practiced the 20 items that make up the core basic nursing skills using clinical scenarios. Participants' self-confidence in the core clinical nursing skills was measured using a 10-point scale, while their clinical competence with these skills was measured using the core clinical nursing skills checklist. Independent t-test and chi-square tests were used to analyze the data. The mean scores in self-confidence and clinical competence were higher in the experimental group than in the control group. This intensive clinical skills courses had a positive effect on senior nursing students' self-confidence and clinical competence for the core clinical nursing skills. This study emphasizes the importance of reeducation using a clinical skills course during the transition from student to nursing professional. Copyright © 2017. Published by Elsevier Ltd.

A mind map for managing minimal residual disease in acute myeloid leukemia.

Science.gov (United States)

Benton, Christopher B; Ravandi, Farhad

2017-11-01

Advances in detecting traces of leukemia that were previously unidentifiable have increasingly led to the incorporation of information about residual disease into clinical decision making for patients with leukemia in both the postinduction and consolidation settings. This review discusses current concepts related to minimal residual disease (MRD), which is defined as submicroscopic disease detected during morphologic complete remission. The focus is on acute myeloid leukemia (AML). Basic methods for detecting MRD include flow cytometry, reverse transcription-polymerase chain reaction, and mutation analysis. Several studies using these assays have demonstrated prognostic implications based on MRD-positive vs MRD-negative status. As our understanding of the biological factors responsible for MRD in AML evolves, residual disease should be evaluated in the context of other prognostic markers. Current therapeutic options for managing MRD in AML are limited, and the clinical implications of a positive MRD test result can be significant. Regarding individual patients, an evidence-based approach must be applied while the institution- and assay-specific differences that currently exist are considered. Challenges associated with MRD assessment, such as the limited standardization of available assays and the paucity of effective agents to eradicate MRD, will need to be overcome before physicians who treat leukemia can use MRD as a tool for clinical management.

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

African Journals Online (AJOL)

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

GA(2)LEN skin test study II: clinical relevance of inhalant allergen sensitizations in Europe

DEFF Research Database (Denmark)

Burbach, G J; Heinzerling, L M; Edenharter, G

2009-01-01

BACKGROUND: Skin prick testing is the standard for diagnosing IgE-mediated allergies. A positive skin prick reaction, however, does not always correlate with clinical symptoms. A large database from a Global Asthma and Allergy European Network (GA(2)LEN) study with data on clinical relevance was ...... the clinical relevance of positive skin prick tests and calls for further studies, which may, ultimately, help increase the positive predictive value of allergy testing.......BACKGROUND: Skin prick testing is the standard for diagnosing IgE-mediated allergies. A positive skin prick reaction, however, does not always correlate with clinical symptoms. A large database from a Global Asthma and Allergy European Network (GA(2)LEN) study with data on clinical relevance...... was used to determine the clinical relevance of sensitizations against the 18 most frequent inhalant allergens in Europe. The study population consisted of patients referred to one of the 17 allergy centres in 14 European countries (n = 3034, median age = 33 years). The aim of the study was to assess...

Months backward test: A review of its use in clinical studies.

Science.gov (United States)

Meagher, James; Leonard, Maeve; Donoghue, Laura; O'Regan, Niamh; Timmons, Suzanne; Exton, Chris; Cullen, Walter; Dunne, Colum; Adamis, Dimitrios; Maclullich, Alasdair J; Meagher, David

2015-09-22

To review the use of the Months Backwards Test (MBT) in clinical and research contexts. We conducted a systematic review of reports relating to the MBT based upon a search of PsychINFO and MEDLINE between January 1980 and December 2014. Only reports that specifically described findings pertaining to the MBT were included. Findings were considered in terms of rating procedures, testing performance, psychometric properties, neuropsychological studies and use in clinical populations. We identified 22 data reports. The MBT is administered and rated in a variety of ways with very little consistency across studies. It has been used to assess various cognitive functions including focused and sustained attention as well as central processing speed. Performance can be assessed in terms of the ability to accurately complete the test without errors ("MB accuracy"), and time taken to complete the test ("MB duration"). Completion time in cognitively intact subjects is usually upper limits of 60-90 s typically applied in studies. The majority of cognitively intact adults can complete the test without error such that any errors of omission are strongly suggestive of cognitive dysfunction. Coverage of clinical populations, including those with significant cognitive difficulties is high with the majority of subjects able to engage with MBT procedures. Performance correlates highly with other cognitive tests, especially of attention, including the digit span backwards, trailmaking test B, serial threes and sevens, tests of simple and complex choice reaction time, delayed story recall and standardized list learning measures. Test-retest and inter-rater reliability are high (both > 0.90). Functional magnetic resonance imaging studies comparing the months forward test and MBT indicate greater involvement of more complex networks (bilateral middle and inferior frontal gyri, the posterior parietal cortex and the left anterior cingulate gyrus) for backwards cognitive processing. The MBT

A new minimally invasive mesotherapy technique for facial rejuvenation.

Science.gov (United States)

Savoia, Antonella; Landi, Simone; Baldi, Alfonso

2013-06-01

This study describes a pivotal clinical trial of a new minimally invasive mesotherapy technique for facial rejuvenation. The authors utilized two formulations: formulation A with hyaluronic acid, vitamins, amino acids, minerals, coenzymes, and antioxidant substances; formulation B with hyaluronic acid and idebenone. Fifty participants were enrolled in the study and divided in two groups. Group 1 (50-65 years) treated with formulation A. Group 2 (35-50 years) treated with formulation B. The groups underwent four sessions of mesotherapy involving multiple injections. Treatment was conducted at 15 day intervals. All participants had pre- and posttreatment photographs. Punch biopsies were taken from randomly selected participants, baseline and after 6 weeks, and stained for interleukin (IL)-6, IL-1β, matrix metalloproteinase (MMP)-1, and collagen 1. Clinical evaluation was based on the Global Aesthetic Scale (GAIS) and on the Wrinkle Severity Rating Scale (WSRS). The results produced were statistically analyzed and resulted in a significant and long-lasting effect on facial rejuvenation. Evaluation of photographs at 0, 1, and 2 months revealed significant clinical improvement: brightness, texture, and firmness of the skin. The analysis of the GAIS and WSRS scores in the two groups demonstrated statistically significant results after 2 months. The biopsies taken from randomly selected participants at baseline and after 3 months showed a decrease in IL-1β, IL-6, and MMP1, and an increase in collagen 1. The new minimally invasive mesotherapy technique described can improve the clinical appearance of the skin in different age groups.

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

Science.gov (United States)

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

2017-09-01

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

Variation in the Use of Vestibular Diagnostic Testing for Patients Presenting to Otolaryngology Clinics with Dizziness

Science.gov (United States)

Piker, Erin G.; Schulz, Kris; Parham, Kourosh; Vambutas, Andrea; Witsell, David; Tucci, Debara; Shin, Jennifer J.; Pynnonen, Melissa A.; Nguyen-Huynh, Anh; Crowson, Matthew; Ryan, Sheila E.; Langman, Alan; Roberts, Rhonda; Wolfley, Anne; Lee, Walter T.

2016-01-01

Objective We used a national otolaryngology practice–based research network database to characterize the utilization of vestibular function testing in patients diagnosed with dizziness and/or a vestibular disorder. Study Design Database review. Setting The Creating Healthcare Excellence through Education and Research (CHEER) practice-based research network of academic and community providers Subjects and Methods Dizzy patients in the CHEER retrospective database were identified through ICD-9 codes; vestibular testing procedures were identified with CPT codes. Demographics and procedures per patient were tabulated. Analysis included number and type of vestibular tests ordered, stratified by individual clinic and by practice type (community vs academic). Chi-square tests were performed to assess if the percentage of patients receiving testing was statistically significant across clinics. A logistic regression model was used to examine the association between receipt of testing and being tested on initial visit. Results A total of 12,468 patients diagnosed with dizziness and/or a vestibular disorder were identified from 7 community and 5 academic CHEER network clinics across the country. One-fifth of these patients had at least 1 vestibular function test. The percentage of patients tested varied widely by site, from 3% to 72%; academic clinics were twice as likely to test. Initial visit vestibular testing also varied, from 0% to 96% of dizzy patients, and was 15 times more likely in academic clinics. Conclusion There is significant variation in use and timing of vestibular diagnostic testing across otolaryngology clinics. The CHEER network research database does not contain outcome data. These results illustrate the critical need for research that examines outcomes as related to vestibular testing. PMID:27371625

Minimally invasive surgical treatment of malignant pleural effusions.

Science.gov (United States)

Ciuche, Adrian; Nistor, Claudiu; Pantile, Daniel; Prof Horvat, Teodor

2011-10-01

Usually the pleural cavity contains a small amount of liquid (approximately 10 ml). Pleural effusions appear when the liquid production rate overpasses the absorption rate with a greater amount of liquid inside the pleural cavity. Between January 1998 to December 2008 we conducted a study in order to establish the adequate surgical treatment for MPEs. Effective control of a recurrent malignant pleural effusion can greatly improve the quality of life of the cancer patient. The present review collects and examines the clinical results of minimally invasive techniques designed to treat this problem. Patients with MPEs were studied according to several criteria. In our study we observed the superiority of intraoperative talc poudrage, probably due to a more uniform distribution of talc particles over the pleural surface. Minimal pleurotomy with thoracic drainage and instillation of a talc suspension is also a safe and effective technique and should be employed when there are contraindications for the thoracoscopic minimally invasive procedure. On the basis of comparisons involving effectiveness, morbidity, and convenience, we recommend the thoracoscopic insufflations of talc as a fine powder with pleural drainage as the procedure of choice.

Covert hepatic encephalopathy: not as minimal as you might think.

Science.gov (United States)

Kappus, Matthew R; Bajaj, Jasmohan S

2012-11-01

Hepatic encephalopathy (HE) is a serious neuropsychiatric and neurocognitive complication of acute and chronic liver disease. Symptoms are often overt (confusion, disorientation, ataxia, or coma) but can also be subtle (difficulty with cognitive abilities such as executive decision-making and psychomotor speed). There is consensus that HE is characterized as a spectrum of neuropsychiatric symptoms in the absence of brain disease, ranging from overt HE (OHE) to minimal HE (MHE). The West Haven Criteria are most often used to grade HE, with scores ranging from 0-4 (4 being coma). However, it is a challenge to diagnose patients with MHE or grade 1 HE; it might be practical to combine these entities and name them covert HE for clinical use. The severity of HE is associated with the stage of liver disease. Although the pathologic mechanisms of HE are not well understood, they are believed to involve increased levels of ammonia and inflammation, which lead to low-grade cerebral edema. A diagnosis of MHE requires dedicated psychometric tests and neurophysiological techniques rather than a simple clinical assessment. Although these tests can be difficult to perform in practice, they are cost effective and important; the disorder affects patients' quality of life, socioeconomic status, and driving ability and increases their risk for falls and the development of OHE. Patients with MHE are first managed by excluding other causes of neurocognitive dysfunction. Therapy with gut-specific agents might be effective. We review management strategies and important areas of research for MHE and covert HE. Copyright © 2012 AGA Institute. Published by Elsevier Inc. All rights reserved.

Clinical symptoms, signs and tests for identification of impending and current water-loss dehydration in older people.

Science.gov (United States)

Hooper, Lee; Abdelhamid, Asmaa; Attreed, Natalie J; Campbell, Wayne W; Channell, Adam M; Chassagne, Philippe; Culp, Kennith R; Fletcher, Stephen J; Fortes, Matthew B; Fuller, Nigel; Gaspar, Phyllis M; Gilbert, Daniel J; Heathcote, Adam C; Kafri, Mohannad W; Kajii, Fumiko; Lindner, Gregor; Mack, Gary W; Mentes, Janet C; Merlani, Paolo; Needham, Rowan A; Olde Rikkert, Marcel G M; Perren, Andreas; Powers, James; Ranson, Sheila C; Ritz, Patrick; Rowat, Anne M; Sjöstrand, Fredrik; Smith, Alexandra C; Stookey, Jodi J D; Stotts, Nancy A; Thomas, David R; Vivanti, Angela; Wakefield, Bonnie J; Waldréus, Nana; Walsh, Neil P; Ward, Sean; Potter, John F; Hunter, Paul

2015-04-30

There is evidence that water-loss dehydration is common in older people and associated with many causes of morbidity and mortality. However, it is unclear what clinical symptoms, signs and tests may be used to identify early dehydration in older people, so that support can be mobilised to improve hydration before health and well-being are compromised. To determine the diagnostic accuracy of state (one time), minimally invasive clinical symptoms, signs and tests to be used as screening tests for detecting water-loss dehydration in older people by systematically reviewing studies that have measured a reference standard and at least one index test in people aged 65 years and over. Water-loss dehydration was defined primarily as including everyone with either impending or current water-loss dehydration (including all those with serum osmolality ≥ 295 mOsm/kg as being dehydrated). Structured search strategies were developed for MEDLINE (OvidSP), EMBASE (OvidSP), CINAHL, LILACS, DARE and HTA databases (The Cochrane Library), and the International Clinical Trials Registry Platform (ICTRP). Reference lists of included studies and identified relevant reviews were checked. Authors of included studies were contacted for details of further studies. Titles and abstracts were scanned and all potentially relevant studies obtained in full text. Inclusion of full text studies was assessed independently in duplicate, and disagreements resolved by a third author. We wrote to authors of all studies that appeared to have collected data on at least one reference standard and at least one index test, and in at least 10 people aged ≥ 65 years, even where no comparative analysis has been published, requesting original dataset so we could create 2 x 2 tables. Diagnostic accuracy of each test was assessed against the best available reference standard for water-loss dehydration (serum or plasma osmolality cut-off ≥ 295 mOsm/kg, serum osmolarity or weight change) within each study. For

Impact of the clinical context on the 14-3-3 test for the diagnosis of sporadic CJD

Directory of Open Access Journals (Sweden)

Sierra-Moros Maríajosé

2006-07-01

Full Text Available Abstract Background The 14-3-3 test appears to be a valuable aid for the clinical diagnosis of sporadic Creutzfeldt-Jakob disease (sCJD in selected populations. However, its usefulness in routine practice has been challenged. In this study, the influence of the clinical context on the performance of the 14-3-3 test for the diagnosis of sCJD is investigated through the analysis of a large prospective clinical series. Methods Six hundred seventy-two Spanish patients with clinically suspected sCJD were analyzed. Clinical classification at sample reception according to the World Health Organization's (WHO criteria (excluding the 14-3-3 test result was used to explore the influence of the clinical context on the pre-test probabilities, and positive (PPV and negative (NPV predictive values of the 14-3-3 test. Results Predictive values of the test varied greatly according to the initial clinical classification: PPV of 98.8%, 96.5% and 45.0%, and NPV of 26.1%, 66.6% and 100% for probable sCJDi (n = 115, possible sCJDi (n = 73 and non-sCJDi (n = 484 cases, respectively. According to multivariate and Bayesian analyses, these values represent an improvement of diagnostic certainty compared to clinical data alone. Conclusion In three different contexts of sCJD suspicion, the 14-3-3 assay provides useful information complementary to clinical and electroencephalographic (EEG data. The test is most useful supporting a clinical impression, whilst it may show deceptive when it is not in agreement with clinical data.

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

Science.gov (United States)

2010-10-01

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

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

DEFF Research Database (Denmark)

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

2008-01-01

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

Genetic testing in the epilepsies—Report of the ILAE Genetics Commission

Science.gov (United States)

Ottman, Ruth; Hirose, Shinichi; Jain, Satish; Lerche, Holger; Lopes-Cendes, Iscia; Noebels, Jeffrey L.; Serratosa, José; Zara, Federico; Scheffer, Ingrid E.

2010-01-01

SUMMARY In this report, the International League Against Epilepsy (ILAE) Genetics Commission discusses essential issues to be considered with regard to clinical genetic testing in the epilepsies. Genetic research on the epilepsies has led to the identification of more than 20 genes with a major effect on susceptibility to idiopathic epilepsies. The most important potential clinical application of these discoveries is genetic testing: the use of genetic information, either to clarify the diagnosis in people already known or suspected to have epilepsy (diagnostic testing), or to predict onset of epilepsy in people at risk because of a family history (predictive testing). Although genetic testing has many potential benefits, it also has potential harms, and assessment of these potential benefits and harms in particular situations is complex. Moreover, many treating clinicians are unfamiliar with the types of tests available, how to access them, how to decide whether they should be offered, and what measures should be used to maximize benefit and minimize harm to their patients. Because the field is moving rapidly, with new information emerging practically every day, we present a framework for considering the clinical utility of genetic testing that can be applied to many different syndromes and clinical contexts. Given the current state of knowledge, genetic testing has high0020clinical utility in few clinical contexts, but in some of these it carries implications for daily clinical practice. PMID:20100225

Minimally invasive surgical treatment for unstable fractures of the proximal phalanx: intramedullary screw

Directory of Open Access Journals (Sweden)

Marcio Aurélio Aita

2016-02-01

Full Text Available ABSTRACT OBJECTIVE: To analyze the clinical-functional parameters and quality of life of patients undergoing minimally invasive surgical treatment for extra-articular fractures of the proximal phalanx, using an intramedullary screw (Acutrak(r. METHODS: Between January 2011 and September 2014, a prospective study was conducted on 41 patients (48 fingers with unstable extra-articular fractures of the proximal phalanx, who underwent minimally invasive surgical treatment using an intramedullary screw (Acutrak(r. These patients were evaluated 12 months after the surgery by means of the DASH quality-of-life questionnaire, VAS pain scale, measurement of range of motion (ROM, in degrees and radiographic assessment. RESULTS: All the patients achieved adequate reduction and consolidation of their fractures. There were statistically significant improvements in quality of life on the DASH scale, pain on the VAS scale and range of motion. CONCLUSION: The minimally invasive technique for treating unstable extra-articular fractures of the proximal phalanx using an intramedullary screw (Acutrak(r is effective and safe, and it presents satisfactory clinical-functional results.

