A review of empirical research related to the use of small quantitative samples in clinical outcome scale development.

PubMed

Houts, Carrie R; Edwards, Michael C; Wirth, R J; Deal, Linda S

2016-11-01

There has been a notable increase in the advocacy of using small-sample designs as an initial quantitative assessment of item and scale performance during the scale development process. This is particularly true in the development of clinical outcome assessments (COAs), where Rasch analysis has been advanced as an appropriate statistical tool for evaluating the developing COAs using a small sample. We review the benefits such methods are purported to offer from both a practical and statistical standpoint and detail several problematic areas, including both practical and statistical theory concerns, with respect to the use of quantitative methods, including Rasch-consistent methods, with small samples. The feasibility of obtaining accurate information and the potential negative impacts of misusing large-sample statistical methods with small samples during COA development are discussed.

Validity of the WISC-IV Spanish for a clinically referred sample of Hispanic children.

PubMed

San Miguel Montes, Liza E; Allen, Daniel N; Puente, Antonio E; Neblina, Cris

2010-06-01

The Wechsler Intelligence Scale for Children (WISC) is the most commonly used intelligence test for children. Five years ago, a Spanish version of the WISC-IV was published (WISC-IV Spanish; Wechsler, 2005), but a limited amount of published information is available regarding its utility when assessing clinical samples. The current study included 107 children who were Spanish speaking and of Puerto Rican descent that had been administered the WISC-IV Spanish. They were subdivided into a clinical sample of 35 children with diagnoses of various forms of brain dysfunction (primarily learning disability, attention-deficit/hyperactivity disorder, and epilepsy) and a comparison group made up of 72 normal children who were part of the WISC-IV Spanish version standardization sample. Comparisons between these groups and the standardization sample were performed for the WISC-IV Spanish index and subtest scores. Results indicated that the clinical sample performed worse than the comparison samples on the Working Memory and Processing Speed Indexes, although findings varied to some extent depending on whether the clinical group was compared with the normal comparison group or the standardization sample. These findings provide support for the criterion validity of the WISC-IV Spanish when it is used to assess a clinically referred sample with brain dysfunction.

Embedding clinical interventions into observational studies.

PubMed

Newman, Anne B; Avilés-Santa, M Larissa; Anderson, Garnet; Heiss, Gerardo; Howard, Wm James; Krucoff, Mitchell; Kuller, Lewis H; Lewis, Cora E; Robinson, Jennifer G; Taylor, Herman; Treviño, Roberto P; Weintraub, William

2016-01-01

Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed. Copyright © 2015. Published by Elsevier Inc.

Pre-Clinical Evaluation of a Real-Time PCR Assay on a Portable Instrument as a Possible Field Diagnostic Tool: Experiences from the Testing of Clinical Samples for African and Classical Swine Fever Viruses.

PubMed

Liu, L; Luo, Y; Accensi, F; Ganges, L; Rodríguez, F; Shan, H; Ståhl, K; Qiu, H-J; Belák, S

2017-10-01

African swine fever (ASF) and classical swine fever (CSF) are two highly infectious transboundary animal diseases (TADs) that are serious threats to the pig industry worldwide, including in China, the world's largest pork producer. In this study, a duplex real-time PCR assay was developed for the rapid detection and differentiation of African swine fever virus (ASFV) and classical swine fever virus (CSFV). The assay was performed on a portable, battery-powered PCR thermocycler with a low sample throughput (termed as 'T-COR4 assay'). The feasibility and reliability of the T-COR4 assay as a possible field method was investigated by testing clinical samples collected in China. When evaluated with reference materials or samples from experimental infections, the assay performed in a reliable manner, producing results comparable to those obtained from stationary PCR platforms. Of 59 clinical samples, 41 had results identical to a two-step CSFV real-time PCR assay. No ASFV was detected in these samples. The T-COR4 assay was technically easy to perform and produced results within 3 h, including sample preparation. In combination with a simple sample preparation method, the T-COR4 assay provides a new tool for the field diagnosis and differentiation of ASF and CSF, which could be of particular value in remote areas. © 2016 Blackwell Verlag GmbH.

Agreement between parents and teachers on preschool children's behavior in a clinical sample with externalizing behavioral problems.

PubMed

Korsch, Franziska; Petermann, Franz

2014-10-01

An accurate interpretation of information obtained from multiple assessors is indispensible when complex diagnoses of behavioral problems in children need to be confirmed. The present study examined the similarity of parents and kindergarten teachers ratings on children's behavior in a sample of 160 preschool children (a clinical group including 80 children with externalizing behavioral problems and a matched control group including 80 children). Behavioral problems were assessed using the SDQ, and the DISYPS-II questionnaires for ADHD and conduct disorders. The results revealed low levels of parent-teacher agreement for their ratings on the children's behavior in both groups with the highest correlations in the non-clinical sample. Parent-teacher agreement did not differ significantly across the samples. Parent and teacher ratings correlated with the prevalence of externalizing disorders and were found to be almost independent of each other. The results highlight the importance of multiple informants and their independent influence within the diagnostic process.

Integrated Blood Barcode Chips

PubMed Central

Fan, Rong; Vermesh, Ophir; Srivastava, Alok; Yen, Brian K.H.; Qin, Lidong; Ahmad, Habib; Kwong, Gabriel A.; Liu, Chao-Chao; Gould, Juliane; Hood, Leroy; Heath, James R.

2008-01-01

Blood comprises the largest version of the human proteome1. Changes of plasma protein profiles can reflect physiological or pathological conditions associated with many human diseases, making blood the most important fluid for clinical diagnostics2-4. Nevertheless, only a handful of plasma proteins are utilized in routine clinical tests. This is due to a host of reasons, including the intrinsic complexity of the plasma proteome1, the heterogeneity of human diseases and the fast kinetics associated with protein degradation in sampled blood5. Simple technologies that can sensitively sample large numbers of proteins over broad concentration ranges, from small amounts of blood, and within minutes of sample collection, would assist in solving these problems. Herein, we report on an integrated microfluidic system, called the Integrated Blood Barcode Chip (IBBC). It enables on-chip blood separation and the rapid measurement of a panel of plasma proteins from small quantities of blood samples including a fingerprick of whole blood. This platform holds potential for inexpensive, non-invasive, and informative clinical diagnoses, particularly, for point-of-care. PMID:19029914

Analysis of Environmental Contamination resulting from Catastrophic Incidents: Part two: Building Laboratory Capability by Selecting and Developing Analytical Methodologies

EPA Science Inventory

Catastrophic incidents can generate a large number of samples with analytically diverse types including forensic, clinical, environmental, food, and others. Environmental samples include water, wastewater, soil, air, urban building and infrastructure materials, and surface resid...

Group-sequential three-arm noninferiority clinical trial designs

PubMed Central

Ochiai, Toshimitsu; Hamasaki, Toshimitsu; Evans, Scott R.; Asakura, Koko; Ohno, Yuko

2016-01-01

We discuss group-sequential three-arm noninferiority clinical trial designs that include active and placebo controls for evaluating both assay sensitivity and noninferiority. We extend two existing approaches, the fixed margin and fraction approaches, into a group-sequential setting with two decision-making frameworks. We investigate the operating characteristics including power, Type I error rate, maximum and expected sample sizes, as design factors vary. In addition, we discuss sample size recalculation and its’ impact on the power and Type I error rate via a simulation study. PMID:26892481

Preflight and postflight microbiological results from 25 space shuttle crews

NASA Technical Reports Server (NTRS)

Pierson, Duane L.; Bassinger, Virginia J.; Molina, Thomas C.; Gunter, Emelie G.; Groves, Theron O.; Cioletti, Louis J.; Mishra, S. K.

1993-01-01

Clinical-microbiological investigations are an important aspect of the crew health stabilization program. To ensure that space crews have neither active nor latent infections, clinical specimens, including throat and nasal swabs and urine samples, are collected at 10 days (L-10) and 2days (L-2) before launch, and immediately after landing (L+0). All samples are examined for the presence of bacteria and fungi. In addition, fecal samples are collected at L-10 and examined for bacteria, fungi and parasites. This paper describes clinical-microbiological findings from 144 astronauts participating in 25 Space Shuttle missions spanning Space Transportation System (STS)-26 to STS-50. The spectrum of microbiological findings from the specimens included 25 bacterial and 11 fungal species. Among the bacteria isolated most frequently were Staphylococcus aureus, Enterobacter aerogenes, Enterococcus faecalis, Escherichia coli, Proteus mirabilis and Streptococcus agalactiae. Candida albicans was the most frequently isolated fungal pathogen.

Occurrence of Clinical and Sub-Clinical Mastitis in Dairy Herds in the West Littoral Region in Uruguay

PubMed Central

Gianneechini, R; Concha, C; Rivero, R; Delucci, I; López, J Moreno

2002-01-01

Twenty-nine dairy farms were selected to determine the incidence of clinical mastitis, prevalence of sub-clinical mastitis and bacterial aetiology in the West Littoral Region of Uruguay. In samples taken by the owner and frozen at -20°C during a week the incidence rate of clinical mastitis was determined as 1.2 cases per 100 cow-months at risk. Staphylococcus aureus was the most common isolated pathogen in 37.5% of 40 milk samples from clinical cases obtained in 1 month. No bacteria grew in the 32.5% of the total samples. A sub-sample including 1077 dairy cows from randomly selected farms was used to determine the prevalence of sub-clinical mastitis. These samples were taken on one visit to each farm. The prevalence was 52.4% on a cow basis and 26.7% on an udder quarter basis. In 55.1% of the quarters of the selected animals with more than 300 000 cells/ml there was no growth. The isolated pathogens from sub-clinical cases and their relative frequencies were: Staphylococcus aureus 62.8%, Streptococcus agalactiae 11.3%, Enterococcus sp. 8%, coagulase-negative staphylococci 7.4%, Streptococus uberis 6.4%, Streptococcus dysgalactiae 1.8%, Escherichia coli 1.5% and Staphylococcus hyicus coagulase-positive 0.6%. PMID:12831175

General Health Questionnaire-12 validity in Colombia and factorial equivalence between clinical and nonclinical participants.

PubMed

Ruiz, Francisco J; García-Beltrán, Diana M; Suárez-Falcón, Juan C

2017-10-01

The General Health Questionnaire - 12 (GHQ-12) is a widely used screening self-report for emotional disorders among adults. However, there is little evidence concerning the validity of the GHQ-12 in Colombia and its factorial invariance between nonclinical and clinical samples. Accordingly, the current study aims to explore the GHQ-12 validity in Colombian nonclinical and clinical samples. The GHQ-12 was administered to a total of 1641 participants, including a sample of undergraduates, one of general population, and a clinical sample. The internal consistency of the GHQ-12 across samples was good (overall alpha of .90). The one-factor model showed a good fit to the data and was considered theoretically more coherent than the two-factor model with positive and negative items loading in separate factors. Metric and scalar invariance were observed across nonclinical and clinical samples. The GHQ-12 scores were strongly and positively related to emotional symptoms and experiential avoidance, and negatively related to life satisfaction. According to the receiver operating characteristic (ROC) curves, a threshold score of 11/12 was optimal to identify emotional disorders. In conclusion, the GHQ-12 is a valid screening self-report in Colombia that provides scores that can be compared across clinical and nonclinical participants. Copyright © 2017 Elsevier B.V. All rights reserved.

Gender Ratio in a Clinical Population Sample, Age of Diagnosis and Duration of Assessment in Children and Adults with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Rutherford, Marion; McKenzie, Karen; Johnson, Tess; Catchpole, Ciara; O'Hare, Anne; McClure, Iain; Forsyth, Kirsty; McCartney, Deborah; Murray, Aja

2016-01-01

This article reports on gender ratio, age of diagnosis and the duration of assessment procedures in autism spectrum disorder diagnosis in a national study which included all types of clinical services for children and adults. Findings are reported from a retrospective case note analysis undertaken with a representative sample of 150 Scottish…

Clinical Implications of DSM-IV Subtyping of Bipolar Disorders in Referred Children and Adolescents

ERIC Educational Resources Information Center

Masi, Gabriele; Perugi, Giulio; Millepiedi, Stefania; Mucci, Maria; Pari, Cinzia; Pfanner, Chiara; Berloffa, Stefano; Toni, Cristina

2007-01-01

Objective: According to DSM-IV, bipolar disorders (BDs) include four subtypes, BD I, BD II, cyclothymic disorder, and BD not otherwise specified (NOS). We explore the clinical implications of this subtyping in a naturalistic sample of referred youths with BD I, BD II, and BD-NOS. Method: The sample consisted of 217 patients, 135 males and 82…

Variation of clinical outcomes used in glaucoma randomised controlled trials: a systematic review.

PubMed

Ismail, Rehab; Azuara-Blanco, Augusto; Ramsay, Craig R

2014-04-01

In randomised clinical trials (RCTs) the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. The purpose of this review is to identify different clinical outcomes reported in glaucoma trials. We conducted a systematic review of glaucoma RCTs. A sample or selection of glaucoma trials were included bounded by a time frame (between 2006 and March 2012). Only studies in English language were considered. All clinical measured and reported outcomes were included. The possible variations of clinical outcomes were defined prior to data analysis. Information on reported clinical outcomes was tabulated and analysed using descriptive statistics. Other data recorded included type of intervention and glaucoma, duration of the study, defined primary outcomes, and outcomes used for sample size calculation, if nominated. The search strategy identified 4323 potentially relevant abstracts. There were 315 publications retrieved, of which 233 RCTs were included. A total of 967 clinical measures were reported. There were large variations in the definitions used to describe different outcomes and their measures. Intraocular pressure was the most commonly reported outcome (used in 201 RCTs, 86%) with a total of 422 measures (44%). Safety outcomes were commonly reported in 145 RCTs (62%) whereas visual field outcomes were used in 38 RCTs (16%). There is a large variation in the reporting of clinical outcomes in glaucoma RCTs. This lack of standardisation may impair the ability to evaluate the evidence of glaucoma interventions.

The Revised Child Anxiety and Depression Scale 25-Parent Version: Scale Development and Validation in a School-Based and Clinical Sample.

PubMed

Ebesutani, Chad; Korathu-Larson, Priya; Nakamura, Brad J; Higa-McMillan, Charmaine; Chorpita, Bruce

2017-09-01

To help facilitate the dissemination and implementation of evidence-based assessment practices, we examined the psychometric properties of the shortened 25-item version of the Revised Child Anxiety and Depression Scale-parent report (RCADS-25-P), which was based on the same items as the previously published shortened 25-item child version. We used two independent samples of youth-a school sample ( N = 967, Grades 3-12) and clinical sample ( N = 433; 6-18 years)-to examine the factor structure, reliability, and validity of the RCADS-25-P scale scores. Results revealed that the two-factor structure (i.e., depression and broad anxiety factor) fit the data well in both the school and clinical sample. All reliability estimates, including test-retest indices, exceeded benchmark for good reliability. In the school sample, the RCADS-25-P scale scores converged significantly with related criterion measures and diverged with nonrelated criterion measures. In the clinical sample, the RCADS-25-P scale scores successfully discriminated between those with and without target problem diagnoses. In both samples, child-parent agreement indices were in the expected ranges. Normative data were also reported. The RCADS-25-P thus demonstrated robust psychometric properties across both a school and clinical sample as an effective brief screening instrument to assess for depression and anxiety in children and adolescents.

Clinical Research Nurse | Center for Cancer Research

Cancer.gov

We are looking for a Research Nurse to join our women’s malignancies clinical team to help us manage the care of patients participating in clinical trials. Duties include, but are not limited to, collection and reporting of clinical data; reporting adverse events; filing amendments and regulatory documents; consenting, screening and collecting samples from patients and

Molecular and serological findings in suspected patients with Crimean-Congo hemorrhagic fever virus in Iran.

PubMed

Karlberg, Helen; Sharifi-Mood, Batool; Mousavi-Jazi, Mehrdad; Dilcher, Meik; Lindegren, Gunnel; Mardani, Masoud; Bereskly, Sandor; Weidmann, Manfred; Mirazimi, Ali

2015-04-01

Crimean-Congo hemorrhagic fever (CCHF) is an arthropod-borne disease of humans associated with a severe clinical picture, including hemorrhagic syndrome and a high mortality rate. CCHF virus is widely distributed throughout large areas of the world. To characterize the serological status in CCHF patients, paired clinical samples were collected from suspected CCHF patients and analyzed by microbiological and other laboratory analyses with the aim of: determining the presence of neutralizing antibodies against CCHF virus; investigating the cross-reactivity of these neutralizing antibodies against virus isolated from the same outbreak and against other available laboratory strain; and studying the relationship between the isolated virus with other virus by whole genome sequencing. Patients at Boo-Ali Hospital, Zahedan, Iran, with clinical symptoms ranging from mild to severe hemorrhagic fever were included in the study. Two serum samples were taken from each patient, the first as soon as the patient matched the criteria for CCHF notification and the second when the patient was discharged from hospital (2 weeks later). Commercial and in-house assays revealed a positive IgM signal in acute serum samples from six patients. A novel finding was that CCHF patients develop neutralizing antibodies soon after infection. Interestingly these antibodies were able to neutralize other CCHF virus strains too. The complete sequence of the Zahedan 2007 isolate, including the hitherto unknown first L-segment sequence, was identified using an original clinical sample from one patient with confirmed CCHF infection. © 2015 Wiley Periodicals, Inc.

Oncology biomarkers: discovery, validation, and clinical use.

PubMed

Heckman-Stoddard, Brandy M

2012-05-01

To discuss the discovery, validation, and clinical use of multiple types of biomarkers. Medical literature and published guidelines. Formal validation of biomarkers should include both retrospective analyses of well-characterized samples as well as a prospective clinical trial in which the biomarker is tested for its ability to predict the presence of disease or the efficacy of a cancer therapy. Biomarker development is complicated, with very few biomarker discoveries leading to clinically useful tests. Nurses should understand how a biomarker was developed, including the sensitivity and specificity before applying new biomarkers in the clinical setting. Copyright © 2012. Published by Elsevier Inc.

Psychometric properties of the Penn State Worry Questionnaire for children in a large clinical sample.

PubMed

Pestle, Sarah L; Chorpita, Bruce F; Schiffman, Jason

2008-04-01

The Penn State Worry Questionnaire for Children (PSWQ-C; Chorpita, Tracey, Brown, Collica, & Barlow, 1997) is a 14-item self-report measure of worry in children and adolescents. Although the PSWQ-C has demonstrated favorable psychometric properties in small clinical and large community samples, this study represents the first psychometric evaluation of the PSWQ-C in a large clinical sample (N = 491). Factor analysis indicated a two-factor structure, in contrast to all previously published findings on the measure. The PSWQ-C demonstrated favorable psychometric properties in this sample, including high internal consistency, high convergent validity with related constructs, and acceptable discriminative validity between diagnostic categories. The performance of the 3 reverse-scored items was closely examined, and results indicated retaining all 14 items.

The predictive validity of selection for entry into postgraduate training in general practice: evidence from three longitudinal studies

PubMed Central

Patterson, Fiona; Lievens, Filip; Kerrin, Máire; Munro, Neil; Irish, Bill

2013-01-01

Background The selection methodology for UK general practice is designed to accommodate several thousand applicants per year and targets six core attributes identified in a multi-method job-analysis study Aim To evaluate the predictive validity of selection methods for entry into postgraduate training, comprising a clinical problem-solving test, a situational judgement test, and a selection centre. Design and setting A three-part longitudinal predictive validity study of selection into training for UK general practice. Method In sample 1, participants were junior doctors applying for training in general practice (n = 6824). In sample 2, participants were GP registrars 1 year into training (n = 196). In sample 3, participants were GP registrars sitting the licensing examination after 3 years, at the end of training (n = 2292). The outcome measures include: assessor ratings of performance in a selection centre comprising job simulation exercises (sample 1); supervisor ratings of trainee job performance 1 year into training (sample 2); and licensing examination results, including an applied knowledge examination and a 12-station clinical skills objective structured clinical examination (OSCE; sample 3). Results Performance ratings at selection predicted subsequent supervisor ratings of job performance 1 year later. Selection results also significantly predicted performance on both the clinical skills OSCE and applied knowledge examination for licensing at the end of training. Conclusion In combination, these longitudinal findings provide good evidence of the predictive validity of the selection methods, and are the first reported for entry into postgraduate training. Results show that the best predictor of work performance and training outcomes is a combination of a clinical problem-solving test, a situational judgement test, and a selection centre. Implications for selection methods for all postgraduate specialties are considered. PMID:24267856

The predictive validity of selection for entry into postgraduate training in general practice: evidence from three longitudinal studies.

PubMed

Patterson, Fiona; Lievens, Filip; Kerrin, Máire; Munro, Neil; Irish, Bill

2013-11-01

The selection methodology for UK general practice is designed to accommodate several thousand applicants per year and targets six core attributes identified in a multi-method job-analysis study To evaluate the predictive validity of selection methods for entry into postgraduate training, comprising a clinical problem-solving test, a situational judgement test, and a selection centre. A three-part longitudinal predictive validity study of selection into training for UK general practice. In sample 1, participants were junior doctors applying for training in general practice (n = 6824). In sample 2, participants were GP registrars 1 year into training (n = 196). In sample 3, participants were GP registrars sitting the licensing examination after 3 years, at the end of training (n = 2292). The outcome measures include: assessor ratings of performance in a selection centre comprising job simulation exercises (sample 1); supervisor ratings of trainee job performance 1 year into training (sample 2); and licensing examination results, including an applied knowledge examination and a 12-station clinical skills objective structured clinical examination (OSCE; sample 3). Performance ratings at selection predicted subsequent supervisor ratings of job performance 1 year later. Selection results also significantly predicted performance on both the clinical skills OSCE and applied knowledge examination for licensing at the end of training. In combination, these longitudinal findings provide good evidence of the predictive validity of the selection methods, and are the first reported for entry into postgraduate training. Results show that the best predictor of work performance and training outcomes is a combination of a clinical problem-solving test, a situational judgement test, and a selection centre. Implications for selection methods for all postgraduate specialties are considered.

Clinical protein science developments for patient monitoring in hospital central laboratories.

PubMed

Malm, Johan; Marko-Varga, György

2016-12-01

Patient care relies heavily on standardized tests performed in hospital laboratories, typically including clinical chemistry, pathology and microbiology. With the introduction of personalized medicine tremendous efforts have been made to identify new biomarkers of disease with various omics technologies, often including mass spectrometry. In order to validate new biomarkers and perform clinical studies high quality biobank samples are of key importance. In this editorial different aspects of mass spectrometry in future personalized medicine are discussed.

Synthesizing Information From Language Samples and Standardized Tests in School-Age Bilingual Assessment

PubMed Central

Pham, Giang

2017-01-01

Purpose Although language samples and standardized tests are regularly used in assessment, few studies provide clinical guidance on how to synthesize information from these testing tools. This study extends previous work on the relations between tests and language samples to a new population—school-age bilingual speakers with primary language impairment—and considers the clinical implications for bilingual assessment. Method Fifty-one bilingual children with primary language impairment completed narrative language samples and standardized language tests in English and Spanish. Children were separated into younger (ages 5;6 [years;months]–8;11) and older (ages 9;0–11;2) groups. Analysis included correlations with age and partial correlations between language sample measures and test scores in each language. Results Within the younger group, positive correlations with large effect sizes indicated convergence between test scores and microstructural language sample measures in both Spanish and English. There were minimal correlations in the older group for either language. Age related to English but not Spanish measures. Conclusions Tests and language samples complement each other in assessment. Wordless picture-book narratives may be more appropriate for ages 5–8 than for older children. We discuss clinical implications, including a case example of a bilingual child with primary language impairment, to illustrate how to synthesize information from these tools in assessment. PMID:28055056

Comparative typing analyses of clinical and environmental strains of the Cryptococcus neoformans/Cryptococcus gattii species complex from Ivory Coast.

PubMed

Kassi, Fulgence K; Bellet, Virginie; Drakulovski, Pascal; Krasteva, Donika; Roger, Frédéric; Valérie, Bedia-Tanoh A; Aboubakar, Touré; Doumbia, Adama; Kouakou, Gisèle A; Delaporte, Eric; Reynes, Jacques; Yavo, William; Menan, Hervé I E; Bertout, Sebastien

2018-01-01

The aim of this study was to assess the biotope of the Cryptococcus neoformans/Cryptococcus gattii species complex from Ivory Coast, and clarify the possible epidemiological relationship between environmental and clinical strains. Samples from Eucalyptus camaldulensis (n=136), Mangifera indica (n=13) and pigeon droppings (n=518) were collected from different sites close to the living environment of Ivorian HIV patients with cryptococcosis (n=10, 50 clinical strains). Clinical and environmental strains were characterized by molecular serotyping and genotyping [RFLP analysis of the URA5 gene, (GACA)4, (GTG)5 and M13 PCR fingerprinting] and compared.Results/Key findings. Environmental strains were recovered only from the pigeon droppings. In vitro susceptibility profiles showed that all strains were susceptible to fluconazole, flucytosine and amphotericin B. All environmental strains consisted of C. neoformans (A, AFLP1/VNI), whereas clinical strains included C. neoformans (A, AFLP1/VNI), C. neoformans x Cryptococcus deneoformans hybrids (AD, AFLP3/VNIII) and Cryptococcus deuterogattii (B, AFLP6/VGII). Two patients were co-infected with both C. neoformans and C. neoformans x C. deneoformans hybrids. We noticed a low genetic diversity among the environmental samples compared to the high diversity of the clinical samples. Some clinical strains were genetically more similar to environmental strains than to other clinical strains, including those from the same patient. These results provide new information on the ecology and epidemiology of the C. neoformans/C. gattii species complex in Ivory Coast.

Assessing quality of life in severe obesity: development and psychometric properties of the ORWELL-R.

PubMed

Camolas, José; Ferreira, André; Mannucci, Edoardo; Mascarenhas, Mário; Carvalho, Manuel; Moreira, Pedro; do Carmo, Isabel; Santos, Osvaldo

2016-06-01

Several health-related quality-of-life (HRQoL) dimensions are affected by obesity. Our goal was to characterize the psychometric properties of the ORWELL-R, a new obesity-related quality-of-life instrument for assessing the "individual experience of overweightness". This psychometric assessment included two different samples: one multicenter clinical sample, used for assessing internal consistency, construct validity and temporal reliability; and a community sample (collected through a cross-sectional mailing survey design), used for additional construct validity assessment and model fit confirmation. Overall, 946 persons participated (188 from the clinical sample; 758 from community sample). An alpha coefficient of 0.925 (clinical sample) and 0.934 (community sample) was found. Three subscales were identified (53.2 % of variance): Body environment experience (alpha = 0.875), Illness perception and distress (alpha = 0.864), Physical symptoms (alpha = 0.674). Adequate test-retest reliability has been confirmed (ICC: 0.78 for the overall score). ORWELL-R scores were worse in the clinical sample. Worst HRQoL, as measured by higher ORWELL-R scores, was associated with BMI increases. ORWELL-R scores were associated with IWQOL-Lite and lower scores in happiness. ORWELL-R shows good internal consistency and adequate test-retest reliability. Good construct validity was also observed (for convergent and discriminant validity) and confirmed through confirmatory factor analysis (in both clinical and community samples). Presented data sustain ORWELL-R as a reliable and useful instrument to assess obesity-related QoL, in both research and clinical contexts.

A males only clinic session.

PubMed

Stupples, A

1980-01-01

The pressure to establish the Dunedin (New Zealand) Male Advice Clinic came from members of the Psychology Department of the University of Otago as a result of a study of attitudes towards the use and purchase of contraceptives among the local young people. The study findings and the suggestions made for the establishment of a male advice center are summarized. 3 samples were studied: a university sample (N=80); a sample of high school students (N=243); and a general population sample (N=70). The males in all samples were questioned regarding the process of purchasing contraceptives. The study findings indicated that embarrassment functioned as an impediment to obtaining contraceptive supplies. 76% of the university sample, 36% of the school sample, and 57% of the general population thought that males needed advice in choosing condoms. The male advice center would be open to anyone but designed specifically to cater to young men who anticipate or are already engaged in sexual intercourse. Services available would include contraceptive advice, contraceptive supplies, and sexual advice and counseling. Initial interest in the Dunedin Male Advice Clinic was considerable, but the question remained as to whether the group for whom the clinic was intended was really reached.

Correlations of fatty acid supplementation, aeroallergens, shampoo, and ear cleanser with multiple parameters in pruritic dogs.

PubMed

Nesbitt, Gene H; Freeman, Lisa M; Hannah, Steven S

2004-01-01

Seventy-two pruritic dogs were fed one of four diets controlled for n-6:n-3 fatty acid ratios and total dietary intake of fatty acids. Multiple parameters were evaluated, including clinical and cytological findings, aeroallergen testing, microbial sampling techniques, and effects of an anti-fungal/antibacterial shampoo and ear cleanser. Significant correlations were observed between many clinical parameters, anatomical sampling sites, and microbial counts when data from the diet groups was combined. There were no statistically significant differences between individual diets for any of the clinical parameters. The importance of total clinical management in the control of pruritus was demonstrated.

Analysis of on-line clinical laboratory manuals and practical recommendations.

PubMed

Beckwith, Bruce; Schwartz, Robert; Pantanowitz, Liron

2004-04-01

On-line clinical laboratory manuals are a valuable resource for medical professionals. To our knowledge, no recommendations currently exist for their content or design. To analyze publicly accessible on-line clinical laboratory manuals and to propose guidelines for their content. We conducted an Internet search for clinical laboratory manuals written in English with individual test listings. Four individual test listings in each manual were evaluated for 16 data elements, including sample requirements, test methodology, units of measure, reference range, and critical values. Web sites were also evaluated for supplementary information and search functions. We identified 48 on-line laboratory manuals, including 24 academic or community hospital laboratories and 24 commercial or reference laboratories. All manuals had search engines and/or test indices. No single manual contained all 16 data elements evaluated. An average of 8.9 (56%) elements were present (range, 4-14). Basic sample requirements (specimen and volume needed) were the elements most commonly present (98% of manuals). The frequency of the remaining data elements varied from 10% to 90%. On-line clinical laboratory manuals originate from both hospital and commercial laboratories. While most manuals were user-friendly and contained adequate specimen-collection information, other important elements, such as reference ranges, were frequently absent. To ensure that clinical laboratory manuals are of maximal utility, we propose the following 13 data elements be included in individual test listings: test name, synonyms, test description, test methodology, sample requirements, volume requirements, collection guidelines, transport guidelines, units of measure, reference range, critical values, test availability, and date of latest revision.

Retrospective testing and case series study of porcine delta coronavirus in U.S. swine herds.

PubMed

McCluskey, Brian J; Haley, Charles; Rovira, Albert; Main, Rodger; Zhang, Yan; Barder, Sunny

2016-01-01

Porcine deltacoronavirus (PDCoV) was first reported in the United States (US) in February 2014. This was the second novel swine enteric coronavirus detected in the US since May 2013. In this study, we conducted retrospective testing of samples submitted to three veterinary diagnostic laboratories where qualifying biological samples were derived from previously submitted diagnostic case submissions from US commercial swine farms with a clinical history of enteric disease or from cases that had been previously tested for transmissible gastroenteritis virus, PEDV, or rotavirus. Overall, 2286 banked samples were tested from 27 States. Samples were collected in 3 separate years and in 17 different months. Test results revealed 4 positive samples, 3 collected in August 2013 and 1 collected in October 2013. In addition, a case series including 42 operations in 10 States was conducted through administration of a survey. Survey data collected included information on characteristics of swine operations that had experienced PDCoV clinical signs. Special emphasis was placed on obtaining descriptive estimates of biosecurity practices and disease status over time of each operation. Clinical signs of PDCoV were reported to be similar to those of PEDV. The average number of animals on each operation exhibiting clinical signs (morbidity) and the average number of case fatalities was greatest for suckling and weaned pigs. Average operation-level weaned pig morbidity was greatest in the first week of the outbreak while average operation-level suckling pig case fatality was greatest in the second week of the outbreak. The survey included questions regarding biosecurity practices for visitors and operation employees; trucks, equipment and drivers; and feed sources. These questions attempted to identify a likely pathway of introduction of PDCoV onto the operations surveyed. Published by Elsevier B.V.

Research Nurse | Center for Cancer Research

Cancer.gov

We are looking for a Research Nurse to join our women’s malignancies clinical team to help us manage the care of patients participating in clinical trials. Duties include, but are not limited to, collection and reporting of clinical data; reporting adverse events; filing amendments and regulatory documents; consenting, screening and collecting samples from patients and

The views of genitourinary medicine (GUM) clinic users on unlinked anonymous testing for HIV: evidence from a pilot study of clinics in two English cities.

PubMed

Datta, Jessica; Kessel, Anthony; Wellings, Kaye; Nanchahal, Kiran; Marks, Dalya; Kinghorn, George

2011-11-01

A study was undertaken of the views of users of two genitourinary medicine (GUM) clinics in England on unlinked anonymous testing (UAT) for HIV. The UAT programme measures the prevalence of HIV in the population, including undiagnosed prevalence, by testing residual blood (from samples taken for clinical purposes) which is anonymised and irreversibly unlinked from the source. 424 clinic users completed an anonymous questionnaire about their knowledge of, and attitudes towards, UAT. Only 1/7 (14%) were aware that blood left over from clinical testing may be tested anonymously for HIV. A large majority (89%) said they would agree to their blood being tested, although 74% wanted the opportunity to consent. These findings indicate broad support for UAT of blood in a group of patients whose samples are included in the HIV surveillance programme. The findings suggest the need for greater attention to be given to the provision of information and, if replicated in a larger survey, may justify a reappraisal of UK policy on UAT.

An Interactive Teddy Bear Clinic Tour: Teaching Veterinary Students How to Interact with Young Children.

PubMed

Dalley, Jessica S; Creary, Patricia R; Durzi, Tiffany; McMurtry, C Meghan

Although there are existing guidelines for teaching and learning skillful client communication, there remains a need to integrate a developmental focus into veterinary medical curricula to prepare students for interactions with children who accompany their companion animals. The objectives of this teaching tip are (1) to describe the use of a Teddy Bear Clinic Tour as an innovative, applied practice method for teaching veterinary students about clinical communication with children, and (2) to provide accompanying resources to enable use of this method to teach clinical communication at other facilities. This paper includes practical guidelines for organizing a Teddy Bear Clinic Tour at training clinics or colleges of veterinary medicine; an anecdotal description of a pilot study at the Ontario Veterinary College Smith Lane Animal Hospital; and printable resources, including a list of specific clinical communication skills, a sample evaluation sheet for supervisors and students, recommendations for creating a child-friendly environment, examples of child-friendly veterinary vocabulary, and a sample script for a Teddy Bear Clinic Tour. Informed by the resources provided in this teaching tip paper, the Teddy Bear Clinic Tour can be used at your facility as a unique teaching method for clinical communication with children and as a community outreach program to advertise the services at the facility.

The economic impact of poor sample quality in clinical chemistry laboratories: results from a global survey.

PubMed

Erdal, Erik P; Mitra, Debanjali; Khangulov, Victor S; Church, Stephen; Plokhoy, Elizabeth

2017-03-01

Background Despite advances in clinical chemistry testing, poor blood sample quality continues to impact laboratory operations and the quality of results. While previous studies have identified the preanalytical causes of lower sample quality, few studies have examined the economic impact of poor sample quality on the laboratory. Specifically, the costs associated with workarounds related to fibrin and gel contaminants remain largely unexplored. Methods A quantitative survey of clinical chemistry laboratory stakeholders across 10 international regions, including countries in North America, Europe and Oceania, was conducted to examine current blood sample testing practices, sample quality issues and practices to remediate poor sample quality. Survey data were used to estimate costs incurred by laboratories to mitigate sample quality issues. Results Responses from 164 participants were included in the analysis, which was focused on three specific issues: fibrin strands, fibrin masses and gel globules. Fibrin strands were the most commonly reported issue, with an overall incidence rate of ∼3%. Further, 65% of respondents indicated that these issues contribute to analyzer probe clogging, and the majority of laboratories had visual inspection and manual remediation practices in place to address fibrin- and gel-related quality problems (55% and 70%, respectively). Probe maintenance/replacement, visual inspection and manual remediation were estimated to carry significant costs for the laboratories surveyed. Annual cost associated with lower sample quality and remediation related to fibrin and/or gel globules for an average US laboratory was estimated to be $100,247. Conclusions Measures to improve blood sample quality present an important step towards improved laboratory operations.

Molecular characterization of diarrheagenic Escherichia coli strains from stools samples and food products in Colombia

PubMed Central

Rúgeles, Laura Cristina; Bai, Jing; Martínez, Aída Juliana; Vanegas, María Consuelo; Gómez-Duarte, Oscar Gilberto

2010-01-01

The prevalence of diarrheagenic E. coli in childhood diarrhea and the role of contaminated food products in disease transmission in Colombia are largely unknown. The aim of this study is to identify E. coli pathotypes, including E. coli O157:H7, from 108 stool samples from children with acute diarrhea, 38 meat samples and 38 vegetable samples. Multiplex PCR and Bax Dupont systems were used for E. coli pathotype detection. Eighteen (9.8%) E. coli diarrheagenic pathotypes were detected among all clinical and food product samples tested. Four different pathotypes were identified from clinical samples, including enteroaggregative E. coli, enterotoxigenic E. coli, shiga-toxin producing E. coli, and enteropathogenic E. coli. Food product samples were positive for enteroaggregative and shiga-toxin producing E. coli, suggesting that meat and vegetables may be involved in transmission of these E. coli pathotypes in the community. Most E. coli strains identified belong to the phylogenetic groups A and B1, known to be associated with intestinal rather than extraintestinal E. coli clones. Our data is the first molecular E. coli report that confirms the presence of E. coli pathotypes circulating in Colombia among children with diarrhea and food products for human consumption. Implementation of multiplex PCR technology in Latin America and other countries with limited resources may provide an important epidemiological tool for the surveillance of E. coli pathotypes from clinical isolates as well as from water and food product samples. PMID:20153069

Longitudinal changes in white matter disease and cognition in the first year of the Alzheimer disease neuroimaging initiative.

PubMed

Carmichael, Owen; Schwarz, Christopher; Drucker, David; Fletcher, Evan; Harvey, Danielle; Beckett, Laurel; Jack, Clifford R; Weiner, Michael; DeCarli, Charles

2010-11-01

To evaluate relationships between magnetic resonance imaging (MRI)-based measures of white matter hyperintensities (WMHs), measured at baseline and longitudinally, and 1-year cognitive decline using a large convenience sample in a clinical trial design with a relatively mild profile of cardiovascular risk factors. Convenience sample in a clinical trial design. A total of 804 participants in the Alzheimer Disease Neuroimaging Initiative who received MRI scans, cognitive testing, and clinical evaluations at baseline, 6-month follow-up, and 12-month follow-up visits. For each scan, WMHs were detected automatically on coregistered sets of T1, proton density, and T2 MRI images using a validated method. Mixed-effects regression models evaluated relationships between risk factors for WMHs, WMH volume, and change in outcome measures including Mini-Mental State Examination (MMSE), Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), and Clinical Dementia Rating Scale sum of boxes scores. Covariates in these models included race, sex, years of education, age, apolipoprotein E genotype, baseline clinical diagnosis (cognitively normal, mild cognitive impairment, or Alzheimer disease), cardiovascular risk score, and MRI-based hippocampal and brain volumes. Higher baseline WMH volume was associated with greater subsequent 1-year increase in ADAS-Cog and decrease in MMSE scores. Greater WMH volume at follow-up was associated with greater ADAS-Cog and lower MMSE scores at follow-up. Higher baseline age and cardiovascular risk score and more impaired baseline clinical diagnosis were associated with higher baseline WMH volume. White matter hyperintensity volume predicts 1-year cognitive decline in a relatively healthy convenience sample that was similar to clinical trial samples, and therefore should be considered as a covariate of interest at baseline and longitudinally in future AD treatment trials.

Customized laboratory information management system for a clinical and research leukemia cytogenetics laboratory.

PubMed

Bakshi, Sonal R; Shukla, Shilin N; Shah, Pankaj M

2009-01-01

We developed a Microsoft Access-based laboratory management system to facilitate database management of leukemia patients referred for cytogenetic tests in regards to karyotyping and fluorescence in situ hybridization (FISH). The database is custom-made for entry of patient data, clinical details, sample details, cytogenetics test results, and data mining for various ongoing research areas. A number of clinical research laboratoryrelated tasks are carried out faster using specific "queries." The tasks include tracking clinical progression of a particular patient for multiple visits, treatment response, morphological and cytogenetics response, survival time, automatic grouping of patient inclusion criteria in a research project, tracking various processing steps of samples, turn-around time, and revenue generated. Since 2005 we have collected of over 5,000 samples. The database is easily updated and is being adapted for various data maintenance and mining needs.

Bias Assessment of General Chemistry Analytes using Commutable Samples.

PubMed

Koerbin, Gus; Tate, Jillian R; Ryan, Julie; Jones, Graham Rd; Sikaris, Ken A; Kanowski, David; Reed, Maxine; Gill, Janice; Koumantakis, George; Yen, Tina; St John, Andrew; Hickman, Peter E; Simpson, Aaron; Graham, Peter

2014-11-01

Harmonisation of reference intervals for routine general chemistry analytes has been a goal for many years. Analytical bias may prevent this harmonisation. To determine if analytical bias is present when comparing methods, the use of commutable samples, or samples that have the same properties as the clinical samples routinely analysed, should be used as reference samples to eliminate the possibility of matrix effect. The use of commutable samples has improved the identification of unacceptable analytical performance in the Netherlands and Spain. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has undertaken a pilot study using commutable samples in an attempt to determine not only country specific reference intervals but to make them comparable between countries. Australia and New Zealand, through the Australasian Association of Clinical Biochemists (AACB), have also undertaken an assessment of analytical bias using commutable samples and determined that of the 27 general chemistry analytes studied, 19 showed sufficiently small between method biases as to not prevent harmonisation of reference intervals. Application of evidence based approaches including the determination of analytical bias using commutable material is necessary when seeking to harmonise reference intervals.

A causal framework for understanding the effect of losses to follow-up on epidemiologic analyses in clinic-based cohorts: the case of HIV-infected patients on antiretroviral therapy in Africa.

PubMed

Geng, Elvin H; Glidden, David V; Bangsberg, David R; Bwana, Mwebesa Bosco; Musinguzi, Nicholas; Nash, Denis; Metcalfe, John Z; Yiannoutsos, Constantin T; Martin, Jeffrey N; Petersen, Maya L

2012-05-15

Although clinic-based cohorts are most representative of the "real world," they are susceptible to loss to follow-up. Strategies for managing the impact of loss to follow-up are therefore needed to maximize the value of studies conducted in these cohorts. The authors evaluated adult patients starting antiretroviral therapy at an HIV/AIDS clinic in Uganda, where 29% of patients were lost to follow-up after 2 years (January 1, 2004-September 30, 2007). Unweighted, inverse probability of censoring weighted (IPCW), and sampling-based approaches (using supplemental data from a sample of lost patients subsequently tracked in the community) were used to identify the predictive value of sex on mortality. Directed acyclic graphs (DAGs) were used to explore the structural basis for bias in each approach. Among 3,628 patients, unweighted and IPCW analyses found men to have higher mortality than women, whereas the sampling-based approach did not. DAGs encoding knowledge about the data-generating process, including the fact that death is a cause of being classified as lost to follow-up in this setting, revealed "collider" bias in the unweighted and IPCW approaches. In a clinic-based cohort in Africa, unweighted and IPCW approaches-which rely on the "missing at random" assumption-yielded biased estimates. A sampling-based approach can in general strengthen epidemiologic analyses conducted in many clinic-based cohorts, including those examining other diseases.

Recommendations for clinical biomarker specimen preservation and stability assessments.

PubMed

Dakappagari, Naveen; Zhang, Hui; Stephen, Laurie; Amaravadi, Lakshmi; Khan, Masood U

2017-04-01

With the wide use of biomarkers to enable critical drug-development decisions, there is a growing concern from scientific community on the need for a 'standardized process' for ensuring biomarker specimen stability and hence, a strong desire to share best practices on preserving the integrity of biomarker specimens in clinical trials and the design of studies to evaluate analyte stability. By leveraging representative industry experience, we have attempted to provide an overview of critical aspects of biomarker specimen stability commonly encountered during clinical development, including: planning of clinical sample collection procedures, clinical site training, selection of sample preservation buffers, shipping logistics, fit-for-purpose stability assessments in the analytical laboratory and presentation of case studies covering widely utilized biomarker specimen types.

Mass spectrometric detection of ricin and its activity in food and clinical samples.

PubMed

Kalb, Suzanne R; Barr, John R

2009-03-15

Ricin is a potent toxin capable of inhibiting protein synthesis and causing death or respiratory failure. Because of its high availability and lethality, ricin is considered a likely agent for bioterrorism. Rapidly determining contamination of food product with ricin and human exposure to ricin is therefore an important public health goal. In this work, we report the development of a method that detects ricin and its activity in food or clinical samples. This method involves immunocapture of the toxin, an examination of the activity of the ricin protein upon a DNA substrate that mimics the toxin's natural RNA target, and analysis of tryptic fragments of the toxin itself. It is the combination of these three techniques, all performed on the same sample, which allows for a sensitive and selective analysis of ricin isolated from a food or clinical sample. This measurement includes a measure of the toxin's activity. The utility of this method was demonstrated on ricin spiked into food and clinical samples consisting of milk, apple juice, serum, and saliva.

Learning, techniques, and complications of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline.

PubMed

Polkowski, M; Larghi, A; Weynand, B; Boustière, C; Giovannini, M; Pujol, B; Dumonceau, J-M

2012-02-01

This article is the second of a two-part publication that expresses the current view of the European Society of Gastrointestinal Endoscopy (ESGE) about endoscopic ultrasound (EUS)-guided sampling, including EUS-guided fine needle aspiration (EUS-FNA) and EUS-guided Trucut biopsy. The first part (the Clinical Guideline) focused on the results obtained with EUS-guided sampling, and the role of this technique in patient management, and made recommendations on circumstances that warrant its use. The current Technical Guideline discusses issues related to learning, techniques, and complications of EUS-guided sampling, and to processing of specimens. Technical issues related to maximizing the diagnostic yield (e.g., rapid on-site cytopathological evaluation, needle diameter, microcore isolation for histopathological examination, and adequate number of needle passes) are discussed and recommendations are made for various settings, including solid and cystic pancreatic lesions, submucosal tumors, and lymph nodes. The target readership for the Clinical Guideline mostly includes gastroenterologists, oncologists, internists, and surgeons while the Technical Guideline should be most useful to endoscopists who perform EUS-guided sampling. A two-page executive summary of evidence statements and recommendations is provided. © Georg Thieme Verlag KG Stuttgart · New York.

Nontuberculous Mycobacteria Isolation from Clinical and Environmental Samples in Iran: Twenty Years of Surveillance.

PubMed

Velayati, Ali Akbar; Farnia, Parissa; Mozafari, Mohadese; Mirsaeidi, Mehdi

2015-01-01

Nontuberculous mycobacteria (NTM) are opportunistic pathogens that are widely distributed in the environment. There is a lack of data on species distribution of these organisms from Iran. This study consists of a review of NTM articles published in Iran between the years 1992 and 2014. In this review, 20 articles and 14 case reports were identified. Among the 20 articles, 13 (65%) studies focused on NTM isolates from clinical specimens, 6 (30%) studies examined NTM isolates from environmental samples, and one (5%) article included both clinical and environmental isolates. M. fortuitum (229/997; 23%) was recorded as the most prevalent and rapid growing mycobacteria (RGM) species in both clinical (28%) and environmental (19%) isolated samples (P < 0.05). Among slow growing mycobacteria (SGM), M. simiae (103/494; 21%) demonstrated a higher frequency in clinical samples whereas in environmental samples it was M. flavescens (44/503; 9%). These data represent information from 14 provinces out of 31 provinces of Iran. No information is available in current published data on clinical or environmental NTM from the remaining 17 provinces in Iran. These results emphasize the potential importance of NTM as well as the underestimation of NTM frequency in Iran. NTM is an important clinical problem associated with significant morbidity and mortality in Iran. Continued research is needed from both clinical and environmental sources to help clinicians and researchers better understand and address NTM treatment and prevention.

Nontuberculous Mycobacteria Isolation from Clinical and Environmental Samples in Iran: Twenty Years of Surveillance

PubMed Central

Velayati, Ali Akbar; Farnia, Parissa; Mozafari, Mohadese

2015-01-01

Nontuberculous mycobacteria (NTM) are opportunistic pathogens that are widely distributed in the environment. There is a lack of data on species distribution of these organisms from Iran. This study consists of a review of NTM articles published in Iran between the years 1992 and 2014. In this review, 20 articles and 14 case reports were identified. Among the 20 articles, 13 (65%) studies focused on NTM isolates from clinical specimens, 6 (30%) studies examined NTM isolates from environmental samples, and one (5%) article included both clinical and environmental isolates. M. fortuitum (229/997; 23%) was recorded as the most prevalent and rapid growing mycobacteria (RGM) species in both clinical (28%) and environmental (19%) isolated samples (P < 0.05). Among slow growing mycobacteria (SGM), M. simiae (103/494; 21%) demonstrated a higher frequency in clinical samples whereas in environmental samples it was M. flavescens (44/503; 9%). These data represent information from 14 provinces out of 31 provinces of Iran. No information is available in current published data on clinical or environmental NTM from the remaining 17 provinces in Iran. These results emphasize the potential importance of NTM as well as the underestimation of NTM frequency in Iran. NTM is an important clinical problem associated with significant morbidity and mortality in Iran. Continued research is needed from both clinical and environmental sources to help clinicians and researchers better understand and address NTM treatment and prevention. PMID:26180788

A replicated molecular genetic basis for subtyping antisocial behavior in children with attention-deficit/hyperactivity disorder.

PubMed

Caspi, Avshalom; Langley, Kate; Milne, Barry; Moffitt, Terrie E; O'Donovan, Michael; Owen, Michael J; Polo Tomas, Monica; Poulton, Richie; Rutter, Michael; Taylor, Alan; Williams, Benjamin; Thapar, Anita

2008-02-01

Attention-deficit/hyperactivity disorder (ADHD) is a heterogeneous neurodevelopmental disorder that in some cases is accompanied by antisocial behavior. To test if variations in the catechol O-methyltransferase gene (COMT) would prove useful in identifying the subset of children with ADHD who exhibit antisocial behavior. Three independent samples composed of 1 clinical sample of ADHD cases and 2 birth cohort studies. Participants in the clinical sample were drawn from child psychiatry and child health clinics in England and Wales. The 2 birth cohort studies included 1 sample of 2232 British children born in 1994-1995 and a second sample of 1037 New Zealander children born in 1972-1973. Diagnosis of ADHD and measures of antisocial behavior. We present replicated evidence that the COMT valine/methionine polymorphism at codon 158 (COMT Val158Met) was associated with phenotypic variation among children with ADHD. Across the 3 samples, valine/valine homozygotes had more symptoms of conduct disorder, were more aggressive, and were more likely to be convicted of criminal offenses compared with methionine carriers. The findings confirm the presence of genetic heterogeneity in ADHD and illustrate how genetic information may provide biological evidence pointing to clinical subtypes.

Clinical Correlates of Comorbid Obsessive-Compulsive Disorder and Depression in Youth

ERIC Educational Resources Information Center

Canavera, Kristin E.; Ollendick, Thomas H.; Ehrenreich May, Jill T.; Pincus, Donna B.

2010-01-01

A burgeoning body of literature addresses the comorbidity of depression and OCD in adults. The purpose of this study was to extend this area of research to children and adolescents by examining the clinical correlates associated with co-occurring depressive disorders in a clinical sample of youth with OCD. Participants included children and…

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review

PubMed Central

van den Ende, Cornelia H. M.; Houterman, Anne E. J.; Heemskerk, Charlotte P. M.; van Dulmen, Sandra; van den Bemt, Bart J. F.

2017-01-01

Objective This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. Methods A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Results Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Conclusion Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF. PMID:28991903

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review.

PubMed

van Heuckelum, Milou; van den Ende, Cornelia H M; Houterman, Anne E J; Heemskerk, Charlotte P M; van Dulmen, Sandra; van den Bemt, Bart J F

2017-01-01

This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF.

Establishing a Southern Swedish Malignant Melanoma OMICS and biobank clinical capability

PubMed Central

2013-01-01

Background The objectives and goals of the Southern Swedish Malignant Melanoma (SSMM) are to develop, build and utilize cutting edge biobanks and OMICS platforms to better understand disease pathology and drug mechanisms. The SSMM research team is a truly cross-functional group with members from oncology, surgery, bioinformatics, proteomics, and genomics initiatives. Within the research team there are members who daily diagnose patients with suspect melanomas, do follow-ups on malignant melanoma patients and remove primary or metastatic lesions by surgery. This inter-disciplinary clinical patient care ensures a competence build as well as a best practice procedure where the patient benefits. Methods Clinical materials from patients before, during and after treatments with clinical end points are being collected. Tissue samples as well as bio-fluid samples such as blood fractions, plasma, serum and whole blood will be archived in 384-high density sample tube formats. Standardized approaches for patient selections, patient sampling, sample-processing and analysis platforms with dedicated protein assays and genomics platforms that will hold value for the research community are used. The patient biobank archives are fully automated with novel ultralow temperature biobank storage units and used as clinical resources. Results An IT-infrastructure using a laboratory information management system (LIMS) has been established, that is the key interface for the research teams in order to share and explore data generated within the project. The cross-site data repository in Lund forms the basis for sample processing, together with biological samples in southern Sweden, including blood fractions and tumor tissues. Clinical registries are associated with the biobank materials, including pathology reports on disease diagnosis on the malignant melanoma (MM) patients. Conclusions We provide data on the developments of protein profiling and targeted protein assays on isolated melanoma tumors, as well as reference blood standards that is used by the team members in the respective laboratories. These pilot data show biobank access and feasibility of performing quantitative proteomics in MM biobank repositories collected in southern Sweden. The scientific outcomes further strengthen the build of healthcare benefit in the complex challenges of malignant melanoma pathophysiology that is addressed by the novel personalized medicines entering the market. PMID:23445834

Establishing a Southern Swedish Malignant Melanoma OMICS and biobank clinical capability.

PubMed

Welinder, Charlotte; Jönsson, Göran; Ingvar, Christian; Lundgren, Lotta; Olsson, Håkan; Breslin, Thomas; Végvári, Akos; Laurell, Thomas; Rezeli, Melinda; Jansson, Bo; Baldetorp, Bo; Marko-Varga, György

2013-02-27

The objectives and goals of the Southern Swedish Malignant Melanoma (SSMM) are to develop, build and utilize cutting edge biobanks and OMICS platforms to better understand disease pathology and drug mechanisms. The SSMM research team is a truly cross-functional group with members from oncology, surgery, bioinformatics, proteomics, and genomics initiatives. Within the research team there are members who daily diagnose patients with suspect melanomas, do follow-ups on malignant melanoma patients and remove primary or metastatic lesions by surgery. This inter-disciplinary clinical patient care ensures a competence build as well as a best practice procedure where the patient benefits. Clinical materials from patients before, during and after treatments with clinical end points are being collected. Tissue samples as well as bio-fluid samples such as blood fractions, plasma, serum and whole blood will be archived in 384-high density sample tube formats. Standardized approaches for patient selections, patient sampling, sample-processing and analysis platforms with dedicated protein assays and genomics platforms that will hold value for the research community are used. The patient biobank archives are fully automated with novel ultralow temperature biobank storage units and used as clinical resources. An IT-infrastructure using a laboratory information management system (LIMS) has been established, that is the key interface for the research teams in order to share and explore data generated within the project. The cross-site data repository in Lund forms the basis for sample processing, together with biological samples in southern Sweden, including blood fractions and tumor tissues. Clinical registries are associated with the biobank materials, including pathology reports on disease diagnosis on the malignant melanoma (MM) patients. We provide data on the developments of protein profiling and targeted protein assays on isolated melanoma tumors, as well as reference blood standards that is used by the team members in the respective laboratories. These pilot data show biobank access and feasibility of performing quantitative proteomics in MM biobank repositories collected in southern Sweden. The scientific outcomes further strengthen the build of healthcare benefit in the complex challenges of malignant melanoma pathophysiology that is addressed by the novel personalized medicines entering the market.

The clinical content of NHS trust board meetings: an initial exploration.

PubMed

Watkins, Mary; Jones, Ray; Lindsey, Laura; Sheaff, Rod

2008-09-01

To differentiate between English NHS trust board meetings according to the percentage of clinical content and to explore which characteristics of board meetings might explain this. Definition of scoring system for clinical content. Scoring of minutes for a random sample of 60 trusts. Qualitative analysis of a sub-sample, generated hypotheses about factors leading to higher percentage of clinical items was undertaken; testing of hypotheses in a longitudinal sample of minutes from 24 trusts over 1 year. Clinical content varied from 2% to 30%. Boards with a more clinical focus tended to link other issues including finance to clinical issues; have non-executive directors able to question board executives openly; make less use of acronyms in minutes; had more liaison with social services; and accepted questions from the public. Counting items in board minutes has prima facie validity as a means of defining how clinically focussed board meetings are, although more research is required to refine the method. The present method of analysing board minutes may provide one way of assessing board culture. Directors of nursing can help focus trust board meetings on clinical matters. Further research is required to determine whether greater clinical content in trust board meetings has impacts on clinical practice or organizational performance.

Leprosy Associated with Atypical Cutaneous Leishmaniasis in Nicaragua and Honduras.

PubMed

Soto, Lucrecia Acosta; Caballero, Nelson; Fuentes, Lesny Ruth; Muñoz, Pedro Torres; Gómez Echevarría, Jose Ramón; López, Montserrat Pérez; Bornay Llinares, Fernando Jorge; Stanford, John L; Stanford, Cynthia A; Donoghue, Helen D

2017-10-01

In Central America, few cases of leprosy have been reported, but the disease may be unrecognized. Diagnosis is based on clinical criteria and histology. Preliminary field work in Nicaragua and Honduras found patients, including many children, with skin lesions clinically suggestive of atypical cutaneous leishmaniasis or indeterminate leprosy. Histology could not distinguish these diseases although acid-fast organisms were visible in a few biopsies. Lesions healed after standard antimicrobial therapy for leprosy. In the present study, patients, family members, and other community members were skin-tested and provided nasal swabs and blood samples. Biopsies were taken from a subgroup of patients with clinical signs of infection. Two laboratories analyzed samples, using local in-house techniques. Mycobacterium leprae , Leishmania spp. and Leishmania infantum were detected using polymerase chain reactions. Mycobacterium leprae DNA was detected in blood samples and nasal swabs, including some cases where leprosy was not clinically suspected. Leishmania spp. were also detected in blood and nasal swabs. Most biopsies contained Leishmania DNA and coinfection of Leishmania spp. with M. leprae occurred in 33% of cases. Mycobacterium leprae DNA was also detected and sequenced from Nicaraguan and Honduran environmental samples. In conclusion, leprosy and leishmaniasis are present in both regions, and leprosy appears to be widespread. The nature of any relationship between these two pathogens and the epidemiology of these infections need to be elucidated.

Negative Affectivity Predicts Lower Quality of Life and Metabolic Control in Type 2 Diabetes Patients: A Structural Equation Modeling Approach

PubMed Central

Conti, Chiara; Di Francesco, Giulia; Fontanella, Lara; Carrozzino, Danilo; Patierno, Chiara; Vitacolonna, Ester; Fulcheri, Mario

2017-01-01

Introduction: It is essential to consider the clinical assessment of psychological aspects in patients with Diabetes Mellitus (DM), in order to prevent potentially adverse self-management care behaviors leading to diabetes-related complications, including declining levels of Quality of Life (QoL) and negative metabolic control. Purpose: In the framework of Structural Equation Modeling (SEM), the specific aim of this study is to evaluate the influence of distressed personality factors as Negative Affectivity (NA) and Social Inhibition (SI) on diabetes-related clinical variables (i.e., QoL and glycemic control). Methods: The total sample consists of a clinical sample, including 159 outpatients with Type 2 Diabetes Mellitus (T2DM), and a control group composed of 102 healthy respondents. All participants completed the following self- rating scales: The Type D Scale (DS14) and the World Health Organization QoL Scale (WHOQOLBREF). Furthermore, the participants of the clinical group were assessed for HbA1c, disease duration, and BMI. The observed covariates were BMI, gender, and disease duration, while HbA1c was considered an observed variable. Results: SEM analysis revealed significant differences between groups in regards to the latent construct of NA and the Environmental dimension of QoL. For the clinical sample, SEM showed that NA had a negative impact on both QoL dimensions and metabolic control. Conclusions: Clinical interventions aiming to improve medication adherence in patients with T2DM should include the psychological evaluation of Type D Personality traits, by focusing especially on its component of NA as a significant risk factor leading to negative health outcomes. PMID:28596745

HIV-1 and HCV viral load cost models for bDNA: 440 Molecular System versus real-time PCR AmpliPrep/TaqMan test.

PubMed

Elbeik, Tarek; Dalessandro, Ralph; Loftus, Richard A; Beringer, Scott

2007-11-01

Comparative cost models were developed to assess cost-per-reportable result and annual costs for HIV-1 and HCV bDNA and AmpliPrep/TaqMan Test (PCR). Model cost components included kit, disposables, platform and related equipment, equipment service plan, equipment maintenance, equipment footprint, waste and labor. Model assessment was most cost-effective when run by bDNA with 36 or more clinical samples and PCR with 30 or fewer clinical samples. Lower costs are attained with maximum samples (84-168) run daily. Highest cost contributors include kit, platform and PCR proprietary disposables. Understanding component costs and the most economic use of HIV-1 and HCV viral load will aid in attaining lowest costs through selection of the appropriate assay and effective negotiations.

Community-Based Validation of the Social Phobia Screener (SOPHS).

PubMed

Batterham, Philip J; Mackinnon, Andrew J; Christensen, Helen

2017-10-01

There is a need for brief, accurate screening scales for social anxiety disorder to enable better identification of the disorder in research and clinical settings. A five-item social anxiety screener, the Social Phobia Screener (SOPHS), was developed to address this need. The screener was validated in two samples: (a) 12,292 Australian young adults screened for a clinical trial, including 1,687 participants who completed a phone-based clinical interview and (b) 4,214 population-based Australian adults recruited online. The SOPHS (78% sensitivity, 72% specificity) was found to have comparable screening performance to the Social Phobia Inventory (77% sensitivity, 71% specificity) and Mini-Social Phobia Inventory (74% sensitivity, 73% specificity) relative to clinical criteria in the trial sample. In the population-based sample, the SOPHS was also accurate (95% sensitivity, 73% specificity) in identifying Diagnostic and Statistical Manual of Mental Disorders-Fifth edition social anxiety disorder. The SOPHS is a valid and reliable screener for social anxiety that is freely available for use in research and clinical settings.

A dimensional approach to measuring anxiety for DSM-5.

PubMed

Lebeau, Richard T; Glenn, Daniel E; Hanover, Lauren N; Beesdo-Baum, Katja; Wittchen, Hans-Ulrich; Craske, Michelle G

2012-12-01

In preparation for DSM-5's planned inclusion of dimensional assessments of psychopathology as a complement to traditional categorical diagnoses, we developed brief self-rated scales for anxiety disorders that are consistent in content and structure. In the present paper, we discuss the creation of the scales and examine their psychometric properties and clinical sensitivity. Phase One assessed psychometric properties of the initial versions of the scales in a large non-clinical sample (n = 702). Phase Two assessed the psychometric properties of revised versions of the scales, including test-retest reliability, in a non-clinical sample (n = 57). Phase Three examined the scales' psychometric properties and relationship with clinician ratings of disorder severity in a clinical sample (n = 48). The scales demonstrated internal consistency (α = 0.85-0.92), convergent validity (r(s)  = 0.39-0.69), and test-retest reliability in the non-clinical samples (ICC = 0.51-0.81). In the clinical sample, the scales demonstrated significantly higher total scores than in the non-clinical sample (Cohen's d = 0.72-1.50) and moderate to high correlations with clinician ratings of disorder severity (r = 0.43-0.82) Although further evaluation and refinement of the scales (particularly the specific phobia and agoraphobia scales) is needed, the results provide preliminary support for the use of these scales in DSM-5 and thus take an important step toward the integration of standardized dimensional measurement into the diagnosis of anxiety disorders. Copyright © 2012 American Psychiatric Association. All rights reserved.

Textual data in psychiatry: reasoning by analogy to quantitative principles.

PubMed

Yang, Suzanne; Mulvey, Edward P; Falissard, Bruno

2012-08-01

Personal meaning in subjective experience is a key element in the treatment of persons with mental disorders. Open-response speech samples would appear to be suitable for studying this type of subjective experience, but there are still important challenges in using language as data. Scientific principles involved in sample size calculation, validity, and reliability may be applicable, by analogy, to data collected in the form of words. We describe a rationale for including computer-assisted techniques as one step of a qualitative analysis procedure that includes manual reading. Clarification of a framework for including language as data in psychiatric research may allow us to more effectively bridge biological and psychometric research with clinical practice, a setting where the patient's clinical "data" are, in large part, conveyed in words.

High-throughput, automated extraction of DNA and RNA from clinical samples using TruTip technology on common liquid handling robots.

PubMed

Holmberg, Rebecca C; Gindlesperger, Alissa; Stokes, Tinsley; Brady, Dane; Thakore, Nitu; Belgrader, Philip; Cooney, Christopher G; Chandler, Darrell P

2013-06-11

TruTip is a simple nucleic acid extraction technology whereby a porous, monolithic binding matrix is inserted into a pipette tip. The geometry of the monolith can be adapted for specific pipette tips ranging in volume from 1.0 to 5.0 ml. The large porosity of the monolith enables viscous or complex samples to readily pass through it with minimal fluidic backpressure. Bi-directional flow maximizes residence time between the monolith and sample, and enables large sample volumes to be processed within a single TruTip. The fundamental steps, irrespective of sample volume or TruTip geometry, include cell lysis, nucleic acid binding to the inner pores of the TruTip monolith, washing away unbound sample components and lysis buffers, and eluting purified and concentrated nucleic acids into an appropriate buffer. The attributes and adaptability of TruTip are demonstrated in three automated clinical sample processing protocols using an Eppendorf epMotion 5070, Hamilton STAR and STARplus liquid handling robots, including RNA isolation from nasopharyngeal aspirate, genomic DNA isolation from whole blood, and fetal DNA extraction and enrichment from large volumes of maternal plasma (respectively).

A predictive approach to selecting the size of a clinical trial, based on subjective clinical opinion.

PubMed

Spiegelhalter, D J; Freedman, L S

1986-01-01

The 'textbook' approach to determining sample size in a clinical trial has some fundamental weaknesses which we discuss. We describe a new predictive method which takes account of prior clinical opinion about the treatment difference. The method adopts the point of clinical equivalence (determined by interviewing the clinical participants) as the null hypothesis. Decision rules at the end of the study are based on whether the interval estimate of the treatment difference (classical or Bayesian) includes the null hypothesis. The prior distribution is used to predict the probabilities of making the decisions to use one or other treatment or to reserve final judgement. It is recommended that sample size be chosen to control the predicted probability of the last of these decisions. An example is given from a multi-centre trial of superficial bladder cancer.

Comparing clinical and social-personality conceptualizations of narcissism.

PubMed

Miller, Joshua D; Campbell, W Keith

2008-06-01

There is a lack of consensus surrounding the conceptualization of narcissism. The present study compared two measures of narcissism-one used in clinical settings (Personality Diagnostic Questionnaire, PDQ-4+; Hyler, 1994) and one used in social-personality research (Narcissistic Personality Inventory, NPI; Raskin & Terry, 1988)-across two samples. Sample 1 (N=271) was composed of undergraduates, whereas Sample 2 (N=211) was composed of parents of the Sample 1 participants. The scales were significantly interrelated but manifested divergent relations with general personality traits, personality disorders (including expert prototypal ratings of narcissism), recollections of parenting received, and psychological distress and self-esteem. PDQ-4 narcissism captured an emotionally unstable, negative-affect-laden, and introverted variant of narcissism; NPI narcissism captured an emotionally resilient, extraverted form. The clinical and social-personality conceptualizations of narcissism primarily share a tendency to use an antagonistic interpersonal style. Implications for the DSM-V are discussed.

Clinical implementation of integrated whole-genome copy number and mutation profiling for glioblastoma

PubMed Central

Ramkissoon, Shakti H.; Bi, Wenya Linda; Schumacher, Steven E.; Ramkissoon, Lori A.; Haidar, Sam; Knoff, David; Dubuc, Adrian; Brown, Loreal; Burns, Margot; Cryan, Jane B.; Abedalthagafi, Malak; Kang, Yun Jee; Schultz, Nikolaus; Reardon, David A.; Lee, Eudocia Q.; Rinne, Mikael L.; Norden, Andrew D.; Nayak, Lakshmi; Ruland, Sandra; Doherty, Lisa M.; LaFrankie, Debra C.; Horvath, Margaret; Aizer, Ayal A.; Russo, Andrea; Arvold, Nils D.; Claus, Elizabeth B.; Al-Mefty, Ossama; Johnson, Mark D.; Golby, Alexandra J.; Dunn, Ian F.; Chiocca, E. Antonio; Trippa, Lorenzo; Santagata, Sandro; Folkerth, Rebecca D.; Kantoff, Philip; Rollins, Barrett J.; Lindeman, Neal I.; Wen, Patrick Y.; Ligon, Azra H.; Beroukhim, Rameen; Alexander, Brian M.; Ligon, Keith L.

2015-01-01

Background Multidimensional genotyping of formalin-fixed paraffin-embedded (FFPE) samples has the potential to improve diagnostics and clinical trials for brain tumors, but prospective use in the clinical setting is not yet routine. We report our experience with implementing a multiplexed copy number and mutation-testing program in a diagnostic laboratory certified by the Clinical Laboratory Improvement Amendments. Methods We collected and analyzed clinical testing results from whole-genome array comparative genomic hybridization (OncoCopy) of 420 brain tumors, including 148 glioblastomas. Mass spectrometry–based mutation genotyping (OncoMap, 471 mutations) was performed on 86 glioblastomas. Results OncoCopy was successful in 99% of samples for which sufficient DNA was obtained (n = 415). All clinically relevant loci for glioblastomas were detected, including amplifications (EGFR, PDGFRA, MET) and deletions (EGFRvIII, PTEN, 1p/19q). Glioblastoma patients ≤40 years old had distinct profiles compared with patients >40 years. OncoMap testing reliably identified mutations in IDH1, TP53, and PTEN. Seventy-seven glioblastoma patients enrolled on trials, of whom 51% participated in targeted therapeutic trials where multiplex data informed eligibility or outcomes. Data integration identified patients with complete tumor suppressor inactivation, albeit rarely (5% of patients) due to lack of whole-gene coverage in OncoMap. Conclusions Combined use of multiplexed copy number and mutation detection from FFPE samples in the clinical setting can efficiently replace singleton tests for clinical diagnosis and prognosis in most settings. Our results support incorporation of these assays into clinical trials as integral biomarkers and their potential to impact interpretation of results. Limited tumor suppressor variant capture by targeted genotyping highlights the need for whole-gene sequencing in glioblastoma. PMID:25754088

Clinical mastitis in dairy cattle in Ontario: frequency of occurrence and bacteriological isolates.

PubMed Central

Sargeant, J M; Scott, H M; Leslie, K E; Ireland, M J; Bashiri, A

1998-01-01

The objective of this study was to describe the frequency of occurrence of clinical mastitis in dairy herds in Ontario. The study group consisted of 65 dairy farms involved in a 2-year observational study, which included recording all clinical mastitis cases and milk sampling of quarters with clinical mastitis. Lactational incidence risks of 9.8% for abnormal milk only, 8.2% for abnormal milk with a hard or swollen udder, and 4.4% for abnormal milk plus systemic signs of illness related to mastitis were calculated for 2840 cows and heifers. Overall, 19.8% of cows experienced one or more cases of clinical mastitis during location. Teat injuries occurred in 2.1% of lactations. Standard bacteriology was performed on pretreatment milk samples from 834 cows with clinical mastitis. The bacteria isolated were Staphylococcus aureus (6.7%), Streptococcus agalactiae (0.7%), other Streptococcus spp. (14.1%), coliforms (17.2%), gram-positive bacilli (5.5%), Corynebacterium bovis (1.7%), and other Staphylococcus spp. (28.7%). There was no growth in 17.7% of samples, and 8.3% of samples were contaminated. Clinical mastitis is a common disease in dairy cows in Ontario; approximately 1 in 5 cow lactations have at lease one episode of clinical mastitis. There is, however, considerable variation in the incidence of clinical mastitis among farms. The majority of 1st cases of clinical mastitis occur early in lactation, and the risk of clinical mastitis increases with increasing parity. Environmental, contagious, and minor pathogens were all associated with cases of clinical mastitis. Images Figure 1. Figure 3. PMID:9442950

Assessing the Use of the Child Attachment Interview in a Sample of Israeli Jewish Children.

PubMed

Baumel, Amit; Wolmer, Leo; Laor, Nathaniel; Toren, Paz

2016-01-01

This manuscript assesses the use of the Child Attachment Interview (CAI) in a sample of Israeli Jewish children in middle childhood in order to add to empirical data on this measure. Forty-one children between the ages of 7 and 13 were consecutively recruited to the study. The clinical sample included 29 children diagnosed with anxiety disorder, major depression or ADHD. The Father Focused Referral (FFR) sample included 12 children whose father was unavailable to them. Participants were administered the CAI and coded by certified personnel. 81.4% concordance was found between maternal and paternal secure-insecure attachment classifications in the clinical sample; 100% of the children in the FFR group were classified as insecurely attached to their fathers suggesting convergent validity for the classification of father attachment; 45.4% of the children in the FFR sample were also classified as insecurely attached to their mothers, pointing to the difference that can be found between the two parental attachment classifications in relevant cases, and therefore to sufficient discriminant validity between the two classifications. The clinical sample concordance rate, which was lower than in previous studies, indicates that parental concordance rates should be further investigated using different samples and countries. The study's findings regarding the difference that can be found between parental attachment classifications show the instrument's relevance in cases which the parental representations may differ. In these cases, using an instrument that does not examine the attachment toward both parents might not suffice. Study limitations and further implications are discussed.

The Role of Hope in Bereavement for Chinese People in Hong Kong

ERIC Educational Resources Information Center

Chow, Amy Y. M.

2010-01-01

This study examined the relationships between hope and the emotional reactions of bereaved Chinese people in Hong Kong. Three groups--a clinical bereaved sample (n = 140), a general bereaved sample (n = 152), and a non-bereaved comparison sample (n = 144)--were included. Significant differences in 3 hope measures, hope (pathway), hope (agency) and…

Junk food seen at pediatric clinic visits: is it a problem?

PubMed

Frazier, Johnnie P; Land, Megan; Hsieh, Pei-Hsuan; Barratt, Michelle S

2014-04-01

To document the prevalence of junk foods seen at clinic visits. A cross-sectional 23-item survey of observed food items were completed by medical staff using a convenience sample of families from June 2, 2011 to March 2, 2012. The study was conducted in pediatric clinics affiliated with the University of Texas Medical School at Houston. A convenience sample consisting of 738 families with children from 4 months to 16 years old presenting for visits were included in the study. Children exclusively breast and formula fed was excluded. Junk food was observed 20.9% at the clinic visits. Junk food was often seen at clinic visits. There was a trend toward higher body mass index in patients whose families had junk food at the visit.

The vector homology problem in diagnostic nucleic acid hybridization of clinical specimens.

PubMed Central

Ambinder, R F; Charache, P; Staal, S; Wright, P; Forman, M; Hayward, S D; Hayward, G S

1986-01-01

Nucleic acid hybridization techniques using cloned probes are finding application in assays of clinical specimens in research and diagnostic laboratories. The probes that we and others have used are recombinant plasmids composed of viral inserts and bacterial plasmid vectors such as pBR322. We suspected that there was material homologous to pBR322 present in many clinical samples. because hybridization occurred in samples which lacked evidence of virus by other techniques. If the presence of this vector-homologous material was unrecognized, hybridization in the test sample might erroneously be interpreted as indicating the presence of viral sequences. In this paper we demonstrate specific hybridization of labeled pBR322 DNA with DNA from various clinical samples. Evidence is presented that nonspecific probe trapping could not account for this phenomenon. In mixing experiments, it is shown that contamination of clinical samples with bacteria would explain such a result. Approaches tested to circumvent this problem included the use of isolated insert probes, alternate cloning vectors, and cold competitor pBR322 DNA in prehybridization and hybridization mixes. None proved entirely satisfactory. We therefore emphasize that it is essential that all hybridization detection systems use a control probe of the vector alone in order to demonstrate the absence of material with vector homology in the specimen tested. Images PMID:3013928

Impact of Different Visual Field Testing Paradigms on Sample Size Requirements for Glaucoma Clinical Trials.