MINIMALLY INVASIVE SINGLE FLAP APPROACH WITH CONNECTIVE TISSUE WALL FOR PERIODONTAL REGENERATION

Directory of Open Access Journals (Sweden)

Kamen Kotsilkov

2017-09-01

Full Text Available INTRODUCTION: The destructive periodontal diseases are among the most prevalent in the human population. In some cases, bony defects are formed during the disease progression, thus sustaining deep periodontal pockets. The reconstruction of these defects is usually done with the classical techniques of bone substitutes placement and guided tissue regeneration. The clinical and histological data from the recent years, however, demonstrate the relatively low regenerative potential of these techniques. The contemporary approaches for periodontal regeneration rely on minimally invasive surgical protocols, aimed at complete tissue preservation in order to achieve and maintain primary closure and at stimulating the natural regenerative potential of the periodontal tissues. AIM: This presentation demonstrates the application of a new, minimally invasive, single flap surgical technique for periodontal regeneration in a clinical case with periodontitis and a residual deep intrabony defect. MATERIALS AND METHODS: A 37 years old patient presented with chronic generalised periodontitis. The initial therapy led to good control of the periodontal infection with a single residual deep periodontal pocket medially at 11 due to a deep intrabony defect. A single flap approach with an enamel matrix derivate application and a connective tissue wall technique were performed. The proper primary closure was obtained. RESULT: One month after surgery an initial mineralisation process in the defect was detected. At the third month, a complete clinical healing was observed. The radiographic control showed finished bone mineralisation and periodontal space recreation. CONCLUSION: In the limitation of the presented case, the minimally invasive surgical approach led to complete clinical healing and new bone formation, which could be proof for periodontal regeneration.

Minimally invasive aortic valve replacement

DEFF Research Database (Denmark)

Foghsgaard, Signe; Schmidt, Thomas Andersen; Kjaergard, Henrik K

2009-01-01

In this descriptive prospective study, we evaluate the outcomes of surgery in 98 patients who were scheduled to undergo minimally invasive aortic valve replacement. These patients were compared with a group of 50 patients who underwent scheduled aortic valve replacement through a full sternotomy...... operations were completed as mini-sternotomies, 4 died later of noncardiac causes. The aortic cross-clamp and perfusion times were significantly different across all groups (P replacement...... is an excellent operation in selected patients, but its true advantages over conventional aortic valve replacement (other than a smaller scar) await evaluation by means of randomized clinical trial. The "extended mini-aortic valve replacement" operation, on the other hand, is a risky procedure that should...

The Clinical and Economic Benefits of Co-Testing Versus Primary HPV Testing for Cervical Cancer Screening: A Modeling Analysis.

Science.gov (United States)

Felix, Juan C; Lacey, Michael J; Miller, Jeffrey D; Lenhart, Gregory M; Spitzer, Mark; Kulkarni, Rucha

2016-06-01

Consensus United States cervical cancer screening guidelines recommend use of combination Pap plus human papillomavirus (HPV) testing for women aged 30 to 65 years. An HPV test was approved by the Food and Drug Administration in 2014 for primary cervical cancer screening in women age 25 years and older. Here, we present the results of clinical-economic comparisons of Pap plus HPV mRNA testing including genotyping for HPV 16/18 (co-testing) versus DNA-based primary HPV testing with HPV 16/18 genotyping and reflex cytology (HPV primary) for cervical cancer screening. A health state transition (Markov) model with 1-year cycling was developed using epidemiologic, clinical, and economic data from healthcare databases and published literature. A hypothetical cohort of one million women receiving triennial cervical cancer screening was simulated from ages 30 to 70 years. Screening strategies compared HPV primary to co-testing. Outcomes included total and incremental differences in costs, invasive cervical cancer (ICC) cases, ICC deaths, number of colposcopies, and quality-adjusted life years for cost-effectiveness calculations. Comprehensive sensitivity analyses were performed. In a simulation cohort of one million 30-year-old women modeled up to age 70 years, the model predicted that screening with HPV primary testing instead of co-testing could lead to as many as 2,141 more ICC cases and 2,041 more ICC deaths. In the simulation, co-testing demonstrated a greater number of lifetime quality-adjusted life years (22,334) and yielded $39.0 million in savings compared with HPV primary, thereby conferring greater effectiveness at lower cost. Model results demonstrate that co-testing has the potential to provide improved clinical and economic outcomes when compared with HPV primary. While actual cost and outcome data are evaluated, these findings are relevant to U.S. healthcare payers and women's health policy advocates seeking cost-effective cervical cancer screening

Clinical identification of compensatory structures on projective tests: a self psychological approach.

Science.gov (United States)

Silverstein, M L

2001-06-01

In this article I discuss compensatory structure, a concept from Kohut's (1971, 1977) psychology of the self that is not as familiar as Kohut's other views about the self. Compensatory structures are attempts to repair selfobject failure, usually by strengthening idealization or twinship in the face of mirroring deficits. Compensatory structures, particularly their early indications, can be detected on projective tests for identifying adaptive resources and treatment potential. The clinical identification of compensatory structures on test findings is described using Rorschach and Thematic Apperception Test (Murray, 1943) content. Particular attention is devoted to the 2-part process of demonstrating first, an injury to the self, and second, how attempts to recover from such injuries can be detected on projective tests. Clinical examples are provided, and the differentiation between compensatory structures and defenses and sublimation is discussed.

Minimally invasive treatment of hepatic adenoma in special cases

Energy Technology Data Exchange (ETDEWEB)

Nasser, Felipe; Affonso, Breno Boueri; Galastri, Francisco Leonardo [Hospital Israelita Albert Einstein, São Paulo, SP (Brazil); Odisio, Bruno Calazans [MD Anderson Cancer Center, Houston (United States); Garcia, Rodrigo Gobbo [Hospital Israelita Albert Einstein, São Paulo, SP (Brazil)

2013-07-01

Hepatocellular adenoma is a rare benign tumor that was increasingly diagnosed in the 1980s and 1990s. This increase has been attributed to the widespread use of oral hormonal contraceptives and the broader availability and advances of radiological tests. We report two cases of patients with large hepatic adenomas who were subjected to minimally invasive treatment using arterial embolization. One case underwent elective embolization due to the presence of multiple adenomas and recent bleeding in one of the nodules. The second case was a victim of blunt abdominal trauma with rupture of a hepatic adenoma and clinical signs of hemodynamic shock secondary to intra-abdominal hemorrhage, which required urgent treatment. The development of minimally invasive locoregional treatments, such as arterial embolization, introduced novel approaches for the treatment of individuals with hepatic adenoma. The mortality rate of emergency resection of ruptured hepatic adenomas varies from 5 to 10%, but this rate decreases to 1% when resection is elective. Arterial embolization of hepatic adenomas in the presence of bleeding is a subject of debate. This observation suggests a role for transarterial embolization in the treatment of ruptured and non-ruptured adenomas, which might reduce the indication for surgery in selected cases and decrease morbidity and mortality. Magnetic resonance imaging showed a reduction of the embolized lesions and significant avascular component 30 days after treatment in the two cases in this report. No novel lesions were observed, and a reduction in the embolized lesions was demonstrated upon radiological assessment at a 12-month follow-up examination.

Minimally invasive treatment of hepatic adenoma in special cases

International Nuclear Information System (INIS)

Nasser, Felipe; Affonso, Breno Boueri; Galastri, Francisco Leonardo; Odisio, Bruno Calazans; Garcia, Rodrigo Gobbo

2013-01-01

Hepatocellular adenoma is a rare benign tumor that was increasingly diagnosed in the 1980s and 1990s. This increase has been attributed to the widespread use of oral hormonal contraceptives and the broader availability and advances of radiological tests. We report two cases of patients with large hepatic adenomas who were subjected to minimally invasive treatment using arterial embolization. One case underwent elective embolization due to the presence of multiple adenomas and recent bleeding in one of the nodules. The second case was a victim of blunt abdominal trauma with rupture of a hepatic adenoma and clinical signs of hemodynamic shock secondary to intra-abdominal hemorrhage, which required urgent treatment. The development of minimally invasive locoregional treatments, such as arterial embolization, introduced novel approaches for the treatment of individuals with hepatic adenoma. The mortality rate of emergency resection of ruptured hepatic adenomas varies from 5 to 10%, but this rate decreases to 1% when resection is elective. Arterial embolization of hepatic adenomas in the presence of bleeding is a subject of debate. This observation suggests a role for transarterial embolization in the treatment of ruptured and non-ruptured adenomas, which might reduce the indication for surgery in selected cases and decrease morbidity and mortality. Magnetic resonance imaging showed a reduction of the embolized lesions and significant avascular component 30 days after treatment in the two cases in this report. No novel lesions were observed, and a reduction in the embolized lesions was demonstrated upon radiological assessment at a 12-month follow-up examination

Minimally processed vegetable salads: microbial quality evaluation.

Science.gov (United States)

Fröder, Hans; Martins, Cecília Geraldes; De Souza, Katia Leani Oliveira; Landgraf, Mariza; Franco, Bernadette D G M; Destro, Maria Teresa

2007-05-01

The increasing demand for fresh fruits and vegetables and for convenience foods is causing an expansion of the market share for minimally processed vegetables. Among the more common pathogenic microorganisms that can be transmitted to humans by these products are Listeria monocytogenes, Escherichia coli O157:H7, and Salmonella. The aim of this study was to evaluate the microbial quality of a selection of minimally processed vegetables. A total of 181 samples of minimally processed leafy salads were collected from retailers in the city of Sao Paulo, Brazil. Counts of total coliforms, fecal coliforms, Enterobacteriaceae, psychrotrophic microorganisms, and Salmonella were conducted for 133 samples. L. monocytogenes was assessed in 181 samples using the BAX System and by plating the enrichment broth onto Palcam and Oxford agars. Suspected Listeria colonies were submitted to classical biochemical tests. Populations of psychrotrophic microorganisms >10(6) CFU/g were found in 51% of the 133 samples, and Enterobacteriaceae populations between 10(5) and 106 CFU/g were found in 42% of the samples. Fecal coliform concentrations higher than 10(2) CFU/g (Brazilian standard) were found in 97 (73%) of the samples, and Salmonella was detected in 4 (3%) of the samples. Two of the Salmonella-positive samples had minimally processed vegetables had poor microbiological quality, and these products could be a vehicle for pathogens such as Salmonella and L. monocytogenes.

Minimizing Mutual Couping

DEFF Research Database (Denmark)

2010-01-01

Disclosed herein are techniques, systems, and methods relating to minimizing mutual coupling between a first antenna and a second antenna.......Disclosed herein are techniques, systems, and methods relating to minimizing mutual coupling between a first antenna and a second antenna....

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

Science.gov (United States)

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

2017-12-20

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

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

African Journals Online (AJOL)

2018-03-01

Mar 1, 2018 ... testing processes impair the clinical decision-making process. Such errors are ... and external quality control exceeding the target range, (14.4%) and (51.4%) .... version 3.5.3 and transferred to Statistical. Package for the ...

Patient safety risk factors in minimally invasive surgery : A validation study

NARCIS (Netherlands)

Rodrigues, S.P.; Ter Kuile, M.; Dankelman, J.; Jansen, F.W.

2012-01-01

This study was conducted to adapt and validate a patient safety (PS) framework for minimally invasive surgery (MIS) as a first step in understanding the clinical relevance of various PS risk factors in MIS. Eight patient safety risk factor domains were identified using frameworks from a systems

21 CFR 50.53 - Clinical investigations involving greater than minimal risk and no prospect of direct benefit to...

Science.gov (United States)

2010-04-01

... minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable... minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable... intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or...

MASTER: a model to improve and standardize clinical breakpoints for antimicrobial susceptibility testing using forecast probabilities.

Science.gov (United States)

Blöchliger, Nicolas; Keller, Peter M; Böttger, Erik C; Hombach, Michael

2017-09-01

The procedure for setting clinical breakpoints (CBPs) for antimicrobial susceptibility has been poorly standardized with respect to population data, pharmacokinetic parameters and clinical outcome. Tools to standardize CBP setting could result in improved antibiogram forecast probabilities. We propose a model to estimate probabilities for methodological categorization errors and defined zones of methodological uncertainty (ZMUs), i.e. ranges of zone diameters that cannot reliably be classified. The impact of ZMUs on methodological error rates was used for CBP optimization. The model distinguishes theoretical true inhibition zone diameters from observed diameters, which suffer from methodological variation. True diameter distributions are described with a normal mixture model. The model was fitted to observed inhibition zone diameters of clinical Escherichia coli strains. Repeated measurements for a quality control strain were used to quantify methodological variation. For 9 of 13 antibiotics analysed, our model predicted error rates of  0.1% for ampicillin, cefoxitin, cefuroxime and amoxicillin/clavulanic acid. Increasing the susceptible CBP (cefoxitin) and introducing ZMUs (ampicillin, cefuroxime, amoxicillin/clavulanic acid) decreased error rates to < 0.1%. ZMUs contained low numbers of isolates for ampicillin and cefuroxime (3% and 6%), whereas the ZMU for amoxicillin/clavulanic acid contained 41% of all isolates and was considered not practical. We demonstrate that CBPs can be improved and standardized by minimizing methodological categorization error rates. ZMUs may be introduced if an intermediate zone is not appropriate for pharmacokinetic/pharmacodynamic or drug dosing reasons. Optimized CBPs will provide a standardized antibiotic susceptibility testing interpretation at a defined level of probability. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For

Minimally invasive plating osteosynthesis for mid-distal third humeral shaft fractures.

Science.gov (United States)

Lian, Kejian; Wang, Lei; Lin, Dasheng; Chen, Zhiwen

2013-08-01

Mid-distal third humeral shaft fractures can be effectively treated with minimally invasive plating osteosynthesis and intramedullary nailing (IMN). However, these 2 treatments have not been adequately compared. Forty-seven patients (47 fractures) with mid-distal third humeral shaft fractures were randomly allocated to undergo either minimally invasive plating osteosynthesis (n=24) or IMN (n=23). The 2 groups were similar in terms of fracture patterns, fracture location, age, and associated injuries. Intraoperative measurements included blood loss and operative time. Clinical outcome measurements included fracture healing, radial nerve recovery, and elbow and shoulder discomfort. Radiographic measurements included fracture alignment, time to healing, delayed union, and nonunion. Functional outcome was satisfactory in both groups. Mean American Shoulder and Elbow Surgeons score and Mayo score were both better for the minimally invasive plating osteosynthesis group than for the IMN group (98.2 vs 97.6, respectively, and 93.5 vs 94.1, respectively; Pshaft fractures. Minimally invasive plating osteosynthesis is more suitable for complex fractures, especially for radial protection and motion recovery of adjacent joints, compared with IMN for simple fractures. Copyright 2013, SLACK Incorporated.

[Quality use of commercial laboratory for clinical testing services - considering laboratory's role].

Science.gov (United States)

Ogawa, Shinji

2014-12-01

The number of commercial laboratories for clinical testing in Japan run privately has decreased to about 30 companies, and their business is getting tougher. Branch Lab. and FMS businesses have not expanded recently due to the new reimbursement system which adds an additional sample management fee, becoming effective in 2010. This presentation gives an outline of each role for hospital and commercial laboratories, and their pros & cons considering the current medical situation. Commercial laboratories have investigated how to utilize ICT systems for sharing test information between hospitals and our facilities. It would be very helpful to clarify issues for each hospital. We will develop and create new values for clinical laboratory testing services and forge mutually beneficial relationships with medical institutions. (Review).

Validation of Clinical Testing for Warfarin Sensitivity

Science.gov (United States)

Langley, Michael R.; Booker, Jessica K.; Evans, James P.; McLeod, Howard L.; Weck, Karen E.

2009-01-01

Responses to warfarin (Coumadin) anticoagulation therapy are affected by genetic variability in both the CYP2C9 and VKORC1 genes. Validation of pharmacogenetic testing for warfarin responses includes demonstration of analytical validity of testing platforms and of the clinical validity of testing. We compared four platforms for determining the relevant single nucleotide polymorphisms (SNPs) in both CYP2C9 and VKORC1 that are associated with warfarin sensitivity (Third Wave Invader Plus, ParagonDx/Cepheid Smart Cycler, Idaho Technology LightCycler, and AutoGenomics Infiniti). Each method was examined for accuracy, cost, and turnaround time. All genotyping methods demonstrated greater than 95% accuracy for identifying the relevant SNPs (CYP2C9 *2 and *3; VKORC1 −1639 or 1173). The ParagonDx and Idaho Technology assays had the shortest turnaround and hands-on times. The Third Wave assay was readily scalable to higher test volumes but had the longest hands-on time. The AutoGenomics assay interrogated the largest number of SNPs but had the longest turnaround time. Four published warfarin-dosing algorithms (Washington University, UCSF, Louisville, and Newcastle) were compared for accuracy for predicting warfarin dose in a retrospective analysis of a local patient population on long-term, stable warfarin therapy. The predicted doses from both the Washington University and UCSF algorithms demonstrated the best correlation with actual warfarin doses. PMID:19324988

Minimal Residual Disease in Acute Myeloid Leukemia

Science.gov (United States)

Hourigan, Christopher S.; Karp, Judith E.

2014-01-01

Technological advances in the laboratory have lead to substantial improvements in clinical decision-making by the use of pre-treatment prognostic risk stratification factors in acute myeloid leukemia (AML). Unfortunately similar progress has not been made in treatment response criteria, with the definition of “complete remission” in AML largely unchanged for over half a century. Several recent clinical trials have demonstrated that higher sensitivity measurements of residual disease burden during or after treatment can be performed, that results are predictive for clinical outcome and can be used to improve outcomes by guiding additional therapeutic intervention to patients in clinical complete remission but at increased relapse risk. We review here these recent trials, the characteristics and challenges of the modalities currently used to detect minimal residual disease (MRD), and outline opportunities to both refine detection and better clinically utilize MRD measurements. MRD measurement is already the standard of care in other myeloid malignancies such as chronic myelogenous leukemia (CML) and acute promyelocytic leukemia (APL). It is our belief that response criteria for non-APL AML should be updated to include assessment for molecular complete remission (mCR) and that recommendations for post-consolidation surveillance should include regular monitoring for molecular relapse as a standard of care. PMID:23799371

Biological pacemaker created by minimally invasive somatic reprogramming in pigs with complete heart block

Science.gov (United States)

Hu, Yu-Feng; Dawkins, James Frederick; Cho, Hee Cheol; Marbán, Eduardo; Cingolani, Eugenio

2016-01-01

Somatic reprogramming by reexpression of the embryonic transcription factor T-box 18 (TBX18) converts cardiomyocytes into pacemaker cells. We hypothesized that this could be a viable therapeutic avenue for pacemaker-dependent patients afflicted with device-related complications, and therefore tested whether adenoviral TBX18 gene transfer could create biological pacemaker activity in vivo in a large-animal model of complete heart block. Biological pacemaker activity, originating from the intramyocardial injection site, was evident in TBX18-transduced animals starting at day 2 and persisted for the duration of the study (14 days) with minimal backup electronic pacemaker use. Relative to controls transduced with a reporter gene, TBX18-transduced animals exhibited enhanced autonomic responses and physiologically superior chronotropic support of physical activity. Induced sinoatrial node cells could be identified by their distinctive morphology at the site of injection in TBX18-transduced animals, but not in controls. No local or systemic safety concerns arose. Thus, minimally invasive TBX18 gene transfer creates physiologically relevant pacemaker activity in complete heart block, providing evidence for therapeutic somatic reprogramming in a clinically relevant disease model. PMID:25031269

Minimizing student’s faults in determining the design of experiment through inquiry-based learning

Science.gov (United States)

Nilakusmawati, D. P. E.; Susilawati, M.

2017-10-01

The purpose of this study were to describe the used of inquiry method in an effort to minimize student’s fault in designing an experiment and to determine the effectiveness of the implementation of the inquiry method in minimizing student’s faults in designing experiments on subjects experimental design. This type of research is action research participants, with a model of action research design. The data source were students of the fifth semester who took a subject of experimental design at Mathematics Department, Faculty of Mathematics and Natural Sciences, Udayana University. Data was collected through tests, interviews, and observations. The hypothesis was tested by t-test. The result showed that the implementation of inquiry methods to minimize of students fault in designing experiments, analyzing experimental data, and interpret them in cycle 1 students can reduce fault by an average of 10.5%. While implementation in Cycle 2, students managed to reduce fault by an average of 8.78%. Based on t-test results can be concluded that the inquiry method effectively used to minimize of student’s fault in designing experiments, analyzing experimental data, and interpreting them. The nature of the teaching materials on subject of Experimental Design that demand the ability of students to think in a systematic, logical, and critical in analyzing the data and interpret the test cases makes the implementation of this inquiry become the proper method. In addition, utilization learning tool, in this case the teaching materials and the students worksheet is one of the factors that makes this inquiry method effectively minimizes of student’s fault when designing experiments.

Reliability, construct and discriminative validity of clinical testing in subjects with and without chronic neck pain

DEFF Research Database (Denmark)

Jørgensen, René; Ris Hansen, Inge; Falla, Deborah

2014-01-01

-retest reliability in people with and without chronic neck pain. Moreover, construct and between-group discriminative validity of the tests were examined. METHODS: Twenty-one participants with chronic neck pain and 21 asymptomatic participants were included. Intra- and inter-reliability were evaluated for the Cranio-Cervical...... Flexion Test (CCFT), Range of Movement (ROM), Joint Position Error (JPE), Gaze Stability (GS), Smooth Pursuit Neck Torsion Test (SPNTT), and neuromuscular control of the Deep Cervical Extensors (DCE). Test-retest reliability was assessed for Postural Control (SWAY) and Pressure Pain Threshold (PPT) over......BACKGROUND: The reliability of clinical tests for the cervical spine has not been adequately evaluated. Six cervical clinical tests, which are low cost and easy to perform in clinical settings, were tested for intra- and inter-examiner reliability, and two performance tests were assessed for test...

Angiomyolipoma with minimal fat: Differentiation from papillary renal cell carcinoma by helical CT

International Nuclear Information System (INIS)

Zhang, Y.-Y.; Luo, S.; Liu, Y.; Xu, R.-T.

2013-01-01

Aim: To evaluate whether helical computed tomography (CT) images can be used to differentiate angiomyolipomas (AMLs) with minimal fat from papillary renal cell carcinomas (PRCCs) based on their morphological characteristics and enhancement features. Materials and methods: This retrospective study was approved by the institutional review board. Informed consent was waived. Forty-four patients (21 with AMLs with minimal fat and 23 with PRCCs) who underwent enhanced helical CT before total or partial nephrectomy were included. Two radiologists, who were blinded to the histopathology results, read the CT images and recorded the attenuation value, morphological characteristics, and enhancement features of the tumours, which were subsequently evaluated. An independent samples t-test, χ 2 test, and rank sum test were performed between the tumours. The predictive value of a CT finding was determined by multivariate logistic regression analysis. Results: AML with minimal fat had an apparent female prevalence (p < 0.01). Intra-tumoural vessels were noted in 11 cases of AML with minimal fat and three PRCC cases (p < 0.01). The unenhanced attenuation characteristic was significantly different between the two diseases (p < 0.001). The absolute attenuation values (AAVs) and the corrected attenuation values (CAVs) of the AML with minimal fat group of unenhanced and two phases of enhanced images were greater compared with that of the PRCC group (p < 0.05). After contrast medium injection, the tumour enhancement value (TEV) of the AML with minimal fat group in the corticomedullary phase was greater than that of the PRCC group (p < 0.01). Most cases of both tumour types demonstrated early enhancement characteristics; the enhancement value of the AML with minimal fat group was greater compared with that of the PRCC group (p < 0.01). The unenhanced attenuation characteristic, intra-tumoural vessels, and CAVs of unenhanced and early excretory phase scans were valuable parameters to

Development of a dynamic quality assurance testing protocol for multisite clinical trial DCE-CT accreditation

Energy Technology Data Exchange (ETDEWEB)

Driscoll, B. [Department of Radiation Physics, Princess Margaret Cancer Center, 610 University Avenue, Toronto, Ontario M5G 2M9 (Canada); Keller, H. [Department of Radiation Physics, Princess Margaret Cancer Center, 610 University Avenue, Toronto, Ontario M5G 2M9, Canada and Department of Radiation Oncology, University of Toronto, 150 College Street, Toronto, Ontario M5S 3E2 (Canada); Jaffray, D.; Coolens, C. [Department of Radiation Physics, Princess Margaret Cancer Center, 610 University Avenue, Toronto, Ontario M5G 2M9 (Canada); Department of Radiation Oncology, University of Toronto, 150 College Street, Toronto, Ontario M5S 3E2 (Canada); Techna Institute, University Health Network, 124-100 College Street, Toronto, Ontario M5G 1L5 (Canada)

2013-08-15

Purpose: Credentialing can have an impact on whether or not a clinical trial produces useful quality data that is comparable between various institutions and scanners. With the recent increase of dynamic contrast enhanced-computed tomography (DCE-CT) usage as a companion biomarker in clinical trials, effective quality assurance, and control methods are required to ensure there is minimal deviation in the results between different scanners and protocols at various institutions. This paper attempts to address this problem by utilizing a dynamic flow imaging phantom to develop and evaluate a DCE-CT quality assurance (QA) protocol.Methods: A previously designed flow phantom, capable of producing predictable and reproducible time concentration curves from contrast injection was fully validated and then utilized to design a DCE-CT QA protocol. The QA protocol involved a set of quantitative metrics including injected and total mass error, as well as goodness of fit comparison to the known truth concentration curves. An additional region of interest (ROI) sensitivity analysis was also developed to provide additional details on intrascanner variability and determine appropriate ROI sizes for quantitative analysis. Both the QA protocol and ROI sensitivity analysis were utilized to test variations in DCE-CT results using different imaging parameters (tube voltage and current) as well as alternate reconstruction methods and imaging techniques. The developed QA protocol and ROI sensitivity analysis was then applied at three institutions that were part of clinical trial involving DCE-CT and results were compared.Results: The inherent specificity of robustness of the phantom was determined through calculation of the total intraday variability and determined to be less than 2.2 ± 1.1% (total calculated output contrast mass error) with a goodness of fit (R{sup 2}) of greater than 0.99 ± 0.0035 (n= 10). The DCE-CT QA protocol was capable of detecting significant deviations from

Reach-to-grasp movement as a minimization process.

Science.gov (United States)

Yang, Fang; Feldman, Anatol G

2010-02-01

It is known that hand transport and grasping are functionally different but spatially coordinated components of reach-to-grasp (RTG) movements. As an extension of this notion, we suggested that body segments involved in RTG movements are controlled as a coherent ensemble by a global minimization process associated with the necessity for the hand to reach the motor goal. Different RTG components emerge following this process without pre-programming. Specifically, the minimization process may result from the tendency of neuromuscular elements to diminish the spatial gap between the actual arm-hand configuration and its virtual (referent) configuration specified by the brain. The referent configuration is specified depending on the object shape, localization, and orientation. Since the minimization process is gradual, it can be interrupted and resumed following mechanical perturbations, at any phase during RTG movements, including hand closure. To test this prediction of the minimization hypothesis, we asked subjects to reach and grasp a cube placed within the reach of the arm. Vision was prevented during movement until the hand returned to its initial position. As predicted, by arresting wrist motion at different points of hand transport in randomly selected trials, it was possible to halt changes in hand aperture at any phase, not only during hand opening but also during hand closure. Aperture changes resumed soon after the wrist was released. Another test of the minimization hypothesis was made in RTG movements to an object placed beyond the reach of the arm. It has previously been shown (Rossi et al. in J Physiol 538:659-671, 2002) that in such movements, the trunk motion begins to contribute to hand transport only after a critical phase when the shifts in the referent arm configuration have finished (at about the time when hand velocity is maximal). The minimization rule suggests that when the virtual contribution of the arm to hand transport is completed

Diagnostic value of patient characteristics, history, and six clinical tests for traumatic anterior shoulder instability

NARCIS (Netherlands)

van Kampen, D.A.; van den Berg, T.; van der Woude, H.J.; Castelein, R.M.; Terwee, C.B.; Willems, W.J.

2013-01-01

Background: It is unknown which combination of patient information and clinical tests might beoptimal for the diagnosis of traumatic anterior shoulder instability. This study aimed to determinethe diagnostic value of individual clinical tests and to develop a prediction model that combined patient

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

Science.gov (United States)

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

2015-01-01

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

Cost-effectiveness of minimally invasive sacroiliac joint fusion

Directory of Open Access Journals (Sweden)

Cher DJ

2015-12-01

Full Text Available Daniel J Cher,1 Melissa A Frasco,2 Renée JG Arnold,2,3 David W Polly4,5 1Clinical Affairs, SI-BONE, Inc., San Jose, CA, USA; 2Division of Health Economics and Outcomes Research, Quorum Consulting, Inc., San Francisco, CA, USA; 3Department of Preventive Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA; 4Department of Orthopaedic Surgery, University of Minnesota, Minneapolis, MN, USA; 5Department of Neurosurgery, University of Minnesota, Minneapolis, MN, USA Background: Sacroiliac joint (SIJ disorders are common in patients with chronic lower back pain. Minimally invasive surgical options have been shown to be effective for the treatment of chronic SIJ dysfunction. Objective: To determine the cost-effectiveness of minimally invasive SIJ fusion. Methods: Data from two prospective, multicenter, clinical trials were used to inform a Markov process cost-utility model to evaluate cumulative 5-year health quality and costs after minimally invasive SIJ fusion using triangular titanium implants or non-surgical treatment. The analysis was performed from a third-party perspective. The model specifically incorporated variation in resource utilization observed in the randomized trial. Multiple one-way and probabilistic sensitivity analyses were performed. Results: SIJ fusion was associated with a gain of approximately 0.74 quality-adjusted life years (QALYs at a cost of US$13,313 per QALY gained. In multiple one-way sensitivity analyses all scenarios resulted in an incremental cost-effectiveness ratio (ICER <$26,000/QALY. Probabilistic analyses showed a high degree of certainty that the maximum ICER for SIJ fusion was less than commonly selected thresholds for acceptability (mean ICER =$13,687, 95% confidence interval $5,162–$28,085. SIJ fusion provided potential cost savings per QALY gained compared to non-surgical treatment after a treatment horizon of greater than 13 years. Conclusion: Compared to traditional non-surgical treatments

Minimally invasive tubular resection of the anomalous transverse process in patients with Bertolotti's syndrome: presented at the 2013 Joint Spine Section Meeting: clinical article.

Science.gov (United States)

Li, Yumeng; Lubelski, Daniel; Abdullah, Kalil G; Mroz, Thomas E; Steinmetz, Michael P

2014-03-01

Bertolotti's syndrome consists of low-back pain caused by lumbosacral transitional vertebrae (LSTVs) and LSTV-associated biomechanical spinal changes. There is a lack of consensus regarding the cause, clinical significance, and treatment of this condition. The authors aim to characterize the clinical presentation of patients with Bertolotti's syndrome and describe a minimally invasive surgical treatment for this condition. Seven patients who underwent minimally invasive paramedian tubular-based resection of the LSTV for Bertolotti's syndrome were identified over the course of 5 years. Diagnosis was based on patient history of chronic low-back pain, radiographic findings of LSTV, and pain relief on trigger-site injection with steroid and/or anesthetics. Electronic medical records were reviewed to identify demographics, operative data, and outcomes. All patients presented with severe, chronic low-back pain lasting an average of 8 years that was resistant to nonoperative care. At presentation, 6 (86%) of 7 patients experienced radicular pain that was ipsilateral to the LSTV. Radiographic evidence showed a presence of LSTV in all patients on the left (43%), right (29%), or bilaterally (29%). Degenerative disc changes at the L4-5 level immediately above the anomalous LSTV were observed in 6 of 7 (86%) patients; these changes were not seen at the level below the LSTV. Following pseudo-joint injection, all patients experienced temporary relief of their symptoms. All patients underwent a minimally invasive, paramedian tubular-based approach for resection of the LSTV. Three (43%) of 7 patients reported complete resolution of low-back pain, 2 (29%) of 7 patients had reduced low-back pain, and 2 patients (29%) experienced initial relief but return of low-back pain at 1 and 4 years postoperatively. Three (50%) of the 6 patients with radicular pain had complete relief of this symptom. The median follow-up time was 12 months. No intraoperative complication was reported. Two (29

"Think aloud" and "Near live" usability testing of two complex clinical decision support tools.

Science.gov (United States)

Richardson, Safiya; Mishuris, Rebecca; O'Connell, Alexander; Feldstein, David; Hess, Rachel; Smith, Paul; McCullagh, Lauren; McGinn, Thomas; Mann, Devin

2017-10-01

Low provider adoption continues to be a significant barrier to realizing the potential of clinical decision support. "Think Aloud" and "Near Live" usability testing were conducted on two clinical decision support tools. Each was composed of an alert, a clinical prediction rule which estimated risk of either group A Streptococcus pharyngitis or pneumonia and an automatic order set based on risk. The objective of this study was to further understanding of the facilitators of usability and to evaluate the types of additional information gained from proceeding to "Near Live" testing after completing "Think Aloud". This was a qualitative observational study conducted at a large academic health care system with 12 primary care providers. During "Think Aloud" testing, participants were provided with written clinical scenarios and asked to verbalize their thought process while interacting with the tool. During "Near Live" testing participants interacted with a mock patient. Morae usability software was used to record full screen capture and audio during every session. Participant comments were placed into coding categories and analyzed for generalizable themes. Themes were compared across usability methods. "Think Aloud" and "Near Live" usability testing generated similar themes under the coding categories visibility, workflow, content, understand-ability and navigation. However, they generated significantly different themes under the coding categories usability, practical usefulness and medical usefulness. During both types of testing participants found the tool easier to use when important text was distinct in its appearance, alerts were passive and appropriately timed, content was up to date, language was clear and simple, and each component of the tool included obvious indicators of next steps. Participant comments reflected higher expectations for usability and usefulness during "Near Live" testing. For example, visit aids, such as automatically generated order sets

Genetic testing in congenital heart disease:A clinical approach

Institute of Scientific and Technical Information of China (English)

Marie A Chaix; Gregor Andelfinger; Paul Khairy

2016-01-01

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

Blinded trials taken to the test: an analysis of randomized clinical trials that report tests for the success of blinding

DEFF Research Database (Denmark)

Hróbjartsson, A; Forfang, E; Haahr, M T

2007-01-01

Blinding can reduce bias in randomized clinical trials, but blinding procedures may be unsuccessful. Our aim was to assess how often randomized clinical trials test the success of blinding, the methods involved and how often blinding is reported as being successful....

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

NARCIS (Netherlands)

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

2014-01-01

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

[Benefits of using rapid HIV testing at the PMU-FLON walk-in clinic in Lausanne].

Science.gov (United States)

Gilgien, W; Aubert, J; Bischoff, T; Herzig, L; Perdrix, J

2012-05-16

Lab tests are frequently used in primary care to guide patient care. This is particularly the case when a severe disorder, or one that will affect patients' initial care, needs to be excluded rapidly. At the PMU-FLON walk-in clinic the use of HIV testing as recommended by the Swiss Office of Public Health was hampered by the delay in obtaining test results. This led us to introduce rapid HIV testing which provides results within 30 minutes. Following the first 250 tests the authors discuss the results as well as the benefits of rapid HIV testing in an urban walk-in clinic.