PubMed

Wu, Zhichao; Medeiros, Felipe A

2018-03-20

Visual field testing is an important endpoint in glaucoma clinical trials, and the testing paradigm used can have a significant impact on the sample size requirements. To investigate this, this study included 353 eyes of 247 glaucoma patients seen over a 3-year period to extract real-world visual field rates of change and variability estimates to provide sample size estimates from computer simulations. The clinical trial scenario assumed that a new treatment was added to one of two groups that were both under routine clinical care, with various treatment effects examined. Three different visual field testing paradigms were evaluated: a) evenly spaced testing, b) United Kingdom Glaucoma Treatment Study (UKGTS) follow-up scheme, which adds clustered tests at the beginning and end of follow-up in addition to evenly spaced testing, and c) clustered testing paradigm, with clusters of tests at the beginning and end of the trial period and two intermediary visits. The sample size requirements were reduced by 17-19% and 39-40% using the UKGTS and clustered testing paradigms, respectively, when compared to the evenly spaced approach. These findings highlight how the clustered testing paradigm can substantially reduce sample size requirements and improve the feasibility of future glaucoma clinical trials.

Evaluation of Targeted Next-Generation Sequencing for Detection of Bovine Pathogens in Clinical Samples.

PubMed

Anis, Eman; Hawkins, Ian K; Ilha, Marcia R S; Woldemeskel, Moges W; Saliki, Jeremiah T; Wilkes, Rebecca P

2018-07-01

The laboratory diagnosis of infectious diseases, especially those caused by mixed infections, is challenging. Routinely, it requires submission of multiple samples to separate laboratories. Advances in next-generation sequencing (NGS) have provided the opportunity for development of a comprehensive method to identify infectious agents. This study describes the use of target-specific primers for PCR-mediated amplification with the NGS technology in which pathogen genomic regions of interest are enriched and selectively sequenced from clinical samples. In the study, 198 primers were designed to target 43 common bovine and small-ruminant bacterial, fungal, viral, and parasitic pathogens, and a bioinformatics tool was specifically constructed for the detection of targeted pathogens. The primers were confirmed to detect the intended pathogens by testing reference strains and isolates. The method was then validated using 60 clinical samples (including tissues, feces, and milk) that were also tested with other routine diagnostic techniques. The detection limits of the targeted NGS method were evaluated using 10 representative pathogens that were also tested by quantitative PCR (qPCR), and the NGS method was able to detect the organisms from samples with qPCR threshold cycle ( C T ) values in the 30s. The method was successful for the detection of multiple pathogens in the clinical samples, including some additional pathogens missed by the routine techniques because the specific tests needed for the particular organisms were not performed. The results demonstrate the feasibility of the approach and indicate that it is possible to incorporate NGS as a diagnostic tool in a cost-effective manner into a veterinary diagnostic laboratory. Copyright © 2018 Anis et al.

Realizing the promise of reverse phase protein arrays for clinical, translational, and basic research: a workshop report: the RPPA (Reverse Phase Protein Array) society.

PubMed

Akbani, Rehan; Becker, Karl-Friedrich; Carragher, Neil; Goldstein, Ted; de Koning, Leanne; Korf, Ulrike; Liotta, Lance; Mills, Gordon B; Nishizuka, Satoshi S; Pawlak, Michael; Petricoin, Emanuel F; Pollard, Harvey B; Serrels, Bryan; Zhu, Jingchun

2014-07-01

Reverse phase protein array (RPPA) technology introduced a miniaturized "antigen-down" or "dot-blot" immunoassay suitable for quantifying the relative, semi-quantitative or quantitative (if a well-accepted reference standard exists) abundance of total protein levels and post-translational modifications across a variety of biological samples including cultured cells, tissues, and body fluids. The recent evolution of RPPA combined with more sophisticated sample handling, optical detection, quality control, and better quality affinity reagents provides exquisite sensitivity and high sample throughput at a reasonable cost per sample. This facilitates large-scale multiplex analysis of multiple post-translational markers across samples from in vitro, preclinical, or clinical samples. The technical power of RPPA is stimulating the application and widespread adoption of RPPA methods within academic, clinical, and industrial research laboratories. Advances in RPPA technology now offer scientists the opportunity to quantify protein analytes with high precision, sensitivity, throughput, and robustness. As a result, adopters of RPPA technology have recognized critical success factors for useful and maximum exploitation of RPPA technologies, including the following: preservation and optimization of pre-analytical sample quality, application of validated high-affinity and specific antibody (or other protein affinity) detection reagents, dedicated informatics solutions to ensure accurate and robust quantification of protein analytes, and quality-assured procedures and data analysis workflows compatible with application within regulated clinical environments. In 2011, 2012, and 2013, the first three Global RPPA workshops were held in the United States, Europe, and Japan, respectively. These workshops provided an opportunity for RPPA laboratories, vendors, and users to share and discuss results, the latest technology platforms, best practices, and future challenges and opportunities. The outcomes of the workshops included a number of key opportunities to advance the RPPA field and provide added benefit to existing and future participants in the RPPA research community. The purpose of this report is to share and disseminate, as a community, current knowledge and future directions of the RPPA technology. © 2014 by The American Society for Biochemistry and Molecular Biology, Inc.

Population-Based Pediatric Reference Intervals in General Clinical Chemistry: A Swedish Survey.

PubMed

Ridefelt, Peter

2015-01-01

Very few high quality studies on pediatric reference intervals for general clinical chemistry and hematology analytes have been performed. Three recent prospective community-based projects utilising blood samples from healthy children in Sweden, Denmark and Canada have substantially improved the situation. The Swedish survey included 701 healthy children. Reference intervals for general clinical chemistry and hematology were defined.

Costs of School-Located Influenza Vaccination Clinics in Maine during the 2009-2010 H1N1 Pandemic

ERIC Educational Resources Information Center

Cho, Bo-Hyun; Asay, Garrett R. Beeler; Lorick, Suchita A.; Tipton, Meredith L.; Dube, Nancy L.; Messonnier, Mark L.

2012-01-01

This study retrospectively estimated costs for a convenience sample of school-located vaccination (SLV) clinics conducted in Maine during the 2009-2010 influenza season. Surveys were developed to capture the cost of labor including unpaid volunteers as well as supplies and materials used in SLV clinics. Six nurses from different school districts…

Features of ciguatera fish poisoning cases in Hong Kong 2004-2007.

PubMed

Wong, Chun-Kwan; Hung, Patricia; Lee, Kellie L H; Mok, Tina; Chung, Thomas; Kam, Kai-Man

2008-12-01

To review the clinical features and laboratory investigations of ciguatera patients in Hong Kong between 2004 and 2007 in order to show the timely sampling of implicated fish from ciguatera victims and application of validated mouse bioassay for confirming suspected clinical cases of ciguatera. Diagnosis of the ciguatera victims was based on history of coral fish consumption and clinical presentations stated in official guidelines for clinical diagnosis of ciguatera fish poisoning in Hong Kong. Food remnants of coral fish samples were collected swiftly from ciguatera victims between 2004 and 2007 for ciguatoxins (CTXs) analysis. Major clinical symptoms in ciguatera patients included gastrointestinal and neurological effects including limb numbness and diarrhoea, which developed at 0.5 to 15 hours after consumption of fish. In most cases, neurological symptoms were more common than gastrointestinal symptoms. A broad range of attack rate (10%-100%) was observed in each ciguatera outbreak. Validated mouse bioassay on ether extracts of the food remnant samples confirmed that all were CTXs-positive (<0.5 - 4.3 MU/20 mg ether extract) and directly linked to the corresponding ciguatera cases. Consistency between clinical and laboratory analysis for ciguatera poisoning illustrates the application of laboratory mouse bioassay in a timely fashion for confirming ciguatera poisoning cases and implementing effective public health measures. With further improvement in laboratory techniques, features of ciguatera fish poisoning cases can be better defined. Further studies are needed to determine the risk of each class of CTXs (Pacific-, Indian- and Caribbean-CTXs) in Hong Kong.

Development of automated high throughput single molecular microfluidic detection platform for signal transduction analysis

NASA Astrophysics Data System (ADS)

Huang, Po-Jung; Baghbani Kordmahale, Sina; Chou, Chao-Kai; Yamaguchi, Hirohito; Hung, Mien-Chie; Kameoka, Jun

2016-03-01

Signal transductions including multiple protein post-translational modifications (PTM), protein-protein interactions (PPI), and protein-nucleic acid interaction (PNI) play critical roles for cell proliferation and differentiation that are directly related to the cancer biology. Traditional methods, like mass spectrometry, immunoprecipitation, fluorescence resonance energy transfer, and fluorescence correlation spectroscopy require a large amount of sample and long processing time. "microchannel for multiple-parameter analysis of proteins in single-complex (mMAPS)"we proposed can reduce the process time and sample volume because this system is composed by microfluidic channels, fluorescence microscopy, and computerized data analysis. In this paper, we will present an automated mMAPS including integrated microfluidic device, automated stage and electrical relay for high-throughput clinical screening. Based on this result, we estimated that this automated detection system will be able to screen approximately 150 patient samples in a 24-hour period, providing a practical application to analyze tissue samples in a clinical setting.

Psychopathology and Thought Suppression: A Quantitative Review

PubMed Central

Magee, Joshua C.; Harden, K. Paige; Teachman, Bethany A.

2012-01-01

Recent theories of psychopathology have suggested that thought suppression intensifies the persistence of intrusive thoughts, and proposed that difficulty with thought suppression may differ between groups with and without psychopathology. The current meta-analytic review evaluates empirical evidence for difficulty with thought suppression as a function of the presence and specific type of psychopathology. Based on theoretical proposals from the psychopathology literature, diagnosed and analogue samples were expected to show greater recurrence of intrusive thoughts during thought suppression attempts than non-clinical samples. However, results showed no overall differences in the recurrence of thoughts due to thought suppression between groups with and without psychopathology. There was, nevertheless, variation in the recurrence of thoughts across different forms of psychopathology, including relatively less recurrence during thought suppression for samples with symptoms of Obsessive-Compulsive Disorder, compared to non-clinical samples. However, these differences were typically small and provided only mixed support for existing theories. Implications for cognitive theories of intrusive thoughts are discussed, including proposed mechanisms underlying thought suppression. PMID:22388007

A multiplexed reverse transcriptase PCR assay for identification of viral respiratory pathogens at point-of-care

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

Letant, S E; .Ortiz, J I; Tammero, L

2007-04-11

We have developed a nucleic acid-based assay that is rapid, sensitive, specific, and can be used for the simultaneous detection of 5 common human respiratory pathogens including influenza A, influenza B, parainfluenza type 1 and 3, respiratory syncytial virus, and adenovirus group B, C, and E. Typically, diagnosis on an un-extracted clinical sample can be provided in less than 3 hours, including sample collection, preparation, and processing, as well as data analysis. Such a multiplexed panel would enable rapid broad-spectrum pathogen testing on nasal swabs, and therefore allow implementation of infection control measures, and timely administration of antiviral therapies. Thismore » article presents a summary of the assay performance in terms of sensitivity and specificity. Limits of detection are provided for each targeted respiratory pathogen, and result comparisons are performed on clinical samples, our goal being to compare the sensitivity and specificity of the multiplexed assay to the combination of immunofluorescence and shell vial culture currently implemented at the UCDMC hospital. Overall, the use of the multiplexed RT-PCR assay reduced the rate of false negatives by 4% and reduced the rate of false positives by up to 10%. The assay correctly identified 99.3% of the clinical negatives, 97% of adenovirus, 95% of RSV, 92% of influenza B, and 77% of influenza A without any extraction performed on the clinical samples. The data also showed that extraction will be needed for parainfluenza virus, which was only identified correctly 24% of the time on un-extracted samples.« less

First report of isolation and characterization of Aurantimonas altamirensis from clinical samples.

PubMed

Luong, Me-Linh; Békal, Sadjia; Vinh, Donald C; Lauzon, Dominique; Leung, Vicki; Al-Rawahi, Ghada N; Ng, Betty; Burdz, Tamara; Bernard, Kathryn

2008-07-01

The genus Aurantimonas, proposed in 2003, encompasses four species from environmental sources, including Aurantimonas altamirensis, isolated from a cave wall in Spain. Here, we report what we believe are the first cases of the recovery of A. altamirensis from human clinical materials.

Accreditation of Predoctoral Dental Education: Clinical Outcomes Assessment.

ERIC Educational Resources Information Center

Boyd, Marcia A.; And Others

1991-01-01

The Curriculum Outcomes Review and Evaluation system of outcomes assessment for accreditation of Canadian dental faculties is described. Features include chart reviews; evaluation of diagnosis and treatment planning and case presentation for a student sample; structured clinical observation; presite visit survey; and solicitation of feedback from…

Impact of deploying multiple point-of-care tests with a 'sample first' approach on a sexual health clinical care pathway. A service evaluation.

PubMed

Harding-Esch, Emma M; Nori, Achyuta V; Hegazi, Aseel; Pond, Marcus J; Okolo, Olanike; Nardone, Anthony; Lowndes, Catherine M; Hay, Phillip; Sadiq, S Tariq

2017-09-01

To assess clinical service value of STI point-of-care test (POCT) use in a 'sample first' clinical pathway (patients providing samples on arrival at clinic, before clinician consultation). Specific outcomes were: patient acceptability; whether a rapid nucleic acid amplification test (NAAT) for Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) could be used as a POCT in practice; feasibility of non-NAAT POCT implementation for Trichomonas vaginalis (TV) and bacterial vaginosis (BV); impact on patient diagnosis and treatment. Service evaluation in a south London sexual health clinic. Symptomatic female and male patients and sexual contacts of CT/NG-positive individuals provided samples for diagnostic testing on clinic arrival, prior to clinical consultation. Tests included routine culture and microscopy; CT/NG (GeneXpert) NAAT; non-NAAT POCTs for TV and BV. All 70 (35 males, 35 females) patients approached participated. The 'sample first' pathway was acceptable, with >90% reporting they were happy to give samples on arrival and receive results in the same visit. Non-NAAT POCT results were available for all patients prior to leaving clinic; rapid CT/NG results were available for only 21.4% (15/70; 5 males, 10 females) of patients prior to leaving clinic. Known negative CT/NG results led to two females avoiding presumptive treatment, and one male receiving treatment directed at possible Mycoplasma genitalium infection causing non-gonococcal urethritis. Non-NAAT POCTs detected more positives than routine microscopy (TV 3 vs 2; BV 24 vs 7), resulting in more patients receiving treatment. A 'sample first' clinical pathway to enable multiple POCT use was acceptable to patients and feasible in a busy sexual health clinic, but rapid CT/NG processing time was too long to enable POCT use. There is need for further development to improve test processing times to enable POC use of rapid NAATs. 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/.

Clinical and immunological characteristics associated with the presence of protozoa in sputum smears.

PubMed

Martínez-Girón, Rafael; van Woerden, Hugo Cornelis

2013-01-01

The objective of this study is to assess the relationship between protozoa in spontaneously expectorated sputum samples and a range of clinical and immunological variables. Clinical details including age, gender, smoking status, and use of oral or inhaled steroids were recorded for a cohort of 199 patients whose spontaneously expectorated sputum samples were submitted to a Cytology Laboratory in Spain between January 2005 and December 2006. Slides were scanned for protozoa under light microscopy and scanned for monocytes/small macrophages highlighted by immunocytochemistry (CD68 monoclonal antibody). One hundred ninety-one patients provided adequate sputum samples, of whom 70 had protozoa in their sputum. There was a strong relationship between the presence of protozoa and monocytes/small macrophages identified under light microscopy (P < 0.001). A binary logistic regression model also indicated a relationship between protozoa and both smoking status and steroid use. The diagnoses in those with protozoa included infection (including tuberculosis), chronic obstructive pulmonary disease (COPD), lung fibrosis, asthma, chronic liver disease, immunosuppression, cancer, pancreatic or renal disease, heart failure, and AIDS. The identified association between protozoa and monocytes/small macrophages in sputum suggests an immune response and warrants further investigation to clarify whether or not these organisms have any pathological significance in this wide range of conditions. Copyright © 2011 Wiley Periodicals, Inc.

Predictive model for inflammation grades of chronic hepatitis B: Large-scale analysis of clinical parameters and gene expressions.

PubMed

Zhou, Weichen; Ma, Yanyun; Zhang, Jun; Hu, Jingyi; Zhang, Menghan; Wang, Yi; Li, Yi; Wu, Lijun; Pan, Yida; Zhang, Yitong; Zhang, Xiaonan; Zhang, Xinxin; Zhang, Zhanqing; Zhang, Jiming; Li, Hai; Lu, Lungen; Jin, Li; Wang, Jiucun; Yuan, Zhenghong; Liu, Jie

2017-11-01

Liver biopsy is the gold standard to assess pathological features (eg inflammation grades) for hepatitis B virus-infected patients although it is invasive and traumatic; meanwhile, several gene profiles of chronic hepatitis B (CHB) have been separately described in relatively small hepatitis B virus (HBV)-infected samples. We aimed to analyse correlations among inflammation grades, gene expressions and clinical parameters (serum alanine amino transaminase, aspartate amino transaminase and HBV-DNA) in large-scale CHB samples and to predict inflammation grades by using clinical parameters and/or gene expressions. We analysed gene expressions with three clinical parameters in 122 CHB samples by an improved regression model. Principal component analysis and machine-learning methods including Random Forest, K-nearest neighbour and support vector machine were used for analysis and further diagnosis models. Six normal samples were conducted to validate the predictive model. Significant genes related to clinical parameters were found enriching in the immune system, interferon-stimulated, regulation of cytokine production, anti-apoptosis, and etc. A panel of these genes with clinical parameters can effectively predict binary classifications of inflammation grade (area under the ROC curve [AUC]: 0.88, 95% confidence interval [CI]: 0.77-0.93), validated by normal samples. A panel with only clinical parameters was also valuable (AUC: 0.78, 95% CI: 0.65-0.86), indicating that liquid biopsy method for detecting the pathology of CHB is possible. This is the first study to systematically elucidate the relationships among gene expressions, clinical parameters and pathological inflammation grades in CHB, and to build models predicting inflammation grades by gene expressions and/or clinical parameters as well. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[Do lactoferrin, lysozyme and the lactoperoxidase-thiocyanate-hydrogen peroxide-system cause negative microbiological results in mastitis secretions?].

PubMed

Schmedt Auf Der Günne, H; Tenhagen, B A; Kutzer, P; Forderung, D; Heuwieser, W

2002-07-01

Lactoferrin, lysozyme and the lactoperoxidase-thiocyanate-peroxide-system are naturally occurring antimicrobial components of milk. The objective of this study was to examine, whether these components were responsible for negative results, when mastitis milk is cultured microbiologically. Quarter milk samples from 75 cows with clinical mastitis on a dairy farm in Brandenburg were submitted for microbiological culture and analysed for the content and the activities of the three components. Animals from all stages of lactation with clinical mastitis were included in the study. Animals were examined clinically and milk samples were collected prior to first treatment. Secretions from quarters with clinical mastitis were compared to those of neighbouring quarters without clinical mastitis. Secretions with positive cultural results were compared to those with negative results. The concentrations or activities of the three factors were significantly higher in the diseased quarters than in the quarters without clinical signs of mastitis. The concentration of lysozyme increased with severity of the clinical signs (local swelling and changes in secretion). The concentration of lactoferrin was significantly higher in quarters with slight alterations of glandular tissue than in quarters with medium or severe alterations (P < 0.05). LPS-activities did not correlate with the severity of clinical signs. No differences in the concentration of lactoferrin or LPS-activities were seen between mastitis with positive and negative culture results. The concentration of lysozyme was even higher in culturally positive samples than in negative samples (P < 0.05). Results from this study indicate that the three factors examined did not impair the results of microbiological culture of milk samples from quarters with clinical mastitis.

Multiple stage MS in analysis of plasma, serum, urine and in vitro samples relevant to clinical and forensic toxicology.

PubMed

Meyer, Golo M; Maurer, Hans H; Meyer, Markus R

2016-01-01

This paper reviews MS approaches applied to metabolism studies, structure elucidation and qualitative or quantitative screening of drugs (of abuse) and/or their metabolites. Applications in clinical and forensic toxicology were included using blood plasma or serum, urine, in vitro samples, liquids, solids or plant material. Techniques covered are liquid chromatography coupled to low-resolution and high-resolution multiple stage mass analyzers. Only PubMed listed studies published in English between January 2008 and January 2015 were considered. Approaches are discussed focusing on sample preparation and mass spectral settings. Comments on advantages and limitations of these techniques complete the review.

Health effects of groundwater fluoride contamination.

PubMed

Nayak, Bishwajit; Roy, Madan Mohan; Das, Bhaskar; Pal, Arup; Sengupta, Mrinal Kumar; De, Shankar Prasad; Chakraborti, Dipankar

2009-04-01

The people in Berhait block, Sahibganj district, Jharkhand state, India, have been exposed chronically to fluoridecontaminated groundwater. Hereby, we report the clinical effects of chronic exposure to fluoride. The study population was a convenience sample of 342 adults and 258 children living in the affected area. All volunteers filled out questionnaires and were examined. Well water from the six affected villages and urine samples were analyzed for fluoride using an ion-sensitive electrode. Twenty nine percent of 89 well water samples had fluoride concentrations above the Indian permissible limit of fluoride in drinking water. Eighty-five children and 72 adults had clinical fluorosis. Urine fluoride concentrations in children were 0.758-2.88 mg/L whereas in adults they were 0.331-10.36 mg/L. Clinical effects of fluoride included abnormal tooth enamel in children; adults had joint pain and deformity of the limbs and spine, along with ligamentous calcifications and exostosis formations in seven patients. Elevated urine fluoride concentrations supported the clinical diagnosis of fluorosis. Owing to insufficient fluoride-safe wells and lack of awareness of the danger of fluoride toxicity, villagers often drink fluoride-contaminated water. Villagers of Berhait block, including children, are at risk from chronic fluoride toxicity. To combat the situation, villagers need fluoride-safe water, education, and awareness of the danger about fluoride toxicity.

Limited-sampling strategies for anti-infective agents: systematic review.

PubMed

Sprague, Denise A; Ensom, Mary H H

2009-09-01

Area under the concentration-time curve (AUC) is a pharmacokinetic parameter that represents overall exposure to a drug. For selected anti-infective agents, pharmacokinetic-pharmacodynamic parameters, such as AUC/MIC (where MIC is the minimal inhibitory concentration), have been correlated with outcome in a few studies. A limited-sampling strategy may be used to estimate pharmacokinetic parameters such as AUC, without the frequent, costly, and inconvenient blood sampling that would be required to directly calculate the AUC. To discuss, by means of a systematic review, the strengths, limitations, and clinical implications of published studies involving a limited-sampling strategy for anti-infective agents and to propose improvements in methodology for future studies. The PubMed and EMBASE databases were searched using the terms "anti-infective agents", "limited sampling", "optimal sampling", "sparse sampling", "AUC monitoring", "abbreviated AUC", "abbreviated sampling", and "Bayesian". The reference lists of retrieved articles were searched manually. Included studies were classified according to modified criteria from the US Preventive Services Task Force. Twenty studies met the inclusion criteria. Six of the studies (involving didanosine, zidovudine, nevirapine, ciprofloxacin, efavirenz, and nelfinavir) were classified as providing level I evidence, 4 studies (involving vancomycin, didanosine, lamivudine, and lopinavir-ritonavir) provided level II-1 evidence, 2 studies (involving saquinavir and ceftazidime) provided level II-2 evidence, and 8 studies (involving ciprofloxacin, nelfinavir, vancomycin, ceftazidime, ganciclovir, pyrazinamide, meropenem, and alpha interferon) provided level III evidence. All of the studies providing level I evidence used prospectively collected data and proper validation procedures with separate, randomly selected index and validation groups. However, most of the included studies did not provide an adequate description of the methods or the characteristics of included patients, which limited their generalizability. Many limited-sampling strategies have been developed for anti-infective agents that do not have a clearly established link between AUC and clinical outcomes in humans. Future studies should first determine if there is an association between AUC monitoring and clinical outcomes. Thereafter, it may be worthwhile to prospectively develop and validate a limited-sampling strategy for the particular anti-infective agent in a similar population.

Clinical flow cytometric screening of SAP and XIAP expression accurately identifies patients with SH2D1A and XIAP/BIRC4 mutations.

PubMed

Gifford, Carrie E; Weingartner, Elizabeth; Villanueva, Joyce; Johnson, Judith; Zhang, Kejian; Filipovich, Alexandra H; Bleesing, Jack J; Marsh, Rebecca A

2014-07-01

X-linked lymphoproliferative disease is caused by mutations in two genes, SH2D1A and XIAP/BIRC4. Flow cytometric methods have been developed to detect the gene products, SAP and XIAP. However, there is no literature describing the accuracy of flow cytometric screening performed in a clinical lab setting. We reviewed the clinical flow cytometric testing results for 656 SAP and 586 XIAP samples tested during a 3-year period. Genetic testing was clinically performed as directed by the managing physician in 137 SAP (21%) and 115 XIAP (20%) samples. We included these samples for analyses of flow cytometric test accuracy. SH2D1A mutations were detected in 15/137 samples. SAP expression was low in 13/15 (sensitivity 87%, CI 61-97%). Of the 122 samples with normal sequencing, SAP was normal in 109 (specificity 89%, CI 82-94%). The positive predictive values (PPVs) and the negative predictive values (NPVs) were 50% and 98%, respectively. XIAP/BIRC4 mutations were detected in 19/115 samples. XIAP expression was low in 18/19 (sensitivity 95%, CI 73-100%). Of the 96 samples with normal sequencing, 59 had normal XIAP expression (specificity 61%, CI 51-71%). The PPVs and NPVs were 33% and 98%, respectively. Receiver-operating characteristic analysis was able to improve the specificity to 75%. Clinical flow cytometric screening tests for SAP and XIAP deficiencies offer good sensitivity and specificity for detecting genetic mutations, and are characterized by high NPVs. We recommend these tests for patients suspected of having X-linked lymphoproliferative disease type 1 (XLP1) or XLP2. © 2014 Clinical Cytometry Society.

A multiplex real-time PCR assay for identification of Pneumocystis jirovecii, Histoplasma capsulatum, and Cryptococcus neoformans/Cryptococcus gattii in samples from AIDS patients with opportunistic pneumonia.

PubMed

Gago, Sara; Esteban, Cristina; Valero, Clara; Zaragoza, Oscar; Puig de la Bellacasa, Jorge; Buitrago, María José

2014-04-01

A molecular diagnostic technique based on real-time PCR was developed for the simultaneous detection of three of the most frequent causative agents of fungal opportunistic pneumonia in AIDS patients: Pneumocystis jirovecii, Histoplasma capsulatum, and Cryptococcus neoformans/Cryptococcus gattii. This technique was tested in cultured strains and in clinical samples from HIV-positive patients. The methodology used involved species-specific molecular beacon probes targeted to the internal transcribed spacer regions of the rDNA. An internal control was also included in each assay. The multiplex real-time PCR assay was tested in 24 clinical strains and 43 clinical samples from AIDS patients with proven fungal infection. The technique developed showed high reproducibility (r(2) of >0.98) and specificity (100%). For H. capsulatum and Cryptococcus spp., the detection limits of the method were 20 and 2 fg of genomic DNA/20 μl reaction mixture, respectively, while for P. jirovecii the detection limit was 2.92 log10 copies/20 μl reaction mixture. The sensitivity in vitro was 100% for clinical strains and 90.7% for clinical samples. The assay was positive for 92.5% of the patients. For one of the patients with proven histoplasmosis, P. jirovecii was also detected in a bronchoalveolar lavage sample. No PCR inhibition was detected. This multiplex real-time PCR technique is fast, sensitive, and specific and may have clinical applications.

Use of Mobile Phones, Computers and Internet Among Clients of an Inner-City Community Psychiatric Clinic

PubMed Central

COLDER CARRAS, MICHELLE; MOJTABAI, RAMIN; FURR-HOLDEN, C. DEBRA; EATON, WILLIAM; CULLEN, BERNADETTE A.M.

2017-01-01

Objective Recent years have witnessed an expansion of Internet- and mobile-phone-based interventions for health promotion, yet few studies have focused on the use of technology by individuals with mental illness. This study examined the extent to which patients at an inner-city community psychiatry clinic had access to information and communications technology (ICT) and how they used those resources. Methods Patients of an outpatient, inner-city community psychiatry program (N = 189) completed a survey that included questions about demographics and ICT use which were adapted from an existing local population-based health survey (community sample, N = 968). Frequencies of ICT use were assessed for the clinic sample and questions common to both the surveys completed by the clinic and community samples were compared using logistic regression. Results Among clinic cases, 105 (55.6%) reported owning or using a computer, 162 (85.7%) reported owning or using a mobile phone, and 112 (59.3%) reported using the Internet. Among those who used mobile phones, the majority reported using them daily; 42% of those who used the Internet reported using it several times per day. Differences in frequency of Internet use between samples were not significant, but clinic participants used the Internet more intensively to email, instant message, access health information, and use social media sites. Conclusions A majority of patients in this community psychiatry clinic sample use ICT. Greater access to and use of the Internet by those with mental illness has important implications for the feasibility and impact of technology-based interventions. PMID:24638044

Use of mobile phones, computers and internet among clients of an inner-city community psychiatric clinic.

PubMed

Colder Carras, Michelle; Mojtabai, Ramin; Furr-Holden, C Debra; Eaton, William; Cullen, Bernadette A M

2014-03-01

Recent years have witnessed an expansion of Internet- and mobile-phone-based interventions for health promotion, yet few studies have focused on the use of technology by individuals with mental illness. This study examined the extent to which patients at an inner-city community psychiatry clinic had access to information and communications technology (ICT) and how they used those resources. Patients of an outpatient, inner-city community psychiatry program (N=189) completed a survey that included questions about demographics and ICT use which were adapted from an existing local population-based health survey (community sample, N=968). Frequencies of ICT use were assessed for the clinic sample and questions common to both the surveys completed by the clinic and community samples were compared using logistic regression. Among clinic cases, 105 (55.6%) reported owning or using a computer, 162 (85.7%) reported owning or using a mobile phone, and 112 (59.3%) reportedf using the Internet. Among those who used mobile phones, the majority reported using them daily; 42% of those who used the Internet reported using it several times per day. Differences in frequency of Internet use between samples were not significant, but clinic participants used the Internet more intensively to email, instant message, access health information, and use social media sites. A majority of patients in this community psychiatry clinic sample use ICT. Greater access to and use of the Internet by those with mental illness has important implications for the feasibility and impact of technology-based interventions.

Determining the effect of different environmental conditions on Ebola virus viability in clinically relevant specimens.

PubMed

Palyi, Bernadett; Magyar, Nora; Henczko, Judit; Szalai, Balint; Farkas, Agnes; Strecker, Thomas; Takacs, Maria; Kis, Zoltan

2018-03-29

In 2013-2016, West Africa experienced the largest and longest Ebola virus disease outbreak ever documented. The wide geographic spread and magnitude of the outbreak often limited the timely and rapid testing of diagnostic samples from patients with suspected Ebola virus disease, raising questions regarding the optimal storage and shipping conditions of clinically relevant specimens, including EDTA-whole blood, plasma, capillary blood, urine and seminal fluid (associated with sexual transmission of the Ebola virus after recovery from the disease). Therefore, the aim of our study was to identify the extent to which storage temperature and clinical specimen type influence Ebola virus viability. Virus infectivity was determined using a fluorescent focus-forming assay. In our study, we show that Ebola virus was the most stable in EDTA-whole blood and plasma samples, whereas rapid decay of infectivity was observed in simulated capillary blood, urine and semen samples, especially when these samples were stored at higher temperatures. The analysis of variance results demonstrated that both temperature and clinical specimen type have significant effects on virus viability, whereas donor differences were not observed. Repeated freeze and thaw cycles of the samples also had a notable impact on virus viability in EDTA-whole blood and urine. Due to the rapid temperature- and specimen-dependent degradation of the virus observed here, our study highlights the importance of proper clinical sample storage at low temperatures during transportation and laboratory analysis.

A short version of the revised 'experience of close relationships questionnaire': investigating non-clinical and clinical samples.

PubMed

Wongpakaran, Tinakon; Wongpakaran, Nahathai

2012-01-01

This study seeks to investigate the psychometric properties of the short version of the revised 'Experience of Close Relationships' questionnaire, comparing non-clinical and clinical samples. In total 702 subjects participated in this study, of whom 531 were non-clinical participants and 171 were psychiatric patients. They completed the short version of the revised 'Experience of Close Relationships' questionnaire (ECR-R-18), the Perceived Stress Scale-10(PSS-10), the Rosenberg Self-Esteem Scale (RSES) and the UCLA Loneliness scale. A retest of the ECR-R-18 was then performed at four-week intervals. Then, confirmatory factor analyses were performed to test the validity of the new scale. The ECR-R-18 showed a fair to good internal consistency (α 0.77 to 0.87) for both samples, and the test-retest reliability was found to be satisfactory (ICC = 0.75). The anxiety sub-scale demonstrated concurrent validity with PSS-10 and RSES, while the avoidance sub-scale showed concurrent validity with the UCLA Loneliness Scale. Confirmatory factor analysis using method factors yielded two factors with an acceptable model fit for both groups. An invariance test revealed that the ECR-R-18 when used on the clinical group differed from when used with the non-clinical group. The ECR-R-18 questionnaire revealed an overall better level of fit than the original 36 item questionnaire, indicating its suitability for use with a broader group of samples, including clinical samples. The reliability of the ECR-R- 18 might be increased if a modified scoring system is used and if our suggestions with regard to future studies are followed up.

Comparison of biochemical values in serum and plasma, fresh and frozen plasma, and hemolyzed samples from orange-winged Amazon parrots (Amazona amazonica).

PubMed

Hawkins, Michelle G; Kass, Philip H; Zinkl, Joseph G; Tell, Lisa A

2006-06-01

To the authors' knowledge, on the basis of sample type, storage condition, or hemolysis, differences in serum and plasma biochemical values have not been evaluated in orange-winged Amazon parrots (Amazona amazonica). The purpose of this study was to compare values for biochemical analytes in serum vs plasma, fresh vs frozen plasma, and nonhemolyzed vs hemolyzed samples in orange-winged Amazon parrots. We also compared differences in serum and plasma yield from whole-blood aliquots. Fifteen biochemical analytes were evaluated in paired serum and plasma, fresh and frozen plasma, nonhemolyzed and hemolyzed serum and plasma samples from orange-winged Amazon parrots (n = 10) using a wet reagent analyzer. Hemolysis was assessed qualitatively (visually) and quantitatively (hemoglobin [Hgb] measured spectrophotometrically). Serum and plasma yields from 500-microl whole-blood aliquots were determined from centrifuged samples. Analyte values significantly differed among sample groups, but were still within published reference intervals, with the exception of increases in potassium concentration in markedly hemolyzed serum and plasma samples. Clinically important changes in hemolyzed serum and plasma samples included increases in potassium, phosphorus, and albumin concentrations and lactate dehydrogenase activity. The degree of hemolysis assigned qualitatively did not correlate with quantitative Hgb concentration. A significantly greater yield of plasma (288 +/- 13 microL) than serum (241 +/- 44 microL) was obtained. Significant differences may occur in different sample types, however, only changes in potassium, phosphorus, albumin, and lactate dehydrogenase values in hemolyzed samples were considered clinically relevant. Lack of agreement between qualitative and quantitative Hgb concentration indicates the unreliability of visual estimation. Based on higher sample yield, and lack of clinically relevant differences from serum, plasma is a better sample choice for clinical chemistry analysis in birds.

Reporting of sample size calculations in analgesic clinical trials: ACTTION systematic review.

PubMed

McKeown, Andrew; Gewandter, Jennifer S; McDermott, Michael P; Pawlowski, Joseph R; Poli, Joseph J; Rothstein, Daniel; Farrar, John T; Gilron, Ian; Katz, Nathaniel P; Lin, Allison H; Rappaport, Bob A; Rowbotham, Michael C; Turk, Dennis C; Dworkin, Robert H; Smith, Shannon M

2015-03-01

Sample size calculations determine the number of participants required to have sufficiently high power to detect a given treatment effect. In this review, we examined the reporting quality of sample size calculations in 172 publications of double-blind randomized controlled trials of noninvasive pharmacologic or interventional (ie, invasive) pain treatments published in European Journal of Pain, Journal of Pain, and Pain from January 2006 through June 2013. Sixty-five percent of publications reported a sample size calculation but only 38% provided all elements required to replicate the calculated sample size. In publications reporting at least 1 element, 54% provided a justification for the treatment effect used to calculate sample size, and 24% of studies with continuous outcome variables justified the variability estimate. Publications of clinical pain condition trials reported a sample size calculation more frequently than experimental pain model trials (77% vs 33%, P < .001) but did not differ in the frequency of reporting all required elements. No significant differences in reporting of any or all elements were detected between publications of trials with industry and nonindustry sponsorship. Twenty-eight percent included a discrepancy between the reported number of planned and randomized participants. This study suggests that sample size calculation reporting in analgesic trial publications is usually incomplete. Investigators should provide detailed accounts of sample size calculations in publications of clinical trials of pain treatments, which is necessary for reporting transparency and communication of pre-trial design decisions. In this systematic review of analgesic clinical trials, sample size calculations and the required elements (eg, treatment effect to be detected; power level) were incompletely reported. A lack of transparency regarding sample size calculations may raise questions about the appropriateness of the calculated sample size. Copyright © 2015 American Pain Society. All rights reserved.

Pre-analytical effects of pneumatic tube system transport on routine haematology and coagulation tests, global coagulation assays and platelet function assays.

PubMed

Le Quellec, Sandra; Paris, Mickaël; Nougier, Christophe; Sobas, Frédéric; Rugeri, Lucia; Girard, Sandrine; Bordet, Jean-Claude; Négrier, Claude; Dargaud, Yesim

2017-05-01

Pneumatic tube system (PTS) in hospitals is commonly used for the transport of blood samples to clinical laboratories, as it is rapid and cost-effective. The aim was to compare the effects on haematology samples of a newly acquired ~2km-long PTS that links 2 hospitals with usual transport (non-pneumatic tube system, NPTS). Complete blood cell count, routine coagulation assays, platelet function tests (PFT) with light-transmission aggregometry and global coagulation assays including ROTEM® and thrombin generation assay (TGA) were performed on blood samples from 30 healthy volunteers and 9 healthy volunteers who agreed to take aspirin prior to blood sampling. The turnaround time was reduced by 31% (p<0.001) with the use of PTS. No statistically significant difference was observed for most routine haematology assays including PFT, and ROTEM® analysis. A statistically significant, but not clinically relevant, shortening of the APTT after sample transport by PTS was found (mean±SD: 30s±1.8 vs. 29.5s±2.1 for NPTS). D-dimer levels were 7.4% higher after transport through PTS but were not discordant. A statistically significant increase of thrombin generation was found in both platelet poor- and platelet rich- plasma samples after PTS transport compared to NPTS transport. PTS is suitable for the transport of samples prior to routine haematology assays including PFT, but should not be used for samples intended for thrombin generation measurement. Copyright © 2017 Elsevier Ltd. All rights reserved.

In vitro and in vivo evaluation of fluoroquinolone resistance associated with DNA gyrase mutations in Francisella tularensis, including in tularaemia patients with treatment failure.

PubMed

Sutera, V; Hoarau, G; Renesto, P; Caspar, Y; Maurin, M

2017-09-01

Fluoroquinolones (FQs) are highly effective for treating tularaemia, a zoonosis caused by Francisella tularensis, but failures and relapses remain common in patients with treatment delay or immunocompromised status. FQ-resistant strains of F. tularensis harboring mutations in the quinolone-resistance determining region (QRDR) of gyrA and gyrB, the genes encoding subunits A and B of DNA gyrase, have been selected in vitro. Such mutants have never been isolated from humans as this microorganism is difficult to culture. In this study, the presence of FQ-resistant mutants of F. tularensis was assessed in tularaemia patients using combined culture- and PCR-based approaches. We analyzed 42 F. tularensis strains and 82 tissue samples collected from 104 tularaemia cases, including 32 (30.7%) with FQ treatment failure or relapse. Forty F. tularensis strains and 55 clinical samples were obtained before any FQ treatment, while 2 strains and 15 tissue samples were collected after treatment. FQ resistance was evaluated by the minimum inhibitory concentration (MIC) for the bacterial strains, and by newly developed PCR-based methods targeting the gyrA and gyrB QRDRs for both the bacterial strains and the clinical samples. None of the F. tularensis strains displayed an increased MIC compared with FQ-susceptible controls. Neither gyrA nor gyrB QRDR mutation was found in bacterial strains and tissue samples tested, including those from patients with FQ treatment failure or relapse. Further phenotypic and genetic resistance traits should be explored to explain the poor clinical response to FQ treatment in such tularaemia patients. Copyright © 2017 Elsevier B.V. and International Society of Chemotherapy. All rights reserved.

Determination of nucleoside analog mono-, di-, and tri-phosphates in cellular matrix by solid phase extraction and ultra-sensitive LC-MS/MS detection.

PubMed

Bushman, Lane R; Kiser, Jennifer J; Rower, Joseph E; Klein, Brandon; Zheng, Jia-Hua; Ray, Michelle L; Anderson, Peter L

2011-09-10

An ultra-sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) assay was developed and validated to facilitate the assessment of clinical pharmacokinetics of nucleotide analogs from lysed intracellular matrix. The method utilized a strong anion exchange isolation of mono-(MP), di-(DP), and tri-phosphates (TP) from intracellular matrix. Each fraction was then dephosphorylated to the parent moiety yielding a molar equivalent to the original nucleotide analog intracellular concentration. The analytical portion of the methodology was optimized in specific nucleoside analog centric modes (i.e. tenofovir (TFV) centric, zidovudine (ZDV) centric), which included desalting/concentration by solid phase extraction and detection by LC-MS/MS. Nucleotide analog MP-, DP-, and TP-determined on the TFV centric mode of analysis include TFV, lamivudine (3TC), and emtricitibine (FTC). The quantifiable linear range for TFV was 2.5-2000 fmol/sample, and that for 3TC/FTC was 0.1 200 pmol/sample. Nucleoside analog MP-, DP-, and TP-determined on the ZDV centric mode of analysis included 3TC and ZDV. The quantifiable linear range for 3TC was 0.1 100 pmol/sample, and 5-2000 fmol/sample for ZDV. Stable labeled isotopic internal standards facilitated accuracy and precision in alternative cell matrices, which supported the intended use of the method for MP, DP, and TP determinations in various cell types. The method was successfully applied to clinical research samples generating novel intracellular information for TFV, FTC, ZDV, and 3TC nucleotides. This document outlines method development, validation, and application to clinical research. Copyright © 2011 Elsevier B.V. All rights reserved.

Garment workers in California: health outcomes of the Asian Immigrant Women Workers Clinic.

PubMed

Burgel, Barbara J; Lashuay, Nan; Israel, Leslie; Harrison, Robert

2004-11-01

In this cross sectional descriptive study, the demographics, risk factors, and health outcomes of a volunteer, symptomatic sample of monolingual Cantonese garment workers in the Oakland, California Chinatown area are documented. Methods included a questionnaire and clinical examination and treatment at the Asian Immigrant Women Workers Clinic, a free clinic providing culturally focused occupational health consultation and treatment for painful musculoskeletal disorders. Because garment work involves highly repetitious, sustained awkward postures, focused education on stretching and ergonomics also was provided. Results from the first 100 clients revealed a highly symptomatic sample, with an average age of 48.7 years. Sixty-six percent rated their health status as fair or poor. Sixteen percent of the sample had nerve entrapments, and 99% had a diagnosed strain or sprain of the spine or upper extremities. This population did not file workers' compensation claims because of a lack of knowledge and a fear of reprisal. This study documented the barriers to seeking care for this low wage, immigrant population.

Familiality of major depressive disorder and patterns of lifetime comorbidity. The NEMESIS and GenMood studies. A comparison of three samples.

PubMed

Verhagen, Maaike; van der Meij, Annemarie; Franke, Barbara; Vollebergh, Wilma A M; de Graaf, Ron; Buitelaar, Jan K; Janzing, Joost G E

2008-12-01

Major depressive disorder (MDD) aggregates in families and is associated with high rates of lifetime axis-I comorbidity. This study examined whether familiality of MDD is associated with the presence of specific comorbid disorders, which might be an important factor to be taken into account in MDD treatment and research into MDD etiology. A population sample was divided into subjects with familial (f-MDD; n=432) and nonfamilial MDD (nf-MDD; n=454). Since, more comorbidity was expected in clinical cases, a clinical sample with f-MDD (n=120) was also studied. Subjects were assessed with the Composite International Diagnostic Interview and family history methods. Binary logistic regression analyses were carried out to examine the influence of familiality of MDD on comorbidity. Analyses were adjusted for potential confounders, including MDD characteristics such as severity and age of onset. Dysthymia, anxiety disorders, and alcohol use disorders were significantly more prevalent in subjects with f-MDD than in subjects with nf-MDD. Clinical f-MDD was associated with more anxiety disorders and fewer alcohol use disorders than population f-MDD. After adjustment for MDD characteristics including age at onset, severity, and disease course, comorbid disorders remained more prevalent in f-MDD than in nf-MDD. The instruments used in the population and the clinical samples were not identical, however, they were comparable to a substantial degree. F-MDD, especially in clinical cases, appears to increase the risk of development of comorbid disorders, regardless of MDD characteristics. The link between familiality and comorbidity is important because it will aid a better understanding of the MDD phenotype, and it contributes to planning of effective treatment and to molecular genetic studies.

Perceptions, knowledge, and commitment of clinical staff to shared governance.

PubMed

Frith, Karen; Montgomery, Meryl

2006-01-01

The perceptions, knowledge, and commitment of clinical staff to shared governance were explored in a nonexperimental, survey research design, wherein preimplementation responses were compared to postimplementation responses. Using a nonprobability sampling method, all clinical staff members had the opportunity to respond to the Shared Governance Survey at the preimplementation and the 1-year postimplementation period. Thirty-eight clinical areas, including inpatient and outpatient areas, were included in the study. Both surveys contained a short demographic section and the Shared Governance Survey adapted from Minors et al. Results showed a decrease in perception and knowledge of shared governance between the 2 survey periods. This pattern was attributed to the idealism of shared governance in the preimplementation period compared to the reality of implementing shared governance. Interestingly, commitment to shared governance increased during this same time. When the sample was divided into groups, participants in shared governance had significantly higher scores on perception and knowledge of shared governance than did nonparticipants. Overall, participants and nonparticipants were committed to shared governance. The results of the survey indicated that clinical staff members recognized shared governance as a process, not a project, and that it takes time to share responsibility, accountability, and authority for nursing practice.

National Databases for Neurosurgical Outcomes Research: Options, Strengths, and Limitations.

PubMed

Karhade, Aditya V; Larsen, Alexandra M G; Cote, David J; Dubois, Heloise M; Smith, Timothy R

2017-08-05

Quality improvement, value-based care delivery, and personalized patient care depend on robust clinical, financial, and demographic data streams of neurosurgical outcomes. The neurosurgical literature lacks a comprehensive review of large national databases. To assess the strengths and limitations of various resources for outcomes research in neurosurgery. A review of the literature was conducted to identify surgical outcomes studies using national data sets. The databases were assessed for the availability of patient demographics and clinical variables, longitudinal follow-up of patients, strengths, and limitations. The number of unique patients contained within each data set ranged from thousands (Quality Outcomes Database [QOD]) to hundreds of millions (MarketScan). Databases with both clinical and financial data included PearlDiver, Premier Healthcare Database, Vizient Clinical Data Base and Resource Manager, and the National Inpatient Sample. Outcomes collected by databases included patient-reported outcomes (QOD); 30-day morbidity, readmissions, and reoperations (National Surgical Quality Improvement Program); and disease incidence and disease-specific survival (Surveillance, Epidemiology, and End Results-Medicare). The strengths of large databases included large numbers of rare pathologies and multi-institutional nationally representative sampling; the limitations of these databases included variable data veracity, variable data completeness, and missing disease-specific variables. The improvement of existing large national databases and the establishment of new registries will be crucial to the future of neurosurgical outcomes research. Copyright © 2017 by the Congress of Neurological Surgeons

Phenotypic and genetic characterization of bacteria isolated from diseased cultured sea cucumber (Apostichopus japonicus) in Northeastern China

USDA-ARS?s Scientific Manuscript database

During the winter–spring from 2004 to 2006 in northeastern China cultured Japanese sea cucumber Apostichopus japonicus suffered from a serious disease. Clinical signs included swollen mouth, skin ulceration and massive mortality. Clinical samples taken during this period were studied. Thirty-one bac...

Recruitment and retention monitoring: facilitating the mission of the National Institute of Neurological Disorders and Stroke (NINDS)

PubMed Central

Roberts, J; Waddy, S; Kaufmann, P

2012-01-01

It is commonly accepted that inefficient recruitment and inadequate retention continue to threaten the completion of clinical trials intended to reduce the public health burden of neurological disease. This article will discuss the scientific, economic, and ethical implications of failure to recruit and retain adequate samples in clinical trials, including the consequences of failing to recruit adequately diverse samples. We will also discuss the more common challenges and barriers to efficient and effective recruitment and retention, and the impact these have on successful clinical trial planning. We will explain the newly established efforts within National Institute of Neurological Disorders and Stroke (NINDS) to monitor recruitment and retention with well-defined metrics and implementation of grant awards that include feasibility milestones for continued funding. Finally, we will describe our efforts to address some of the common challenges to recruitment and retention through assistance to investigators and coordinators with evidence-based support, tools, and resources for planning and strategizing recruitment and retention as well as a trans-NIH effort to improve awareness of clinical research in the general public. PMID:23230460

Not Your Same Old Story: New Rules for Thematic Apperceptive Techniques (TATs).

PubMed

Jenkins, Sharon Rae

2017-01-01

Stories told about pictures have been used for both research and clinical practice since the beginning of modern personality assessment. However, with the growing science-practice gap, these thematic apperceptive techniques (TATs) have been used differently in those 2 venues. Scientific validation is presumptively general, but clinical application is idiographic and situation-specific. A bridge is needed. The manualized human-scored narrative analysis systems discussed here are valuable scientist-practitioner tools, but they require a validation literature to support further research publication, maintain their role in clinical training, and justify clinicians' reimbursement by third-party payers. To facilitate wider understanding of manualized TAT methodologies, this article addresses long-standing criticisms of TAT reliability and proposes some strategic solutions to the measurement error problem for both researchers and clinicians, including analyzing person-situation interactions, purposeful situation sampling for within-storyteller comparisons, and uses of small samples. The new rules for TATs include conceptual and methodological standards that researchers should aim to meet and report, reviewers should apply to manuscripts, and clinical assessors can use to analyze their own data and justify third-party payment.

Gathering Opinions on Depression Information Needs and Preferences: Samples and Opinions in Clinic Versus Web-Based Surveys

PubMed Central

Bernstein, Matthew T; Sexton, Kathryn A; Katz, Alan; Beatie, Brooke E

2017-01-01

Background There has been limited research on the information needs and preferences of the public concerning treatment for depression. Very little research is available comparing samples and opinions when recruitment for surveys is done over the Web as opposed to a personal invitation to complete a paper survey. Objective This study aimed to (1) to explore information needs and preferences among members of the public and (2) compare Clinic and Web samples on sample characteristics and survey findings. Methods Web survey participants were recruited with a notice on three self-help association websites (N=280). Clinic survey participants were recruited by a research assistant in the waiting rooms of a family medicine clinic and a walk-in medical clinic (N=238) and completed a paper version of the survey. Results The Clinic and Web samples were similar in age (39.0 years, SD 13.9 vs 40.2 years, SD 12.5, respectively), education, and proportion in full time employment. The Clinic sample was more diverse in demographic characteristics and closer to the demographic characteristics of the region (Winnipeg, Canada) with a higher proportion of males (102/238 [42.9%] vs 45/280 [16.1%]) and nonwhites (Aboriginal, Asian, and black) (69/238 [29.0%] vs 39/280 [13.9%]). The Web sample reported a higher level of emotional distress and had more previous psychological (224/280 [80.0%] vs 83/238 [34.9%]) and pharmacological (202/280 [72.1%] vs 57/238 [23.9%]) treatment. In terms of opinions, most respondents in both settings saw information on a wide range of topics around depression treatment as very important including information about treatment choices, effectiveness of treatment, how long it takes treatment to work, how long treatment continues, what happens when treatment stops, advantages and disadvantages of treatments, and potential side effects. Females, respondents with a white background, and those who had received or felt they would have benefited from therapy in the past saw more information topics as very important. Those who had received or thought they would have benefited in the past from medication treatment saw fewer topics as important. Participants in both groups expressed an interest in receiving information through discussion with a counselor or a physician, through written brochures, or through a recommended website. Conclusions The recruitment strategies were helpful in obtaining opinions from members of the public with different concerns and perspectives, and the results from the two methods were complementary. Persons coping with emotional distress and individuals not specifically seeking help for depression would be interested in information to answer a wide range of important questions about depression treatment. The Clinic sample yielded more cultural diversity that is a closer match to the population. The Web sample was less costly to recruit and included persons who were most interested in receiving information. PMID:28438729

[Performance of a standardized interrogation to improve the screening of Chlamydia trachomatis infection].

PubMed

Grandcolin, S; de Hauteclocque, A; Lafoscade, A; Fritel, X

2015-10-01

To estimate the performance of a standardized interrogation tool facilitating the detection and screening of patients for the Chlamydia trachomatis infection, to estimate the prevalence of the infection in the family planning population studied. Prospective observational study, including the patients who had a consultation in the abortion center in the CHU of Poitiers. A sampling of the cervix was systematically carried out after the standardized interrogation in search of four clinical signs. The samples were analyzed by genetic amplification. Three hundred and eighty-six women were included and 56 (14.5 %) infections were identified. The medical history questionnaire was relatively effective for 2 or 3 clinical signs. The positive predictive value (PPV) was respectively 34.8 % and 53.8 % and was very relevant for 4 clinical signs with PPV at 83.3 % [CI 95 %: 74-93 %]. Among the infected women, 48.2 % had no clinical sign revealed by the medical history questionnaire. The presence of any clinical sign was strongly associated with the C. trachomatis infection (P<0.05). The clinical signs find in the standardized interrogation are all significantly associated with the C. trachomatis infection. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Perceived Barriers to and Facilitators of Hypertension Management among Underserved African American Older Adults.

PubMed

Rimando, Marylen

2015-08-07

To understand the perceived barriers to and facilitators of hypertension self-management among underserved African American older adults in a southeastern clinic. Qualitative descriptive. Urban cardiovascular health clinic in a southeastern state. 28 African Americans diagnosed with hypertension. Interview questions were focused on knowledge of hypertension management and barriers and facilitators to hypertension self-management. Thematic content analysis was applied. Patients reported increased hypertension knowledge after attending the clinic. All patients reported knowledge of the severe consequences of uncontrolled hypertension. Perceived barriers to hypertension management included lack of money, lack of motivation to exercise, and fear of injury from exercising. Perceived facilitators of hypertension management included weight loss, unexpected diagnosis of hypertension, family members with hypertension and diabetes, and social support. Findings suggest that perceived barriers and facilitators influence a patient's decision to manage hypertension. Findings suggest the importance of health literacy and patient-provider communication at this particular clinic. Possible factors in the social environment may influence hypertension management. This study adds to the literature by understanding the perceived barriers to and facilitators of hypertension management of an underserved sample in a southeastern clinic. The results suggest a need for the redesign and transformation of future hypertension education strategies aimed at this clinic sample.

Clinical symptoms predict concurrent social and global functioning in an early psychosis sample.

PubMed

Cacciotti-Saija, Cristina; Langdon, Robyn; Ward, Philip B; Hickie, Ian B; Guastella, Adam J

2018-04-01

Although well established in chronic schizophrenia, the key determinants of functioning remain unknown during the early phase of a psychotic disorder. The aim of this study was to comprehensively examine the social cognitive, basic neurocognitive and clinical predictors of concurrent social functioning and global functioning in an early psychosis sample. This study examined the relationship between social cognition, basic neurocognition and clinical symptoms with concurrent functioning in 51 early psychosis individuals. Assessments included a range of self-report, observational and clinician-rated measures of cognitive, symptom severity and functioning domains. Results revealed a significant association between self-reported social function and lower levels of both social interaction anxiety and negative psychotic symptoms. A significant association was also observed between lower levels of negative psychotic symptoms and observed social functioning. Lastly, results demonstrated a significant association between reduced negative psychotic symptoms and clinician-rated global functioning. Clinical domains such as negative symptoms and social interaction anxiety significantly contribute to an optimal model predicting outcome during the early phase of a psychotic disorder. These clinical features may also provide useful markers of an individual's capacity for social participation. Clinical implications include the need for early targeted intervention to address social anxiety and negative psychotic symptoms to facilitate optimum patient outcome. © 2015 Wiley Publishing Asia Pty Ltd.

Environmental swabs as a tool in norovirus outbreak investigation, including outbreaks on cruise ships.

PubMed

Boxman, Ingeborg L A; Dijkman, Remco; te Loeke, Nathalie A J M; Hägele, Geke; Tilburg, Jeroen J H C; Vennema, Harry; Koopmans, Marion

2009-01-01

In this study, we investigated whether environmental swabs can be used to demonstrate the presence of norovirus in outbreak settings. First, a procedure was set up based on viral RNA extraction using guanidium isothiocyanate buffer and binding of nucleic acids to silica. Subsequently, environmental swabs were taken at 23 Dutch restaurants and four cruise ships involved in outbreaks of gastroenteritis. Outbreaks were selected based on clinical symptoms consistent with viral gastroenteritis and time between consumption of suspected food and onset of clinical symptoms (>12 h). Norovirus RNA was demonstrated by real-time reverse transcriptase PCR in 51 of 86 (59%) clinical specimens from 12 of 14 outbreaks (86%), in 13 of 90 (14%) food specimens from 4 of 18 outbreaks (22%), and in 48 of 119 (40%) swab specimens taken from 14 of 27 outbreaks (52%). Positive swab samples agreed with positive clinical samples in seven outbreaks, showing identical sequences. Furthermore, norovirus was detected on swabs taken from kitchen and bathroom surfaces in five outbreaks in which no clinical samples were collected and two outbreaks with negative fecal samples. The detection rate was highest for outbreaks associated with catered meals and lowest for restaurant-associated outbreaks. The use of environmental swabs may be a useful tool in addition to testing of food and clinical specimens, particularlywhen viral RNA is detected on surfaces used for food preparation.

Propionibacterium acnes: Disease-Causing Agent or Common Contaminant? Detection in Diverse Patient Samples by Next-Generation Sequencing

PubMed Central

Friis-Nielsen, Jens; Vinner, Lasse; Hansen, Thomas Arn; Richter, Stine Raith; Fridholm, Helena; Herrera, Jose Alejandro Romero; Lund, Ole; Brunak, Søren; Izarzugaza, Jose M. G.; Mourier, Tobias; Nielsen, Lars Peter

2016-01-01

Propionibacterium acnes is the most abundant bacterium on human skin, particularly in sebaceous areas. P. acnes is suggested to be an opportunistic pathogen involved in the development of diverse medical conditions but is also a proven contaminant of human clinical samples and surgical wounds. Its significance as a pathogen is consequently a matter of debate. In the present study, we investigated the presence of P. acnes DNA in 250 next-generation sequencing data sets generated from 180 samples of 20 different sample types, mostly of cancerous origin. The samples were subjected to either microbial enrichment, involving nuclease treatment to reduce the amount of host nucleic acids, or shotgun sequencing. We detected high proportions of P. acnes DNA in enriched samples, particularly skin tissue-derived and other tissue samples, with the levels being higher in enriched samples than in shotgun-sequenced samples. P. acnes reads were detected in most samples analyzed, though the proportions in most shotgun-sequenced samples were low. Our results show that P. acnes can be detected in practically all sample types when molecular methods, such as next-generation sequencing, are employed. The possibility of contamination from the patient or other sources, including laboratory reagents or environment, should therefore always be considered carefully when P. acnes is detected in clinical samples. We advocate that detection of P. acnes always be accompanied by experiments validating the association between this bacterium and any clinical condition. PMID:26818667

Clinical genomics information management software linking cancer genome sequence and clinical decisions.

PubMed

Watt, Stuart; Jiao, Wei; Brown, Andrew M K; Petrocelli, Teresa; Tran, Ben; Zhang, Tong; McPherson, John D; Kamel-Reid, Suzanne; Bedard, Philippe L; Onetto, Nicole; Hudson, Thomas J; Dancey, Janet; Siu, Lillian L; Stein, Lincoln; Ferretti, Vincent

2013-09-01

Using sequencing information to guide clinical decision-making requires coordination of a diverse set of people and activities. In clinical genomics, the process typically includes sample acquisition, template preparation, genome data generation, analysis to identify and confirm variant alleles, interpretation of clinical significance, and reporting to clinicians. We describe a software application developed within a clinical genomics study, to support this entire process. The software application tracks patients, samples, genomic results, decisions and reports across the cohort, monitors progress and sends reminders, and works alongside an electronic data capture system for the trial's clinical and genomic data. It incorporates systems to read, store, analyze and consolidate sequencing results from multiple technologies, and provides a curated knowledge base of tumor mutation frequency (from the COSMIC database) annotated with clinical significance and drug sensitivity to generate reports for clinicians. By supporting the entire process, the application provides deep support for clinical decision making, enabling the generation of relevant guidance in reports for verification by an expert panel prior to forwarding to the treating physician. Copyright © 2013 Elsevier Inc. All rights reserved.

Examining differences in culturally based stress among clinical and non-clinical Hispanic adolescents

PubMed Central

Cervantes, Richard C.; Cardoso, Jodi Berger; Goldbach, Jeremy T.

2014-01-01

The purpose of the current study was to determine if, and how, Hispanic adolescents receiving clinical treatment differ from their peers who are not in treatment on the 8 domains (family economic stress, cultural or educational stress, acculturation-gap stress, immigration stress, discrimination stress, family immigration stress, community or gang related stress) of cultural stress (HSI-A), and if the relation between cultural stress domains and depressive symptomology differed by group membership (clinical versus non-clinical). The sample included 1,254 Hispanic adolescents. The clinical sample had significantly higher scores of cultural stress (p < .05) and mean depression scores (< .001). All 8 domains of HSI-A stress were correlated with depression (p < .05). In the GLM, only family economic, acculturation gap, family immigration, discrimination, and family drug stress had a unique effect on depression and effect varied by group. Acculturation gap stress was associated with depression for the non-clinical group but not the clinical group (p < .001) and community gang stress was more strongly related to depression for the clinical group (p < .05). PMID:25364836

The relationships between father involvement and parental acceptance on the psychological adjustment of children and adolescents: The moderating effects of clinical status.

PubMed

Rodríguez Ruiz, Mercedes; Holgado-Tello, Francisco Pablo; Carrasco, Miguel Ángel

2017-10-01

This study analyzes how a child's clinical condition modifies the relationship of father involvement, parental (fathers and mothers) acceptance and the child´s psychological adjustment, including the internalizing and externalizing problems. The cohort studied was composed of 226 subjects (61.94% males) with a mean age of 14.08 years, of which 113 children were from an incidental clinical sample and 113 from the general population. Both groups were matched by sex, age and family status, and the data show that the same structure of parent-child relationships that predict the child´s psychological adjustment can be accepted for both the clinical and non-clinical groups of children. However, the intensity of the relationships between the variables father involvement, parental acceptance and the child´s outcomes differed in function of the child's clinical status. Specifically, in the clinically-referred sample compared to non-clinical sample father involvement had a stronger effect on the children´s internalizing (but not the externalizing) problems and on their global psychological adjustment via their perceived maternal acceptance. The role of father involvement in the family relationships of clinical children is discussed. This study provides important evidence to support the need for enhanced paternal participation in the intervention programs for families. Copyright © 2017 Elsevier B.V. All rights reserved.

Work-related stressors experienced by part-time clinical affiliate nursing faculty in baccalaureate education.

PubMed

Whalen, Kathleen S

2009-01-01

This descriptive and multivariate correlational study identifies work-related situations that were perceived as stressful in a sample of part-time clinical affiliate nursing faculty (n = 91) from a western state who teach in baccalaureate programs. The most stressful conditions include being physically and emotionally drained; working outside regular hours; dealing with the number of role expectations; and receiving inadequate monetary compensation. Subjects reported other specific stressful situations related to their work with clinical agencies, universities, and students. The researcher also examined the relationships between selected background factors (number of years of clinical teaching experience, clinical teacher education, and holding a second job), role stress, and job satisfaction. Even though this sample had a high job satisfaction rating, the variable, role stress, was shown to significantly predict job satisfaction. Lastly, implications for nurse educators in baccalaureate programs are explored.

Can Psychological, Social and Demographical Factors Predict Clinical Characteristics Symptomatology of Bipolar Affective Disorder and Schizophrenia?

PubMed

Maciukiewicz, Malgorzata; Pawlak, Joanna; Kapelski, Pawel; Łabędzka, Magdalena; Skibinska, Maria; Zaremba, Dorota; Leszczynska-Rodziewicz, Anna; Dmitrzak-Weglarz, Monika; Hauser, Joanna

2016-09-01

Schizophrenia (SCH) is a complex, psychiatric disorder affecting 1 % of population. Its clinical phenotype is heterogeneous with delusions, hallucinations, depression, disorganized behaviour and negative symptoms. Bipolar affective disorder (BD) refers to periodic changes in mood and activity from depression to mania. It affects 0.5-1.5 % of population. Two types of disorder (type I and type II) are distinguished by severity of mania episodes. In our analysis, we aimed to check if clinical and demographical characteristics of the sample are predictors of symptom dimensions occurrence in BD and SCH cases. We included total sample of 443 bipolar and 439 schizophrenia patients. Diagnosis was based on DSM-IV criteria using Structured Clinical Interview for DSM-IV. We applied regression models to analyse associations between clinical and demographical traits from OPCRIT and symptom dimensions. We used previously computed dimensions of schizophrenia and bipolar affective disorder as quantitative traits for regression models. Male gender seemed protective factor for depression dimension in schizophrenia and bipolar disorder sample. Presence of definite psychosocial stressor prior disease seemed risk factor for depressive and suicidal domain in BD and SCH. OPCRIT items describing premorbid functioning seemed related with depression, positive and disorganised dimensions in schizophrenia and psychotic in BD. We proved clinical and demographical characteristics of the sample are predictors of symptom dimensions of schizophrenia and bipolar disorder. We also saw relation between clinical dimensions and course of disorder and impairment during disorder.

PCR examination of bronchoalveolar lavage samples is a useful tool in pre-clinical diagnosis of ovine pulmonary adenocarcinoma (Jaagsiekte).

PubMed

Voigt, K; Brügmann, M; Huber, K; Dewar, P; Cousens, C; Hall, M; Sharp, J M; Ganter, M

2007-12-01

Ovine pulmonary adenocarcinoma (OPA) is a contagious lung tumour of sheep caused by Jaagsiekte sheep retrovirus (JSRV). The disease is a particular problem in flocks in many parts of the world. The aim of the study was to assess screening methods for individual animals as a prelude to future eradication trials. Results of histological examination were used as the standard to evaluate the relative sensitivity and specificity of an established heminested polymerase chain reaction (PCR) test for JSRV proviral DNA from blood and bronchoalveolar lavage (BAL) samples. PCR results from tissue samples are included as control data. PCR testing of blood samples was found to have an estimated sensitivity of only 10% (95% confidence interval (CI) 3-20) while the sensitivity of the PCR test on BAL samples was 89% (CI 79-96) in comparison to the results of histological examination. We conclude that PCR testing of BAL samples is an effective confirmatory test for sheep with suspected clinical OPA. It is also a useful tool for the pre-clinical identification of individual infected sheep within an infected flock and therefore may prove beneficial in future control or eradication programmes.

The Alzheimer’s Disease Centers’ Uniform Data Set (UDS): The Neuropsychological Test Battery

PubMed Central

Weintraub, Sandra; Salmon, David; Mercaldo, Nathaniel; Ferris, Steven; Graff-Radford, Neill R.; Chui, Helena; Cummings, Jeffrey; DeCarli, Charles; Foster, Norman L.; Galasko, Douglas; Peskind, Elaine; Dietrich, Woodrow; Beekly, Duane L.; Kukull, Walter A.; Morris, John C.

2009-01-01

The neuropsychological test battery from the Uniform Data Set (UDS) of the Alzheimer’s Disease Centers (ADC) program of the National Institute on Aging (NIA) consists of brief measures of attention, processing speed, executive function, episodic memory and language. This paper describes development of the battery and preliminary data from the initial UDS evaluation of 3,268 clinically cognitively normal men and women collected over the first 24 months of utilization. The subjects represent a sample of community-dwelling, individuals who volunteer for studies of cognitive aging. Subjects were considered “clinically cognitively normal” based on clinical assessment, including the Clinical Dementia Rating scale and the Functional Assessment Questionnaire. The results demonstrate performance on tests sensitive to cognitive aging and to the early stages of Alzheimer disease (AD) in a relatively well-educated sample. Regression models investigating the impact of age, education, and gender on test scores indicate that these variables will need to be incorporated in subsequent normative studies. Future plans include: 1) determining the psychometric properties of the battery; 2) establishing normative data, including norms for different ethnic minority groups; and 3) conducting longitudinal studies on cognitively normal subjects, individuals with mild cognitive impairment, and individuals with AD and other forms of dementia. PMID:19474567

The bovine colostrum microbiome and its association with clinical mastitis.

PubMed

Lima, Svetlana F; Teixeira, Andre G V; Lima, Fabio S; Ganda, Erika K; Higgins, Catherine H; Oikonomou, Georgios; Bicalho, Rodrigo C

2017-04-01

In an effort to characterize colostrum microbial diversity and its potential associations with early-lactation clinical mastitis, we used high-throughput sequencing of the 16S rRNA gene to investigate the bovine colostrum microbiome. A prospective observational study was conducted that included 70 Holstein cows; colostrum samples were collected from all 4 mammary gland quarters. Colostrum samples were categorized according to whether the quarter was diagnosed (CMC) or not diagnosed (NCMC) with clinical mastitis during the first 30 d postpartum. Colostrum samples were dominated by Firmicutes, Bacteroidetes, Proteobacteria, Actinobacteria, Fusobacteria, and Tenericutes phyla, with the 6 most common taxa [order (o), family (f), and genus (g)] being g_Staphylococcus, g_Prevotella, f_Ruminococcaceae, o_Bacteroidales, o_Clostridiales, and g_Pseudomonas. The colostrum microbiota of primiparous cows was significantly richer (higher number of bacterial species) than that of multiparous cows, and differences in colostrum taxonomic structure between parities were also observed. The microbial community of NCMC samples of primiparous cows was significantly more diverse than that of CMC samples, and the relative abundances of the Tenericutes and Fusobacteria phyla as well as the Mycoplasma and Fusobacterium genera were significantly higher in NCMC than in CMC samples of primiparous cows. The colostrum core microbiome, defined as the bacterial taxa common to all colostrum samples examined, was composed of 20 taxa and included bacterial genera already known to be associated with mastitis (e.g., Staphylococcus, Mycoplasma, and Streptococcus spp.). Our results indicate that the colostrum microbiome of primiparous cows differs from that of multiparous cows, and it harbors some diversity and taxonomic markers of mammary gland health specific to primiparous cows only. Copyright © 2017 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Determination of N-acylhomoserine lactones of Pseudomonas aeruginosa in clinical samples from dogs with otitis externa.

PubMed

Kušar, Darja; Šrimpf, Karin; Isaković, Petra; Kalšek, Lina; Hosseini, Javid; Zdovc, Irena; Kotnik, Tina; Vengušt, Modest; Tavčar-Kalcher, Gabrijela

2016-10-18

Bacterial intercellular communication, called quorum sensing, takes place via the production and collective response to signal molecules. In Gram-negative bacteria, like Pseudomonas aeruginosa, these signaling molecules are N-acylhomoserine lactones (AHLs). P. aeruginosa is a common cause of inflammation of the ear canal (otitis externa) in dogs. It employs quorum sensing to coordinate the expression of host tissue-damaging factors, which are largely responsible for its virulence. The treatment of P. aeruginosa-associated otitis is challenging due to a high intrinsic resistance of P. aeruginosa to several antibiotics. Attenuation of quorum sensing signals to inhibit bacterial virulence is a novel strategy for the treatment of resistant bacterial pathogens, including P. aeruginosa. Therefore, it is important to recognize and define quorum sensing signal molecules in clinical samples. To date, there are no reports on determination of AHLs in the veterinary clinical samples. The purpose of this study was to validate an analytical procedure for determination of the concentration of AHLs in the ear rinses from dogs with P. aeruginosa-associated otitis externa. Samples were obtained with rinsing the ear canals with physiological saline solution. For validation, samples from healthy dogs were spiked with none or different known amounts of the selected AHLs. With the validated procedure, AHLs were analyzed in the samples taken in weekly intervals from two dogs, receiving a standard treatment for P. aeruginosa-associated otitis externa. Validation proved that the procedure enables quantification of AHLs in non-clinical and clinical samples. In addition, a time dependent reduction of AHL concentration was detected for the treated dogs. Our results indicate that liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) is superior in detecting AHLs compared to other chromatographic techniques. This is the first report on determination of AHLs in the clinical samples of veterinary importance. The analytical procedure described in this paper is capable of supporting novel antimicrobial strategies, which target quorum sensing.

Glycemic Control in a Clinic-Based Sample of Diabetics in M'Bour Senegal

ERIC Educational Resources Information Center

BeLue, Rhonda; Ndiaye, Khadidiatou; NDao, Fatou; Ba, Fatou Niass Niang; Diaw, Mor

2016-01-01

Background: Sub-Saharan Africa (SSA) including Senegal is faced with a significant and increasing burden of type 2 diabetes. However, little information is available about diabetes management among Senegalese diabetics. Purpose: The current study aims to describe the level of glycemic control among a convenience sample of diabetics who receive…

Is Season of Birth Related to Developmental Dyslexia?

ERIC Educational Resources Information Center

Donfrancesco, Renato; Iozzino, Roberto; Caruso, Barbara; Ferrante, Laura; Mugnaini, Daniele; Talamo, Alessandra; Miano, Silvia; Dimitri, Andrea; Masi, Gabriele

2010-01-01

Different moderators/mediators of risk are involved in developmental dyslexia (DD), but data are inconsistent. We explored the prevalence of season of birth and its association with gender and age of school entry in an Italian sample of dyslexic children compared to an Italian normal control group. The clinical sample included 498 children (345…

Incorporating Computer-Aided Language Sample Analysis into Clinical Practice

ERIC Educational Resources Information Center

Price, Lisa Hammett; Hendricks, Sean; Cook, Colleen

2010-01-01

Purpose: During the evaluation of language abilities, the needs of the child are best served when multiple types and sources of data are included in the evaluation process. Current educational policies and practice guidelines further dictate the use of authentic assessment data to inform diagnosis and treatment planning. Language sampling and…

Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries.

PubMed

Tomlinson, Lindsay; Boone, Laura I; Ramaiah, Lila; Penraat, Kelley A; von Beust, Barbara R; Ameri, Mehrdad; Poitout-Belissent, Florence M; Weingand, Kurt; Workman, Heather C; Aulbach, Adam D; Meyer, Dennis J; Brown, Diane E; MacNeill, Amy L; Bolliger, Anne Provencher; Bounous, Denise I

2013-09-01

The purpose of this paper by the Regulatory Affairs Committee (RAC) of the American Society for Veterinary Clinical Pathology (ASVCP) is to review the current regulatory guidances (eg, guidelines) and published recommendations for best practices in veterinary toxicologic clinical pathology, particularly in the pharmaceutical and biotechnology industries, and to utilize the combined experience of ASVCP RAC to provide updated recommendations. Discussion points include (1) instrumentation, validation, and sample collection, (2) routine laboratory variables, (3) cytologic laboratory variables, (4) data interpretation and reporting (including peer review, reference intervals and statistics), and (5) roles and responsibilities of clinical pathologists and laboratory personnel. Revision and improvement of current practices should be in alignment with evolving regulatory guidance documents, new technology, and expanding understanding and utility of clinical pathology. These recommendations provide a contemporary guide for the refinement of veterinary toxicologic clinical pathology best practices. © 2013 American Society for Veterinary Clinical Pathology.