Computer-aided test selection and result validation-opportunities and pitfalls

DEFF Research Database (Denmark)

McNair, P; Brender, J; Talmon, J

1998-01-01

/or to increase cost-efficiency). Our experience shows that there is a practical limit to the extent of exploitation of the principle of dynamic test scheduling, unless it is automated in one way or the other. This paper analyses some issues of concern related to the profession of clinical biochemistry, when......Dynamic test scheduling is concerned with pre-analytical preprocessing of the individual samples within a clinical laboratory production by means of decision algorithms. The purpose of such scheduling is to provide maximal information with minimal data production (to avoid data pollution and...... implementing such dynamic test scheduling within a Laboratory Information System (and/or an advanced analytical workstation). The challenge is related to 1) generation of appropriately validated decision models, and 2) mastering consequences of analytical imprecision and bias....

Platelet Function Tests: Preanalytical Variables, Clinical Utility, Advantages, and Disadvantages.

Science.gov (United States)

Hvas, Anne-Mette; Grove, Erik Lerkevang

2017-01-01

Platelet function tests are mainly used in the diagnostic work-up of platelet disorders. During the last decade, the additional use of platelet function tests to evaluate the effect of antiplatelet therapy has also emerged in an attempt to identify patients with an increased risk of arterial thrombosis. Furthermore, platelet function tests are increasingly used to measure residual effect of antiplatelet therapy prior to surgery with the aim of reducing the risk of bleeding. To a limited extend, platelet function tests are also used to evaluate hyperaggregability as a potential marker of a prothrombotic state outside the setting of antiplatelet therapy. This multifaceted use of platelet function tests and the development of simpler point-of-care tests with narrower application have increased the use of platelet function testing and also facilitated the use of platelet function tests outside the highly specialized laboratories. The present chapter describes the preanalytical variables, which should be taken into account when planning platelet function testing. Also, the most widely used platelet function tests are introduced, and their clinical utility and their relative advantages and disadvantages are discussed.

Electric dipole moment constraints on minimal electroweak baryogenesis

CERN Document Server

Huber, S J; Ritz, A; Huber, Stephan J.; Pospelov, Maxim; Ritz, Adam

2007-01-01

We study the simplest generic extension of the Standard Model which allows for conventional electroweak baryogenesis, through the addition of dimension six operators in the Higgs sector. At least one such operator is required to be CP-odd, and we study the constraints on such a minimal setup, and related scenarios with minimal flavor violation, from the null results of searches for electric dipole moments (EDMs), utilizing the full set of two-loop contributions to the EDMs. The results indicate that the current bounds are stringent, particularly that of the recently updated neutron EDM, but fall short of ruling out these scenarios. The next generation of EDM experiments should be sufficiently sensitive to provide a conclusive test.

Legal incentives for minimizing waste

International Nuclear Information System (INIS)

Clearwater, S.W.; Scanlon, J.M.

1991-01-01

Waste minimization, or pollution prevention, has become an integral component of federal and state environmental regulation. Minimizing waste offers many economic and public relations benefits. In addition, waste minimization efforts can also dramatically reduce potential criminal requirements. This paper addresses the legal incentives for minimizing waste under current and proposed environmental laws and regulations

Utility of Intraoperative Neuromonitoring during Minimally Invasive Fusion of the Sacroiliac Joint.

Science.gov (United States)

Woods, Michael; Birkholz, Denise; MacBarb, Regina; Capobianco, Robyn; Woods, Adam

2014-01-01

Study Design. Retrospective case series. Objective. To document the clinical utility of intraoperative neuromonitoring during minimally invasive surgical sacroiliac joint fusion for patients diagnosed with sacroiliac joint dysfunction (as a direct result of sacroiliac joint disruptions or degenerative sacroiliitis) and determine stimulated electromyography thresholds reflective of favorable implant position. Summary of Background Data. Intraoperative neuromonitoring is a well-accepted adjunct to minimally invasive pedicle screw placement. The utility of intraoperative neuromonitoring during minimally invasive surgical sacroiliac joint fusion using a series of triangular, titanium porous plasma coated implants has not been evaluated. Methods. A medical chart review of consecutive patients treated with minimally invasive surgical sacroiliac joint fusion was undertaken at a single center. Baseline patient demographics and medical history, intraoperative electromyography thresholds, and perioperative adverse events were collected after obtaining IRB approval. Results. 111 implants were placed in 37 patients. Sensitivity of EMG was 80% and specificity was 97%. Intraoperative neuromonitoring potentially avoided neurologic sequelae as a result of improper positioning in 7% of implants. Conclusions. The results of this study suggest that intraoperative neuromonitoring may be a useful adjunct to minimally invasive surgical sacroiliac joint fusion in avoiding nerve injury during implant placement.

Utility of Intraoperative Neuromonitoring during Minimally Invasive Fusion of the Sacroiliac Joint

Directory of Open Access Journals (Sweden)

Michael Woods

2014-01-01

Full Text Available Study Design. Retrospective case series. Objective. To document the clinical utility of intraoperative neuromonitoring during minimally invasive surgical sacroiliac joint fusion for patients diagnosed with sacroiliac joint dysfunction (as a direct result of sacroiliac joint disruptions or degenerative sacroiliitis and determine stimulated electromyography thresholds reflective of favorable implant position. Summary of Background Data. Intraoperative neuromonitoring is a well-accepted adjunct to minimally invasive pedicle screw placement. The utility of intraoperative neuromonitoring during minimally invasive surgical sacroiliac joint fusion using a series of triangular, titanium porous plasma coated implants has not been evaluated. Methods. A medical chart review of consecutive patients treated with minimally invasive surgical sacroiliac joint fusion was undertaken at a single center. Baseline patient demographics and medical history, intraoperative electromyography thresholds, and perioperative adverse events were collected after obtaining IRB approval. Results. 111 implants were placed in 37 patients. Sensitivity of EMG was 80% and specificity was 97%. Intraoperative neuromonitoring potentially avoided neurologic sequelae as a result of improper positioning in 7% of implants. Conclusions. The results of this study suggest that intraoperative neuromonitoring may be a useful adjunct to minimally invasive surgical sacroiliac joint fusion in avoiding nerve injury during implant placement.

Design of a test system for the development of advanced video chips and software algorithms.

Science.gov (United States)

Falkinger, Marita; Kranzfelder, Michael; Wilhelm, Dirk; Stemp, Verena; Koepf, Susanne; Jakob, Judith; Hille, Andreas; Endress, Wolfgang; Feussner, Hubertus; Schneider, Armin

2015-04-01

Visual deterioration is a crucial point in minimally invasive surgery impeding surgical performance. Modern image processing technologies appear to be promising approaches for further image optimization by digital elimination of disturbing particles. To make them mature for clinical application, an experimental test environment for evaluation of possible image interferences would be most helpful. After a comprehensive review of the literature (MEDLINE, IEEE, Google Scholar), a test bed for generation of artificial surgical smoke and mist was evolved. Smoke was generated by a fog machine and mist produced by a nebulizer. The size of resulting droplets was measured microscopically and compared with biological smoke (electrocautery) and mist (ultrasound dissection) emerging during minimally invasive surgical procedures. The particles resulting from artificial generation are in the range of the size of biological droplets. For surgical smoke, the droplet dimension produced by the fog machine was 4.19 µm compared with 4.65 µm generated by electrocautery during a surgical procedure. The size of artificial mist produced by the nebulizer ranged between 45.38 and 48.04 µm compared with the range between 30.80 and 56.27 µm that was generated during minimally invasive ultrasonic dissection. A suitable test bed for artificial smoke and mist generation was developed revealing almost identical droplet characteristics as produced during minimally invasive surgical procedures. The possibility to generate image interferences comparable to those occurring during laparoscopy (electrocautery and ultrasound dissection) provides a basis for the future development of image processing technologies for clinical applications. © The Author(s) 2014.

Early benefits of minimally invasive transforaminal lumbar interbody fusion in comparison with the traditional open procedure

Directory of Open Access Journals (Sweden)

Gregor Rečnik

2015-06-01

Full Text Available AbstractBackgroundLumbar interbody fusion is a standard operative procedure in orthopedic spine surgery. Morphological and functional changes in the multifidus muscle after an open procedure have led to the development of a minimally invasive technique, after which no such muscle changes were observed. MethodsSixty-four patients, with clinical and radiological criteria for one-level transforaminal lumbar interbody fusion were enrolled in our prospective randomized study between December 2011 and March 2014. They were randomized into two groups: open approach (33 patients vs. minimally invasive approach (31 patients; one patient was excluded from each group due to postoperative complications. Independent samples T-test was used to compare average values of increase in creatin kinase (CK, which is an enzymatic marker of muscle injury, average surgical time, loss of blood during and after surgery, back pain according to the Visual Analogue Scale (VAS and day of discharge from the hospital. ResultsStatistically important (P< 0.001 lower blood loss (188 ml vs. 527 ml total, less CK increase (15 ukat/L vs. 29 ukat/L, lower VAS score after surgery (7.3 vs. 8.7 and earlier discharge from the hospital (3.5 days vs. 5.2 days were observed in the minimally invasive transforaminal lumbar interbody fusion group. No significant difference in average surgical time was recorded. Conclusions Our results suggest, that minimally invasive transforaminal lumbar interbody fusion causes is associated with less muscle damage, lower blood loss, less post surgical pain and faster early rehabilitation, which is in accordance with previous studies.

MOCUS, Minimal Cut Sets and Minimal Path Sets from Fault Tree Analysis

International Nuclear Information System (INIS)

Fussell, J.B.; Henry, E.B.; Marshall, N.H.

1976-01-01

1 - Description of problem or function: From a description of the Boolean failure logic of a system, called a fault tree, and control parameters specifying the minimal cut set length to be obtained MOCUS determines the system failure modes, or minimal cut sets, and the system success modes, or minimal path sets. 2 - Method of solution: MOCUS uses direct resolution of the fault tree into the cut and path sets. The algorithm used starts with the main failure of interest, the top event, and proceeds to basic independent component failures, called primary events, to resolve the fault tree to obtain the minimal sets. A key point of the algorithm is that an and gate alone always increases the number of path sets; an or gate alone always increases the number of cut sets and increases the size of path sets. Other types of logic gates must be described in terms of and and or logic gates. 3 - Restrictions on the complexity of the problem: Output from MOCUS can include minimal cut and path sets for up to 20 gates

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

International Nuclear Information System (INIS)

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

2005-01-01

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

Is non-minimal inflation eternal?

International Nuclear Information System (INIS)

Feng, Chao-Jun; Li, Xin-Zhou

2010-01-01

The possibility that the non-minimal coupling inflation could be eternal is investigated. We calculate the quantum fluctuation of the inflaton in a Hubble time and find that it has the same value as that in the minimal case in the slow-roll limit. Armed with this result, we have studied some concrete non-minimal inflationary models including the chaotic inflation and the natural inflation, in which the inflaton is non-minimally coupled to the gravity. We find that the non-minimal coupling inflation could be eternal in some parameter spaces.

Provider Initiated Testing and Counseling (PITC for HIV in resource-limited clinical settings: important questions unanswered

Directory of Open Access Journals (Sweden)

Peter Twyman

2009-09-01

Full Text Available Testing is the gateway to HIV care and support services, and efforts to broaden treatment must include a proactive and inclusive approach to testing. Provider Initiated Testing and Counseling (PITC for HIV utilizes the opportunity afforded by the clinical encounter for the care provider to make a clinical recommendation that the patient have a voluntary HIV test. It is hoped that by broadening testing by such strategies as PITC more patients may be identified and linked to treatment and support. However, there exist multiple challenges and questions regarding the provision of routine HIV testing and counseling in clinical facilities. In order to support further PITC efforts and scale up of current testing programs, a research agenda that addresses the ethical, social and operational components of PITC programming in health facilities, is critically needed to further guide its expansion.

Road map for the clinical application of the basophil activation test in food allergy.

Science.gov (United States)

Santos, A F; Shreffler, W G

2017-09-01

The diagnosis of IgE-mediated food allergy based solely on the clinical history and the documentation of specific IgE to whole allergen extract or single allergens is often ambiguous, requiring oral food challenges (OFCs), with the attendant risk and inconvenience to the patient, to confirm the diagnosis of food allergy. This is a considerable proportion of patients assessed in allergy clinics. The basophil activation test (BAT) has emerged as having superior specificity and comparable sensitivity to diagnose food allergy, when compared with skin prick test and specific IgE. BAT, therefore, may reduce the number of OFC required for accurate diagnosis, particularly positive OFC. BAT can also be used to monitor resolution of food allergy and the clinical response to immunomodulatory treatments. Given the practicalities involved in the performance of BAT, we propose that it can be applied for selected cases where the history, skin prick test and/or specific IgE are not definitive for the diagnosis of food allergy. In the cases that the BAT is positive, food allergy is sufficiently confirmed without OFC; in the cases that BAT is negative or the patient has non-responder basophils, OFC may still be indicated. However, broad clinical application of BAT demands further standardization of the laboratory procedure and of the flow cytometry data analyses, as well as clinical validation of BAT as a diagnostic test for multiple target allergens and confirmation of its feasibility and cost-effectiveness in multiple settings. © 2017 The Authors. Clinical & Experimental Allergy published by John Wiley & Sons Ltd.

Successful Integration of Hepatitis C Virus Point-of-Care Tests into the Denver Metro Health Clinic

Directory of Open Access Journals (Sweden)

A. Jewett

2013-01-01

Full Text Available Background. The Centers for Disease Control and Prevention (CDC recommends testing and linkage to care for persons most likely infected with hepatitis C virus (HCV, including persons with human immunodeficiency virus. We explored facilitators and barriers to integrating HCV point-of-care (POC testing into standard operations at an urban STD clinic. Methods. The OraQuick HCV rapid antibody test was integrated at the Denver Metro Health Clinic (DMHC. All clients with at least one risk factor were offered the POC test. Research staff conducted interviews with clients (three HCV positive and nine HCV negative. Focus groups were conducted with triage staff, providers, and linkage-to-care counselors. Results. Clients were pleased with the ease of use and rapid return of results from the HCV POC test. Integrating the test into this setting required more time but was not overly burdensome. While counseling messages were clear to staff, clients retained little knowledge of hepatitis C infection or factors related to risk. Barriers to integrating the HCV POC test into clinic operations were loss to follow-up and access to care. Conclusion. DMHC successfully integrated HCV POC testing and piloted a HCV linkage-to-care program. Providing testing opportunities at STD clinics could increase identification of persons with HCV infection.

The script concordance test as a tool to evaluate clinical reasoning in neonatology.

Science.gov (United States)

Ben Hamida, Emira; Ayadi, Imen; Marrakchi, Zahra; Quinton, André

2017-05-01

Script concordance test aims to evaluate knowledge organization, which represents an essential component of the clinical competence. To build a script concordance test and demonstrate its relevance in the evaluation of Neonatology skills. A script concordance test including 20 vignettes and 20 items, was provided to 52 fourth year medical students and 11 family medicine interns. Script concordance test scores obtained by experts were higher then those obtained by students and family medicine interns. The scores (out of 100) were 82.52 ± 7.35 CI95% [77.26-87.78] for the experts, 58.52 ± 9.72 CI95% [55.82-61.23] for the students, and 63.17±11.36 IC95%  [55.53-70.81] (p<0.0001) for the interns. Our data suggest that script concordance tests could be used to assess the acquisition of clinical reasoning among fourth year medical students in neonatolgy.

Minimal families of curves on surfaces

KAUST Repository

Lubbes, Niels

2014-11-01

A minimal family of curves on an embedded surface is defined as a 1-dimensional family of rational curves of minimal degree, which cover the surface. We classify such minimal families using constructive methods. This allows us to compute the minimal families of a given surface.The classification of minimal families of curves can be reduced to the classification of minimal families which cover weak Del Pezzo surfaces. We classify the minimal families of weak Del Pezzo surfaces and present a table with the number of minimal families of each weak Del Pezzo surface up to Weyl equivalence.As an application of this classification we generalize some results of Schicho. We classify algebraic surfaces that carry a family of conics. We determine the minimal lexicographic degree for the parametrization of a surface that carries at least 2 minimal families. © 2014 Elsevier B.V.

Hexavalent Chromium Minimization Strategy

Science.gov (United States)

2011-05-01

Logistics 4 Initiative - DoD Hexavalent Chromium Minimization Non- Chrome Primer IIEXAVAJ ENT CHRO:M I~UMI CHROMIUM (VII Oil CrfVli.J CANCEfl HAnRD CD...Management Office of the Secretary of Defense Hexavalent Chromium Minimization Strategy Report Documentation Page Form ApprovedOMB No. 0704-0188...00-2011 4. TITLE AND SUBTITLE Hexavalent Chromium Minimization Strategy 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6

Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act.

Science.gov (United States)

Logvinov, Ilana

2014-03-01

Clinical trial research is the cornerstone for successful advancement of medicine that provides hope for millions of people in the future. Full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data, and potentially eliminate duplicate studies. Current regulatory system and publishers rely on investigators and pharmaceutical industries for complete and accurate reporting of results from completed clinical trials. Legislation seems to be the only way to enforce mandatory disclosure of results. The Trial and Experimental Studies Transparency (TEST) Act of 2012 was introduced to the legislators in the United States to promote greater transparency in research industry. Public safety and advancement of science are the driving forces for the proposed policy change. The TEST Act may benefit the society and researchers; however, there are major concerns with participants' privacy and intellectual property protection. Copyright © 2014 Elsevier Inc. All rights reserved.

Emergency department assessment of abdominal pain: clinical indicator tests for detecting peritonism.

Science.gov (United States)

Taylor, Scott; Watt, Martin

2005-12-01

Peritonism is a finding that leads to a more cautious approach in the emergency department management of abdominal pain. This study examined whether peritonism assessment using inspiration, expiration and cough tests was associated with the patient's clinical management. This prospective observational study evaluated consecutive patients presenting directly to the emergency department for 3 months from June 2000 with abdominal pain. Triage initial observations of blood pressure, pulse, respiratory rate, oxygen saturation and temperature were recorded. The examining emergency physician recorded each patient's response and pain score to the individual peritonism tests and scored it as positive if there was an indication of it being a painful manoeuvre. The results were blinded from the receiving specialty if subsequent referral was required. Sixty-seven patients had peritonism tests performed. No individual test was more painful than the others with similar values in pain scores. In all, 70% (7/10) were admitted when all three tests were positive, compared with 21% (12/57) when two or less of the tests scored positive (P=0.004, Fisher's exact test). Admission was not associated with any individual test or combination of tests, or any other variable. The peritonism tests were not associated with any other physiological observation or measurement. These peritonism tests represent a simple investigation, and are significantly associated with admission when all three tests are positive. They seem to be a clinical predictor of cases in which continuing assessment was required, and may be useful as a departmental 'safety net' in the management of abdominal pain.

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

Science.gov (United States)

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

2011-01-01

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

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

Directory of Open Access Journals (Sweden)

Magdy Gomaa

2016-12-01

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

Clinical Neuropathology practice news 1-2014: Pyrosequencing meets clinical and analytical performance criteria for routine testing of MGMT promoter methylation status in glioblastoma

Science.gov (United States)

Preusser, Matthias; Berghoff, Anna S.; Manzl, Claudia; Filipits, Martin; Weinhäusel, Andreas; Pulverer, Walter; Dieckmann, Karin; Widhalm, Georg; Wöhrer, Adelheid; Knosp, Engelbert; Marosi, Christine; Hainfellner, Johannes A.

2014-01-01

Testing of the MGMT promoter methylation status in glioblastoma is relevant for clinical decision making and research applications. Two recent and independent phase III therapy trials confirmed a prognostic and predictive value of the MGMT promoter methylation status in elderly glioblastoma patients. Several methods for MGMT promoter methylation testing have been proposed, but seem to be of limited test reliability. Therefore, and also due to feasibility reasons, translation of MGMT methylation testing into routine use has been protracted so far. Pyrosequencing after prior DNA bisulfite modification has emerged as a reliable, accurate, fast and easy-to-use method for MGMT promoter methylation testing in tumor tissues (including formalin-fixed and paraffin-embedded samples). We performed an intra- and inter-laboratory ring trial which demonstrates a high analytical performance of this technique. Thus, pyrosequencing-based assessment of MGMT promoter methylation status in glioblastoma meets the criteria of high analytical test performance and can be recommended for clinical application, provided that strict quality control is performed. Our article summarizes clinical indications, practical instructions and open issues for MGMT promoter methylation testing in glioblastoma using pyrosequencing. PMID:24359605

Genetic testing in congenital heart disease: A clinical approach

Science.gov (United States)

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

2016-01-01

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

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

Science.gov (United States)

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

2016-01-01

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

Varietal improvement of irrigated rice under minimal water conditions

International Nuclear Information System (INIS)

Abdul Rahim Harun; Marziah Mahmood; Sobri Hussein

2010-01-01

Varietal improvement of irrigated rice under minimal water condition is a research project under Program Research of Sustainable Production of High Yielding Irrigated Rice under Minimal Water Input (IRPA- 01-01-03-0000/ PR0068/ 0504). Several agencies were involved in this project such as Malaysian Nuclear Agency (MNA), Malaysian Agricultural Research and Development Institute (MARDI), Universiti Putra Malaysia (UPM) and Ministry of Agriculture (MOA). The project started in early 2004 with approved IRPA fund of RM 275,000.00 for 3 years. The main objective of the project is to generate superior genotypes for minimal water requirement through induced mutation techniques. A cultivated rice Oryza sativa cv MR219 treated with gamma radiation at 300 and 400 Gray were used in the experiment. Two hundred gm M2 seeds from each dose were screened under minimal water stress in greenhouse at Mardi Seberang Perai. Five hundred panicles with good filled grains were selected for paddy field screening with simulate precise water stress regime. Thirty eight potential lines with required adaptive traits were selected in M3. After several series of selection, 12 promising mutant line were observed tolerance to minimal water stress where two promising mutant lines designated as MR219-4 and MR219-9 were selected for further testing under several stress environments. (author)

A predictive model of suitability for minimally invasive parathyroid surgery in the treatment of primary hyperparathyroidism [corrected].

LENUS (Irish Health Repository)

Kavanagh, Dara O

2012-05-01

Improved preoperative localizing studies have facilitated minimally invasive approaches in the treatment of primary hyperparathyroidism (PHPT). Success depends on the ability to reliably select patients who have PHPT due to single-gland disease. We propose a model encompassing preoperative clinical, biochemical, and imaging studies to predict a patient\\'s suitability for minimally invasive surgery.

Clinical Objective Dry Eye Tests in a Population of Tannery Workers in North India.

Science.gov (United States)

Ranjan, Ratnesh; Kushwaha, Raj Nath; Khan, Perwez; Mohan, Shalini; Gupta, Ramesh Chandra

2016-10-01

To analyze the correlation between subjective symptoms and clinical signs of dry eye among tannery workers. In this cross-sectional study, three classic clinical tests, namely the fluorescein tear film break-up time (FTBUT) test, the fluorescein staining (FS) test, and the Schirmer test (ST), were performed to assess the clinical signs of dry eye disease in 246 tanners who were found symptomatic for dry eye in a prior ocular surface disease index survey. All workers were male with a mean age of 35 ± 9 years, and the mean duration of work at tanneries was 8 ± 5 years. Among 246 symptomatic subjects, the FTBUT test, the FS test and the ST were positive in 63.8%, 30.9% and 41.9% workers, respectively. Mean FTBUT and ST scores were 10.6 ± 4.2 seconds and 10.1 ± 7.7mm, respectively. Mean FTBUT for mild, moderate and severe symptom categories differed significantly. Mean ST scores for the mild symptom group were significantly higher than that of the moderate group (p < 0.0001). The FTBUT and ST score showed a strong negative correlation with severity of symptoms (p < 0.0001). A moderate positive correlation was observed between FS positivity and increasing symptom severity (p < 0.0001). The effect of age was insignificant for FTBUT (p = 0.10), while significant for ST score (p < 0.001). The effect of duration of tannery work was significant for both FTBUT and ST scores (p < 0.0001). Clinical tests correlated well with symptom severity among tanners, and a multifactorial etiology is suggested for dry eye diseases.

Home-based HIV testing for men preferred over clinic-based testing by pregnant women and their male partners, a nested cross-sectional study.

Science.gov (United States)

Osoti, Alfred Onyango; John-Stewart, Grace; Kiarie, James Njogu; Barbra, Richardson; Kinuthia, John; Krakowiak, Daisy; Farquhar, Carey

2015-07-30

Male partner HIV testing and counseling (HTC) is associated with enhanced uptake of prevention of mother-to-child HIV transmission (PMTCT), yet male HTC during pregnancy remains low. Identifying settings preferred by pregnant women and their male partners may improve male involvement in PMTCT. Participants in a randomized clinical trial (NCT01620073) to improve male partner HTC were interviewed to determine whether the preferred male partner HTC setting was the home, antenatal care (ANC) clinic or VCT center. In this nested cross sectional study, responses were evaluated at baseline and after 6 weeks. Differences between the two time points were compared using McNemar's test and correlates of preference were determined using logistic regression. Among 300 pregnant female participants, 54% preferred home over ANC clinic testing (34.0%) or VCT center (12.0%). Among 188 male partners, 68% preferred home-based HTC to antenatal clinic (19%) or VCT (13%). Men who desired more children and women who had less than secondary education or daily income Pregnant women and their male partners preferred home-based compared to clinic or VCT-center based male partner HTC. Home-based HTC during pregnancy appears acceptable and may improve male testing and involvement in PMTCT.

Minimal and non-minimal standard models: Universality of radiative corrections

International Nuclear Information System (INIS)

Passarino, G.

1991-01-01

The possibility of describing electroweak processes by means of models with a non-minimal Higgs sector is analyzed. The renormalization procedure which leads to a set of fitting equations for the bare parameters of the lagrangian is first reviewed for the minimal standard model. A solution of the fitting equations is obtained, which correctly includes large higher-order corrections. Predictions for physical observables, notably the W boson mass and the Z O partial widths, are discussed in detail. Finally the extension to non-minimal models is described under the assumption that new physics will appear only inside the vector boson self-energies and the concept of universality of radiative corrections is introduced, showing that to a large extent they are insensitive to the details of the enlarged Higgs sector. Consequences for the bounds on the top quark mass are also discussed. (orig.)

Maximizing biomarker discovery by minimizing gene signatures

Directory of Open Access Journals (Sweden)

Chang Chang

2011-12-01

Full Text Available Abstract Background The use of gene signatures can potentially be of considerable value in the field of clinical diagnosis. However, gene signatures defined with different methods can be quite various even when applied the same disease and the same endpoint. Previous studies have shown that the correct selection of subsets of genes from microarray data is key for the accurate classification of disease phenotypes, and a number of methods have been proposed for the purpose. However, these methods refine the subsets by only considering each single feature, and they do not confirm the association between the genes identified in each gene signature and the phenotype of the disease. We proposed an innovative new method termed Minimize Feature's Size (MFS based on multiple level similarity analyses and association between the genes and disease for breast cancer endpoints by comparing classifier models generated from the second phase of MicroArray Quality Control (MAQC-II, trying to develop effective meta-analysis strategies to transform the MAQC-II signatures into a robust and reliable set of biomarker for clinical applications. Results We analyzed the similarity of the multiple gene signatures in an endpoint and between the two endpoints of breast cancer at probe and gene levels, the results indicate that disease-related genes can be preferably selected as the components of gene signature, and that the gene signatures for the two endpoints could be interchangeable. The minimized signatures were built at probe level by using MFS for each endpoint. By applying the approach, we generated a much smaller set of gene signature with the similar predictive power compared with those gene signatures from MAQC-II. Conclusions Our results indicate that gene signatures of both large and small sizes could perform equally well in clinical applications. Besides, consistency and biological significances can be detected among different gene signatures, reflecting the

Evaluation of diabetic foot osteomyelitis using probe to bone test and magnetic resonance imaging and their impact on surgical intervention

Directory of Open Access Journals (Sweden)

Fatma Zaiton

2014-09-01

Conclusion: PTB test is a simple, minimally invasive, low cost test and can be done at outpatient clinic. Its sensitivity and specificity are good when compared to those of MRI, but when we need to diagnose associated soft tissue infection and planning the surgical management MRI was the image of choice.

Point-of-care testing for chlamydia and gonorrhoea: implications for clinical practice.

Directory of Open Access Journals (Sweden)

Lisa Natoli

Full Text Available Point-of-care (POC testing for chlamydia (CT and gonorrhoea (NG offers a new approach to the diagnosis and management of these sexually transmitted infections (STIs in remote Australian communities and other similar settings. Diagnosis of STIs in remote communities is typically symptom driven, and for those who are asymptomatic, treatment is generally delayed until specimens can be transported to the reference laboratory, results returned and the patient recalled. The objective of this study was to explore the clinical implications of using CT/NG POC tests in routine clinical care in remote settings.In-depth qualitative interviews were conducted with a purposively selected group of 18 key informants with a range of sexual health and laboratory expertise.Participants highlighted the potential impact POC testing would have on different stages of the current STI management pathway in remote Aboriginal communities and how the pathway would change. They identified implications for offering a POC test, specimen collection, conducting the POC test, syndromic management of STIs, pelvic inflammatory disease diagnosis and management, interpretation and delivery of POC results, provision of treatment, contact tracing, management of client flow and wait time, and re-testing at 3 months after infection.The introduction of POC testing to improve STI service delivery requires careful consideration of both its advantages and limitations. The findings of this study will inform protocols for the implementation of CT/NG POC testing, and also STI testing and management guidelines.

Point-of-Care Testing for Chlamydia and Gonorrhoea: Implications for Clinical Practice

Science.gov (United States)

Natoli, Lisa; Maher, Lisa; Shephard, Mark; Hengel, Belinda; Tangey, Annie; Badman, Steven G.; Ward, James; Guy, Rebecca J.

2014-01-01

Objectives Point-of-care (POC) testing for chlamydia (CT) and gonorrhoea (NG) offers a new approach to the diagnosis and management of these sexually transmitted infections (STIs) in remote Australian communities and other similar settings. Diagnosis of STIs in remote communities is typically symptom driven, and for those who are asymptomatic, treatment is generally delayed until specimens can be transported to the reference laboratory, results returned and the patient recalled. The objective of this study was to explore the clinical implications of using CT/NG POC tests in routine clinical care in remote settings. Methods In-depth qualitative interviews were conducted with a purposively selected group of 18 key informants with a range of sexual health and laboratory expertise. Results Participants highlighted the potential impact POC testing would have on different stages of the current STI management pathway in remote Aboriginal communities and how the pathway would change. They identified implications for offering a POC test, specimen collection, conducting the POC test, syndromic management of STIs, pelvic inflammatory disease diagnosis and management, interpretation and delivery of POC results, provision of treatment, contact tracing, management of client flow and wait time, and re-testing at 3 months after infection. Conclusions The introduction of POC testing to improve STI service delivery requires careful consideration of both its advantages and limitations. The findings of this study will inform protocols for the implementation of CT/NG POC testing, and also STI testing and management guidelines. PMID:24956111

Clinical accuracy of a patient-specific femoral osteotomy guide in minimally-invasive posterior hip arthroplasty.

Science.gov (United States)

Schneider, Adrian K; Pierrepont, Jim W; Hawdon, Gabrielle; McMahon, Stephen

2018-04-01

Patient specific guides can be a valuable tool in improving the precision of planned femoral neck osteotomies, especially in minimally invasive hip surgery, where bony landmarks are often inaccessible. The aim of our study was to validate the accuracy of a novel patient specific femoral osteotomy guide for THR through a minimally invasive posterior approach, the direct superior approach (DSA). As part of our routine preoperative planning 30 patients underwent low dose CT scans of their arthritic hip. 3D printed patient specific femoral neck osteotomy guides were then produced. Intraoperatively, having cleared all soft tissue from the postero-lateral neck of the enlocated hip, the guide was placed and pinned onto the posterolateral femoral neck. The osteotomy was performed using an oscillating saw and the uncemented hip components were implanted as per routine. Postoperatively, the achieved level of the osteotomy at the medial calcar was compared with the planned level of resection using a 3D/2D matching analysis (Mimics X-ray module, Materialise, Belgium). A total of 30 patients undergoing uncemented Trinity™ acetabular and TriFit TS™ femoral component arthroplasty (Corin, UK) were included in our analysis. All but one of our analysed osteotomies were found to be within 3 mm from the planned height of osteotomy. In one patient the level of osteotomy deviated 5 mm below the planned level of resection. Preoperative planning and the use of patient specific osteotomy guides provides an accurate method of performing femoral neck osteotomies in minimally invasive hip arthroplasty using the direct superior approach. IV (Case series).

Identifying Minimal Changes in Nonerosive Reflux Disease: Is the Pay Worth the Labor?

Science.gov (United States)

Gabbard, Scott L; Fass, Ronnie; Maradey-Romero, Carla; Gingold Belfer, Rachel; Dickman, Ram

2016-01-01

Gastroesophageal reflux disease has a variable presentation on upper endoscopy. Gastroesophageal reflux disease can be divided into 3 endoscopic categories: Barrett's esophagus, erosive esophagitis, and normal mucosa/nonerosive reflux disease (NERD). Each of these phenotypes behave in a distinct manner, in regards to symptom response to treatment, and risk of development of complications such as esophageal adenocarcinoma. Recently, it has been proposed to further differentiate NERD into 2 categories: those with and those without "minimal changes." These minimal changes include endoscopic abnormalities, such as villous mucosal surface, mucosal islands, microerosions, and increased vascularity at the squamocolumnar junction. Although some studies have shown that patients with minimal changes may have higher rates of esophageal acid exposure compared with those without minimal changes, it is currently unclear if these patients behave differently than those currently categorized as having NERD. The clinical utility of identifying these lesions should be weighed against the cost of the requisite equipment and the additional time required for diagnosis, compared with conventional white light endoscopy.

26 CFR 1.28-1 - Credit for clinical testing expenses for certain drugs for rare diseases or conditions.

Science.gov (United States)

2010-04-01

...) Definition of “carried out under” section 505(i). Human clinical testing is not carried out under section 505... disregarded. (B) In-house research expenses. If one member of a group conducts clinical testing on behalf of... expense. For purposes of determining whether the in-house research for that work is clinical testing, the...

Clinical impact of minimal residual disease in children with different subtypes of acute lymphoblastic leukemia treated with Response-Adapted therapy.

Science.gov (United States)

Pui, C-H; Pei, D; Raimondi, S C; Coustan-Smith, E; Jeha, S; Cheng, C; Bowman, W P; Sandlund, J T; Ribeiro, R C; Rubnitz, J E; Inaba, H; Gruber, T A; Leung, W H; Yang, J J; Downing, J R; Evans, W E; Relling, M V; Campana, D

2017-02-01

To determine the clinical significance of minimal residual disease (MRD) in patients with prognostically relevant subtypes of childhood acute lymphoblastic leukemia (ALL), we analyzed data from 488 patients treated in St Jude Total Therapy Study XV with treatment intensity based mainly on MRD levels measured during remission induction. MRD levels on day 19 predicted treatment outcome for patients with hyperdiploid >50 ALL, National Cancer Institute (NCI) standard-risk B-ALL or T-cell ALL, while MRD levels on day 46 were prognostic for patients with NCI standard-risk or high-risk B-ALL. Patients with t(12;21)/(ETV6-RUNX1) or hyperdiploidy >50 ALL had the best prognosis; those with a negative MRD on day 19 had a particularly low risk of relapse: 1.9% and 3.8%, respectively. Patients with NCI high-risk B-ALL or T-cell ALL had an inferior outcome; even with undetectable MRD on day 46, cumulative risk of relapse was 12.7% and 15.5%, respectively. Among patients with NCI standard-risk B-ALL, the outcome was intermediate overall but was poor if MRD was ⩾1% on day 19 or MRD was detectable at any level on day 46. Our results indicate that the clinical impact of MRD on treatment outcome in childhood ALL varies considerably according to leukemia subtype and time of measurement.