Overview of 'Omics Technologies for Military Occupational Health Surveillance and Medicine.

PubMed

Bradburne, Christopher; Graham, David; Kingston, H M; Brenner, Ruth; Pamuku, Matt; Carruth, Lucy

2015-10-01

Systems biology ('omics) technologies are emerging as tools for the comprehensive analysis and monitoring of human health. In order for these tools to be used in military medicine, clinical sampling and biobanking will need to be optimized to be compatible with downstream processing and analysis for each class of molecule measured. This article provides an overview of 'omics technologies, including instrumentation, tools, and methods, and their potential application for warfighter exposure monitoring. We discuss the current state and the potential utility of personalized data from a variety of 'omics sources including genomics, epigenomics, transcriptomics, metabolomics, proteomics, lipidomics, and efforts to combine their use. Issues in the "sample-to-answer" workflow, including collection and biobanking are discussed, as well as national efforts for standardization and clinical interpretation. Establishment of these emerging capabilities, along with accurate xenobiotic monitoring, for the Department of Defense could provide new and effective tools for environmental health monitoring at all duty stations, including deployed locations. Reprint & Copyright © 2015 Association of Military Surgeons of the U.S.

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

PubMed

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

2015-12-01

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

Mothers' and fathers' ratings of family relationship quality: associations with preadolescent and adolescent anxiety and depressive symptoms in a clinical sample.

PubMed

Queen, Alexander H; Stewart, Lindsay M; Ehrenreich-May, Jill; Pincus, Donna B

2013-06-01

This study examined the independent associations among three family relationship quality factors--cohesion, expressiveness, and conflict--with youth self-reported depressive and anxiety symptoms in a clinical sample of anxious and depressed youth. Ratings of family relationship quality were obtained through both mother and father report. The sample included families of 147 preadolescents and adolescents (56.6 % female; 89.8 % Caucasian), 11-18 years old (M = 13.64, SD = 1.98) assigned a principal diagnosis of an anxiety or depressive disorder. When controlling for age and concurrent anxiety symptoms, regression analyses revealed that for boys, both father- and mother-rated family cohesion predicted depressive symptoms. For girls, mother-rated family expressiveness and conflict predicted depressive symptoms. Youth anxiety symptoms were not significantly associated with any family relationship variables, controlling for concurrent depressive symptoms. Findings suggest that parent-rated family relationship factors may be more related to youth depressive than anxiety symptoms in this clinical sample. In addition, family cohesion, as perceived by parents, may be more related to boys' depression, whereas expressiveness and conflict (as rated by mothers) may be more related to girls' depression. Clinical implications and recommendations for future research are discussed.

Comprehensive Genomic Profiling of Esthesioneuroblastoma Reveals Additional Treatment Options.

PubMed

Gay, Laurie M; Kim, Sungeun; Fedorchak, Kyle; Kundranda, Madappa; Odia, Yazmin; Nangia, Chaitali; Battiste, James; Colon-Otero, Gerardo; Powell, Steven; Russell, Jeffery; Elvin, Julia A; Vergilio, Jo-Anne; Suh, James; Ali, Siraj M; Stephens, Philip J; Miller, Vincent A; Ross, Jeffrey S

2017-07-01

Esthesioneuroblastoma (ENB), also known as olfactory neuroblastoma, is a rare malignant neoplasm of the olfactory mucosa. Despite surgical resection combined with radiotherapy and adjuvant chemotherapy, ENB often relapses with rapid progression. Current multimodality, nontargeted therapy for relapsed ENB is of limited clinical benefit. We queried whether comprehensive genomic profiling (CGP) of relapsed or refractory ENB can uncover genomic alterations (GA) that could identify potential targeted therapies for these patients. CGP was performed on formalin-fixed, paraffin-embedded sections from 41 consecutive clinical cases of ENBs using a hybrid-capture, adaptor ligation based next-generation sequencing assay to a mean coverage depth of 593X. The results were analyzed for base substitutions, insertions and deletions, select rearrangements, and copy number changes (amplifications and homozygous deletions). Clinically relevant GA (CRGA) were defined as GA linked to drugs on the market or under evaluation in clinical trials. A total of 28 ENBs harbored GA, with a mean of 1.5 GA per sample. Approximately half of the ENBs (21, 51%) featured at least one CRGA, with an average of 1 CRGA per sample. The most commonly altered gene was TP53 (17%), with GA in PIK3CA , NF1 , CDKN2A , and CDKN2C occurring in 7% of samples. We report comprehensive genomic profiles for 41 ENB tumors. CGP revealed potential new therapeutic targets, including targetable GA in the mTOR, CDK and growth factor signaling pathways, highlighting the clinical value of genomic profiling in ENB. Comprehensive genomic profiling of 41 relapsed or refractory ENBs reveals recurrent alterations or classes of mutation, including amplification of tyrosine kinases encoded on chromosome 5q and mutations affecting genes in the mTOR/PI3K pathway. Approximately half of the ENBs (21, 51%) featured at least one clinically relevant genomic alteration (CRGA), with an average of 1 CRGA per sample. The most commonly altered gene was TP53 (17%), and alterations in PIK3CA , NF1 , CDKN2A , or CDKN2C were identified in 7% of samples. Responses to treatment with the kinase inhibitors sunitinib, everolimus, and pazopanib are presented in conjunction with tumor genomics. © AlphaMed Press 2017.

Clinical features and prognosis of a sample of patients with trisomy 13 (Patau syndrome) from Brazil.

PubMed

Petry, Patrícia; Polli, Janaina B; Mattos, Vinícius F; Rosa, Rosana C M; Zen, Paulo R G; Graziadio, Carla; Paskulin, Giorgio A; Rosa, Rafael F M

2013-06-01

Trisomy 13 or Patau syndrome (PS) is a chromosomal disorder characterized by a well known presentation of multiple congenital anomalies. Our objective was to determine the clinical features and prognosis observed in a sample of patients with PS. The series was composed of patients with diagnosis of PS consecutively evaluated by a Clinical Genetics Service from a reference hospital of southern Brazil, in the period between 1975 and 2012. Statistical analysis was performed using PEPI program (version 4.0), with two-tailed Fisher's exact test for comparison of frequencies (P<0.05). The sample consisted of 30 patients, 60% male, median age at first evaluation of 9 days. Full trisomy of chromosome 13 was the main cytogenetic alteration (73%). The major clinical findings included: cryptorchidism (78%), abnormal auricles (77%), congenital heart defects (76%), polydactyly (63%), microphthalmia (60%) and micrognathia (50%). Four patients (13%) simultaneously had micro/anophthalmia, oral clefts and polydactyly. Some findings were only observed in our sample and included, among others, preauricular tags (10%), duplication of the hallux (3%) and spots following the lines of Blaschko (3%). Mosaicism (20% of cases) had a statistically significant association only with absence of cryptorchidism. The median of survival was 26 days. Patients with and without mosaicism had similar median of survival. Our findings, in agreement with the literature, show that the anomalies in patients with PS can be quite variable, sometimes even atypical. There is no pathognomonic finding, which may make the early identification of these patients challenging. Copyright © 2013 Wiley Periodicals, Inc.

Subclinical and clinical mastitis in heifers following the use of a teat sealant precalving.

PubMed

Parker, K I; Compton, C; Anniss, F M; Weir, A; Heuer, C; McDougall, S

2007-01-01

This study investigated the effect in heifers of infusion of a bismuth subnitrate teat-canal sealant and bacterial intramammary infection (IMI) precalving on prevalence of postcalving IMI and incidence of clinical mastitis in the first 2 wk postcalving. Glands (n = 1,020) from heifers (n = 255) in 5 seasonally calving, pasture-fed dairy herds were randomly assigned within heifer to 1 of 4 treatment groups (no treatment; mammary gland secretion collection; infusion of a teat sealant; or sample collection with infusion of teat sealant). Heifers within a herd were enrolled on one calendar day, 31 d on average before the planned start of the seasonal calving period. Duplicate milk samples were collected from each gland within 4 d after calving for bacterial culture. Herd owners collected duplicate milk samples, before treatment, for bacterial culture from glands they defined as having clinical mastitis. The gland prevalence of IMI precalving was 15.5% and did not differ between herds. Bacteria isolated precalving included coagulase-negative staphylococci (76.9% of all bacteriologically positive samples), Streptococcus uberis (14.1%), Staphylococcus aureus (5.1%), Corynebacterium spp. (3.8%), and others (0.1%). The presence of an IMI precalving increased the risk of an IMI postcalving 3.6-fold and the risk of clinical mastitis 4-fold, relative to no IMI precalving. Infusion of the teat sealant reduced the risk of postcalving IMI due to Strep. uberis by 84%, and of clinical mastitis by 68%. Sampling the glands precalving had no effect on postcalving IMI or on clinical mastitis incidence. Use of an internal teat canal sealant in heifers precalving may be a useful tool for reducing the risk of subclinical and clinical mastitis in heifers.

Internal quality assurance in a clinical virology laboratory. II. Internal quality control.

PubMed Central

Gray, J J; Wreghitt, T G; McKee, T A; McIntyre, P; Roth, C E; Smith, D J; Sutehall, G; Higgins, G; Geraghty, R; Whetstone, R

1995-01-01

AIMS--In April 1991 additional quality control procedures were introduced into the virology section of the Clinical Microbiology and Public Health Laboratory, Cambridge. Internal quality control (IQC) samples were gradually included in the serological assays performed in the laboratory and supplemented kit controls and standard sera. METHODS--From April 1991 to December 1993, 2421 IQC procedures were carried out with reference sera. RESULTS--The IQC samples were evaluated according to the Westgard rules. Violations were recorded in 60 of 1808 (3.3%) controls and were highest in the IQC samples of complement fixation tests (25/312 (8%) of controls submitted for complement fixation tests). CONCLUSIONS--The inclusion of IQC samples in the serological assays performed in the laboratory has highlighted batch to batch variation in commercial assays. The setting of acceptable limits for the IQC samples has increased confidence in the validity of assay results. PMID:7730475

Genotyping of clinical isolates of Acanthamoeba genus in Venezuela.

PubMed

Wagner, Carolina; Reyes-Batlle, María; Ysea, María Alejandra Vethencourt; Pérez, Mónica V Galindo; de Rondón, Carmen Guzmán; Paduani, Anaibeth J Nessi; Pérez, Angelyseb Dorta; López-Arencibia, Atteneri; Sifaoui, Ines; de Galindo, María Virginia Pérez; de Suárez, Eva Pérez; Martínez-Carretero, Enrique; Valladares, Basilio; Piñero, José E; Lorenzo-Morales, Jacob

2016-12-01

Free-living amoebae of Acanthamoeba genus are opportunistic pathogens distributed worldwide. Strains included in this genus are causative agents of a fatal encephalitis and a sight-threating keratitis in humans and other animals. In this study, 550 clinical samples which were collected between 1984 and 2014 from different patients with suspected infections due to Acanthamoeba were initially screened for the presence of this amoebic genus at the Laboratorio de Amibiasis-Escuela de Bioanálisis at the Universidad Central de Venezuela. Samples were cultured in 2% Non-Nutrient agar plates seeded with a layer of heat killed Escherichia coli. From the 550 clinical samples included in this study, 18 of them were positive for Acanthamoeba genus after culture identification. Moreover, positive samples were confirmed after amplification of the Diagnostic Fragment 3 (DF3) of the Acanthamoeba18S rDNA genus and sequencing was carried out in order to genotype the isolated strains of Acanthamoeba. Furthermore, the pathogenic potential of the strains was checked by performing thermotolerance and osmotolerance assays. Sequencing of the DF3 region resulted in the identification of genotype T4 in all the isolated strains. Moreover, most isolates were thermotolerant or both thermotolerant and osmotolerant and thus were classified as potentially pathogenic strains. To the best of our knowledge, this is the first report on the molecular characterization at the genotype level of Acanthamoeba strains in Venezuela.

Comparison of Ion Personal Genome Machine Platforms for the Detection of Variants in BRCA1 and BRCA2.

PubMed

Hwang, Sang Mee; Lee, Ki Chan; Lee, Min Seob; Park, Kyoung Un

2018-01-01

Transition to next generation sequencing (NGS) for BRCA1 / BRCA2 analysis in clinical laboratories is ongoing but different platforms and/or data analysis pipelines give different results resulting in difficulties in implementation. We have evaluated the Ion Personal Genome Machine (PGM) Platforms (Ion PGM, Ion PGM Dx, Thermo Fisher Scientific) for the analysis of BRCA1 /2. The results of Ion PGM with OTG-snpcaller, a pipeline based on Torrent mapping alignment program and Genome Analysis Toolkit, from 75 clinical samples and 14 reference DNA samples were compared with Sanger sequencing for BRCA1 / BRCA2 . Ten clinical samples and 14 reference DNA samples were additionally sequenced by Ion PGM Dx with Torrent Suite. Fifty types of variants including 18 pathogenic or variants of unknown significance were identified from 75 clinical samples and known variants of the reference samples were confirmed by Sanger sequencing and/or NGS. One false-negative results were present for Ion PGM/OTG-snpcaller for an indel variant misidentified as a single nucleotide variant. However, eight discordant results were present for Ion PGM Dx/Torrent Suite with both false-positive and -negative results. A 40-bp deletion, a 4-bp deletion and a 1-bp deletion variant was not called and a false-positive deletion was identified. Four other variants were misidentified as another variant. Ion PGM/OTG-snpcaller showed acceptable performance with good concordance with Sanger sequencing. However, Ion PGM Dx/Torrent Suite showed many discrepant results not suitable for use in a clinical laboratory, requiring further optimization of the data analysis for calling variants.

History of Interpersonal Violence, Abuse, and Nonvictimization Trauma and Severity of Psychiatric Symptoms among Children in Outpatient Psychiatric Treatment

ERIC Educational Resources Information Center

Ford, Julian D.; Gagnon, Kerry; Connor, Daniel F.; Pearson, Geraldine

2011-01-01

In a clinical sample of child psychiatry outpatients, chart review data were collected for 114 consecutive admissions over a 1-year period at a Child and Adolescent Outpatient Psychiatry Clinic. Data included history of documented maltreatment, potentially traumatic domestic or community violence, neglect or emotional abuse, and noninterpersonal…

Factors Influencing M.S.W. Students' Interest in Clinical Practice

ERIC Educational Resources Information Center

Perry, Robin

2009-01-01

This study utilizes linear and log-linear stochastic models to examine the impact that a variety of variables (including graduate education) have on M.S.W. students' desires to work in clinical practice. Data was collected biannually (between 1992 and 1998) from a complete population sample of all students entering and exiting accredited graduate…

A qualitative grounded theory study of the conceptions of clinical practice in osteopathy - a continuum from technical rationality to professional artistry.

PubMed

Thomson, Oliver P; Petty, Nicola J; Moore, Ann P

2014-02-01

How practitioners conceive clinical practice influences many aspects of their clinical work including how they view knowledge, clinical decision-making, and their actions. Osteopaths have relied upon the philosophical and theoretical foundations upon which the profession was built to guide clinical practice. However, it is currently unknown how osteopaths conceive clinical practice, and how these conceptions develop and influence their clinical work. This paper reports the conceptions of practice of experienced osteopaths in the UK. A constructivist grounded theory approach was taken in this study. The constant comparative method of analysis was used to code and analyse data. Purposive sampling was employed to initially select participants. Subsequent theoretical sampling, informed by data analysis, allowed specific participants to be sampled. Data collection methods involved semi-structured interviews and non-participant observation of practitioners during a patient appointment, which was video-recorded and followed by a video-prompted reflective interview. Participants' conception of practice lay on a continuum, from technical rationality to professional artistry and the development of which was influenced by their educational experience, view of health and disease, epistemology of practice knowledge, theory-practice relationship and their perceived therapeutic role. The findings from this study provide the first theoretical insight of osteopaths' conceptions of clinical practice and the factors which influence such conceptions. Copyright © 2013 Elsevier Ltd. All rights reserved.

[Current panorama of the teaching of microbiology and parasitology in Spain].

PubMed

Cantón, Rafael; Sánchez-Romero, María Isabel; Gómez-Mampaso, Enrique

2010-10-01

The training program of residents in microbiology and parasitology in Spain includes clinical skills, ranging from the diagnostic approach to the patient and adequate sample collection for diagnosis of infectious diseases to antimicrobial therapy and infection control measures. Training also includes new challenges in clinical microbiology that ensure residents' participation in infection control programs of health-care associated infections, training in the resolution of public health problems, and application of new molecular microbiology methods. Specialization in clinical microbiology may be undertaken by graduates in Medicine, Biology, Biochemistry and Chemistry. The training is performed in accredited microbiology laboratories at different hospitals (n = 61) across the country through 4-year residency programs. In the last few years, there has been a major imbalance between the number of intended residents (0.17 per 100,000 inhabitants) and those graduating as specialists in clinical microbiology (0.13 per 100,000 inhabitants), with wide variations across the country. The current tendency in Europe is to strengthen the role of clinical microbiologists as key figures in the diagnosis of infectious diseases and in public health microbiology. Training programs have been hampered by the practice of sending samples for microbiological tests to external, centralized multipurpose laboratories with few clinical microbiologists and without a core curriculum. Essential elements in the training of specialists in clinical microbiology are a close relationship between the laboratory and the clinical center and collaboration with other specialists. Copyright © 2010 Elsevier España S.L. All rights reserved.

ASVCP quality assurance guidelines: external quality assessment and comparative testing for reference and in-clinic laboratories.

PubMed

Camus, Melinda S; Flatland, Bente; Freeman, Kathleen P; Cruz Cardona, Janice A

2015-12-01

The purpose of this document is to educate providers of veterinary laboratory diagnostic testing in any setting about comparative testing. These guidelines will define, explain, and illustrate the importance of a multi-faceted laboratory quality management program which includes comparative testing. The guidelines will provide suggestions for implementation of such testing, including which samples should be tested, frequency of testing, and recommendations for result interpretation. Examples and a list of vendors and manufacturers supplying control materials and services to veterinary laboratories are also included. © 2015 American Society for Veterinary Clinical Pathology.

Minor Physical Anomalies as a Window into the Prenatal Origins of Pedophilia.

PubMed

Dyshniku, Fiona; Murray, Michelle E; Fazio, Rachel L; Lykins, Amy D; Cantor, James M

2015-11-01

Evidence is steadily accumulating to support a neurodevelopmental basis for pedophilia. This includes increased incidence of non-right-handedness, which is a result primarily of prenatal neural development and solidified very early in life. Minor physical anomalies (MPAs; superficial deviations from typical morphological development, such as un-detached earlobes) also develop only prenatally, suggesting them as another potential marker of atypical physiological development during the prenatal period among pedophiles. This study administered the Waldrop Physical Anomaly Scale to assess the prevalence of MPAs in a clinical sample of men referred for assessment following a sexual assault, or another illegal or clinically significant sexual behavior. Significant associations emerged between MPA indices and indicators of pedophilia, including penile responses to depictions of children, number of child victims, and possession of child pornography. Moreover, greater sexual attraction to children was associated with an elevated craniofacial-to-peripheral anomalies ratio. The overall sample demonstrated a greater number of MPAs relative to prior samples of individuals with schizophrenia as well as to healthy controls.

The childhood executive function inventory: confirmatory factor analyses and cross-cultural clinical validity in a sample of 8- to 11-year-old children.

PubMed

Catale, Corinne; Meulemans, Thierry; Thorell, Lisa B

2015-06-01

The aim was to investigate the psychometric characteristics of the French adaptation of the Childhood Executive Functioning Inventory (CHEXI) in children and to explore the cross-cultural validity of the CHEXI in discriminating between children with ADHD and controls in two culturally different samples (Belgian and Swedish). Study I included normally developing children (n = 242), whereas Study II included both children diagnosed with ADHD (n = 87) and controls (n = 87). CHEXI ratings were collected from parents. Confirmatory factor analyses replicated the two-factor solution, referred to as inhibition and working memory, which had been identified previously. Both subscales had good psychometric properties. Furthermore, the CHEXI was found to discriminate, with high sensitivity and specificity, between children with ADHD and controls in both cultural samples. The CHEXI can be considered as a valuable screening measure for ADHD in children, but the cross-cultural clinical implications of ratings have to be considered. © 2013 SAGE Publications.

Clinical validation of the C-VAT 2.0 assessment tool for gaming disorder: A sensitivity analysis of the proposed DSM-5 criteria and the clinical characteristics of young patients with 'video game addiction'.

PubMed

van Rooij, Antonius J; Schoenmakers, Tim M; van de Mheen, Dike

2017-01-01

Clinicians struggle with the identification of video gaming problems. To address this issue, a clinical assessment tool (C-VAT 2.0) was developed and tested in a clinical setting. The instrument allows exploration of the validity of the DSM-5 proposal for 'internet gaming disorder'. Using C-VAT 2.0, the current study provides a sensitivity analysis of the proposed DSM-5 criteria in a clinical youth sample (13-23years old) in treatment for video gaming disorder (N=32). The study also explores the clinical characteristics of these patients. The patients were all male and reported spending extensive amounts of time on video games. At least half of the patients reported playing online games (n=15). Comorbid problems were common (n=22) and included (social) anxiety disorders, PDD NOS, ADHD/ADD, Parent-Child relationship problem, and various types of depressive mood problems. The sensitivity of the test was good: results further show that the C-VAT correctly identified 91% of the sample at the proposed cut-off score of at least 5 out of 9 of the criteria. As our study did not include healthy, extreme gamers, we could not assess the specificity of the tool: future research should make this a priority. Using the proposed DSM-5 cut-off score, the C-VAT 2.0 shows preliminary validity in a sample of gamers in treatment for gaming disorder, but the discriminating value of the instrument should be studied further. In the meantime, it is crucial that therapists try to avoid false positives by using expert judgment of functional impairment in each case. Copyright © 2015 Elsevier Ltd. All rights reserved.

CHAracteristics of research studies that iNfluence practice: a GEneral survey of Canadian orthopaedic Surgeons (CHANGES): a pilot survey.

PubMed

de Sa, Darren; Thornley, Patrick; Evaniew, Nathan; Madden, Kim; Bhandari, Mohit; Ghert, Michelle

2015-01-01

Evidence Based Medicine (EBM) is increasingly being applied to inform clinical decision-making in orthopaedic surgery. Despite the promotion of EBM in Orthopaedic Surgery, the adoption of results from high quality clinical research seems highly unpredictable and does not appear to be driven strictly by randomized trial data. The objective of this study was to pilot a survey to determine if we could identify surgeon opinions on the characteristics of research studies that are perceived as being most likely to influence clinical decision-making among orthopaedic surgeons in Canada. A 28-question electronic survey was distributed to active members of the Canadian Orthopaedic Association (COA) over a period of 11 weeks. The questionnaire sought to analyze the influence of both extrinsic and intrinsic characteristics of research studies and their potential to influence practice patterns. Extrinsic factors included the perceived journal quality and investigator profiles, economic impact, peer/patient/industry influence and individual surgeon residency/fellowship training experiences. Intrinsic factors included study design, sample size, and outcomes reported. Descriptive statistics are provided. Of the 109 members of the COA who opened the survey, 95 (87%) completed the survey in its entirety. The overall response rate was 11% (95/841). Surgeons achieved consensus on the influence of three key designs on their practices: 1) randomized controlled trials 94 (99%), 2) meta-analysis 83 (87%), and 3) systematic reviews 81 (85%). Sixty-seven percent of surgeons agreed that studies with sample sizes of 101-500 or more were more likely to influence clinical practice than smaller studies (n = <100). Factors other than design influencing adoption included 1) reputation of the investigators (99%) and 2) perceived quality of the journal (75%). Although study design and sample size (i.e. minimum of 100 patients) have some influence on clinical decision making, surgeon respondents are equally influenced by investigator reputation and perceived journal quality. At present, continued emphasis on the generation of large, methodologically sound clinical trials remains paramount to translating research findings to clinical practice changes. Specific to this pilot survey, strategies to solicit more widespread responses will be pursued.

A developmental approach to complex PTSD: childhood and adult cumulative trauma as predictors of symptom complexity.

PubMed

Cloitre, Marylene; Stolbach, Bradley C; Herman, Judith L; van der Kolk, Bessel; Pynoos, Robert; Wang, Jing; Petkova, Eva

2009-10-01

Exposure to multiple traumas, particularly in childhood, has been proposed to result in a complex of symptoms that includes posttraumatic stress disorder (PTSD) as well as a constrained, but variable group of symptoms that highlight self-regulatory disturbances. The relationship between accumulated exposure to different types of traumatic events and total number of different types of symptoms (symptom complexity) was assessed in an adult clinical sample (N = 582) and a child clinical sample (N = 152). Childhood cumulative trauma but not adulthood trauma predicted increasing symptom complexity in adults. Cumulative trauma predicted increasing symptom complexity in the child sample. Results suggest that Complex PTSD symptoms occur in both adult and child samples in a principled, rule-governed way and that childhood experiences significantly influenced adult symptoms. Copyright © 2009 International Society for Traumatic Stress Studies.

The Classification Accuracy of the Minnesota Multiphasic Personality Inventory--Adolescent: Effects of Modifying the Normative Sample

ERIC Educational Resources Information Center

Hand, Cynthia G.; Archer, Robert P.; Handel, Richard W.; Forbey, Johnathan D.

2007-01-01

Numerous studies have reported that the Minnesota Multiphasic Personality Inventory-Adolescent (MMPI-A) produces a high frequency of within-normal-limits basic scale profiles for adolescents with significant clinical pathology (e.g., Archer, 2005). The current study builds on the observation that the MMPI-A normative sample included participants…

Gender Differences in the Clinical Presentation of PTSD and Its Concomitants in Survivors of Interpersonal Assault

ERIC Educational Resources Information Center

Galovski, Tara E.; Mott, Juliette; Young-Xu, Yinong; Resick, Patricia A.

2011-01-01

This study compares a sample of PTSD-positive, female survivors of interpersonal assault (n = 162) to a sample of similarly traumatized male counterparts (n = 45) on a number of variables, including PTSD-symptom severity, depressive symptoms, anger, guilt, and health-related concerns. Results indicate that male and female interpersonal assault…

Characterization of the Theta to Beta Ratio in ADHD: Identifying Potential Sources of Heterogeneity

ERIC Educational Resources Information Center

Loo, Sandra K.; Cho, Alexander; Hale, T. Sigi; McGough, James; McCracken, James; Smalley, Susan L.

2013-01-01

Objective: The goal of this study is to characterize the theta to beta ratio (THBR) obtained from electroencephalogram (EEG) measures, in a large sample of community and clinical participants with regard to (a) ADHD diagnosis and subtypes, (b) common psychiatric comorbidities, and (c) cognitive correlates. Method: The sample includes 871…

How to design and write a clinical research protocol in Cosmetic Dermatology*

PubMed Central

Bagatin, Ediléia; Miot, Helio A.

2013-01-01

Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment. PMID:23539006

Preanalytical considerations in detection of colorectal cancer in blood serum using Raman molecular imaging (Conference Presentation)

NASA Astrophysics Data System (ADS)

Treado, Patrick J.; Stewart, Shona D.; Smith, Aaron; Kirschner, Heather; Post, Christopher; Overholt, Bergein F.

2016-03-01

Colorectal cancer (CRC) is the third most common cancer in men and women in the United States. Raman Molecular Imaging (RMI) is an effective technique to evaluate human tissue, cells and bodily fluids, including blood serum for disease diagnosis. ChemImage Corporation, in collaboration with clinicians, has been engaged in development of an in vitro diagnostic Raman assay focused on CRC detection. The Raman Assay for Colorectal Cancer (RACC) exploits the high specificity of Raman imaging to distinguish diseased from normal dried blood serum droplets without additional reagents. Pilot Study results from testing of hundreds of biobank patient samples have demonstrated that RACC detects CRC with high sensitivity and specificity. However, expanded clinical trials, which are ongoing, are revealing a host of important preanalytical considerations associated with sample collection, sample storage and stability, sample shipping, sample preparation and sample interferents, which impact detection performance. Results from recent clinical studies will be presented.

ROC curves in clinical chemistry: uses, misuses, and possible solutions.

PubMed

Obuchowski, Nancy A; Lieber, Michael L; Wians, Frank H

2004-07-01

ROC curves have become the standard for describing and comparing the accuracy of diagnostic tests. Not surprisingly, ROC curves are used often by clinical chemists. Our aims were to observe how the accuracy of clinical laboratory diagnostic tests is assessed, compared, and reported in the literature; to identify common problems with the use of ROC curves; and to offer some possible solutions. We reviewed every original work using ROC curves and published in Clinical Chemistry in 2001 or 2002. For each article we recorded phase of the research, prospective or retrospective design, sample size, presence/absence of confidence intervals (CIs), nature of the statistical analysis, and major analysis problems. Of 58 articles, 31% were phase I (exploratory), 50% were phase II (challenge), and 19% were phase III (advanced) studies. The studies increased in sample size from phase I to III and showed a progression in the use of prospective designs. Most phase I studies were powered to assess diagnostic tests with ROC areas >/=0.70. Thirty-eight percent of studies failed to include CIs for diagnostic test accuracy or the CIs were constructed inappropriately. Thirty-three percent of studies provided insufficient analysis for comparing diagnostic tests. Other problems included dichotomization of the gold standard scale and inappropriate analysis of the equivalence of two diagnostic tests. We identify available software and make some suggestions for sample size determination, testing for equivalence in diagnostic accuracy, and alternatives to a dichotomous classification of a continuous-scale gold standard. More methodologic research is needed in areas specific to clinical chemistry.

Invited review: study design considerations for clinical research in veterinary radiology and radiation oncology.

PubMed

Scrivani, Peter V; Erb, Hollis N

2013-01-01

High quality clinical research is essential for advancing knowledge in the areas of veterinary radiology and radiation oncology. Types of clinical research studies may include experimental studies, method-comparison studies, and patient-based studies. Experimental studies explore issues relative to pathophysiology, patient safety, and treatment efficacy. Method-comparison studies evaluate agreement between techniques or between observers. Patient-based studies investigate naturally acquired disease and focus on questions asked in clinical practice that relate to individuals or populations (e.g., risk, accuracy, or prognosis). Careful preplanning and study design are essential in order to achieve valid results. A key point to planning studies is ensuring that the design is tailored to the study objectives. Good design includes a comprehensive literature review, asking suitable questions, selecting the proper sample population, collecting the appropriate data, performing the correct statistical analyses, and drawing conclusions supported by the available evidence. Most study designs are classified by whether they are experimental or observational, longitudinal or cross-sectional, and prospective or retrospective. Additional features (e.g., controlled, randomized, or blinded) may be described that address bias. Two related challenging aspects of study design are defining an important research question and selecting an appropriate sample population. The sample population should represent the target population as much as possible. Furthermore, when comparing groups, it is important that the groups are as alike to each other as possible except for the variables of interest. Medical images are well suited for clinical research because imaging signs are categorical or numerical variables that might be predictors or outcomes of diseases or treatments. © 2013 Veterinary Radiology & Ultrasound.

Hepatitis C Among Clients of Health Care for the Homeless Primary Care Clinics

PubMed Central

Strehlow, Aaron J; Robertson, Marjorie J.; Zerger, Suzanne; Rongey, Catherine; Arangua, Lisa; Farrell, Ed; O’Sullivan, Adele; Gelberg, Lillian

2013-01-01

Objectives To describe the prevalence, distribution and risk factors for hepatitis C virus (HCV) infection among homeless adults using eight Health Care for the Homeless (HCH) clinics nationally. Methods Data were collected for 387 participants through blood draws, structured interviews, chart reviews. Results Overall prevalence of HCV-antibody positivity was 31.0%, including 70.0% among injection drug users and 15.5% among reported non-injectors. Much HCV infection was “hidden” as the majority (53.3%) of HCV-antibody positive participants was unaware of their status. Independent risk factors for HCV among the total sample included injection drug use, prison and tattoos; among injectors, risk factors included prison and ≥ 3 years of injection drug use; and among reported non-injectors, risk factors included tattoos and prison. Conclusion These HCH clinics serve high concentrations of HCV-infected injectors, making these and similar clinics priority intervention sites for aggressive screening, education, testing, and treatment for HCV and other blood-borne diseases. PMID:22643626

Gathering Opinions on Depression Information Needs and Preferences: Samples and Opinions in Clinic Versus Web-Based Surveys.

PubMed

Bernstein, Matthew T; Walker, John R; Sexton, Kathryn A; Katz, Alan; Beatie, Brooke E

2017-04-24

There has been limited research on the information needs and preferences of the public concerning treatment for depression. Very little research is available comparing samples and opinions when recruitment for surveys is done over the Web as opposed to a personal invitation to complete a paper survey. This study aimed to (1) to explore information needs and preferences among members of the public and (2) compare Clinic and Web samples on sample characteristics and survey findings. Web survey participants were recruited with a notice on three self-help association websites (N=280). Clinic survey participants were recruited by a research assistant in the waiting rooms of a family medicine clinic and a walk-in medical clinic (N=238) and completed a paper version of the survey. The Clinic and Web samples were similar in age (39.0 years, SD 13.9 vs 40.2 years, SD 12.5, respectively), education, and proportion in full time employment. The Clinic sample was more diverse in demographic characteristics and closer to the demographic characteristics of the region (Winnipeg, Canada) with a higher proportion of males (102/238 [42.9%] vs 45/280 [16.1%]) and nonwhites (Aboriginal, Asian, and black) (69/238 [29.0%] vs 39/280 [13.9%]). The Web sample reported a higher level of emotional distress and had more previous psychological (224/280 [80.0%] vs 83/238 [34.9%]) and pharmacological (202/280 [72.1%] vs 57/238 [23.9%]) treatment. In terms of opinions, most respondents in both settings saw information on a wide range of topics around depression treatment as very important including information about treatment choices, effectiveness of treatment, how long it takes treatment to work, how long treatment continues, what happens when treatment stops, advantages and disadvantages of treatments, and potential side effects. Females, respondents with a white background, and those who had received or felt they would have benefited from therapy in the past saw more information topics as very important. Those who had received or thought they would have benefited in the past from medication treatment saw fewer topics as important. Participants in both groups expressed an interest in receiving information through discussion with a counselor or a physician, through written brochures, or through a recommended website. The recruitment strategies were helpful in obtaining opinions from members of the public with different concerns and perspectives, and the results from the two methods were complementary. Persons coping with emotional distress and individuals not specifically seeking help for depression would be interested in information to answer a wide range of important questions about depression treatment. The Clinic sample yielded more cultural diversity that is a closer match to the population. The Web sample was less costly to recruit and included persons who were most interested in receiving information. ©Matthew T Bernstein, John R Walker, Kathryn A Sexton, Alan Katz, Brooke E Beatie, Mobilizing Minds Research Group. Originally published in JMIR Mental Health (http://mental.jmir.org), 24.04.2017.

Relationship between dietary intake and behaviors with oxytocin: a systematic review of studies in adults.

PubMed

Skinner, Janelle A; Garg, Manohar L; Dayas, Christopher V; Fenton, Sasha; Burrows, Tracy L

2018-05-01

Oxytocin plays an important hormonal role in the regulation of feeding and energy intake. The aims of this review were to 1) determine the effects of dietary intake/behaviors on endogenous oxytocin and 2) examine the effect of exogenous oxytocin on dietary intake/behaviors. Published studies up to December 2016 were identified through searches of 5 electronic databases. Eligible studies included those in adults that included a measure related to an individual's diet and a measure of oxytocin and the relationship between the 2 outcomes. Twenty-six studies (n = 912 participants; 77% female) were included. The most common dietary outcomes assessed were alcohol, caffeine, calcium, sodium, fat, and calorie intake. It was found that endogenous oxytocin (n = 13) in nonclinical samples did not change significantly (P > 0.05) through altered diet or behaviors (neutral effect); in contrast, significant (P < 0.05) differences (increases and decreases) were identified in clinical samples. Exogenous oxytocin studies (n = 13) found reduced indices of food intake (positive effect) in clinical and nonclinical samples. Overall, few studies included comprehensive investigation of dietary intakes through the use of validated assessment tools. Dietary intake and behaviors appear to have some influence on oxytocin, with more pronounced effects found with exogenously administered oxytocin.

ClinicalKey 2.0: Upgrades in a Point-of-Care Search Engine.

PubMed

Huslig, Mary Ann; Vardell, Emily

2015-01-01

ClinicalKey 2.0, launched September 23, 2014, offers a mobile-friendly design with a search history feature for targeting point-of-care resources for health care professionals. Browsing is improved with searchable, filterable listings of sources highlighting new resources. ClinicalKey 2.0 improvements include more than 1,400 new Topic Pages for quick access to point-of-care content. A sample search details some of the upgrades and content options.

Application of an oligonucleotide microarray-based nano-amplification technique for the detection of fungal pathogens.

PubMed

Lu, Weiping; Gu, Dayong; Chen, Xingyun; Xiong, Renping; Liu, Ping; Yang, Nan; Zhou, Yuanguo

2010-10-01

The traditional techniques for diagnosis of invasive fungal infections in the clinical microbiology laboratory need improvement. These techniques are prone to delay results due to their time-consuming process, or result in misidentification of the fungus due to low sensitivity or low specificity. The aim of this study was to develop a method for the rapid detection and identification of fungal pathogens. The internal transcribed spacer two fragments of fungal ribosomal DNA were amplified using a polymerase chain reaction for all samples. Next, the products were hybridized with the probes immobilized on the surface of a microarray. These species-specific probes were designed to detect nine different clinical pathogenic fungi including Candida albicans, Candida tropocalis, Candida glabrata, Candida parapsilosis, Candida krusei, Candida lusitaniae, Candida guilliermondii, Candida keyfr, and Cryptococcus neoformans. The hybridizing signals were enhanced with gold nanoparticles and silver deposition, and detected using a flatbed scanner or visually. Fifty-nine strains of fungal pathogens, including standard and clinically isolated strains, were correctly identified by this method. The sensitivity of the assay for Candida albicans was 10 cells/mL. Ten cultures from clinical specimens and 12 clinical samples spiked with fungi were also identified correctly. This technique offers a reliable alternative to conventional methods for the detection and identification of fungal pathogens. It has higher efficiency, specificity and sensitivity compared with other methods commonly used in the clinical laboratory.

Estimation of clinical trial success rates and related parameters.

PubMed

Wong, Chi Heem; Siah, Kien Wei; Lo, Andrew W

2018-01-31

Previous estimates of drug development success rates rely on relatively small samples from databases curated by the pharmaceutical industry and are subject to potential selection biases. Using a sample of 406 038 entries of clinical trial data for over 21 143 compounds from January 1, 2000 to October 31, 2015, we estimate aggregate clinical trial success rates and durations. We also compute disaggregated estimates across several trial features including disease type, clinical phase, industry or academic sponsor, biomarker presence, lead indication status, and time. In several cases, our results differ significantly in detail from widely cited statistics. For example, oncology has a 3.4% success rate in our sample vs. 5.1% in prior studies. However, after declining to 1.7% in 2012, this rate has improved to 2.5% and 8.3% in 2014 and 2015, respectively. In addition, trials that use biomarkers in patient-selection have higher overall success probabilities than trials without biomarkers. © The Author 2018. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

φ(2)GFP10, a high-intensity fluorophage, enables detection and rapid drug susceptibility testing of Mycobacterium tuberculosis directly from sputum samples.

PubMed

Jain, Paras; Hartman, Travis E; Eisenberg, Nell; O'Donnell, Max R; Kriakov, Jordan; Govender, Karnishree; Makume, Mantha; Thaler, David S; Hatfull, Graham F; Sturm, A Willem; Larsen, Michelle H; Moodley, Preshnie; Jacobs, William R

2012-04-01

The difficulty of diagnosing active tuberculosis (TB) and lack of rapid drug susceptibility testing (DST) at the point of care remain critical obstacles to TB control. This report describes a high-intensity mycobacterium-specific-fluorophage (φ(2)GFP10) that for the first time allows direct visualization of Mycobacterium tuberculosis in clinical sputum samples. Engineered features distinguishing φ(2)GFP10 from previous reporter phages include an improved vector backbone with increased cloning capacity and superior expression of fluorescent reporter genes through use of an efficient phage promoter. φ(2)GFP10 produces a 100-fold increase in fluorescence per cell compared to existing reporter phages. DST for isoniazid and oxofloxacin, carried out in cultured samples, was complete within 36 h. Use of φ(2)GFP10 detected M. tuberculosis in clinical sputum samples collected from TB patients. DST for rifampin and kanamycin from sputum samples yielded results after 12 h of incubation with φ(2)GFP10. Fluorophage φ(2)GFP10 has potential for clinical development as a rapid, sensitive, and inexpensive point-of-care diagnostic tool for M. tuberculosis infection and for rapid DST.

Points to consider: efficacy and safety evaluations in the clinical development of ultra-orphan drugs.

PubMed

Maeda, Kojiro; Kaneko, Masayuki; Narukawa, Mamoru; Arato, Teruyo

2017-08-23

The unmet medical needs of individuals with very rare diseases are high. The clinical trial designs and evaluation methods used for 'regular' drugs are not applicable in the clinical development of ultra-orphan drugs (<1000 patients) in many cases. In order to improve the clinical development of ultra-orphan drugs, we examined several points regarding the efficient evaluations of drug efficacy and safety that could be conducted even with very small sample sizes, based on the review reports of orphan drugs approved in Japan. The clinical data packages of 43 ultra-orphan drugs approved in Japan from January 2001 to December 2014 were investigated. Japanese clinical trial data were not included in the clinical data package for eight ultra-orphan drugs, and non-Japanese clinical trial data were included for six of these eight drug. Japanese supportive data that included retrospective studies, published literature, clinical research and Japanese survey results were clinical data package attachments in 22 of the 43 ultra-orphan drugs. Multinational trials were conducted for three ultra-orphan drugs. More than two randomized controlled trials (RCTs) were conducted for only 11 of the 43 ultra-orphan drugs. The smaller the number of patients, the greater the proportion of forced titration and optional titration trials were conducted. Extension trials were carried out for enzyme preparations and monoclonal antibodies with high ratio. Post-marketing surveillance of all patients was required in 36 of the 43 ultra-orphan drugs. For ultra-orphan drugs, clinical endpoints were used as the primary efficacy endpoint of the pivotal trial only for two drugs. The control groups in RCTs were classified as follows: placebo groups different dosage groups, and active controls groups. Sample sizes have been determined on the basis of feasibility for some ultra-orphan drugs. We provide "Draft Guidance on the Clinical Development of Ultra-Orphan Drugs" based on this research. The development of ultra-orphan drugs requires various arrangements regarding evidence collection, data sources and the clinical trial design. We expect that this draft guidance is useful for ultra-orphan drugs developments in future.

Simultaneous immunostaining with anti-S100P and anti-SV40 antibodies revealed the origin of BK virus-infected decoy cells in voided urine samples.

PubMed

Ariyasu, S; Yanai, H; Sato, M; Shinno, Y; Taniguchi, K; Yamadori, I; Miki, Y; Sato, Y; Yoshino, T; Takahashi, K

2015-08-01

Methods for determining the origin of BK virus (BKV)-infected cells (decoy cells) in clinical urine samples have not been established although they could enhance the diagnosis of BKV infection in immunocompromised patients. We performed simultaneous immunostaining with anti-S100P (a urothelial marker) and anti-SV40 antibodies in 66 clinical urine samples exhibiting SV40 positivity and a decoy-cell appearance on Papanicolaou staining. The clinical voided urine samples included seven cases of renal transplantation, 47 cases of cancer therapy and 12 cases of non-neoplastic disease. SurePath(™) liquid-based cytology was used for the urine samples. BKV-infected cells were categorized as SV40(+)/S100P(+) and SV40 (+)/S100p(-). SV40(+)/S100P(-) cells were found in 55 cases (83.4%); nine cases (13.6%) carried both SV40(+)/S100P(-) and SV40(+)/S100P(+) cells. The former were identified as BKV infection in renal tubules and the latter in both the renal tubules and urothelial epithelia. The remaining two cases (3.0%) had only SV40(+)/S100P(+) cells of urothelial origin. Simultaneous immunostaining with anti-S100P and anti-SV40 is a useful method for determining the origin of BKV-infected cells in clinical urine samples from immunocompromised patients such as renal transplantation recipients. © 2014 John Wiley & Sons Ltd.

Early detection of the growth of Mycobacterium tuberculosis using magnetophoretic immunoassay in liquid culture.

PubMed

Kim, Jeonghyo; Lee, Kil-Soo; Kim, Eun Bee; Paik, Seungwha; Chang, Chulhun L; Park, Tae Jung; Kim, Hwa-Jung; Lee, Jaebeom

2017-10-15

Tuberculosis (TB) is an often neglected, epidemic disease that remains to be controlled by contemporary techniques of medicine and biotechnology. In this study, a nanoscale sensing system, referred to as magnetophoretic immunoassay (MPI) was designed to capture culture filtrate protein (CFP)-10 antigens effectively using two different types of nanoparticles (NPs). Two specific monoclonal antibodies against CFP-10 antigen were used, including gold NPs for signaling and magnetic particles for separation. These results were carefully compared with those obtained using the commercial mycobacteria growth indicator tube (MGIT) test via 2 sequential clinical tests (with ca. 260 clinical samples). The sensing linearity of MPI was shown in the range of pico- to micromoles and the detection limit was 0.3pM. MPI using clinical samples shows robust and reliable sensing while monitoring Mycobacterium tuberculosis (MTB) growth with monitoring time 3-10 days) comparable to that with the MGIT test. Furthermore, MPI distinguished false-positive samples from MGIT-positive samples, probably containing non-tuberculous mycobacteria. Thus, MPI shows promise in early TB diagnosis. Copyright © 2017 Elsevier B.V. All rights reserved.

Establishment of Kawasaki disease database based on metadata standard.

PubMed

Park, Yu Rang; Kim, Jae-Jung; Yoon, Young Jo; Yoon, Young-Kwang; Koo, Ha Yeong; Hong, Young Mi; Jang, Gi Young; Shin, Soo-Yong; Lee, Jong-Keuk

2016-07-01

Kawasaki disease (KD) is a rare disease that occurs predominantly in infants and young children. To identify KD susceptibility genes and to develop a diagnostic test, a specific therapy, or prevention method, collecting KD patients' clinical and genomic data is one of the major issues. For this purpose, Kawasaki Disease Database (KDD) was developed based on the efforts of Korean Kawasaki Disease Genetics Consortium (KKDGC). KDD is a collection of 1292 clinical data and genomic samples of 1283 patients from 13 KKDGC-participating hospitals. Each sample contains the relevant clinical data, genomic DNA and plasma samples isolated from patients' blood, omics data and KD-associated genotype data. Clinical data was collected and saved using the common data elements based on the ISO/IEC 11179 metadata standard. Two genome-wide association study data of total 482 samples and whole exome sequencing data of 12 samples were also collected. In addition, KDD includes the rare cases of KD (16 cases with family history, 46 cases with recurrence, 119 cases with intravenous immunoglobulin non-responsiveness, and 52 cases with coronary artery aneurysm). As the first public database for KD, KDD can significantly facilitate KD studies. All data in KDD can be searchable and downloadable. KDD was implemented in PHP, MySQL and Apache, with all major browsers supported.Database URL: http://www.kawasakidisease.kr. © The Author(s) 2016. Published by Oxford University Press.

Increased prevalence of vegetarianism among women with eating pathology.

PubMed

Zuromski, Kelly L; Witte, Tracy K; Smith, April R; Goodwin, Natalie; Bodell, Lindsay P; Bartlett, Mary; Siegfried, Nicole

2015-12-01

Prior research has established a link between vegetarianism and disordered eating but has typically sampled vegetarians. This study examined prevalence of and variables related to vegetarianism in three samples with varying severity of eating pathology. Sample 1 consisted of female undergraduates who denied history of or current disordered eating (i.e., nonclinical; n=73), or engaged in disordered eating over past month (i.e., subclinical; n=136). Sample 2 included 69 female patients receiving residential treatment at an eating disorder center (i.e., clinical sample). Differences between groups were analyzed using Fisher's exact test. The prevalence of lifetime vegetarianism was lowest in the nonclinical group (6.80%) and highest in the clinical group (34.80%), with the subclinical group falling in between (17.60%). According to Fisher's exact test, all pairwise comparisons between groups were statistically significant (p's<.05). Regarding current vegetarian status, the clinical group was more likely (11.10%) than both other groups to self-identify as current vegetarians. Endorsement of vegetarianism was highest among females with severe eating pathology. Future research should use longitudinal data to examine the temporal relationship between these variables, or other underlying factors that may contribute to the co-occurrence of eating pathology and vegetarianism. Clinically, endorsement of vegetarianism may also be an important variable to consider in treatment disordered eating. Copyright © 2015 Elsevier Ltd. All rights reserved.

An Optimized Set of Fluorescence In Situ Hybridization Probes for Detection of Pancreatobiliary Tract Cancer in Cytology Brush Samples.

PubMed

Barr Fritcher, Emily G; Voss, Jesse S; Brankley, Shannon M; Campion, Michael B; Jenkins, Sarah M; Keeney, Matthew E; Henry, Michael R; Kerr, Sarah M; Chaiteerakij, Roongruedee; Pestova, Ekaterina V; Clayton, Amy C; Zhang, Jun; Roberts, Lewis R; Gores, Gregory J; Halling, Kevin C; Kipp, Benjamin R

2015-12-01

Pancreatobiliary cancer is detected by fluorescence in situ hybridization (FISH) of pancreatobiliary brush samples with UroVysion probes, originally designed to detect bladder cancer. We designed a set of new probes to detect pancreatobiliary cancer and compared its performance with that of UroVysion and routine cytology analysis. We tested a set of FISH probes on tumor tissues (cholangiocarcinoma or pancreatic carcinoma) and non-tumor tissues from 29 patients. We identified 4 probes that had high specificity for tumor vs non-tumor tissues; we called this set of probes pancreatobiliary FISH. We performed a retrospective analysis of brush samples from 272 patients who underwent endoscopic retrograde cholangiopancreatography for evaluation of malignancy at the Mayo Clinic; results were available from routine cytology and FISH with UroVysion probes. Archived residual specimens were retrieved and used to evaluate the pancreatobiliary FISH probes. Cutoff values for FISH with the pancreatobiliary probes were determined using 89 samples and validated in the remaining 183 samples. Clinical and pathologic evidence of malignancy in the pancreatobiliary tract within 2 years of brush sample collection was used as the standard; samples from patients without malignancies were used as negative controls. The validation cohort included 85 patients with malignancies (46.4%) and 114 patients with primary sclerosing cholangitis (62.3%). Samples containing cells above the cutoff for polysomy (copy number gain of ≥2 probes) were classified as positive in FISH with the UroVysion and pancreatobiliary probes. Multivariable logistic regression was used to estimate associations between clinical and pathology findings and results from FISH. The combination of FISH probes 1q21, 7p12, 8q24, and 9p21 identified cancer cells with 93% sensitivity and 100% specificity in pancreatobiliary tissue samples and were therefore included in the pancreatobiliary probe set. In the validation cohort of brush samples, pancreatobiliary FISH identified samples from patients with malignancy with a significantly higher level of sensitivity (64.7%) than the UroVysion probes (45.9%) (P < .001) or routine cytology analysis (18.8%) (P < .001), but similar specificity (92.9%, 90.8%, and 100.0% respectively). Factors significantly associated with detection of carcinoma, in adjusted analyses, included detection of polysomy by pancreatobiliary FISH (P < .001), a mass by cross-sectional imaging (P < .001), cancer cells by routine cytology (overall P = .003), as well as absence of primary sclerosing cholangitis (P = .011). We identified a set of FISH probes that detects cancer cells in pancreatobiliary brush samples from patients with and without primary sclerosing cholangitis with higher levels of sensitivity than UroVysion probes. Cytologic brushing test results and clinical features were independently associated with detection of cancer and might be used to identify patients with pancreatobiliary cancers. Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

Handwashing with soap or alcoholic solutions? A randomized clinical trial of its effectiveness.

PubMed

Zaragoza, M; Sallés, M; Gomez, J; Bayas, J M; Trilla, A

1999-06-01

The effectiveness of an alcoholic solution compared with the standard hygienic handwashing procedure during regular work in clinical wards and intensive care units of a large public university hospital in Barcelona was assessed. A prospective, randomized clinical trial with crossover design, paired data, and blind evaluation was done. Eligible health care workers (HCWs) included permanent and temporary HCWs of wards and intensive care units. From each category, a random sample of persons was selected. HCWs were randomly assigned to regular handwashing (liquid soap and water) or handwashing with the alcoholic solution by using a crossover design. The number of colony-forming units on agar plates from hands printing in 3 different samples was counted. A total of 47 HCWs were included. The average reduction in the number of colony-forming units from samples before handwashing to samples after handwashing was 49.6% for soap and water and 88.2% for the alcoholic solution. When both methods were compared, the average number of colony-forming units recovered after the procedure showed a statistically significant difference in favor of the alcoholic solution (P <.001). The alcoholic solution was well tolerated by HCWs. Overall acceptance rate was classified as "good" by 72% of HCWs after 2 weeks use. Of all HCWs included, 9.3% stated that the use of the alcoholic solution worsened minor pre-existing skin conditions. Although the regular use of hygienic soap and water handwashing procedures is the gold standard, the use of alcoholic solutions is effective and safe and deserves more attention, especially in situations in which the handwashing compliance rate is hampered by architectural problems (lack of sinks) or nursing work overload.

21 CFR 862.2310 - Clinical sample concentrator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Clinical sample concentrator. 862.2310 Section 862...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2310 Clinical sample concentrator. (a) Identification. A clinical sample concentrator is a device...

Methodological requirements for valid tissue-based biomarker studies that can be used in clinical practice.

PubMed

True, Lawrence D

2014-03-01

Paralleling the growth of ever more cost efficient methods to sequence the whole genome in minute fragments of tissue has been the identification of increasingly numerous molecular abnormalities in cancers--mutations, amplifications, insertions and deletions of genes, and patterns of differential gene expression, i.e., overexpression of growth factors and underexpression of tumor suppressor genes. These abnormalities can be translated into assays to be used in clinical decision making. In general terms, the result of such an assay is subject to a large number of variables regarding the characteristics of the available sample, particularities of the used assay, and the interpretation of the results. This review discusses the effects of these variables on assays of tissue-based biomarkers, classified by macromolecule--DNA, RNA (including micro RNA, messenger RNA, long noncoding RNA, protein, and phosphoprotein). Since the majority of clinically applicable biomarkers are immunohistochemically detectable proteins this review focuses on protein biomarkers. However, the principles outlined are mostly applicable to any other analyte. A variety of preanalytical variables impacts on the results obtained, including analyte stability (which is different for different analytes, i.e., DNA, RNA, or protein), period of warm and of cold ischemia, fixation time, tissue processing, sample storage time, and storage conditions. In addition, assay variables play an important role, including reagent specificity (notably but not uniquely an issue concerning antibodies used in immunohistochemistry), technical components of the assay, quantitation, and assay interpretation. Finally, appropriateness of an assay for clinical application is an important issue. Reference is made to publicly available guidelines to improve on biomarker development in general and requirements for clinical use in particular. Strategic goals are formulated in order to improve on the quality of biomarker reporting, including issues of analyte quality, experimental detail, assay efficiency and precision, and assay appropriateness.

Molecular and Parasitological Survey of Bovine Piroplasms in the Black Sea Region, Including the First Report of Babesiosis Associated with Babesia divergens in Turkey.

PubMed

Aktas, M; Ozubek, S

2015-11-01

Clinical cases of babesiosis were evaluated, and the frequency of bovine Babesia and Theileria parasites was determined in cattle. Blood samples and thin blood smears were collected from 23 cattle exhibiting clinical signs of babesiosis. In addition, tick and blood samples were collected from 100 apparently healthy cattle cograzing from the same area. Egg masses obtained from fully engorged female ticks were included. DNA isolated from blood and tick samples was screened for Babesia and Theileria by reverse line blot assay. Piroplasms compatible with Babesia spp. were observed microscopically for symptomatic cattle as circular, oval, elongated, or pear-shaped bodies. Parasitemia ranged from 0.08 to 0.9% for Babesia bovis, 2.5 to 15.4% for Babesia bigemina, and 7.4% for Babesia divergens. Reverse line blot showed positivity in 13 (13%) of the sampled clinically normal cattle and revealed the presence of three Babesia species. Babesia bovis was the most prevalent (9/100, 9%), followed by Babesia occultans (3/100, 3%) and B. bigemina (1/100, 1%). One animal infected with B. bigemina was also infected with B. bovis. The single animal infected with B. divergens showed symptoms of babesiosis. Ticks were identified as Rhipicephalus annulatus, Rhipicephalus turanicus, and Ixodes ricinus. One female R. annulatus and its egg mass were infected with B. bigemina. Neither Theileria annulata nor Theileria buffeli/orientalis infections were observed in cattle or ticks. This is the first report of clinical babesiosis caused by B. divergens in cattle from Turkey. © The Authors 2015. Published by Oxford University Press on behalf of Entomological Society of America. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Relating oxygen partial pressure, saturation and content: the haemoglobin-oxygen dissociation curve.

PubMed

Collins, Julie-Ann; Rudenski, Aram; Gibson, John; Howard, Luke; O'Driscoll, Ronan

2015-09-01

The delivery of oxygen by arterial blood to the tissues of the body has a number of critical determinants including blood oxygen concentration (content), saturation (S O2 ) and partial pressure, haemoglobin concentration and cardiac output, including its distribution. The haemoglobin-oxygen dissociation curve, a graphical representation of the relationship between oxygen satur-ation and oxygen partial pressure helps us to understand some of the principles underpinning this process. Historically this curve was derived from very limited data based on blood samples from small numbers of healthy subjects which were manipulated in vitro and ultimately determined by equations such as those described by Severinghaus in 1979. In a study of 3524 clinical specimens, we found that this equation estimated the S O2 in blood from patients with normal pH and S O2 >70% with remarkable accuracy and, to our knowledge, this is the first large-scale validation of this equation using clinical samples. Oxygen saturation by pulse oximetry (S pO2 ) is nowadays the standard clinical method for assessing arterial oxygen saturation, providing a convenient, pain-free means of continuously assessing oxygenation, provided the interpreting clinician is aware of important limitations. The use of pulse oximetry reduces the need for arterial blood gas analysis (S aO2 ) as many patients who are not at risk of hypercapnic respiratory failure or metabolic acidosis and have acceptable S pO2 do not necessarily require blood gas analysis. While arterial sampling remains the gold-standard method of assessing ventilation and oxygenation, in those patients in whom blood gas analysis is indicated, arterialised capillary samples also have a valuable role in patient care. The clinical role of venous blood gases however remains less well defined.

Hot and steamy: outbreak of Bacillus cereus in Singapore associated with construction work and laundry practices.

PubMed

Balm, M N D; Jureen, R; Teo, C; Yeoh, A E J; Lin, R T P; Dancer, S J; Fisher, D A

2012-08-01

A sudden increase in invasive infections caused by Bacillus cereus group organisms prompted an investigation at the National University Hospital in Singapore. To describe the investigation and management and subsequent difficulties controlling the outbreak. Clinical case reviews were performed on all patients with B. cereus group recovered from clinical samples. Widespread environmental sampling was performed followed by review of hospital ventilation systems, domestic cleaning and laundry practices. B. cereus was recovered from 171 patients during a six-month period coinciding with large-scale construction work beside the hospital. Most patients presented with bacteraemia (146/171; 85.4%) with 46/171 (26.9%) requiring extended treatment courses with vancomycin or other interventions. Sampling confirmed extensive airborne dispersal inside the hospital, including isolation rooms and air-conditioned wards. Hospital linen was heavily contaminated [7403 cfu/cm(2); 95% confidence interval (CI): 6349-8457; for 30 towels sampled], encouraged by inappropriate storage in airtight plastic bags (4437 cfu/cm(2); CI: 3125-5750) compared with storage in porous canvas bags (166 cfu/cm(2); CI: 76-256; P < 0.001). Interventions introduced included revision of laundry practices, transport and storage of hospital linen and towels; bleach-based environmental cleaning; and upgrading of ventilation systems throughout the hospital. Clinical case numbers returned to baseline levels within three months, only to rise again following relaxation of laundry practices. Construction work beside this Singapore hospital encouraged heavy contamination of air and environment with Bacillus spp., assumed to be responsible for the outbreak described. Failure to maintain revised laundry practices allowed resurgence of clinical cases, particularly among immunocompromised patients. Copyright © 2012 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Clinical Assessment of a Nocardia PCR-Based Assay for Diagnosis of Nocardiosis.

PubMed

Rouzaud, Claire; Rodriguez-Nava, Véronica; Catherinot, Emilie; Méchaï, Frédéric; Bergeron, Emmanuelle; Farfour, Eric; Scemla, Anne; Poirée, Sylvain; Delavaud, Christophe; Mathieu, Daniel; Durupt, Stéphane; Larosa, Fabrice; Lengelé, Jean-Philippe; Christophe, Jean-Louis; Suarez, Felipe; Lortholary, Olivier; Lebeaux, David

2018-06-01

The diagnosis of nocardiosis, a severe opportunistic infection, is challenging. We assessed the specificity and sensitivity of a 16S rRNA Nocardia PCR-based assay performed on clinical samples. In this multicenter study (January 2014 to April 2015), patients who were admitted to three hospitals and had an underlying condition favoring nocardiosis, clinical and radiological signs consistent with nocardiosis, and a Nocardia PCR assay result for a clinical sample were included. Patients were classified as negative control (NC) (negative Nocardia culture results and proven alternative diagnosis or improvement at 6 months without anti- Nocardia treatment), positive control (PC) (positive Nocardia culture results), or probable nocardiosis (positive Nocardia PCR results, negative Nocardia culture results, and no alternative diagnosis). Sixty-eight patients were included; 47 were classified as NC, 8 as PC, and 13 as probable nocardiosis. PCR results were negative for 35/47 NC patients (74%). For the 12 NC patients with positive PCR results, the PCR assay had been performed with respiratory samples. These NC patients had chronic bronchopulmonary disease more frequently than did the NC patients with negative PCR results (8/12 patients [67%] versus 11/35 patients [31%]; P = 0.044). PCR results were positive for 7/8 PC patients (88%). There were 13 cases of probable nocardiosis, diagnosed solely using the PCR results; 9 of those patients (69%) had lung involvement (consolidation or nodule). Nocardia PCR testing had a specificity of 74% and a sensitivity of 88% for the diagnosis of nocardiosis. Nocardia PCR testing may be helpful for the diagnosis of nocardiosis in immunocompromised patients but interpretation of PCR results from respiratory samples is difficult, because the PCR assay may also detect colonization. Copyright © 2018 American Society for Microbiology.

Stressful Life Events in a Clinical Sample of Depressed Children in Hungary

PubMed Central

Mayer, László; Lopez-Duran, Nestor L.; Kovacs, Maria; George, Charles; Baji, Ildikó; Kapornai, Krisztina; Kiss, Enikő; Vetró, Ágnes

2009-01-01

Background There is limited information on the characteristics of stressful life events in depressed pediatric clinical populations and the extent to which sex, age, and their interactions may influence the relations of life events and depression. Using a very large clinical sample of children and adolescents with major depressive disorder (MDD), we therefore examined life events in various ways as well as their relations to age and sex. Method The study included a clinic-based sample of 434 children (ages 7–14) with a DSM-IV diagnosis of MDD and their mothers, and a school-based comparison sample of 724 children and their mothers. Life event information was obtained from the mothers. Results Children with MDD had twice the number of lifetime stressful events than did the comparison group, with very high levels of stressors by the age of 7–9 that stabilized across adolescence. In contrast, the comparison sample experienced a gradual increase in stressful life events as a function of age up to mid-adolescence. Parental health events, death of close relatives, and intra-familial events were significantly associated with MDD diagnosis. There were significantly stronger associations between parental health- as well as death-event clusters and MDD diagnosis among younger children than adolescents. Limitations Geographical differences between the clinical and comparison samples, as well as possible parental reporting biases may affect the generalizability of these findings. Conclusion The association between some stressful life events and MDD seems to be moderated by age, underscoring the need to examine specific events, as well as clusters of events. Better understanding of such interactions may facilitate early identification of possible risk factors for pediatric MDD. PMID:18845343

Stressful life events in a clinical sample of depressed children in Hungary.

PubMed

Mayer, László; Lopez-Duran, Nestor L; Kovacs, Maria; George, Charles J; Baji, Ildikó; Kapornai, Krisztina; Kiss, Eniko; Vetró, Agnes

2009-05-01

There is limited information on the characteristics of stressful life events in depressed pediatric clinical populations and the extent to which sex, age, and their interactions may influence the relations of life events and depression. Using a very large clinical sample of children and adolescents with major depressive disorder (MDD), we therefore examined life events in various ways, as well as their relations to age and sex. The study included a clinic-based sample of 434 children (ages 7-14) with a DSM-IV diagnosis of MDD and their mothers, and a school-based comparison sample of 724 children and their mothers. Life event information was obtained from the mothers. Children with MDD had twice the number of lifetime stressful events than did the comparison group, with very high levels of stressors by the age of 7-9 that stabilized across adolescence. In contrast, the comparison sample experienced a gradual increase in stressful life events as a function of age up to mid-adolescence. Parental health events, death of close relatives, and intrafamilial events were significantly associated with MDD diagnosis. There were significantly stronger associations between parental health- as well as death-event clusters and MDD diagnosis among younger children than adolescents. Geographical differences between the clinical and comparison samples, as well as possible parental reporting biases may affect the generalizability of these findings. The association between some stressful life events and MDD seems to be moderated by age, underscoring the need to examine specific events, as well as clusters of events. Better understanding of such interactions may facilitate early identification of possible risk factors for pediatric MDD.

Standardization of pathologic evaluation and reporting of postneoadjuvant specimens in clinical trials of breast cancer: recommendations from an international working group.

PubMed

Provenzano, Elena; Bossuyt, Veerle; Viale, Giuseppe; Cameron, David; Badve, Sunil; Denkert, Carsten; MacGrogan, Gaëtan; Penault-Llorca, Frédérique; Boughey, Judy; Curigliano, Giuseppe; Dixon, J Michael; Esserman, Laura; Fastner, Gerd; Kuehn, Thorsten; Peintinger, Florentia; von Minckwitz, Gunter; White, Julia; Yang, Wei; Symmans, W Fraser

2015-09-01

Neoadjuvant systemic therapy is being used increasingly in the treatment of early-stage breast cancer. Response, in the form of pathological complete response, is a validated and evaluable surrogate end point of survival after neoadjuvant therapy. Thus, pathological complete response has become a primary end point for clinical trials. However, there is a current lack of uniformity in the definition of pathological complete response. A review of standard operating procedures used by 28 major neoadjuvant breast cancer trials and/or 25 sites involved in such trials identified marked variability in specimen handling and histologic reporting. An international working group was convened to develop practical recommendations for the pathologic assessment of residual disease in neoadjuvant clinical trials of breast cancer and information expected from pathology reports. Systematic sampling of areas identified by informed mapping of the specimen and close correlation with radiological findings is preferable to overly exhaustive sampling, and permits taking tissue samples for translational research. Controversial areas are discussed, including measurement of lesion size, reporting of lymphovascular space invasion and the presence of isolated tumor cells in lymph nodes after neoadjuvant therapy, and retesting of markers after treatment. If there has been a pathological complete response, this must be clearly stated, and the presence/absence of residual ductal carcinoma in situ must be described. When there is residual invasive carcinoma, a comment must be made as to the presence/absence of chemotherapy effect in the breast and lymph nodes. The Residual Cancer Burden is the preferred method for quantifying residual disease in neoadjuvant clinical trials in breast cancer; other methods can be included per trial protocols and regional preference. Posttreatment tumor staging using the Tumor-Node-Metastasis system should be included. These recommendations for standardized pathological evaluation and reporting of neoadjuvant breast cancer specimens should improve prognostication for individual patients and allow comparison of treatment outcomes within and across clinical trials.

Is a 'convenience' sample useful for estimating immunization coverage in a small population?

PubMed

Weir, Jean E; Jones, Carrie

2008-01-01

Rapid survey methodologies are widely used for assessing immunization coverage in developing countries, approximating true stratified random sampling. Non-random ('convenience') sampling is not considered appropriate for estimating immunization coverage rates but has the advantages of low cost and expediency. We assessed the validity of a convenience sample of children presenting to a travelling clinic by comparing the coverage rate in the convenience sample to the true coverage established by surveying each child in three villages in rural Papua New Guinea. The rate of DTF immunization coverage as estimated by the convenience sample was within 10% of the true coverage when the proportion of children in the sample was two-thirds or when only children over the age of one year were counted, but differed by 11% when the sample included only 53% of the children and when all eligible children were included. The convenience sample may be sufficiently accurate for reporting purposes and is useful for identifying areas of low coverage.

Appropriate Handling, Processing and Analysis of Blood Samples Is Essential to Avoid Oxidation of Vitamin C to Dehydroascorbic Acid

PubMed Central

Pullar, Juliet M.; Carr, Anitra C.

2018-01-01

Vitamin C (ascorbate) is the major water-soluble antioxidant in plasma and its oxidation to dehydroascorbic acid (DHA) has been proposed as a marker of oxidative stress in vivo. However, controversy exists in the literature around the amount of DHA detected in blood samples collected from various patient cohorts. In this study, we report on DHA concentrations in a selection of different clinical cohorts (diabetes, pneumonia, cancer, and critically ill). All clinical samples were collected into EDTA anticoagulant tubes and processed at 4 °C prior to storage at −80 °C for subsequent analysis by HPLC with electrochemical detection. We also investigated the effects of different handling and processing conditions on short-term and long-term ascorbate and DHA stability in vitro and in whole blood and plasma samples. These conditions included metal chelation, anticoagulants (EDTA and heparin), and processing temperatures (ice, 4 °C and room temperature). Analysis of our clinical cohorts indicated very low to negligible DHA concentrations. Samples exhibiting haemolysis contained significantly higher concentrations of DHA. Metal chelation inhibited oxidation of vitamin C in vitro, confirming the involvement of contaminating metal ions. Although EDTA is an effective metal chelator, complexes with transition metal ions are still redox active, thus its use as an anticoagulant can facilitate metal ion-dependent oxidation of vitamin C in whole blood and plasma. Handling and processing blood samples on ice (or at 4 °C) delayed oxidation of vitamin C by a number of hours. A review of the literature regarding DHA concentrations in clinical cohorts highlighted the fact that studies using colourimetric or fluorometric assays reported significantly higher concentrations of DHA compared to those using HPLC with electrochemical detection. In conclusion, careful handling and processing of samples, combined with appropriate analysis, is crucial for accurate determination of ascorbate and DHA in clinical samples. PMID:29439480

Profiling the clinical presentation of diagnostic characteristics of a sample of symptomatic TMD patients.

PubMed

Pimenta e Silva Machado, Luciana; de Macedo Nery, Marianita Batista; de Góis Nery, Cláudio; Leles, Cláudio Rodrigues

2012-08-02

Temporomandibular disorder (TMD) patients might present a number of concurrent clinical diagnoses that may be clustered according to their similarity. Profiling patients' clinical presentations can be useful for better understanding the behavior of TMD and for providing appropriate treatment planning. The aim of this study was to simultaneously classify symptomatic patients diagnosed with a variety of subtypes of TMD into homogenous groups based on their clinical presentation and occurrence of comorbidities. Clinical records of 357 consecutive TMD patients seeking treatment in a private specialized clinic were included in the study sample. Patients presenting multiple subtypes of TMD diagnosed simultaneously were categorized according to the AAOP criteria. Descriptive statistics and two-step cluster analysis were used to characterize the clinical presentation of these patients based on the primary and secondary clinical diagnoses. The most common diagnoses were localized masticatory muscle pain (n = 125) and disc displacement without reduction (n = 104). Comorbidity was identified in 288 patients. The automatic selection of an optimal number of clusters included 100% of cases, generating an initial 6-cluster solution and a final 4-cluster solution. The interpretation of within-group ranking of the importance of variables in the clustering solutions resulted in the following characterization of clusters: chronic facial pain (n = 36), acute muscle pain (n = 125), acute articular pain (n = 75) and chronic articular impairment (n = 121). Subgroups of acute and chronic TMD patients seeking treatment can be identified using clustering methods to provide a better understanding of the clinical presentation of TMD when multiple diagnosis are present. Classifying patients into identifiable symptomatic profiles would help clinicians to estimate how common a disorder is within a population of TMD patients and understand the probability of certain pattern of clinical complaints.

Prion-Seeding Activity in Cerebrospinal Fluid of Deer with Chronic Wasting Disease

PubMed Central

Haley, Nicholas J.; Van de Motter, Alexandra; Carver, Scott; Henderson, Davin; Davenport, Kristen; Seelig, Davis M.; Mathiason, Candace; Hoover, Edward

2013-01-01

Transmissible spongiform encephalopathies (TSEs), or prion diseases, are a uniformly fatal family of neurodegenerative diseases in mammals that includes chronic wasting disease (CWD) of cervids. The early and ante-mortem identification of TSE-infected individuals using conventional western blotting or immunohistochemistry (IHC) has proven difficult, as the levels of infectious prions in readily obtainable samples, including blood and bodily fluids, are typically beyond the limits of detection. The development of amplification-based seeding assays has been instrumental in the detection of low levels of infectious prions in clinical samples. In the present study, we evaluated the cerebrospinal fluid (CSF) of CWD-exposed (n=44) and naïve (n=4) deer (n=48 total) for CWD prions (PrPd) using two amplification assays: serial protein misfolding cyclic amplification with polytetrafluoroethylene beads (sPMCAb) and real-time quaking induced conversion (RT-QuIC) employing a truncated Syrian hamster recombinant protein substrate. Samples were evaluated blindly in parallel with appropriate positive and negative controls. Results from amplification assays were compared to one another and to obex immunohistochemistry, and were correlated to available clinical histories including CWD inoculum source (e.g. saliva, blood), genotype, survival period, and duration of clinical signs. We found that both sPMCAb and RT-QuIC were capable of amplifying CWD prions from cervid CSF, and results correlated well with one another. Prion seeding activity in either assay was observed in approximately 50% of deer with PrPd detected by IHC in the obex region of the brain. Important predictors of amplification included duration of clinical signs and time of first tonsil biopsy positive results, and ultimately the levels of PrPd identified in the obex by IHC. Based on our findings, we expect that both sPMCAb and RT-QuIC may prove to be useful detection assays for the detection of prions in CSF. PMID:24282599

Genomic Investigation of a Legionellosis Outbreak in a Persistently Colonized Hotel.

PubMed

Sánchez-Busó, Leonor; Guiral, Silvia; Crespi, Sebastián; Moya, Víctor; Camaró, María L; Olmos, María P; Adrián, Francisco; Morera, Vicente; González-Morán, Francisco; Vanaclocha, Hermelinda; González-Candelas, Fernando

2015-01-01

A long-lasting legionellosis outbreak was reported between November 2011 and July 2012 in a hotel in Calpe (Spain) affecting 44 patients including six deaths. Intensive epidemiological and microbiological investigations were performed in order to detect the reservoirs. Clinical and environmental samples were tested for the presence and genetic characterization of Legionella pneumophila. Six of the isolates were subjected to whole-genome sequencing. Sequencing of 14 clinical and 260 environmental samples revealed sequence type (ST) 23 as the main responsible strain for the infections. This ST was found in the spa pool, from where it spread to other hotel public spaces, explaining the ST23 clinical cases, including guests who had not visited the spa. Uncultured clinical specimens showed profiles compatible with ST23, ST578, and mixed patterns. Profiles compatible with ST578 were obtained by direct sequencing from biofilm samples collected from the domestic water system, which provided evidence for the source of infection for non ST23 patients. Whole genome data from five ST23 strains and the identification of different STs and Legionella species showed that different hotel premises were likely colonized since the hotel opening thus explaining how different patients had been infected by distinct STs. Both epidemiological and molecular data are essential in the investigation of legionellosis outbreaks. Whole-genome sequencing data revealed significant intra-ST variability and allowed to make further inference on the short-term evolution of a local colonization of L. pneumophila.