Initial clinical test of a breast-PET scanner

International Nuclear Information System (INIS)

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

2011-01-01

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

Genomic Testing and Therapies for Breast Cancer in Clinical Practice

Science.gov (United States)

Haas, Jennifer S.; Phillips, Kathryn A.; Liang, Su-Ying; Hassett, Michael J.; Keohane, Carol; Elkin, Elena B.; Armstrong, Joanne; Toscano, Michele

2011-01-01

Purpose: Given the likely proliferation of targeted testing and treatment strategies for cancer, a better understanding of the utilization patterns of human epidermal growth factor receptor 2 (HER2) testing and trastuzumab and newer gene expression profiling (GEP) for risk stratification and chemotherapy decision making are important. Study Design: Cross-sectional. Methods: We performed a medical record review of women age 35 to 65 years diagnosed between 2006 and 2007 with invasive localized breast cancer, identified using claims from a large national health plan (N = 775). Results: Almost all women received HER2 testing (96.9%), and 24.9% of women with an accepted indication received GEP. Unexplained socioeconomic differences in GEP use were apparent after adjusting for age and clinical characteristics; specifically, GEP use increased with income. For example, those in the lowest income category (< $40,000) were less likely than those with an income of $125,000 or more to receive GEP (odds ratio, 0.34; 95% CI, 0.16 to 0.73). A majority of women (57.7%) with HER2-positive disease received trastuzumab; among these women, differences in age and clinical characteristics were not apparent, although surprisingly, those in the lowest income category were more likely than those in the high-income category to receive trastuzumab (P = .02). Among women who did not have a positive HER2 test, 3.9% still received trastuzumab. Receipt of adjuvant chemotherapy increased as GEP score indicated greater risk of recurrence. Conclusion: Identifying and eliminating unnecessary variation in the use of these expensive tests and treatments should be part of quality improvement and efficiency programs. PMID:21886507

Evaluating students' perception of their clinical placements - testing the clinical learning environment and supervision and nurse teacher scale (CLES + T scale) in Germany.

Science.gov (United States)

Bergjan, Manuela; Hertel, Frank

2013-11-01

Clinical nursing education in Germany has not received attention in nursing science and practice for a long time, as it often seems to be a more or less "formalized appendix" of nursing education. Several development projects of clinical education taking place are mainly focused on the qualification of clinical preceptors. However, the clinical context and its influence on learning processes have still not been sufficiently investigated. The aim of this study was the testing of a German version of the clinical learning environment and supervision and nurse teacher scale (CLES + T scale). The sample of the pilot study consists of first-, second- and third-year student nurses (n=240) of a university nursing school from January to March 2011. Psychometric testing of the instrument is carried out by selected methods of classical testing theories using SPPS 19. The results show transferability of all subcategories of the CLES + T scale in the non-academic nursing education system of a university hospital in Germany, without the teacher scale. The strongest factor is "supervisory relationship". The German version of the CLES + T scale may help to evaluate and compare traditional and new models in clinical nursing education. Copyright © 2012 Elsevier Ltd. All rights reserved.

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

Science.gov (United States)

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

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

The predictive validity of the BioMedical Admissions Test for pre-clinical examination performance.

Science.gov (United States)

Emery, Joanne L; Bell, John F

2009-06-01

Some medical courses in the UK have many more applicants than places and almost all applicants have the highest possible previous and predicted examination grades. The BioMedical Admissions Test (BMAT) was designed to assist in the student selection process specifically for a number of 'traditional' medical courses with clear pre-clinical and clinical phases and a strong focus on science teaching in the early years. It is intended to supplement the information provided by examination results, interviews and personal statements. This paper reports on the predictive validity of the BMAT and its predecessor, the Medical and Veterinary Admissions Test. Results from the earliest 4 years of the test (2000-2003) were matched to the pre-clinical examination results of those accepted onto the medical course at the University of Cambridge. Correlation and logistic regression analyses were performed for each cohort. Section 2 of the test ('Scientific Knowledge') correlated more strongly with examination marks than did Section 1 ('Aptitude and Skills'). It also had a stronger relationship with the probability of achieving the highest examination class. The BMAT and its predecessor demonstrate predictive validity for the pre-clinical years of the medical course at the University of Cambridge. The test identifies important differences in skills and knowledge between candidates, not shown by their previous attainment, which predict their examination performance. It is thus a valid source of additional admissions information for medical courses with a strong scientific emphasis when previous attainment is very high.

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

Science.gov (United States)

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

2017-05-01

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

New method for minimizing regular functions with constraints on parameter region

International Nuclear Information System (INIS)

Kurbatov, V.S.; Silin, I.N.

1993-01-01

The new method of function minimization is developed. Its main features are considered. It is possible minimization of regular function with the arbitrary structure. For χ 2 -like function the usage of simplified second derivatives is possible with the control of correctness. The constraints of arbitrary structure can be used. The means for fast movement along multidimensional valleys are used. The method is tested on real data of K π2 decay of the experiment on rare K - -decays. 6 refs

Review of the Reported Measures of Clinical Validity and Clinical Utility as Arguments for the Implementation of Pharmacogenetic Testing: A Case Study of Statin-Induced Muscle Toxicity

Directory of Open Access Journals (Sweden)

Marleen E. Jansen

2017-08-01

Full Text Available Advances from pharmacogenetics (PGx have not been implemented into health care to the expected extent. One gap that will be addressed in this study is a lack of reporting on clinical validity and clinical utility of PGx-tests. A systematic review of current reporting in scientific literature was conducted on publications addressing PGx in the context of statins and muscle toxicity. Eighty-nine publications were included and information was selected on reported measures of effect, arguments, and accompanying conclusions. Most authors report associations to quantify the relationship between a genetic variation an outcome, such as adverse drug responses. Conclusions on the implementation of a PGx-test are generally based on these associations, without explicit mention of other measures relevant to evaluate the test's clinical validity and clinical utility. To gain insight in the clinical impact and select useful tests, additional outcomes are needed to estimate the clinical validity and utility, such as cost-effectiveness.

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

Science.gov (United States)

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

2013-01-01

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

Nurse-delivered universal point-of-care testing for HIV in an open-access returning traveller clinic.

Science.gov (United States)

Herbert, R; Ashraf, A N; Yates, T A; Spriggs, K; Malinnag, M; Durward-Brown, E; Phillips, D; Mewse, E; Daniel, A; Armstrong, M; Kidd, I M; Waite, J; Wilks, P; Burns, F; Bailey, R; Brown, M

2012-09-01

Early diagnosis of HIV infection reduces morbidity and mortality associated with late presentation. Despite UK guidelines, the HIV testing rate has not increased. We have introduced universal HIV screening in an open-access returning traveller clinic. Data were prospectively recorded for all patients attending the open-access returning traveller clinic between August 2008 and December 2010. HIV testing was offered to all patients from May 2009; initially testing with laboratory samples (phase 1) and subsequently a point-of-care test (POCT) (phase 2). A total of 4965 patients attended the clinic; 1342 in phase 0, 792 in phase 1 and 2831 in phase 2. Testing rates for HIV increased significantly from 2% (38 of 1342) in phase 0 to 23.1% (183 of 792) in phase 1 and further increased to 44.5% (1261 of 2831) during phase 2 (P travelling to the Middle East and Europe were less likely to accept an HIV test with POCT. A nurse-delivered universal point-of-care HIV testing service has been successfully introduced and sustained in an acute medical clinic in a low-prevalence country. Caution is required in communicating reactive results in low-prevalence settings where there may be alternative diagnoses or a low population prevalence of HIV infection. © 2012 British HIV Association.

The development and psychometric testing of a theory-based instrument to evaluate nurses' perception of clinical reasoning competence.

Science.gov (United States)

Liou, Shwu-Ru; Liu, Hsiu-Chen; Tsai, Hsiu-Min; Tsai, Ying-Huang; Lin, Yu-Ching; Chang, Chia-Hao; Cheng, Ching-Yu

2016-03-01

The purpose of the study was to develop and psychometrically test the Nurses Clinical Reasoning Scale. Clinical reasoning is an essential skill for providing safe and quality patient care. Identifying pre-graduates' and nurses' needs and designing training courses to improve their clinical reasoning competence becomes a critical task. However, there is no instrument focusing on clinical reasoning in the nursing profession. Cross-sectional design was used. This study included the development of the scale, a pilot study that preliminary tested the readability and reliability of the developed scale and a main study that implemented and tested the psychometric properties of the developed scale. The Nurses Clinical Reasoning Scale was developed based on the Clinical Reasoning Model. The scale includes 15 items using a Likert five-point scale. Data were collected from 2013-2014. Two hundred and fifty-one participants comprising clinical nurses and nursing pre-graduates completed and returned the questionnaires in the main study. The instrument was tested for internal consistency and test-retest reliability. Its validity was tested with content, construct and known-groups validity. One factor emerged from the factor analysis. The known-groups validity was confirmed. The Cronbach's alpha for the entire instrument was 0·9. The reliability and validity of the Nurses Clinical Reasoning Scale were supported. The scale is a useful tool and can be easily administered for the self-assessment of clinical reasoning competence of clinical nurses and future baccalaureate nursing graduates. Study limitations and further recommendations are discussed. © 2015 John Wiley & Sons Ltd.

Minimal Gromov-Witten rings

International Nuclear Information System (INIS)

Przyjalkowski, V V

2008-01-01

We construct an abstract theory of Gromov-Witten invariants of genus 0 for quantum minimal Fano varieties (a minimal class of varieties which is natural from the quantum cohomological viewpoint). Namely, we consider the minimal Gromov-Witten ring: a commutative algebra whose generators and relations are of the form used in the Gromov-Witten theory of Fano varieties (of unspecified dimension). The Gromov-Witten theory of any quantum minimal variety is a homomorphism from this ring to C. We prove an abstract reconstruction theorem which says that this ring is isomorphic to the free commutative ring generated by 'prime two-pointed invariants'. We also find solutions of the differential equation of type DN for a Fano variety of dimension N in terms of the generating series of one-pointed Gromov-Witten invariants

Primary hyperparathyroidism surgical management since the introduction of minimally invasive parathyroidectomy: Mayo Clinic experience.

Science.gov (United States)

Grant, Clive S; Thompson, Geoffrey; Farley, David; van Heerden, Jon

2005-05-01

Minimally invasive parathyroidectomy (MIP) for primary hyperparathyroidism (HPT) has equal cure and recurrence rates as standard cervical exploration. Changes in the management of primary HPT have occurred since introducing MIP including localization, anesthesia, intraoperative parathyroid hormone monitoring, and indications for parathyroidectomy. Cohort analysis of 1361 consecutive patients with primary HPT operated on at the Mayo Clinic, Rochester, Minn, from June 1998 through March 2004. Mean follow-up, 25 months. Tertiary referral center. One thousand three hundred sixty-one patients operated on for primary HPT, excluding 160 patients who were reoperated on. Standard cervical exploration MIP. Cure, recurrence, localization, anesthesia, hospitalization, intraoperative parathyroid hormone level monitoring, contraindications to MIP, surgical indications, assessment of osteoporosis and osteopenia, postoperative patient assessment of general patient health, and operative satisfaction. Cure of primary HPT for both conventional exploration and MIP was 97%; only 1 patient who underwent MIP had a potential recurrence. Imaging sensitivity and positive predictive values were as follows: sestamibi scintigraphy, 86% and 93%; ultrasonography, 61% and 87%, respectively. Usage of general vs local anesthesia with intravenous sedation was 46% and 49%, respectively, in patients w ho underwent MIP; 46% were dismissed as outpatients, 49% had single-night stays. The accuracy of intraoperative parathyroid hormone level monitoring was as follows: 98% (8% had true-negative results); the frequency of multiple gland disease was 13%. Accounting for causes precluding MIP, an estimated 60% to 70% of all patients would be eligible for MIP. By preoperative assessment, 79% had osteoporosis-osteopenia; 58% with postoperative bone mineral density measurements were improved. More than 85% were satisfied with the results of their operation. With high-quality localization and intraoperative

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

OpenAIRE

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

2016-01-01

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

Clinical Trials

Medline Plus

Full Text Available ... always, parents must give legal consent for their child to take part in a clinical trial. When ... minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

Performance potential of mechanical ventilation systems with minimized pressure loss

DEFF Research Database (Denmark)

Terkildsen, Søren; Svendsen, Svend

2013-01-01

simulations that quantify fan power consumption, heating demand and indoor environmental conditions. The system was designed with minimal pressure loss in the duct system and heat exchanger. Also, it uses state-of-the-art components such as electrostatic precipitators, diffuse ceiling inlets and demand......In many locations mechanical ventilation has been the most widely used principle of ventilation over the last 50 years but the conventional system design must be revised to comply with future energy requirements. This paper examines the options and describes a concept for the design of mechanical...... ventilation systems with minimal pressure loss and minimal energy use. This can provide comfort ventilation and avoid overheating through increased ventilation and night cooling. Based on this concept, a test system was designed for a fictive office building and its performance was documented using building...

Minimal Marking: A Success Story

Science.gov (United States)

McNeilly, Anne

2014-01-01

The minimal-marking project conducted in Ryerson's School of Journalism throughout 2012 and early 2013 resulted in significantly higher grammar scores in two first-year classes of minimally marked university students when compared to two traditionally marked classes. The "minimal-marking" concept (Haswell, 1983), which requires…

Pain and Opioid use Outcomes Following Minimally Invasive Sacroiliac Joint Fusion with Decortication and Bone Grafting: The Evolusion Clinical Trial.

Science.gov (United States)

Araghi, Ali; Woodruff, Robert; Colle, Kyle; Boone, Christopher; Ingham, Lisa; Tomeh, Antoine; Fielding, Louis C

2017-01-01

This report documents six-month results of the first 50 patients treated in a prospective, multi-center study of a minimally invasive (MI) sacroiliac (SI) joint fusion system. This cohort includes 50 patients who had MI SI joint fusion surgery and completed 6 month follow-up. Average age at baseline was 61.5, 58% were female, and SI joint-related pain duration was ≥2yrs in 54.0% of patients. Visual Analog Scale (VAS) SI joint pain, Oswestry Disability Index (ODI), quality of life and opioid use were assessed preoperatively and at 6 months. At 6 months, mean VAS pain demonstrated a significant reduction from 76.2 at baseline to 35.1 (54% reduction, p<0.0001), with 72% of patients attaining the minimal clinically important difference (MCID, ≥20 point improvement). Mean ODI improved from 55.5 to 35.3 at 6 months (p < 0.001), with 56% of patients achieving the MCID (≥15 point improvement). Prior to surgery 33/50 (66%) of patients were taking opioids, but by 6 months the number of patients taking opioids had decreased by 55% to 15/50 (30%). Few procedural complications were reported. Two procedure-related events required hospitalization: a revision procedure (2%) for nerve impingement and one case of ongoing low back pain. Analysis of patients treated with MI SI joint fusion using the SImmetry System demonstrated that the procedure can be performed safely and results in significant improvements in pain, disability, and opioid use at 6 months. Longer term follow-up in this study will determine whether these improvements are durable, as well as the associated radiographic fusion rates.

Minimal families of curves on surfaces

KAUST Repository

Lubbes, Niels

2014-01-01

A minimal family of curves on an embedded surface is defined as a 1-dimensional family of rational curves of minimal degree, which cover the surface. We classify such minimal families using constructive methods. This allows us to compute the minimal

Diagnostic accuracy of the Thessaly test, standardised clinical history and other clinical examination tests (Apley's, McMurray's and joint line tenderness) for meniscal tears in comparison with magnetic resonance imaging diagnosis.

Science.gov (United States)

Blyth, Mark; Anthony, Iain; Francq, Bernard; Brooksbank, Katriona; Downie, Paul; Powell, Andrew; Jones, Bryn; MacLean, Angus; McConnachie, Alex; Norrie, John

2015-08-01

Reliable non-invasive diagnosis of meniscal tears is difficult. Magnetic resonance imaging (MRI) is often used but is expensive and incidental findings are problematic. There are a number of physical examination tests for the diagnosis of meniscal tears that are simple, cheap and non-invasive. To determine the diagnostic accuracy of the Thessaly test and to determine if the Thessaly test (alone or in combination with other physical tests) can obviate the need for further investigation by MRI or arthroscopy for patients with a suspected meniscal tear. Single-centre prospective diagnostic accuracy study. Although the study was performed in a secondary care setting, it was designed to replicate the results that would have been achieved in a primary care setting. Two cohorts of patients were recruited: patients with knee pathology (n = 292) and a control cohort with no knee pathology (n = 75). Sensitivity, specificity and diagnostic accuracy of the Thessaly test in determining the presence of meniscal tears. Participants were assessed by both a primary care clinician and a musculoskeletal clinician. Both clinicians performed the Thessaly test, McMurray's test, Apley's test, joint line tenderness test and took a standardised clinical history from the patient. The Thessaly test had a sensitivity of 0.66, a specificity of 0.39 and a diagnostic accuracy of 54% when utilised by primary care clinicians. This compared with a sensitivity of 0.62, a specificity of 0.55 and diagnostic accuracy of 59% when used by musculoskeletal clinicians. The diagnostics accuracy of the other tests when used by primary care clinicians was 54% for McMurray's test, 53% for Apley's test, 54% for the joint line tenderness test and 55% for clinical history. For primary care clinicians, age and past history of osteoarthritis were both significant predictors of MRI diagnosis of meniscal tears. For musculoskeletal clinicians age and a positive diagnosis of meniscal tears on clinical history

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

Science.gov (United States)

Augustsson, Jesper

2016-08-01

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

HIV-1 Tropism Testing and Clinical Management of CCR5 Antagonists: Quebec Review and Recommendations

Directory of Open Access Journals (Sweden)

Cécile Tremblay

2013-01-01

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

Use of an Automated Suture Fastening Device in Minimally Invasive Aortic Valve Replacement.