Genomic Investigation of a Legionellosis Outbreak in a Persistently Colonized Hotel

PubMed Central

Sánchez-Busó, Leonor; Guiral, Silvia; Crespi, Sebastián; Moya, Víctor; Camaró, María L.; Olmos, María P.; Adrián, Francisco; Morera, Vicente; González-Morán, Francisco; Vanaclocha, Hermelinda; González-Candelas, Fernando

2016-01-01

Objectives: A long-lasting legionellosis outbreak was reported between November 2011 and July 2012 in a hotel in Calpe (Spain) affecting 44 patients including six deaths. Intensive epidemiological and microbiological investigations were performed in order to detect the reservoirs. Methods: Clinical and environmental samples were tested for the presence and genetic characterization of Legionella pneumophila. Six of the isolates were subjected to whole-genome sequencing. Results: Sequencing of 14 clinical and 260 environmental samples revealed sequence type (ST) 23 as the main responsible strain for the infections. This ST was found in the spa pool, from where it spread to other hotel public spaces, explaining the ST23 clinical cases, including guests who had not visited the spa. Uncultured clinical specimens showed profiles compatible with ST23, ST578, and mixed patterns. Profiles compatible with ST578 were obtained by direct sequencing from biofilm samples collected from the domestic water system, which provided evidence for the source of infection for non ST23 patients. Whole genome data from five ST23 strains and the identification of different STs and Legionella species showed that different hotel premises were likely colonized since the hotel opening thus explaining how different patients had been infected by distinct STs. Conclusions: Both epidemiological and molecular data are essential in the investigation of legionellosis outbreaks. Whole-genome sequencing data revealed significant intra-ST variability and allowed to make further inference on the short-term evolution of a local colonization of L. pneumophila. PMID:26834713

Putting Meaning Back Into the Mean: A Comment on the Misuse of Elementary Statistics in a Sample of Manuscripts Submitted to Clinical Therapeutics.

PubMed

Forrester, Janet E

2015-12-01

Errors in the statistical presentation and analyses of data in the medical literature remain common despite efforts to improve the review process, including the creation of guidelines for authors and the use of statistical reviewers. This article discusses common elementary statistical errors seen in manuscripts recently submitted to Clinical Therapeutics and describes some ways in which authors and reviewers can identify errors and thus correct them before publication. A nonsystematic sample of manuscripts submitted to Clinical Therapeutics over the past year was examined for elementary statistical errors. Clinical Therapeutics has many of the same errors that reportedly exist in other journals. Authors require additional guidance to avoid elementary statistical errors and incentives to use the guidance. Implementation of reporting guidelines for authors and reviewers by journals such as Clinical Therapeutics may be a good approach to reduce the rate of statistical errors. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

A preliminary investigation of sleep quality in functional neurological disorders: Poor sleep appears common, and is associated with functional impairment.

PubMed

Graham, Christopher D; Kyle, Simon D

2017-07-15

Functional neurological disorders (FND) are disabling conditions for which there are few empirically-supported treatments. Disturbed sleep appears to be part of the FND context; however, the clinical importance of sleep disturbance (extent, characteristics and impact) remains largely unknown. We described sleep quality in two samples, and investigated the relationship between sleep and FND-related functional impairment. We included a sample recruited online via patient charities (N=205) and a consecutive clinical sample (N=20). Participants completed validated measures of sleep quality and sleep characteristics (e.g. total sleep time, sleep efficiency), mood, and FND-related functional impairment. Poor sleep was common in both samples (89% in the clinical range), which was characterised by low sleep efficiency (M=65.40%) and low total sleep time (M=6.05h). In regression analysis, sleep quality was negatively associated with FND-related functional impairment, accounting for 16% of the variance and remaining significant after the introduction of mood variables. These preliminary analyses suggest that subjective sleep disturbance (low efficiency, short sleep) is common in FND. Sleep quality was negatively associated with the functional impairment attributed to FND, independent of depression. Therefore, sleep disturbance may be a clinically important feature of FND. Copyright © 2017 Elsevier B.V. All rights reserved.

Percutaneous CT-guided sacroiliac joint sampling for infection: aspiration, biopsy, and technique.

PubMed

Knipp, David; Simeone, F Joseph; Nelson, Sandra B; Huang, Ambrose J; Chang, Connie Y

2018-04-01

To evaluate methods of CT-guided sacroiliac joint sampling in patients with suspected infection. All CT-guided sacroiliac joint sampling procedures for suspected infection were reviewed for sampling type (aspiration, lavage aspiration, biopsy), microbiology results, and clinical and imaging follow-up. The primary gold standard was anatomic pathology. If pathology was not available, then positive blood culture with the same organism as SIJ sampling, imaging and clinical follow-up, or clinical follow-up only were used. Anterior and posterior joint distention was evaluated by MRI within 7 days of the procedure. A total of 34 patients (age 39 ± 20 (range, 6-75) years; 21 F, 13 M) were included. Aspiration samples only were obtained in 13/34 (38%) cases, biopsy samples only in 9/34 (26%) cases, and both samples in 12/34 (35%) cases. There was an overall 54% sensitivity and 86% specificity. For the aspiration samples, sensitivity and specificity were 60 and 81%, respectively, compared to 45 and 90% for the biopsy samples. In cases with both samples, biopsy did not add additional microbial information. Seventeen (17/34, 50%) patients had an MRI. The anterior joint was more distended than the posterior joint in 15/17 (88%) of patients, and this difference was significant (P = 0.0003). All of these 17 patients had an attempted aspiration by a posterior approach; 6/17 (35%) resulted in a successful aspiration. Aspiration of the sacroiliac joint has a higher sensitivity than biopsy and should always be attempted first. MRI may be helpful for procedure planning.

Long-Term Physical and Mental Health Consequences of Childhood Physical Abuse: Results from a Large Population-Based Sample of Men and Women

ERIC Educational Resources Information Center

Springer, Kristen W.; Sheridan, Jennifer; Kuo, Daphne; Carnes, Molly

2007-01-01

Objective: Child maltreatment has been linked to negative adult health outcomes; however, much past research includes only clinical samples of women, focuses exclusively on sexual abuse and/or fails to control for family background and childhood characteristics, both potential confounders. Further research is needed to obtain accurate,…

Employment among Working-Age Adults with Multiple Sclerosis: A Data-Mining Approach to Identifying Employment Interventions

ERIC Educational Resources Information Center

Bishop, Malachy; Chan, Fong; Rumrill, Phillip D., Jr.; Frain, Michael P.; Tansey, Timothy N.; Chiu, Chung-Yi; Strauser, David; Umeasiegbu, Veronica I.

2015-01-01

Purpose: To examine demographic, functional, and clinical multiple sclerosis (MS) variables affecting employment status in a national sample of adults with MS in the United States. Method: The sample included 4,142 working-age (20-65 years) Americans with MS (79.1% female) who participated in a national survey. The mean age of participants was…

The Structure of Adult ADHD

PubMed Central

Adler, Lenard A.; Faraone, Stephen V.; Spencer, Thomas J.; Berglund, Patricia; Alperin, Samuel; Kessler, Ronald C.

2017-01-01

Although DSM-5 stipulates that symptoms of attention-deficit/hyperactivity disorder (ADHD) are the same for adults as children, clinical observations suggest that adults have more diverse deficits than children in higher-level executive functioning and emotional control. Previous psychometric analyses to evaluate these observations have been limited in ways addressed in the current study, which analyzes the structure of an expanded set of adult ADHD symptoms in 3 pooled U.S. samples: a national household sample, a sample of health plan members, and a sample of adults referred for evaluation at an adult ADHD clinic. Exploratory factor analysis found 4 factors representing executive dysfunction/inattention (including, but not limited to, all the DSM-5 inattentive symptoms, with non-DSM symptoms having factor loadings comparable to those of DSM symptoms), hyperactivity, impulsivity, and emotional dyscontrol. Empirically-derived multivariate symptom profiles were broadly consistent with the DSM-5 inattentive-only, hyperactive/impulsive-only, and combined presentations, but with inattention including executive dysfunction/inattention and hyperactivity-only limited to hyperactivity without high symptoms of impulsivity. These results show that executive dysfunction is as central as DSM-5 symptoms to adult ADHD, while emotional dyscontrol is more distinct but prominent resent in the combined presentation of adult ADHD. PMID:28211596

Generalizability of Evidence-Based Assessment Recommendations for Pediatric Bipolar Disorder

PubMed Central

Jenkins, Melissa M.; Youngstrom, Eric A.; Youngstrom, Jennifer Kogos; Feeny, Norah C.; Findling, Robert L.

2013-01-01

Bipolar disorder is frequently clinically diagnosed in youths who do not actually satisfy DSM-IV criteria, yet cases that would satisfy full DSM-IV criteria are often undetected clinically. Evidence-based assessment methods that incorporate Bayesian reasoning have demonstrated improved diagnostic accuracy, and consistency; however, their clinical utility is largely unexplored. The present study examines the effectiveness of promising evidence-based decision-making compared to the clinical gold standard. Participants were 562 youth, ages 5-17 and predominantly African American, drawn from a community mental health clinic. Research diagnoses combined semi-structured interview with youths’ psychiatric, developmental, and family mental health histories. Independent Bayesian estimates relied on published risk estimates from other samples discriminated bipolar diagnoses, Area Under Curve=.75, p<.00005. The Bayes and confidence ratings correlated rs =.30. Agreement about an evidence-based assessment intervention “threshold model” (wait/assess/treat) had K=.24, p<.05. No potential moderators of agreement between the Bayesian estimates and confidence ratings, including type of bipolar illness, were significant. Bayesian risk estimates were highly correlated with logistic regression estimates using optimal sample weights, r=.81, p<.0005. Clinical and Bayesian approaches agree in terms of overall concordance and deciding next clinical action, even when Bayesian predictions are based on published estimates from clinically and demographically different samples. Evidence-based assessment methods may be useful in settings that cannot routinely employ gold standard assessments, and they may help decrease rates of overdiagnosis while promoting earlier identification of true cases. PMID:22004538

Evaluation of a rapid immunodiagnostic test kit for rabies virus.

PubMed

Kang, BoKyu; Oh, JinSik; Lee, ChulSeung; Park, Bong-Kyun; Park, YoungNam; Hong, KyungSoo; Lee, KyungGi; Cho, ByungKi; Song, DaeSub

2007-10-01

A rapid immunodiagnostic test kit for rabies virus detection was evaluated using 51 clinical samples and 4 isolates of rabies virus. The quick detection of rabies virus under field conditions may be helpful in determining if post-exposure prophylaxis is needed, thereby avoiding unnecessary treatments, as well as undue economic burden. There are several widely used diagnostic methods for rabies, including fluorescent antibody tests, reverse transcription polymerase chain reaction, and electron microscopy; however, these methods include time-consuming, intricate, and costly procedures. The rapid immunodiagnostic test was able to detect rabies virus in clinical samples, including brain tissue and saliva, in addition to 10(3.2) 50% lethal dose (LD(50))/mL cell-adapted rabies virus. The assay was not cross-reactive with non-rabies virus microbes. When the performance of the rapid immunodiagnostic test was compared to a fluorescent antibody test, the rapid immunodiagnostic test had a sensitivity of 91.7% and specificity of 100% (95.8% CI).

Successive potassium hydroxide testing for improved diagnosis of tinea pedis.

PubMed

Karaman, Bilge F; Topal, Suhan G; Aksungur, Varol L; Ünal, İlker; İlkit, Macit

2017-08-01

In this study, we investigated the role of successive potassium hydroxide (KOH) tests for the diagnosis of tinea pedis with different clinical presentations. The study included 135 patients with 200 lesions that were clinically suspicious for tinea pedis. Three samples of skin scrapings were taken from each lesion in the same session and were examined using a KOH test. This study offers an inexpensive, rapid, and useful technique for the daily practice of clinicians and mycologists managing patients with clinically suspected tinea pedis.

Validation of DESS as a DNA Preservation Method for the Detection of Strongyloides spp. in Canine Feces.

PubMed

Beknazarova, Meruyert; Millsteed, Shelby; Robertson, Gemma; Whiley, Harriet; Ross, Kirstin

2017-06-09

Strongyloides stercoralis is a gastrointestinal parasitic nematode with a life cycle that includes free-living and parasitic forms. For both clinical (diagnostic) and environmental evaluation, it is important that we can detect Strongyloides spp. in both human and non-human fecal samples. Real-time PCR is the most feasible method for detecting the parasite in both clinical and environmental samples that have been preserved. However, one of the biggest challenges with PCR detection is DNA degradation during the postage time from rural and remote areas to the laboratory. This study included a laboratory assessment and field validation of DESS (dimethyl sulfoxide, disodium EDTA, and saturated NaCl) preservation of Strongyloides spp. DNA in fecal samples. The laboratory study investigated the capacity of 1:1 and 1:3 sample to DESS ratios to preserve Strongyloides ratti in spike canine feces. It was found that both ratios of DESS significantly prevented DNA degradation compared to the untreated sample. This method was then validated by applying it to the field-collected canine feces and detecting Strongyloides DNA using PCR. A total of 37 canine feces samples were collected and preserved in the 1:3 ratio (sample: DESS) and of these, 17 were positive for Strongyloides spp. The study shows that both 1:1 and 1:3 sample to DESS ratios were able to preserve the Strongyloides spp. DNA in canine feces samples stored at room temperature for up to 56 days. This DESS preservation method presents the most applicable and feasible method for the Strongyloides DNA preservation in field-collected feces.

Differentiating neoplastic from benign lesions of the pancreas: translational techniques.

PubMed

Khalid, Asif

2009-11-01

There has been substantial recent progress in our ability to image and sample the pancreas leading to the improved recognition of benign and premalignant conditions of the pancreas such as autoimmune pancreatitis (AIP) and mucinous lesions (mucinous cystic neoplasms [MCN] and intraductal papillary mucinous neoplasms [IPMN]), respectively. Clinically relevant and difficult situations that continue to be faced in this context include differentiating MCN and IPMN from nonmucinous pancreatic cysts, the early detection of malignant degeneration in MCN and IPMN, and accurate differentiation between pancreatic cancer and inflammatory masses, especially AIP. These challenges arise primarily due to the less than perfect sensitivity for malignancy utilizing cytological samples obtained via EUS and ERCP. Aspirates from pancreatic cysts are often paucicellular further limiting the accuracy of cytology. One approach to improve the diagnostic yield from these very small samples is through the use of molecular techniques. Because the development of pancreatic cancer and malignant degeneration in MCN and IPMN is associated with well studied genetic insults including oncogene activation (eg, k-ras), tumor suppressor gene losses (eg, p53, p16, and DPC4), and genome maintenance gene mutations (eg, BRCA2 and telomerase), detecting these molecular abnormalities may aid in improving our diagnostic accuracy. A number of studies have shown the utility of testing clinical samples from pancreatic lesions and bile duct strictures for these molecular markers of malignancy to differentiate between cancer and inflammation. The information from these studies will be discussed with emphasis on how to use this information in clinical practice.

The relationship between two-dimensional self-esteem and problem solving style in an anorexic inpatient sample.

PubMed

Paterson, Gillian; Power, Kevin; Yellowlees, Alex; Park, Katy; Taylor, Louise

2007-01-01

Research examining cognitive and behavioural determinants of anorexia is currently lacking. This has implications for the success of treatment programmes for anorexics, particularly, given the high reported dropout rates. This study examines two-dimensional self-esteem (comprising of self-competence and self-liking) and social problem-solving in an anorexic population and predicts that self-esteem will mediate the relationship between problem-solving and eating pathology by facilitating/inhibiting use of faulty/effective strategies. Twenty-seven anorexic inpatients and 62 controls completed measures of social problem solving and two-dimensional self-esteem. Anorexics scored significantly higher than the non-clinical group on measures of eating pathology, negative problem orientation, impulsivity/carelessness and avoidance and significantly lower on positive problem orientation and both self-esteem components. In the clinical sample, disordered eating correlated significantly with self-competence, negative problem-orientation and avoidance. Associations between disordered eating and problem solving lost significance when self-esteem was controlled in the clinical group only. Self-competence was found to be the main predictor of eating pathology in the clinical sample while self-liking, impulsivity and negative and positive problem orientation were main predictors in the non-clinical sample. Findings support the two-dimensional self-esteem theory with self-competence only being relevant to the anorexic population and support the hypothesis that self-esteem mediates the relationship between disordered eating and problem solving ability in an anorexic sample. Treatment implications include support for programmes emphasising increasing self-appraisal and self-efficacy. 2006 John Wiley & Sons, Ltd and Eating Disorders Association

The liver tissue bank and clinical database in China.

PubMed

Yang, Yuan; Liu, Yi-Min; Wei, Ming-Yue; Wu, Yi-Fei; Gao, Jun-Hui; Liu, Lei; Zhou, Wei-Ping; Wang, Hong-Yang; Wu, Meng-Chao

2010-12-01

To develop a standardized and well-rounded material available for hepatology research, the National Liver Tissue Bank (NLTB) Project began in 2008 in China to make well-characterized and optimally preserved liver tumor tissue and clinical database. From Dec 2008 to Jun 2010, over 3000 individuals have been enrolled as liver tumor donors to the NLTB, including 2317 cases of newly diagnosed hepatocellular carcinoma (HCC) and about 1000 cases of diagnosed benign or malignant liver tumors. The clinical database and sample store can be managed easily and correctly with the data management platform used. We believe that the high-quality samples with detailed information database will become the cornerstone of hepatology research especially in studies exploring the diagnosis and new treatments for HCC and other liver diseases.

A Review of Inflammatory Processes of the Breast with a Focus on Diagnosis in Core Biopsy Samples

PubMed Central

D’Alfonso, Timothy M.; Ginter, Paula S.; Shin, Sandra J.

2015-01-01

Inflammatory and reactive lesions of the breast are relatively uncommon among benign breast lesions and can be the source of an abnormality on imaging. Such lesions can simulate a malignant process, based on both clinical and radiographic findings, and core biopsy is often performed to rule out malignancy. Furthermore, some inflammatory processes can mimic carcinoma or other malignancy microscopically, and vice versa. Diagnostic difficulty may arise due to the small and fragmented sample of a core biopsy. This review will focus on the pertinent clinical, radiographic, and histopathologic features of the more commonly encountered inflammatory lesions of the breast that can be characterized in a core biopsy sample. These include fat necrosis, mammary duct ectasia, granulomatous lobular mastitis, diabetic mastopathy, and abscess. The microscopic differential diagnoses for these lesions when seen in a core biopsy sample will be discussed. PMID:26095437

A Review of Inflammatory Processes of the Breast with a Focus on Diagnosis in Core Biopsy Samples.

PubMed

D'Alfonso, Timothy M; Ginter, Paula S; Shin, Sandra J

2015-07-01

Inflammatory and reactive lesions of the breast are relatively uncommon among benign breast lesions and can be the source of an abnormality on imaging. Such lesions can simulate a malignant process, based on both clinical and radiographic findings, and core biopsy is often performed to rule out malignancy. Furthermore, some inflammatory processes can mimic carcinoma or other malignancy microscopically, and vice versa. Diagnostic difficulty may arise due to the small and fragmented sample of a core biopsy. This review will focus on the pertinent clinical, radiographic, and histopathologic features of the more commonly encountered inflammatory lesions of the breast that can be characterized in a core biopsy sample. These include fat necrosis, mammary duct ectasia, granulomatous lobular mastitis, diabetic mastopathy, and abscess. The microscopic differential diagnoses for these lesions when seen in a core biopsy sample will be discussed.

Single molecule targeted sequencing for cancer gene mutation detection.

PubMed

Gao, Yan; Deng, Liwei; Yan, Qin; Gao, Yongqian; Wu, Zengding; Cai, Jinsen; Ji, Daorui; Li, Gailing; Wu, Ping; Jin, Huan; Zhao, Luyang; Liu, Song; Ge, Liangjin; Deem, Michael W; He, Jiankui

2016-05-19

With the rapid decline in cost of sequencing, it is now affordable to examine multiple genes in a single disease-targeted clinical test using next generation sequencing. Current targeted sequencing methods require a separate step of targeted capture enrichment during sample preparation before sequencing. Although there are fast sample preparation methods available in market, the library preparation process is still relatively complicated for physicians to use routinely. Here, we introduced an amplification-free Single Molecule Targeted Sequencing (SMTS) technology, which combined targeted capture and sequencing in one step. We demonstrated that this technology can detect low-frequency mutations using artificially synthesized DNA sample. SMTS has several potential advantages, including simple sample preparation thus no biases and errors are introduced by PCR reaction. SMTS has the potential to be an easy and quick sequencing technology for clinical diagnosis such as cancer gene mutation detection, infectious disease detection, inherited condition screening and noninvasive prenatal diagnosis.

IDENTIFICATION OF BACTERIA IN BLOOD CULTURES FROM CLINICALLY ILL CAPTIVE ANTILLEAN MANATEES (TRICHECHUS MANATUS MANATUS).

PubMed

Silva, Mariana C O; Attademo, Fernanda F L; Freire, Augusto C B; Sousa, Glaucia P; Luna, Fábia O; Lima, Débora C V; Mota, Rinaldo A; Mendes, Emiko S; Silva, Jean C R

2017-03-01

Between September 2001 and March 2013, 62 bacterial cultures (37 aerobic and 25 anaerobic) were performed on 37 blood samples from 23 Antillean manatees ( Trichechus manatus manatus) that were kept in captivity at the Brazilian National Center for Research and Conservation of Aquatic Mammals (CMA) in Pernambuco (CMA-PE) and Alagoas (CMA-AL), Brazil. All of the animals sampled exhibited clinical signs at the time of sampling including abscesses (n = 8), debilitation and anorexia (n = 22), and profound lethargy-moribundity (n = 7). The 4 animals with profound lethargy-moribundity died shortly after sampling of unknown causes. Bacteria were isolated from 15/37 (40.5%) and aerobic blood cultures from 13/23 animals (56.5%). None of the anaerobic cultures were positive. Aeromonas caviae , Aeromonas hydrophila , Aeromonas sp., Escherichia coli , Leclercia adecarboxylata , Pantoea agglomerans , Pseudomonas aeruginosa , Pseudomonas stutzeri , Pseudomonas sp., Sphingomonas paucimobilis , coagulase-negative Staphylococcus, and Staphylococcus epidermidis were each found in only one animal; Staphylococcus spp. was found in two; and Vibrio fluvialis in four. Thirteen samples had only one bacteria isolated, one sample had two bacteria, and one sample had three bacteria isolated. Regarding sex, age group, and origin among the manatees examined, 54.5% (6/11) of the females, 58.3% (7/12) of the males, 40% (2/5) of the calves, 66.7% (8/12) of the juveniles, 50% (3/6) of the adults, 55.5% (10/18) at CMA-PE, and 60% (3/5) at CMA-AL were found to be positive for bacterial growth during at least one sampling time. All Antillean manatees were clinically ill. Regarding clinical signs, bacteria were found in 50% (11/22) of blood samples of the animals showing debilitation and anorexia, 1 of 8 (12.5%) of blood samples of the animals showing abscesses, and 3 of 7 (42.9%) of blood samples of the animals showing profound lethargy-moribundity.

Laboratory maintenance of Treponema denticola.

PubMed

Fenno, J Christopher

2005-10-01

This unit describes the methods, media, and equipment necessary for routine laboratory culture and handling of the anaerobic oral spirochete Treponema denticola. Topics discussed include nutrient requirements, recommended media formulations, and expected growth kinetics, as well as methods and equipment necessary to maintain anaerobic conditions. An additional protocol on isolation of T. denticola from clinical samples is included.

Analysis of Platelet-Rich Plasma Extraction

PubMed Central

Fitzpatrick, Jane; Bulsara, Max K.; McCrory, Paul Robert; Richardson, Martin D.; Zheng, Ming Hao

2017-01-01

Background: Platelet-rich plasma (PRP) has been extensively used as a treatment in tissue healing in tendinopathy, muscle injury, and osteoarthritis. However, there is variation in methods of extraction, and this produces different types of PRP. Purpose: To determine the composition of PRP obtained from 4 commercial separation kits, which would allow assessment of current classification systems used in cross-study comparisons. Study Design: Controlled laboratory study. Methods: Three normal adults each donated 181 mL of whole blood, some of which served as a control and the remainder of which was processed through 4 PRP separation kits: GPS III (Biomet Biologics), Smart-Prep2 (Harvest Terumo), Magellan (Arteriocyte Medical Systems), and ACP (Device Technologies). The resultant PRP was tested for platelet count, red blood cell count, and white blood cell count, including differential in a commercial pathology laboratory. Glucose and pH measurements were obtained from a blood gas autoanalyzer machine. Results: Three kits taking samples from the “buffy coat layer” were found to have greater concentrations of platelets (3-6 times baseline), while 1 kit taking samples from plasma was found to have platelet concentrations of only 1.5 times baseline. The same 3 kits produced an increased concentration of white blood cells (3-6 times baseline); these consisted of neutrophils, leukocytes, and monocytes. This represents high concentrations of platelets and white blood cells. A small drop in pH was thought to relate to the citrate used in the sample preparation. Interestingly, an unexpected increase in glucose concentrations, with 3 to 6 times greater than baseline levels, was found in all samples. Conclusion: This study reveals the variation of blood components, including platelets, red blood cells, leukocytes, pH, and glucose in PRP extractions. The high concentrations of cells are important, as the white blood cell count in PRP samples has frequently been ignored, being considered insignificant. The lack of standardization of PRP preparation for clinical use has contributed at least in part to the varying clinical efficacy in PRP use. Clinical Relevance: The variation of platelet and other blood component concentrations between commercial PRP kits may affect clinical treatment outcomes. There is a need for standardization of PRP for clinical use. PMID:28210651

Symptomatic and asymptomatic apical periodontitis associated with red complex bacteria: clinical and microbiological evaluation.

PubMed

Buonavoglia, Alessio; Latronico, Francesca; Pirani, Chiara; Greco, Maria Fiorella; Corrente, Marialaura; Prati, Carlo

2013-01-01

In this study, the association of red complex (RC) bacteria that include Treponema denticola, Tannerella forsythia and Porphyromonas gingivalis with acute, exacerbated or chronic apical periodontitis was evaluated. Seventy-one patients with periapical disease were evaluated by clinical examination and microbiological samples obtained from the root canals were analyzed by a polymerase chain reaction assay. Twenty-one (29.6%) samples were positive for RC bacteria, with T. denticola, T. forsythia and P. gingivalis being detected in 14 (19.7%), 10 (14.1%) and 6 (8.5%) samples, respectively. RC bacteria were mainly associated with acute apical periodontitis (29.2%) and phoenix abscess (63.2%), while they were only sporadically detected (7.1%) in patients with chronic apical periodontitis. Generally, RC bacteria were associated with pain and a higher frequency of intracanalar/intrasulcular pus drainage. Involvement of RC bacteria in symptomatic periapical disease should be suspected in the presence of particularly severe clinical pain and pus drainage.

Psychometric properties of the social anxiety subscale of the Youth Anxiety Measure for DSM-5 (YAM-5-I-SAD) in a clinical sample of Spanish-speaking adolescents.

PubMed

Fuentes-Rodriguez, Gema; Saez-Castillo, Antonio J; Garcia-Lopez, Luis-Joaquin

2018-08-01

The Youth Anxiety Measure-I for DSM-5 has recently been developed to assess youth's anxiety symptomatology. As social anxiety is one of the most common disorders in adolescence, this scale includes a subscale measuring social anxiety. However, psychometric properties of the YAM-5-I social anxiety subscale (YAM-5-I-SAD) in clinical samples are lacking. This paper aims to bridge the gap. The sample comprised 24 clinically diagnosed and 24 healthy control Spanish-speaking adolescents aged 14-17 years. Data revealed that the YAM-5- I-SAD yielded excellent sensitivity, which makes it particularly useful as a screening tool to early detect socially anxious adolescents. In addition, the YAM-5-I-SAD evidenced good internal consistency and construct validity. Data are limited to the social anxiety subscale. The YAM-5-I-SAD is a sensitive and specific measure to screen for adolescents with social anxiety. Copyright © 2018 Elsevier B.V. All rights reserved.

Wechsler Adult Intelligence Scale-IV Dyads for Estimating Global Intelligence.

PubMed

Girard, Todd A; Axelrod, Bradley N; Patel, Ronak; Crawford, John R

2015-08-01

All possible two-subtest combinations of the core Wechsler Adult Intelligence Scale-IV (WAIS-IV) subtests were evaluated as possible viable short forms for estimating full-scale IQ (FSIQ). Validity of the dyads was evaluated relative to FSIQ in a large clinical sample (N = 482) referred for neuropsychological assessment. Sample validity measures included correlations, mean discrepancies, and levels of agreement between dyad estimates and FSIQ scores. In addition, reliability and validity coefficients were derived from WAIS-IV standardization data. The Coding + Information dyad had the strongest combination of reliability and validity data. However, several other dyads yielded comparable psychometric performance, albeit with some variability in their particular strengths. We also observed heterogeneity between validity coefficients from the clinical and standardization-based estimates for several dyads. Thus, readers are encouraged to also consider the individual psychometric attributes, their clinical or research goals, and client or sample characteristics when selecting among the dyadic short forms. © The Author(s) 2014.

College clinic service quality and patient satisfaction.

PubMed

Deshwal, Pankaj; Ranjan, Vini; Mittal, Geetika

2014-01-01

The purpose of this paper is to identify the service quality dimensions that play an important role in patient satisfaction in campus clinics in Delhi; assess student satisfaction with service; and suggests ways to improve areas of dissatisfaction. A questionnaire was distributed to students who had completed at least two consultations at the college clinic. Convenience sampling was used to approach respondents. The questionnaire uses modified SERVQUAL and other instruments, including original dimensions and those constructed through detailed discussions. Factor analyses, reliability tests and the Kaiser-Meyer-Olkin measure of sampling adequacy were conducted. The final sample had a total of 445 respondents. After factor analysis, the authors found that the dimensions affecting patient satisfaction are: staff professionalism; clinic staff reliability; clinic accessibility and basic facilities; tangibles; cleanliness; awareness of the clinic/diseases and how clinic staff deals with emergencies. Most students were satisfied with the professionalism of the clinic staff. More than 70 percent of the respondents reported that the clinic staff paid good attention to them. The campus clinic was deemed reliable by more than 50 percent of respondents. The students found the clinic's location convenient, with more than 50 percent supporting its location. However, there was dissatisfaction among the students regarding the tangibles of the clinic, with more than 50 percent favoring upgrading. There was satisfaction among the respondents regarding the availability of the doctor after clinic hours, but contact details for the clinic staff were not easily accessible on campus. More than 60 percent of respondents were satisfied with the cleanliness of the campus clinic. More than 50 percent felt that the campus clinic was not equipped to deal with emergencies efficiently. At the same time, 90 percent of respondents reported the availability of referral facilities in case of emergencies. The authors believe that this is the first study conducted to assess patient satisfaction in the campus clinics of engineering institutes in Delhi region. This paper provides valuable information to college clinic administrators.

Performing skin microbiome research: A method to the madness

PubMed Central

Kong, Heidi H.; Andersson, Björn; Clavel, Thomas; Common, John E.; Jackson, Scott A.; Olson, Nathan D.; Segre, Julia A.; Traidl-Hoffmann, Claudia

2017-01-01

Growing interest in microbial contributions to human health and disease has increasingly led investigators to examine the microbiome in both healthy skin and cutaneous disorders, including acne, psoriasis and atopic dermatitis. The need for common language, effective study design, and validated methods are critical for high-quality, standardized research. Features, unique to skin, pose particular challenges when conducting microbiome research. This review discusses microbiome research standards and highlights important factors to consider, including clinical study design, skin sampling, sample processing, DNA sequencing, control inclusion, and data analysis. PMID:28063650

Increasing Ethnic Minority Participation in Substance Abuse Clinical Trials: Lessons Learned in the National Institute on Drug Abuse’s Clinical Trials Network

PubMed Central

Burlew, Kathleen; Larios, Sandra; Suarez-Morales, Lourdes; Holmes, Beverly; Venner, Kamilla; Chavez, Roberta

2012-01-01

Underrepresentation in clinical trials limits the extent to which ethnic minorities benefit from advances in substance abuse treatment. The objective of this article is to share the knowledge gained within the Clinical Trials Network (CTN) of the National Institute on Drug Abuse and other research on recruiting and retaining ethnic minorities into substance abuse clinical trials. The article includes a discussion of two broad areas for improving inclusion— community involvement and cultural adaptation. CTN case studies are included to illustrate three promising strategies for improving ethnic minority inclusion: respondent-driven sampling, community-based participatory research, and the cultural adaptation of the recruitment and retention procedures. The article concludes with two sections describing a number of methodological concerns in the current research base and our proposed research agenda for improving ethnic minority inclusion that builds on the CTN experience. PMID:21988575

Increasing ethnic minority participation in substance abuse clinical trials: lessons learned in the National Institute on Drug Abuse's Clinical Trials Network.

PubMed

Burlew, Kathleen; Larios, Sandra; Suarez-Morales, Lourdes; Holmes, Beverly; Venner, Kamilla; Chavez, Roberta

2011-10-01

Underrepresentation in clinical trials limits the extent to which ethnic minorities benefit from advances in substance abuse treatment. The objective of this article is to share the knowledge gained within the Clinical Trials Network (CTN) of the National Institute on Drug Abuse and other research on recruiting and retaining ethnic minorities into substance abuse clinical trials. The article includes a discussion of two broad areas for improving inclusion-community involvement and cultural adaptation. CTN case studies are included to illustrate three promising strategies for improving ethnic minority inclusion: respondent-driven sampling, community-based participatory research, and the cultural adaptation of the recruitment and retention procedures. The article concludes with two sections describing a number of methodological concerns in the current research base and our proposed research agenda for improving ethnic minority inclusion that builds on the CTN experience.

Calculating a Continuous Metabolic Syndrome Score Using Nationally Representative Reference Values.

PubMed

Guseman, Emily Hill; Eisenmann, Joey C; Laurson, Kelly R; Cook, Stephen R; Stratbucker, William

2018-02-26

The prevalence of metabolic syndrome in youth varies on the basis of the classification system used, prompting implementation of continuous scores; however, the use of these scores is limited to the sample from which they were derived. We sought to describe the derivation of the continuous metabolic syndrome score using nationally representative reference values in a sample of obese adolescents and a national sample obtained from National Health and Nutrition Examination Survey (NHANES) 2011-2012. Clinical data were collected from 50 adolescents seeking obesity treatment at a stage 3 weight management center. A second analysis relied on data from adolescents included in NHANES 2011-2012, performed for illustrative purposes. The continuous metabolic syndrome score was calculated by regressing individual values onto nationally representative age- and sex-specific standards (NHANES III). Resultant z scores were summed to create a total score. The final sample included 42 obese adolescents (15 male and 35 female subjects; mean age, 14.8 ± 1.9 years) and an additional 445 participants from NHANES 2011-2012. Among the clinical sample, the mean continuous metabolic syndrome score was 4.16 ± 4.30, while the NHANES sample mean was quite a bit lower, at -0.24 ± 2.8. We provide a method to calculate the continuous metabolic syndrome by comparing individual risk factor values to age- and sex-specific percentiles from a nationally representative sample. Copyright © 2018 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

CPTAC Releases Cancer Proteome Confirmatory Colon Study Data | Office of Cancer Clinical Proteomics Research

Cancer.gov

The National Cancer Institute (NCI) Clinical Proteomic Tumor Analysis Consortium (CPTAC) announces the release of the cancer proteome confirmatory colon study data. The goal of the study is to analyze the proteomes of approximately 100 confirmatory colon tumor patients, which includes tumor and adjacent normal samples, with liquid chromatography-tandem mass spectrometry (LC-MS/MS) global proteomic and phosphoproteomic profiling.

The academic story: introducing the clinical nurse leader role in a multifacility health care system.

PubMed

Moore, Penny

2013-01-01

Introducing the clinical nurse leader (CNL) role in a multifacility health care system is an exciting but obstacle-filled journey. This story includes facilitating factors, opportunities, and successes plus suggestions for other academic-practice partners considering implementing the CNL role. A sample course sequence with course descriptions is provided. Copyright © 2013 Elsevier Inc. All rights reserved.

The Soil Microbiota Harbors a Diversity of Carbapenem-Hydrolyzing β-Lactamases of Potential Clinical Relevance.

PubMed

Gudeta, Dereje Dadi; Bortolaia, Valeria; Amos, Greg; Wellington, Elizabeth M H; Brandt, Kristian K; Poirel, Laurent; Nielsen, Jesper Boye; Westh, Henrik; Guardabassi, Luca

2016-01-01

The origin of carbapenem-hydrolyzing metallo-β-lactamases (MBLs) acquired by clinical bacteria is largely unknown. We investigated the frequency, host range, diversity, and functionality of MBLs in the soil microbiota. Twenty-five soil samples of different types and geographical origins were analyzed by antimicrobial selective culture, followed by phenotypic testing and expression of MBL-encoding genes in Escherichia coli, and whole-genome sequencing of MBL-producing strains was performed. Carbapenemase activity was detected in 29 bacterial isolates from 13 soil samples, leading to identification of seven new MBLs in presumptive Pedobacter roseus (PEDO-1), Pedobacter borealis (PEDO-2), Pedobacter kyungheensis (PEDO-3), Chryseobacterium piscium (CPS-1), Epilithonimonas tenax (ESP-1), Massilia oculi (MSI-1), and Sphingomonas sp. (SPG-1). Carbapenemase production was likely an intrinsic feature in Chryseobacterium and Epilithonimonas, as it occurred in reference strains of different species within these genera. The amino acid identity to MBLs described in clinical bacteria ranged between 40 and 69%. Remarkable features of the new MBLs included prophage integration of the encoding gene (PEDO-1), an unusual amino acid residue at a key position for MBL structure and catalysis (CPS-1), and overlap with a putative OXA β-lactamase (MSI-1). Heterologous expression of PEDO-1, CPS-1, and ESP-1in E. coli significantly increased the MICs of ampicillin, ceftazidime, cefpodoxime, cefoxitin, and meropenem. Our study shows that MBL producers are widespread in soil and include four genera that were previously not known to produce MBLs. The MBLs produced by these bacteria are distantly related to MBLs identified in clinical samples but constitute resistance determinants of clinical relevance if acquired by pathogenic bacteria. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

The Soil Microbiota Harbors a Diversity of Carbapenem-Hydrolyzing β-Lactamases of Potential Clinical Relevance

PubMed Central

Gudeta, Dereje Dadi; Bortolaia, Valeria; Amos, Greg; Wellington, Elizabeth M. H.; Brandt, Kristian K.; Poirel, Laurent; Nielsen, Jesper Boye; Westh, Henrik

2015-01-01

The origin of carbapenem-hydrolyzing metallo-β-lactamases (MBLs) acquired by clinical bacteria is largely unknown. We investigated the frequency, host range, diversity, and functionality of MBLs in the soil microbiota. Twenty-five soil samples of different types and geographical origins were analyzed by antimicrobial selective culture, followed by phenotypic testing and expression of MBL-encoding genes in Escherichia coli, and whole-genome sequencing of MBL-producing strains was performed. Carbapenemase activity was detected in 29 bacterial isolates from 13 soil samples, leading to identification of seven new MBLs in presumptive Pedobacter roseus (PEDO-1), Pedobacter borealis (PEDO-2), Pedobacter kyungheensis (PEDO-3), Chryseobacterium piscium (CPS-1), Epilithonimonas tenax (ESP-1), Massilia oculi (MSI-1), and Sphingomonas sp. (SPG-1). Carbapenemase production was likely an intrinsic feature in Chryseobacterium and Epilithonimonas, as it occurred in reference strains of different species within these genera. The amino acid identity to MBLs described in clinical bacteria ranged between 40 and 69%. Remarkable features of the new MBLs included prophage integration of the encoding gene (PEDO-1), an unusual amino acid residue at a key position for MBL structure and catalysis (CPS-1), and overlap with a putative OXA β-lactamase (MSI-1). Heterologous expression of PEDO-1, CPS-1, and ESP-1in E. coli significantly increased the MICs of ampicillin, ceftazidime, cefpodoxime, cefoxitin, and meropenem. Our study shows that MBL producers are widespread in soil and include four genera that were previously not known to produce MBLs. The MBLs produced by these bacteria are distantly related to MBLs identified in clinical samples but constitute resistance determinants of clinical relevance if acquired by pathogenic bacteria. PMID:26482314

Single molecule molecular inversion probes for targeted, high-accuracy detection of low-frequency variation.

PubMed

Hiatt, Joseph B; Pritchard, Colin C; Salipante, Stephen J; O'Roak, Brian J; Shendure, Jay

2013-05-01

The detection and quantification of genetic heterogeneity in populations of cells is fundamentally important to diverse fields, ranging from microbial evolution to human cancer genetics. However, despite the cost and throughput advances associated with massively parallel sequencing, it remains challenging to reliably detect mutations that are present at a low relative abundance in a given DNA sample. Here we describe smMIP, an assay that combines single molecule tagging with multiplex targeted capture to enable practical and highly sensitive detection of low-frequency or subclonal variation. To demonstrate the potential of the method, we simultaneously resequenced 33 clinically informative cancer genes in eight cell line and 45 clinical cancer samples. Single molecule tagging facilitated extremely accurate consensus calling, with an estimated per-base error rate of 8.4 × 10(-6) in cell lines and 2.6 × 10(-5) in clinical specimens. False-positive mutations in the single molecule consensus base-calls exhibited patterns predominantly consistent with DNA damage, including 8-oxo-guanine and spontaneous deamination of cytosine. Based on mixing experiments with cell line samples, sensitivity for mutations above 1% frequency was 83% with no false positives. At clinically informative sites, we identified seven low-frequency point mutations (0.2%-4.7%), including BRAF p.V600E (melanoma, 0.2% alternate allele frequency), KRAS p.G12V (lung, 0.6%), JAK2 p.V617F (melanoma, colon, two lung, 0.3%-1.4%), and NRAS p.Q61R (colon, 4.7%). We anticipate that smMIP will be broadly adoptable as a practical and effective method for accurately detecting low-frequency mutations in both research and clinical settings.

Single molecule molecular inversion probes for targeted, high-accuracy detection of low-frequency variation

PubMed Central

Hiatt, Joseph B.; Pritchard, Colin C.; Salipante, Stephen J.; O'Roak, Brian J.; Shendure, Jay

2013-01-01

The detection and quantification of genetic heterogeneity in populations of cells is fundamentally important to diverse fields, ranging from microbial evolution to human cancer genetics. However, despite the cost and throughput advances associated with massively parallel sequencing, it remains challenging to reliably detect mutations that are present at a low relative abundance in a given DNA sample. Here we describe smMIP, an assay that combines single molecule tagging with multiplex targeted capture to enable practical and highly sensitive detection of low-frequency or subclonal variation. To demonstrate the potential of the method, we simultaneously resequenced 33 clinically informative cancer genes in eight cell line and 45 clinical cancer samples. Single molecule tagging facilitated extremely accurate consensus calling, with an estimated per-base error rate of 8.4 × 10−6 in cell lines and 2.6 × 10−5 in clinical specimens. False-positive mutations in the single molecule consensus base-calls exhibited patterns predominantly consistent with DNA damage, including 8-oxo-guanine and spontaneous deamination of cytosine. Based on mixing experiments with cell line samples, sensitivity for mutations above 1% frequency was 83% with no false positives. At clinically informative sites, we identified seven low-frequency point mutations (0.2%–4.7%), including BRAF p.V600E (melanoma, 0.2% alternate allele frequency), KRAS p.G12V (lung, 0.6%), JAK2 p.V617F (melanoma, colon, two lung, 0.3%–1.4%), and NRAS p.Q61R (colon, 4.7%). We anticipate that smMIP will be broadly adoptable as a practical and effective method for accurately detecting low-frequency mutations in both research and clinical settings. PMID:23382536

Measurement properties, feasibility and clinical utility of the Doloplus-2 pain scale in older adults with cognitive impairment: a systematic review.

PubMed

Rostad, Hanne Marie; Utne, Inger; Grov, Ellen Karine; Puts, Martine; Halvorsrud, Liv

2017-11-02

The Doloplus-2 is a pain assessment scale for assessing pain in older adults with cognitive impairment. It is used in clinical practice and research. However, evidence for its measurement properties, feasibility and clinical utility remain incomplete. This systematic review synthesizes previous research on the measurement properties, feasibility and clinical utility of the scale. We conducted a systematic search in three databases (CINAHL, Medline and PsycINFO) for studies published in English, French, German, Dutch/Flemish or a Scandinavian language between 1990 and April 2017. We also reviewed the Doloplus-2 homepage and reference lists of included studies to supplement our search. Two reviewers independently reviewed titles and abstracts and performed the quality assessment and data abstraction. A total of 24 studies were included in this systematic review. The quality of the studies varied, but many lacked sufficient detail about the samples and response rates. The Doloplus-2 has been studied using diverse samples in a variety of settings; most study participants were in long-term care and in people with dementia. Sixteen studies addressed various aspects of the scale's feasibility and clinical utility, but their results are limited and inconsistent across settings and samples. Support for the scale's reliability, validity and responsiveness varied widely across the studies. Generally, the reliability coefficients reached acceptable benchmarks, but the evidence for different aspects of the scale's validity and responsiveness was incomplete. Additional high-quality studies are warranted to determine in which populations of older adults with cognitive impairment the Doloplus-2 is reliable, valid and feasible. The ability of the Doloplus-2 to meaningfully quantify pain, measure treatment response and improve patient outcomes also needs further investigation. PROSPERO reg. no.: CRD42016049697 registered 20. Oct. 2016.

Direct and indirect forms of childhood maltreatment and nonsuicidal self-injury among clinically-referred children and youth.

PubMed

Armiento, Jenna; Hamza, Chloe A; Stewart, Shannon L; Leschied, Alan

2016-08-01

Although exposure to direct forms of childhood maltreatment is among the most widely studied risk factors for nonsuicidal self-injury (NSSI), research on NSSI has largely overlooked the role of exposure to indirect forms of child maltreatment (i.e., witnessing domestic violence). To address this gap in the literature, the present study examined associations among both direct and indirect forms of child maltreatment and NSSI among clinically-referred children and youth. Data was collected using the interRAI Child and Youth Mental Health Assessment (ChYMH) at ten mental health agencies. The ChYMH is a comprehensive standardized clinical assessment tool completed by trained assessors using multiple sources. The study included a convenience sample of 747 children and youth (68% male) between ages 8-18 with complex mental health histories referred for inpatient or outpatient care in Ontario, Canada. Univariate chi-square analyses indicated positive associations with NSSI and both direct (i.e., physical, sexual) and indirect child maltreatment (i.e., witnessing domestic violence). In a binary multivariate logistic regression analysis controlling for participant age and sex, only exposure to indirect child maltreatment emerged as multivariate predictor of NSSI. The sample was limited to only 10 mental health agencies and only consenting parents/guardians referred to mental health services suggesting the study may not be generalizable to all clinical samples. The present study provides evidence that witnessing domestic violence in childhood is an important risk factor for NSSI. Clinical relevance includes implications for clinicians to develop targeted intervention and prevention strategies for NSSI for children who have witnessed domestic violence. Copyright © 2016 Elsevier B.V. All rights reserved.

Risk factors for human papillomavirus detection in urine samples of heterosexual men visiting urological clinics in Japan.

PubMed

Nakashima, Kazufumi; Shigehara, Kazuyoshi; Kitamura, Tadaichi; Yaegashi, Hiroshi; Shimamura, Masayoshi; Kawaguchi, Shohei; Izumi, Kouji; Kadono, Yoshifumi; Mizokami, Atsushi

2018-05-11

The present study aimed to investigate human papillomavirus (HPV) prevalence and identify risk factors for HPV detection in urine samples among heterosexual men attending urological clinics. Spot urine samples including initial stream were collected from 845 participants, and the cell pellets were preserved into liquid-based cytological solution. After DNA extraction from each sample, HPV-DNA amplification and genotyping were performed using Luminex multiplex polymerase chain reaction. Participants completed a questionnaire on their age, education, smoking status, sexuality, age of sexual debut, marital status, and present history of sexually transmitted infections. Data from 803 patients were included in the analysis. Overall HPV and high-risk (HR)HPV prevalence in urine samples were 6.2% and 3.1%, respectively. HPV and HR-HPV prevalences were the highest in men with urethritis, and were significantly higher than those without urethritis. HPV detection was the most common in men aged 40-49 years, although significant detection differences were not age-related. Urethritis was an independent risk factor for HPV detection from urine samples, with an odds ratio (OR) of 4.548 (95%CI; 1.802-11.476) (p = 0.001). On the other hand, a sub-analysis excluding men with urethritis demonstrated that prostate cancer was a significant risk factor for HPV detection, with OR of 2.844 (95%CI; 1.046-7.732) (p = 0.0410), whereas was not a significant risk for HR-HPV detection in urine samples. Prostate cancer may represent a risk factor for HPV detection in the urine of men without urethritis. The authors did not register to Clinical Trial because this is observational and cross-sectional study. Copyright © 2018 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Intestinal microbiota composition after antibiotic treatment in early life: the INCA study.

PubMed

Rutten, N B M M; Rijkers, G T; Meijssen, C B; Crijns, C E; Oudshoorn, J H; van der Ent, C K; Vlieger, A M

2015-12-09

The acquisition and development of infant gut microbiota can be influenced by numerous factors, of which early antibiotic treatment is an important one. However, studies on the effects of antibiotic treatment in early life on clinical outcomes and establishment and development of the gut microbiota of term infants are limited. Disturbed microbiota composition is hypothesized to be an underlying mechanism of an aberrant development of the immune system. This study aims to investigate the potential clinical and microbial consequences of empiric antibiotic use in early life. 450 term born infants, of whom 150 are exposed to antibiotic treatment in early life and 300 are not (control group), are included in this observational cohort study with a one-year follow-up. Clinical outcomes, including coughing, wheezing, fever >38 °C, runny nose, glue ear, rash, diarrhea and >3 crying hours a day, are recorded daily by parents and examined by previously defined doctor's diagnosis. A blood sample is taken at closure to investigate the infant's vaccination response and sensitization for food and inhalant allergens. Fecal samples are obtained at eight time points during the first year of life. Potential differences in microbial profiles of infants treated with antibiotics versus healthy controls will be determined by use of 16S-23S rRNA gene analysis (IS-pro). Microbiota composition will be described by means of abundance, diversity and (dis)similarity. Diversity is calculated using the Shannon index. Dissimilarities between samples are calculated as the cosine distance between each pair of samples and analyzed with principal coordinate analysis. Clinical variables and possible associations are assessed by appropriate statistics. Both clinical quantitative and qualitative microbial effects of antibiotic treatment in early life may be demonstrated. These findings can be important, since there is evidence that manipulation of the infant microbiota by using pre- or probiotics can restore the ecological balance of the microbiota and may mitigate potential negative effects on the developing immune system, when use of antibiotics cannot be avoided. ClinicalTrials.gov NCT02536560. Registered 28 August 2015.

Epidemiology of Sarcocystis neurona infections in domestic cats (Felis domesticus) and its association with equine protozoal myeloencephalitis (EPM) case farms and feral cats from a mobile spay and neuter clinic.

PubMed

Stanek, J F; Stich, R W; Dubey, J P; Reed, S M; Njoku, C J; Lindsay, D S; Schmall, L M; Johnson, G K; LaFave, B M; Saville, W J A

2003-11-28

Equine protozoal myeloencephalitis (EPM) is a serious neurologic disease in the horse most commonly caused by Sarcocystis neurona. The domestic cat (Felis domesticus) is an intermediate host for S. neurona. In the present study, nine farms, known to have prior clinically diagnosed cases of EPM and a resident cat population were identified and sampled accordingly. In addition to the farm cats sampled, samples were also collected from a mobile spay and neuter clinic. Overall, serum samples were collected in 2001 from 310 cats, with samples including barn, feral and inside/outside cats. Of these 310 samples, 35 were from nine horse farms. Horse serum samples were also collected and traps were set for opossums at each of the farms. The S. neurona direct agglutination test (SAT) was used for both the horse and cat serum samples (1:25 dilution). Fourteen of 35 (40%) cats sampled from horse farms had circulating S. neurona agglutinating antibodies. Twenty-seven of the 275 (10%) cats from the spay/neuter clinic also had detectable S. neurona antibodies. Overall, 115 of 123 (93%) horses tested positive for anti-S. neurona antibodies, with each farm having greater than a 75% exposure rate among sampled horses. Twenty-one opossums were trapped on seven of the nine farms. Eleven opossums had Sarcocystis sp. sporocysts, six of them were identified as S. neurona sporocysts based on bioassays in gamma-interferon gene knockout mice with each opossum representing a different farm. Demonstration of S. neurona agglutinating antibodies in domestic and feral cats corroborates previous research demonstrating feral cats to be naturally infected, and also suggests that cats can be frequently infected with S. neurona and serve as one of several natural intermediate hosts for S. neurona.

A Portable Immunoassay Platform for Multiplexed Detection of Biotoxins in Clinical and Environmental Samples

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

Koh, Chung-Yan; Piccini, Matthew Ernest; Schaff, Ulrich Y.

Multiple cases of attempted bioterrorism events using biotoxins have highlighted the urgent need for tools capable of rapid screening of suspect samples in the field (e.g., mailroom and public events). We present a portable microfluidic device capable of analyzing environmental (e.g., white powder), food (e.g., milk) and clinical (e.g., blood) samples for multiplexed detection of biotoxins. The device is rapid (<15-30 min sample-to-answer), sensitive (< 0.08 pg/mL detection limit for botulinum toxin), multiplexed (up to 64 parallel assays) and capable of analyzing small volume samples (< 20 μL total sample input). The immunoassay approach (SpinDx) is based on binding ofmore » toxins in a sample to antibody-laden capture particles followed by sedimentation of particles through a density-media in a microfluidic disk and quantification using a laser-induced fluorescence detector. A direct, blinded comparison with a gold standard ELISA revealed a 5-fold more sensitive detection limit for botulinum toxin while requiring 250-fold less sample volume and a 30 minute assay time with a near unity correlation. A key advantage of the technique is its compatibility with a variety of sample matrices with no additional sample preparation required. Ultrasensitive quantification has been demonstrated from direct analysis of multiple clinical, environmental and food samples, including white powder, whole blood, saliva, salad dressing, whole milk, peanut butter, half and half, honey, and canned meat. We believe that this device can met an urgent need in screening both potentially exposed people as well as suspicious samples in mail-rooms, airports, public sporting venues and emergency rooms. The general-purpose immunodiagnostics device can also find applications in screening of infectious and systemic diseases or serve as a lab device for conducting rapid immunoassays.« less

RICKETS IN RURAL KENYAN PRESCHOOL CHILDREN: CASE REPORT.

PubMed

Bwibo, N O; Nyawade, S; Neumann, C G

2013-03-01

Clinical rickets has not been reported previously in Embu district, Kenya. Baseline clinical assessments performed for a nutrition intervention study in preschool children (n=324) identified 28 cases of rickets (8.6% of study sample). Clinical characteristics included: delays of sitting, walking, and teething; bone and chest deformities; widened wrists and ankles; and bowed lower extremities. Risk factors identified were short duration of breastfeeding with feeding of cereal-based supplements with little or no milk, low calcium intake, limited sunlight exposure. Vitamin D and calcium deficiencies likely contributed to these cases. Treatment with Vitamin D3 and milk resulted in clinical improvement.

Psychometric properties of the Chinese version of the Obsessive Beliefs Questionnaire-44 (OBQ-44).

PubMed

Wang, Jing; Wei, Zhen; Wang, He; Jiang, Zeyu; Peng, Ziwen

2015-08-04

The Obsessive Beliefs Questionnaire-44 (OBQ-44) is originally developed by the Obsessive Compulsive Cognitions Working Group and has been translated into several languages. This paper is aimed to investigate the psychometric properties of the Chinese version of the Obsessive Beliefs Questionnaire-44 (OBQ-44) in both clinical and non-clinical samples. Five hundred and sixty-nine undergraduate volunteers and sixty-six OCD patients were included in the study. All participants have completed Chinese version of OBQ-44, Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), and Beck Depression Inventory (BDI). Confirmatory factor analysis was conducted to examine the construct validity of Chinese version of OBQ-44. The internal consistency and test-retest reliabilities at 4-week interval were examined in both non-clinical and clinical groups. The confirmatory factor analysis of the non-clinical sample confirmed a 3-factor model which was suggested by the original authors of the instrument (χ (2)/d.f = 2.96, GFI = 0.83, NFI = 0.82, CFI = 0.88 and RMSEA = 0.06). The internal consistency and test-retest reliability were at an acceptable range for the two samples. The Chinese version of OBQ-44 is a valid and reliable instrument for assessing dysfunctional beliefs related to the etiology and maintenance of obsessions and compulsions.

A survey of cannabis (marijuana) use and self-reported benefit in men with chronic prostatitis/chronic pelvic pain syndrome.

PubMed

Tripp, Dean A; Nickel, J Curtis; Katz, Laura; Krsmanovic, Adrijana; Ware, Mark A; Santor, Darcy

2014-11-01

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a chronic pelvic pain condition largely refractory to treatment. Cannabis (marijuana) use has been reported for a wide variety of chronic pain conditions, but no study has examined prevalence of cannabis use, symptom benefit or side effects, or frequency in CP/CPPS. Participants were recruited from an outpatient CP/CPPS urology clinic (n = 98) and online through the Prostatitis Foundation website (n = 244). Participants completed questionnaires (demographics, CP/CPPS, depression, cannabis). The clinic sample included Canadian patients and the online sample included primarily American patients. Due to differences, groups were examined separately. Almost 50% of respondents reported using cannabis (clinic n = 49; online n = 89). Of the cannabis users, 36.8% of clinic and 75% of online respondents reported that it improved their symptoms. Most of the respondents (from the clinic and online groups) reported that cannabis improved their mood, pain, muscle spasms, and sleep. However, they did not note any improvements for weakness, fatigue, numbness, ambulation, and urination. Overall, the effectiveness of cannabis for CP/CPPS was "somewhat/very effective" (57% clinic; 63% online). There were no differences between side effects or choice of consumption and most reported using cannabis rarely. These are the first estimates in men suffering from CP/CPPS and suggest that while cannabis use is prevalent, its medical use and benefit are unknown. This is an understudied area and the benefit or hazard for cannabis use awaits further study.

Suicidal tendency in a sample of adolescent outpatients with adjustment disorder: gender differences.

PubMed

Ferrer, Laia; Kirchner, Teresa

2014-08-01

Although Adjustment Disorder (AD) is a prevalent diagnosis in adolescent mental health services and linked to suicidal tendency in adolescence, little research exists examining prevalence and gender differences of suicidal symptoms among AD patients using standardized instruments. The present study aims to assess the presence of suicidal tendency in a clinical sample of Spanish adolescents with AD analyzing gender differences. Ninety-seven adolescents with AD were recruited at a public mental health center and included in the AD sample; they were administered the Inventario de Riesgo Suicida para Adolescentes (Suicide Risk Inventory for Adolescents-IRIS) and the Millon Adolescent Clinical Inventory (MACI). Ninety-nine community adolescents were recruited and administered the IRIS inventory. The community sample works as a contrast group. Girls with AD show higher levels of suicidal symptoms than boys on both the IRIS Suicidal Ideation and Intention scale (t=8.15, p<.001) and the MACI Suicidal Tendency scale (t=6.6, p<.001). Girls with AD scored significantly higher than girls from the community contrast group sample in the IRIS Suicidal Ideation and Intention scale, but boys with AD presented no differences with regard to boys form the community contrast group sample. Compared with normative clinical samples of the MACI, no differences in the Suicidal Tendency scale scores were found between AD and normative girls, but AD boys showed significantly lower mean scores than normative boys. Suicidal symptoms were presented by 27% of girls and 18% of boys, although only 6% of the girls and none of the boys presented clear suicidal tendencies. Considering suicidal tendencies in adolescents with Adjustment Disorder is important-especially in girls, who present high suicidal tendencies in relation both to boys and to community peers and the normative clinical population. Copyright © 2014 Elsevier Inc. All rights reserved.

Detection of JAK2 V617F mutation increases the diagnosis of myeloproliferative neoplasms

PubMed Central

ZHANG, SHU-PENG; LI, HUI; LAI, REN-SHENG

2015-01-01

The Janus kinase (JAK)2 gene, which is located on chromosome 9p24, is involved in the signaling transduction pathways of the hematopoietic and immune system. Mutations in the JAK2 gene have served as disease markers for myeloproliferative neoplasms (MPNs). The aim of the present study was to investigate the occurrence of the JAK2 gene mutation in 140 clinical samples, and to evaluate its clinical significance in MPNs and other hematological diseases. Genomic DNA was extracted from the peripheral blood leukocytes or bone marrow karyocytes of 140 clinical samples, which included 130 patients with various types of hematological disease and 10 control patients. In addition, exons 12 and 14 of the JAK2 gene were analyzed by direct sequencing and the mutation rates of various MPN subtypes were evaluated. Of the 140 samples, exons 12 and 14 were tested in 74 samples, however, exon 14 only was tested in 66 samples. No mutations were identified in exon 12. The V617F mutation rate in polycythemia vera was 82.1% (23/28), and the mutation rates in essential thrombocythemia histiocytosis, primary myelofibrosis and other MPNs were 53.1% (17/32), 40.0% (4/10) and 60.0% (6/10), respectively. Therefore, the total mutation rate of the JAK2 gene in MPN was 62.5% (50/80). For non-MPN hematological diseases, four V617F mutations were detected in samples of leukocytosis of unknown origin (4/12), however, no JAK2 V617F mutations were identified in the 10 controls. Therefore, JAK2 V617F mutations may present a novel marker for diagnosis of MPNs. Furthermore, the direct sequencing method appeared to be satisfactory for the clinical gene testing of hematological samples. PMID:25624900

Confirmatory Factor Analysis of the Minnesota Nicotine Withdrawal Scale

PubMed Central

Toll, Benjamin A.; O’Malley, Stephanie S.; McKee, Sherry A.; Salovey, Peter; Krishnan-Sarin, Suchitra

2008-01-01

The authors examined the factor structure of the Minnesota Nicotine Withdrawal Scale (MNWS) using confirmatory factor analysis in clinical research samples of smokers trying to quit (n = 723). Three confirmatory factor analytic models, based on previous research, were tested with each of the 3 study samples at multiple points in time. A unidimensional model including all 8 MNWS items was found to be the best explanation of the data. This model produced fair to good internal consistency estimates. Additionally, these data revealed that craving should be included in the total score of the MNWS. Factor scores derived from this single-factor, 8-item model showed that increases in withdrawal were associated with poor smoking outcome for 2 of the clinical studies. Confirmatory factor analyses of change scores showed that the MNWS symptoms cohere as a syndrome over time. Future investigators should report a total score using all of the items from the MNWS. PMID:17563141

Integrative data analysis in clinical psychology research.

PubMed

Hussong, Andrea M; Curran, Patrick J; Bauer, Daniel J

2013-01-01

Integrative data analysis (IDA), a novel framework for conducting the simultaneous analysis of raw data pooled from multiple studies, offers many advantages including economy (i.e., reuse of extant data), power (i.e., large combined sample sizes), the potential to address new questions not answerable by a single contributing study (e.g., combining longitudinal studies to cover a broader swath of the lifespan), and the opportunity to build a more cumulative science (i.e., examining the similarity of effects across studies and potential reasons for dissimilarities). There are also methodological challenges associated with IDA, including the need to account for sampling heterogeneity across studies, to develop commensurate measures across studies, and to account for multiple sources of study differences as they impact hypothesis testing. In this review, we outline potential solutions to these challenges and describe future avenues for developing IDA as a framework for studies in clinical psychology.

Integrative Data Analysis in Clinical Psychology Research

PubMed Central

Hussong, Andrea M.; Curran, Patrick J.; Bauer, Daniel J.

2013-01-01

Integrative Data Analysis (IDA), a novel framework for conducting the simultaneous analysis of raw data pooled from multiple studies, offers many advantages including economy (i.e., reuse of extant data), power (i.e., large combined sample sizes), the potential to address new questions not answerable by a single contributing study (e.g., combining longitudinal studies to cover a broader swath of the lifespan), and the opportunity to build a more cumulative science (i.e., examining the similarity of effects across studies and potential reasons for dissimilarities). There are also methodological challenges associated with IDA, including the need to account for sampling heterogeneity across studies, to develop commensurate measures across studies, and to account for multiple sources of study differences as they impact hypothesis testing. In this review, we outline potential solutions to these challenges and describe future avenues for developing IDA as a framework for studies in clinical psychology. PMID:23394226

ADHD and nicotine use in schizophrenia or Asperger syndrome: a controlled study.

PubMed

Hallerbäck, Maria Unenge; Lugnegård, Tove; Gillberg, Christopher

2014-07-01

To examine ADHD prevalence, rating scales, and relationship to nicotine use in adults with schizophrenia or Asperger syndrome. Ninety-five individuals, 41 with schizophrenia and 54 with Asperger syndrome, were included. Self-rating of adult ADHD symptoms with the Wender-Reimherr Adult Attention Deficit Diagnostic Rating Scale (WRAADDS), parent rating of proband's ADHD childhood and adult life symptoms using the Swanson, Nolan, and Pelham Questionnaire (SNAP), and report of clinical ADHD diagnosis were included as ADHD measures. Nicotine use data were compared with data from a population sample. In all, 10% of the schizophrenia group and 30% of the Asperger syndrome group had a clinical ADHD diagnosis. Nicotine dependency in the whole sample was closely linked to ADHD. The prevalence of comorbid ADHD was high in schizophrenia and Asperger syndrome. The WRAADDS self-rating scale for ADHD can be one useful tool for assessing comorbid ADHD in these patient groups. © 2012 SAGE Publications.

Anaplasma phagocytophilum infection in a domestic cat in Finland: Case report

PubMed Central

2010-01-01

Background Anaplasmosis is a vectorborne disease caused by the gram-negative bacterium Anaplasma phagocytophilum. This species displays positive tropism to granulocytes and can cause illness in several mammalian species, including cats, dogs, and humans. It is considered as an emerging disease in Europe. The clinical signs are nonspecific and include fever, lethargy, and inappetence. The most typical hematologic abnormality is thrombocytopenia. A tentative diagnosis can be made by detecting intracytoplasmic morulae inside neutrophils. The diagnosis is confirmed by PCR and serology in paired serum samples. A sample for PCR analysis should be taken before treatment. Anaplasmosis is treated with doxycycline. Case presentation A feline case of anaplasmosis is presented. The history, clinical presentation, diagnostics, treatment, and follow-up are discussed. Conclusions This case indicates that Anaplasma phagocytophilum infects cats in Finland. To provide accurate treatment, anaplasmosis should be listed as a differential diagnosis in cats suffering from acute febrile illness with previous tick exposure. PMID:21078141

Advanced Techniques in Pulmonary Function Test Analysis Interpretation and Diagnosis

PubMed Central

Gildea, T.J.; Bell, C. William

1980-01-01

The Pulmonary Functions Analysis and Diagnostic System is an advanced clinical processing system developed for use at the Pulmonary Division, Department of Medicine at the University of Nebraska Medical Center. The system generates comparative results and diagnostic impressions for a variety of routine and specialized pulmonary functions test data. Routine evaluation deals with static lung volumes, breathing mechanics, diffusing capacity, and blood gases while specialized tests include lung compliance studies, small airways dysfunction studies and dead space to tidal volume ratios. Output includes tabular results of normal vs. observed values, clinical impressions and commentary and, where indicated, a diagnostic impression. A number of pulmonary physiological and state variables are entered or sampled (A to D) with periodic status reports generated for the test supervisor. Among the various physiological variables sampled are respiratory frequency, minute ventilation, oxygen consumption, carbon dioxide production, and arterial oxygen saturation.

Attitudes and Perceptions of Cancer Patients Toward Biospecimen Donation for Cancer Research: A Cross-Sectional Survey Among Chinese Cancer Patients.

PubMed

He, Na; Guo, Yan; He, Min; Qiang, Wanmin; Li, Haixin

2017-08-01

High-quality biospecimen collection from consented patients is crucial for cancer research activities. Patients' attitudes and willingness toward specimen donation influence high-quality biospecimen collection for cancer research activities. We carried out a cross-sectional study among randomly selected patients from 11 cancer departments of Tianjin Medical University Cancer Institute and Hospital between August 2014 and August 2015. A total of 784 patients were included to complete a 30-item self-administered survey. We evaluated the patients' willingness to consider providing leftover samples and additional samples for cancer research purposes. Among 784 patients, 683 (87.1%) and 653 (83.3%) were willing to donate leftover tissue and surplus blood after diagnosis, respectively. Six hundred thirty-one (80.5%) were favorably disposed to consider donating both tissue and blood samples for future cancer research. Female patients showed less willingness to donate biospecimens or related clinical data for research. First-hospitalized or older patients were less willing to provide leftover biospecimens or additional blood samples or even clinical data for research. By contrast, patients with a higher education level were more likely to donate leftover tissues after biopsy or surgery for research activities. Most Chinese cancer patients were willing to consider donating blood and tissue samples for cancer research. Several factors, including age, gender, first hospitalization, and education level, can influence their willingness to donate biospecimens. We need to provide proper education to increase understanding of patients in biobanking activities. This study provides novel empirical data on the likelihood of donating surplus and additional biospecimens and clinical health information among Chinese cancer patients.

Prevalence of EGFR mutations in newly diagnosed locally advanced or metastatic non-small cell lung cancer Spanish patients and its association with histological subtypes and clinical features: The Spanish REASON study.

PubMed

Esteban, E; Majem, M; Martinez Aguillo, M; Martinez Banaclocha, N; Dómine, M; Gómez Aldaravi, L; Juan, O; Cajal, R; Gonzalez Arenas, M C; Provencio, M

2015-06-01

The aim of the REASON study is to determine the frequency of EGFR mutation in advanced non-small cell lung cancer (aNSCLC) patients in Spain (all histologies), and to better understand the clinical factors (gender, smoking habits and histological subtypes) that may be associated with EGFR mutations, in an unselected sample of aNSCLC patients. All newly diagnosed aNSCLC patients from 40 selected centers in Spain were prospectively included for a 6-month period. Patient characteristics were obtained from clinical records. Mutation testing was performed on available tumor samples. Exploratory analyses were performed to characterize the clinico-pathological factors associated with presence of EGFR mutations. From March 2010 to March 2011, 1113 patients were included in the study, of which 1009 patients provided sample for EGFR mutation analysis (90.7%). Mutation analysis was not feasible in 146/1113 patients (13.1%) due to either sample unavailability (79/1113; 7.1%) or sample inadequacy (67/1113; 6.0%). Twenty-five out of 1113 patients (2.3%) were excluded due to unavailable information. Most patients (99.5%) were Caucasian, 74.5% were male, and predominantly were current (38.1%) or former smokers (44.0%). Median age was 66 years (range 25-90) and 70.7% of patients had non-squamous histology (57.8% adenocarcinoma, 1.8% bronchoalveolar, 11.1% large-cell carcinoma). Exon 19 deletions and the exon 21 L858R point mutation were analyzed in 942/1009 (93.4%) samples. Mutation rate was 11.6% (82.6% exon 19 dels and 17.4% L858R). To be never smoker (38.1%), female (25.4%), with bronchioloalveolar carcinoma (22.2%) or adenocarcinoma (15.4%) histology was associated with a higher prevalence of EGFR mutations. Exons 18, 20 and 21 (excluding L858R) were analyzed in 505/942 samples, and EGFR mutations were found in 22/505 samples (4.4%). The estimated prevalence of sensitizing EGFR mutations (exon 19 del, exon 21 L858R) in an unselected samples of newly diagnosed aNSCLC patients in Spain (all histologies) is consistent with previous published data in Caucasian patients. When a sample is available, EGFR mutation testing is feasible in over 90% of cases, and may therefore be suitable for routine clinical practice. CLINICALTRIALS. NCT01081496. Copyright © 2015 Elsevier Ltd. All rights reserved.

Clinical and translational research capacity building needs in minority medical and health science Hispanic institutions.

PubMed

Estapé-Garrastazu, Estela S; Noboa-Ramos, Carlamarie; De Jesús-Ojeda, Lizbelle; De Pedro-Serbiá, Zulmarie; Acosta-Pérez, Edna; Camacho-Feliciano, Delia M

2014-10-01

A preliminary needs assessment was conducted among faculty and students of three minority medical and health science institutions comprising the Puerto Rico Clinical and Translational Research Consortium (PRCTRC). The Web-based survey was focused on evaluating the training interests in the clinical and translational research core areas and competencies developed by the National Institutes of Health-Clinical and Translational Sciences Award. The survey was the result of a team effort of three PRCTRC key function's leaderships: Multidisciplinary Training and Career Development, Tracking and Evaluation and Community Research and Engagement. The questionnaire included 45 items distributed across five content areas including demographics, research training needs, training activities coordination and knowledge about the services offered by the PRCTRC. Analysis of research needs includes a sample distribution according to professor, assistant/associate professor and graduate students. The thematic area with highest response rate among the three groups was: "Identify major clinical/public health problems and relevant translational research questions," with the competency "Identify basic and preclinical studies that are potential testable clinical research hypothesis." These preliminary results will guide the training and professional development of the new generation of clinical and translational researchers needed to eliminate health disparities. © 2014 The Authors. Clinical and Translational Science Published by Wiley Periodicals, Inc.

Clinical whole-genome sequencing from routine formalin-fixed, paraffin-embedded specimens: pilot study for the 100,000 Genomes Project.

PubMed

Robbe, Pauline; Popitsch, Niko; Knight, Samantha J L; Antoniou, Pavlos; Becq, Jennifer; He, Miao; Kanapin, Alexander; Samsonova, Anastasia; Vavoulis, Dimitrios V; Ross, Mark T; Kingsbury, Zoya; Cabes, Maite; Ramos, Sara D C; Page, Suzanne; Dreau, Helene; Ridout, Kate; Jones, Louise J; Tuff-Lacey, Alice; Henderson, Shirley; Mason, Joanne; Buffa, Francesca M; Verrill, Clare; Maldonado-Perez, David; Roxanis, Ioannis; Collantes, Elena; Browning, Lisa; Dhar, Sunanda; Damato, Stephen; Davies, Susan; Caulfield, Mark; Bentley, David R; Taylor, Jenny C; Turnbull, Clare; Schuh, Anna

2018-02-01

PurposeFresh-frozen (FF) tissue is the optimal source of DNA for whole-genome sequencing (WGS) of cancer patients. However, it is not always available, limiting the widespread application of WGS in clinical practice. We explored the viability of using formalin-fixed, paraffin-embedded (FFPE) tissues, available routinely for cancer patients, as a source of DNA for clinical WGS.MethodsWe conducted a prospective study using DNAs from matched FF, FFPE, and peripheral blood germ-line specimens collected from 52 cancer patients (156 samples) following routine diagnostic protocols. We compared somatic variants detected in FFPE and matching FF samples.ResultsWe found the single-nucleotide variant agreement reached 71% across the genome and somatic copy-number alterations (CNAs) detection from FFPE samples was suboptimal (0.44 median correlation with FF) due to nonuniform coverage. CNA detection was improved significantly with lower reverse crosslinking temperature in FFPE DNA extraction (80 °C or 65 °C depending on the methods). Our final data showed somatic variant detection from FFPE for clinical decision making is possible. We detected 98% of clinically actionable variants (including 30/31 CNAs).ConclusionWe present the first prospective WGS study of cancer patients using FFPE specimens collected in a routine clinical environment proving WGS can be applied in the clinic.GENETICS in MEDICINE advance online publication, 1 February 2018; doi:10.1038/gim.2017.241.

The ClinicalTrials.gov results database--update and key issues.

PubMed

Zarin, Deborah A; Tse, Tony; Williams, Rebecca J; Califf, Robert M; Ide, Nicholas C

2011-03-03

The ClinicalTrials.gov trial registry was expanded in 2008 to include a database for reporting summary results. We summarize the structure and contents of the results database, provide an update of relevant policies, and show how the data can be used to gain insight into the state of clinical research. We analyzed ClinicalTrials.gov data that were publicly available between September 2009 and September 2010. As of September 27, 2010, ClinicalTrials.gov received approximately 330 new and 2000 revised registrations each week, along with 30 new and 80 revised results submissions. We characterized the 79,413 registry and 2178 results of trial records available as of September 2010. From a sample cohort of results records, 78 of 150 (52%) had associated publications within 2 years after posting. Of results records available publicly, 20% reported more than two primary outcome measures and 5% reported more than five. Of a sample of 100 registry record outcome measures, 61% lacked specificity in describing the metric used in the planned analysis. In a sample of 700 results records, the mean number of different analysis populations per study group was 2.5 (median, 1; range, 1 to 25). Of these trials, 24% reported results for 90% or less of their participants. ClinicalTrials.gov provides access to study results not otherwise available to the public. Although the database allows examination of various aspects of ongoing and completed clinical trials, its ultimate usefulness depends on the research community to submit accurate, informative data.

Design and analysis of three-arm trials with negative binomially distributed endpoints.

PubMed

Mütze, Tobias; Munk, Axel; Friede, Tim

2016-02-20

A three-arm clinical trial design with an experimental treatment, an active control, and a placebo control, commonly referred to as the gold standard design, enables testing of non-inferiority or superiority of the experimental treatment compared with the active control. In this paper, we propose methods for designing and analyzing three-arm trials with negative binomially distributed endpoints. In particular, we develop a Wald-type test with a restricted maximum-likelihood variance estimator for testing non-inferiority or superiority. For this test, sample size and power formulas as well as optimal sample size allocations will be derived. The performance of the proposed test will be assessed in an extensive simulation study with regard to type I error rate, power, sample size, and sample size allocation. For the purpose of comparison, Wald-type statistics with a sample variance estimator and an unrestricted maximum-likelihood estimator are included in the simulation study. We found that the proposed Wald-type test with a restricted variance estimator performed well across the considered scenarios and is therefore recommended for application in clinical trials. The methods proposed are motivated and illustrated by a recent clinical trial in multiple sclerosis. The R package ThreeArmedTrials, which implements the methods discussed in this paper, is available on CRAN. Copyright © 2015 John Wiley & Sons, Ltd.

Dimensions of design space: a decision-theoretic approach to optimal research design.

PubMed

Conti, Stefano; Claxton, Karl

2009-01-01

Bayesian decision theory can be used not only to establish the optimal sample size and its allocation in a single clinical study but also to identify an optimal portfolio of research combining different types of study design. Within a single study, the highest societal payoff to proposed research is achieved when its sample sizes and allocation between available treatment options are chosen to maximize the expected net benefit of sampling (ENBS). Where a number of different types of study informing different parameters in the decision problem could be conducted, the simultaneous estimation of ENBS across all dimensions of the design space is required to identify the optimal sample sizes and allocations within such a research portfolio. This is illustrated through a simple example of a decision model of zanamivir for the treatment of influenza. The possible study designs include: 1) a single trial of all the parameters, 2) a clinical trial providing evidence only on clinical endpoints, 3) an epidemiological study of natural history of disease, and 4) a survey of quality of life. The possible combinations, samples sizes, and allocation between trial arms are evaluated over a range of cost-effectiveness thresholds. The computational challenges are addressed by implementing optimization algorithms to search the ENBS surface more efficiently over such large dimensions.

Education strategies to foster health professional students' clinical reasoning skills.

PubMed

Rochmawati, Erna; Wiechula, Rick

2010-06-01

Clinical reasoning is an important skill for health professionals that should be developed to achieve high levels of expertise. Several education strategies have been suggested for implementation by health professional educators to foster their students' clinical reasoning skills. The strategies have included the following: problem-based learning, the integrative curriculum, reflection, and concept mapping. This review assesses which is the most effective education strategy for developing the clinical reasoning skills of health professional students. Four publications, from a total of 692 identified records, were included. Overall, this review was not able to make a final conclusion to answer the question. Therefore, there is a need to conduct more studies with larger samples and to undertake research that evaluates the following aspects: more alternate education interventions, variations in the delivery of education interventions, and the cost-effectiveness of implementing education strategies.

The Association Between Internet Use and Ambulatory Care-Seeking Behaviors in Taiwan: A Cross-Sectional Study

PubMed Central

Chen, Tsung-Fu; Liang, Jyh-Chong; Lin, Tzu-Bin; Tsai, Chin-Chung

2016-01-01

Background Compared with the traditional ways of gaining health-related information from newspapers, magazines, radio, and television, the Internet is inexpensive, accessible, and conveys diverse opinions. Several studies on how increasing Internet use affected outpatient clinic visits were inconclusive. Objective The objective of this study was to examine the role of Internet use on ambulatory care-seeking behaviors as indicated by the number of outpatient clinic visits after adjusting for confounding variables. Methods We conducted this study using a sample randomly selected from the general population in Taiwan. To handle the missing data, we built a multivariate logistic regression model for propensity score matching using age and sex as the independent variables. The questionnaires with no missing data were then included in a multivariate linear regression model for examining the association between Internet use and outpatient clinic visits. Results We included a sample of 293 participants who answered the questionnaire with no missing data in the multivariate linear regression model. We found that Internet use was significantly associated with more outpatient clinic visits (P=.04). The participants with chronic diseases tended to make more outpatient clinic visits (P<.01). Conclusions The inconsistent quality of health-related information obtained from the Internet may be associated with patients’ increasing need for interpreting and discussing the information with health care professionals, thus resulting in an increasing number of outpatient clinic visits. In addition, the media literacy of Web-based health-related information seekers may also affect their ambulatory care-seeking behaviors, such as outpatient clinic visits. PMID:27927606

Temporal and geographical external validation study and extension of the Mayo Clinic prediction model to predict eGFR in the younger population of Swiss ADPKD patients.

PubMed

Girardat-Rotar, Laura; Braun, Julia; Puhan, Milo A; Abraham, Alison G; Serra, Andreas L

2017-07-17

Prediction models in autosomal dominant polycystic kidney disease (ADPKD) are useful in clinical settings to identify patients with greater risk of a rapid disease progression in whom a treatment may have more benefits than harms. Mayo Clinic investigators developed a risk prediction tool for ADPKD patients using a single kidney value. Our aim was to perform an independent geographical and temporal external validation as well as evaluate the potential for improving the predictive performance by including additional information on total kidney volume. We used data from the on-going Swiss ADPKD study from 2006 to 2016. The main analysis included a sample size of 214 patients with Typical ADPKD (Class 1). We evaluated the Mayo Clinic model performance calibration and discrimination in our external sample and assessed whether predictive performance could be improved through the addition of subsequent kidney volume measurements beyond the baseline assessment. The calibration of both versions of the Mayo Clinic prediction model using continuous Height adjusted total kidney volume (HtTKV) and using risk subclasses was good, with R 2 of 78% and 70%, respectively. Accuracy was also good with 91.5% and 88.7% of the predicted within 30% of the observed, respectively. Additional information regarding kidney volume did not substantially improve the model performance. The Mayo Clinic prediction models are generalizable to other clinical settings and provide an accurate tool based on available predictors to identify patients at high risk for rapid disease progression.

Clinical validity of prototype personality disorder ratings in adolescents.

PubMed

Defife, Jared A; Haggerty, Greg; Smith, Scott W; Betancourt, Luis; Ahmed, Zain; Ditkowsky, Keith

2015-01-01

A growing body of research shows that personality pathology in adolescents is clinically distinctive and frequently stable into adulthood. A reliable and useful method for rating personality pathology in adolescent patients has the potential to enhance conceptualization, dissemination, and treatment effectiveness. The aim of this study is to examine the clinical validity of a prototype matching approach (derived from the Shedler Westen Assessment Procedure-Adolescent Version) for quantifying personality pathology in an adolescent inpatient sample. Sixty-six adolescent inpatients and their parents or legal guardians completed forms of the Child Behavior Checklist (CBCL) assessing emotional and behavioral problems. Clinical criterion variables including suicide history, substance use, and fights with peers were also assessed. Patients' individual and group therapists on the inpatient unit completed personality prototype ratings. Prototype diagnoses demonstrated substantial reliability (median intraclass correlation coefficient =.75) across independent ratings from individual and group therapists. Personality prototype ratings correlated with the CBCL scales and clinical criterion variables in anticipated and meaningful ways. As seen in prior research with adult samples, prototype personality ratings show clinical validity across independent clinician raters previously unfamiliar with the approach, and they are meaningfully related to clinical symptoms, behavioral problems, and adaptive functioning.

Clinical Validity of Prototype Personality Disorder Ratings in Adolescents

PubMed Central

DeFife, Jared A.; Haggerty, Greg; Smith, Scott W.; Betancourt, Luis; Ahmed, Zain; Ditkowsky, Keith

2015-01-01

A growing body of research shows that personality pathology in adolescents is clinically distinctive and frequently stable into adulthood. A reliable and useful method for rating personality pathology in adolescent patients has the potential to enhance conceptualization, dissemination, and treatment effectiveness. The aim of this study is to examine the clinical validity of a prototype matching approach (derived from the Shedler Westen Assessment Procedure – Adolescent Version) for quantifying personality pathology in an adolescent inpatient sample. Sixty-six adolescent inpatients and their parents or legal guardians completed forms of the Child Behavior Checklist (CBCL) assessing emotional and behavioral problems. Clinical criterion variables including suicide history, substance use, and fights with peers were also assessed. Patients’ individual and group therapists on the inpatient unit completed personality prototype ratings. Prototype diagnoses demonstrated substantial reliability (median ICC = .75) across independent ratings from individual and group therapists. Personality prototype ratings correlated with the CBCL scales and clinical criterion variables in anticipated and meaningful ways. As seen in prior research with adult samples, prototype personality ratings show clinical validity across independent clinician raters previously unfamiliar with the approach, and they are meaningfully related to clinical symptoms, behavioral problems, and adaptive functioning. PMID:25457971

Next-generation sequencing and clinical outcomes of patients with lung adenocarcinoma treated with stereotactic body radiotherapy.

PubMed

Cassidy, Richard J; Zhang, Xinyan; Patel, Pretesh R; Shelton, Joseph W; Escott, Chase E; Sica, Gabriel L; Rossi, Michael R; Hill, Charles E; Steuer, Conor E; Pillai, Rathi N; Ramalingam, Suresh S; Owonikoko, Taofeek K; Behera, Madhusmita; Force, Seth D; Fernandez, Felix G; Curran, Walter J; Higgins, Kristin A

2017-10-01

Genetic aberrations are well characterized in lung adenocarcinomas (LACs) and clinical outcomes have been influenced by targeted therapies in the advanced setting. Stereotactic body radiotherapy (SBRT) is the standard-of-care therapy for patients with nonoperable, early-stage LAC, but to the authors' knowledge, no information is available regarding the impact of genomic changes in these patients. The current study sought to determine the frequency and clinical impact of genetic aberrations in this population. Under an Institutional Review Board-approved protocol, the records of 242 consecutive patients with early-stage lung cancers were reviewed; inclusion criteria included LAC histology with an adequate tumor sample for the successful use of next-generation sequencing and fluorescence in situ hybridization testing. Univariate analysis was performed to identify factors associated with clinical outcomes. LAC samples from 98 of the 242 patients were reviewed (40.5%), of whom 45 patients (46.0%) had genetic testing. The following mutations were noted: KRAS in 20.0% of samples, BRAF in 2.2% of samples, SMAD family member 4 (SMAD4) in 4.4% of samples, epidermal growth factor receptor (EGFR) in 15.6% of samples, STK1 in 2.2% of samples, tumor protein 53 (TP53) in 15.6% of samples, and phosphatase and tensin homolog (PTEN) in 2.2% of samples. The following gene rearrangements were observed: anaplastic lymphoma kinase (ALK) in 8.9% of samples, RET in 2.2% of samples, and MET amplification in 17.8% of samples. The median total delivered SBRT dose was 50 grays (range, 48-60 grays) over a median of 5 fractions (range, 3-8 fractions). The KRAS mutation was associated with worse local control (odds ratio [OR], 3.64; P<.05). MET amplification was associated with worse regional (OR, 4.64; P<.05) and distant (OR, 3.73; P<.05) disease control. To the authors' knowledge, the current series is the first to quantify genetic mutations and their association with clinical outcomes in patients with early-stage LAC treated with SBRT. KRAS mutations were associated with worse local control and MET amplification was associated with worse regional and distant disease control, findings that need to be validated in a prospective setting. Cancer 2017;123:3681-3690. © 2017 American Cancer Society. © 2017 American Cancer Society.

Prevalence of HIV among Aboriginal and Torres Strait Islander Australians: a systematic review and meta-analysis.

PubMed

Graham, Simon; O'Connor, Catherine C; Morgan, Stephen; Chamberlain, Catherine; Hocking, Jane

2017-06-01

Background Aboriginal and Torres Strait Islanders (Aboriginal) are Australia's first peoples. Between 2006 and 2015, HIV notifications increased among Aboriginal people; however, among non-Aboriginal people, notifications remained relatively stable. This systematic review and meta-analysis aims to examine the prevalence of HIV among Aboriginal people overall and by subgroups. In November 2015, a search of PubMed and Web of Science, grey literature and abstracts from conferences was conducted. A study was included if it reported the number of Aboriginal people tested and those who tested positive for HIV. The following variables were extracted: gender; Aboriginal status; population group (men who have sex with men, people who inject drugs, adults, youth in detention and pregnant females) and geographical location. An assessment of between study heterogeneity (I 2 test) and within study bias (selection, measurement and sample size) was also conducted. Seven studies were included; all were cross-sectional study designs. The overall sample size was 3772 and the prevalence of HIV was 0.1% (I 2 =38.3%, P=0.136). Five studies included convenient samples of people attending Australian Needle and Syringe Program Centres, clinics, hospitals and a youth detention centre, increasing the potential of selection bias. Four studies had a sample size, thus decreasing the ability to report pooled estimates. The prevalence of HIV among Aboriginal people in Australia is low. Community-based programs that include both prevention messages for those at risk of infection and culturally appropriate clinical management and support for Aboriginal people living with HIV are needed to prevent HIV increasing among Aboriginal people.

Motivation to Quit Smoking after Acute Coronary Syndrome.

PubMed

Rocha, Vânia; Guerra, Marina; Lemos, Marina; Maciel, Júlia; Williams, Geoffrey

2017-01-31

Self-Determination Theory explores the process through which a person acquires motivation to initiate new behaviours related to health and to maintain them over time. This study aimed to determine the overall fit of Self-Determination Theory Model for Health Behavior to the data obtained from a sample of smokers hospitalized with acute coronary syndrome, and to identify the predictors of smoking status six months after clinical discharge. The sample included 110 participants, regular smokers, hospitalized due to acute coronary syndrome. Questionnaires were administered to assess autonomous self-regulation, perceived competence, family support, depressive symptoms and meaning in life. Participants were asked if they were currently smokers six months after clinical discharge. The results showed that the process variables specified by Self-Determination Theory fit the data well. Perceived competence predicted abstinence from smoking six months after clinical discharge. Our findings have similar characteristics to other international samples in which Self-Determination Theory models havebeen tested. It is important to facilitate perceived competence, as the patients who continue to smoke have shorter length of life. This study highlights the importance of considering clinical interventions based on Self-Determination Theory to facilitatesmoking cessation.

Implementation of Cloud based next generation sequencing data analysis in a clinical laboratory.

PubMed

Onsongo, Getiria; Erdmann, Jesse; Spears, Michael D; Chilton, John; Beckman, Kenneth B; Hauge, Adam; Yohe, Sophia; Schomaker, Matthew; Bower, Matthew; Silverstein, Kevin A T; Thyagarajan, Bharat

2014-05-23

The introduction of next generation sequencing (NGS) has revolutionized molecular diagnostics, though several challenges remain limiting the widespread adoption of NGS testing into clinical practice. One such difficulty includes the development of a robust bioinformatics pipeline that can handle the volume of data generated by high-throughput sequencing in a cost-effective manner. Analysis of sequencing data typically requires a substantial level of computing power that is often cost-prohibitive to most clinical diagnostics laboratories. To address this challenge, our institution has developed a Galaxy-based data analysis pipeline which relies on a web-based, cloud-computing infrastructure to process NGS data and identify genetic variants. It provides additional flexibility, needed to control storage costs, resulting in a pipeline that is cost-effective on a per-sample basis. It does not require the usage of EBS disk to run a sample. We demonstrate the validation and feasibility of implementing this bioinformatics pipeline in a molecular diagnostics laboratory. Four samples were analyzed in duplicate pairs and showed 100% concordance in mutations identified. This pipeline is currently being used in the clinic and all identified pathogenic variants confirmed using Sanger sequencing further validating the software.

Symptom Profile of ADHD in Youth With High-Functioning Autism Spectrum Disorder: A Comparative Study in Psychiatrically Referred Populations.

PubMed

Joshi, Gagan; Faraone, Stephen V; Wozniak, Janet; Tarko, Laura; Fried, Ronna; Galdo, Maribel; Furtak, Stephannie L; Biederman, Joseph

2017-08-01

To compare the clinical presentation of ADHD between youth with autism spectrum disorder (ASD) and ADHD and a sample of youth with ADHD only. A psychiatrically referred sample of autism spectrum disorder (ASD) youth with ADHD attending a specialized ambulatory program for ASD ( n = 107) and a sample of youth with ADHD attending a general child psychiatry ambulatory clinic ( n = 74) were compared. Seventy-six percent of youth with ASD met Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) criteria for ADHD. The clinical presentation of ADHD in youth with ASD was predominantly similar to its typical presentation including age at onset (3.5 ± 1.7 vs. 4.0 ± 1.9; p = .12), distribution of diagnostic subtypes, the qualitative and quantitative symptom profile, and symptom severity. Combined subtype was the most frequent presentation of ADHD in ASD youth. Despite the robust presentation of ADHD, a significant majority of ASD youth with ADHD failed to receive appropriate ADHD treatment (41% vs. 24%; p = .02). A high rate of comorbidity with ADHD was observed in psychiatrically referred youth with ASD, with a clinical presentation typical of the disorder.

Next-Generation Proteomics and Its Application to Clinical Breast Cancer Research.

PubMed

Mardamshina, Mariya; Geiger, Tamar

2017-10-01

Proteomics technology aims to map the protein landscapes of biological samples, and it can be applied to a variety of samples, including cells, tissues, and body fluids. Because the proteins are the main functional molecules in the cells, their levels reflect much more accurately the cellular phenotype and the regulatory processes within them than gene levels, mutations, and even mRNA levels. With the advancement in the technology, it is possible now to obtain comprehensive views of the biological systems and to study large patient cohorts in a streamlined manner. In this review we discuss the technological advancements in mass spectrometry-based proteomics, which allow analysis of breast cancer tissue samples, leading to the first large-scale breast cancer proteomics studies. Furthermore, we discuss the technological developments in blood-based biomarker discovery, which provide the basis for future development of assays for routine clinical use. Although these are only the first steps in implementation of proteomics into the clinic, extensive collaborative work between these worlds will undoubtedly lead to major discoveries and advances in clinical practice. Copyright © 2017 American Society for Investigative Pathology. Published by Elsevier Inc. All rights reserved.

Design of a multi-center immunophenotyping analysis of peripheral blood, sputum and bronchoalveolar lavage fluid in the Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS).

PubMed

Freeman, Christine M; Crudgington, Sean; Stolberg, Valerie R; Brown, Jeanette P; Sonstein, Joanne; Alexis, Neil E; Doerschuk, Claire M; Basta, Patricia V; Carretta, Elizabeth E; Couper, David J; Hastie, Annette T; Kaner, Robert J; O'Neal, Wanda K; Paine, Robert; Rennard, Stephen I; Shimbo, Daichi; Woodruff, Prescott G; Zeidler, Michelle; Curtis, Jeffrey L

2015-01-27

Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS) is a multi-center longitudinal, observational study to identify novel phenotypes and biomarkers of chronic obstructive pulmonary disease (COPD). In a subset of 300 subjects enrolled at six clinical centers, we are performing flow cytometric analyses of leukocytes from induced sputum, bronchoalveolar lavage (BAL) and peripheral blood. To minimize several sources of variability, we use a "just-in-time" design that permits immediate staining without pre-fixation of samples, followed by centralized analysis on a single instrument. The Immunophenotyping Core prepares 12-color antibody panels, which are shipped to the six Clinical Centers shortly before study visits. Sputum induction occurs at least two weeks before a bronchoscopy visit, at which time peripheral blood and bronchoalveolar lavage are collected. Immunostaining is performed at each clinical site on the day that the samples are collected. Samples are fixed and express shipped to the Immunophenotyping Core for data acquisition on a single modified LSR II flow cytometer. Results are analyzed using FACS Diva and FloJo software and cross-checked by Core scientists who are blinded to subject data. Thus far, a total of 152 sputum samples and 117 samples of blood and BAL have been returned to the Immunophenotyping Core. Initial quality checks indicate useable data from 126 sputum samples (83%), 106 blood samples (91%) and 91 BAL samples (78%). In all three sample types, we are able to identify and characterize the activation state or subset of multiple leukocyte cell populations (including CD4+ and CD8+ T cells, B cells, monocytes, macrophages, neutrophils and eosinophils), thereby demonstrating the validity of the antibody panel. Our study design, which relies on bi-directional communication between clinical centers and the Core according to a pre-specified protocol, appears to reduce several sources of variability often seen in flow cytometric studies involving multiple clinical sites. Because leukocytes contribute to lung pathology in COPD, these analyses will help achieve SPIROMICS aims of identifying subgroups of patients with specific COPD phenotypes. Future analyses will correlate cell-surface markers on a given cell type with smoking history, spirometry, airway measurements, and other parameters. This study was registered with ClinicalTrials.gov as NCT01969344 .

Cognitive and family correlates of current suicidal ideation in children with bipolar disorder.

PubMed

Weinstein, Sally M; Van Meter, Anna; Katz, Andrea C; Peters, Amy T; West, Amy E

2015-03-01

Suicidality among youth with bipolar disorder is an extreme, but largely unaddressed, public health problem. The current study examined the psychosocial characteristics differentiating youth with varying severities of suicidal ideation that may dictate targets for suicide prevention interventions. Participants included 72 youth aged 7-13 (M=9.19, SD=1.61) with DSM-IV-TR bipolar I, II, or NOS and a parent/caregiver. Current suicidal ideation and correlates were assessed at intake, including: demographics and clinical factors (diagnosis, symptom severity, psychiatric comorbidity); child factors (cognitive risk and quality of life); and family factors (parenting stress, family cohesion, and family rigidity). Current ideation was prevalent in this young sample: 41% endorsed any ideation, and 31% endorsed active forms. Depression symptoms, quality of life, hopelessness, self-esteem, and family rigidity differentiated youth with increasing ideation severity. Separate logistic regressions examined all significant child- and family-level factors, controlling for demographic and clinical variables. Greater family rigidity and lower self-esteem remained significant predictors of current planful ideation. Diagnosis, index episode, comorbidity, and mania severity did not differentiate non-ideators from those with current ideation. Limitations include the small sample to examine low base-rate severe ideation, cross-sectional analyses and generalizability of findings beyond the outpatient clinical sample. Findings underscore the importance of assessing and addressing suicidality in preadolescent youth with bipolar disorder, before youth progress to more severe suicidal behaviors. Results also highlight child self-esteem and family rigidity as key treatment targets to reduce suicide risk in pediatric bipolar disorder. Copyright © 2014 Elsevier B.V. All rights reserved.

Post-traumatic stress disorder in older adults: a systematic review of the psychotherapy treatment literature.

PubMed

Dinnen, Stephanie; Simiola, Vanessa; Cook, Joan M

2015-01-01

Older adults represent the fastest growing segment of the US and industrialized populations. However, older adults have generally not been included in randomized clinical trials of psychotherapy for post-traumatic stress disorder (PTSD). This review examined reports of psychological treatment for trauma-related problems, primarily PTSD, in studies with samples of at least 50% adults aged 55 and older using standardized measures. A systematic review of the literature was conducted on psychotherapy for PTSD with older adults using PubMed, Medline, PsychInfo, CINAHL, PILOTS, and Google Scholar. A total of 42 studies were retrieved for full review; 22 were excluded because they did not provide at least one outcome measure or results were not reported by age in the case of mixed-age samples. Of the 20 studies that met review criteria, there were: 13 case studies or series, three uncontrolled pilot studies, two randomized clinical trials, one non-randomized concurrent control study and one post hoc effectiveness study. Significant methodological limitations in the current older adult PTSD treatment outcome literature were found reducing its internal validity and generalizability, including non-randomized research designs, lack of comparison conditions and small sample sizes. Select evidence-based interventions validated in younger and middle-aged populations appear acceptable and efficacious with older adults. There are few treatment studies on subsets of the older adult population including cultural and ethnic minorities, women, the oldest old (over 85), and those who are cognitively impaired. Implications for clinical practice and future research directions are discussed.

Cognitive and Family Correlates of Current Suicidal Ideation in Children with Bipolar Disorder

PubMed Central

Weinstein, Sally M.; Van Meter, Anna; Katz, Andrea C.; Peters, Amy T.; West, Amy E.

2014-01-01

Background Suicidality among youth with bipolar disorder is an extreme, but largely unaddressed, public health problem. The current study examined the psychosocial characteristics differentiating youth with varying severities of suicidal ideation that may dictate targets for suicide prevention interventions. Methods Participants included 72 youth aged 7–13 (M = 9.19, SD = 1.61) with DSM-IV-TR bipolar I, II, or NOS and a parent/caregiver. Current suicidal ideation and correlates were assessed at intake, including: demographics and clinical factors (diagnosis, symptom severity, psychiatric comorbidity); child factors (cognitive risk and quality of life); and family factors (parenting stress, family cohesion, and family rigidity). Results Current ideation was prevalent in this young sample: 41% endorsed any ideation, and 31% endorsed active forms. Depression symptoms, quality of life, hopelessness, self-esteem, and family rigidity differentiated youth with increasing ideation severity. Separate logistic regressions examined all significant child- and family-level factors, controlling for demographic and clinical variables. Greater family rigidity and lower self-esteem remained significant predictors of current planful ideation. Diagnosis, index episode, comorbidity, and mania severity did not differentiate non-ideators from those with current ideation. Limitations Limitations include the small sample to examine low base-rate severe ideation, cross-sectional analyses and generalizability of findings beyond the outpatient clinical sample. Conclusions Findings underscore the importance of assessing and addressing suicidality in preadolescent youth with bipolar disorder, before youth progress to more severe suicidal behaviors. Results also highlight child self-esteem and family rigidity as key treatment targets to reduce suicide risk in pediatric bipolar disorder. PMID:25462390

Gender Differences in Borderline Personality Disorder: Results From a Multinational, Clinical Trial Sample.

PubMed

Silberschmidt, Amy; Lee, Susanne; Zanarini, Mary; Schulz, S Charles

2015-12-01

This study aims to extend previous research by considering gender differences in borderline personality (BPD) using both dimensional self-reported and clinical measures of symptomatology. Drawing from a cross-cultural, clinical trial sample, the authors compared female and male BPD subjects (N = 770; 211 male) between the ages of 18 and 65 using diagnostic and self-report data. The authors found that women with BPD have greater hostility and relationship disruption than men. Gender differences in eating disorders, particularly bulimia, are more divergent than in the general population. Generally, gender differences in BPD in this sample are consistent with known general population differences. Women show greater overall symptomatology, including depressive, anxious, and somatic symptoms. Men have higher rates of antisocial personality disorder and a trend toward higher rates of narcissistic personality disorder. However, several gender differences consistently found in the general population are not present in this BPD sample. There are no differences in aggression, suicidality, substance abuse, panic disorder, or obsessive-compulsive disorder. Gender differences in major depression and posttraumatic stress disorder are attenuated. These findings support the conclusion that BPD may diminish normal gender differences.

Hantavirus pulmonary syndrome clinical findings: evaluating a surveillance case definition.

PubMed

Knust, Barbara; Macneil, Adam; Rollin, Pierre E

2012-05-01

Clinical cases of hantavirus pulmonary syndrome (HPS) can be challenging to differentiate from other acute respiratory diseases, which can lead to delays in diagnosis, treatment, and disease reporting. Rapid onset of severe disease occurs, at times before diagnostic test results are available. This study's objective was to examine the clinical characteristics of patients that would indicate HPS to aid in detection and reporting. Test results of blood samples from U.S. patients suspected of having HPS submitted to the Centers for Disease Control and Prevention from 1998-2010 were reviewed. Patient information collected by case report forms was compared between HPS-confirmed and test-negative patients. Diagnostic sensitivity, specificity, predictive values, and likelihood ratios were calculated for individual clinical findings and combinations of variables. Of 567 patients included, 36% were HPS-confirmed. Thrombocytopenia, chest x-rays with suggestive signs, and receiving supplemental oxygenation were highly sensitive (>95%), while elevated hematocrit was highly specific (83%) in detecting HPS. Combinations that maximized sensitivity required the presence of thrombocytopenia. Using a national sample of suspect patients, we found that thrombocytopenia was a highly sensitive indicator of HPS and should be included in surveillance definitions for suspected HPS. Using a sensitive suspect case definition to identify potential HPS patients that are confirmed by highly specific diagnostic testing will ensure accurate reporting of this disease.

Reporting of research quality characteristics of studies published in 6 major clinical dental specialty journals.

PubMed

Pandis, Nikolaos; Polychronopoulou, Argy; Madianos, Phoebus; Makou, Margarita; Eliades, Theodore

2011-06-01

The objective of this article was to record reporting characteristics related to study quality of research published in major specialty dental journals with the highest impact factor (Journal of Endodontics, Journal of Oral and Maxillofacial Surgery, American Journal of Orthodontics and Dentofacial Orthopedics; Pediatric Dentistry, Journal of Clinical Periodontology, and International Journal of Prosthetic Dentistry). The included articles were classified into the following 3 broad subject categories: (1) cross-sectional (snap-shot), (2) observational, and (3) interventional. Multinomial logistic regression was conducted for effect estimation using the journal as the response and randomization, sample calculation, confounding discussed, multivariate analysis, effect measurement, and confidence intervals as the explanatory variables. The results showed that cross-sectional studies were the dominant design (55%), whereas observational investigations accounted for 13%, and interventions/clinical trials for 32%. Reporting on quality characteristics was low for all variables: random allocation (15%), sample size calculation (7%), confounding issues/possible confounders (38%), effect measurements (16%), and multivariate analysis (21%). Eighty-four percent of the published articles reported a statistically significant main finding and only 13% presented confidence intervals. The Journal of Clinical Periodontology showed the highest probability of including quality characteristics in reporting results among all dental journals. Copyright © 2011 Elsevier Inc. All rights reserved.

A methodological approach to improve the sexual health of vulnerable female populations: incentivized peer-recruitment and field-based STD testing.

PubMed

Roth, Alexis M; Rosenberger, Joshua G; Reece, Michael; Van Der Pol, Barbara

2012-02-01

Transactional sex has been associated with increased risk of adverse health outcomes, including sexually transmitted infections (STIs). Participants included female sex workers and men they recruited utilizing incentivized snowball sampling. Participants provided specimens for STI diagnostic testing and completed a semi-structured interview. Forty-four participants aged 19-65 were interviewed. Participants found self-sampling to be acceptable and overwhelmingly endorsed sampling outside of a clinic (90%) for reasons such as convenience, privacy, and lack of stigma. A substantial minority (38%) tested positive for at least one STI. Novel strategies may encourage sexual health care and prevent STIs among sex workers. High infection and screening acceptance rates across the sample suggests that individuals engaged in transactional sex would benefit from, and would be responsive to, community-based self-sampling for STI screening.

Impact of genomic profiling on the treatment and outcomes of patients with advanced gastrointestinal malignancies.

PubMed

Dhir, Mashaal; Choudry, Haroon A; Holtzman, Matthew P; Pingpank, James F; Ahrendt, Steven A; Zureikat, Amer H; Hogg, Melissa E; Bartlett, David L; Zeh, Herbert J; Singhi, Aatur D; Bahary, Nathan

2017-01-01

The impact of genomic profiling on the outcomes of patients with advanced gastrointestinal (GI) malignancies remains unknown. The primary objectives of the study were to investigate the clinical benefit of genomic-guided therapy, defined as complete response (CR), partial response (PR), or stable disease (SD) at 3 months, and its impact on progression-free survival (PFS) in patients with advanced GI malignancies. Clinical and genomic data of all consecutive GI tumor samples from April, 2013 to April, 2016 sequenced by FoundationOne were obtained and analyzed. A total of 101 samples from 97 patients were analyzed. Ninety-eight samples from 95 patients could be amplified making this approach feasible in 97% of the samples. After removing duplicates, 95 samples from 95 patients were included in the further analysis. Median time from specimen collection to reporting was 11 days. Genomic alteration-guided treatment recommendations were considered new and clinically relevant in 38% (36/95) of the patients. Rapid decline in functional status was noted in 25% (9/36) of these patients who could therefore not receive genomic-guided therapy. Genomic-guided therapy was utilized in 13 patients (13.7%) and 7 patients (7.4%) experienced clinical benefit (6 PR and 1 SD). Among these seven patients, median PFS was 10 months with some ongoing durable responses. Genomic profiling-guided therapy can lead to clinical benefit in a subset of patients with advanced GI malignancies. Attempting genomic profiling earlier in the course of treatment prior to functional decline may allow more patients to benefit from these therapies. © 2016 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Isolation and molecular characterization of Salmonella enterica serovar Javiana from food, environmental and clinical samples.

PubMed

Mezal, Ezat H; Stefanova, Rossina; Khan, Ashraf A

2013-06-03

A total of 50 Salmonella enterica serovar Javiana isolates, isolated from food, environmental and clinical samples, were analyzed for antibiotic resistance, presence of virulence genes, plasmids and plasmid replicon types. To assess the genetic diversity, pulsed-field gel electrophoresis (PFGE) fingerprinting and plasmid profiles were performed. All of the isolates were sensitive to chloramphenicol, nalidixic acid, and sulfisoxazole, and four isolates showed intermediate resistance to gentamicin or kanamycin. Eleven isolates, including representatives from each of the source types, were resistant to ampicillin. Four isolates from either clinical or environmental sources were resistant to tetracycline, while an additional 20 isolates showed intermediate resistance to this drug. Fourteen isolates, primarily from food sources, showed intermediate resistance to streptomycin. The S. Javiana isolates were screened by PCR for 17 virulence genes (spvB, spiA, pagC, msgA, invA, sipB, prgH, spaN, orgA, tolC, iroN, sitC, IpfC, sifA, sopB, cdtB, and pefA). All isolates were positive for nine to fourteen of these genes, but none were positive for pefA, spvB and lpfC, which are typically present on the Salmonella virulence plasmid. Seven of the virulence genes including cdtB were found in all 50 isolates, suggesting that S. Javiana from food and environmental sources had virulence similar to clinical isolates. Four clinical isolates and two food isolates carried one or more plasmids of approximately 30, 38, and 58 kb, with the 58 kb plasmids belonging to incompatibility group IncFIIA. Two clinical isolates carried IncI1 type mega plasmid (80 kb), and one clinical isolate carried plasmids of 4.5 and 7 kb. The PFGE profiles resulted 34 patterns in five clusters at a 90% similarity threshold. Our results indicate that S. Javiana isolates have a diverse clonal population among the clinical, food and environmental samples and this serotype possesses several virulent genes and plasmids that can contribute to the development of salmonellosis in human. This study provides data that support the potential transmission of S. Javiana virulence factors from food and environmental sources to cause infections in humans. Published by Elsevier B.V.

Reasons for faculty departures from an academic medical center: a survey and comparison across faculty lines.

PubMed

Girod, Sabine C; Fassiotto, Magali; Menorca, Roseanne; Etzkowitz, Henry; Wren, Sherry M

2017-01-10

Faculty departure can present significant intellectual costs to an institution. The authors sought to identify the reasons for clinical and non-clinical faculty departures at one academic medical center (AMC). In May and June 2010, the authors surveyed 137 faculty members who left a west coast School of Medicine (SOM) between 1999 and 2009. In May and June 2015, the same survey was sent to 40 faculty members who left the SOM between 2010-2014, for a total sample size of 177 former faculty members. The survey probed work history and experience, reasons for departure, and satisfaction at the SOM versus their current workplace. Statistical analyses included Pearson's chi-square test of independence and independent sample t-tests to understand quantitative differences between clinical and non-clinical respondents, as well as coding of qualitative open-ended responses. Eighty-eight faculty members responded (50%), including three who had since returned to the SOM. Overall, professional and advancement opportunities, salary concerns, and personal/family reasons were the three most cited factors for leaving. The average length of time at this SOM was shorter for faculty in clinical roles, who expressed lower workplace satisfaction and were more likely to perceive incongruence and inaccuracy in institutional expectations for their success than those in non-clinical roles. Clinical faculty respondents noted difficulty in balancing competing demands and navigating institutional expectations for advancement as reasons for leaving. AMCs may not be meeting faculty needs, especially those in clinical roles who balance multiple missions as clinicians, researchers, and educators. Institutions should address the challenges these faculty face in order to best recruit, retain, and advance faculty.

Australian Schizophrenia Research Bank: a database of comprehensive clinical, endophenotypic and genetic data for aetiological studies of schizophrenia.

PubMed

Loughland, Carmel; Draganic, Daren; McCabe, Kathryn; Richards, Jacqueline; Nasir, Aslam; Allen, Joanne; Catts, Stanley; Jablensky, Assen; Henskens, Frans; Michie, Patricia; Mowry, Bryan; Pantelis, Christos; Schall, Ulrich; Scott, Rodney; Tooney, Paul; Carr, Vaughan

2010-11-01

This article describes the establishment of the Australian Schizophrenia Research Bank (ASRB), which operates to collect, store and distribute linked clinical, cognitive, neuroimaging and genetic data from a large sample of people with schizophrenia and healthy controls. Recruitment sources for the schizophrenia sample include a multi-media national advertising campaign, inpatient and community treatment services and non-government support agencies. Healthy controls have been recruited primarily through multi-media advertisements. All participants undergo an extensive diagnostic and family history assessment, neuropsychological evaluation, and blood sample donation for genetic studies. Selected individuals also complete structural MRI scans. Preliminary analyses of 493 schizophrenia cases and 293 healthy controls are reported. Mean age was 39.54 years (SD = 11.1) for the schizophrenia participants and 37.38 years (SD = 13.12) for healthy controls. Compared to the controls, features of the schizophrenia sample included a higher proportion of males (cases 65.9%; controls 46.8%), fewer living in married or de facto relationships (cases 16.1%; controls 53.6%) and fewer years of education (cases 13.05, SD = 2.84; controls 15.14, SD = 3.13), as well as lower current IQ (cases 102.68, SD = 15.51; controls 118.28, SD = 10.18). These and other sample characteristics are compared to those reported in another large Australian sample (i.e. the Low Prevalence Disorders Study), revealing some differences that reflect the different sampling methods of these two studies. The ASRB is a valuable and accessible schizophrenia research facility for use by approved scientific investigators. As recruitment continues, the approach to sampling for both cases and controls will need to be modified to ensure that the ASRB samples are as broadly representative as possible of all cases of schizophrenia and healthy controls.

The ethical use of existing samples for genome research.

PubMed

Bathe, Oliver F; McGuire, Amy L

2009-10-01

Modern biobanking efforts consist of prospective collections of tissues linked to clinical data for patients who have given informed consent for the research use of their specimens and data, including their DNA. In such efforts, patient autonomy and privacy are well respected because of the prospective nature of the informed consent process. However, one of the richest sources of tissue for research continues to be the millions of archived samples collected by pathology departments during normal clinical care or for research purposes without specific consent for future research or genetic analysis. Because specific consent was not obtained a priori, issues related to individual privacy and autonomy are much more complicated. A framework for accessing these existing samples and related clinical data for research is presented. Archival tissues may be accessed only when there is a reasonable likelihood of generating beneficial and scientifically valid information. To minimize risks, databases containing information related to the tissue and to clinical data should be coded, no personally identifying phenotypic information should be included, and access should be restricted to bona fide researchers for legitimate research purposes. These precautions, if implemented appropriately, should ensure that the research use of archival tissue and data are no more than minimal risk. A waiver of the requirement for informed consent would then be justified if reconsent is shown to be impracticable. A waiver of consent should not be granted, however, if there is a significant risk to privacy, if the proposed research use is inconsistent with the original consent (where there is one), or if the potential harm from a privacy breach is considerable.

The periodontal abscess (I). Clinical and microbiological findings.

PubMed

Herrera, D; Roldán, S; González, I; Sanz, M

2000-06-01

Little information is available regarding the diagnosis and microbiology of periodontal abscesses. The aim of this descriptive clinical and microbiological study was to provide more information in order to help in the characterisation of the periodontal abscess associated to periodontitis. 29 consecutive patients with a periodontal abscess were studied by the assessment of clinical variables, including both subjective (pain, edema, redness and swelling) and objective (bleeding on probing, suppuration, probing pocket depth, tooth mobility and cervical lymphadenopathy) parameters. Microbiological samples were taken for anaerobic microbiology and processed by means of culture. Systemic involvement was also studied through the analysis of blood and urine samples using conventional laboratory standards. 62% of the abscesses affected untreated periodontitis patients, and 69% were associated with a molar tooth. More than 75% of the abscesses had moderate-severe scores related to edema, redness and swelling, and 90% of the patients reported pain. Bleeding occurred in all abscesses, while suppuration on sampling was detected in 66%. Mean associated pocket depth was 7.28 mm, and 79% of teeth presented some degree of mobility. Cervical lymphadenopathy was seen in 10% of patients, while elevated leucocyte counts were observed in 31.6%. The absolute number of neutrophils was elevated in 42% of the patients. High prevalences of putative periodontal pathogens were found, including Fusobacterium nucleatum, Peptostreptococcus micros, Porphyromonas gingivalis, Prevotella intermedia and Bacteroides forsythus. The periodontal abscess has clear clinical characteristics and is usually associated with severe periodontal destruction. This condition may cause systemic involvement and the lesion generally has a large bacterial mass with a high prevalence of well-recognised periodontal pathogens.

Prevalence, clinical features and risk assessment of pre-diabetes in Spain: the prospective Mollerussa cohort study

PubMed Central

Vilanova, María Belén; Falguera, Mireia; Marsal, Josep Ramon; Rubinat, Esther; Alcubierre, Núria; Catelblanco, Esmeralda; Granado-Casas, Minerva; Miró, Neus; Molló, Àngels; Mata-Cases, Manel; Franch-Nadal, Josep; Mauricio, Didac

2017-01-01

Purpose The Mollerussa prospective cohort was created to study pre-diabetes in a population-based sample from the primary care setting in the semirural area of Pla d’Urgell in Catalonia (Spain). The aims of the study were to assess the prevalence of pre-diabetes in our population, the likelihood to develop overt diabetes over time and to identify risk factors associated with the progression of the condition. Participants The cohort includes 594 subjects randomly selected between March 2011 and July 2014 from our primary care population, who were older than 25 years, consented to participate and did not have a recorded diagnosis of diabetes. Findings to date At baseline, we performed a clinical interview to collect demographic, clinical and lifestyle (including a nutritional survey) characteristics; carotid ultrasound imaging to assess subclinical cardiovascular disease was also performed, and a blood sample was collected, with an overall <5% rate of missing data. An additional blood draw was performed 12 months after initial recruitment to reassess laboratory results in patients initially identified as having pre-diabetes, with an 89.6% retention rate. Several studies investigating various hypotheses are currently ongoing. Future plans All subjects recruited during the cohort creation will be followed long-term through annual extraction of data from health records stored in the electronic Clinical station in Primary Care database. The Mollerussa cohort will thus be a sound population-based sample for multiple future research projects to generate insights into the epidemiology and natural history of pre-diabetes in Spain. PMID:28606902

Validation of Roche LightCycler Epstein-Barr virus quantification reagents in a clinical laboratory setting.

PubMed

Gulley, Margaret L; Fan, Hongxin; Elmore, Sandra H

2006-11-01

Epstein-Barr virus (EBV) is associated with a wide range of benign and malignant diseases, including infectious mononucleosis, lymphoma, posttransplant lymphoproliferative disorder, and nasopharyngeal carcinoma. Measurement of EBV viral load in plasma is increasingly used for rapid assessment of disease status. We evaluated the performance characteristics of an EBV polymerase chain reaction assay that uses commercial reagents and instruments from Roche Diagnostics (Indianapolis, IN). DNA was extracted from plasma using a MagNaPure instrument, and viral load was measured by real-time polymerase chain reaction on a LightCycler. Analyte-specific reagents included primers and hybridization probes targeting the EBV LMP2 gene and a spiked control sequence. Accuracy and reproducibility were established using DNA from three cell lines. The assay was sensitive to approximately 750 copies of EBV DNA per milliliter of plasma and was linear across at least four orders of magnitude. The assay detected EBV DNA in three of five samples from nasopharyngeal carcinoma patients, seven of nine infectious mononucleosis samples, and 34/34 samples from immunosuppressed patients with clinically significant EBV-related disease, whereas EBV DNA was undetectable in plasma from 21 individuals without EBV-related disease. In conclusion, this LightCycler EBV assay is rapid, sensitive, and linear for quantifying EBV viral load. The assay appears to be useful for measuring clinically significant EBV levels in immunodeficient patients.

Longitudinal white matter change in frontotemporal dementia subtypes and sporadic late onset Alzheimer's disease.

PubMed

Elahi, Fanny M; Marx, Gabe; Cobigo, Yann; Staffaroni, Adam M; Kornak, John; Tosun, Duygu; Boxer, Adam L; Kramer, Joel H; Miller, Bruce L; Rosen, Howard J

2017-01-01

Degradation of white matter microstructure has been demonstrated in frontotemporal lobar degeneration (FTLD) and Alzheimer's disease (AD). In preparation for clinical trials, ongoing studies are investigating the utility of longitudinal brain imaging for quantification of disease progression. To date only one study has examined sample size calculations based on longitudinal changes in white matter integrity in FTLD. To quantify longitudinal changes in white matter microstructural integrity in the three canonical subtypes of frontotemporal dementia (FTD) and AD using diffusion tensor imaging (DTI). 60 patients with clinical diagnoses of FTD, including 27 with behavioral variant frontotemporal dementia (bvFTD), 14 with non-fluent variant primary progressive aphasia (nfvPPA), and 19 with semantic variant PPA (svPPA), as well as 19 patients with AD and 69 healthy controls were studied. We used a voxel-wise approach to calculate annual rate of change in fractional anisotropy (FA) and mean diffusivity (MD) in each group using two time points approximately one year apart. Mean rates of change in FA and MD in 48 atlas-based regions-of-interest, as well as global measures of cognitive function were used to calculate sample sizes for clinical trials (80% power, alpha of 5%). All FTD groups showed statistically significant baseline and longitudinal white matter degeneration, with predominant involvement of frontal tracts in the bvFTD group, frontal and temporal tracts in the PPA groups and posterior tracts in the AD group. Longitudinal change in MD yielded a larger number of regions with sample sizes below 100 participants per therapeutic arm in comparison with FA. SvPPA had the smallest sample size based on change in MD in the fornix (n = 41 participants per study arm to detect a 40% effect of drug), and nfvPPA and AD had their smallest sample sizes based on rate of change in MD within the left superior longitudinal fasciculus (n = 49 for nfvPPA, and n = 23 for AD). BvFTD generally showed the largest sample size estimates (minimum n = 140 based on MD in the corpus callosum). The corpus callosum appeared to be the best region for a potential study that would include all FTD subtypes. Change in global measure of functional status (CDR box score) yielded the smallest sample size for bvFTD (n = 71), but clinical measures were inferior to white matter change for the other groups. All three of the canonical subtypes of FTD are associated with significant change in white matter integrity over one year. These changes are consistent enough that drug effects in future clinical trials could be detected with relatively small numbers of participants. While there are some differences in regions of change across groups, the genu of the corpus callosum is a region that could be used to track progression in studies that include all subtypes.

Analytical Validation of Quantitative Real-Time PCR Methods for Quantification of Trypanosoma cruzi DNA in Blood Samples from Chagas Disease Patients

PubMed Central

Ramírez, Juan Carlos; Cura, Carolina Inés; Moreira, Otacilio da Cruz; Lages-Silva, Eliane; Juiz, Natalia; Velázquez, Elsa; Ramírez, Juan David; Alberti, Anahí; Pavia, Paula; Flores-Chávez, María Delmans; Muñoz-Calderón, Arturo; Pérez-Morales, Deyanira; Santalla, José; Guedes, Paulo Marcos da Matta; Peneau, Julie; Marcet, Paula; Padilla, Carlos; Cruz-Robles, David; Valencia, Edward; Crisante, Gladys Elena; Greif, Gonzalo; Zulantay, Inés; Costales, Jaime Alfredo; Alvarez-Martínez, Miriam; Martínez, Norma Edith; Villarroel, Rodrigo; Villarroel, Sandro; Sánchez, Zunilda; Bisio, Margarita; Parrado, Rudy; Galvão, Lúcia Maria da Cunha; da Câmara, Antonia Cláudia Jácome; Espinoza, Bertha; de Noya, Belkisyole Alarcón; Puerta, Concepción; Riarte, Adelina; Diosque, Patricio; Sosa-Estani, Sergio; Guhl, Felipe; Ribeiro, Isabela; Aznar, Christine; Britto, Constança; Yadón, Zaida Estela; Schijman, Alejandro G.

2015-01-01

An international study was performed by 26 experienced PCR laboratories from 14 countries to assess the performance of duplex quantitative real-time PCR (qPCR) strategies on the basis of TaqMan probes for detection and quantification of parasitic loads in peripheral blood samples from Chagas disease patients. Two methods were studied: Satellite DNA (SatDNA) qPCR and kinetoplastid DNA (kDNA) qPCR. Both methods included an internal amplification control. Reportable range, analytical sensitivity, limits of detection and quantification, and precision were estimated according to international guidelines. In addition, inclusivity and exclusivity were estimated with DNA from stocks representing the different Trypanosoma cruzi discrete typing units and Trypanosoma rangeli and Leishmania spp. Both methods were challenged against 156 blood samples provided by the participant laboratories, including samples from acute and chronic patients with varied clinical findings, infected by oral route or vectorial transmission. kDNA qPCR showed better analytical sensitivity than SatDNA qPCR with limits of detection of 0.23 and 0.70 parasite equivalents/mL, respectively. Analyses of clinical samples revealed a high concordance in terms of sensitivity and parasitic loads determined by both SatDNA and kDNA qPCRs. This effort is a major step toward international validation of qPCR methods for the quantification of T. cruzi DNA in human blood samples, aiming to provide an accurate surrogate biomarker for diagnosis and treatment monitoring for patients with Chagas disease. PMID:26320872

Developing Psychosis and Its Risk States Through the Lens of Schizotypy

PubMed Central

Debbané, Martin; Eliez, Stephan; Badoud, Deborah; Conus, Philippe; Flückiger, Rahel; Schultze-Lutter, Frauke

2015-01-01

Starting from the early descriptions of Kraepelin and Bleuler, the construct of schizotypy was developed from observations of aberrations in nonpsychotic family members of schizophrenia patients. In contemporary diagnostic manuals, the positive symptoms of schizotypal personality disorder were included in the ultra high-risk (UHR) criteria 20 years ago, and nowadays are broadly employed in clinical early detection of psychosis. The schizotypy construct, now dissociated from strict familial risk, also informed research on the liability to develop any psychotic disorder, and in particular schizophrenia-spectrum disorders, even outside clinical settings. Against the historical background of schizotypy it is surprising that evidence from longitudinal studies linking schizotypy, UHR, and conversion to psychosis has only recently emerged; and it still remains unclear how schizotypy may be positioned in high-risk research. Following a comprehensive literature search, we review 18 prospective studies on 15 samples examining the evidence for a link between trait schizotypy and conversion to psychosis in 4 different types of samples: general population, clinical risk samples according to UHR and/or basic symptom criteria, genetic (familial) risk, and clinical samples at-risk for a nonpsychotic schizophrenia-spectrum diagnosis. These prospective studies underline the value of schizotypy in high-risk research, but also point to the lack of evidence needed to better define the position of the construct of schizotypy within a developmental psychopathology perspective of emerging psychosis and schizophrenia-spectrum disorders. PMID:25548386

Clinical studies of the High-Intensity Narrow-Spectrum light Environmental Decontamination System (HINS-light EDS), for continuous disinfection in the burn unit inpatient and outpatient settings.

PubMed

Bache, Sarah E; Maclean, Michelle; MacGregor, Scott J; Anderson, John G; Gettinby, George; Coia, John E; Taggart, Ian

2012-02-01

Infections are the leading cause of morbidity and mortality in burn patients and prevention of contamination from exogenous sources including the hospital environment is becoming increasingly emphasised. The High-Intensity Narrow-Spectrum light Environmental Decontamination System (HINS-light EDS) is bactericidal yet safe for humans, allowing continuous disinfection of the environment surrounding burn patients. Environmental samples were collected from inpatient isolation rooms and the outpatient clinic in the burn unit, and comparisons were then made between the bacterial contamination levels observed with and without use of the HINS-light EDS. Over 1000 samples were taken. Inpatient studies, with sampling carried out at 0800 h, demonstrated a significant reduction in the average number of bacterial colonies following HINS-light EDS use of between 27% and 75%, (p<0.05). There was more variation when samples were taken at times of increased activity in the room. Outpatient studies during clinics demonstrated a 61% efficacy in the reduction of bacterial contamination on surfaces throughout the room during the course of a clinic (p=0.02). The results demonstrate that use of the HINS-light EDS allows efficacious bacterial reductions over and above that achieved by standard cleaning and infection control measures in both inpatient and outpatient settings in the burn unit. Copyright © 2011 Elsevier Ltd and ISBI. All rights reserved.

Presence of infective Epstein-Barr virus in the urine of patients with infectious mononucleosis.

PubMed

Landau, Z; Gross, R; Sanilevich, A; Friedmann, A; Mitrani-Rosenbaum, S

1994-11-01

The presence of Epstein-Barr virus (EBV) in the blood and urine of 20 patients with infectious mononucleosis (IM) was investigated together with the clinical course of the disease, and in 9 patients up to 2-7 months after recovery. EBV DNA, analyzed by the polymerase chain reaction (PCR), was detected in the blood of all 20 patients from the first sample obtained and detected between 3 to 42 days from the beginning of symptoms and up to 2-3 months after recovery. In the urine, EBV DNA was detected in 15 out of 16 (93%) patients in the first sample obtained and detected between 3 to 50 days during the clinical course of the disease. In four patients EBV DNA was detected in the urine up to 3 months after full recovery. Seventeen out of 26 (65%) urine samples including 3 which were obtained 2-7 months after recovery infected B cells as assessed by PCR. Nine out of 12 (75%) urine samples tested induced Epstein-Barr nuclear antigen (EBNA) in the infected B-cell line. In addition to the persistence of EBV in the blood of IM patients, these studies show for the first time the presence of infective EBV in the urine during the clinical course of the disease and up to 7 months after full clinical recovery.

Adverse Childhood Experiences (ACEs) questionnaire and Adult Attachment Interview (AAI): implications for parent child relationships.

PubMed

Murphy, Anne; Steele, Miriam; Dube, Shanta Rishi; Bate, Jordan; Bonuck, Karen; Meissner, Paul; Goldman, Hannah; Steele, Howard

2014-02-01

Although Adverse Childhood Experiences (ACEs) are linked to increased health problems and risk behaviors in adulthood, there are no studies on the association between ACEs and adults' states of mind regarding their early childhood attachments, loss, and trauma experiences. To validate the ACEs questions, we analyzed the association between ACEs and emotional support indicators and Adult Attachment Interview (AAI) classifications in terms of unresolved mourning regarding past loss or trauma and discordant states of mind in cannot classify (U/CC) interviews. Seventy-five urban women (41 clinical and 34 community) completed a questionnaire on ACEs, which included 10 categories of abuse, neglect, and household dysfunction, in addition to emotional support. Internal psychological processes or states of mind concerning attachment were assessed using the AAI. ACE responses were internally consistent (Cronbach's α=.88). In the clinical sample, 84% reported≥4 ACEs compared to 27% among the community sample. AAIs judged U/CC occurred in 76% of the clinical sample compared to 9% in the community sample. When ACEs were≥4, 65% of AAIs were classified U/CC. Absence of emotional support in the ACEs questionnaire was associated with 72% of AAIs being classified U/CC. As the number of ACEs and the lack of emotional support increases so too does the probability of AAIs being classified as U/CC. Findings provide rationale for including ACEs questions in pediatric screening protocols to identify and offer treatment reducing the intergenerational transmission of risk associated with problematic parenting. Copyright © 2013 Elsevier Ltd. All rights reserved.

Comparison of mania patients suitable for treatment trials versus clinical treatment

PubMed Central

Talamo, Alessandra; Baldessarini, Ross J.; Centorrino, Franca

2008-01-01

It remains uncertain whether bipolar disorder (BPD) patients in randomized-controlled trials (RCTs) are sufficiently representative of clinically encountered patients as to guide clinical-therapeutic practice. We complied inclusion/exclusion criteria by frequency from reports of 21 RCTs for mania, and applied them in a pilot study of patients hospitalized for DSM-IV BPD manic/mixed states to compare characteristics and clinical responses of patients who did versus did not meet exclusion criteria. From 27 initially identified inclusion/exclusion criteria ranked by citation frequency, we derived six inclusion, and 10 non-redundant-exclusion factors. Of 67 consecutive patients meeting inclusion criteria, 15 (22.4%) potential “research subjects” met all 10 exclusion criteria. The remaining 52 “clinical patients” differed markedly on exclusion criteria, including more psychiatric co-morbidity, substance abuse, involuntary hospitalization, and suicide attempts or violence, but were otherwise similar. In both groups responses to clinically determined inpatient treatments were similar, including improvement in mania ratings. Based on applying reported inclusion/exclusion criteria for RCTs to a pilot sample of hospitalized-manic patients, those likely to be included in modern RCTs were similar to patients who would be excluded, most notably in short-term antimanic-treatment responses. The findings encourage further comparisons of subjects included/excluded from RCTs to test potential clinical generalizability of research findings. The pilot study is limited in numbers and exposure times with which to test for the minor differences between “research subjects” and “clinical patients.” PMID:18484680

Comparison of mania patients suitable for treatment trials versus clinical treatment.

PubMed

Talamo, Alessandra; Baldessarini, Ross J; Centorrino, Franca

2008-08-01

It remains uncertain whether bipolar disorder (BPD) patients in randomized-controlled trials (RCTs) are sufficiently representative of clinically encountered patients as to guide clinical-therapeutic practice. We complied inclusion/exclusion criteria by frequency from reports of 21 RCTs for mania, and applied them in a pilot study of patients hospitalized for DSM-IV BPD manic/mixed states to compare characteristics and clinical responses of patients who did versus did not meet exclusion criteria. From 27 initially identified inclusion/exclusion criteria ranked by citation frequency, we derived six inclusion, and 10 non-redundant-exclusion factors. Of 67 consecutive patients meeting inclusion criteria, 15 (22.4%) potential "research subjects" met all 10 exclusion criteria. The remaining 52 "clinical patients" differed markedly on exclusion criteria, including more psychiatric co-morbidity, substance abuse, involuntary hospitalization, and suicide attempts or violence, but were otherwise similar. In both groups responses to clinically determined inpatient treatments were similar, including improvement in mania ratings. Based on applying reported inclusion/exclusion criteria for RCTs to a pilot sample of hospitalized-manic patients, those likely to be included in modern RCTs were similar to patients who would be excluded, most notably in short-term antimanic-treatment responses. The findings encourage further comparisons of subjects included/excluded from RCTs to test potential clinical generalizability of research findings. The pilot study is limited in numbers and exposure times with which to test for the minor differences between "research subjects" and "clinical patients." (c) 2008 John Wiley & Sons, Ltd.

A National Study of Autistic Symptoms in the General Population of School-Age Children and Those Diagnosed with Autism Spectrum Disorders

ERIC Educational Resources Information Center

Goldstein, Sam; Naglieri, Jack A.; Rzepa, Sara; Williams, Kevin M.

2012-01-01

We examined the interrelationships among symptoms related to autism spectrum disorders (ASD) using a large representative sample and clinical groups of children aged 6 to 11 and youth aged 12 to 18 years rated by parents (N = 1,881) or teachers (N = 2,171). The samples included individuals from the United States and Canada from the standardization…

Measurement of DSM-5 section II personality disorder constructs using the MMPI-2-RF in clinical and forensic samples.

PubMed

Anderson, Jaime L; Sellbom, Martin; Pymont, Carly; Smid, Wineke; De Saeger, Hilde; Kamphuis, Jan H

2015-09-01

In the current study, we evaluated the associations between the Minnesota Multiphasic Personality Inventory-2 Restructured Form (MMPI-2-RF; Ben-Porath & Tellegen, 2008) scale scores and the Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5; American Psychiatric Association, 2013) Section II personality disorder (PD) criterion counts in inpatient and forensic psychiatric samples from The Netherlands using structured clinical interviews to operationalize PDs. The inpatient psychiatric sample included 190 male and female patients and the forensic sample included 162 male psychiatric patients. We conducted correlation and count regression analyses to evaluate the utility of relevant MMPI-2-RF scales in predicting PD criterion count scores. Generally, results from these analyses emerged as conceptually expected and provided evidence that MMPI-2-RF scales can be useful in assessing PDs. At the zero-order level, most hypothesized associations between Section II disorders and MMPI-2-RF scales were supported. Similarly, in the regression analyses, a unique set of predictors emerged for each PD that was generally in line with conceptual expectations. Additionally, the results provided general evidence that PDs can be captured by dimensional psychopathology constructs, which has implications for both DSM-5 Section III specifically and the personality psychopathology literature more broadly. (c) 2015 APA, all rights reserved.

Routine conventional karyotyping of lymphoma staging bone marrow samples does not contribute clinically relevant information.

PubMed

Nardi, Valentina; Pulluqi, Olja; Abramson, Jeremy S; Dal Cin, Paola; Hasserjian, Robert P

2015-06-01

Bone marrow (BM) evaluation is an important part of lymphoma staging, which guides patient management. Although positive staging marrow is defined as morphologically identifiable disease, such samples often also include flow cytometric analysis and conventional karyotyping. Cytogenetic analysis is a labor-intensive and costly procedure and its utility in this setting is uncertain. We retrospectively reviewed pathological reports of 526 staging marrow specimens in which conventional karyotyping had been performed. All samples originated from a single institution from patients with previously untreated Hodgkin and non-Hodgkin lymphomas presenting in an extramedullary site. Cytogenetic analysis revealed clonal abnormalities in only eight marrow samples (1.5%), all of which were positive for lymphoma by morphologic evaluation. Flow cytometry showed a small clonal lymphoid population in three of the 443 morphologically negative marrow samples (0.7%). Conventional karyotyping is rarely positive in lymphoma staging marrow samples and, in our cohort, the BM karyotype did not contribute clinically relevant information in the vast majority of cases. Our findings suggest that karyotyping should not be performed routinely on BM samples taken to stage previously diagnosed extramedullary lymphomas unless there is pathological evidence of BM involvement by lymphoma. © 2015 Wiley Periodicals, Inc.

Immunophenotype Discovery, Hierarchical Organization, and Template-Based Classification of Flow Cytometry Samples

DOE PAGES

Azad, Ariful; Rajwa, Bartek; Pothen, Alex

2016-08-31

We describe algorithms for discovering immunophenotypes from large collections of flow cytometry samples and using them to organize the samples into a hierarchy based on phenotypic similarity. The hierarchical organization is helpful for effective and robust cytometry data mining, including the creation of collections of cell populations’ characteristic of different classes of samples, robust classification, and anomaly detection. We summarize a set of samples belonging to a biological class or category with a statistically derived template for the class. Whereas individual samples are represented in terms of their cell populations (clusters), a template consists of generic meta-populations (a group ofmore » homogeneous cell populations obtained from the samples in a class) that describe key phenotypes shared among all those samples. We organize an FC data collection in a hierarchical data structure that supports the identification of immunophenotypes relevant to clinical diagnosis. A robust template-based classification scheme is also developed, but our primary focus is in the discovery of phenotypic signatures and inter-sample relationships in an FC data collection. This collective analysis approach is more efficient and robust since templates describe phenotypic signatures common to cell populations in several samples while ignoring noise and small sample-specific variations. We have applied the template-based scheme to analyze several datasets, including one representing a healthy immune system and one of acute myeloid leukemia (AML) samples. The last task is challenging due to the phenotypic heterogeneity of the several subtypes of AML. However, we identified thirteen immunophenotypes corresponding to subtypes of AML and were able to distinguish acute promyelocytic leukemia (APL) samples with the markers provided. Clinically, this is helpful since APL has a different treatment regimen from other subtypes of AML. Core algorithms used in our data analysis are available in the flowMatch package at www.bioconductor.org. It has been downloaded nearly 6,000 times since 2014.« less

Immunophenotype Discovery, Hierarchical Organization, and Template-Based Classification of Flow Cytometry Samples

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

Azad, Ariful; Rajwa, Bartek; Pothen, Alex

We describe algorithms for discovering immunophenotypes from large collections of flow cytometry samples and using them to organize the samples into a hierarchy based on phenotypic similarity. The hierarchical organization is helpful for effective and robust cytometry data mining, including the creation of collections of cell populations’ characteristic of different classes of samples, robust classification, and anomaly detection. We summarize a set of samples belonging to a biological class or category with a statistically derived template for the class. Whereas individual samples are represented in terms of their cell populations (clusters), a template consists of generic meta-populations (a group ofmore » homogeneous cell populations obtained from the samples in a class) that describe key phenotypes shared among all those samples. We organize an FC data collection in a hierarchical data structure that supports the identification of immunophenotypes relevant to clinical diagnosis. A robust template-based classification scheme is also developed, but our primary focus is in the discovery of phenotypic signatures and inter-sample relationships in an FC data collection. This collective analysis approach is more efficient and robust since templates describe phenotypic signatures common to cell populations in several samples while ignoring noise and small sample-specific variations. We have applied the template-based scheme to analyze several datasets, including one representing a healthy immune system and one of acute myeloid leukemia (AML) samples. The last task is challenging due to the phenotypic heterogeneity of the several subtypes of AML. However, we identified thirteen immunophenotypes corresponding to subtypes of AML and were able to distinguish acute promyelocytic leukemia (APL) samples with the markers provided. Clinically, this is helpful since APL has a different treatment regimen from other subtypes of AML. Core algorithms used in our data analysis are available in the flowMatch package at www.bioconductor.org. It has been downloaded nearly 6,000 times since 2014.« less

Rapid Identification of Methicillin-Resistant Staphylococcus aureus (MRSA) by the Vitek MS Saramis system.

PubMed

Shan, Weiguang; Li, Jiaping; Fang, Ying; Wang, Xuan; Gu, Danxia; Zhang, Rong

2016-01-01

A rapid, sensitive, and accurate Vitek MS assay was developed to distinguish clinical isolates of methicillin-resistant Staphylococcus aureus (MRSA) from clinical isolates of methicillin-sensitive Staphylococcus aureus (MSSA) by developing an in-house knowledgebase of SuperSpectra. Three unique peaks, including peaks at 2305.6 and 3007.3 Da specific to MRSA, and 6816.7 Da specific to MSSA, were selected for differentiating MRSA and MSSA. This assay accurately identified 84 and 91% of clinical MRSA and MSSA strains out of the total 142 clinically acquired S. aureus strains that were tested. This method will greatly improve the efficiency of single clinical sample identification of MRSA, thereby facilitating a reduction in the transmission of MRSA in clinical settings.

Incidence of postoperative hypothermia and the relationship to clinical variables.

PubMed

Burns, Shari M; Piotrowski, Kathy; Caraffa, Guy; Wojnakowski, Mary

2010-10-01

A prospective, quantitative, correlational study was conducted to determine the incidence of postoperative hypothermia and the relationship of hypothermia to numerous clinical variables previously studied. The study reflects the researchers' interest in updating previous data regarding the incidence of hypothermia. Although hypothermia remains a significant clinical concern, interventions aimed at minimizing hypothermia have evolved over the past 20 years, thus prompting new interest in determining the extent to which hypothermia exists in today's PACU patients. A convenience sample of 287 adult, nonemergency patients scheduled for surgery were included in the study. Hypothermia (temperature <36°C) was demonstrated in only 4% of the sample (N = 287). Because of the low incidence of hypothermia, correlation statistics were not performed. The study provides a foundation for future research regarding this important clinical phenomenon while offering evidence supporting efforts to avoid hypothermia in today's surgical patients. Copyright © 2010 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.

Computer-based intervention in HIV clinical care setting improves antiretroviral adherence: the LifeWindows Project.

PubMed

Fisher, Jeffrey D; Amico, K Rivet; Fisher, William A; Cornman, Deborah H; Shuper, Paul A; Trayling, Cynthia; Redding, Caroline; Barta, William; Lemieux, Anthony F; Altice, Frederick L; Dieckhaus, Kevin; Friedland, Gerald

2011-11-01

We evaluated the efficacy of LifeWindows, a theory-based, computer-administered antiretroviral (ARV) therapy adherence support intervention, delivered to HIV + patients at routine clinical care visits. 594 HIV + adults receiving HIV care at five clinics were randomized to intervention or control arms. Intervention vs. control impact in the intent-to-treat sample (including participants whose ARVs had been entirely discontinued, who infrequently attended care, or infrequently used LifeWindows) did not reach significance. Intervention impact in the On Protocol sample (328 intervention and control arm participants whose ARVs were not discontinued, who attended care and were exposed to LifeWindows regularly) was significant. On Protocol intervention vs. control participants achieved significantly higher levels of perfect 3-day ACTG-assessed adherence over time, with sensitivity analyses maintaining this effect down to 70% adherence. This study supports the utility of LifeWindows and illustrates that patients on ARVs who persist in care at clinical care sites can benefit from adherence promotion software.

Use of nonintrusive sensor-based information and communication technology for real-world evidence for clinical trials in dementia.

PubMed

Teipel, Stefan; König, Alexandra; Hoey, Jesse; Kaye, Jeff; Krüger, Frank; Robillard, Julie M; Kirste, Thomas; Babiloni, Claudio

2018-06-21

Cognitive function is an important end point of treatments in dementia clinical trials. Measuring cognitive function by standardized tests, however, is biased toward highly constrained environments (such as hospitals) in selected samples. Patient-powered real-world evidence using information and communication technology devices, including environmental and wearable sensors, may help to overcome these limitations. This position paper describes current and novel information and communication technology devices and algorithms to monitor behavior and function in people with prodromal and manifest stages of dementia continuously, and discusses clinical, technological, ethical, regulatory, and user-centered requirements for collecting real-world evidence in future randomized controlled trials. Challenges of data safety, quality, and privacy and regulatory requirements need to be addressed by future smart sensor technologies. When these requirements are satisfied, these technologies will provide access to truly user relevant outcomes and broader cohorts of participants than currently sampled in clinical trials. Copyright © 2018. Published by Elsevier Inc.

Psychosocial service needs of pediatric transport accident survivors: Using clinical data-mining to establish demographic and service usage characteristics.

PubMed

Manguy, Alys-Marie; Joubert, Lynette; Bansemer, Leah

2016-09-01

The objectives in this article are the exploration of demographic and service usage data gained through clinical data mining audit and suggesting recommendations for social work service delivery model and future research. The method is clinical data-mining audit of 100 sequentially sampled cases gathering quantitative demographic and service usage data. Descriptive analysis of file audit data raised interesting trends with potential to inform service delivery and usage; the key areas of the results included patient demographics, family involvement and impact, and child safety and risk issues. Transport accidents involving children often include other family members. Care planning must take into account psychosocial issues including patient and family emotional responses, availability of primary carers, and other practical needs that may impact on recovery and discharge planning. This study provides evidence to plan for further research and development of more integrated models of care.

Proteomic Data Resources for EDRN Ovary Cancer Researchers within the EDRN — EDRN Public Portal

Cancer.gov

This project will generate a highly valuable data resource and make it available to all EDRN ovarian cancer researchers. The resource will include comprehensive proteomic (tandem mass spectrometry, MS/MS) data generated from plasma samples that have been collected between four months and four years prior to clinical detection of ovarian cancer. These pre-clinical samples, provided from the Beta Carotene and Retinol Efficacy Trial (CARET) prospective study, will be interrogated using IPAS, the proteomic profiling method developed by the Hanash Laboratory and with the quantitative methods developed by the McIntosh laboratory. In addition, we will combine these pre-clinical data with already completed IPAS interrogations of plasma collected at the time of ovarian cancer diagnosis. Thus together we will provide information on both pre-clinical and clinical behavior of a large number of proteins. Based on our preliminary work we are able to quantify over 500 plasma proteins in each of these experiments, many of which are putative ovarian cancer biomarkers, showing the platform is capable of providing useful information regarding biomarker candidates.

Demographic and Clinical Profile of Patients With Dementia Receiving Electroconvulsive Therapy: A Case-Control Study.

PubMed

Zhang, Qing-E; Sha, Sha; Ungvari, Gabor S; Chiu, Helen F K; Ng, Chee H; He, Hong-Bo; Forester, Brent P; Xiang, Yu-Tao

2016-09-01

Little is known about the clinical characteristics of patients with dementia receiving electroconvulsive therapy (ECT) for the treatment of behavioral symptoms. This study examined the demographic and clinical profile of patients with dementia receiving ECT in China. This was a retrospective, case-control study. The sample was composed of 23 patients with dementia treated with ECT and 71 sex- and age-matched controls treated for a period of 8 years (2007-2014) at the National Clinical Research Centre of Mental Disorders, China. Sociodemographic and clinical data were collected from the electronic chart management system. Multiple logistic regression analysis revealed that ECT was independently associated with high risk for suicide at admission. The recorded indications for ECT included both high risk for suicide and aggressive behavior. Most patients responded to ECT satisfactorily (56.5%) or partially (34.8%) with only mild-moderate transient memory impairment (30.4%). Although this is a preliminary study limited by the retrospective design and small sample size, findings suggest that ECT is an effective and safe therapeutic intervention to reduce the risk for suicide and aggressive behavior in dementia.

Prevalence of sexually transmitted infections in female clinic attendees in Honiara, Solomon Islands.

PubMed

Marks, M; Kako, H; Butcher, R; Lauri, B; Puiahi, E; Pitakaka, R; Sokana, O; Kilua, G; Roth, A; Solomon, A W; Mabey, D C

2015-04-28

This study sought to determine the prevalence of common bacterial sexually transmitted infections, including Chlamydia trachomatis and Neisseria gonorrhoeae, in women attending clinics in the Solomon Islands. We conducted a sexual health survey among women attending three nurse-led community outpatient clinics in August 2014, to establish the prevalence of bacterial sexually transmitted infections in female clinic attenders in Honiara, Solomon Islands. Vaginal swab samples were tested for infection with C. trachomatis and N. gonorrhoeae using a commercial strand displacement amplification assay. Serum samples were tested for syphilis. We enrolled 296 women, aged 16-49, attending three clinics. Knowledge of safe sexual practices was high but reported condom usage was low. The prevalence of infection with C. trachomatis was 20%. The prevalence of infection with N. gonorrhoeae and syphilis were 5.1% and 4.1%, respectively. Bacterial sexually transmitted infections are a major health problem in the Solomon Islands. Interventions are urgently needed. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A Multiplexed Diagnostic Platform for Point-of-Care Pathogen Detection

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

Regan, J F; Letant, S E; Adams, K L

2008-02-04

We developed an automated point-of-care diagnostic instrument that is capable of analyzing nasal swab samples for the presence of respiratory diseases. This robust instrument, called FluIDx, performs autonomous multiplexed RT-PCR reactions that are analyzed by microsphere xMAP technology. We evaluated the performance of FluIDx, in comparison rapid tests specific for influenza and respiratory syncytial virus, in a clinical study performed at the UC Davis Medical Center. The clinical study included samples positive for RSV (n = 71), influenza A (n = 16), influenza B (n = 4), adenovirus (n = 5), parainfluenza virus (n = 2), and 44 negative samples,more » according to a composite reference method. FluIDx and the rapid tests detected 85.9% and 62.0% of the RSV positive samples, respectively. Similar sensitivities were recorded for the influenza B samples; whereas the influenza A samples were poorly detected, likely due to the utilization of an influenza A signature that did not accurately match currently circulating influenza A strains. Data for all pathogens were compiled and indicate that FluIDx is more sensitive than the rapid tests, detecting 74.2% (95% C.I. of 64.7-81.9%) of the positive samples in comparison to 53.6% (95% C.I. of 43.7-63.2%) for the rapid tests. The higher sensitivity of FluIDx was partially offset by a lower specificity, 77.3% versus 100.0%. Overall, these data suggest automated flow-through PCR-based instruments that perform multiplexed assays can successfully screen clinical samples for infectious diseases.« less

Procedures for mastitis diagnosis and control.