Science.gov (United States)

Beute, Tyler J; Orem, Matthew D; Schiller, Timothy M; Goehler, Matthew; Parker, Jessica; Willekes, Charles L; Timek, Tomasz

2018-03-01

Minimally invasive aortic valve replacement (mAVR) is gaining clinical acceptance, however, it is associated with increased operative times due to limited surgical field and access. The Cor-Knot is an automated fastening device designed to facilitate suture fastening, but clinical data in mAVR are lacking. From May 2014 to February 2017, 92 patients underwent mAVR at our center with 39 valves secured with manually-tied (MT) sutures and 53 valves entirely secured with the Cor-Knot (CK). Pre-operative characteristics and 30-day outcomes data were extracted from our local Society of Thoracic Surgeons database and the electronic medical record. Survival data were obtained from the Michigan State Social Security Death Index. No significant difference in pre-operative characteristics were noted between the two groups. Aortic cross-clamp time (72±12 min vs 82±15 min, p=0.001) was significantly shorter with CK. There was no difference in post-operative mortality (0% vs 0%), stroke (0% vs 1.9%), atrial fibrillation (28% vs 33%), renal failure (0% vs 3.8%), or pacemaker implantation (5.1% vs 5.7%) between MT and CK. Valve function on post-operative echocardiography and 1-year patient survival were similar. In minimally invasive aortic valve replacement, the Cor-Knot device was associated with reduced aortic cross-clamp time while providing equivalent clinical outcomes. Larger studies are needed to confirm efficacy, safety, and cost-effectiveness of the Cor-Knot device in minimally invasive aortic valve surgery. Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Interventions to Increase Male Attendance and Testing for Sexually Transmitted Infections at Publicly-Funded Family Planning Clinics.

Science.gov (United States)

Fine, David; Warner, Lee; Salomon, Sarah; Johnson, David M

2017-07-01

We assessed the impact of staff, clinic, and community interventions on male and female family planning client visit volume and sexually transmitted infection testing at a multisite community-based health care agency. Staff training, clinic environmental changes, in-reach/outreach, and efficiency assessments were implemented in two Family Health Center (San Diego, CA) family planning clinics during 2010-2012; five Family Health Center family planning programs were identified as comparison clinics. Client visit records were compared between preintervention (2007-2009) and postintervention (2010-2012) for both sets of clinics. Of 7,826 male client visits during the time before intervention, most were for clients who were aged male visits (4,004 to 8,385; Δ = +109%); for comparison clinics, male visits increased modestly (3,822 to 4,500; Δ = +18%). The proportion of male clinic visits where chlamydia testing was performed increased in intervention clinics (35% to 42%; p males yielded similar findings for male client volume and chlamydia testing. The number of female visits declined nearly 40% in both comparison (21,800 to 13,202; -39%) and intervention clinics (30,830 to 19,971; -35%) between preintervention and postintervention periods. Multilevel interventions designed to increase male client volume and sexually transmitted infection testing services in family planning clinics succeeded without affecting female client volume or services. Copyright © 2017 Society for Adolescent Health and Medicine. All rights reserved.

Waste minimization assessment procedure

International Nuclear Information System (INIS)

Kellythorne, L.L.

1993-01-01

Perry Nuclear Power Plant began developing a waste minimization plan early in 1991. In March of 1991 the plan was documented following a similar format to that described in the EPA Waste Minimization Opportunity Assessment Manual. Initial implementation involved obtaining management's commitment to support a waste minimization effort. The primary assessment goal was to identify all hazardous waste streams and to evaluate those streams for minimization opportunities. As implementation of the plan proceeded, non-hazardous waste streams routinely generated in large volumes were also evaluated for minimization opportunities. The next step included collection of process and facility data which would be useful in helping the facility accomplish its assessment goals. This paper describes the resources that were used and which were most valuable in identifying both the hazardous and non-hazardous waste streams that existed on site. For each material identified as a waste stream, additional information regarding the materials use, manufacturer, EPA hazardous waste number and DOT hazard class was also gathered. Once waste streams were evaluated for potential source reduction, recycling, re-use, re-sale, or burning for heat recovery, with disposal as the last viable alternative

Westinghouse Hanford Company waste minimization actions

International Nuclear Information System (INIS)

Greenhalgh, W.O.

1988-09-01

Companies that generate hazardous waste materials are now required by national regulations to establish a waste minimization program. Accordingly, in FY88 the Westinghouse Hanford Company formed a waste minimization team organization. The purpose of the team is to assist the company in its efforts to minimize the generation of waste, train personnel on waste minimization techniques, document successful waste minimization effects, track dollar savings realized, and to publicize and administer an employee incentive program. A number of significant actions have been successful, resulting in the savings of materials and dollars. The team itself has been successful in establishing some worthwhile minimization projects. This document briefly describes the waste minimization actions that have been successful to date. 2 refs., 26 figs., 3 tabs

En Route towards European Clinical breakpoints for veterinary antimicrobial susceptibility testing

NARCIS (Netherlands)

Toutain, Pierre Louis; Bousquet-Mélou, Alain; Damborg, Peter; Ferran, Aude A.; Mevius, Dik; Pelligand, Ludovic; Veldman, Kees T.; Lees, Peter

2017-01-01

VetCAST is the EUCAST sub-committee for Veterinary Antimicrobial Susceptibility Testing. Its remit is to define clinical breakpoints (CBPs) for antimicrobial drugs (AMDs) used in veterinary medicine in Europe. This position paper outlines the procedures and reviews scientific options to solve

Comparison of Psychomotor Development Screening Test and Clinical Assessment of Psychomotor Development

Science.gov (United States)

Radmilović, Goranka; Matijević, Valentina; Zavoreo, Iris

2016-12-01

Numerous adverse factors are acting in the prenatal, perinatal and postnatal period of life and may be the cause of later mild or severe deviations from normal psychomotor development. Therefore, it is crucial to identify infants with neurological risk factors and infants that already have a delay from orderly development, in order to immediately initiate the rehabilitation process. The aim of this study was to determine whether there is difference in the assessment of psychomotor development in neurological risk children based on the psychomotor development test (Croatian, Razvoj psihomotorike, RPM test) and clinical evaluation of neuromotor development. RPM test is designed for rough estimate of psychomotor development in children in the first two years of life. The study included 15 full term children (8 male and 7 female) with clinical diagnosis of mild paraparesis and mild deviation from normal psychological and social development, and 15 full term children (8 male and 7 female) without neurological risk factors and deviations from normal psychomotor development, all at the age of 12-24 months. Of the 15 children diagnosed with mild paraparesis, none had delayed psychomotor development, 6.7% had suspect development and 93.3% had normal development on RPM test. All children in the control group had normal development on RPM test. According to the results, the RPM test is not sensitive enough to detect mild neurodevelopmental disorders.

Real-Time PCR in Clinical Microbiology: Applications for Routine Laboratory Testing

Science.gov (United States)

Espy, M. J.; Uhl, J. R.; Sloan, L. M.; Buckwalter, S. P.; Jones, M. F.; Vetter, E. A.; Yao, J. D. C.; Wengenack, N. L.; Rosenblatt, J. E.; Cockerill, F. R.; Smith, T. F.

2006-01-01

Real-time PCR has revolutionized the way clinical microbiology laboratories diagnose many human microbial infections. This testing method combines PCR chemistry with fluorescent probe detection of amplified product in the same reaction vessel. In general, both PCR and amplified product detection are completed in an hour or less, which is considerably faster than conventional PCR detection methods. Real-time PCR assays provide sensitivity and specificity equivalent to that of conventional PCR combined with Southern blot analysis, and since amplification and detection steps are performed in the same closed vessel, the risk of releasing amplified nucleic acids into the environment is negligible. The combination of excellent sensitivity and specificity, low contamination risk, and speed has made real-time PCR technology an appealing alternative to culture- or immunoassay-based testing methods for diagnosing many infectious diseases. This review focuses on the application of real-time PCR in the clinical microbiology laboratory. PMID:16418529

Finding a vein or obtaining consent: a qualitative study of hepatitis C testing in GP methadone clinics.

Science.gov (United States)

Perry, Mark; Chew-Graham, Carolyn

2003-10-01

Informed consent is a professional norm, but the promotion of testing for infectious disease in organized clinics and the introduction of targets for uptake, such as those for human immunodeficiency virus (HIV) testing in antenatal clinics, might impair truly voluntary consent. Hepatitis C virus (HCV) is highly prevalent among intravenous drug users (IDUs) and the 'offer' of a serological test for HCV antibodies is now seen as a national standard within drug misuse services, including GP methadone clinics. We hoped that GPs' descriptions of the context and offer of HCV testing could provide an exploratory study of consent within primary care clinics. The aim of this study was to understand GPs' ethical practice when negotiating consent to HCV testing with IDUs. A qualitative semi-structured interview study of 20 GPs in Greater Manchester was carried out. GPs reported that they or their attached drug workers commonly tested for HCV, and many stressed the need for good teamwork and building relationships with 'stable' IDUs before testing. GPs' views on the beneficence of testing and their practices in obtaining consent were diverse. GPs' discourse highlighted important management problems: (i) the adequacy of preparation of some IDUs for testing; (ii) 'opportunistic' HCV testing; and (iii) GPs' recognition of denial after testing. While GPs offered little explicit ethical reflection, occasionally they remarked on tendencies to control a patient's decision, and a deviant case analysis demonstrates how poor teamwork can be associated with coercion. GPs' descriptions suggest that an effective informed consent process is the norm for HCV testing within GP methadone clinics. Importantly, a minority of GPs alluded to the directive effect of team protocols or other problems in obtaining valid consent. We offer recommendations for managing testing to ensure voluntary choice.

Minimal but non-minimal inflation and electroweak symmetry breaking

Energy Technology Data Exchange (ETDEWEB)

Marzola, Luca [National Institute of Chemical Physics and Biophysics,Rävala 10, 10143 Tallinn (Estonia); Institute of Physics, University of Tartu,Ravila 14c, 50411 Tartu (Estonia); Racioppi, Antonio [National Institute of Chemical Physics and Biophysics,Rävala 10, 10143 Tallinn (Estonia)

2016-10-07

We consider the most minimal scale invariant extension of the standard model that allows for successful radiative electroweak symmetry breaking and inflation. The framework involves an extra scalar singlet, that plays the rôle of the inflaton, and is compatibile with current experimental bounds owing to the non-minimal coupling of the latter to gravity. This inflationary scenario predicts a very low tensor-to-scalar ratio r≈10{sup −3}, typical of Higgs-inflation models, but in contrast yields a scalar spectral index n{sub s}≃0.97 which departs from the Starobinsky limit. We briefly discuss the collider phenomenology of the framework.

Epsilon aminocaproic acid reduces blood transfusion and improves the coagulation test after pediatric open-heart surgery: a meta-analysis of 5 clinical trials.

Science.gov (United States)

Lu, Jun; Meng, Haoyu; Meng, Zhaoyi; Sun, Ying; Pribis, John P; Zhu, Chunyan; Li, Quan

2015-01-01

Excessive postoperative blood loss after cardiopulmonary bypass is a common problem, especially in patients suffering from congenital heart diseases. The efficacy of epsilon aminocaproic acid (EACA) as a prophylactic treatment for postoperative bleeding after pediatric open-heart surgery has not been determined. This meta-analysis investigates the efficacy of EACA in the minimization of bleeding and blood transfusion and the maintenance of coagulation tests after pediatric open-heart surgery. A comprehensive literature search was performed to identify all randomized clinical trials on the subject. PubMed, Embase, the Cochrane Library, and the Chinese Medical Journal Network were screened. The primary outcome used for the analysis was postoperative blood loss. Secondary outcomes included postoperative blood transfusion, re-exploration rate and postoperative coagulation tests. The mean difference (MD) and risk ratio (RR) with 95% confidence intervals (CI) were used as summary statistics. Five trials were included in this meta-analysis of 515 patients. Prophylactic EACA was associated with a reduction in postoperative blood loss, but this difference did not reach statistical significance (MD: -7.08; 95% CI: -16.11 to 1.95; P = 0.12). Patients treated with EACA received fewer postoperative blood transfusions, including packed red blood cells (MD: -8.36; 95% CI: -12.63 to -4.09; P = 0.0001), fresh frozen plasma (MD: -3.85; 95% CI: -5.63 to -2.08; P open-heart surgery. Prophylactic EACA minimizes postoperative blood transfusion and helps maintain coagulation in pediatric patients undergoing open-heart surgery. Therefore, the results of this study indicate that adjunctive EACA is a good choice for the prevention of postoperative blood transfusion following pediatric cardiac surgery.

Anorectal function and outcomes after transanal minimally invasive surgery for rectal tumors

Directory of Open Access Journals (Sweden)

Feza Y Karakayali

2015-01-01

Full Text Available Background: Transanal endoscopic microsurgery is a minimally invasive technique that allows full-thickness resection and suture closure of the defect for large rectal adenomas, selected low-risk rectal cancers, or small cancers in patients who have a high risk for major surgery. Our aim, in the given prospective study was to report our initial clinical experience with TAMIS, and to evaluate its effects on postoperative anorectal functions. Materials and Methods: In 10 patients treated with TAMIS for benign and malignant rectal tumors, preoperative and postoperative anorectal function was evaluated with anorectal manometry and Cleveland Clinic Incontinence Score. Results: The mean distance of the tumors from the anal verge was 5.6 cm, and mean tumor diameter was 2.6 cm. All resection margins were tumor free. There was no difference in preoperative and 3-week postoperative anorectalmanometry findings; only mean minimum rectal sensory volume was lower at 3 weeks after surgery. The Cleveland Clinic Incontinence Score was normal in all patients except one which resolved by 6 weeks after surgery.The mean postoperative follow-up was 28 weeks without any recurrences. Conclusion: Transanal minimally invasive surgery is a safe and effective procedure for treatment of rectal tumors and can be performed without impairing anorectal functions.

Myocardial Protection and Financial Considerations of Custodiol Cardioplegia in Minimally Invasive and Open Valve Surgery.

Science.gov (United States)

Hummel, Brian W; Buss, Randall W; DiGiorgi, Paul L; Laviano, Brittany N; Yaeger, Nalani A; Lucas, M Lee; Comas, George M

Single-dose antegrade crystalloid cardioplegia with Custodiol-HTK (histidine-tryptophan-ketoglutarate) has been used for many years. Its safety and efficacy were established in experimental and clinical studies. It is beneficial in complex valve surgery because it provides a long period of myocardial protection with a single dose. Thus, valve procedures (minimally invasive or open) can be performed with limited interruption. The aim of this study is to compare the use of Custodiol-HTK cardioplegia with traditional blood cardioplegia in patients undergoing minimally invasive and open valve surgery. A single-institution, retrospective case-control review was performed on patients who underwent valve surgery in Lee Memorial Health System at either HealthPark Medical Center or Gulf Coast Medical Center from July 1, 2011, through March 7, 2015. A total of 181 valve cases (aortic or mitral) performed using Custodiol-HTK cardioplegia were compared with 181 cases performed with traditional blood cardioplegia. Each group had an equal distribution of minimally invasive and open valve cases. Right chest thoracotomy or partial sternotomy was performed on minimally invasive valve cases. Demographics, perioperative data, clinical outcomes, and financial data were collected and analyzed. Patient outcomes were superior in the Custodiol-HTK cardioplegia group for blood transfusion, stroke, and hospital readmission within 30 days (P < 0.05). No statistical differences were observed in the other outcomes categories. Hospital charges were reduced on average by $3013 per patient when using Custodiol-HTK cardioplegia. Use of Custodiol-HTK cardioplegia is safe and cost-effective when compared with traditional repetitive blood cardioplegia in patients undergoing minimally invasive and open valve surgery.

Performance Validity Testing in Neuropsychology: Scientific Basis and Clinical Application-A Brief Review.

Science.gov (United States)

Greher, Michael R; Wodushek, Thomas R

2017-03-01

Performance validity testing refers to neuropsychologists' methodology for determining whether neuropsychological test performances completed in the course of an evaluation are valid (ie, the results of true neurocognitive function) or invalid (ie, overly impacted by the patient's effort/engagement in testing). This determination relies upon the use of either standalone tests designed for this sole purpose, or specific scores/indicators embedded within traditional neuropsychological measures that have demonstrated this utility. In response to a greater appreciation for the critical role that performance validity issues play in neuropsychological testing and the need to measure this variable to the best of our ability, the scientific base for performance validity testing has expanded greatly over the last 20 to 30 years. As such, the majority of current day neuropsychologists in the United States use a variety of measures for the purpose of performance validity testing as part of everyday forensic and clinical practice and address this issue directly in their evaluations. The following is the first article of a 2-part series that will address the evolution of performance validity testing in the field of neuropsychology, both in terms of the science as well as the clinical application of this measurement technique. The second article of this series will review performance validity tests in terms of methods for development of these measures, and maximizing of diagnostic accuracy.