PubMed

Sears, P M; González, R N; Wilson, D J; Han, H R

1993-11-01

Procedures for mastitis diagnosis and control include culturing individual cow and bulk tank milk samples, antibiotic susceptibility testing, and evaluation of somatic cell count reports and clinical mastitis treatment records. Integrated use of such procedures is necessary for effective mastitis diagnosis and control.

Clinical nurse specialist prescriber characteristics and challenges in Oregon.

PubMed

Klein, Tracy

2015-01-01

The purpose of this study was to assess role characteristics of clinical nurse specialists (CNSs) with prescriptive authority in Oregon 10 years after passage of Senate Bill 460. Factors examined included role preparation and mentorship, use and maintenance of authority, prescribing benefits and barriers, and types of drugs/nondrugs prescribed. This study was a descriptive survey using both quantitative and qualitative analysis. The sample was obtained from a list provided on June 13, 2014, by the Oregon State Board of Nursing of all CNSs in Oregon who had ever been granted prescriptive authority (n = 40). Twenty-nine with active authority, 7 with expired authority, and 4 with inactive status were sampled. E-mail distribution with Qualtrics software was released on June 27, 2014. Reminder e-mails were sent at 1 and 2 weeks. Of the 38 e-mails successfully delivered, 23 responses were received for a total response rate of 60%. Clinical nurse specialists successfully maintained their authority in Oregon and felt well prepared for their role. Their prescribing mentorship included nurse and nonnurse prescribers. They were most likely to have ever prescribed psychiatric, noncontrolled analgesics and durable medical equipment. They most frequently prescribed nutrition/electrolytes/fluids, durable medical equipment, and controlled analgesics. Lapse in authority was attributed to constraints regarding certification or credentialing in the role. Clinical nurse specialists uniformly expressed benefits from prescriptive authority. There were no differences in perceptions of preparation based on type of mentorship or educational modality for completion of prescribing requirements. There were systems barriers including lack of employer and colleague support to use of authority. Durable medical equipment authority is important to the CNS role. Clinical nurse specialists valued and maintained their prescriptive authority despite barriers. Further research is recommended to support success for CNS prescribers from multiple settings and specialties.

Safe Use of Acoustic Vestibular-Evoked Myogenic Potential Stimuli: Protocol and Patient-Specific Considerations.

PubMed

Portnuff, Cory D F; Kleindienst, Samantha; Bogle, Jamie M

2017-09-01

Vestibular-evoked myogenic potentials (VEMPs) are commonly used clinical assessments for patients with complaints of dizziness. However, relatively high air-conducted stimuli are required to elicit the VEMP, and ultimately may compromise safe noise exposure limits. Recently, research has reported the potential for noise-induced hearing loss (NIHL) from VEMP stimulus exposure through studies of reduced otoacoustic emission levels after VEMP testing, as well as a recent case study showing permanent sensorineural hearing loss associated with VEMP exposure. The purpose of this report is to review the potential for hazardous noise exposure from VEMP stimuli and to suggest clinical parameters for safe VEMP testing. Literature review with presentation of clinical guidelines and a clinical tool for estimating noise exposure. The literature surrounding VEMP stimulus-induced hearing loss is reviewed, including several cases of overexposure. The article then presents a clinical calculation tool for the estimation of a patient's safe noise exposure from VEMP stimuli, considering stimulus parameters, and includes a discussion of how varying stimulus parameters affect a patient's noise exposure. Finally, recommendations are provided for recognizing and managing specific patient populations who may be at higher risk for NIHL from VEMP stimulus exposure. A sample protocol is provided that allows for safe noise exposure. VEMP stimuli have the potential to cause NIHL due to high sound exposure levels. However, with proper safety protocols in place, clinicians may reduce or eliminate this risk to their patients. Use of the tools provided, including the noise exposure calculation tool and sample protocols, may help clinicians to understand and ensure safe use of VEMP stimuli. American Academy of Audiology

Bias from historical control groups used in orthodontic research: a meta-epidemiological study.

PubMed

Papageorgiou, Spyridon N; Koretsi, Vasiliki; Jäger, Andreas

2017-02-01

The validity of meta-analysis is dependent upon the quality of included studies. Here, we investigated whether the design of untreated control groups (i.e. source and timing of data collection) influences the results of clinical trials in orthodontic research. This meta-epidemiological study used unrestricted literature searching for meta-analyses in orthodontics including clinical trials with untreated control groups. Differences in standardized mean differences (ΔSMD) and their 95% confidence intervals (CIs) were calculated according to the untreated control group through multivariable random-effects meta-regression controlling for nature of the interventional group and study sample size. Effects were pooled with random-effects synthesis, followed by mixed-effect subgroup and sensitivity analyses. Studies with historical control groups reported deflated treatment effects compared to studies with concurrent control groups (13 meta-analyses; ΔSMD = -0.31; 95% CI = -0.53, -0.10; P = 0.004). Significant differences were found according to the type of historical control group (based either on growth study or clinical archive; 11 meta-analyses; ΔSMD = 0.40; 95% CI = 0.21, 0.59; P < 0.001). The use of historical control groups in orthodontic clinical research was associated with deflation of treatment effects, which was independent from whether the interventional group was prospective or retrospective and from the study's sample size. Caution is warranted when interpreting clinical studies with historical untreated control groups or when interpreting systematic reviews that include such studies. PROSPERO (CRD42015024179). None. © The Author 2016. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

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

PubMed Central

2013-01-01

Background The Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) is a 34-item instrument developed to monitor clinically significant change in out-patients. The CORE-OM covers four domains: well-being, problems/symptoms, functioning and risk, and sums up in two total scores: the mean of All items, and the mean of All non-risk items. The aim of this study was to examine the psychometric properties of the Norwegian translation of the CORE-OM. Methods A clinical sample of 527 out-patients from North Norwegian specialist psychiatric services, and a non-clinical sample of 464 persons were obtained. The non-clinical sample was a convenience sample consisting of friends and family of health personnel, and of students of medicine and clinical psychology. Students also reported psychological stress. Exploratory factor analysis (EFA) was employed in half the clinical sample. Confirmatory (CFA) factor analyses modelling the theoretical sub-domains were performed in the remaining half of the clinical sample. Internal consistency, means, and gender and age differences were studied by comparing the clinical and non-clinical samples. Stability, effect of language (Norwegian versus English), and of psychological stress was studied in the sub-sample of students. Finally, cut-off scores were calculated, and distributions of scores were compared between clinical and non-clinical samples, and between students reporting stress or no stress. Results The results indicate that the CORE-OM both measures general (g) psychological distress and sub-domains, of which risk of harm separates most clearly from the g factor. Internal consistency, stability and cut-off scores compared well with the original English version. No, or only negligible, language effects were found. Gender differences were only found for the well-being domain in the non-clinical sample and for the risk domain in the clinical sample. Current patient status explained differences between clinical and non-clinical samples, also when gender and age were controlled for. Students reporting psychological distress during last week scored significantly higher than students reporting no stress. These results further validate the recommended cut-off point of 1 between clinical and non-clinical populations. Conclusions The CORE-OM in Norwegian has psychometric properties at the same level as the English original, and could be recommended for general clinical use. A cut-off point of 1 is recommended for both genders. PMID:23521746

A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials

PubMed Central

2009-01-01

Background Decisions about interim analysis and early stopping of clinical trials, as based on recommendations of Data Monitoring Committees (DMCs), have far reaching consequences for the scientific validity and clinical impact of a trial. Our aim was to evaluate the frequency and quality of the reporting on DMC composition and roles, interim analysis and early termination in pediatric trials. Methods We conducted a systematic review of randomized controlled clinical trials published from 2005 to 2007 in a sample of four general and four pediatric journals. We used full-text databases to identify trials which reported on DMCs, interim analysis or early termination, and included children or adolescents. Information was extracted on general trial characteristics, risk of bias, and a set of parameters regarding DMC composition and roles, interim analysis and early termination. Results 110 of the 648 pediatric trials in this sample (17%) reported on DMC or interim analysis or early stopping, and were included; 68 from general and 42 from pediatric journals. The presence of DMCs was reported in 89 of the 110 included trials (81%); 62 papers, including 46 of the 89 that reported on DMCs (52%), also presented information about interim analysis. No paper adequately reported all DMC parameters, and nine (15%) reported all interim analysis details. Of 32 trials which terminated early, 22 (69%) did not report predefined stopping guidelines and 15 (47%) did not provide information on statistical monitoring methods. Conclusions Reporting on DMC composition and roles, on interim analysis results and on early termination of pediatric trials is incomplete and heterogeneous. We propose a minimal set of reporting parameters that will allow the reader to assess the validity of trial results. PMID:20003383

A systematic review of reboxetine for treating patients with attention deficit hyperactivity disorder.

PubMed

Ghanizadeh, Ahmad

2015-05-01

No published systematic review has ever assessed the efficacy and safety of reboxetine for treating of patients with attention deficit hyperactivity disorder (ADHD). This systematic review aimed to review the available evidence regarding the efficacy of reboxetine for treating ADHD. The databases of Pubmed/Medline, Google scholar, SCOPUS and Web of Science were searched using the Keywords: "reboxetine", "ADHD" and "attention deficit hyperactivity disorder". The reference lists of the included studies were screened to find any possible other relevant articles. All the non-controlled and controlled clinical trials were included. The current evidence mainly consists of un-controlled studies, such as case series. Only three of 33 studies were controlled clinical trials. They are from single sites and included a sub-sample of patients with ADHD. Non-controlled studies and controlled trials support the promising effect of reboxetine for treating ADHD in a sub-sample of patients that are without co-morbid psychiatric disorder and mental retardation. Reboxetine is tolerated well. However, more controlled trials are needed to reach any firm conclusion.

Return of Individual Research Results & Incidental Findings: Facing the Challenges of Translational Science

PubMed Central

Wolf, Susan M.

2014-01-01

The debate over return of individual research results and incidental findings to research participants is a key frontier in research ethics and practice. Fundamentally, this is a problem of translational science, a question of when information about an individual that is generated in research should be communicated for clinical attention, as the technology itself is moving into clinical care. There is growing consensus that investigators should offer participants at least those individual findings of high clinical importance and actionability. Increasing attention to what information biobanks and secondary researchers owe people who provide data and samples offers an opportunity to treat these source individuals as research partners. Cutting-edge issues include return of results in pediatric populations and return to kin and family, including after death of the proband. Progress will require facing the continuum linking research and clinical care and developing standards and models for return. PMID:23875796

Clinical evaluation of fiber-reinforced epoxy resin posts and cast post and cores.

PubMed

Ferrari, M; Vichi, A; García-Godoy, F

2000-05-01

This retrospective study evaluated treatment outcome of cast post and core and Composipost systems after 4 yrs of clinical service. 200 patients were included in the study. They were divided in two groups of 100 endodontically treated teeth restored with a post. Group 1: Composipost systems were luted into root canal following the manufacturer's instructions. Group 2: Cast post and cores were cemented into root canal preparations with a traditional technique. The patients were recalled after 6 months, 1, 2 and 4 yrs and clinical and radiographic examinations were completed. Endodontic and prosthodontic results were recorded. Group 1: 95% of the teeth restored with Composiposts showed clinical success; 3% of these samples were excluded for noncompliance and 2% showed endodontic failure. Group 2: Clinical success was found with 84% of teeth restored with cast post and core. 2% of these samples were excluded for noncompliance, 9% showed root fracture, 2% dislodgment of crown and 3% endodontic failure. Statistical evaluation showed significant differences between Groups 1 and 2 (P < 0.001). The results of this retrospective study indicated that the Composipost system was superior to the conventional cast post and core system after 4 yrs of clinical service.

Memory Complaints Associated with Seeking Clinical Care

PubMed Central

Pires, Carolina; Silva, Dina; Maroco, João; Ginó, Sandra; Mendes, Tiago; Schmand, Ben A.; Guerreiro, Manuela; de Mendonça, Alexandre

2012-01-01

Diagnosis of mild cognitive impairment relies on the presence of memory complaints. However, memory complaints are very frequent in healthy people. The objective of this study was to determine the severity and type of memory difficulties presented by elderly patients who seek for clinical help, as compared to the memory difficulties reported by subjects in the community. Assessment of subjective memory complaints was done with the subjective memory complaints scale (SMC). The mini-mental state examination was used for general cognitive evaluation and the geriatric depression scale for the assessment of depressive symptoms. Eight-hundred and seventy-one nondemented subjects older than 50 years were included. Participants in the clinical setting had a higher total SMC score (10.3 ± 4.2) than those in the community (5.1 ± 3.0). Item 3 of the SMC, Do you ever forget names of family members or friends? contributed significantly more to the variance of the total SMC score in the clinical sample (18%) as compared to the community sample (11%). Forgetting names of family members or friends plays an important role in subjective memory complaints in the clinical setting. This symptom is possibly perceived as particularly worrisome and likely drives people to seek for clinical help. PMID:22536537

The national DBS brain tissue network pilot study: need for more tissue and more standardization.

PubMed

Vedam-Mai, V; Krock, N; Ullman, M; Foote, K D; Shain, W; Smith, K; Yachnis, A T; Steindler, D; Reynolds, B; Merritt, S; Pagan, F; Marjama-Lyons, J; Hogarth, P; Resnick, A S; Zeilman, P; Okun, M S

2011-08-01

Over 70,000 DBS devices have been implanted worldwide; however, there remains a paucity of well-characterized post-mortem DBS brains available to researchers. We propose that the overall understanding of DBS can be improved through the establishment of a Deep Brain Stimulation-Brain Tissue Network (DBS-BTN), which will further our understanding of DBS and brain function. The objectives of the tissue bank are twofold: (a) to provide a complete (clinical, imaging and pathological) database for DBS brain tissue samples, and (b) to make available DBS tissue samples to researchers, which will help our understanding of disease and underlying brain circuitry. Standard operating procedures for processing DBS brains were developed as part of the pilot project. Complete data files were created for individual patients and included demographic information, clinical information, imaging data, pathology, and DBS lead locations/settings. 19 DBS brains were collected from 11 geographically dispersed centers from across the U.S. The average age at the time of death was 69.3 years (51-92, with a standard deviation or SD of 10.13). The male:female ratio was almost 3:1. Average post-mortem interval from death to brain collection was 10.6 h (SD of 7.17). The DBS targets included: subthalamic nucleus, globus pallidus interna, and ventralis intermedius nucleus of the thalamus. In 16.7% of cases the clinical diagnosis failed to match the pathological diagnosis. We provide neuropathological findings from the cohort, and perilead responses to DBS. One of the most important observations made in this pilot study was the missing data, which was approximately 25% of all available data fields. Preliminary results demonstrated the feasibility and utility of creating a National DBS-BTN resource for the scientific community. We plan to improve our techniques to remedy omitted clinical/research data, and expand the Network to include a larger donor pool. We will enhance sample preparation to facilitate advanced molecular studies and progenitor cell retrieval.

Large-Scale and Deep Quantitative Proteome Profiling Using Isobaric Labeling Coupled with Two-Dimensional LC-MS/MS

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

Gritsenko, Marina A.; Xu, Zhe; Liu, Tao

Comprehensive, quantitative information on abundances of proteins and their post-translational modifications (PTMs) can potentially provide novel biological insights into diseases pathogenesis and therapeutic intervention. Herein, we introduce a quantitative strategy utilizing isobaric stable isotope-labelling techniques combined with two-dimensional liquid chromatography-tandem mass spectrometry (2D-LC-MS/MS) for large-scale, deep quantitative proteome profiling of biological samples or clinical specimens such as tumor tissues. The workflow includes isobaric labeling of tryptic peptides for multiplexed and accurate quantitative analysis, basic reversed-phase LC fractionation and concatenation for reduced sample complexity, and nano-LC coupled to high resolution and high mass accuracy MS analysis for high confidence identification andmore » quantification of proteins. This proteomic analysis strategy has been successfully applied for in-depth quantitative proteomic analysis of tumor samples, and can also be used for integrated proteome and PTM characterization, as well as comprehensive quantitative proteomic analysis across samples from large clinical cohorts.« less

Bayesian sample size calculations in phase II clinical trials using a mixture of informative priors.

PubMed

Gajewski, Byron J; Mayo, Matthew S

2006-08-15

A number of researchers have discussed phase II clinical trials from a Bayesian perspective. A recent article by Mayo and Gajewski focuses on sample size calculations, which they determine by specifying an informative prior distribution and then calculating a posterior probability that the true response will exceed a prespecified target. In this article, we extend these sample size calculations to include a mixture of informative prior distributions. The mixture comes from several sources of information. For example consider information from two (or more) clinicians. The first clinician is pessimistic about the drug and the second clinician is optimistic. We tabulate the results for sample size design using the fact that the simple mixture of Betas is a conjugate family for the Beta- Binomial model. We discuss the theoretical framework for these types of Bayesian designs and show that the Bayesian designs in this paper approximate this theoretical framework. Copyright 2006 John Wiley & Sons, Ltd.

Large-Scale and Deep Quantitative Proteome Profiling Using Isobaric Labeling Coupled with Two-Dimensional LC-MS/MS.

PubMed

Gritsenko, Marina A; Xu, Zhe; Liu, Tao; Smith, Richard D

2016-01-01

Comprehensive, quantitative information on abundances of proteins and their posttranslational modifications (PTMs) can potentially provide novel biological insights into diseases pathogenesis and therapeutic intervention. Herein, we introduce a quantitative strategy utilizing isobaric stable isotope-labeling techniques combined with two-dimensional liquid chromatography-tandem mass spectrometry (2D-LC-MS/MS) for large-scale, deep quantitative proteome profiling of biological samples or clinical specimens such as tumor tissues. The workflow includes isobaric labeling of tryptic peptides for multiplexed and accurate quantitative analysis, basic reversed-phase LC fractionation and concatenation for reduced sample complexity, and nano-LC coupled to high resolution and high mass accuracy MS analysis for high confidence identification and quantification of proteins. This proteomic analysis strategy has been successfully applied for in-depth quantitative proteomic analysis of tumor samples and can also be used for integrated proteome and PTM characterization, as well as comprehensive quantitative proteomic analysis across samples from large clinical cohorts.

International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct Oral Anticoagulants.

PubMed

Gosselin, Robert C; Adcock, Dorothy M; Bates, Shannon M; Douxfils, Jonathan; Favaloro, Emmanuel J; Gouin-Thibault, Isabelle; Guillermo, Cecilia; Kawai, Yohko; Lindhoff-Last, Edelgard; Kitchen, Steve

2018-03-01

This guidance document was prepared on behalf of the International Council for Standardization in Haematology (ICSH) for providing haemostasis-related guidance documents for clinical laboratories. This inaugural coagulation ICSH document was developed by an ad hoc committee, comprised of international clinical and laboratory direct acting oral anticoagulant (DOAC) experts. The committee developed consensus recommendations for laboratory measurement of DOACs (dabigatran, rivaroxaban, apixaban and edoxaban), which would be germane for laboratories assessing DOAC anticoagulation. This guidance document addresses all phases of laboratory DOAC measurements, including pre-analytical (e.g. preferred time sample collection, preferred sample type, sample stability), analytical (gold standard method, screening and quantifying methods) and post analytical (e.g. reporting units, quality assurance). The committee addressed the use and limitations of screening tests such as prothrombin time, activated partial thromboplastin time as well as viscoelastic measurements of clotting blood and point of care methods. Additionally, the committee provided recommendations for the proper validation or verification of performance of laboratory assays prior to implementation for clinical use, and external quality assurance to provide continuous assessment of testing and reporting method. Schattauer GmbH Stuttgart.

Detection of Shigella in Milk and Clinical Samples by Magnetic Immunocaptured-Loop-Mediated Isothermal Amplification Assay

PubMed Central

Zhang, Liding; Wei, Qiujiang; Han, Qinqin; Chen, Qiang; Tai, Wenlin; Zhang, Jinyang; Song, Yuzhu; Xia, Xueshan

2018-01-01

Shigella is an important human food-borne zoonosis bacterial pathogen, and can cause clinically severe diarrhea. There is an urgent need to develop a specific, sensitive, and rapid methodology for detection of this pathogen. In this study, loop-mediated isothermal amplification (LAMP) combined with magnetic immunocapture assay (IC-LAMP) was first developed for the detection of Shigella in pure culture, artificial milk, and clinical stool samples. This method exhibited a detection limit of 8.7 CFU/mL. Compared with polymerase chain reaction, IC-LAMP is sensitive, specific, and reliable for monitoring Shigella. Additionally, IC-LAMP is more convenient, efficient, and rapid than ordinary LAMP, as it is more efficiently enriches pathogen cells without extraction of genomic DNA. Under isothermal conditions, the amplification curves and the green fluorescence were detected within 30 min in the presence of genomic DNA template. The overall analysis time was approximately 1 h, including the enrichment and lysis of the bacterial cells, a significantly short detection time. Therefore, the IC-LAMP methodology described here is potentially useful for the efficient detection of Shigella in various samples. PMID:29467730

Neuroticism and introversion: a risky combination for disordered eating among a non-clinical sample of undergraduate women.

PubMed

Miller, Jessie L; Schmidt, Louis A; Vaillancourt, Tracy; McDougall, Patricia; Laliberte, Michele

2006-01-01

Recent evidence suggests that people who score low on measures of sociability may be at risk for certain types of psychopathology, including mood and anxiety disorders. In an attempt to extend these findings to other forms of psychopathology, we examined levels of neuroticism and extraversion in relation to eating problems in a non-clinical sample of undergraduate women. The Eysenck Personality Questionnaire (EPQ), Eating Disorders Inventory (EDI), and the Eating Attitudes Test (EAT-26) were completed by 196 first-year undergraduate females. We found that high neuroticism was related to high scores on both of the EDI subscales (Bulimia and Drive for Thinness) as well as high scores on the EAT-26 measure, replicating previous work. In addition, neuroticism served as a moderator such that lower extraversion (i.e., introversion) was related to greater disordered eating, but only for those women who scored high on neuroticism. Thus, a combination of neuroticism and introversion may be a risk-factor for symptoms of eating disorders in a non-clinical sample of university women.

Schizoaffective disorder diagnosed according to different diagnostic criteria--systematic literature search and meta-analysis of key clinical characteristics and heterogeneity.

PubMed

Pagel, Tobias; Franklin, Jeremy; Baethge, Christopher

2014-03-01

Schizoaffective disorder is viewed as a heterogeneous diagnosis among psychotic illnesses. Different diagnostic systems differ in their definition with DSM (-IIIR, -IV, and -V) providing a narrower definition than RDC and ICD-10. It is unclear whether this difference is reflected in patient samples diagnosed according to different diagnostic systems. Exploratory study based on a systematic review of studies of schizoaffective disorder samples diagnosed by either RDC and ICD-10 (group of "broad criteria") or DSM-IIIR and -IV ("narrow criteria"); comparison (by Mann-Whitney-U-tests) of key characteristics, such as age, number of hospitalizations, or scores in psychometric tests, between more broadly and more narrowly defined schizoaffective disorder samples using standard deviations as a measurement of heterogeneity as well as weighted means and percentages. To reduce selection bias only studies including schizoaffective patient samples together with affective disorder and schizophrenia samples were selected. 55 studies were included, 14 employing RDC, 4 ICD-10, 20 DSM-IIIR, and 17 DSM-IV. Thirteen characteristics were compared: patients diagnosed according to broader criteria had fewer previous hospitalizations (2.2 vs. 5.4) and were both less often male (42 vs. 51%) and married (21 vs. 40%). Heterogeneity was similar in both groups but slightly higher in RDC and ICD-10 samples than in DSM-IIIR and -IV-samples: +4% regarding demographic and clinical course data and +13% regarding psychometric tests (pooled SD). Secular trends and different designs may have confounded the results and limit generalizability. Some comparisons were underpowered. Differences in diagnostic criteria are reflected in key characteristics of samples. The association of larger heterogeneity with wider diagnostic criteria supports employing standard deviations as a measurement of heterogeneity. Copyright © 2013 Elsevier B.V. All rights reserved.

One practice's experiment in refusing detail rep visits.

PubMed

Evans, David V; Hartung, Daniel M; Andeen, Gabriel; Mahler, Jo; Haxby, Dean G; Kraemer, Dale F; Fagnan, Lyle J

2011-08-01

The physician-pharmaceutical industry relationship has come under increasing scrutiny. Little guidance exists concerning how smaller practices should manage this relationship.In 2006, Madras Medical Group, a small family practice in rural Oregon, implemented a policy prohibiting visits from representatives of the pharmaceutical industry and the acceptance of drug samples. This qualitative study documents the attitudes of clinic personnel in response to this policy. Semistructured interviews were conducted using standardized questions related to 4 areas of policy perception: verification of policy decision, impact on clinic operations,influence of pharmaceutical industry, and lessons to share. Common themes were identified. Three physicians and 3 nurses participated in the study. There was consensus on the existence and effectiveness of the clinic policy. Key themes identified from both groups of interviewees included the perception of enhanced clinic operation after eliminating interruptions from pharmaceutical representatives, positive response from the public, and reduced diversion of samples for personal use. Clinicians interviewed agreed that samples were of questionable benefit,that information obtained from industry representatives was incomplete or of questionable veracity or objectivity, and that it was helpful to substitute other drug information sources and clinic-sponsored lunches for past industry offerings. In this case study, a policy prohibiting pharmaceutical representatives from a small family practice was well accepted and a source of pride among physicians and nurses. Other clinics wishing to enact a similar policy may wish to supplement their efforts by proactively using other sources of drug information.

Chinese SLE Treatment and Research group (CSTAR) registry: I. Major clinical characteristics of Chinese patients with systemic lupus erythematosus.

PubMed

Li, M; Zhang, W; Leng, X; Li, Z; Ye, Z; Li, C; Li, X; Zhu, P; Wang, Z; Zheng, Y; Li, X; Zhang, M; Zhang, F; Zhao, Y; Zeng, X

2013-10-01

The Chinese systemic lupus erythematosus (SLE) treatment and research group (CSTAR) provides major clinical characteristics of SLE in China and establishes a platform to provide resources for future basic and clinical studies. CSTAR originated as a multicentre, consecutive, and prospective design. The data were collected online from 104 rheumatology centers, which covered 30 provinces in China. The registered patients were required to meet four or more of the American College of Rheumatology (ACR) criteria for the classification of SLE. All CSTAR centers use the same protocol-directed methods to provide uniform evaluations, which included demographic data, clinical features, laboratory examinations, and disease activity evaluations. The patient samples, including DNA samples and sera, were also collected for further quality controls and additional studies. Preliminary analysis from 2104 baseline evaluations was available for this analysis. Of 1914 female and 190 male patients (F:M=10.1), the mean age at onset was 29.2 y with confirmed diagnosis one year later at the age of 30.3 y. Eighty four (4.2%) of 2002 patients had a family history of rheumatic diseases, including 34 (1.7%) cases with SLE. In addition, one hundred and seven (5.2%) abnormal pregnancies were recorded among 2026 experiences. The characteristics of the CSTAR cohort were compared to similarly sized cohorts from other studies. We found that 56.1% of patients presented with concurrent hematological disorders compared to only 18.2% of European patients. Moreover, 47.4% of patients presented with nephropathy compared to 27.9% of European patients. Conversely, neurological manifestations were only seen in 4.8% of Chinese SLE patients compared to 19.4% of European patients, 12.1% of U.S. patients, 22.8% of Malaysian patients and 26.4% of Latin Americans. Pulmonary arterial hypertension and interstitial lung diseases were complications identified in 3.8% and 4.2% of Chinese lupus patients, respectively. The CSTAR registry has provided epidemiological data and phenotypes of Chinese patients with SLE, and has demonstrated several differences between ethnicities. Clinical data and biologic samples would be valuable resources for future translational studies with national and international collaboration.

Practical characteristics of adaptive design in phase 2 and 3 clinical trials.

PubMed

Sato, A; Shimura, M; Gosho, M

2018-04-01

Adaptive design methods are expected to be ethical, reflect real medical practice, increase the likelihood of research and development success and reduce the allocation of patients into ineffective treatment groups by the early termination of clinical trials. However, the comprehensive details regarding which types of clinical trials will include adaptive designs remain unclear. We examined the practical characteristics of adaptive design used in clinical trials. We conducted a literature search of adaptive design clinical trials published from 2012 to 2015 using PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials, with common search terms related to adaptive design. We systematically assessed the types and characteristics of adaptive designs and disease areas employed in the adaptive design trials. Our survey identified 245 adaptive design clinical trials. The number of trials by the publication year increased from 2012 to 2013 and did not greatly change afterwards. The most frequently used adaptive design was group sequential design (n = 222, 90.6%), especially for neoplasm or cardiovascular disease trials. Among the other types of adaptive design, adaptive dose/treatment group selection (n = 21, 8.6%) and adaptive sample-size adjustment (n = 19, 7.8%) were frequently used. The adaptive randomization (n = 8, 3.3%) and adaptive seamless design (n = 6, 2.4%) were less frequent. Adaptive dose/treatment group selection and adaptive sample-size adjustment were frequently used (up to 23%) in "certain infectious and parasitic diseases," "diseases of nervous system," and "mental and behavioural disorders" in comparison with "neoplasms" (<6.6%). For "mental and behavioural disorders," adaptive randomization was used in two trials of eight trials in total (25%). Group sequential design and adaptive sample-size adjustment were used frequently in phase 3 trials or in trials where study phase was not specified, whereas the other types of adaptive designs were used more in phase 2 trials. Approximately 82% (202 of 245 trials) resulted in early termination at the interim analysis. Among the 202 trials, 132 (54% of 245 trials) had fewer randomized patients than initially planned. This result supports the motive to use adaptive design to make study durations shorter and include a smaller number of subjects. We found that adaptive designs have been applied to clinical trials in various therapeutic areas and interventions. The applications were frequently reported in neoplasm or cardiovascular clinical trials. The adaptive dose/treatment group selection and sample-size adjustment are increasingly common, and these adaptations generally follow the Food and Drug Administration's (FDA's) recommendations. © 2017 John Wiley & Sons Ltd.

Adult attachment and psychotic phenomenology in clinical and non-clinical samples: a systematic review.

PubMed

Korver-Nieberg, Nikie; Berry, Katherine; Meijer, Carin J; de Haan, Lieuwe

2014-06-01

It has been argued that attachment theory could enhance our knowledge and understanding of psychotic phenomenology. We systematically reviewed and critically appraised research investigating attachment and psychotic phenomenology in clinical and non-clinical samples. We searched databases Pub Med, PsycINFO, Medline and Web of Science using the keywords. Attachment, Adult Attachment, Psychosis, Schizotypy and Schizophrenia and identified 29 studies assessing adult attachment in combination with psychotic phenomenology. The findings indicated that both insecure anxious and insecure avoidant attachment are associated with psychotic phenomenology. Insecurely attached individuals are more vulnerable to developing maladaptive coping strategies in recovering from psychosis. The importance of attachment experiences for processing social information, mentalization skills and developing social relationships, including therapeutic relationships, in samples with psychosis is also highlighted. Attachment style is a clinically relevant construct in relation to development, course and treatment of psychosis. Understanding the role of attachment in symptoms may help to gain insight into the development or persistence of symptoms. Associations between attachment and recovery style suggest that it may be helpful to improve attachment security in a context of therapeutic relationships or other social relationships before encouraging people to explore their experiences of psychosis. Associations between insecure attachment and impaired mentalization skills may help in understanding interpersonal difficulties and this knowledge can be used to improve recovery. © 2013 The British Psychological Society.

Wound healing outcomes: Using big data and a modified intent-to-treat method as a metric for reporting healing rates.

PubMed

Ennis, William J; Hoffman, Rachel A; Gurtner, Geoffrey C; Kirsner, Robert S; Gordon, Hanna M

2017-08-01

Chronic wounds are increasing in prevalence and are a costly problem for the US healthcare system and throughout the world. Typically outcomes studies in the field of wound care have been limited to small clinical trials, comparative effectiveness cohorts and attempts to extrapolate results from claims databases. As a result, outcomes in real world clinical settings may differ from these published studies. This study presents a modified intent-to-treat framework for measuring wound outcomes and measures the consistency of population based outcomes across two distinct settings. In this retrospective observational analysis, we describe the largest to date, cohort of patient wound outcomes derived from 626 hospital based clinics and one academic tertiary care clinic. We present the results of a modified intent-to-treat analysis of wound outcomes as well as demographic and descriptive data. After applying the exclusion criteria, the final analytic sample includes the outcomes from 667,291 wounds in the national sample and 1,788 wounds in the academic sample. We found a consistent modified intent to treat healing rate of 74.6% from the 626 clinics and 77.6% in the academic center. We recommend that a standard modified intent to treat healing rate be used to report wound outcomes to allow for consistency and comparability in measurement across providers, payers and healthcare systems. © 2017 by the Wound Healing Society.

Assessing emotional status following acquired brain injury: the clinical potential of the depression, anxiety and stress scales.

PubMed

Ownsworth, Tamara; Little, Trudi; Turner, Ben; Hawkes, Anna; Shum, David

2008-10-01

To investigate the clinical potential of the Depression, Anxiety and Stress Scales (DASS 42) and its shorter version (DASS 21) for assessing emotional status following acquired brain injury. Participants included 23 individuals with traumatic brain injury (TBI), 25 individuals with brain tumour and 29 non-clinical controls. Investigations of internal consistency, test-re-test reliability, theory-consistent differences, sensitivity to change and concurrent validity were conducted. Internal consistency of the DASS was generally acceptable (r > 0.70), with the exception of the anxiety scale for the TBI sample. Test-re-test reliability (1-3 weeks) was sound for the depression scale (r > 0.75) and significant but comparatively lower for other scales (r = 0.60-0.73, p < 0.01). Theory-consistent differences were only evident between the brain tumour sample and non-clinical control sample on the anxiety scale (p < 0.01). Sensitivity to change of the DASS in the context of hospital discharge was demonstrated for depression and stress (p < 0.01), but not for anxiety (p > 0.05). Concurrent validity with the Hospital Anxiety and Depression Scale was significant for all scales of the DASS (p < 0.05). While the results generally support the clinical application of the DASS following ABI, further research examining the factor structure of existing and modified versions of the DASS is recommended.

Minnesota Impulse Disorders Interview (MIDI): Validation of a structured diagnostic clinical interview for impulse control disorders in an enriched community sample.

PubMed

Chamberlain, Samuel R; Grant, Jon E

2018-07-01

Disorders of impulsivity are common, functionally impairing, and highly relevant across different clinical and research settings. Few structured clinical interviews for the identification and diagnosis of impulse control disorders exist, and none have been validated in a community sample in terms of psychometric properties. The Minnesota Impulse control disorders Interview (MIDI v2.0) was administered to an enriched sample of 293 non-treatment seeking adults aged 18-35 years, recruited using media advertisements in two large US cities. In addition to the MIDI, participants undertook extended clinical interview for other mental disorders, the Barratt impulsiveness questionnaire, and the Padua obsessive-compulsive inventory. The psychometric properties of the MIDI were characterized. In logistic regression, the MIDI showed good concurrent validity against the reference measures (versus gambling disorder interview, p < 0.001; Barratt impulsiveness attentional and non-planning scores p < 0.05), and good discriminant validity versus primarily non-impulsive symptoms, including against anxiety, depression, and obsessive-compulsive symptoms (all p > 0.05). Test re-test reliability was excellent (0.95). The MIDI has good psychometric properties and thus may be a valuable interview tool for clinical and research studies involving impulse control disorders. Further research is needed to better understanding the optimal diagnostic classification and neurobiology of these neglected disorders. Crown Copyright © 2018. Published by Elsevier B.V. All rights reserved.

Equity and the Sun Quality Health Private Provider Social Franchise: comparative analysis of patient survey data and a nationally representative TB prevalence survey.

PubMed

Montagu, Dominic; Sudhinaraset, May; Lwin, Thandar; Onozaki, Ikushi; Win, Zaw; Aung, Tin

2013-01-10

Since 2004, the Sun Quality Health (SQH) franchise network has provided TB care in Myanmar through a network of established private medical clinics. This study compares the wealth distribution of the TB patients to non-TB patients to determine if TB is most common among the poor, and compares the wealth of all TB patients to SQH TB patients to assess whether the franchise achieves its goal of serving the poor. The study uses data from two sources: 1) Myanmar's first nationally representative TB prevalence study conducted in 2009, and 2) client exit interviews from TB patients from SQH clinics. In total, 1,114 TB-positive individuals were included in the study, including 739 from the national sample and 375 from the SQH sample. TB patients at SQH clinics were poorer than TB-positive individuals in the overall population, though not at a statistically significant level (p > 0.05). After stratification we found that in urban areas, TB patients at SQH clinics were more likely to be in the poorest quartile compared to general TB positive population (16.8% vs. 8.6%, respectively; p < 0.05). In rural areas, there was no statistically significant difference between the wealth distribution of SQH clinic patients and general TB positive individuals (p > 0.05). Franchised clinics in Myanmar are reaching poor populations of TB patients in urban areas; more efforts are needed in order to reach the most vulnerable in rural areas.

Equity and the Sun Quality Health Private Provider Social Franchise: comparative analysis of patient survey data and a nationally representative TB prevalence survey

PubMed Central

2013-01-01

Introduction Since 2004, the Sun Quality Health (SQH) franchise network has provided TB care in Myanmar through a network of established private medical clinics. This study compares the wealth distribution of the TB patients to non-TB patients to determine if TB is most common among the poor, and compares the wealth of all TB patients to SQH TB patients to assess whether the franchise achieves its goal of serving the poor. Methods The study uses data from two sources: 1) Myanmar’s first nationally representative TB prevalence study conducted in 2009, and 2) client exit interviews from TB patients from SQH clinics. In total, 1,114 TB-positive individuals were included in the study, including 739 from the national sample and 375 from the SQH sample. Results TB patients at SQH clinics were poorer than TB-positive individuals in the overall population, though not at a statistically significant level (p > 0.05). After stratification we found that in urban areas, TB patients at SQH clinics were more likely to be in the poorest quartile compared to general TB positive population (16.8% vs. 8.6%, respectively; p < 0.05). In rural areas, there was no statistically significant difference between the wealth distribution of SQH clinic patients and general TB positive individuals (p > 0.05). Conclusion Franchised clinics in Myanmar are reaching poor populations of TB patients in urban areas; more efforts are needed in order to reach the most vulnerable in rural areas. PMID:23305063

Early awareness and uptake of an effective waiting room video intervention by STD clinics.

PubMed

DeShazo, Jonathan P; Richardson, Douglas B; Malotte, C Kevin; Rietmeijer, Cornelis A

2011-12-01

Successful diffusion and adoption is critical for the effectiveness and impact of a new intervention. The objective of this research was to evaluate the uptake and implementation of a newly released educational waiting room video in US sexually transmitted diseases (STD) Clinics. A telephone survey was administered to a random sample of 73 clinic directors representing 76 US STD clinics 3 to 5 months following the availability of the intervention. A qualitative analysis was used to categorize survey responses and detect associations among them. Of the 76 clinics, 22% were aware of the intervention and 17% had ordered the intervention kit. The most frequently reported sources for hearing about the video were interpersonal communication/word of mouth, national conferences, and the STDPreventionOnline.org Website. The majority (74%) of clinic directors reported using state or local entities as primary sources of new information; however, reporting these channels was associated with unawareness of the new intervention. Facilitators to adoption included having adequate video/DVD equipment (55%) and a separate, nonshared waiting room for STD services in which to show the video (47%). The data from this sample suggest that making greater use of prominent thought leaders and interpersonal communication, including social networking, and professional groups may improve awareness of new interventions. Some barriers to adoption, such as lack of equipment, have relatively inexpensive solutions yet bureaucratic or technical support issues may still play a role. However, some structural barriers, such as shared waiting areas, will require innovative alternatives to conventional practice.

Validation of a score tool for measurement of histological severity in juvenile dermatomyositis and association with clinical severity of disease

PubMed Central

Varsani, Hemlata; Charman, Susan C; Li, Charles K; Marie, Suely K N; Amato, Anthony A; Banwell, Brenda; Bove, Kevin E; Corse, Andrea M; Emslie-Smith, Alison M; Jacques, Thomas S; Lundberg, Ingrid E; Minetti, Carlo; Nennesmo, Inger; Rushing, Elisabeth J; Sallum, Adriana M E; Sewry, Caroline; Pilkington, Clarissa A; Holton, Janice L; Wedderburn, Lucy R

2015-01-01

Objectives To study muscle biopsy tissue from patients with juvenile dermatomyositis (JDM) in order to test the reliability of a score tool designed to quantify the severity of histological abnormalities when applied to biceps humeri in addition to quadriceps femoris. Additionally, to evaluate whether elements of the tool correlate with clinical measures of disease severity. Methods 55 patients with JDM with muscle biopsy tissue and clinical data available were included. Biopsy samples (33 quadriceps, 22 biceps) were prepared and stained using standardised protocols. A Latin square design was used by the International Juvenile Dermatomyositis Biopsy Consensus Group to score cases using our previously published score tool. Reliability was assessed by intraclass correlation coefficient (ICC) and scorer agreement (α) by assessing variation in scorers’ ratings. Scores from the most reliable tool items correlated with clinical measures of disease activity at the time of biopsy. Results Inter- and intraobserver agreement was good or high for many tool items, including overall assessment of severity using a Visual Analogue Scale. The tool functioned equally well on biceps and quadriceps samples. A modified tool using the most reliable score items showed good correlation with measures of disease activity. Conclusions The JDM biopsy score tool has high inter- and intraobserver agreement and can be used on both biceps and quadriceps muscle tissue. Importantly, the modified tool correlates well with clinical measures of disease activity. We propose that standardised assessment of muscle biopsy tissue should be considered in diagnostic investigation and clinical trials in JDM. PMID:24064003

Culture-independent Analysis of Pediatric Broncho-alveolar Lavage (BAL) Specimens.

PubMed

Zachariah, Philip; Ryan, Chanelle; Nadimpalli, Sruti; Coscia, Gina; Kolb, Michelle; Smith, Hannah; Foca, Marc; Saiman, Lisa; Planet, Paul J

2018-06-07

The clinical utility of culture-independent testing of pediatric bronchoalveolar lavage (BAL) specimens is unknown. Additionally, the variability of the pediatric pulmonary microbiome with patient characteristics is not well understood. Study subjects were ≤22 years old and underwent BAL from May 2013 - July 2015 as part of clinical care. DNA extracted from BAL specimens was used for 16S rRNA gene-based (16S-based) microbiome analysis, and results compared to routine cultures from the same samples. Indices of microbial diversity and relative taxon abundances were compared based on subject characteristics. From 81 participants (51% male, median age 9 years), 89 samples were collected and the 16S rRNA genes of 77 (86.5%) samples were successfully analyzed. Subjects included 23 cystic fibrosis (CF), 19 immunocompromised (IC), and 28 non-immunocompromised (nIC) patients. Of 68 organisms identified in culture, 16S-based analyses were concordant with culture results in 66 (97.1%), and also identified potentially clinically significant taxa missed by cultures (e.g. Staphylococcus, Legionella, Pseudomonas). Significant differences in abundance were noted mostly for non-cultured taxa with diagnosis and antibiotic use (Veillonella, Corynebacterium, Haemophilus). The microbiota of CF samples was less diverse and a "core" group of fifteen taxa shared across samples was identified. 16S-based culture independent analysis was concordant with routine cultures and showed potential to detect non-cultured pathogens. While 16S- based testing identified relative changes in organism abundance associated with clinical characteristics, distinct microbiome profiles associated with disease states were not identified.

Developing clinically suitable measures of social cognition for children: initial findings from a normative sample.

PubMed

Saltzman-Benaiah, Jennifer; Lalonde, Christopher E

2007-03-01

Our understanding of children's social competence has increased tremendously over the past two decades. There is increasing evidence to suggest that social-cognitive impairments are not restricted to children on the autistic spectrum, but rather may be associated with a host of developmental and acquired neurological conditions including learning disabilities, attention deficit disorder, traumatic brain injury, and stroke. Although many investigators have begun to bridge the gap between clinical practice and research by applying experimental tasks to clinical populations, few tools are available for the clinical evaluation of social competence, particularly in children. This study marks a series of first steps in the development of measures suitable for the assessment of children between 6 and 12 years of age. The results of the study provide data for a number of experimental tasks that have been adapted with clinical practice in mind. A discussion of the developmental progressions and the relationships among the measures is also included.

The ClinicalTrials.gov Results Database — Update and Key Issues

PubMed Central

Zarin, Deborah A.; Tse, Tony; Williams, Rebecca J.; Califf, Robert M.; Ide, Nicholas C.

2011-01-01

BACKGROUND The ClinicalTrials.gov trial registry was expanded in 2008 to include a database for reporting summary results. We summarize the structure and contents of the results database, provide an update of relevant policies, and show how the data can be used to gain insight into the state of clinical research. METHODS We analyzed ClinicalTrials.gov data that were publicly available between September 2009 and September 2010. RESULTS As of September 27, 2010, ClinicalTrials.gov received approximately 330 new and 2000 revised registrations each week, along with 30 new and 80 revised results submissions. We characterized the 79,413 registry and 2178 results of trial records available as of September 2010. From a sample cohort of results records, 78 of 150 (52%) had associated publications within 2 years after posting. Of results records available publicly, 20% reported more than two primary outcome measures and 5% reported more than five. Of a sample of 100 registry record outcome measures, 61% lacked specificity in describing the metric used in the planned analysis. In a sample of 700 results records, the mean number of different analysis populations per study group was 2.5 (median, 1; range, 1 to 25). Of these trials, 24% reported results for 90% or less of their participants. CONCLUSIONS ClinicalTrials.gov provides access to study results not otherwise available to the public. Although the database allows examination of various aspects of ongoing and completed clinical trials, its ultimate usefulness depends on the research community to submit accurate, informative data. PMID:21366476

Clinical manifestation and molecular genetic characterization of MYH9 disorders.

PubMed

Provaznikova, Dana; Geierova, Vera; Kumstyrova, Tereza; Kotlin, Roman; Mikulenkova, Dana; Zurkova, Kamila; Matoska, Vaclav; Hrachovinova, Ingrid; Rittich, Simon

2009-08-01

Currently, the May-Hegglin anomaly (MHA), Sebastian (SBS), Fechtner (FTNS) and Epstein (EPS) syndrome are considered to be distinct clinical manifestations of a single disease caused by mutations of the MYH9 gene encoding the heavy chain of non-muscle myosin IIA (NMMHC-IIA). Manifestations of these disorders include giant platelets, thrombocytopenia and combinations of the presence of granulocyte inclusions, deafness, cataracts and renal failure. We examined 15 patients from 10 unrelated families on whom we performed immunostaining of NMMHC-IIA in blood samples. Polymerase chain reaction (PCR) analysis of selected exons of the MYH9 gene revealed mutations in nine samples with one novel mutation. Results of fluorescence and mutational analysis were compared with clinical manifestations of the MYH9 disorder. We also determined the number of glycoprotein sites on the surface of platelets. Most patients had an increased number of glycoproteins, which could be due to platelet size.

Linguistic analysis of discourse in aphasia: A review of the literature.

PubMed

Bryant, Lucy; Ferguson, Alison; Spencer, Elizabeth

This review examined previous research applications of linguistic discourse analysis to assess the language of adults with aphasia. A comprehensive literature search of seven databases identified 165 studies that applied linguistic measures to samples of discourse collected from people with aphasia. Analysis of methodological applications revealed an increase in published research using linguistic discourse analysis over the past 40 years, particularly to measure the generalisation of therapy outcomes to language in use. Narrative language samples were most frequently subject to analysis though all language genres were observed across included studies. A total of 536 different linguistic measures were applied to examine language behaviours. Growth in the research use of linguistic discourse analysis and suggestions that this growth may be reflected in clinical practice requires further investigation. Future research directions are discussed to investigate clinical use of discourse analysis and examine the differences that exist between research and clinical practice.

Lack of correlation between serum soluble Fas/APO-1 levels and autoimmune disease.

PubMed

Goel, N; Ulrich, D T; St Clair, E W; Fleming, J A; Lynch, D H; Seldin, M F

1995-12-01

To determine whether elevated soluble Fas/APO-1 (sFas/APO-1) levels are associated with either autoimmune disease or evidence of flares in autoimmune disease. Thirty-seven serum samples were retrospectively obtained from normal controls and patients with laboratory evidence of autoimmune disease activity. These samples were assayed for sFas/APO-1 levels by an enzyme-linked immunosorbent assay, and hospital medical records were retrospectively reviewed for clinical and laboratory characteristics of the patients. Soluble Fas/APO-1 levels did not correlate with clinical diagnoses or laboratory abnormalities. The mean and range of sFas/APO-1 levels were similar in systemic lupus erythematosus patients (including those with active disease), patients with other autoimmune diseases, and normal controls. These data strongly suggest that measurement of sFas/APO-1 levels is unlikely to hold clinical value or play a role in the pathogenesis of autoimmune disease.

The Association Between Internet Use and Ambulatory Care-Seeking Behaviors in Taiwan: A Cross-Sectional Study.

PubMed

Hsieh, Ronan Wenhan; Chen, Likwang; Chen, Tsung-Fu; Liang, Jyh-Chong; Lin, Tzu-Bin; Chen, Yen-Yuan; Tsai, Chin-Chung

2016-12-07

Compared with the traditional ways of gaining health-related information from newspapers, magazines, radio, and television, the Internet is inexpensive, accessible, and conveys diverse opinions. Several studies on how increasing Internet use affected outpatient clinic visits were inconclusive. The objective of this study was to examine the role of Internet use on ambulatory care-seeking behaviors as indicated by the number of outpatient clinic visits after adjusting for confounding variables. We conducted this study using a sample randomly selected from the general population in Taiwan. To handle the missing data, we built a multivariate logistic regression model for propensity score matching using age and sex as the independent variables. The questionnaires with no missing data were then included in a multivariate linear regression model for examining the association between Internet use and outpatient clinic visits. We included a sample of 293 participants who answered the questionnaire with no missing data in the multivariate linear regression model. We found that Internet use was significantly associated with more outpatient clinic visits (P=.04). The participants with chronic diseases tended to make more outpatient clinic visits (P<.01). The inconsistent quality of health-related information obtained from the Internet may be associated with patients' increasing need for interpreting and discussing the information with health care professionals, thus resulting in an increasing number of outpatient clinic visits. In addition, the media literacy of Web-based health-related information seekers may also affect their ambulatory care-seeking behaviors, such as outpatient clinic visits. ©Ronan Wenhan Hsieh, Likwang Chen, Tsung-Fu Chen, Jyh-Chong Liang, Tzu-Bin Lin, Yen-Yuan Chen, Chin-Chung Tsai. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 07.12.2016.

Validity of a computerized population registry of dementia based on clinical databases.

PubMed

Mar, J; Arrospide, A; Soto-Gordoa, M; Machón, M; Iruin, Á; Martinez-Lage, P; Gabilondo, A; Moreno-Izco, F; Gabilondo, A; Arriola, L

2018-05-08

The handling of information through digital media allows innovative approaches for identifying cases of dementia through computerized searches within the clinical databases that include systems for coding diagnoses. The aim of this study was to analyze the validity of a dementia registry in Gipuzkoa based on the administrative and clinical databases existing in the Basque Health Service. This is a descriptive study based on the evaluation of available data sources. First, through review of medical records, the diagnostic validity was evaluated in 2 samples of cases identified and not identified as dementia. The sensitivity, specificity and positive and negative predictive value of the diagnosis of dementia were measured. Subsequently, the cases of living dementia in December 31, 2016 were searched in the entire Gipuzkoa population to collect sociodemographic and clinical variables. The validation samples included 986 cases and 327 no cases. The calculated sensitivity was 80.2% and the specificity was 99.9%. The negative predictive value was 99.4% and positive value was 95.1%. The cases in Gipuzkoa were 10,551, representing 65% of the cases predicted according to the literature. Antipsychotic medication were taken by a 40% and a 25% of the cases were institutionalized. A registry of dementias based on clinical and administrative databases is valid and feasible. Its main contribution is to show the dimension of dementia in the health system. Copyright © 2018 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

Is medical perspective on clinical governance practices associated with clinical units' performance and mortality? A cross-sectional study through a record-linkage procedure.

PubMed

Sarchielli, Guido; De Plato, Giovanni; Cavalli, Mario; Albertini, Stefano; Nonni, Ilaria; Bencivenni, Lucia; Montali, Arianna; Ventura, Antonio; Montali, Francesca

2016-01-01

Assessment of the knowledge and application as well as perceived utility by doctors of clinical governance tools in order to explore their impact on clinical units' performance measured through mortality rates and efficiency indicators. This research is a cross-sectional study with a deterministic record-linkage procedure. The sample includes n = 1250 doctors (n = 249 chiefs of clinical units; n = 1001 physicians) working in six public hospitals located in the Emilia-Romagna Region in Italy. Survey instruments include a checklist and a research-made questionnaire which were used for data collection about doctors' knowledge and application as well as perceived utility of clinical governance tools. The analysis was based on clinical units' performance indicators which include patients' mortality, extra-region active mobility rate, average hospital stay, bed occupancy, rotation and turnover rates, and the comparative performance index as efficiency indicators. The clinical governance tools are known and applied differently in all the considered clinical units. Significant differences emerged between roles and organizational levels at which the medical leadership is carried out. The levels of knowledge and application of clinical governance practices are correlated with the clinical units' efficiency indicators (bed occupancy rate, bed turnover interval, and extra-region mobility). These multiple linear regression analyses highlighted that the clinical governance knowledge and application is correlated with clinical units' mortality rates (odds ratio, -8.677; 95% confidence interval, -16.654, -0.700). The knowledge and application, as well as perceived utility by medical professionals of clinical governance tools, are associated with the mortality rates of their units and with some efficiency indicators. However, the medical frontline staff seems to not consider homogeneously useful the clinical governance tools application on its own clinical practice.

A global map of genetic diversity in Babesia microti reveals strong population structure and identifies variants associated with clinical relapse

PubMed Central

Lemieux, Jacob E.; Tran, Alice D.; Freimark, Lisa; Schaffner, Stephen F.; Goethert, Heidi; Andersen, Kristian G.; Bazner, Suzane; Li, Amy; McGrath, Graham; Sloan, Lynne; Vannier, Edouard; Milner, Dan; Pritt, Bobbi; Rosenberg, Eric; Telford, Sam; Bailey, Jeffrey A.; Sabeti, Pardis C.

2017-01-01

Human babesiosis caused by Babesia microti is an emerging tick-borne zoonosis of increasing importance due to rising incidence and expanding geographic range1. Infection with this organism, an intraerythrocytic parasite of the phylum Apicomplexa, causes a febrile syndrome similar to malaria2. Relapsing disease is common among immunocompromised and asplenic individuals3,4, and drug resistance has recently been reported5. To investigate the origin and genetic diversity of this parasite, we sequenced the complete genomes of 42 B. microti samples from around the world, including deep coverage of clinical infections at endemic sites in the continental United States. Samples from the continental US segregate into a Northeast lineage and a Midwest lineage, with subsequent divergence of subpopulations along geographic lines. We identify parasite variants that associate with relapsing disease, including amino acid substitutions in the atovaquone-binding regions of cytochrome b (cytb) and the azithromycin-binding region of ribosomal protein subunit L4 (rpl4). Our results shed light on the origin, diversity, and evolution of B. microti, suggest possible mechanisms for clinical relapse, and create the foundation for further research on this emerging pathogen. PMID:27572973

A global map of genetic diversity in Babesia microti reveals strong population structure and identifies variants associated with clinical relapse.

PubMed

Lemieux, Jacob E; Tran, Alice D; Freimark, Lisa; Schaffner, Stephen F; Goethert, Heidi; Andersen, Kristian G; Bazner, Suzane; Li, Amy; McGrath, Graham; Sloan, Lynne; Vannier, Edouard; Milner, Dan; Pritt, Bobbi; Rosenberg, Eric; Telford, Sam; Bailey, Jeffrey A; Sabeti, Pardis C

2016-06-13

Human babesiosis caused by Babesia microti is an emerging tick-borne zoonosis of increasing importance due to its rising incidence and expanding geographic range(1). Infection with this organism, an intraerythrocytic parasite of the phylum Apicomplexa, causes a febrile syndrome similar to malaria(2). Relapsing disease is common among immunocompromised and asplenic individuals(3,4) and drug resistance has recently been reported(5). To investigate the origin and genetic diversity of this parasite, we sequenced the complete genomes of 42 B. microti samples from around the world, including deep coverage of clinical infections at endemic sites in the continental USA. Samples from the continental USA segregate into a Northeast lineage and a Midwest lineage, with subsequent divergence of subpopulations along geographic lines. We identify parasite variants that associate with relapsing disease, including amino acid substitutions in the atovaquone-binding regions of cytochrome b (cytb) and the azithromycin-binding region of ribosomal protein subunit L4 (rpl4). Our results shed light on the origin, diversity and evolution of B. microti, suggest possible mechanisms for clinical relapse, and create the foundation for further research on this emerging pathogen.

[Clinical factors associated with invasive pulmonary aspergillosis in patients with chronic pneumopathies and respiratory isolation of Aspergillus spp].

PubMed

Castón, Juan José; Linares, María José; Rivero, Antonio; Casal, Manuel; Torre-Cisneros, Julián

2012-12-15

To determine clinical variables to distinguish invasive pulmonary aspergillosis (IPA) from colonization in patients with chronic pneumopathies with positive culture of Aspergillus spp. in respiratory samples. Retrospective cohort study including patients with respiratory isolations of Aspergillus spp. during a period of 10 years. IPA was evaluated according to the Bulpa criteria. Clinical variables were collected and a multiple logistic regression analysis was carried out. Eighty-three patients with isolation of Aspergillus spp. from respiratory samples were included; 68.7% (n=57) of the patients had chronic obstructive pulmonary disease, 18% (n=15) pulmonary fibrosis and 13.3% (n=11) bronchial asthma. Twenty-two patients (26.6%) had IPA. The use of fluconazole (OR 4.49; CI 95% 1.5-13.4; P=.007), severe respiratory failure (OR 4.64; CI 95% 1.46-14.72; P=.009) and hospitalization time (OR 1.05; CI 95% 1.01-1.1; P=.006) were associated with IPA. Prior use of fluconazole, severe respiratory failure and hospitalization time are associated with IPA in patients with chronic pneumopathies with respiratory isolation of Aspergillus spp. Copyright © 2012 Elsevier España, S.L. All rights reserved.

A Systematic Review of Risk Factors for Intimate Partner Violence

PubMed Central

Capaldi, Deborah M.; Knoble, Naomi B.; Shortt, Joann Wu; Kim, Hyoun K.

2012-01-01

A systematic review of risk factors for intimate partner violence was conducted. Inclusion criteria included publication in a peer-reviewed journal, a representative community sample or a clinical sample with a control-group comparison, a response rate of at least 50%, use of a physical or sexual violence outcome measure, and control of confounding factors in the analyses. A total of 228 articles were included (170 articles with adult and 58 with adolescent samples). Organized by levels of a dynamic developmental systems perspective, risk factors included: (a) contextual characteristics of partners (demographic, neighborhood, community and school factors), (b) developmental characteristics and behaviors of the partners (e.g., family, peer, psychological/behavioral, and cognitive factors), and (c) relationship influences and interactional patterns. Comparisons to a prior review highlight developments in the field in the past 10 years. Recommendations for intervention and policy along with future directions for intimate partner violence (IPV) risk factor research are presented. PMID:22754606

Effects of Sampling Conditions and Environmental Factors on Fecal Volatile Organic Compound Analysis by an Electronic Nose Device

PubMed Central

Berkhout, Daniel J. C.; Benninga, Marc A.; van Stein, Ruby M.; Brinkman, Paul; Niemarkt, Hendrik J.; de Boer, Nanne K. H.; de Meij, Tim G. J.

2016-01-01

Prior to implementation of volatile organic compound (VOC) analysis in clinical practice, substantial challenges, including methodological, biological and analytical difficulties are faced. The aim of this study was to evaluate the influence of several sampling conditions and environmental factors on fecal VOC profiles, analyzed by an electronic nose (eNose). Effects of fecal sample mass, water content, duration of storage at room temperature, fecal sample temperature, number of freeze–thaw cycles and effect of sampling method (rectal swabs vs. fecal samples) on VOC profiles were assessed by analysis of totally 725 fecal samples by means of an eNose (Cyranose320®). Furthermore, fecal VOC profiles of totally 1285 fecal samples from 71 infants born at three different hospitals were compared to assess the influence of center of origin on VOC outcome. We observed that all analyzed variables significantly influenced fecal VOC composition. It was feasible to capture a VOC profile using rectal swabs, although this differed significantly from fecal VOC profiles of similar subjects. In addition, 1285 fecal VOC-profiles could significantly be discriminated based on center of birth. In conclusion, standardization of methodology is necessary before fecal VOC analysis can live up to its potential as diagnostic tool in clinical practice. PMID:27886068

Evaluation of anti-microbial activity of spore powder of Ganoderma lucidum on clinical isolates of Prevotella intermedia: A pilot study.

PubMed

Nayak, Ranganath N; Dixitraj, P T; Nayak, Aarati; Bhat, Kishore

2015-09-01

This study aimed at evaluating the anti-microbial activity of spore powder of Ganoderma lucidum on Prevotella intermedia isolated from subgingival plaque from chronic periodontitis patients. Written informed consent was obtained from each subject enrolled in the study. The Institutional Ethics Committee granted the ethical clearance for the study. This study included 20 patients diagnosed with chronic periodontitis. Pooled subgingival plaque samples were collected using sterile curettes from the deepest sites of periodontal pockets. The collected samples were then transported in 1 mL of reduced transport fluid. The organisms were cultured and confirmed. These organisms were then used for minimum inhibitory concentration (MIC) procedure. Mean of the MIC value obtained was calculated. Thirteen out of the 20 clinical samples were tested that showed sensitivity at various concentrations. Five samples showed sensitivity at all concentrations. Twelve samples showed sensitivity at 8 mcg/ml. Eleven samples showed sensitivity at 4 mcg/ml, 8 samples showed sensitivity at 2 mcg/ml, and 5 samples showed sensitivity even at 1 mcg/ml. Mean MIC value of G. lucidum spore powder for P. intermedia obtained was 3.62 mcg/ml. G. lucidum with its multipotential bioactivity could be used as an anti-microbial, in conjunction with conventional therapy in periodontal disease.

Actor and Partner Effects of Attachment on Relationship Satisfaction and Sexual Satisfaction Across the Genders: An APIM Approach.

PubMed

Conradi, Henk Jan; Noordhof, Arjen; Dingemanse, Pieter; Barelds, Dick P H; Kamphuis, Jan H

2017-10-01

Previous studies found gender differences in relationship satisfaction and sexuality. We tested gender differences in associations between attachment, a lasting relationship determinant, and two outcomes, relationship and sexual satisfaction. This study improves on earlier research by examining these associations in one Actor-Partner-Interdependence-Model, making direct statistical testing between outcomes possible. Furthermore, a community and a distressed sample (N = 113 heterosexual couples each) were included to attempt replication across samples and to examine clinical implications. In both genders, actor attachment avoidance negatively affected relationship satisfaction and (with one exception) sexual satisfaction. Also in both genders, partner attachment avoidance negatively affected sexual satisfaction. However, whereas partner attachment avoidance influenced female relationship satisfaction, it did not affect male relationship satisfaction. The findings replicated across samples. Clinical implications are discussed. © 2017 American Association for Marriage and Family Therapy.

Serial immune markers do not correlate with clinical exacerbations in pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections.

PubMed

Singer, Harvey S; Gause, Colin; Morris, Christina; Lopez, Pablo

2008-06-01

Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections is hypothesized to be a poststreptococcal autoimmune disorder. If clinical exacerbations are triggered by a streptococcal infection that activates cross-reacting antibodies against neuronal tissue or alters the production of cytokines, then a longitudinal analysis would be expected to identify a correlation between clinical symptoms and a change in autoimmune markers. Serial serum samples were available on 12 children with pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections participating in a prospective blinded study: 2 samples before an exacerbation point, 1 during the clinical exacerbation, and 2 after the exacerbation. Six subjects had a well-defined clinical exacerbation in association with a documented streptococcal infection, and 6 had a clinical exacerbation without an associated streptococcal infection. All of the serum samples were assayed for antibodies against human postmortem caudate, putamen, and prefrontal cortex; commercially prepared antigens; and complex sugars. Cytokines were measured by 2 different methodologies. No correlation was identified between clinical exacerbations and autoimmune markers, including: enzyme-linked immunosorbent assay measures of antineuronal antibodies; Western immunoblotting with emphasis on brain region proteins located at 40, 45, and 60 kDa or their corresponding identified antigens; competitive inhibition enzyme-linked immunosorbent assay to evaluate lysoganglioside G(M1) antibodies; and measures of inflammatory cytokines. No differences were identified between individuals with pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections with or without exacerbations triggered by streptococcal infections. The failure of immune markers to correlate with clinical exacerbations in children with pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections raises serious concerns about the viability of autoimmunity as a pathophysiological mechanism in this disorder.

Prevalence of HIV, STIs, and risk behaviors in a cross-sectional community- and clinic-based sample of men who have sex with men (MSM) in Lima, Peru.

PubMed

Perez-Brumer, Amaya G; Konda, Kelika A; Salvatierra, H Javier; Segura, Eddy R; Hall, Eric R; Montano, Silvia M; Coates, Thomas J; Klausner, Jeff D; Caceres, Carlos F; Clark, Jesse L

2013-01-01

Further research is necessary to understand the factors contributing to the high prevalence of HIV/STIs among men who have sex with men (MSM) in Peru. We compared HIV/STI prevalence and risk factors between two non-probability samples of MSM, one passively enrolled from an STI clinic and the other actively enrolled from community venues surrounding the clinic in Lima, Peru. A total of 560 self-identified MSM were enrolled between May-December, 2007. 438 subjects enrolled from a municipal STI clinic and 122 subjects enrolled during community outreach visits. All participants underwent screening for HIV, syphilis, HSV-2, gonorrhoea, and chlamydia and completed a survey assessing their history of HIV/STIs, prior HIV testing, and sexual behavior. HIV prevalence was significantly higher among MSM enrolled from the clinic, with previously undiagnosed HIV identified in 9.1% compared with 2.6% of community participants. 15.4 % of all MSM screened were infected with ≥ 1 curable STI, 7.4% with early syphilis (RPR ≥ 1:16) and 5.5% with urethral gonorrhoea and/or chlamydia. No significant differences between populations were reported in prevalence of STIs, number of male sex partners, history of unprotected anal intercourse, or alcohol and/or drug use prior to sex. Exchange of sex for money or goods was reported by 33.5% of MSM enrolled from the clinic and 21.2% of MSM from the community (p = 0.01). Our data demonstrate that the prevalence of HIV and STIs, including syphilis, gonorrhoea, and chlamydia are extremely high among MSM enrolled from both clinic and community venues in urban Peru. New strategies are needed to address differences in HIV/STI epidemiology between clinic- and community-enrolled samples of MSM.

How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study

PubMed Central

Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming

2017-01-01

Objectives Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. Setting The setting for this research was a major academic institution in Beijing, China. Participants The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Methods Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Results Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. Conclusion These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive planning procedures such as those used by expert clinical researchers. PMID:28928184

How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study.

PubMed

Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming

2017-09-18

Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. The setting for this research was a major academic institution in Beijing, China. The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive planning procedures such as those used by expert clinical researchers. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Prevalence, aetiology and antibiotic sensitivity profile of asymptomatic bacteriuria isolates from pregnant women in selected antenatal clinic from Nairobi, Kenya.

PubMed

Ayoyi, Adelaide Ogutu; Kikuvi, Gideon; Bii, Christine; Kariuki, Samuel

2017-01-01

Asymptomatic bacteriuria (ASB) is the presence of bacteria in urine without apparent symptoms of urinary tract infections. The importance of asymptomatic bacteriuria lies in the insight it provides into symptomatic infections. To determine prevalence, bacterial isolates and Antibiotic Sensitivity Profile of asymptomatic bacterial urinary tract infection in pregnant women in selected clinics in Nairobi. This was a cross-sectional study involving women attending antenatal clinic at selected clinics of Nairobi County. The women who met the inclusion criteria were included in the study. The midstream urine samples of these women were subjected to microscopy, culture and sensitivity. A total of 1020 of women on their first antenatal clinic visit participated in the study; 219 of them had ASB, giving a prevalence of 21.5 % at 95% confidence level. Escherichia coli were the common organism isolated at 38.8%. The majority of the organisms were sensitive to imipenem and gentamycin. There is a high prevalence of ASB among pregnant women included in the study from the Nairobi county clinics. Therefore, routine ASB screening of pregnant women is recommended among the women attending antennal clinics in Nairobi county clinics.

Prevalence, aetiology and antibiotic sensitivity profile of asymptomatic bacteriuria isolates from pregnant women in selected antenatal clinic from Nairobi, Kenya

PubMed Central

Ayoyi, Adelaide Ogutu; Kikuvi, Gideon; Bii, Christine; Kariuki, Samuel

2017-01-01

Introduction Asymptomatic bacteriuria (ASB) is the presence of bacteria in urine without apparent symptoms of urinary tract infections. The importance of asymptomatic bacteriuria lies in the insight it provides into symptomatic infections. To determine prevalence, bacterial isolates and Antibiotic Sensitivity Profile of asymptomatic bacterial urinary tract infection in pregnant women in selected clinics in Nairobi. Methods This was a cross-sectional study involving women attending antenatal clinic at selected clinics of Nairobi County. The women who met the inclusion criteria were included in the study. The midstream urine samples of these women were subjected to microscopy, culture and sensitivity. Results A total of 1020 of women on their first antenatal clinic visit participated in the study; 219 of them had ASB, giving a prevalence of 21.5 % at 95% confidence level. Escherichia coli were the common organism isolated at 38.8%. The majority of the organisms were sensitive to imipenem and gentamycin. Conclusion There is a high prevalence of ASB among pregnant women included in the study from the Nairobi county clinics. Therefore, routine ASB screening of pregnant women is recommended among the women attending antennal clinics in Nairobi county clinics. PMID:28451019

Methodological reporting of randomized clinical trials in respiratory research in 2010.

PubMed

Lu, Yi; Yao, Qiuju; Gu, Jie; Shen, Ce

2013-09-01

Although randomized controlled trials (RCTs) are considered the highest level of evidence, they are also subject to bias, due to a lack of adequately reported randomization, and therefore the reporting should be as explicit as possible for readers to determine the significance of the contents. We evaluated the methodological quality of RCTs in respiratory research in high ranking clinical journals, published in 2010. We assessed the methodological quality, including generation of the allocation sequence, allocation concealment, double-blinding, sample-size calculation, intention-to-treat analysis, flow diagrams, number of medical centers involved, diseases, funding sources, types of interventions, trial registration, number of times the papers have been cited, journal impact factor, journal type, and journal endorsement of the CONSORT (Consolidated Standards of Reporting Trials) rules, in RCTs published in 12 top ranking clinical respiratory journals and 5 top ranking general medical journals. We included 176 trials, of which 93 (53%) reported adequate generation of the allocation sequence, 66 (38%) reported adequate allocation concealment, 79 (45%) were double-blind, 123 (70%) reported adequate sample-size calculation, 88 (50%) reported intention-to-treat analysis, and 122 (69%) included a flow diagram. Multivariate logistic regression analysis revealed that journal impact factor ≥ 5 was the only variable that significantly influenced adequate allocation sequence generation. Trial registration and journal impact factor ≥ 5 significantly influenced adequate allocation concealment. Medical interventions, trial registration, and journal endorsement of the CONSORT statement influenced adequate double-blinding. Publication in one of the general medical journal influenced adequate sample-size calculation. The methodological quality of RCTs in respiratory research needs improvement. Stricter enforcement of the CONSORT statement should enhance the quality of RCTs.

Mycobacterium leprae is identified in the oral mucosa from paucibacillary and multibacillary leprosy patients.

PubMed

Morgado de Abreu, M A M; Roselino, A M; Enokihara, M; Nonogaki, S; Prestes-Carneiro, L E; Weckx, L L M; Alchorne, M M A

2014-01-01

In leprosy, the nasal mucosa is considered as the principal route of transmission for the bacillus Mycobacterium leprae. The objective of this study was to identify M. leprae in the oral mucosa of 50 untreated leprosy patients, including 21 paucibacillary (PB) and 29 multibacillary (MB) patients, using immunohistochemistry (IHC), with antibodies against bacillus Calmette-Guérin (BCG) and phenolic glycolipid antigen-1 (PGL-1), and polymerase chain reaction (PCR), with MntH-specific primers for M. leprae, and to compare the results. The material was represented by 163 paraffin blocks containing biopsy samples obtained from clinically normal sites (including the tongue, buccal mucosa and soft palate) and visible lesions anywhere in the oral mucosa. All patients and 158 available samples were included for IHC study. Among the 161 available samples for PCR, 110 had viable DNA. There was viable DNA in at least one area of the oral mucosa for 47 patients. M. leprae was detected in 70% and 78% of patients using IHC and PCR, respectively, and in 94% of the patients by at least one of the two diagnostic methods. There were no differences in detection of M. leprae between MB and PB patients. Similar results were obtained using anti-BCG and anti-PGL-1 antibodies, and immunoreactivity occurred predominantly on free-living bacteria on the epithelial surface, with a predilection for the tongue. Conversely, there was no area of predilection according to the PCR results. M. leprae is present in the oral mucosa at a high frequency, implicating this site as a potential means of leprosy transmission. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

Conventional Morphology Versus PCR Sequencing, rep-PCR, and MALDI-TOF-MS for Identification of Clinical Aspergillus Isolates Collected Over a 2-Year Period in a University Hospital at Kayseri, Turkey.

PubMed

Atalay, Altay; Koc, Ayse Nedret; Suel, Ahmet; Sav, Hafize; Demir, Gonca; Elmali, Ferhan; Cakir, Nuri; Seyedmousavi, Seyedmojtaba

2016-09-01

Aspergillus species cause a wide range of diseases in humans, including allergies, localized infections, or fatal disseminated diseases. Rapid detection and identification of Aspergillus spp. facilitate effective patient management. In the current study we compared conventional morphological methods with PCR sequencing, rep-PCR, and matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF-MS) for the identification of Aspergillus strains. A total of 24 consecutive clinical isolates of Aspergillus were collected during 2012-2014. Conventional morphology and rep-PCR were performed in our Mycology Laboratory. The identification, evaluation, and reporting of strains using MALDI-TOF-MS were performed by BioMérieux Diagnostic, Inc. in Istanbul. DNA sequence analysis of the clinical isolates was performed by the BMLabosis laboratory in Ankara. Samples consisted of 18 (75%) lower respiratory tract specimens, 3 otomycosis (12.5%) ear tissues, 1 sample from keratitis, and 1 sample from a cutaneous wound. According to DNA sequence analysis, 12 (50%) specimens were identified as A. fumigatus, 8 (33.3%) as A. flavus, 3 (12.5%) as A. niger, and 1 (4.2%) as A. terreus. Statistically, there was good agreement between the conventional morphology and rep-PCR and MALDI-TOF methods; kappa values were κ = 0.869, 0.871, and 0.916, respectively (P < 0.001). The good level of agreement between the methods included in the present study and sequence method could be due to the identification of Aspergillus strains that were commonly encountered. Therefore, it was concluded that studies conducted with a higher number of isolates, which include other Aspergillus strains, are required. © 2016 Wiley Periodicals, Inc.

Clinical characteristics of a sample of patients with cat eye syndrome.

PubMed

Rosa, Rafael Fabiano Machado; Mombach, Rômulo; Zen, Paulo Ricardo Gazzola; Graziadio, Carla; Paskulin, Giorgio Adriano

2010-01-01

Cat eye syndrome is considered a rare chromosome disease with a highly variable phenotype. The objective of this paper was to describe the clinical characteristics of a sample of patients with cat eye syndrome who were seen at our service. This is a retrospective analysis of a sample of six patients with diagnoses of cat eye syndrome. All of these patients’ karyotypes exhibited the presence of an additional marker chromosome, inv dup(22)(pter->q11.2::q11.2->pter). One patient also exhibited mosaicism with a lineage that had a normal chromosomal constitution. Clinical and follow-up data were collected from the patients’ medical records. Fisher’s exact test was used to compare the frequencies observed in our study with figures given in the literature (P<0.05). The main abnormalities observed were preauricular tags and/or pits and anal atresia (both observed in 83% of cases). Coloboma of the iris, an important finding with this syndrome, was observed in two cases (33%). Congenital heart disease was detected in four patients (67%) and the main defect found was interatrial communication (75%). Uncommon findings included hemifacial microsomia combined with unilateral microtia and biliary atresia. Just one of these patients died, from chylothorax and sepsis. The phenotype observed in cat eye syndrome is highly variable and may be superimposed on the phenotype of the oculo-auriculo-vertebral spectrum. Although these patients usually have good prognosis, including from a neurological point of view, we believe that all patients with the syndrome should be assessed very early on for the presence of cardiac, biliary and anorectal malformations, which may avoid possible complications in the future, including patient deaths.

Preferences for trauma treatment: A systematic review of the empirical literature.

PubMed

Simiola, Vanessa; Neilson, Elizabeth C; Thompson, Richard; Cook, Joan M

2015-11-01

The prevalence of trauma histories and related psychological problems is high in general clinical settings, but little is known about trauma patient preferences for mental health treatment. The purpose of this article is to systematically review and synthesize the literature on treatment preferences in survivors of traumatic events. Studies were identified using comprehensive searches of PsycINFO, Medline, PubMed, Published International Literature on Traumatic Stress, and Cumulative Index to Nursing and Allied Health Literature databases. Included in the review were articles published between January 1980 and September 2014, in English that reported patient preference of treatment for trauma related disorders in either clinical or nonclinical (e.g., analog) samples. The total number of individual participants was 6,091. Of the identified studies, 35 were quantitative and 6 were qualitative. Methodological concerns included the use of analog samples, small sample sizes, and the assessment of a limited number of treatment options (e.g., asking about only 1 type of psychotherapy or medication). Overall, participants expressed a preference for psychotherapy over medication and for talking about their trauma. Understanding and addressing trauma patient preferences may assist in improving treatment initiation as well as facilitate engagement, retention and outcome. (c) 2015 APA, all rights reserved).

Structure and properties of clinical coralline implants measured via 3D imaging and analysis.

PubMed

Knackstedt, Mark Alexander; Arns, Christoph H; Senden, Tim J; Gross, Karlis

2006-05-01

The development and design of advanced porous materials for biomedical applications requires a thorough understanding of how material structure impacts on mechanical and transport properties. This paper illustrates a 3D imaging and analysis study of two clinically proven coral bone graft samples (Porites and Goniopora). Images are obtained from X-ray micro-computed tomography (micro-CT) at a resolution of 16.8 microm. A visual comparison of the two images shows very different structure; Porites has a homogeneous structure and consistent pore size while Goniopora has a bimodal pore size and a strongly disordered structure. A number of 3D structural characteristics are measured directly on the images including pore volume-to-surface-area, pore and solid size distributions, chord length measurements and tortuosity. Computational results made directly on the digitized tomographic images are presented for the permeability, diffusivity and elastic modulus of the coral samples. The results allow one to quantify differences between the two samples. 3D digital analysis can provide a more thorough assessment of biomaterial structure including the pore wall thickness, local flow, mechanical properties and diffusion pathways. We discuss the implications of these results to the development of optimal scaffold design for tissue ingrowth.

Evidence-Base Update of Psychosocial Treatments for Child and Adolescent Depression

PubMed Central

Weersing, V. Robin; Jeffreys, Megan; Do, Minh-Chau T.; Schwartz, Karen T. G.; Bolano, Carl

2017-01-01

Depression in youth is prevalent and disabling and tends to presage a chronic and recurrent course of illness and impairment in adulthood. Clinical trial research in youth depression has a 30 year history, and evidence-based treatment reviews appeared in 1998 and 2008. The current review of 42 randomized controlled trials (RCTs) updates these reviews to include RCTs published between 2008 and 2014 (N = 14) and re-evaluates previously reviewed literature. Given the growing maturity of the field, this review utilized a stringent set of methodological criteria for trial inclusion, most notable for excluding trials based in sub-clinical samples of youth that had been included in previous reviews (N = 12) and including well-designed RCTs with null and negative findings (N = 8). Findings from the current review suggest that evidence for child treatments is notably weaker than for adolescent interventions, with no child treatments achieving well-established status and the evidentiary basis of treatments downgraded from previous reports. Cognitive behavioral therapy (CBT) for clinically depressed children appears to be possibly efficacious, with mixed findings across trials. For depressed adolescents, both CBT and Interpersonal Psychotherapy (IPT) are well-established interventions, with evidence of efficacy in multiple trials by independent investigative teams. This positive conclusion is tempered by the small size of the IPT literature (N = 6) and concern that CBT effects may be attenuated in clinically complicated samples and when compared against active control conditions. In conclusion, data on predictors, moderators, and mediators are examined and priorities for future research discussed. PMID:27870579

Symptom Profile of Attention-Deficit/Hyperactivity Disorder in Youth with High-functioning Autism Spectrum Disorder: A Comparative Study in Psychiatrically Referred Populations

PubMed Central

Joshi, Gagan; Faraone, Stephen V.; Wozniak, Janet; Tarko, Laura; Fried, Ronna; Galdo, Maribel; Furtak, Stephannie L.; Biederman, Joseph

2014-01-01

Objective To compare the clinical presentation of ADHD between youth with autism spectrum disorder (ASD) and ADHD and a sample of youth with ADHD only. Method A psychiatrically referred sample of autism spectrum disorder (ASD) youth with ADHD attending a specialized ambulatory program for ASD (n = 107) and a sample of youth with ADHD attending a general child psychiatry ambulatory clinic (n = 74) were compared. Results Seventy-six percent of youth with ASD met Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) criteria for ADHD. The clinical presentation of ADHD in youth with ASD was predominantly similar to its typical presentation including age at onset (3.5 ± 1.7 vs. 4.0 ± 1.9; p = .12), distribution of diagnostic subtypes, the qualitative and quantitative symptom profile, and symptom severity. Combined subtype was the most frequent presentation of ADHD in ASD youth. Conclusion Despite the robust presentation of ADHD, a significant majority of ASD youth with ADHD failed to receive appropriate ADHD treatment (41% vs. 24%; p = .02). A high rate of comorbidity with ADHD was observed in psychiatrically referred youth with ASD, with a clinical presentation typical of the disorder. PMID:25085653

The Brunnsviken Brief Quality of Life Scale (BBQ): Development and Psychometric Evaluation.

PubMed

Lindner, Philip; Frykheden, Ola; Forsström, David; Andersson, Erik; Ljótsson, Brjánn; Hedman, Erik; Andersson, Gerhard; Carlbring, Per

2016-04-01

Measurements of subjective quality of life (QoL) are an important complement to symptom ratings in clinical research and practice. Despite there being several established QoL self-rating scales, we identified a need for a freely accessible, easy-to-use inventory, validated for use with both clinical and non-clinical samples, based on the overall life satisfaction conceptualization of QoL. The Brunnsviken Brief Quality of life scale (BBQ) was designed to meet these requirements. Items were selected by performing a factor analysis on a large data-set of QoL ratings collected previously. Six life areas (Leisure time, View on life, Creativity, Learning, Friends and Friendship, and View of self) were identified as important for overall QoL and were included in the BBQ. A psychometric evaluation was performed using two independent samples: healthy undergraduate students (n = 163), and a sample seeking treatment for social anxiety disorder (n = 568). Results suggested a unifactorial structure, with good concurrent and convergent validity, high internal and test-retest reliability, and accurate classification ability. We conclude that the BBQ is a valid and reliable measure of subjective QoL for use in clinical and research settings. The BBQ is presently available in 31 languages and can be freely downloaded from www.bbqscale.com .

Detection of Theileria lestoquardi cross infection in cattle with clinical theileriosis in Iran.

PubMed

Jalali, Seyedeh Missagh; Jolodar, Abbas; Rasooli, Aria; Darabifard, Ameneh

2016-12-01

Theileriosis caused by Theileria lestoquardi (malignant ovine theileriosis) in sheep and Theileria annulata (tropical theileriosis) in cattle is an important hemoprotozoal tick-borne disease in Iran. Due to major biologic and phylogenic similarities of these two species, this study was carried out to investigate the occurrence of natural infections with T.lestoquardi and T.annulata in cattle with clinical theileriosis in Ahvaz, southwest Iran. Fifty one cattle were selected based on clinical signs of theileriosis and confirmation by microscopic examination of blood smears. Blood samples were collected from each animal and hematologic and microscopic examinations were performed. Theileria piroplasmic forms were detected in all affected cattle. Pale mucous membranes (43.14%), icterus (11.76%) and fever (70.6%) were also observed. PCR-RFLP analysis revealed T. annulata infection in all tested cattle while coinfections with T. lestoquardi were found in two samples (3.92%). All sampled cattle including the two with mixed species Theileria infection were anemic. This is the first report of Theileria species cross infections in cattle with clinical theileriosis in Iran. It can be concluded that cattle can be infected with both pathogenic Theileria species, T. lestoquardi and T. annulata which can be an important issue in the epidemiology and spread of ovine malignant theileriosis.

Picking or nibbling: frequency and associated clinical features in bulimia nervosa, anorexia nervosa, and binge eating disorder.

PubMed

Conceição, Eva M; Crosby, Ross; Mitchell, James E; Engel, Scott G; Wonderlich, Stephen A; Simonich, Heather K; Peterson, Caroline B; Crow, Scott J; Le Grange, Daniel

2013-12-01

Picking or ribbling (P&N) is a newly studied eating behavior characterized by eating in an unplanned and repetitious manner in between meals and snacks. This behavior seems to be related to poorer weight loss outcomes after bariatric surgery for weight loss in severely obese patients, but clarification is still required regarding its value in other clinical samples. The purpose of this study was to investigate the frequency of P&N across different eating disorder samples, as well as to examine its association with psychopathological eating disorder features. Our sample included treatment-seeking adult participants, recruited for five different clinical trials: 259 binge eating disorder (BED); 264 bulimia nervosa (BN), and 137 anorexia nervosa (AN). Participants were assessed using the Eating Disorders Examination interview before entering the clinical trials. P&N was reported by 44% of the BED; 57.6% of the BN; and 34.3% of the AN participants. No association was found between P&N and BMI, the presence of compensatory behaviors, binge eating, or any of the eating disorder examination subscales. This study suggests that P&N behavior is highly prevalent across eating disorder diagnoses, but it is not associated with psychopathology symptoms or other eating disordered behaviors. Copyright © 2013 Wiley Periodicals, Inc.

Rapid identification of oral isolates of Aggregatibacter actinomycetemcomitans obtained from humans and primates by an ultrafast super convection based polymerase chain reaction

PubMed Central

Karched, M.; Furgang, D.; Sawalha, N.; Fine, D.H.

2017-01-01

Aggregatibacter actinomycetemcomitans is a Gram negative oral bacterium associated with localized aggressive periodontitis (LAP). Detection of A. actinomycetemcomitans in clinical samples is routinely done by PCR. Our aim was to develop a rapid and reliable PCR method that can be used as a chair-side tool to detect A. actinomycetemcomitans in clinical samples. Sensitivity and specificity assessment was performed on buccal and plaque samples obtained from 40 adolescents enrolled in an ongoing LAP study by comparing 20 A. actinomycetemcomitans-positive subjects and 20 who were negative. In a second study, A. actinomycetemcomitans presence was tested in oral samples from eighty-six primates that included rhesus monkeys, chimpanzees, marmosets, tamarins and baboons. All samples were processed for detection of A. actinomycetemcomitans by means of culture, conventional PCR (cPCR) and rapid PCR (rPCR) using a Super Convection based AmpXpress thermal cycler (AlphaHelix, Sweden). For human samples, culture, cPCR and rPCR showed perfect agreement. Using this method A. actinomycetemcomitans was detected in 27 of 32 rhesus monkeys, 4 of 8 chimpanzees and 1 of 34 marmosets. Rapidity of AmpXpress thermal cycler, combined with Ready-To-Go PCR beads (GE Life sciences), a quick DNA extraction kit (Epicentre Biotechnologies, Madison, Wisconsin, USA) and a bufferless fast agarose gel system, made it possible to obtain results on A. actinomycetemcomitans detection within 35 min. We conclude that AmpXpress fast PCR can be conveniently used as a chair-side tool for rapid detection of A. actinomycetemcomitans in clinical samples. PMID:22326236

Adaptation of an evidence-based intervention to promote colorectal cancer screening: a quasi-experimental study

PubMed Central

2014-01-01

Background To accelerate the translation of research findings into practice for underserved populations, we investigated the adaptation of an evidence-based intervention (EBI), designed to increase colorectal cancer (CRC) screening in one limited English-proficient (LEP) population (Chinese), for another LEP group (Vietnamese) with overlapping cultural and health beliefs. Methods Guided by Diffusion of Innovations Theory, we adapted the EBI to achieve greater reach. Core elements of the adapted intervention included: small media (a DVD and pamphlet) translated into Vietnamese from Chinese; medical assistants distributing the small media instead of a health educator; and presentations on CRC screening to the medical assistants. A quasi-experimental study examined CRC screening adherence among eligible Vietnamese patients at the intervention and control clinics, before and after the 24-month intervention. The proportion of the adherence was assessed using generalized linear mixed models that account for clustering under primary care providers and also within-patient correlation between baseline and follow up. Results Our study included two cross-sectional samples: 1,016 at baseline (604 in the intervention clinic and 412 in the control clinic) and 1,260 post-intervention (746 in the intervention and 514 in the control clinic), including appreciable overlaps between the two time points. Pre-post change in CRC screening over time, expressed as an odds ratio (OR) of CRC screening adherence by time, showed a marginally-significant greater increase in CRC screening adherence at the intervention clinic compared to the control clinic (the ratio of the two ORs = 1.42; 95% CI 0.95, 2.15). In the sample of patients who were non-adherent to CRC screening at baseline, compared to the control clinic, the intervention clinic had marginally-significant greater increase in FOBT (adjusted OR = 1.77; 95% CI 0.98, 3.18) and a statistically-significantly greater increase in CRC screening adherence (adjusted OR = 1.70; 95% CI 1.05, 2.75). Conclusions Theoretically guided adaptations of EBIs may accelerate the translation of research into practice. Adaptation has the potential to mitigate health disparities for hard-to-reach populations in a timely manner. PMID:24989083

Deciphering Sources of Variability in Clinical Pathology.

PubMed

Tripathi, Niraj K; Everds, Nancy E; Schultze, A Eric; Irizarry, Armando R; Hall, Robert L; Provencher, Anne; Aulbach, Adam

2017-01-01

The objectives of this session were to explore causes of variability in clinical pathology data due to preanalytical and analytical variables as well as study design and other procedures that occur in toxicity testing studies. The presenters highlighted challenges associated with such variability in differentiating test article-related effects from the effects of experimental procedures and its impact on overall data interpretation. These presentations focused on preanalytical and analytical variables and study design-related factors and their influence on clinical pathology data, and the importance of various factors that influence data interpretation including statistical analysis and reference intervals. Overall, these presentations touched upon potential effect of many variables on clinical pathology parameters, including animal physiology, sample collection process, specimen handling and analysis, study design, and some discussion points on how to manage those variables to ensure accurate interpretation of clinical pathology data in toxicity studies. This article is a brief synopsis of presentations given in a session entitled "Deciphering Sources of Variability in Clinical Pathology-It's Not Just about the Numbers" that occurred at the 35th Annual Symposium of the Society of Toxicologic Pathology in San Diego, California.

Current V3 genotyping algorithms are inadequate for predicting X4 co-receptor usage in clinical isolates.

PubMed

Low, Andrew J; Dong, Winnie; Chan, Dennison; Sing, Tobias; Swanstrom, Ronald; Jensen, Mark; Pillai, Satish; Good, Benjamin; Harrigan, P Richard

2007-09-12

Integrating CCR5 antagonists into clinical practice would benefit from accurate assays of co-receptor usage (CCR5 versus CXCR4) with fast turnaround and low cost. Published HIV V3-loop based predictors of co-receptor usage were compared with actual phenotypic tropism results in a large cohort of antiretroviral naive individuals to determine accuracy on clinical samples and identify areas for improvement. Aligned HIV envelope V3 loop sequences (n = 977), derived by bulk sequencing were analyzed by six methods: the 11/25 rule; a neural network (NN), two support vector machines, and two subtype-B position specific scoring matrices (PSSM). Co-receptor phenotype results (Trofile Co-receptor Phenotype Assay; Monogram Biosciences) were stratified by CXCR4 relative light unit (RLU) readout and CD4 cell count. Co-receptor phenotype was available for 920 clinical samples with V3 genotypes having fewer than seven amino acid mixtures (n = 769 R5; n = 151 X4-capable). Sensitivity and specificity for predicting X4 capacity were evaluated for the 11/25 rule (30% sensitivity/93% specificity), NN (44%/88%), PSSM(sinsi) (34%/96%), PSSM(x4r5) (24%/97%), SVMgenomiac (22%/90%) and SVMgeno2pheno (50%/89%). Quantitative increases in sensitivity could be obtained by optimizing the cut-off for methods with continuous output (PSSM methods), and/or integrating clinical data (CD4%). Sensitivity was directly proportional to strength of X4 signal in the phenotype assay (P < 0.05). Current default implementations of co-receptor prediction algorithms are inadequate for predicting HIV X4 co-receptor usage in clinical samples, particularly those X4 phenotypes with low CXCR4 RLU signals. Significant improvements can be made to genotypic predictors, including training on clinical samples, using additional data to improve predictions and optimizing cutoffs and increasing genotype sensitivity.

The British Association for Sexual Health and HIV 2016 UK national audit and survey of clinic policies in relation to risk assessment, HIV testing and follow-up.

PubMed

Bhaduri, S; Curtis, H; McClean, H; Sullivan, A K

2018-01-01

This national audit of 142 clinics demonstrated that the majority of clinics surveyed had policies and agreed clinical practice for alcohol and recreational drug enquiry, as well as documentation of HIV test refusal, although this was not the case in 24% of clinics as regards alcohol usage, 21% of clinics as regards recreational drugs use and 43% of clinics as regards chemsex usage. Regarding management of HIV test refusal, there was no policy or agreed practice in 13% of clinics with respect to men having sex with men (MSM) attenders, and in 18% of clinics for heterosexual attenders. Seventy percent of clinics had HIV point of care tests (POCT) available. Recommendations include: all clinics should have a policy of routine enquiry about alcohol, recreational drugs and chemsex, all clinics should record reasons for HIV test refusal and all clinics should provide testing alternatives to improve uptake, e.g. point of care testing or home sampling.

Biomarkers for Early Detection of Clinically Relevant Prostate Cancer. A Multi-Institutional Validation Trial

DTIC Science & Technology

2016-10-01

Study (PASS). We are in the process of evaluating these three biomarker panels in tissue, blood, and urine samples with well annotated clinical and...choice of therapy and decision-making during AS. The objective of the study is to utilize analytically validated assays that take into account tumor...Gleason 6 cancer to Gleason 7 or greater. The analysis plan was determined before specimens were selected for the study , and included 7 breaking

Internal construct validity of the Shirom-Melamed Burnout Questionnaire (SMBQ)

PubMed Central

2012-01-01

Background Burnout is a mental condition defined as a result of continuous and long-term stress exposure, particularly related to psychosocial factors at work. This paper seeks to examine the psychometric properties of the Shirom-Melamed Burnout Questionnaire (SMBQ) for validation of use in a clinical setting. Methods Data from both a clinical (319) and general population (319) samples of health care and social insurance workers were included in the study. Data were analysed using both classical and modern test theory approaches, including Confirmatory Factor Analysis (CFA) and Rasch analysis. Results Of the 638 people recruited into the study 416 (65%) persons were working full or part time. Data from the SMBQ failed a CFA, and initially failed to satisfy Rasch model expectations. After the removal of 4 of the original items measuring tension, and accommodating local dependency in the data, model expectations were met. As such, the total score from the revised scale is a sufficient statistic for ascertaining burnout and an interval scale transformation is available. The scale as a whole was perfectly targeted to the joint sample. A cut point of 4.4 for severe burnout was chosen at the intersection of the distributions of the clinical and general population. Conclusion A revised 18 item version of the SMBQ satisfies modern measurement standards. Using its cut point it offers the opportunity to identify potential clinical cases of burnout. PMID:22214479

Evaluation of Novel Broad-Range Real-Time PCR Assay for Rapid Detection of Human Pathogenic Fungi in Various Clinical Specimens▿

PubMed Central

Vollmer, Tanja; Störmer, Melanie; Kleesiek, Knut; Dreier, Jens

2008-01-01

In the present study, a novel broad-range real-time PCR was developed for the rapid detection of human pathogenic fungi. The assay targets a part of the 28S large-subunit ribosomal RNA (rDNA) gene. We investigated its application for the most important human pathogenic fungal genera, including Aspergillus, Candida, Cryptococcus, Mucor, Penicillium, Pichia, Microsporum, Trichophyton, and Scopulariopsis. Species were identified in PCR-positive reactions by direct DNA sequencing. A noncompetitive internal control was applied to prevent false-negative results due to PCR inhibition. The minimum detection limit for the PCR was determined to be one 28S rDNA copy per PCR, and the 95% detection limit was calculated to 15 copies per PCR. To assess the clinical applicability of the PCR method, intensive-care patients with artificial respiration and patients with infective endocarditis were investigated. For this purpose, 76 tracheal secretion samples and 70 heart valve tissues were analyzed in parallel by real-time PCR and cultivation. No discrepancies in results were observed between PCR analysis and cultivation methods. Furthermore, the application of the PCR method was investigated for other clinical specimens, including cervical swabs, nail and horny skin scrapings, and serum, blood, and urine samples. The combination of a broad-range real-time PCR and direct sequencing facilitates rapid screening for fungal infection in various clinical specimens. PMID:18385440

Evaluation of novel broad-range real-time PCR assay for rapid detection of human pathogenic fungi in various clinical specimens.

PubMed

Vollmer, Tanja; Störmer, Melanie; Kleesiek, Knut; Dreier, Jens

2008-06-01

In the present study, a novel broad-range real-time PCR was developed for the rapid detection of human pathogenic fungi. The assay targets a part of the 28S large-subunit ribosomal RNA (rDNA) gene. We investigated its application for the most important human pathogenic fungal genera, including Aspergillus, Candida, Cryptococcus, Mucor, Penicillium, Pichia, Microsporum, Trichophyton, and Scopulariopsis. Species were identified in PCR-positive reactions by direct DNA sequencing. A noncompetitive internal control was applied to prevent false-negative results due to PCR inhibition. The minimum detection limit for the PCR was determined to be one 28S rDNA copy per PCR, and the 95% detection limit was calculated to 15 copies per PCR. To assess the clinical applicability of the PCR method, intensive-care patients with artificial respiration and patients with infective endocarditis were investigated. For this purpose, 76 tracheal secretion samples and 70 heart valve tissues were analyzed in parallel by real-time PCR and cultivation. No discrepancies in results were observed between PCR analysis and cultivation methods. Furthermore, the application of the PCR method was investigated for other clinical specimens, including cervical swabs, nail and horny skin scrapings, and serum, blood, and urine samples. The combination of a broad-range real-time PCR and direct sequencing facilitates rapid screening for fungal infection in various clinical specimens.

Australasian emergency physicians: a learning and educational needs analysis. Part one: background and methodology. Profile of FACEM.

PubMed

Dent, Andrew W; Asadpour, Ali; Weiland, Tracey J; Paltridge, Debbie

2008-02-01

Fellows of the Australasian College for Emergency Medicine (FACEM) have opportunities to participate in a range of continuing professional development activities. To inform FACEM and assist those involved in planning continuing professional development interventions for FACEM, we undertook a learning needs analysis of emergency physicians. Exploratory study using survey methodology. Following questionnaire development by iterative feedback with emergency physicians and researchers, a mailed survey was distributed to all FACEM. The survey comprised eight items on work and demographic characteristics of FACEM, and 194 items on attitudes to existing learning opportunities, barriers to learning, and perceived learning needs and preferences. Fifty-eight percent (503/854) of all FACEM surveyed responded to the questionnaire, almost half of whom attained their FACEM after year 2000. The sample comprised mostly males (72.8%) with mean age of the sample 41.6 years, similar to ACEM database. Most respondents reported working in ACEM accredited hospitals (89%), major referral hospitals (54%), and practiced on both children and adults (78%). FACEM reported working on average 26.7 clinical hours per week with those at private hospitals working a greater proportion of clinical hours than other hospital types. As the first of six related reports, this paper documents the methodology used, including questionnaire development, and provides the demographics of responding FACEM, including the clinical and non-clinical hours worked and type of hospital of principal employment.

Evaluation of clinical and histopathologic prognostic factors for survival in canine osteosarcoma of the extracranial flat and irregular bones.

PubMed

Kruse, M A; Holmes, E S; Balko, J A; Fernandez, S; Brown, D C; Goldschmidt, M H

2013-07-01

Osteosarcoma is the most common bone tumor in dogs. However, current literature focuses primarily on appendicular osteosarcoma. This study examined the prognostic value of histological and clinical factors in flat and irregular bone osteosarcomas and hypothesized that clinical factors would have a significant association with survival time while histological factors would not. All osteosarcoma biopsy samples of the vertebra, rib, sternum, scapula, or pelvis were reviewed while survival information and clinical data were obtained from medical records, veterinarians, and owners. Forty-six dogs were included in the analysis of histopathological variables and 27 dogs with complete clinical data were included in the analysis of clinical variables. In the histopathologic cox regression model, there was no significant association between any histologic feature of osteosarcoma, including grade, and survival time. In the clinical cox regression model, there was a significant association between the location of the tumor and survival time as well as between the percent elevation of alkaline phosphatase (ALP) above normal and survival time. Controlling for ALP elevation, dogs with osteosarcoma located in the scapula had a significantly greater hazard for death (2.8) compared to dogs with tumors in other locations. Controlling for tumor location, every 100% increase in ALP from normal increased the hazard for death by 1.7. For canine osteosarcomas of the flat and irregular bones, histopathological features, including grade do not appear to be rigorous predictors of survival. Clinical variables such as increased ALP levels and tumor location in the scapula were associated with decreased survival times.

A disparity of words: racial differences in oncologist-patient communication about clinical trials.

PubMed

Eggly, Susan; Barton, Ellen; Winckles, Andrew; Penner, Louis A; Albrecht, Terrance L

2015-10-01

African Americans are consistently underrepresented in cancer clinical trials. Minority under-enrolment may be, in part, due to differences in the way clinical trials are discussed in oncology visits with African American vs. White patients. To investigate differences in oncologist-patient communication during offers to participate in clinical trials in oncology visits with African American and White patients. From an archive of video-recorded oncology visits, we selected all visits with African American patients that included a trial offer (n = 11) and a matched sample of visits with demographically/medically comparable White patients (n = 11). Using mixed qualitative-quantitative methods, we assessed differences by patient race in (i) word count of entire visits and (ii) frequency of mentions and word count of discussions of clinical trials and key elements of consent. Visits with African American patients, compared to visits with White patients, were shorter overall and included fewer mentions of and less discussion of clinical trials. Also, visits with African Americans included less discussion of the purpose and risks of trials offered, but more discussion of voluntary participation. African American patients may make decisions about clinical trial participation based on less discussion with oncologists than do White patients. Possible explanations include a less active communication style of African Americans in medical visits, oncologists' concerns about patient mistrust, and/or oncologist racial bias. Findings suggest oncologists should pay more conscious attention to developing the topic of clinical trials with African American patients, particularly purpose and risks. © 2013 John Wiley & Sons Ltd.

High-Throughput Analysis and Automation for Glycomics Studies.

PubMed

Shubhakar, Archana; Reiding, Karli R; Gardner, Richard A; Spencer, Daniel I R; Fernandes, Daryl L; Wuhrer, Manfred

This review covers advances in analytical technologies for high-throughput (HTP) glycomics. Our focus is on structural studies of glycoprotein glycosylation to support biopharmaceutical realization and the discovery of glycan biomarkers for human disease. For biopharmaceuticals, there is increasing use of glycomics in Quality by Design studies to help optimize glycan profiles of drugs with a view to improving their clinical performance. Glycomics is also used in comparability studies to ensure consistency of glycosylation both throughout product development and between biosimilars and innovator drugs. In clinical studies there is as well an expanding interest in the use of glycomics-for example in Genome Wide Association Studies-to follow changes in glycosylation patterns of biological tissues and fluids with the progress of certain diseases. These include cancers, neurodegenerative disorders and inflammatory conditions. Despite rising activity in this field, there are significant challenges in performing large scale glycomics studies. The requirement is accurate identification and quantitation of individual glycan structures. However, glycoconjugate samples are often very complex and heterogeneous and contain many diverse branched glycan structures. In this article we cover HTP sample preparation and derivatization methods, sample purification, robotization, optimized glycan profiling by UHPLC, MS and multiplexed CE, as well as hyphenated techniques and automated data analysis tools. Throughout, we summarize the advantages and challenges with each of these technologies. The issues considered include reliability of the methods for glycan identification and quantitation, sample throughput, labor intensity, and affordability for large sample numbers.

[Genetic mutation and clinical features of osteogenesis imperfecta type V].

PubMed

Guan, Shizhen; Bai, Xue; Wang, Yi; Liu, Zhigang; Ren, Xiuzhi; Zhang, Tianke; Ju, Mingyan; Li, Keqiu; Li, Guang

2017-12-10

To explore genetic mutations and clinical features of osteogenesis imperfecta type V. Clinical record of five patients (including one familial case) with osteogenesis imperfecta type V were retrospectively analyzed. Peripheral blood samples of the patients, one family member, as well as healthy controls were collected. Mutation of IFITM5 gene was identified by PCR amplification and Sanger sequencing. A heterozygous mutation (c.-14C>T) in the 5-UTR of the IFITM5 gene was identified in all of the patients and one mother. The clinical findings included frequent fractures and spine and/or extremities deformities, absence of dentinogenesis imperfecta, absence of hearing impairment, and blue sclera in 1 case. Radiographic findings revealed calcification of the interosseous membrane between the radius-ulna in all cases. Hyperplastic callus formation was found in 3 cases. Four had radial-head dislocation. A single heterozygous mutation c.-14C>T was found in the 5-UTR of the IFITM5 gene in 5 patients with osteogensis imperfecta type V. The patients showed specific radiological features including calcification of interosseous membrane, hyperplastic callus formation, and radial-head dislocation.

Ultra-sensitive high performance liquid chromatography-laser-induced fluorescence based proteomics for clinical applications.

PubMed

Patil, Ajeetkumar; Bhat, Sujatha; Pai, Keerthilatha M; Rai, Lavanya; Kartha, V B; Chidangil, Santhosh

2015-09-08

An ultra-sensitive high performance liquid chromatography-laser induced fluorescence (HPLC-LIF) based technique has been developed by our group at Manipal, for screening, early detection, and staging for various cancers, using protein profiling of clinical samples like, body fluids, cellular specimens, and biopsy-tissue. More than 300 protein profiles of different clinical samples (serum, saliva, cellular samples and tissue homogenates) from volunteers (normal, and different pre-malignant/malignant conditions) were recorded using this set-up. The protein profiles were analyzed using principal component analysis (PCA) to achieve objective detection and classification of malignant, premalignant and healthy conditions with high sensitivity and specificity. The HPLC-LIF protein profiling combined with PCA, as a routine method for screening, diagnosis, and staging of cervical cancer and oral cancer, is discussed in this paper. In recent years, proteomics techniques have advanced tremendously in life sciences and medical sciences for the detection and identification of proteins in body fluids, tissue homogenates and cellular samples to understand biochemical mechanisms leading to different diseases. Some of the methods include techniques like high performance liquid chromatography, 2D-gel electrophoresis, MALDI-TOF-MS, SELDI-TOF-MS, CE-MS and LC-MS techniques. We have developed an ultra-sensitive high performance liquid chromatography-laser induced fluorescence (HPLC-LIF) based technique, for screening, early detection, and staging for various cancers, using protein profiling of clinical samples like, body fluids, cellular specimens, and biopsy-tissue. More than 300 protein profiles of different clinical samples (serum, saliva, cellular samples and tissue homogenates) from healthy and volunteers with different malignant conditions were recorded by using this set-up. The protein profile data were analyzed using principal component analysis (PCA) for objective classification and detection of malignant, premalignant and healthy conditions. The method is extremely sensitive to detect proteins with limit of detection of the order of femto-moles. The HPLC-LIF combined with PCA as a potential proteomic method for the diagnosis of oral cancer and cervical cancer has been discussed in this paper. This article is part of a Special Issue entitled: Proteomics in India. Copyright © 2015 Elsevier B.V. All rights reserved.

Optimized multiparametric flow cytometric analysis of circulating endothelial cells and their subpopulations in peripheral blood of patients with solid tumors: a technical analysis.

PubMed

Zhou, Fangbin; Zhou, Yaying; Yang, Ming; Wen, Jinli; Dong, Jun; Tan, Wenyong

2018-01-01

Circulating endothelial cells (CECs) and their subpopulations could be potential novel biomarkers for various malignancies. However, reliable enumerable methods are warranted to further improve their clinical utility. This study aimed to optimize a flow cytometric method (FCM) assay for CECs and subpopulations in peripheral blood for patients with solid cancers. An FCM assay was used to detect and identify CECs. A panel of 60 blood samples, including 44 metastatic cancer patients and 16 healthy controls, were used in this study. Some key issues of CEC enumeration, including sample material and anticoagulant selection, optimal titration of antibodies, lysis/wash procedures of blood sample preparation, conditions of sample storage, sufficient cell events to enhance the signal, fluorescence-minus-one controls instead of isotype controls to reduce background noise, optimal selection of cell surface markers, and evaluating the reproducibility of our method, were integrated and investigated. Wilcoxon and Mann-Whitney U tests were used to determine statistically significant differences. In this validation study, we refined a five-color FCM method to detect CECs and their subpopulations in peripheral blood of patients with solid tumors. Several key technical issues regarding preanalytical elements, FCM data acquisition, and analysis were addressed. Furthermore, we clinically validated the utility of our method. The baseline levels of mature CECs, endothelial progenitor cells, and activated CECs were higher in cancer patients than healthy subjects ( P <0.01). However, there was no significant difference in resting CEC levels between healthy subjects and cancer patients ( P =0.193). We integrated and comprehensively addressed significant technical issues found in previously published assays and validated the reproducibility and sensitivity of our proposed method. Future work is required to explore the potential of our optimized method in clinical oncologic applications.

Reference Value Advisor: a new freeware set of macroinstructions to calculate reference intervals with Microsoft Excel.

PubMed

Geffré, Anne; Concordet, Didier; Braun, Jean-Pierre; Trumel, Catherine

2011-03-01

International recommendations for determination of reference intervals have been recently updated, especially for small reference sample groups, and use of the robust method and Box-Cox transformation is now recommended. Unfortunately, these methods are not included in most software programs used for data analysis by clinical laboratories. We have created a set of macroinstructions, named Reference Value Advisor, for use in Microsoft Excel to calculate reference limits applying different methods. For any series of data, Reference Value Advisor calculates reference limits (with 90% confidence intervals [CI]) using a nonparametric method when n≥40 and by parametric and robust methods from native and Box-Cox transformed values; tests normality of distributions using the Anderson-Darling test and outliers using Tukey and Dixon-Reed tests; displays the distribution of values in dot plots and histograms and constructs Q-Q plots for visual inspection of normality; and provides minimal guidelines in the form of comments based on international recommendations. The critical steps in determination of reference intervals are correct selection of as many reference individuals as possible and analysis of specimens in controlled preanalytical and analytical conditions. Computing tools cannot compensate for flaws in selection and size of the reference sample group and handling and analysis of samples. However, if those steps are performed properly, Reference Value Advisor, available as freeware at http://www.biostat.envt.fr/spip/spip.php?article63, permits rapid assessment and comparison of results calculated using different methods, including currently unavailable methods. This allows for selection of the most appropriate method, especially as the program provides the CI of limits. It should be useful in veterinary clinical pathology when only small reference sample groups are available. ©2011 American Society for Veterinary Clinical Pathology.

The potential of volatile organic compounds for the detection of active disease in patients with ulcerative colitis.

PubMed

Smolinska, A; Bodelier, A G L; Dallinga, J W; Masclee, A A M; Jonkers, D M; van Schooten, F-J; Pierik, M J

2017-05-01

To optimise treatment of ulcerative colitis (UC), patients need repeated assessment of mucosal inflammation. Current non-invasive biomarkers and clinical activity indices do not accurately reflect disease activity in all patients and cannot discriminate UC from non-UC colitis. Volatile organic compounds (VOCs) in exhaled air could be predictive of active disease or remission in Crohn's disease. To investigate whether VOCs are able to differentiate between active UC, UC in remission and non-UC colitis. UC patients participated in a 1-year study. Clinical activity index, blood, faecal and breath samples were collected at each out-patient visit. Patients with clear defined active faecal calprotectin >250 μg/g and inactive disease (Simple Clinical Colitis Activity Index <3, C-reactive protein <5 mg/L and faecal calprotectin <100 μg/g) were included for cross-sectional analysis. Non-UC colitis was confirmed by stool culture or radiological evaluation. Breath samples were analysed by gas chromatography time-of-flight mass spectrometry and kernel-based method to identify discriminating VOCs. In total, 72 UC (132 breath samples; 62 active; 70 remission) and 22 non-UC-colitis patients (22 samples) were included. Eleven VOCs predicted active vs. inactive UC in an independent internal validation set with 92% sensitivity and 77% specificity (AUC 0.94). Non-UC colitis patients could be clearly separated from active and inactive UC patients with principal component analysis. Volatile organic compounds can accurately distinguish active disease from remission in UC and profiles in UC are clearly different from profiles in non-UC colitis patients. VOCs have demonstrated potential as new non-invasive biomarker to monitor inflammation in UC. © 2017 John Wiley & Sons Ltd.

A three-year longitudinal study of affective temperaments and risk for psychopathology.

PubMed

DeGeorge, Daniella P; Walsh, Molly A; Barrantes-Vidal, Neus; Kwapil, Thomas R

2014-08-01

Affective temperaments are presumed to underlie bipolar psychopathology. The TEMPS-A has been widely used to assess affective temperaments in clinical and non-clinical samples. Cross-sectional research supports the association of affective temperaments and mood psychopathology; however, longitudinal research examining risk for the development of bipolar disorders is lacking. The present study examined the predictive validity of affective temperaments, using the TEMPS-A, at a three-year follow-up assessment. The study interviewed 112 participants (77% of the original sample) at a three-year follow-up of 145 non-clinically ascertained young adults psychometrically at-risk for bipolar disorders, who previously took part in a cross-sectional examination of affective temperaments and mood psychopathology. At the reassessment, 29 participants (26%) met criteria for bipolar spectrum disorders, including 13 participants who transitioned into disorders during the follow-up period (14% of the originally undiagnosed sample). Cyclothymic/irritable and hyperthymic temperaments predicted both total cases and new cases of bipolar spectrum disorders at the follow-up. Cyclothymic/irritable temperament was associated with more severe outcomes, including DSM-IV-TR bipolar disorders, bipolar spectrum psychopathology, major depressive episodes, and substance use disorders. Hyperthymic temperament was associated with bipolar spectrum psychopathology and hypomania, whereas dysthymic temperament was generally unassociated with psychopathology and impairment. The present sample of young adults is still young relative to the age of onset of mood psychopathology. These results provide the first evidence of the predictive validity of affective temperaments regarding risk for the development of bipolar psychopathology. Affective temperaments provide a useful construct for understanding bipolar psychopathology. Copyright © 2014 Elsevier B.V. All rights reserved.

Development of new method and protocol for cryopreservation related to embryo and oocytes freezing in terms of fertilization rate: A comparative study including review of literature.

PubMed

Barik, Mayadhar; Bajpai, Minu; Patnaik, Santosh; Mishra, Pravash; Behera, Priyamadhaba; Dwivedi, Sada Nanda

2016-01-01

Cryopreservation is basically related to meritorious thin samples or small clumps of cells that are cooled quickly without loss. Our main objective is to establish and formulate an innovative method and protocol development for cryopreservation as a gold standard for clinical uses in laboratory practice and treatment. The knowledge regarding usefulness of cryopreservation in clinical practice is essential to carry forward the clinical practice and research. We are trying to compare different methods of cryopreservation (in two dozen of cells) at the same time we compare the embryo and oocyte freezing interms of fertilization rate according to the International standard protocol. The combination of cryoprotectants and regimes of rapid cooling and rinsing during warming often allows successful cryopreservation of biological materials, particularly cell suspensions or thin tissue samples. Examples include semen, blood, tissue samples like tumors, histological cross-sections, human eggs and human embryos. Although presently many studies have reported that the children born from frozen embryos or "frosties," show consistently positive results with no increase in birth defects or development abnormalities is quite good enough and similar to our study (50-85%). We ensure that cryopreservation technology provided useful cell survivability, tissue and organ preservation in a proper way. Although it varies according to different laboratory conditions, it is certainly beneficial for patient's treatment and research. Further studies are needed for standardization and development of new protocol.

Drug-resistant tuberculosis in subjects included in the Second National Survey on Antituberculosis Drug Resistance in Porto Alegre, Brazil*, **

PubMed Central

Micheletti, Vania Celina Dezoti; Moreira, José da Silva; Ribeiro, Marta Osório; Kritski, Afranio Lineu; Braga, José Ueleres

2014-01-01

OBJECTIVE: To describe the prevalence of multidrug-resistant tuberculosis (MDR-TB) among tuberculosis patients in a major Brazilian city, evaluated via the Second National Survey on Antituberculosis Drug Resistance, as well as the social, demographic, and clinical characteristics of those patients. METHODS: Clinical samples were collected from tuberculosis patients seen between 2006 to 2007 at three hospitals and five primary health care clinics participating in the survey in the city of Porto Alegre, Brazil. The samples were subjected to drug susceptibility testing. The species of mycobacteria was confirmed using biochemical methods. RESULTS: Of the 299 patients included, 221 (73.9%) were men and 77 (27.3%) had a history of tuberculosis. The mean age was 36 years. Of the 252 patients who underwent HIV testing, 66 (26.2%) tested positive. The prevalence of MDR-TB in the sample as a whole was 4.7% (95% CI: 2.3-7.1), whereas it was 2.2% (95% CI: 0.3-4.2) among the new cases of tuberculosis and 12.0% (95% CI: 4.5-19.5) among the patients with a history of tuberculosis treatment. The multivariate analysis showed that a history of tuberculosis and a longer time to diagnosis were both associated with MDR-TB. CONCLUSIONS: If our results are corroborated by other studies conducted in Brazil, a history of tuberculosis treatment and a longer time to diagnosis could be used as predictors of MDR-TB. PMID:24831400

PathoScope 2.0: a complete computational framework for strain identification in environmental or clinical sequencing samples

PubMed Central

2014-01-01

Background Recent innovations in sequencing technologies have provided researchers with the ability to rapidly characterize the microbial content of an environmental or clinical sample with unprecedented resolution. These approaches are producing a wealth of information that is providing novel insights into the microbial ecology of the environment and human health. However, these sequencing-based approaches produce large and complex datasets that require efficient and sensitive computational analysis workflows. Many recent tools for analyzing metagenomic-sequencing data have emerged, however, these approaches often suffer from issues of specificity, efficiency, and typically do not include a complete metagenomic analysis framework. Results We present PathoScope 2.0, a complete bioinformatics framework for rapidly and accurately quantifying the proportions of reads from individual microbial strains present in metagenomic sequencing data from environmental or clinical samples. The pipeline performs all necessary computational analysis steps; including reference genome library extraction and indexing, read quality control and alignment, strain identification, and summarization and annotation of results. We rigorously evaluated PathoScope 2.0 using simulated data and data from the 2011 outbreak of Shiga-toxigenic Escherichia coli O104:H4. Conclusions The results show that PathoScope 2.0 is a complete, highly sensitive, and efficient approach for metagenomic analysis that outperforms alternative approaches in scope, speed, and accuracy. The PathoScope 2.0 pipeline software is freely available for download at: http://sourceforge.net/projects/pathoscope/. PMID:25225611

Fertility Preservation for Transgender Adolescents.

PubMed

Chen, Diane; Simons, Lisa; Johnson, Emilie K; Lockart, Barbara A; Finlayson, Courtney

2017-07-01

To describe fertility preservation (FP) utilization by transgender adolescents within a pediatric gender clinic between July 2013 and July 2016. A retrospective chart review was conducted to abstract demographic and clinical information among adolescents initiating gender-affirming hormones, including patient age at initial FP consultation, birth-assigned sex, race/ethnicity, and outcome of FP consultation. In our sample of 105 transgender adolescents, a total of 13 (seven transgender men and six transgender women) between the age of 14.2 and 20.6 years were seen in formal consultation for FP before initiating hormones. Of these adolescents, four completed sperm cryopreservation and one completed oocyte cryopreservation. Rates of FP utilization among transgender youth were low, which is consistent with a recently published report of FP utilization among transgender youth at another pediatric institution. Identified barriers to FP in our sample included cost, invasiveness of procedures, and desire not to delay medical transition. Copyright © 2017 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

miRNA signature associated with outcome of gastric cancer patients following chemotherapy

PubMed Central

2011-01-01

Background Identification of patients who likely will or will not benefit from cytotoxic chemotherapy through the use of biomarkers could greatly improve clinical management by better defining appropriate treatment options for patients. microRNAs may be potentially useful biomarkers that help guide individualized therapy for cancer because microRNA expression is dysregulated in cancer. In order to identify miRNA signatures for gastric cancer and for predicting clinical resistance to cisplatin/fluorouracil (CF) chemotherapy, a comprehensive miRNA microarray analysis was performed using endoscopic biopsy samples. Methods Biopsy samples were collected prior to chemotherapy from 90 gastric cancer patients treated with CF and from 34 healthy volunteers. At the time of disease progression, post-treatment samples were additionally collected from 8 clinical responders. miRNA expression was determined using a custom-designed Agilent microarray. In order to identify a miRNA signature for chemotherapy resistance, we correlated miRNA expression levels with the time to progression (TTP) of disease after CF therapy. Results A miRNA signature distinguishing gastric cancer from normal stomach epithelium was identified. 30 miRNAs were significantly inversely correlated with TTP whereas 28 miRNAs were significantly positively correlated with TTP of 82 cancer patients (P<0.05). Prominent among the upregulated miRNAs associated with chemosensitivity were miRNAs known to regulate apoptosis, including let-7g, miR-342, miR-16, miR-181, miR-1, and miR-34. When this 58-miRNA predictor was applied to a separate set of pre- and post-treatment tumor samples from the 8 clinical responders, all of the 8 pre-treatment samples were correctly predicted as low-risk, whereas samples from the post-treatment tumors that developed chemoresistance were predicted to be in the high-risk category by the 58 miRNA signature, suggesting that selection for the expression of these miRNAs occurred as chemoresistance arose. Conclusions We have identified 1) a miRNA expression signature that distinguishes gastric cancer from normal stomach epithelium from healthy volunteers, and 2) a chemoreresistance miRNA expression signature that is correlated with TTP after CF therapy. The chemoresistance miRNA expression signature includes several miRNAs previously shown to regulate apoptosis in vitro, and warrants further validation. PMID:22112324

Occurrence of Naegleria species in therapeutic geothermal water sources, Northern Iran.

PubMed

Latifi, Ali Reza; Niyyati, Maryam; Lorenzo-Morales, Jacob; Haghighi, Ali; Tabaei, Seyyed Javad Seyyed; Lasjerdi, Zohreh; Azargashb, Eznolah

2017-03-01

Potentially pathogenic Free-Living Amoebae include members belonging to Naegleria genus. The species N. fowleri is known worldwide as the causative agent of the lethal Primary Amoebic Meningoencephalitis (PAM). Only one clinical case of N. fowleri has been reported in Iran. Several species of Naegleria have been reported to be natural carriers of other potentially pathogenic microbial agents. The thermotolerance properties of this genus facilitates their presence in geothermal water sources including hot springs and spas. In the current study water samples were collected from 22 therapeutic hot springs, Northern Iran and investigated for the presence of Naegleria spp. using morphological keys and PCR/DNA sequencing based methods. Incubation of collected samples were done at both 30°C and 45°C in order to detect Naegleria spp. and N. fowleri, respectively. Thermotolerance assay and flagellation tests were also performed. The obtained results revealed that 54% of the investigated water samples were positive for Naegleria spp. including N. australiensis, N. americana, N. dobsoni, N. pagei, N. polaris and N. fultoni. The pathogenic N. fowleri was not detected. The most detected Naegleria was belonged to N. australiensis. This is the first report on the Naegleria spp. occurrence in hot springs in Northern Iran showing that most of the surveyed hot spring sources were contaminated with non-pathogenic Naegleria spp. However, due to the recent report of PAM in the country, further studies to investigate the presence of pathogenic N. fowleri in the environment and clinical samples is needed in the region and worldwide.

Recovery of different Listeria ribotypes from naturally contaminated, raw refrigerated meat and poultry products with two primary enrichment media.

PubMed Central

Ryser, E T; Arimi, S M; Bunduki, M M; Donnelly, C W

1996-01-01

Isolation rates for Listeria monocytogenes and the other Listeria spp. typically improve when samples are enriched in more than one primary enrichment medium. This study evaluated the abilities of two primary enrichment media, University of Vermont-modified Listeria enrichment broth (UVM) and Listeria repair broth (LRB), to recover different ribotypes of Listeria spp. from raw meat and poultry samples. Forty-five paired 25-g retail samples of ground beef, pork sausage, ground turkey, and chicken (160 samples) underwent primary enrichment in UVM and LRB (30 degrees C for 24 h) followed by secondary enrichment in Fraser broth (35 degrees C for 24 and 40 h) and plating on modified Oxford agar. After 24 h of incubation of 35 degrees C, 608 Listeria colonies from selected positive samples were biochemically confirmed as L. monocytogenes (245 isolates), L innocua (276 isolates), and L. welshimeri (89 isolates) and then ribotyped with the automated Riboprinter microbial characterization system (E. I. du Pont de Nemours & Co., Inc.). Thirty-six different Listeria strains comprising 16 L. monocytogenes (including four known clinical ribotypes), 12 L. innocua, and 8 L. welshimeri ribotypes were identified from selected positive samples (15 samples of each product type; two UVM and two LRB isolates per sample). Twenty-six of 36(13 L. monocytogenes) ribotypes were detected with both UVM and LRB, whereas 3 of 36 (1 L. monocytogenes) and 7 of 36 (3 L. monocytogenes) Listeria ribotypes were observed with only UVM or LRB, respectively. Ground beef, pork sausage, ground turkey, and chicken yielded 22 (8 L. monocytogenes), 21 (12 L. monocytogenes), 20 (9 L. monocytogenes), and 19 (11 L. monocytogenes) different Listeria ribotypes, respectively, with some Listeria ribotypes confined to a particular product. More importantly, major differences in both the number and distribution of Listeria ribotypes, including previously recognized clinical and nonclinical ribotypes of L. monocytogenes, were observed when 10 UVM and 10 LRB isolates from five samples of each product were ribotyped. When a third set of six samples per product type was examined from which two Listeria isolates were obtained by using only one of the two primary enrichment media, UVM and LRB failed to detect L. monocytogenes (both clinical and nonclinical ribotypes) in two and four samples, respectively. These findings stress the importance of using more than one primary enrichment medium and picking a sufficient number of colonies per sample when attempting to isolate specific L. monocytogenes strains during investigations of food-borne listeriosis. PMID:8633878

Analytical Investigations of Toxic p-Phenylenediamine (PPD) Levels in Clinical Urine Samples with Special Focus on MALDI-MS/MS

PubMed Central

Hooff, Gero P.; van Huizen, Nick A.; Meesters, Roland J. W.; Zijlstra, Eduard E.; Abdelraheem, Mohamed; Abdelraheem, Waleed; Hamdouk, Mohamed; Lindemans, Jan; Luider, Theo M.

2011-01-01

Para-phenylenediamine (PPD) is a common chromophoric ingredient in oxidative hair-dyes. In some African countries like Sudan, Egypt and Morocco but also in India this chemical is used alone or in combination with colouring extracts like Henna for dyeing of the hair or the skin. Excessive dermal exposure to PPD mainly leads to the N-mono- and N,N′-diacetylated products (MAPPD, DAPPD) by N-acetyltransferase 1 and 2 (NAT1 and 2) catalyzed reactions. Metabolites and PPD are mainly excreted via renal clearance. Despite a low risk of intoxication when used in due form, there are numerous cases of acute intoxication in those countries every year. At the ENT Hospital - Khartoum (Sudan) alone more than 300 cases are reported every year (∼10% fatal), mostly caused by either an accidental or intended (suicidal) high systemic exposure to pure PPD. Intoxication leads to a severe clinical syndrome including laryngeal edema, rhabdomyolysis and subsequent renal failure, neurotoxicity and acute toxic hepatitis. To date, there is no defined clinical treatment or antidote available and treatment is largely supportive. Herein, we show the development of a quick on-site identification assay to facilitate differential diagnosis in the clinic and, more importantly, the implementation of an advanced analytical platform for future in-depth investigations of PPD intoxication and metabolism is described. The current work shows a sensitive (∼25 µM) wet chemistry assay, a validated MALDI-MS/MS and HPLC-UV assay for the determination of PPD and its metabolites in human urine. We show the feasibility of the methods for measuring PPD over a range of 50–1000 µM. The validation criteria included linearity, lower limit of quantification (LLOQ), accuracy and precision, recovery and stability. Finally, PPD concentrations were determined in clinical urine samples of cases of acute intoxication and the applied technique was expanded to identify MAPPD and DAPPD in the identical samples. PMID:21829608

Analytical investigations of toxic p-phenylenediamine (PPD) levels in clinical urine samples with special focus on MALDI-MS/MS.

PubMed

Hooff, Gero P; van Huizen, Nick A; Meesters, Roland J W; Zijlstra, Eduard E; Abdelraheem, Mohamed; Abdelraheem, Waleed; Hamdouk, Mohamed; Lindemans, Jan; Luider, Theo M

2011-01-01

Para-phenylenediamine (PPD) is a common chromophoric ingredient in oxidative hair-dyes. In some African countries like Sudan, Egypt and Morocco but also in India this chemical is used alone or in combination with colouring extracts like Henna for dyeing of the hair or the skin. Excessive dermal exposure to PPD mainly leads to the N-mono- and N,N'-diacetylated products (MAPPD, DAPPD) by N-acetyltransferase 1 and 2 (NAT1 and 2) catalyzed reactions. Metabolites and PPD are mainly excreted via renal clearance. Despite a low risk of intoxication when used in due form, there are numerous cases of acute intoxication in those countries every year. At the ENT Hospital - Khartoum (Sudan) alone more than 300 cases are reported every year (~10% fatal), mostly caused by either an accidental or intended (suicidal) high systemic exposure to pure PPD. Intoxication leads to a severe clinical syndrome including laryngeal edema, rhabdomyolysis and subsequent renal failure, neurotoxicity and acute toxic hepatitis. To date, there is no defined clinical treatment or antidote available and treatment is largely supportive. Herein, we show the development of a quick on-site identification assay to facilitate differential diagnosis in the clinic and, more importantly, the implementation of an advanced analytical platform for future in-depth investigations of PPD intoxication and metabolism is described. The current work shows a sensitive (~25 µM) wet chemistry assay, a validated MALDI-MS/MS and HPLC-UV assay for the determination of PPD and its metabolites in human urine. We show the feasibility of the methods for measuring PPD over a range of 50-1000 µM. The validation criteria included linearity, lower limit of quantification (LLOQ), accuracy and precision, recovery and stability. Finally, PPD concentrations were determined in clinical urine samples of cases of acute intoxication and the applied technique was expanded to identify MAPPD and DAPPD in the identical samples.

Use of the experience sampling method in the context of clinical trials

PubMed Central

Verhagen, Simone J W; Hasmi, Laila; Drukker, Marjan; van Os, J; Delespaul, Philippe A E G

2016-01-01

Objective The experience sampling method (ESM) is a structured diary technique to appraise subjective experiences in daily life. It is applied in psychiatric patients, as well as in patients with somatic illness. Despite the potential of ESM assessment, the improved logistics and its increased administration in research, its use in clinical trials remains limited. This paper introduces ESM for clinical trials in psychiatry and beyond. Methods ESM is an ecologically valid method that yields a comprehensive view of an individual's daily life. It allows the assessment of various constructs (eg, quality of life, psychopathology) and psychological mechanisms (eg, stress-sensitivity, coping). These constructs are difficult to assess using cross-sectional questionnaires. ESM can be applied in treatment monitoring, as an ecological momentary intervention, in clinical trials, or in single case clinical trials. Technological advances (eg, smartphone applications) make its implementation easier. Results Advantages of ESM are highlighted and disadvantages are discussed. Furthermore, the ecological nature of ESM data and its consequences are explored, including the potential pitfalls of ambiguously formulated research questions and the specificities of ESM in statistical analyses. The last section focuses on ESM in relation to clinical trials and discusses its future use in optimising clinical decision-making. Conclusions ESM can be a valuable asset in clinical trial research and should be used more often to study the benefits of treatment in psychiatry and somatic health. PMID:27443678

Challenges of the ward round teaching based on the experiences of medical clinical teachers.

PubMed

Arabshahi, Kamran Soltani; Haghani, Fariba; Bigdeli, Shoaleh; Omid, Athar; Adibi, Peyman

2015-03-01

Holding educational sessions in a clinical environment is a major concern for faculty members because of its special difficulties and restrictions. This study attempts to recognize the challenges of the ward round teaching through investigating the experiences of clinical teachers in 2011. This qualitative research is carried out through purposive sampling with maximum variation from among the clinical teachers of major departments in Isfahan University of Medical Sciences (9 persons). The sampling continued until data saturation. Data were collected through semi-structured interview and analyzed through Collaizzi method. Data reliability and validity was confirmed through the four aspects of Lincoln and Guba method (credibility, conformability, transferability, and dependability). Three major themes and their related sub-themes (minor themes) were found out including the factors related to the triad of clinical teaching (patient, learner, and clinical teacher) (concern about patient's welfare, poor preparation, lack of motivation, ethical problems), factors related to the educational environment (stressful environment, humiliating environment and poor communication) and the factors related to the educational system of the clinical environment (poor organizing and arrangement of resources, poor system's monitoring, bad planning and inadequate resource). Ward round teaching has many concerns for teachers, and this should be recognized and resolved by authorities and teachers. If these problems are not resolved, it would affect the quality of clinical teaching.

Challenges of the ward round teaching based on the experiences of medical clinical teachers

PubMed Central

Arabshahi, Kamran Soltani; Haghani, Fariba; Bigdeli, Shoaleh; Omid, Athar; Adibi, Peyman

2015-01-01

Background: Holding educational sessions in a clinical environment is a major concern for faculty members because of its special difficulties and restrictions. This study attempts to recognize the challenges of the ward round teaching through investigating the experiences of clinical teachers in 2011. Materials and Methods: This qualitative research is carried out through purposive sampling with maximum variation from among the clinical teachers of major departments in Isfahan University of Medical Sciences (9 persons). The sampling continued until data saturation. Data were collected through semi-structured interview and analyzed through Collaizzi method. Data reliability and validity was confirmed through the four aspects of Lincoln and Guba method (credibility, conformability, transferability, and dependability). Results: Three major themes and their related sub-themes (minor themes) were found out including the factors related to the triad of clinical teaching (patient, learner, and clinical teacher) (concern about patient's welfare, poor preparation, lack of motivation, ethical problems), factors related to the educational environment (stressful environment, humiliating environment and poor communication) and the factors related to the educational system of the clinical environment (poor organizing and arrangement of resources, poor system's monitoring, bad planning and inadequate resource). Conclusion: Ward round teaching has many concerns for teachers, and this should be recognized and resolved by authorities and teachers. If these problems are not resolved, it would affect the quality of clinical teaching. PMID:26109975

Exploring the environment of clinical baccalaureate nursing students' education in Iran; A qualitative descriptive study.

PubMed

Yousefy, Alireza; Yazdannik, Ahmad reza; Mohammadi, Sepideh

2015-12-01

Today's students are the nurses of tomorrow. They need appropriate clinical learning opportunities in order to shape their professional identity, attitudes and values. Despite undeniable progresses of nursing education in Iran, the quality of the clinical education in Iran is not favorable. There is a need to explore the environment of clinical baccalaureate nursing students' education for developing, maintaining and enhancing the quality of clinical program. This is a qualitative study and was conducted based on content analysis multimethod design. Data were collected by individual interviews, focus groups and direct observations. 54 nursing students and 8 clinical educators from the four geographically diverse universities in the Iran composed the study sample. A purposive sampling was used. Five themes were emerged from data analysis including; ambiguity in the nursing care role, routine-based nursing care, uncritical and dependent thinking climate, incompetency of clinical educators and patient education as important component of nursing. The findings of this study describe a clearer understanding of the real environment of the clinical education in Iran. All of themes that emerged from the study play an important role in student learning and nursing education. It is crucial to pay more attention to reconsider care concept as an operational component of nursing, maximize meaningful learning opportunities, reevaluate clinical instructor as role models and prepare effective operational plan to combine theoretical and evidence based knowledge with clinical practice. Copyright © 2015 Elsevier Ltd. All rights reserved.

Standard deviation and standard error of the mean.

PubMed

Lee, Dong Kyu; In, Junyong; Lee, Sangseok

2015-06-01

In most clinical and experimental studies, the standard deviation (SD) and the estimated standard error of the mean (SEM) are used to present the characteristics of sample data and to explain statistical analysis results. However, some authors occasionally muddle the distinctive usage between the SD and SEM in medical literature. Because the process of calculating the SD and SEM includes different statistical inferences, each of them has its own meaning. SD is the dispersion of data in a normal distribution. In other words, SD indicates how accurately the mean represents sample data. However the meaning of SEM includes statistical inference based on the sampling distribution. SEM is the SD of the theoretical distribution of the sample means (the sampling distribution). While either SD or SEM can be applied to describe data and statistical results, one should be aware of reasonable methods with which to use SD and SEM. We aim to elucidate the distinctions between SD and SEM and to provide proper usage guidelines for both, which summarize data and describe statistical results.

Standard deviation and standard error of the mean

PubMed Central

In, Junyong; Lee, Sangseok

2015-01-01

In most clinical and experimental studies, the standard deviation (SD) and the estimated standard error of the mean (SEM) are used to present the characteristics of sample data and to explain statistical analysis results. However, some authors occasionally muddle the distinctive usage between the SD and SEM in medical literature. Because the process of calculating the SD and SEM includes different statistical inferences, each of them has its own meaning. SD is the dispersion of data in a normal distribution. In other words, SD indicates how accurately the mean represents sample data. However the meaning of SEM includes statistical inference based on the sampling distribution. SEM is the SD of the theoretical distribution of the sample means (the sampling distribution). While either SD or SEM can be applied to describe data and statistical results, one should be aware of reasonable methods with which to use SD and SEM. We aim to elucidate the distinctions between SD and SEM and to provide proper usage guidelines for both, which summarize data and describe statistical results. PMID:26045923

Surveillance of Severe Acute Respiratory Infection (SARI) for Hospitalized Patients in Northern Vietnam, 2011-2014.

PubMed

Nguyen, Hang Khanh Le; Nguyen, Son Vu; Nguyen, Anh Phuong; Hoang, Phuong Mai Vu; Le, Thanh Thi; Nguyen, Thach Co; Hoang, Huong Thu; Vuong, Cuong Duc; Tran, Loan Thi Thanh; Le, Mai Quynh

2017-09-25

Severe acute respiratory infections (SARI) are leading causes of hospitalization, morbidity, and mortality in children worldwide. The aim of this study was to identify viral pathogens responsible for SARI in northern Vietnam in the period from 2011 to 2014. Throat swabs and tracheal aspirates were collected from SARI patients according to WHO guidelines. The presence of 13 different viral pathogens (influenza A[H1N1]pdm09; A/H3N2; A/H5; A/H7 and B; para influenza 1,2,3; RSV; HMPV; adeno; severe acute respiratory syndrome-CoV and rhino) was tested by conventional/real-time reverse transcription-polymerase chain reaction. During the study period, 975 samples were collected and tested. More than 30% (32.1%, 313 samples) of the samples showed evidence of infection with influenza viruses, including A/H3N2 (48 samples), A (H1N1) pdm09 (221 samples), influenza B (42 samples), and co-infection of A (H1N1) pdm09 or A/H3N2 and influenza B (2 samples). Other respiratory pathogens were detected in 101 samples, including rhinovirus (73 samples), adenovirus (10 samples), hMPV (9 samples), parainfluenza 3 (5 samples), parainfluenza 2 (3 samples), and RSV (1 sample). Influenza A/H5, A/H7, or SARS-CoV were not detected. Respiratory viral infection, particularly infection of influenza and rhinoviruses, were associated with high rates of SARI hospitalization, and future studies correlating the clinical aspects are needed to design interventions, including targeted vaccination.

Development and validation of an HPLC–MS/MS method to determine clopidogrel in human plasma

PubMed Central

Liu, Gangyi; Dong, Chunxia; Shen, Weiwei; Lu, Xiaopei; Zhang, Mengqi; Gui, Yuzhou; Zhou, Qinyi; Yu, Chen

2015-01-01

A quantitative method for clopidogrel using online-SPE tandem LC–MS/MS was developed and fully validated according to the well-established FDA guidelines. The method achieves adequate sensitivity for pharmacokinetic studies, with lower limit of quantifications (LLOQs) as low as 10 pg/mL. Chromatographic separations were performed on reversed phase columns Kromasil Eternity-2.5-C18-UHPLC for both methods. Positive electrospray ionization in multiple reaction monitoring (MRM) mode was employed for signal detection and a deuterated analogue (clopidogrel-d4) was used as internal standard (IS). Adjustments in sample preparation, including introduction of an online-SPE system proved to be the most effective method to solve the analyte back-conversion in clinical samples. Pooled clinical samples (two levels) were prepared and successfully used as real-sample quality control (QC) in the validation of back-conversion testing under different conditions. The result showed that the real samples were stable in room temperature for 24 h. Linearity, precision, extraction recovery, matrix effect on spiked QC samples and stability tests on both spiked QCs and real sample QCs stored in different conditions met the acceptance criteria. This online-SPE method was successfully applied to a bioequivalence study of 75 mg single dose clopidogrel tablets in 48 healthy male subjects. PMID:26904399

Human Papilloma Virus (HPV) self-sampling: do women accept it?

PubMed

Abdullah, Nik Nairan; Daud, Suzanna; Wang, Seok Mui; Mahmud, Zamalia; Mohd Kornain, Noor Kaslina; Al-Kubaisy, Waqar

2018-04-01

This study aims to determine the acceptability of Human Papilloma Virus (HPV) self-sampling and the factors associated with willingness to buy HPV self-sampling kit in the future. A total of 164 women aged 28-60 years old from Obstetrics & Gynaecology clinics at a teaching hospital performed HPV self-sampling using the Digene HC2 DNA collection kit. After samples were taken, the participants were given self-administered questionnaires. The majority of the participants were Malay (93.9%), had attained tertiary education (65.2%) and were employed (70.1%). The acceptability was good. More than half of the participants felt that self-sampling was easy. Only 1.2% felt that the procedure was difficult to perform. Most reported no pain at all during the procedure (66.9%). The commonest concern was getting a good sample (90.1%). A number of Pap smears were found to be significantly associated with the willingness to buy the HPV self-sampling kit. HPV self-sampling has the potential to be included in the cervical cancer screening programme. Impact Statement What is already known on this subject: HPV self-sampling is acceptable in some developed and developing countries. It is acceptable because it was easy to perform with very minimal pain or discomfort. Studies on the acceptance of self-screening are needed to plan a policy on self-sampling in the future. What the results of this study add: Our study adds new findings to the body of knowledge on self-sampling in the local population. We found that more women are willing to do the self-sampling at the clinic rather than at home. Although more than 90% expressed willingness to do self-sampling in the future, only 70% of them were willing to purchase the kit. Cost is a potential barrier to women who have the interest to perform the self-sampling. Given the global economic challenges, cost is inevitably an important predictor that we have to consider. What the implications are of these findings for clinical practice and/or further research: Future research should examine women from the rural areas and those who are resilient to Pap smear screening. In clinical practice, clinicians should acknowledge that cost is a potential barrier for women who are willing to do self-sampling. Self-sampling could be an option for women with no financial constraint to buy the kit. However, clinicians should counsel women so that they can make an informed choice in determining their screening method.

Bio-analytical applications of mid-infrared spectroscopy using silver halide fiber-optic probes1

NASA Astrophysics Data System (ADS)

Heise, H. M.; Küpper, L.; Butvina, L. N.

2002-10-01

Infrared-spectroscopy has proved to be a powerful method for the study of various biomedical samples, in particular for in-vitro analysis in the clinical laboratory and for non-invasive diagnostics. In general, the analysis of biofluids such as whole blood, urine, microdialysates and bioreactor broth media takes advantage of the fact that a multitude of analytes can be quantified simultaneously and rapidly without the need for reagents. Progress in the quality of infrared silver halide fibers enabled us to construct several flexible fiber-optic probes of different geometries, which are particularly suitable for the measurement of small biosamples. Recent trends show that dry film measurements by mid-infrared spectroscopy could revolutionize analytical tools in the clinical chemistry laboratory, and an example is given. Infrared diagnostic tools show a promising potential for patients, and minimal-invasive blood glucose assays or skin tissue pathology in particular cannot be left out using mid-infrared fiber-based probes. Other applications include the measurement of skin samples including penetration studies of vitamins and constituents of cosmetic cream formulations. A further field is the micro-domain analysis of biopsy samples from bog mummified corpses, and recent results on the chemistry of dermis and hair samples are reported. Another field of application, for which results are reported, is food analysis and bio-reactor monitoring.

Clinical Application of Genome and Exome Sequencing as a Diagnostic Tool for Pediatric Patients: a Scoping Review of the Literature.

PubMed

Smith, Hadley Stevens; Swint, J Michael; Lalani, Seema R; Yamal, Jose-Miguel; de Oliveira Otto, Marcia C; Castellanos, Stephan; Taylor, Amy; Lee, Brendan H; Russell, Heidi V

2018-05-14

Availability of clinical genomic sequencing (CGS) has generated questions about the value of genome and exome sequencing as a diagnostic tool. Analysis of reported CGS application can inform uptake and direct further research. This scoping literature review aims to synthesize evidence on the clinical and economic impact of CGS. PubMed, Embase, and Cochrane were searched for peer-reviewed articles published between 2009 and 2017 on diagnostic CGS for infant and pediatric patients. Articles were classified according to sample size and whether economic evaluation was a primary research objective. Data on patient characteristics, clinical setting, and outcomes were extracted and narratively synthesized. Of 171 included articles, 131 were case reports, 40 were aggregate analyses, and 4 had a primary economic evaluation aim. Diagnostic yield was the only consistently reported outcome. Median diagnostic yield in aggregate analyses was 33.2% but varied by broad clinical categories and test type. Reported CGS use has rapidly increased and spans diverse clinical settings and patient phenotypes. Economic evaluations support the cost-saving potential of diagnostic CGS. Multidisciplinary implementation research, including more robust outcome measurement and economic evaluation, is needed to demonstrate clinical utility and cost-effectiveness of CGS.

Barriers and Strategies for Recruitment of Racial and Ethnic Minorities: Perspectives from Neurological Clinical Research Coordinators.

PubMed

Haley, Sean J; Southwick, Lauren E; Parikh, Nina S; Rivera, Jazmin; Farrar-Edwards, Dorothy; Boden-Albala, Bernadette

2017-12-01

Randomized controlled trials (RCTs) are the gold standard within evidence-based research. Low participant accrual rates, especially of underrepresented groups (e.g., racial-ethnic minorities), may jeopardize clinical studies' viability and strength of findings. Research has begun to unweave clinical trial mechanics, including the roles of clinical research coordinators, to improve trial participation rates. Two semi-structured focus groups were conducted with a purposive sample of 29 clinical research coordinators (CRCs) at consecutive international stroke conferences in 2013 and 2014 to gain in-depth understanding of coordinator-level barriers to racial-ethnic minority recruitment and retention into neurological trials. Coded transcripts were used to create themes to define concepts, identify associations, summarize findings, and posit explanations. Barriers related to translation, literacy, family composition, and severity of medical diagnosis were identified. Potential strategies included a focus on developing personal relationships with patients, community and patient education, centralized clinical trial administrative systems, and competency focused training and education for CRCs. Patient level barriers to clinical trial recruitment are well documented. Less is known about barriers facing CRCs. Further identification of how and when barriers manifest and the effectiveness of strategies to improve CRCs recruitment efforts is warranted.

Variation of SNOMED CT coding of clinical research concepts among coding experts.

PubMed

Andrews, James E; Richesson, Rachel L; Krischer, Jeffrey

2007-01-01

To compare consistency of coding among professional SNOMED CT coders representing three commercial providers of coding services when coding clinical research concepts with SNOMED CT. A sample of clinical research questions from case report forms (CRFs) generated by the NIH-funded Rare Disease Clinical Research Network (RDCRN) were sent to three coding companies with instructions to code the core concepts using SNOMED CT. The sample consisted of 319 question/answer pairs from 15 separate studies. The companies were asked to select SNOMED CT concepts (in any form, including post-coordinated) that capture the core concept(s) reflected in the question. Also, they were asked to state their level of certainty, as well as how precise they felt their coding was. Basic frequencies were calculated to determine raw level agreement among the companies and other descriptive information. Krippendorff's alpha was used to determine a statistical measure of agreement among the coding companies for several measures (semantic, certainty, and precision). No significant level of agreement among the experts was found. There is little semantic agreement in coding of clinical research data items across coders from 3 professional coding services, even using a very liberal definition of agreement.

The Structured Clinical Interview for DSM-IV Childhood Diagnoses (Kid-SCID): first psychometric evaluation in a Dutch sample of clinically referred youths.

PubMed

Roelofs, Jeffrey; Muris, Peter; Braet, Caroline; Arntz, Arnoud; Beelen, Imke

2015-06-01

The Structured Clinical Interview for DSM-IV Childhood Disorders (Kid-SCID) is a semi-structured interview for the classification of psychiatric disorders in children and adolescents. This study presents a first evaluation of the psychometric properties of the Kid-SCID in a Dutch sample of children and adolescents who had been referred to an outpatient treatment centre for mental health problems. Results indicated that the inter-rater reliability of the Kid-SCID classifications and the internal consistency of various (dimensional) criteria of the diagnoses were moderate to good. Further, for most Kid-SCID diagnoses, reasonable agreement between children and parents was found. Finally, the correspondence between the Kid-SCID and the final clinical diagnosis as established after the full intake procedure, which included the information as provided by the Kid-SCID, ranged from poor to good. Results are discussed in the light of methodological issues pertaining to the assessment of psychiatric disorders in youths. The Kid-SCID can generally be seen as a reliable and useful tool that can assist clinicians in carrying out clinical evaluations of children and adolescents.

A work sampling study of provider activities in school-based health centers.

PubMed

Mavis, Brian; Pearson, Rachel; Stewart, Gail; Keefe, Carole

2009-06-01

The purpose of this study was to describe provider activities in a convenience sample of School-Based Health Centers (SBHCs). The goal was to determine the relative proportion of time that clinic staff engaged in various patient care and non-patient care activities. All provider staff at 4 urban SBHCs participated in this study; 2 were in elementary schools, 1 in a middle school, and 1 in a school with kindergarten through grade 8. The study examined provider activity from 6 days sampled at random from the school year. Participants were asked to document their activities in 15-minute intervals from 8:00 a.m. to 5:00 p.m. A structured recording form was used that included 35 activity categories. Overall, 1492 records were completed, accounting for 2708 coded activities. Almost half (48%) of all staff activities were coded as direct patient contact, with clinic operations the second largest category. Limited variations in activities were found across clinic sites and according to season. A significant amount of provider activity was directed at the delivery of health care; direct patient care and clinic operations combined accounted for approximately 75% of clinic activity. Patient, classroom, and group education activities, as well as contacts with parents and school staff accounted for 20% of all clinic activity and represent important SBHC functions that other productivity measures such as billing data might not consistently track. Overall, the method was acceptable to professional staff as a means of tracking activity and was adaptable to meet their needs.

Refining and validating a conceptual model of Clinical Nurse Leader integrated care delivery.