Minimizing the number of segments in a delivery sequence for intensity-modulated radiation therapy with a multileaf collimator

International Nuclear Information System (INIS)

Dai Jianrong; Zhu Yunping

2001-01-01

This paper proposes a sequencing algorithm for intensity-modulated radiation therapy with a multileaf collimator in the static mode. The algorithm aims to minimize the number of segments in a delivery sequence. For a machine with a long verification and recording overhead time (e.g., 15 s per segment), minimizing the number of segments is equivalent to minimizing the delivery time. The proposed new algorithm is based on checking numerous candidates for a segment and selecting the candidate that results in a residual intensity matrix with the least complexity. When there is more than one candidate resulting in the same complexity, the candidate with the largest size is selected. The complexity of an intensity matrix is measured in the new algorithm in terms of the number of segments in the delivery sequence obtained by using a published algorithm. The beam delivery efficiency of the proposed algorithm and the influence of different published algorithms used to calculate the complexity of an intensity matrix were tested with clinical intensity-modulated beams. The results show that no matter which published algorithm is used to calculate the complexity of an intensity matrix, the sequence generated by the algorithm proposed here is always more efficient than that generated by the published algorithm itself. The results also show that the algorithm used to calculate the complexity of an intensity matrix affects the efficiency of beam delivery. The delivery sequences are frequently most efficient when the algorithm of Bortfeld et al. is used to calculate the complexity of an intensity matrix. Because no single variation is most efficient for all beams tested, we suggest implementing multiple variations of our algorithm

Establishing quality control ranges for antimicrobial susceptibility testing of Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus: a cornerstone to develop reference strains for Korean clinical microbiology laboratories.

Science.gov (United States)

Hong, Sung Kuk; Choi, Seung Jun; Shin, Saeam; Lee, Wonmok; Pinto, Naina; Shin, Nari; Lee, Kwangjun; Hong, Seong Geun; Kim, Young Ah; Lee, Hyukmin; Kim, Heejung; Song, Wonkeun; Lee, Sun Hwa; Yong, Dongeun; Lee, Kyungwon; Chong, Yunsop

2015-11-01

Quality control (QC) processes are being performed in the majority of clinical microbiology laboratories to ensure the performance of microbial identification and antimicrobial susceptibility testing by using ATCC strains. To obtain these ATCC strains, some inconveniences are encountered concerning the purchase cost of the strains and the shipping time required. This study was focused on constructing a database of reference strains for QC processes using domestic bacterial strains, concentrating primarily on antimicrobial susceptibility testing. Three strains (Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus) that showed legible results in preliminary testing were selected. The minimal inhibitory concentrations (MICs) and zone diameters (ZDs) of eight antimicrobials for each strain were determined according to the CLSI M23. All resulting MIC and ZD ranges included at least 95% of the data. The ZD QC ranges obtained by using the CLSI method were less than 12 mm, and the MIC QC ranges extended no more than five dilutions. This study is a preliminary attempt to construct a bank of Korean QC strains. With further studies, a positive outcome toward cost and time reduction can be anticipated.

[In vitro activity of ertapenem against clinical bacterial isolates in 69 Spanish medical centers (E-test study)].

Science.gov (United States)

Gobernado, M; Sanz-Rodríguez, C; Villanueva, R; Torroba, L; Redondo, E; González-Esteban, J

2007-12-01

This study was conducted to assess the in vitro activity of ertapenem against clinical bacterial isolates from patients with community-acquired intra-abdominal and lower tract respiratory infections in Spain in 2003. As the study was conducted before the marketing of ertapenem, it was also useful to define a baseline susceptibility pattern for ertapenem in each of the participating hospitals for later surveillance studies. Each partipating site identified a variable number of aerobic and facultative bacteria isolated from patients with community-acquired intra-abdominal infection or pneumonia using standard procedures. E-test strips were used for determining the minimum inhibitory concentration (MIC) of ertapenem, while for other antimicrobials either quantitative dilution techniques or qualitative diffusion procedures were used according to each microbiology laboratory's routine practice. MIC breakpoints for categorization of susceptibility provided by the CLSI were used for interpreting MIC values. A total of 2,901 recent clinical isolates from patients with community-acquired intra-abdominal infection or pneumonia hospitalized in 69 Spanish medical centers were tested. These isolates included 2,039 Gram-negative bacteria (1,646 Enterobacteriaceae, 216 Haemophilus, 123 non-fermenting Gram-negative bacteria [NFGNB] and 54 others) and 862 Gram-positive bacteria (556 pneumococci, 159 staphylococci, 96 streptococci other than S. pneumoniae, 44 enterococci and 7 others). Ertapenem was very active in vitro against Enterobacteriaceae (99.8% susceptible), Haemophilus (96.3% susceptible), pneumococci (99.6% susceptible, of which 31% were penicillin non-susceptible strains), streptococci other than S. pneumoniae (99.0% susceptible) and methicillin-susceptible staphylococci (94.8% susceptible). For other Gram-positive and Gram-negative pathogens for which ertapenem susceptible breakpoints have not been defined, MIC(90) values were 0.38 and 0.064 mg/l, respectively. As

Patch test results of hand eczema patients : relation to clinical types

NARCIS (Netherlands)

Boonstra, M B; Christoffers, W A; Coenraads, P J; Schuttelaar, M L A

BACKGROUND: Allergic contact dermatitis is a well-known cause of hand eczema, although the influence of contact allergens on different clinical types of hand eczema remains still unclear. OBJECTIVE: To identify most common positive tested allergens among hand eczema patients and to define the

Ruled Laguerre minimal surfaces

KAUST Repository

Skopenkov, Mikhail

2011-10-30

A Laguerre minimal surface is an immersed surface in ℝ 3 being an extremal of the functional ∫ (H 2/K-1)dA. In the present paper, we prove that the only ruled Laguerre minimal surfaces are up to isometry the surfaces ℝ (φλ) = (Aφ, Bφ, Cφ + D cos 2φ) + λ(sin φ, cos φ, 0), where A,B,C,D ε ℝ are fixed. To achieve invariance under Laguerre transformations, we also derive all Laguerre minimal surfaces that are enveloped by a family of cones. The methodology is based on the isotropic model of Laguerre geometry. In this model a Laguerre minimal surface enveloped by a family of cones corresponds to a graph of a biharmonic function carrying a family of isotropic circles. We classify such functions by showing that the top view of the family of circles is a pencil. © 2011 Springer-Verlag.

Clinical Validation of a Test for the Diagnosis of Vaginitis.

Science.gov (United States)

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

2017-07-01

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

Patient-reported questionnaires in MS rehabilitation: responsiveness and minimal important difference of the multiple sclerosis questionnaire for physiotherapists (MSQPT).

Science.gov (United States)

van der Maas, Nico Arie

2017-03-16

The Multiple Sclerosis Questionnaire for Physical Therapists (MSQPT) is a patient-rated outcome questionnaire for evaluating the rehabilitation of persons with multiple sclerosis (MS). Responsiveness was evaluated, and minimal important difference (MID) estimates were calculated to provide thresholds for clinical change for four items, three sections and the total score of the MSQPT. This multicentre study used a combined distribution- and anchor-based approach with multiple anchors and multiple rating of change questions. Responsiveness was evaluated using effect size, standardized response mean (SRM), modified SRM and relative efficiency. For distribution-based MID estimates, 0.2 and 0.33 standard deviations (SD), standard error of measurement (SEM) and minimal detectable change were used . Triangulation of anchor- and distribution-based MID estimates provided a range of MID values for each of the four items, the three sections and the total score of the MSQPT. The MID values were tested for their sensitivity and specificity for amelioration and deterioration for each of the four items, the three sections and the total score of the MSQPT. The MID values of each item and section and of the total score with the best sensitivity and specificity were selected as thresholds for clinical change. The outcome measures were the MSQPT, Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS), rating of change questionnaires, Expanded Disability Status Scale, 6-metre timed walking test, Berg Balance Scale and 6-minute walking test. The effect size ranged from 0.46 to 1.49. The SRM data showed comparable results. The modified SRM ranged from 0.00 to 0.60. Anchor-based MID estimates were very low and were comparable with SD- and SEM-based estimates. The MSQPT was more responsive than the HAQUAMS in detecting improvement but less responsive in finding deterioration. The best MID estimates of the items, sections and total score, expressed in percentage of their

Correction of Bowtie-Filter Normalization and Crescent Artifacts for a Clinical CBCT System.

Science.gov (United States)

Zhang, Hong; Kong, Vic; Huang, Ke; Jin, Jian-Yue

2017-02-01

To present our experiences in understanding and minimizing bowtie-filter crescent artifacts and bowtie-filter normalization artifacts in a clinical cone beam computed tomography system. Bowtie-filter position and profile variations during gantry rotation were studied. Two previously proposed strategies (A and B) were applied to the clinical cone beam computed tomography system to correct bowtie-filter crescent artifacts. Physical calibration and analytical approaches were used to minimize the norm phantom misalignment and to correct for bowtie-filter normalization artifacts. A combined procedure to reduce bowtie-filter crescent artifacts and bowtie-filter normalization artifacts was proposed and tested on a norm phantom, CatPhan, and a patient and evaluated using standard deviation of Hounsfield unit along a sampling line. The bowtie-filter exhibited not only a translational shift but also an amplitude variation in its projection profile during gantry rotation. Strategy B was better than strategy A slightly in minimizing bowtie-filter crescent artifacts, possibly because it corrected the amplitude variation, suggesting that the amplitude variation plays a role in bowtie-filter crescent artifacts. The physical calibration largely reduced the misalignment-induced bowtie-filter normalization artifacts, and the analytical approach further reduced bowtie-filter normalization artifacts. The combined procedure minimized both bowtie-filter crescent artifacts and bowtie-filter normalization artifacts, with Hounsfield unit standard deviation being 63.2, 45.0, 35.0, and 18.8 Hounsfield unit for the best correction approaches of none, bowtie-filter crescent artifacts, bowtie-filter normalization artifacts, and bowtie-filter normalization artifacts + bowtie-filter crescent artifacts, respectively. The combined procedure also demonstrated reduction of bowtie-filter crescent artifacts and bowtie-filter normalization artifacts in a CatPhan and a patient. We have developed a step

Excimer PRK testing in the clinic

Science.gov (United States)

Forrest, Gary T.

1994-06-01

Testing of the excimer lasers used in PRK requires special considerations in terms of ease of use, day-to-day reliability, and high resolution to see details of beam interference effects. SensorPhysics employs a patented photochromic material on a polyester substrate to record permanent, instant records of the laser and laser system output. Since each SensorCard is used only once concerns about detection device deterioration are not an issue. The SensorCards have a demonstrated resolving power on the order of 0.1 micrometers . A small, portable reading device is used to convert the SensorCard optical density to a mJ/cm2 value. Special software also measures beam uniformity to +/- 1% to provide both qualitative and quantitative analysis. Results of use in clinic environments will be presented. In particular detection of exposure `islands' will be demonstrated. The techniques employed are similar to those we developed for UV laser micromachining and lithography four years ago.

Minimally Invasive Procedures - Direct and Video-Assisted Forms in the Treatment of Heart Diseases

International Nuclear Information System (INIS)

Castro, Josué Viana Neto; Melo, Emanuel Carvalho; Silva, Juliana Fernandes; Rebouças, Leonardo Lemos; Corrêa, Larissa Chagas; Germano, Amanda de Queiroz; Machado, João José Aquino

2014-01-01

Minimally invasive cardiovascular procedures have been progressively used in heart surgery. To describe the techniques and immediate results of minimally invasive procedures in 5 years. Prospective and descriptive study in which 102 patients were submitted to minimally invasive procedures in direct and video-assisted forms. Clinical and surgical variables were evaluated as well as the in hospital follow-up of the patients. Fourteen patients were operated through the direct form and 88 through the video-assisted form. Between minimally invasive procedures in direct form, 13 had aortic valve disease. Between minimally invasive procedures in video-assisted forms, 43 had mitral valve disease, 41 atrial septal defect and four tumors. In relation to mitral valve disease, we replaced 26 and reconstructed 17 valves. Aortic clamp, extracorporeal and procedure times were, respectively, 91,6 ± 21,8, 112,7 ± 27,9 e 247,1 ± 20,3 minutes in minimally invasive procedures in direct form. Between minimally invasive procedures in video-assisted forms, 71,6 ± 29, 99,7 ± 32,6 e 226,1 ± 42,7 minutes. Considering intensive care and hospitalization times, these were 41,1 ± 14,7 hours and 4,6 ± 2 days in minimally invasive procedures in direct and 36,8 ± 16,3 hours and 4,3 ± 1,9 days in minimally invasive procedures in video-assisted forms procedures. Minimally invasive procedures were used in two forms - direct and video-assisted - with safety in the surgical treatment of video-assisted, atrial septal defect and tumors of the heart. These procedures seem to result in longer surgical variables. However, hospital recuperation was faster, independent of the access or pathology

Waste minimization for commercial radioactive materials users generating low-level radioactive waste

International Nuclear Information System (INIS)

Fischer, D.K.; Gitt, M.; Williams, G.A.; Branch, S.; Otis, M.D.; McKenzie-Carter, M.A.; Schurman, D.L.

1991-07-01

The objective of this document is to provide a resource for all states and compact regions interested in promoting the minimization of low-level radioactive waste (LLW). This project was initiated by the Commonwealth of Massachusetts, and Massachusetts waste streams have been used as examples; however, the methods of analysis presented here are applicable to similar waste streams generated elsewhere. This document is a guide for states/compact regions to use in developing a system to evaluate and prioritize various waste minimization techniques in order to encourage individual radioactive materials users (LLW generators) to consider these techniques in their own independent evaluations. This review discusses the application of specific waste minimization techniques to waste streams characteristic of three categories of radioactive materials users: (1) industrial operations using radioactive materials in the manufacture of commercial products, (2) health care institutions, including hospitals and clinics, and (3) educational and research institutions. Massachusetts waste stream characterization data from key radioactive materials users in each category are used to illustrate the applicability of various minimization techniques. The utility group is not included because extensive information specific to this category of LLW generators is available in the literature

Clinic and Emergency Room Evaluation and Testing of Headache.

Science.gov (United States)

Nye, Barbara L; Ward, Thomas N

2015-10-01

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

Clinical application of minimizing picture archiving and communication system

International Nuclear Information System (INIS)

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

2003-01-01

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

Global Analysis of Minimal Surfaces

CERN Document Server

Dierkes, Ulrich; Tromba, Anthony J

2010-01-01

Many properties of minimal surfaces are of a global nature, and this is already true for the results treated in the first two volumes of the treatise. Part I of the present book can be viewed as an extension of these results. For instance, the first two chapters deal with existence, regularity and uniqueness theorems for minimal surfaces with partially free boundaries. Here one of the main features is the possibility of 'edge-crawling' along free parts of the boundary. The third chapter deals with a priori estimates for minimal surfaces in higher dimensions and for minimizers of singular integ

Minimal Surfaces for Hitchin Representations

DEFF Research Database (Denmark)

Li, Qiongling; Dai, Song

2018-01-01

. In this paper, we investigate the properties of immersed minimal surfaces inside symmetric space associated to a subloci of Hitchin component: $q_n$ and $q_{n-1}$ case. First, we show that the pullback metric of the minimal surface dominates a constant multiple of the hyperbolic metric in the same conformal...... class and has a strong rigidity property. Secondly, we show that the immersed minimal surface is never tangential to any flat inside the symmetric space. As a direct corollary, the pullback metric of the minimal surface is always strictly negatively curved. In the end, we find a fully decoupled system...

Monitoring somatic symptoms in patients with mental disorders: Sensitivity to change and minimal clinically important difference of the Somatic Symptom Scale - 8 (SSS-8).

Science.gov (United States)

Gierk, Benjamin; Kohlmann, Sebastian; Hagemann-Goebel, Marion; Löwe, Bernd; Nestoriuc, Yvonne

2017-09-01

The SSS-8 is a brief questionnaire for the assessment of somatic symptom burden. This study examines its sensitivity to change and the minimal clinically important difference (MCID) in patients with mental disorders. 55 outpatients with mental disorders completed the SSS-8 and measures of anxiety, depression, and disability before and after receiving treatment. Effect sizes and correlations between the change scores were calculated. The MCID was estimated using a one standard error of measurement threshold and the change in disability as an external criterion. There was a medium decline in somatic symptom burden for the complete sample (n=55, d z =0.53) and a large decline in a subgroup with very high somatic symptom burden at baseline (n=11, d z =0.94). Decreases in somatic symptom burden were associated with decreases in anxiety (r=0.68, pSSS-8 is sensitive to change. A 3-point decrease reflects a clinically important improvement. Due to its brevity and sound psychometric properties, the SSS-8 is useful for monitoring somatic symptom burden. Copyright © 2017 Elsevier Inc. All rights reserved.

3T MR-guided minimally-invasive penile fracture repair

Directory of Open Access Journals (Sweden)

Giovanni Rosi

2016-03-01

Full Text Available We present the case of a 21 year old patient with an incomplete tear of the tunica albuginea occurred after violent masturbation. The diagnostic assessment was performed first clinically, then with ultrasound and with 3 Tesla MRI. 3 Tesla MRI, owing to its high resolution, allowed to exactly detect the tear location leading to precise preoperative planning. After adequate diagnosis through imaging and proper planning, we were able to perform a selective minimally invasive surgical approach to repair the lesion.

Minimal Webs in Riemannian Manifolds

DEFF Research Database (Denmark)

Markvorsen, Steen

2008-01-01

For a given combinatorial graph $G$ a {\\it geometrization} $(G, g)$ of the graph is obtained by considering each edge of the graph as a $1-$dimensional manifold with an associated metric $g$. In this paper we are concerned with {\\it minimal isometric immersions} of geometrized graphs $(G, g......)$ into Riemannian manifolds $(N^{n}, h)$. Such immersions we call {\\em{minimal webs}}. They admit a natural 'geometric' extension of the intrinsic combinatorial discrete Laplacian. The geometric Laplacian on minimal webs enjoys standard properties such as the maximum principle and the divergence theorems, which...... are of instrumental importance for the applications. We apply these properties to show that minimal webs in ambient Riemannian spaces share several analytic and geometric properties with their smooth (minimal submanifold) counterparts in such spaces. In particular we use appropriate versions of the divergence...

Waste minimization handbook, Volume 1