PubMed

Bender, Miriam; Williams, Marjory; Su, Wei; Hites, Lisle

2017-02-01

To empirically validate a conceptual model of Clinical Nurse Leader integrated care delivery. There is limited evidence of frontline care delivery models that consistently achieve quality patient outcomes. Clinical Nurse Leader integrated care delivery is a promising nursing model with a growing record of success. However, theoretical clarity is necessary to generate causal evidence of effectiveness. Sequential mixed methods. A preliminary Clinical Nurse Leader practice model was refined and survey items developed to correspond with model domains, using focus groups and a Delphi process with a multi-professional expert panel. The survey was administered in 2015 to clinicians and administrators involved in Clinical Nurse Leader initiatives. Confirmatory factor analysis and structural equation modelling were used to validate the measurement and model structure. Final sample n = 518. The model incorporates 13 components organized into five conceptual domains: 'Readiness for Clinical Nurse Leader integrated care delivery'; 'Structuring Clinical Nurse Leader integrated care delivery'; 'Clinical Nurse Leader Practice: Continuous Clinical Leadership'; 'Outcomes of Clinical Nurse Leader integrated care delivery'; and 'Value'. Sample data had good fit with specified model and two-level measurement structure. All hypothesized pathways were significant, with strong coefficients suggesting good fit between theorized and observed path relationships. The validated model articulates an explanatory pathway of Clinical Nurse Leader integrated care delivery, including Clinical Nurse Leader practices that result in improved care dynamics and patient outcomes. The validated model provides a basis for testing in practice to generate evidence that can be deployed across the healthcare spectrum. © 2016 John Wiley & Sons Ltd.

CIDR

Science.gov Websites

Genotyping General Information Genome Wide Association Custom FFPE Sample Options Methylation Linkage Enrichment Options 51 Mb 51 Mb plus 6.8 - 24Mb custom option 54 Mb Clinical Exome 71 Mb (includes UTRs) Next Generation Sequencing Platform Illumina HiSeq sequencers Options for Formalin-Fixed Paraffin-Embedded (FFPE

Depression, social support, and clinical outcomes following lung transplantation: a single-center cohort study.

PubMed

Smith, Patrick J; Snyder, Laurie D; Palmer, Scott M; Hoffman, Benson M; Stonerock, Gregory L; Ingle, Krista K; Saulino, Caroline K; Blumenthal, James A

2018-05-01

Depressive symptoms are common among lung transplant candidates and have been associated with poorer clinical outcomes in some studies. Previous studies have been plagued by methodologic problems, including small sample sizes, few clinical events, and uncontrolled confounders, particularly perioperative complications. In addition, few studies have examined social support as a potential protective factor. We therefore examined the association between pretransplant depressive symptoms, social support, and mortality in a large sample of lung transplant recipients. As a secondary aim, we also examined the associations between psychosocial factors, perioperative outcomes [indexed by hospital length of stay (LOS)], and mortality. We hypothesized that depression would be associated with longer LOS and that the association between depression, social support, and mortality would be moderated by LOS. Participants included lung transplant recipients, transplanted at Duke University Medical Center from January 2009 to December 2014. Depressive symptoms were evaluated using the Beck Depression Inventory (BDI-II) and social support using the Perceived Social Support Scale (PSSS). Medical risk factors included forced vital capacity (FVC), partial pressure of carbon dioxide (PCO 2 ), donor age, acute rejection, and transplant type. Functional status was assessed using six-minute walk distance (6MWD). We also controlled for demographic factors, including age, gender, and native disease. Transplant hospitalization LOS was examined as a marker of perioperative clinical outcomes. Participants included 273 lung recipients (174 restrictive, 67 obstructive, 26 cystic fibrosis, and six "other"). Pretransplant depressive symptoms were common, with 56 participants (21%) exhibiting clinically elevated levels (BDI-II ≥ 14). Greater depressive symptoms were associated with longer LOS [adjusted b = 0.20 (2 days per 7-point higher BDI-II score), P < 0.01]. LOS moderated the associations between depressive symptoms (P = 0.019), social support (P < 0.001), and mortality, such that greater depressive symptoms and lower social support were associated with greater mortality only among individuals with longer LOS. For individuals with LOS ≥ 1 month, clinically elevated depressive symptoms (BDI-II ≥ 14) were associated with a threefold increased risk of mortality (HR = 2.97). Greater pretransplant depressive symptoms and lower social support may be associated with greater mortality among a subset of individuals with worse perioperative outcomes. © 2017 Steunstichting ESOT.

The prevalence and impact of depression in self-referred clients attending an employee assistance program.

PubMed

Lam, Raymond W; Wolinsky, Debra; Kinsella, Cynthia; Woo, Cindy; Cayley, Paula M; Walker, Anne B

2012-11-01

To determine the prevalence and characteristics of clients with depression attending an employee assistance program (EAP). Anonymized data were obtained from 10,794 consecutive clients, including 9105 employees, self-referred to PPC Canada, a large, external EAP. Assessment measures included the self-rated nine-item Patient Health Questionnaire (PHQ-9). Clinical characteristics of depressed clients (PHQ-9 score ≥ 10) were compared with those of nondepressed clients. Thirty-seven percent of the employee sample met PHQ-9 criteria for clinically significant depression. Compared with clients without depression, they had significantly higher rates of anxiety, psychotropic medication use, problem substance use, global problems with functioning, absenteeism, impairment in work-related tasks, and low job satisfaction. A large proportion of EAP clients were clinically depressed with associated negative effects on personal and occupational functioning.

Increasing Complexity of Clinical Research in Gastroenterology: Implications for Training Clinician-Scientists

PubMed Central

Scott, Frank I.; McConnell, Ryan A.; Lewis, Matthew E.; Lewis, James D.

2014-01-01

Background Significant advances have been made in clinical and epidemiologic research methods over the past 30 years. We sought to demonstrate the impact of these advances on published research in gastroenterology from 1980 to 2010. Methods Three journals (Gastroenterology, Gut, and American Journal of Gastroenterology) were selected for evaluation given their continuous publication during the study period. Twenty original clinical articles were randomly selected from each journal from 1980, 1990, 2000, and 2010. Each article was assessed for topic studied, whether the outcome was clinical or physiologic, study design, sample size, number of authors and centers collaborating, and reporting of statistical methods such as sample size calculations, p-values, confidence intervals, and advanced techniques such as bioinformatics or multivariate modeling. Research support with external funding was also recorded. Results A total of 240 articles were included in the study. From 1980 to 2010, there was a significant increase in analytic studies (p<0.001), clinical outcomes (p=0.003), median number of authors per article (p<0.001), multicenter collaboration (p<0.001), sample size (p<0.001), and external funding (p<0.001)). There was significantly increased reporting of p-values (p=0.01), confidence intervals (p<0.001), and power calculations (p<0.001). There was also increased utilization of large multicenter databases (p=0.001), multivariate analyses (p<0.001), and bioinformatics techniques (p=0.001). Conclusions There has been a dramatic increase in complexity in clinical research related to gastroenterology and hepatology over the last three decades. This increase highlights the need for advanced training of clinical investigators to conduct future research. PMID:22475957

Species diversity of Aspergillus section Versicolores in clinical samples and antifungal susceptibility.

PubMed

Siqueira, João Paulo Zen; Sutton, Deanna A; García, Dania; Gené, Josepa; Thomson, Pamela; Wiederhold, Nathan; Guarro, Josep

2016-11-01

Aspergillus section Versicolores includes species of clinical relevance and many others that have been poorly studied but are occasionally found in clinical samples. The aim of this study was to investigate, using a multilocus phylogenetic approach, the spectrum of species of the section Versicolores and to determine their in vitro antifungal susceptibility. The study was based on a set of 77 clinical isolates from different USA medical centres, which had been previously identified as belonging to this section. The genetic markers used were internal transcribed spacer (ITS), β-tubulin (BenA), calmodulin (CaM), and RNA polymerase II second largest subunit (RPB2), and the drugs tested, following the CLSI guidelines, were amphotericin B (AMB), itraconazole, posaconazole, voriconazole, anidulafungin, caspofungin, micafungin, terbinafine (TBF), and flucytosine (5FC). The most frequent species were Aspergillus sydowii (26 %), Aspergillus creber (22 %), and Aspergillus amoenus (18.2 %), followed by Aspergillus protuberus (13 %), Aspergillus jensenii (10.4 %), and Aspergillus tabacinus (5.2 %); while Aspergillus cvjetkovicii, Aspergillus fructus, Aspergillus puulaauensis, and Aspergillus versicolor were represented by only one isolate each (1.3 %). This is the first time that A. jensenii and A. puulaauensis have been reported from clinical samples. Considering the high number of isolates identified as belonging to this fungal group in this study, its clinical relevance should not be overlooked. Aspergillus versicolor, traditionally considered one of the most common species in this section in a clinical setting, was only rarely recovered in our study. The in vitro antifungal results showed that echinocandins and TBF were the most potent drugs, the azoles showed variable results, AMB was poorly active, and 5FC was the less active. Copyright © 2016 British Mycological Society. Published by Elsevier Ltd. All rights reserved.

Replication of a Modified Factor Structure for the Eating Disorder Examination-Questionnaire: Extension to Clinical Eating Disorder and Non-clinical Samples in Portugal.

PubMed

Machado, Paulo P P; Grilo, Carlos M; Crosby, Ross D

2018-01-01

Psychometric investigations of the Eating Disorder Examination-Questionnaire (EDE-Q) have generally not supported the original scale structure. The present study tested an alternative brief factor structure in two large Portuguese samples: (1) a non-clinical sample of N = 4117 female students and (2) a treatment-seeking sample of N = 609 patients diagnosed with eating disorders. Confirmatory factor analysis revealed a poor fit for the original EDE-Q structure in both the non-clinical and the clinical samples but revealed a good fit for the alternative 7-item 3-factor structure (dietary restraint, shape/weight overvaluation and body dissatisfaction). Factor loadings were invariant across samples and across the different specific eating disorder diagnoses in the clinical sample. These confirmatory factor analysis findings, which replicate findings from studies with diverse predominately overweight/obese samples, supported a modified 7-item, 3-factor structure for the EDE-Q. The reliable findings across different non-clinical and clinical eating disorder groups provide confidence regarding the potential utility of this brief version. Copyright © 2017 John Wiley & Sons, Ltd and Eating Disorders Association. Copyright © 2017 John Wiley & Sons, Ltd and Eating Disorders Association.

Understanding reasons for and outcomes of patients lost to follow-up in antiretroviral therapy programs in Africa through a sampling-based approach.

PubMed

Geng, Elvin H; Bangsberg, David R; Musinguzi, Nicolas; Emenyonu, Nneka; Bwana, Mwebesa Bosco; Yiannoutsos, Constantin T; Glidden, David V; Deeks, Steven G; Martin, Jeffrey N

2010-03-01

Losses to follow-up after initiation of antiretroviral therapy (ART) are common in Africa and are a considerable obstacle to understanding the effectiveness of nascent treatment programs. We sought to characterize, through a sampling-based approach, reasons for and outcomes of patients who become lost to follow-up. Cohort study. We searched for and interviewed a representative sample of lost patients or close informants in the community to determine reasons for and outcomes among lost patients. Three thousand six hundred twenty-eight HIV-infected adults initiated ART between January 1, 2004 and September 30, 2007 in Mbarara, Uganda. Eight hundred twenty-nine became lost to follow-up (cumulative incidence at 1, 2, and 3 years of 16%, 30%, and 39%). We sought a representative sample of 128 lost patients in the community and ascertained vital status in 111 (87%). Top reasons for loss included lack of transportation or money and work/child care responsibilities. Among the 111 lost patients who had their vital status ascertained through tracking, 32 deaths occurred (cumulative 1-year incidence 36%); mortality was highest shortly after the last clinic visit. Lower pre-ART CD4 T-cell count, older age, low blood pressure, and a central nervous system syndrome at the last clinic visit predicted deaths. Of patients directly interviewed, 83% were in care at another clinic and 71% were still using ART. Sociostructural factors are the primary reasons for loss to follow-up. Outcomes among the lost are heterogeneous: both deaths and transfers to other clinics were common. Tracking a sample of lost patients is an efficient means for programs to understand site-specific reasons for and outcomes among patients lost to follow-up.

Clinical and psychopathological features associated with treatment-emergent mania in bipolar-II depressed outpatients exposed to antidepressants.

PubMed

Fornaro, Michele; Anastasia, Annalisa; Monaco, Francesco; Novello, Stefano; Fusco, Andrea; Iasevoli, Felice; De Berardis, Domenico; Veronese, Nicola; Solmi, Marco; de Bartolomeis, Andrea

2018-07-01

Treatment-emergent affective switch (TEAS), including treatment-emergent mania (TEM), carry significant burden in the clinical management of bipolar depression, whereas the use of antidepressants raises both efficacy, safety and tolerability concerns. The present study assesses the prevalence and clinical correlates of TEM in selected sample of Bipolar Disorder (BD) Type-II (BD-II) acute depression outpatients. Post-hoc analysis of the clinical and psychopathological features associated with TEM among 91 BD-II depressed outpatients exposed to antidepressants. Second-generation antipsychotics (SGA) (p = .005), lithium (≤ .001), cyclothymic/irritable/hyperthymic temperaments (p = ≤ .001; p = .001; p = .003, respectively), rapid-cycling (p = .005) and depressive mixed features (p = .003) differed between TEM + cases vs. TEM - controls. Upon multinomial logistic regression, the accounted psychopathological features correctly classified as much as 88.6% of TEM + cases (35/91 overall sample, or 38.46% of the sample), yet not statistically significantly [Exp(B) = .032; p = ns]. Specifically, lithium [B = - 2.385; p = .001], SGAs [B = - 2.354; p = .002] predicted lower rates of TEM + in contrast to the number of lifetime previous psychiatric hospitalizations [B = 2.380; p = .002], whereas mixed features did not [B = 1.267; p = ns]. Post-hoc analysis. Lack of systematic pharmacological history record; chance of recall bias and Berkson's biases. Permissive operational criterion for TEM. Relatively small sample size. Cyclothymic temperament and mixed depression discriminated TEM + between TEM - cases, although only lithium and the SGAs reliably predicted TEM +/- grouping. Larger-sampled/powered longitudinal replication studies are warranted to allow firm conclusions on the matter, ideally contributing to the identification of clear-cut sub-phenotypes of BD towards patient-tailored-pharmacotherapy. Copyright © 2018 Elsevier B.V. All rights reserved.

Assessment of phosphate binding by sevelamer carbonate powder for oral suspension mixed in foods.

PubMed

Hanus, Martin; Zhorov, Eugene; Brommage, Deborah; Plone, Melissa; Holmes-Farley, Stephen Randall

2012-01-01

This study investigated mixing sevelamer carbonate powder with foods and beverages other than water. Food samples, including applesauce, oatmeal, chicken, protein powder, scrambled eggs, ginger ale, and diet ginger ale, were subjected to an in vitro assay, and the difference in the amount of phosphate bound between samples pre-exposed to foods and samples where the drug was exposed to foods concurrently was determined Under these assay conditions, pre-exposure to sevelamer carbonate powder had no effect on the ability to bind phosphate. Clinical testing is needed to further evaluate this finding.

Clinical Chemistry Laboratory Automation in the 21st Century - Amat Victoria curam (Victory loves careful preparation)

PubMed Central

Armbruster, David A; Overcash, David R; Reyes, Jaime

2014-01-01

The era of automation arrived with the introduction of the AutoAnalyzer using continuous flow analysis and the Robot Chemist that automated the traditional manual analytical steps. Successive generations of stand-alone analysers increased analytical speed, offered the ability to test high volumes of patient specimens, and provided large assay menus. A dichotomy developed, with a group of analysers devoted to performing routine clinical chemistry tests and another group dedicated to performing immunoassays using a variety of methodologies. Development of integrated systems greatly improved the analytical phase of clinical laboratory testing and further automation was developed for pre-analytical procedures, such as sample identification, sorting, and centrifugation, and post-analytical procedures, such as specimen storage and archiving. All phases of testing were ultimately combined in total laboratory automation (TLA) through which all modules involved are physically linked by some kind of track system, moving samples through the process from beginning-to-end. A newer and very powerful, analytical methodology is liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS). LC-MS/MS has been automated but a future automation challenge will be to incorporate LC-MS/MS into TLA configurations. Another important facet of automation is informatics, including middleware, which interfaces the analyser software to a laboratory information systems (LIS) and/or hospital information systems (HIS). This software includes control of the overall operation of a TLA configuration and combines analytical results with patient demographic information to provide additional clinically useful information. This review describes automation relevant to clinical chemistry, but it must be recognised that automation applies to other specialties in the laboratory, e.g. haematology, urinalysis, microbiology. It is a given that automation will continue to evolve in the clinical laboratory, limited only by the imagination and ingenuity of laboratory scientists. PMID:25336760

Clinical Chemistry Laboratory Automation in the 21st Century - Amat Victoria curam (Victory loves careful preparation).

PubMed

Armbruster, David A; Overcash, David R; Reyes, Jaime

2014-08-01

The era of automation arrived with the introduction of the AutoAnalyzer using continuous flow analysis and the Robot Chemist that automated the traditional manual analytical steps. Successive generations of stand-alone analysers increased analytical speed, offered the ability to test high volumes of patient specimens, and provided large assay menus. A dichotomy developed, with a group of analysers devoted to performing routine clinical chemistry tests and another group dedicated to performing immunoassays using a variety of methodologies. Development of integrated systems greatly improved the analytical phase of clinical laboratory testing and further automation was developed for pre-analytical procedures, such as sample identification, sorting, and centrifugation, and post-analytical procedures, such as specimen storage and archiving. All phases of testing were ultimately combined in total laboratory automation (TLA) through which all modules involved are physically linked by some kind of track system, moving samples through the process from beginning-to-end. A newer and very powerful, analytical methodology is liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS). LC-MS/MS has been automated but a future automation challenge will be to incorporate LC-MS/MS into TLA configurations. Another important facet of automation is informatics, including middleware, which interfaces the analyser software to a laboratory information systems (LIS) and/or hospital information systems (HIS). This software includes control of the overall operation of a TLA configuration and combines analytical results with patient demographic information to provide additional clinically useful information. This review describes automation relevant to clinical chemistry, but it must be recognised that automation applies to other specialties in the laboratory, e.g. haematology, urinalysis, microbiology. It is a given that automation will continue to evolve in the clinical laboratory, limited only by the imagination and ingenuity of laboratory scientists.

Clinical Reasoning Terms Included in Clinical Problem Solving Exercises?

PubMed Central

Musgrove, John L.; Morris, Jason; Estrada, Carlos A.; Kraemer, Ryan R.

2016-01-01

Background Published clinical problem solving exercises have emerged as a common tool to illustrate aspects of the clinical reasoning process. The specific clinical reasoning terms mentioned in such exercises is unknown. Objective We identified which clinical reasoning terms are mentioned in published clinical problem solving exercises and compared them to clinical reasoning terms given high priority by clinician educators. Methods A convenience sample of clinician educators prioritized a list of clinical reasoning terms (whether to include, weight percentage of top 20 terms). The authors then electronically searched the terms in the text of published reports of 4 internal medicine journals between January 2010 and May 2013. Results The top 5 clinical reasoning terms ranked by educators were dual-process thinking (weight percentage = 24%), problem representation (12%), illness scripts (9%), hypothesis generation (7%), and problem categorization (7%). The top clinical reasoning terms mentioned in the text of 79 published reports were context specificity (n = 20, 25%), bias (n = 13, 17%), dual-process thinking (n = 11, 14%), illness scripts (n = 11, 14%), and problem representation (n = 10, 13%). Context specificity and bias were not ranked highly by educators. Conclusions Some core concepts of modern clinical reasoning theory ranked highly by educators are mentioned explicitly in published clinical problem solving exercises. However, some highly ranked terms were not used, and some terms used were not ranked by the clinician educators. Effort to teach clinical reasoning to trainees may benefit from a common nomenclature of clinical reasoning terms. PMID:27168884

Clinical Reasoning Terms Included in Clinical Problem Solving Exercises?

PubMed

Musgrove, John L; Morris, Jason; Estrada, Carlos A; Kraemer, Ryan R

2016-05-01

Background Published clinical problem solving exercises have emerged as a common tool to illustrate aspects of the clinical reasoning process. The specific clinical reasoning terms mentioned in such exercises is unknown. Objective We identified which clinical reasoning terms are mentioned in published clinical problem solving exercises and compared them to clinical reasoning terms given high priority by clinician educators. Methods A convenience sample of clinician educators prioritized a list of clinical reasoning terms (whether to include, weight percentage of top 20 terms). The authors then electronically searched the terms in the text of published reports of 4 internal medicine journals between January 2010 and May 2013. Results The top 5 clinical reasoning terms ranked by educators were dual-process thinking (weight percentage = 24%), problem representation (12%), illness scripts (9%), hypothesis generation (7%), and problem categorization (7%). The top clinical reasoning terms mentioned in the text of 79 published reports were context specificity (n = 20, 25%), bias (n = 13, 17%), dual-process thinking (n = 11, 14%), illness scripts (n = 11, 14%), and problem representation (n = 10, 13%). Context specificity and bias were not ranked highly by educators. Conclusions Some core concepts of modern clinical reasoning theory ranked highly by educators are mentioned explicitly in published clinical problem solving exercises. However, some highly ranked terms were not used, and some terms used were not ranked by the clinician educators. Effort to teach clinical reasoning to trainees may benefit from a common nomenclature of clinical reasoning terms.

Quantitative analysis of hepatitis C virus activity in vivo in different groups of untreated patients.

PubMed

Manzin, A; Solforosi, L; Giostra, F; Bianchi, F B; Bruno, S; Rossi, S; Gabrielli, A; Candela, M; Petrelli, E; Clementi, M

1997-01-01

Highly sensitive competitive PCR (cPCR) and competitive reverse transcription PCR (cRT-PCR) methodologies were recently developed and applied for quantifying viral DNA and RNA species (including HCV RNA) present in clinical samples at low concentration. In this study, we used cRT-PCR to compare the viral load of 118 untreated patients with HCV infection and different clinical conditions (80 patients with chronic hepatitis, 18 infected subjects with persistently normal ALT levels and various degrees of liver injury, 10 HCV infected subjects that tested positive for anti-LKM1 antibodies, and 10 patients with HCV infection and cryoglobulinemia). The results indicate that while great individual variability of HCV viremia is detectable even among patients with similar clinical conditions, the mean HCV RNA copy number in samples from patients with different clinical conditions was similar in all groups with the single exception of patients that tested positive for anti-liver-kidney microsomal auto-antibodies type 1 (anti-LKM1); interestingly, lower HCV viremia levels were revealed in these anti-LKM1-positive cases with liver disease of uncertain pathogenesis.

[THE TRUE OR FALSE BACTERIEMIA: THE SIGNIFICANCE OF EVALUATION CRITERIA OF CLINICAL SIGNIFICANCE OF POSITIVE HEMOCULTURE].

PubMed

Bagirova, N S

2015-08-01

The diagnostic of infections of blood flow using technique of hemofermentation (blood inoculation) is one of the most significant functions of laboratory of clinical microbiology. The effectiveness of the given technique depends on many factors, including criteria of evaluation of clinical significance of episode of bacteriemia and isolated microorganism applied by physician-microbiologist. The intelligent analysis of received results is needed. The physician-microbiologist has to determine if microorganism isolated from given blood sample, is a genuine agent of infections of bloodflow or it is only effect of contamination of analyzed sample at certain stage. The article presents data concerning taxonomic structure of microorganisms isolated under episodes of bacteriemia of adult oncologic hematologic patients during 2005-2013. The criteria of evaluation of clinical significance of episode of bacteriemia and isolated microorganism are described. The given criteria are developed in the N.N. Blokhin Russian oncological research center and are applied since 1977. The cases of contamination and genuine bacteriemia are established. The comparative analysis of international data and results of one's own study are carried out.

Patterns and predictors of health service utilization in adolescents with pain: comparison between a community and a clinical pain sample.

PubMed

Toliver-Sokol, Marisol; Murray, Caitlin B; Wilson, Anna C; Lewandowski, Amy; Palermo, Tonya M

2011-07-01

There is limited research describing the patterns of healthcare utilization in adolescents with chronic pain. This study describes healthcare utilization in a clinical chronic pain sample, and compares the patterns of service use of this group to a community sample with intermittent pain complaints. We also investigated demographic and clinical factors that predicted healthcare visits and medication use in the clinical sample. Data on 117 adolescents (aged 12-18; n = 59 clinical pain sample, n = 58 community) were collected. Caregivers and adolescents reported on sociodemographics, medical visits, current medications, pain, activity limitations, and depression. As hypothesized, the clinical pain sample had higher rates of healthcare consultation on all types of medical visits (general, specialty care, complementary medicine, mental health, OT/PT), and higher medication use compared to the community sample. Regression analyses revealed that higher annual income, greater pain frequency, and higher levels of caregiver-reported activity limitations were associated with a greater number of healthcare visits for the total sample. Within the clinical pain sample, higher pain frequency and greater activity limitations (caregiver report) predicted more specialty care visits. Additionally, higher income and greater levels of depressive symptoms predicted a higher number of prescribed medications. This study contributes to the limited available data on health service and medication use in a clinical chronic pain sample versus a community sample of adolescents. We also identify clinical factors (pain frequency, parent-reported activity limitations, depressive symptoms) and demographic factors (gender, income) associated with healthcare utilization. Copyright © 2011 American Pain Society. Published by Elsevier Inc. All rights reserved.

Guidelines for the Detection of Rickettsia spp.

PubMed

Portillo, Aránzazu; de Sousa, Rita; Santibáñez, Sonia; Duarte, Ana; Edouard, Sophie; Fonseca, Isabel P; Marques, Cátia; Novakova, Marketa; Palomar, Ana M; Santos, Marcos; Silaghi, Cornelia; Tomassone, Laura; Zúquete, Sara; Oteo, José A

2017-01-01

The genus Rickettsia (Rickettsiales: Rickettsiaceae) includes Gram-negative, small, obligate intracellular, nonmotile, pleomorphic coccobacilli bacteria transmitted by arthropods. Some of them cause human and probably also animal disease (life threatening in some patients). In these guidelines, we give clinical practice advices (microscopy, serology, molecular tools, and culture) for the microbiological study of these microorganisms in clinical samples. Since in our environment rickettsioses are mainly transmitted by ticks, practical information for the identification of these arthropods and for the study of Rickettsia infections in ticks has also been added.

Fractional Brownian motion and long term clinical trial recruitment

PubMed Central

Zhang, Qiang; Lai, Dejian

2015-01-01

Prediction of recruitment in clinical trials has been a challenging task. Many methods have been studied, including models based on Poisson process and its large sample approximation by Brownian motion (BM), however, when the independent incremental structure is violated for BM model, we could use fractional Brownian motion to model and approximate the underlying Poisson processes with random rates. In this paper, fractional Brownian motion (FBM) is considered for such conditions and compared to BM model with illustrated examples from different trials and simulations. PMID:26347306

Fractional Brownian motion and long term clinical trial recruitment.

PubMed

Zhang, Qiang; Lai, Dejian

2011-05-01

Prediction of recruitment in clinical trials has been a challenging task. Many methods have been studied, including models based on Poisson process and its large sample approximation by Brownian motion (BM), however, when the independent incremental structure is violated for BM model, we could use fractional Brownian motion to model and approximate the underlying Poisson processes with random rates. In this paper, fractional Brownian motion (FBM) is considered for such conditions and compared to BM model with illustrated examples from different trials and simulations.

Detection of Rare Drug Resistance Mutations by Digital PCR in a Human Influenza A Virus Model System and Clinical Samples

PubMed Central

Bushell, Claire A.; Grant, Paul R.; Cowen, Simon; Gutierrez-Aguirre, Ion; O'Sullivan, Denise M.; Žel, Jana; Milavec, Mojca; Foy, Carole A.; Nastouli, Eleni; Garson, Jeremy A.; Huggett, Jim F.

2015-01-01

Digital PCR (dPCR) is being increasingly used for the quantification of sequence variations, including single nucleotide polymorphisms (SNPs), due to its high accuracy and precision in comparison with techniques such as quantitative PCR (qPCR) and melt curve analysis. To develop and evaluate dPCR for SNP detection using DNA, RNA, and clinical samples, an influenza virus model of resistance to oseltamivir (Tamiflu) was used. First, this study was able to recognize and reduce off-target amplification in dPCR quantification, thereby enabling technical sensitivities down to 0.1% SNP abundance at a range of template concentrations, a 50-fold improvement on the qPCR assay used routinely in the clinic. Second, a method was developed for determining the false-positive rate (background) signal. Finally, comparison of dPCR with qPCR results on clinical samples demonstrated the potential impact dPCR could have on clinical research and patient management by earlier (trace) detection of rare drug-resistant sequence variants. Ultimately this could reduce the quantity of ineffective drugs taken and facilitate early switching to alternative medication when available. In the short term such methods could advance our understanding of microbial dynamics and therapeutic responses in a range of infectious diseases such as HIV, viral hepatitis, and tuberculosis. Furthermore, the findings presented here are directly relevant to other diagnostic areas, such as the detection of rare SNPs in malignancy, monitoring of graft rejection, and fetal screening. PMID:26659206

Detection of Rare Drug Resistance Mutations by Digital PCR in a Human Influenza A Virus Model System and Clinical Samples.

PubMed

Whale, Alexandra S; Bushell, Claire A; Grant, Paul R; Cowen, Simon; Gutierrez-Aguirre, Ion; O'Sullivan, Denise M; Žel, Jana; Milavec, Mojca; Foy, Carole A; Nastouli, Eleni; Garson, Jeremy A; Huggett, Jim F

2016-02-01

Digital PCR (dPCR) is being increasingly used for the quantification of sequence variations, including single nucleotide polymorphisms (SNPs), due to its high accuracy and precision in comparison with techniques such as quantitative PCR (qPCR) and melt curve analysis. To develop and evaluate dPCR for SNP detection using DNA, RNA, and clinical samples, an influenza virus model of resistance to oseltamivir (Tamiflu) was used. First, this study was able to recognize and reduce off-target amplification in dPCR quantification, thereby enabling technical sensitivities down to 0.1% SNP abundance at a range of template concentrations, a 50-fold improvement on the qPCR assay used routinely in the clinic. Second, a method was developed for determining the false-positive rate (background) signal. Finally, comparison of dPCR with qPCR results on clinical samples demonstrated the potential impact dPCR could have on clinical research and patient management by earlier (trace) detection of rare drug-resistant sequence variants. Ultimately this could reduce the quantity of ineffective drugs taken and facilitate early switching to alternative medication when available. In the short term such methods could advance our understanding of microbial dynamics and therapeutic responses in a range of infectious diseases such as HIV, viral hepatitis, and tuberculosis. Furthermore, the findings presented here are directly relevant to other diagnostic areas, such as the detection of rare SNPs in malignancy, monitoring of graft rejection, and fetal screening. Copyright © 2016 Whale et al.

Using computer assisted learning for clinical skills education in nursing: integrative review.

PubMed

Bloomfield, Jacqueline G; While, Alison E; Roberts, Julia D

2008-08-01

This paper is a report of an integrative review of research investigating computer assisted learning for clinical skills education in nursing, the ways in which it has been studied and the general findings. Clinical skills are an essential aspect of nursing practice and there is international debate about the most effective ways in which these can be taught. Computer assisted learning has been used as an alternative to conventional teaching methods, and robust research to evaluate its effectiveness is essential. The CINAHL, Medline, BNI, PsycInfo and ERIC electronic databases were searched for the period 1997-2006 for research-based papers published in English. Electronic citation tracking and hand searching of reference lists and relevant journals was also undertaken. Twelve studies met the inclusion criteria. An integrative review was conducted and each paper was explored in relation to: design, aims, sample, outcome measures and findings. Many of the study samples were small and there were weaknesses in designs. There is limited empirical evidence addressing the use of computer assisted learning for clinical skills education in nursing. Computer assisted learning has been used to teach a limited range of clinical skills in a variety of settings. The paucity of evaluative studies indicates the need for more rigorous research to investigate the effect of computer assisted learning for this purpose. Areas that need to be addressed in future studies include: sample size, range of skills, longitudinal follow-up and control of confounding variables.

Interpretation of correlations in clinical research.

PubMed

Hung, Man; Bounsanga, Jerry; Voss, Maren Wright

2017-11-01

Critically analyzing research is a key skill in evidence-based practice and requires knowledge of research methods, results interpretation, and applications, all of which rely on a foundation based in statistics. Evidence-based practice makes high demands on trained medical professionals to interpret an ever-expanding array of research evidence. As clinical training emphasizes medical care rather than statistics, it is useful to review the basics of statistical methods and what they mean for interpreting clinical studies. We reviewed the basic concepts of correlational associations, violations of normality, unobserved variable bias, sample size, and alpha inflation. The foundations of causal inference were discussed and sound statistical analyses were examined. We discuss four ways in which correlational analysis is misused, including causal inference overreach, over-reliance on significance, alpha inflation, and sample size bias. Recent published studies in the medical field provide evidence of causal assertion overreach drawn from correlational findings. The findings present a primer on the assumptions and nature of correlational methods of analysis and urge clinicians to exercise appropriate caution as they critically analyze the evidence before them and evaluate evidence that supports practice. Critically analyzing new evidence requires statistical knowledge in addition to clinical knowledge. Studies can overstate relationships, expressing causal assertions when only correlational evidence is available. Failure to account for the effect of sample size in the analyses tends to overstate the importance of predictive variables. It is important not to overemphasize the statistical significance without consideration of effect size and whether differences could be considered clinically meaningful.

Cluster Analysis of Clinical Data Identifies Fibromyalgia Subgroups

PubMed Central

Docampo, Elisa; Collado, Antonio; Escaramís, Geòrgia; Carbonell, Jordi; Rivera, Javier; Vidal, Javier; Alegre, José

2013-01-01

Introduction Fibromyalgia (FM) is mainly characterized by widespread pain and multiple accompanying symptoms, which hinder FM assessment and management. In order to reduce FM heterogeneity we classified clinical data into simplified dimensions that were used to define FM subgroups. Material and Methods 48 variables were evaluated in 1,446 Spanish FM cases fulfilling 1990 ACR FM criteria. A partitioning analysis was performed to find groups of variables similar to each other. Similarities between variables were identified and the variables were grouped into dimensions. This was performed in a subset of 559 patients, and cross-validated in the remaining 887 patients. For each sample and dimension, a composite index was obtained based on the weights of the variables included in the dimension. Finally, a clustering procedure was applied to the indexes, resulting in FM subgroups. Results Variables clustered into three independent dimensions: “symptomatology”, “comorbidities” and “clinical scales”. Only the two first dimensions were considered for the construction of FM subgroups. Resulting scores classified FM samples into three subgroups: low symptomatology and comorbidities (Cluster 1), high symptomatology and comorbidities (Cluster 2), and high symptomatology but low comorbidities (Cluster 3), showing differences in measures of disease severity. Conclusions We have identified three subgroups of FM samples in a large cohort of FM by clustering clinical data. Our analysis stresses the importance of family and personal history of FM comorbidities. Also, the resulting patient clusters could indicate different forms of the disease, relevant to future research, and might have an impact on clinical assessment. PMID:24098674

Quantitative Clinical Chemistry Proteomics (qCCP) using mass spectrometry: general characteristics and application.

PubMed

Lehmann, Sylvain; Hoofnagle, Andrew; Hochstrasser, Denis; Brede, Cato; Glueckmann, Matthias; Cocho, José A; Ceglarek, Uta; Lenz, Christof; Vialaret, Jérôme; Scherl, Alexander; Hirtz, Christophe

2013-05-01

Proteomics studies typically aim to exhaustively detect peptides/proteins in a given biological sample. Over the past decade, the number of publications using proteomics methodologies has exploded. This was made possible due to the availability of high-quality genomic data and many technological advances in the fields of microfluidics and mass spectrometry. Proteomics in biomedical research was initially used in 'functional' studies for the identification of proteins involved in pathophysiological processes, complexes and networks. Improved sensitivity of instrumentation facilitated the analysis of even more complex sample types, including human biological fluids. It is at that point the field of clinical proteomics was born, and its fundamental aim was the discovery and (ideally) validation of biomarkers for the diagnosis, prognosis, or therapeutic monitoring of disease. Eventually, it was recognized that the technologies used in clinical proteomics studies [particularly liquid chromatography-tandem mass spectrometry (LC-MS/MS)] could represent an alternative to classical immunochemical assays. Prior to deploying MS in the measurement of peptides/proteins in the clinical laboratory, it seems likely that traditional proteomics workflows and data management systems will need to adapt to the clinical environment and meet in vitro diagnostic (IVD) regulatory constraints. This defines a new field, as reviewed in this article, that we have termed quantitative Clinical Chemistry Proteomics (qCCP).

Molecular diagnosis of α-thalassemia in a multiethnic population.

PubMed

Gilad, Oded; Shemer, Orna Steinberg; Dgany, Orly; Krasnov, Tanya; Nevo, Michal; Noy-Lotan, Sharon; Rabinowicz, Ron; Amitai, Nofar; Ben-Dor, Shifra; Yaniv, Isaac; Yacobovich, Joanne; Tamary, Hannah

2017-06-01

α-Thalassemia, one of the most common genetic diseases, is caused by deletions or point mutations affecting one to four α-globin genes. Molecular diagnosis is important to prevent the most severe forms of the disease. However, the diagnosis of α-thalassemia is complex due to a high variability of the genetic defects involved, with over 250 described mutations. We summarize herein the findings of genetic analyses of DNA samples referred to our laboratory for the molecular diagnosis of α-thalassemia, along with a detailed clinical description. We utilized a diagnostic algorithm including Gap-PCR, to detect known deletions, followed by sequencing of the α-globin gene, to identify known and novel point mutations, and multiplex ligation-dependent probe amplification (MLPA) for the diagnosis of rare or novel deletions. α-Thalassemia was diagnosed in 662 of 975 samples referred to our laboratory. Most commonly found were deletions (75.3%, including two novel deletions previously described by us); point mutations comprised 25.4% of the cases, including five novel mutations. Our population included mostly Jews (of Ashkenazi and Sephardic origin) and Muslim Arabs, who presented with a higher rate of point mutations and hemoglobin H disease. Overall, we detected 53 different genotype combinations causing a spectrum of clinical phenotypes, from asymptomatic to severe anemia. Our work constitutes the largest group of patients with α-thalassemia originating in the Mediterranean whose clinical characteristics and molecular basis have been determined. We suggest a diagnostic algorithm that leads to an accurate molecular diagnosis in multiethnic populations. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Predictors of childhood immunization completion in a rural population.

PubMed

Gore, P; Madhavan, S; Curry, D; McClung, G; Castiglia, M; Rosenbluth, S A; Smego, R A

1999-04-01

Despite the availability of effective vaccines, immunization rates among two-year old children continue to be low in many areas of the United States including rural West Virginia. The goal of this study was to identify barriers to childhood immunization in rural West Virginia and determine factors that were important in the completion of the childhood immunization schedule. A telephone survey was used to collect data from a randomly selected sample of 316 mothers, of two-year olds, from 18 rural counties of West Virginia. Results indicated that two-thirds or 65% of the children in the study sample had completed their recommended immunizations by two years of age. Immunization barriers identified in this study include: living in health professional shortage areas, lack of health insurance, negative beliefs and attitudes regarding childhood immunizations, problems accessing the immunization clinic, and a perception of inadequate support from the immunization clinic. Results of the structural equation modeling, using LISREL-8, indicated that 20% of the variation in immunization completion (R2 = 0.197) was explained by attitude towards immunization and perceived support received from the immunization clinic. Furthermore, 42% of the variation in attitude towards immunization (R2 = 0.419) was explained by immunization-related beliefs, and 28% of the variation in immunization-related beliefs (the R2 = 0.277) was explained by general problems faced during immunization and perceived clinic support. The study concluded that positive immunization-related beliefs and attitudes, support from the immunization clinic, and ease of the immunization seeking process are important factors in the timely completion of the childhood immunization schedule.

Virtual planning in orthognathic surgery.

PubMed

Stokbro, K; Aagaard, E; Torkov, P; Bell, R B; Thygesen, T

2014-08-01

Numerous publications regarding virtual surgical planning protocols have been published, most reporting only one or two case reports to emphasize the hands-on planning. None have systematically reviewed the data published from clinical trials. This systematic review analyzes the precision and accuracy of three-dimensional (3D) virtual surgical planning of orthognathic procedures compared with the actual surgical outcome following orthognathic surgery reported in clinical trials. A systematic search of the current literature was conducted to identify clinical trials with a sample size of more than five patients, comparing the virtual surgical plan with the actual surgical outcome. Search terms revealed a total of 428 titles, out of which only seven articles were included, with a combined sample size of 149 patients. Data were presented in three different ways: intra-class correlation coefficient, 3D surface area with a difference <2mm, and linear and angular differences in three dimensions. Success criteria were set at 2mm mean difference in six articles; 125 of the 133 patients included in these articles were regarded as having had a successful outcome. Due to differences in the presentation of data, meta-analysis was not possible. Virtual planning appears to be an accurate and reproducible method for orthognathic treatment planning. A more uniform presentation of the data is necessary to allow the performance of a meta-analysis. Currently, the software system most often used for 3D virtual planning in clinical trials is SimPlant (Materialise). More independent clinical trials are needed to further validate the precision of virtual planning. Copyright © 2014 International Association of Oral and Maxillofacial Surgeons. All rights reserved.

Costs of care in a mild-to-moderate Alzheimer clinical trial sample: key resources and their determinants.

PubMed

Gustavsson, Anders; Cattelin, Francoise; Jönsson, Linus

2011-07-01

Costs of care are frequently included as secondary endpoint in Alzheimer clinical trials because payers demand evidence of the budgetary effects of novel therapies. Future clinical trial protocols can be optimized on the basis of the currently available data, including what are the key resources and how are they correlated to disease severity measures. Primary patient-level data from two 18 months clinical trials of a putative disease modifier in mild-to-moderate Alzheimer's disease (n = 2,744) were analyzed to identify key components of costs of care and their determinants in a clinical trial setting. Costs of care were assessed with the resource utilization in dementia Lite (RUD) instrument, which includes patient accommodation, informal care, community care, and hospitalizations. The contribution of each component to total costs of care and their correlation with one another and key disease severity measures (Alzheimer's Disease Assessment Scale--Cognitive Subscale, Mini-Mental State Examination, Clinical Dementia Rating-Sum of Boxes, Alzheimer's Disease Cooperative Study--Activities of Daily Living Inventory, and Neuropsychiatric Inventory Questionnaire) was explored. Informal care constituted 82% to 86% of the total costs of care over the 18-months trial and community care services and patient accommodation contributed 6% to 8% each. Informal care was positively correlated with hospitalizations but negatively to patient accommodation, indicating that these services are supplements. Informal care also had the strongest pair-wise correlation with key disease severity measures, suggesting a higher chance of identifying a treatment effect on this component. ADL-ability (Alzheimer's Disease Cooperative Study--Activities of Daily Living Inventory) was the strongest predictor of costs of care of all disease severity measures. Informal care is the most important component of costs of care in a mild-to-moderate Alzheimer clinical trial sample, and it is primarily driven by the ADL-ability of the patient. Investigators should focus on the assessment of this economic endpoint because a significant treatment effect on this resource is likely to also affect total costs of care. Copyright © 2011 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

Comparison of patient perceived primary care quality in public clinics, public hospitals and private clinics in rural China.

PubMed

Wang, Wenhua; Maitland, Elizabeth; Nicholas, Stephen; Loban, Ekaterina; Haggerty, Jeannie

2017-10-03

In rural China, patients have free choice of health facilities for outpatient services. Comparison studies exploring the attributes of different health facilities can help identify optimal primary care service models. Using a representative sample of Chinese provinces, this study aimed to compare patients' rating of three primary care service models used by rural residents (public clinics, public hospitals and private clinics) on a range of health care attributes related to responsiveness. This was a secondary analysis using the household survey data from World Health Organization (WHO) Study on global AGEing and adult health (SAGE). Using a multistage cluster sampling strategy, eight provinces were selected and finally 3435 overall respondents reporting they had visited public clinics, public hospitals or private clinics during the last year, were included in our analysis. Five items were used to measure patient perceived quality in five domains including prompt attention, communication and autonomy, dignity and confidentiality. ANOVA and Turkey's post hoc tests were used to conduct comparative analysis of five domains. Separate multivariate linear regression models were estimated to examine the association of primary care service models with each domain after controlling for patient characteristics. The distribution of last health facilities visited was: 29.5% public clinics; 31.2% public hospitals and; 39.3% private clinics. Public clinics perform best in all five domains: prompt attention (4.15), dignity (4.17), communication (4.07), autonomy (4.05) and confidentiality (4.02). Public hospitals perform better than private clinics in dignity (4.03 vs 3.94), communication (3.97 vs 3.82), autonomy (3.92 vs 3.74) and confidentiality (3.94 vs 3.73), but equivalently in prompt attention (3.92 vs 3.93). Rural residents who are older, wealthier, and with higher self-rated health status have significantly higher patient perceived quality of care in all domains. Rural public clinics, which share many characteristics with the optimal primary care delivery model, should be strongly strengthened to respond to patients' needs. Better doctor-patient interaction training would improve respect, confidentiality, autonomy and, most importantly, health care quality for rural patients.

National survey of psychotherapy training in psychiatry, psychology, and social work.

PubMed

Weissman, Myrna M; Verdeli, Helen; Gameroff, Marc J; Bledsoe, Sarah E; Betts, Kathryn; Mufson, Laura; Fitterling, Heidi; Wickramaratne, Priya

2006-08-01

Approximately 3% of the US population receives psychotherapy each year from psychiatrists, psychologists, or social workers. A modest number of psychotherapies are evidence-based therapy (EBT) in that they have been defined in manuals and found efficacious in at least 2 controlled clinical trials with random assignment that include a control condition of psychotherapy, placebo, pill, or other treatment and samples of sufficient power with well-characterized patients. Few practitioners use EBT. To determine the amount of EBT taught in accredited training programs in psychiatry, psychology (PhD and PsyD), and social work and to note whether the training was elective or required and presented as a didactic (coursework) or clinical supervision. A cross-sectional survey of a probability sample of all accredited training programs in psychiatry, psychology, and social work in the United States. Responders included training directors (or their designates) from 221 programs (73 in psychiatry, 63 in PhD clinical psychology, 21 in PsyD psychology, and 64 in master's-level social work). The overall response rate was 73.7%. Main Outcome Measure Requiring both a didactic and clinical supervision in an EBT. Although programs offered electives in EBT and non-EBT, few required both a didactic and clinical supervision in EBT, and most required training was non-EBT. Psychiatry required coursework and clinical supervision in the largest percentage of EBT (28.1%). Cognitive behavioral therapy was the EBT most frequently offered and required as a didactic in all 3 disciplines. More than 90% of the psychiatry training programs were complying with the new cognitive behavior therapy requirement. The 2 disciplines with the largest number of students and emphasis on clinical training-professional clinical psychology (PsyD) and social work-had the largest percentage of programs (67.3% and 61.7%, respectively) not requiring a didactic and clinical supervision in any EBT. There is a considerable gap between research evidence for psychotherapy and clinical training. Until the training programs in the major disciplines providing psychotherapy increase training in EBT, the gap between research evidence and clinical practice will remain.

Harmonising and linking biomedical and clinical data across disparate data archives to enable integrative cross-biobank research

PubMed Central

Spjuth, Ola; Krestyaninova, Maria; Hastings, Janna; Shen, Huei-Yi; Heikkinen, Jani; Waldenberger, Melanie; Langhammer, Arnulf; Ladenvall, Claes; Esko, Tõnu; Persson, Mats-Åke; Heggland, Jon; Dietrich, Joern; Ose, Sandra; Gieger, Christian; Ried, Janina S; Peters, Annette; Fortier, Isabel; de Geus, Eco JC; Klovins, Janis; Zaharenko, Linda; Willemsen, Gonneke; Hottenga, Jouke-Jan; Litton, Jan-Eric; Karvanen, Juha; Boomsma, Dorret I; Groop, Leif; Rung, Johan; Palmgren, Juni; Pedersen, Nancy L; McCarthy, Mark I; van Duijn, Cornelia M; Hveem, Kristian; Metspalu, Andres; Ripatti, Samuli; Prokopenko, Inga; Harris, Jennifer R

2016-01-01

A wealth of biospecimen samples are stored in modern globally distributed biobanks. Biomedical researchers worldwide need to be able to combine the available resources to improve the power of large-scale studies. A prerequisite for this effort is to be able to search and access phenotypic, clinical and other information about samples that are currently stored at biobanks in an integrated manner. However, privacy issues together with heterogeneous information systems and the lack of agreed-upon vocabularies have made specimen searching across multiple biobanks extremely challenging. We describe three case studies where we have linked samples and sample descriptions in order to facilitate global searching of available samples for research. The use cases include the ENGAGE (European Network for Genetic and Genomic Epidemiology) consortium comprising at least 39 cohorts, the SUMMIT (surrogate markers for micro- and macro-vascular hard endpoints for innovative diabetes tools) consortium and a pilot for data integration between a Swedish clinical health registry and a biobank. We used the Sample avAILability (SAIL) method for data linking: first, created harmonised variables and then annotated and made searchable information on the number of specimens available in individual biobanks for various phenotypic categories. By operating on this categorised availability data we sidestep many obstacles related to privacy that arise when handling real values and show that harmonised and annotated records about data availability across disparate biomedical archives provide a key methodological advance in pre-analysis exchange of information between biobanks, that is, during the project planning phase. PMID:26306643

Thickened Endometrium in Postmenopausal Women With an Initial Biopsy of Limited, Benign, Surface Endometrium: Clinical Outcome and Subsequent Pathologic Diagnosis.

PubMed

Dermawan, Josephine K T; Hur, Christine; Uberti, Maria G; Flyckt, Rebecca; Falcone, Tommaso; Brainard, Jennifer; Abdul-Karim, Fadi W

2018-05-10

Endometrial biopsy or curetting is indicated for postmenopausal women with abnormal uterine bleeding and/or thickened endometrium. Often, endometrial biopsy or curetting yields limited benign surface endometrium, which may indicate insufficient sampling. This study addresses the clinical outcome and subsequent pathologic diagnoses in postmenopausal women who received this initial diagnosis. Among a total of 370 endometrial biopsy or curetting between 2012 and 2015, 192 (52%) were diagnosed as limited benign surface endometrial epithelium. The women ranged in age from 55 to 91 yr old. Their clinical presentations mainly included postmenopausal bleeding, pelvic pain, and enlarged uterus. Primarily because the initial report was interpreted as "benign," 108 (57%) had no subsequent follow-up. Interestingly, women with an increased endometrial thickness were more likely to receive repeat evaluation. Among the 84 women who underwent follow-up endometrial sampling, 6 (7%) had hyperplasia with atypia or malignancy, 21 (25%) had a repeat diagnosis of limited surface sample, 4 (5%) had insufficient materials, and 53 (63%) had other benign findings. Among the subset of women who did receive subsequent follow-up, endometrial atypia or malignancies are more likely found in those with increased body mass index. In conclusion, a slight majority of women with postmenopausal bleeding and/or thickened endometrium had an initial limited surface endometrial sample. Most had no subsequent endometrial sampling. Among those with subsequent follow-up, the majority had benign findings. The study highlights the inconsistencies in adequacy criteria for endometrial sampling and the lack of standardization of subsequent management.

Exercise and well-being: a review of mental and physical health benefits associated with physical activity.

PubMed

Penedo, Frank J; Dahn, Jason R

2005-03-01

This review highlights recent work evaluating the relationship between exercise, physical activity and physical and mental health. Both cross-sectional and longitudinal studies, as well as randomized clinical trials, are included. Special attention is given to physical conditions, including obesity, cancer, cardiovascular disease and sexual dysfunction. Furthermore, studies relating physical activity to depression and other mood states are reviewed. The studies include diverse ethnic populations, including men and women, as well as several age groups (e.g. adolescents, middle-aged and older adults). Results of the studies continue to support a growing literature suggesting that exercise, physical activity and physical-activity interventions have beneficial effects across several physical and mental-health outcomes. Generally, participants engaging in regular physical activity display more desirable health outcomes across a variety of physical conditions. Similarly, participants in randomized clinical trials of physical-activity interventions show better health outcomes, including better general and health-related quality of life, better functional capacity and better mood states. The studies have several implications for clinical practice and research. Most work suggests that exercise and physical activity are associated with better quality of life and health outcomes. Therefore, assessment and promotion of exercise and physical activity may be beneficial in achieving desired benefits across several populations. Several limitations were noted, particularly in research involving randomized clinical trials. These trials tend to involve limited sample sizes with short follow-up periods, thus limiting the clinical implications of the benefits associated with physical activity.

Behavioral medicine and clinical health psychology: introduction to the special issue.

PubMed

Christensen, Alan J; Nezu, Arthur M

2013-04-01

This issue represents the 4th Journal of Consulting and Clinical Psychology special issue on behavioral medicine and clinical health psychology over the past 4 decades. Recent developments in health care policy, as well as in the maturation of the science, make a special issue in this area particularly timely. This collection includes state of the clinical science reviews, reports of clinical trials, and articles addressing theory and methods in behavioral medicine and clinical health psychology. A multilevel, ecological perspective that considers multiple levels of influences (e.g., cultural influences on behavior-health linkages, individual differences) is salient throughout many of the articles. Our hope is that this sampling of this broad field, and coverage of some key issues and areas, will play a role in stimulating the next 10 years of research, practice, and policy implementation in behavioral medicine and clinical health psychology.

Clinical Application of Volatile Organic Compound Analysis for Detecting Infectious Diseases

PubMed Central

Nanda, Ranjan; Chakraborty, Trinad

2013-01-01

SUMMARY This review article introduces the significance of testing of volatile organic compounds (VOCs) in clinical samples and summarizes important features of some of the technologies. Compared to other human diseases such as cancer, studies on VOC analysis in cases of infectious diseases are limited. Here, we have described results of studies which have used some of the appropriate technologies to evaluate VOC biomarkers and biomarker profiles associated with infections. The publications reviewed include important infections of the respiratory tract, gastrointestinal tract, urinary tract, and nasal cavity. The results highlight the use of VOC biomarker profiles resulting from certain infectious diseases in discriminating between infected and healthy subjects. Infection-related VOC profiles measured in exhaled breath as well as from headspaces of feces or urine samples are a source of information with respect to disease detection. The volatiles emitted in clinical matrices may on the one hand represent metabolites of the infecting pathogen or on the other hand reflect pathogen-induced host responses or, indeed, a combination of both. Because exhaled-breath samples are easy to collect and online instruments are commercially available, VOC analysis in exhaled breath appears to be a promising tool for noninvasive detection and monitoring of infectious diseases. PMID:23824368

A 7-item version of the fatigue severity scale has better psychometric properties among HIV-infected adults: an application of a Rasch model.

PubMed

Lerdal, Anners; Kottorp, Anders; Gay, Caryl; Aouizerat, Bradley E; Portillo, Carmen J; Lee, Kathryn A

2011-11-01

To examine the psychometric properties of the 9-item Fatigue Severity Scale (FSS) using a Rasch model application. A convenience sample of HIV-infected adults was recruited, and a subset of the sample was assessed at 6-month intervals for 2 years. Socio-demographic, clinical, and symptom data were collected by self-report questionnaires. CD4 T-cell count and viral load measures were obtained from medical records. The Rasch analysis included 316 participants with 698 valid questionnaires. FSS item 2 did not advanced monotonically, and items 1 and 2 did not show acceptable goodness-of-fit to the Rasch model. A reduced FSS 7-item version demonstrated acceptable goodness-of-fit and explained 61.2% of the total variance in the scale. In the FSS-7 item version, no uniform Differential Item Functioning was found in relation to time of evaluation or to any of the socio-demographic or clinical variables. This study demonstrated that the FSS-7 has better psychometric properties than the FSS-9 in this HIV sample and that responses to the different items are comparable over time and unrelated to socio-demographic and clinical variables.

Serological diagnosis of hantavirus pulmonary syndrome in a febrile patient in Colombia.

PubMed

Mattar, Salim; Garzon, Denisse; Tadeu, Luis; Faccini-Martínez, Alvaro A; Mills, James N

2014-08-01

Hantavirus pulmonary syndrome (HPS) is an often fatal rodent-borne zoonosis caused by any of at least 20 hantavirus genotypes distributed throughout the Americas. Although HPS has been documented in several bordering countries, it has not been reported in Colombia. Here we report seroconversion to a hantavirus in paired samples from a hospitalized patient with symptoms compatible with HPS from Montería, Córdoba Department, north-western Colombia. Tests for regionally endemic agents including Plasmodium, Leptospira, Salmonella, dengue virus, Brucella, Rickettsia, human immunodeficiency virus and hepatitis viruses were negative. Because the patient was enrolled in a clinical trial for hemorrhagic fevers conducted by the University of Córdoba, serum samples were collected on admission and at discharge. Testing using Sin Nombre virus ELISA showed IgG and IgM seroconversion between samples. The eventual finding of this first clinical case of hantavirus infection in Colombia is consistent with the high prevalence of hantavirus antibodies in humans in the region and the likely exposure of the patient to rodents. The clinical presentation was similar to that found in neighbouring Panama. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

The validation of the Z-Scan technique for the determination of plasma glucose

NASA Astrophysics Data System (ADS)

Alves, Sarah I.; Silva, Elaine A. O.; Costa, Simone S.; Sonego, Denise R. N.; Hallack, Maira L.; Coppini, Ornela L.; Rowies, Fernanda; Azzalis, Ligia A.; Junqueira, Virginia B. C.; Pereira, Edimar C.; Rocha, Katya C.; Fonseca, Fernando L. A.

2013-11-01

Glucose is the main energy source for the human body. The concentration of blood glucose is regulated by several hormones including both antagonists: insulin and glucagon. The quantification of glucose in the blood is used for diagnosing metabolic disorders of carbohydrates, such as diabetes, idiopathic hypoglycemia and pancreatic diseases. Currently, the methodology used for this determination is the enzymatic colorimetric with spectrophotometric. This study aimed to validate the use of measurements of nonlinear optical properties of plasma glucose via the Z-Scan technique. For this we used samples of calibrator patterns that simulate commercial samples of patients (ELITech ©). Besides calibrators, serum glucose levels within acceptable reference values (normal control serum - Brazilian Society of Clinical Pathology and Laboratory Medicine) and also overestimated (pathological control serum - Brazilian Society of Clinical Pathology and Laboratory Medicine) were used in the methodology proposal. Calibrator dilutions were performed and determined by the Z-Scan technique for the preparation of calibration curve. In conclusion, Z-Scan method can be used to determinate glucose levels in biological samples with enzymatic colorimetric reaction and also to apply the same quality control parameters used in biochemistry clinical.

Use of 16S rRNA sequencing and quantitative PCR to correlate venous leg ulcer bacterial bioburden dynamics with wound expansion, antibiotic therapy, and healing

PubMed Central

Sprockett, Daniel D.; Ammons, Christine G.; Tuttle, Marie S.

2016-01-01

Clinical diagnosis of infection in chronic wounds is currently limited to subjective clinical signs and culture-based methods that underestimate the complexity of wound microbial bioburden as revealed by DNA-based microbial identification methods. Here, we use 16S rRNA next generation sequencing and quantitative polymerase chain reaction to characterize weekly changes in bacterial load, community structure, and diversity associated with a chronic venous leg ulcer over the 15-week course of treatment and healing. Our DNA-based methods and detailed sampling scheme reveal that the bacterial bioburden of the wound is unexpectedly dynamic, including changes in the bacterial load and community structure that correlate with wound expansion, antibiotic therapy, and healing. We demonstrate that these multidimensional changes in bacterial bioburden can be summarized using swabs taken prior to debridement, and therefore, can be more easily collected serially than debridement or biopsy samples. Overall, this case illustrates the importance of detailed clinical indicators and longitudinal sampling to determine the pathogenic significance of chronic wound microbial dynamics and guide best use of antimicrobials for improvement of healing outcomes. PMID:25902876

Interpersonal problems across restrictive and binge-purge samples: data from a community-based eating disorders clinic.

PubMed

Raykos, Bronwyn C; McEvoy, Peter M; Carter, Olivia; Fursland, Anthea; Nathan, Paula

2014-08-01

Contemporary models of eating disorders suggest that interpersonal problems contribute to the maintenance of eating disorders. This study examined whether baseline interpersonal problems differed across eating disorder diagnoses and across eating disorder subtypes ("restrictors" vs. "binge-purge" patients) in a large clinical sample. Patients with a primary eating disorder diagnosis (N=406) completed measures of interpersonal problems, eating disorder symptoms, and mood prior to treatment at a specialist eating disorder clinic. Across the sample, more severe eating disorder psychopathology was associated with significantly greater difficulty socializing. Anorexia Nervosa (AN)/restrictor patients reported significantly greater difficulty socializing than Bulimia Nervosa (BN)/binge-purge patients. AN patients reported significantly greater difficulty on a measure of competitiveness/assertiveness compared to BN and Eating Disorder Not Otherwise Specified patients. All findings were significant after controlling for comorbid depression and anxiety symptoms. Interpersonal problems appear to be unique risk factors for eating disorders. Specific interpersonal mechanisms include difficulties socializing and being assertive, which were most pronounced in AN patients. These findings provide potential avenues for enhancing interventions, such as adjunctive assertiveness training for AN. Copyright © 2014 Elsevier Ltd. All rights reserved.

Memory assessment and depression: testing for factor structure and measurement invariance of the Wechsler Memory Scale-Fourth Edition across a clinical and matched control sample.

PubMed

Pauls, Franz; Petermann, Franz; Lepach, Anja Christina

2013-01-01

Between-group comparisons are permissible and meaningfully interpretable only if diagnostic instruments are proved to measure the same latent dimensions across different groups. Addressing this issue, the present study was carried out to provide a rigorous test of measurement invariance. Confirmatory factor analyses were used to determine which model solution could best explain memory performance as measured by the Wechsler Memory Scale-Fourth Edition (WMS-IV) in a clinical depression sample and in healthy controls. Multigroup confirmatory factor analysis was conducted to evaluate the evidence for measurement invariance. A three-factor model solution including the dimensions of auditory memory, visual memory, and visual working memory was identified to best fit the data in both samples, and measurement invariance was partially satisfied. The results supported clinical utility of the WMS-IV--that is, auditory and visual memory performances of patients with depressive disorders are interpretable on the basis of the WMS-IV standardization data. However, possible differences in visual working memory functions between healthy and depressed individuals could restrict comparisons of the WMS-IV working memory index.

Use of Dimethyl Pimelimidate with Microfluidic System for Nucleic Acids Extraction without Electricity.

PubMed

Jin, Choong Eun; Lee, Tae Yoon; Koo, Bonhan; Choi, Kyung-Chul; Chang, Suhwan; Park, Se Yoon; Kim, Ji Yeun; Kim, Sung-Han; Shin, Yong

2017-07-18

The isolation of nucleic acids in the lab on a chip is crucial to achieve the maximal effectiveness of point-of-care testing for detection in clinical applications. Here, we report on the use of a simple and versatile single-channel microfluidic platform that combines dimethyl pimelimidate (DMP) for nucleic acids (both RNA and DNA) extraction without electricity using a thin-film system. The system is based on the adaption of DMP into nonchaotropic-based nucleic acids and the capture of reagents into a low-cost thin-film platform for use as a microfluidic total analysis system, which can be utilized for sample processing in clinical diagnostics. Moreover, we assessed the use of the DMP system for the extraction of nucleic acids from various samples, including mammalian cells, bacterial cells, and viruses from human disease, and we also confirmed that the quality and quantity of the nucleic acids extracted were sufficient to allow for the robust detection of biomarkers and/or pathogens in downstream analysis. Furthermore, this DMP system does not require any instruments and electricity, and has improved time efficiency, portability, and affordability. Thus, we believe that the DMP system may change the paradigm of sample processing in clinical diagnostics.

Cognitive Fusion Questionnaire-Body Image: Psychometric Properties and Its Incremental Power in the Prediction of Binge Eating Severity.

PubMed

Lucena-Santos, Paola; Trindade, Inês A; Oliveira, Margareth; Pinto-Gouveia, José

2017-05-19

Given the clinical usefulness of the CFQ-BI (Cognitive Fusion Questionnaire-Body Image; the only existing measure to assess the body-image-related cognitive fusion), the present study aimed to confirm its one-factor structure, to verify its measurement invariance between clinical and non-clinical samples, to analyze its internal consistency and sensitivity to detect differences between samples, as well as to explore the incremental and convergent validities of the CFQ-BI scores in Brazilian samples.  This was a cross-sectional study, which was conducted in clinical (women with overweight or obesity in treatment for weight loss) and non-clinical samples (women from the general population). The one-factor structure was confirmed showing factorial measurement invariance across clinical and non-clinical samples. The CFQ-BI scores presented an excellent internal consistency, were able to discriminate clinical and non-clinical samples, and were positively associated with binge eating severity, general cognitive fusion, and psychological inflexibility. Furthermore, body-image-related cognitive fusion scores (CFQ-BI) presented incremental validity over a general measure of cognitive fusion in the prediction of binge eating symptoms. This study demonstrated that CFQ-BI is a short scale with reliable and robust scores in Brazilian samples, presenting incremental and convergent validities, measurement invariance, and sensitivity to detect differences between clinical and non-clinical groups of women, enabling comparative studies between them.

Use of CTX-I and PINP as bone turnover markers: National Bone Health Alliance recommendations to standardize sample handling and patient preparation to reduce pre-analytical variability.

PubMed

Szulc, P; Naylor, K; Hoyle, N R; Eastell, R; Leary, E T

2017-09-01

The National Bone Health Alliance (NBHA) recommends standardized sample handling and patient preparation for C-terminal telopeptide of type I collagen (CTX-I) and N-terminal propeptide of type I procollagen (PINP) measurements to reduce pre-analytical variability. Controllable and uncontrollable patient-related factors are reviewed to facilitate interpretation and minimize pre-analytical variability. The IOF and the International Federation of Clinical Chemistry (IFCC) Bone Marker Standards Working Group have identified PINP and CTX-I in blood to be the reference markers of bone turnover for the fracture risk prediction and monitoring of osteoporosis treatment. Although used in clinical research for many years, bone turnover markers (BTM) have not been widely adopted in clinical practice primarily due to their poor within-subject and between-lab reproducibility. The NBHA Bone Turnover Marker Project team aim to reduce pre-analytical variability of CTX-I and PINP measurements through standardized sample handling and patient preparation. Recommendations for sample handling and patient preparations were made based on review of available publications and pragmatic considerations to reduce pre-analytical variability. Controllable and un-controllable patient-related factors were reviewed to facilitate interpretation and sample collection. Samples for CTX-I must be collected consistently in the morning hours in the fasted state. EDTA plasma is preferred for CTX-I for its greater sample stability. Sample collection conditions for PINP are less critical as PINP has minimal circadian variability and is not affected by food intake. Sample stability limits should be observed. The uncontrollable aspects (age, sex, pregnancy, immobility, recent fracture, co-morbidities, anti-osteoporotic drugs, other medications) should be considered in BTM interpretation. Adopting standardized sample handling and patient preparation procedures will significantly reduce controllable pre-analytical variability. The successful adoption of such recommendations necessitates the close collaboration of various stakeholders at the global stage, including the laboratories, the medical community, the reagent manufacturers and the regulatory agencies.

Initial clinical laboratory experience in noninvasive prenatal testing for fetal aneuploidy from maternal plasma DNA samples.

PubMed

Futch, Tracy; Spinosa, John; Bhatt, Sucheta; de Feo, Eileen; Rava, Richard P; Sehnert, Amy J

2013-06-01

The aim of this study is to report the experience of noninvasive prenatal DNA testing using massively parallel sequencing in an accredited clinical laboratory. Laboratory information was examined for blood samples received for testing between February and November 2012 for chromosome 21 (Chr21), Chr18, and Chr13. Monosomy X (MX) testing was available from July 2012 for cystic hygroma indication. Outcomes were collected from providers on samples with positive results. There were 5974 samples tested, and results were issued within an average of 5.1 business days. Aneuploidy was detected in 284 (4.8%) samples (155 Chr21, 66 Chr18, 19 Chr13, 40 MX, and four double aneuploidy). Follow-ups are available for 245/284 (86%), and 77/284 (27.1%) are confirmed, including one double-aneuploidy case concordant with cytogenetics from maternal malignancy. Fourteen (0.2%) discordant (putative false-positive) results (one Chr21, six Chr18, three Chr13, three MX, and one Chr21/13) have been identified. Five (0.08%) false-negative cases are reported (two trisomy 21, two trisomy 18, and one MX). In 170 (2.8%) cases, the result for a single chromosome was indefinite. This report suggests that clinical testing of maternal cell-free DNA for fetal aneuploidy operates within performance parameters established in validation studies. Noninvasive prenatal testing is sensitive to biological contributions from placental and maternal sources. ©2013 Verinata Health, Inc. Prenatal Diagnosis published by John Wiley & Sons, Ltd.

Broad-Range Detection of Microorganisms Directly from Bronchoalveolar Lavage Specimens by PCR/Electrospray Ionization-Mass Spectrometry

PubMed Central

Ullberg, Måns; Lüthje, Petra; Mölling, Paula; Strålin, Kristoffer

2017-01-01

The clinical demand on rapid microbiological diagnostic is constantly increasing. PCR coupled to electrospray ionization-mass spectrometry, PCR/ESI-MS, offers detection and identification of over 750 bacteria and Candida species directly from clinical specimens within 6 hours. In this study, we investigated the clinical performance of the IRIDICA BAC LRT Assay for detection of bacterial pathogens in 121 bronchoalveolar lavage (BAL) samples that were received consecutively at our bacterial laboratory for BAL culture. Commensal or pathogenic microorganisms were detected in 118/121 (98%) BAL samples by PCR/ESI-MS, while in 104/121 (86%) samples by routine culture (P<0.01). Detection of potentially pathogenic microorganisms by PCR/ESI-MS was evaluated in comparison with conventional culture-based or molecular methods. The agreement between positive findings was overall good. Most Staphylococcus aureus-positive PCR/ESI-MS results were confirmed by culture or species-specific PCR (27/33, 82%). The identity of Streptococcus pneumoniae could however be confirmed for only 6/17 (35%) PCR/ESI-MS-positive samples. Non-cultivable and fastidious pathogens, which were not covered by standard culture procedures were readily detected by PCR/ESI-MS, including Legionella pneumophila, Bordetella pertussis, Norcadia species and Mycoplasma pneumoniae. In conclusion, PCR/ESI-MS detected a broad range of potential pathogens with equal or superior sensitivity compared to conventional methods within few hours directly from BAL samples. This novel method might thus provide a relevant tool for diagnostics in critically ill patients. PMID:28085931

Viral pathogen discovery

PubMed Central

Chiu, Charles Y

2015-01-01

Viral pathogen discovery is of critical importance to clinical microbiology, infectious diseases, and public health. Genomic approaches for pathogen discovery, including consensus polymerase chain reaction (PCR), microarrays, and unbiased next-generation sequencing (NGS), have the capacity to comprehensively identify novel microbes present in clinical samples. Although numerous challenges remain to be addressed, including the bioinformatics analysis and interpretation of large datasets, these technologies have been successful in rapidly identifying emerging outbreak threats, screening vaccines and other biological products for microbial contamination, and discovering novel viruses associated with both acute and chronic illnesses. Downstream studies such as genome assembly, epidemiologic screening, and a culture system or animal model of infection are necessary to establish an association of a candidate pathogen with disease. PMID:23725672

Narcissistic Personality Disorder and suicidal behavior in mood disorders.

PubMed

Coleman, Daniel; Lawrence, Ryan; Parekh, Amrita; Galfalvy, Hanga; Blasco-Fontecilla, Hilario; Brent, David A; Mann, J John; Baca-Garcia, Enrique; Oquendo, Maria A

2017-02-01

The relationship of Narcissistic Personality Disorder (NPD) to suicidal behavior is understudied. The modest body of existing research suggests that NPD is protective against low-lethality suicide attempts, but is associated with high lethality attempts. Mood-disordered patients (N = 657) received structured interviews including Axis I and II diagnosis and standardized clinical measures. Following chi-square and t-tests, a logistical regression model was constructed to identify predictors of suicide attempt. While there was no bivariate relationship of NPD on suicide attempt, in the logistic regression patients with NPD were 2.4 times less likely to make a suicide attempt (OR = 0.41; 95% CI = 0.19 - 0.88; p < 0.05), compared with non-NPD patients and controlling for possible confounding variables. NPD was not associated with attempt lethality. NPD patients were more likely to be male, to have a substance use disorder, and to have high aggression and hostility scores. Limitations include that the sample consists of only mood-disordered patients, a modest sample size of NPD, and the data are cross-sectional. The multivariate protective effect of NPD on suicide attempt is consistent with most previous research. The lower impulsivity of NPD patients and less severe personality pathology relative to other personality disorders may contribute to this effect. No relationship of NPD to attempt lethality was found, contradicting other research, but perhaps reflecting differences between study samples. Future studies should oversample NPD patients and include suicide death as an outcome. Clinical implications include discussion of individualized suicide risk assessment with NPD patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

Treatment of Depression in Nursing Home Residents without Significant Cognitive Impairment: a Systematic Review

PubMed Central

Simning, Adam; Simons, Kelsey V.

2017-01-01

Background Depression in nursing facilities is widespread and has been historically under-recognized and inadequately treated. Many interventions have targeted depression among residents with dementia in these settings. Less is known about depression treatment in residents without dementia who may be more likely to return to community living. Our study aimed to systematically evaluate randomized control trials (RCTs) in nursing facilities that targeted depression within samples largely comprised of residents without dementia. Methods The following databases were evaluated with searches covering January 1991 through December 2015 (PubMed, PsycINFO) and March 2016 (CINAHL). We also examined national and international clinical trial registries including ClinicalTrials.gov. RCTs were included if they were published in English, evaluated depression or depressive symptoms as primary or secondary outcomes, and included a sample with a mean age of 65 and older for which most had no or only mild cognitive impairment. Results A total of 32 RCTs met our criteria including those testing psychotherapeutic interventions (n=13), psychosocial and recreation interventions (n=9), and pharmacologic or other biologic interventions (n=10). Seven psychotherapeutic, six psychosocial and recreation, and four pharmacologic or other biologic interventions demonstrated a treatment benefit. Conclusions Many studies had small samples, were of poor methodological quality, and did not select for depressed residents. There is limited evidence suggesting that cognitive behavioral therapies, reminiscence, interventions to reduce social isolation, and exercise-based interventions have some promise for decreasing depression in cognitively intact nursing home residents; little can be concluded from the pharmacologic or other biologic RCTs. PMID:27758728

Certified normal: Alzheimer's disease biomarkers and normative estimates of cognitive functioning.

PubMed

Hassenstab, Jason; Chasse, Rachel; Grabow, Perri; Benzinger, Tammie L S; Fagan, Anne M; Xiong, Chengjie; Jasielec, Mateusz; Grant, Elizabeth; Morris, John C

2016-07-01

Normative samples drawn from older populations may unintentionally include individuals with preclinical Alzheimer's disease (AD) pathology, resulting in reduced means, increased variability, and overestimation of age effects on cognitive performance. A total of 264 cognitively normal (Clinical Dementia Rating = 0) older adults were classified as biomarker negative ("Robust Normal," n = 177) or biomarker positive ("Preclinical Alzheimer's Disease" [PCAD], n = 87) based on amyloid imaging, cerebrospinal fluid biomarkers, and hippocampal volumes. PCAD participants performed worse than robust normals on nearly all cognitive measures. Removing PCAD participants from the normative sample yielded higher means and less variability on episodic memory, visuospatial ability, and executive functioning measures. These results were more pronounced in participants aged 75 years and older. Notably, removing PCAD participants from the sample significantly reduced age effects across all cognitive domains. Applying norms from the robust normal sample to a separate cohort did not improve Clinical Dementia Rating classification when using standard deviation cutoff scores. Overall, removing individuals with biomarker evidence of preclinical AD improves normative sample quality and substantially reduces age effects on cognitive performance but provides no substantive benefit for diagnostic classifications. Copyright © 2016 Elsevier Inc. All rights reserved.

Universal multiplex PCR and CE for quantification of SMN1/SMN2 genes in spinal muscular atrophy.

PubMed

Wang, Chun-Chi; Chang, Jan-Gowth; Jong, Yuh-Jyh; Wu, Shou-Mei

2009-04-01

We established a universal multiplex PCR and CE to calculate the copy number of survival motor neuron (SMN1 and SMN2) genes for clinical screening of spinal muscular atrophy (SMA). In this study, one universal fluorescent primer was designed and applied for multiplex PCR of SMN1, SMN2 and two internal standards (CYBB and KRIT1). These amplicons were separated by conformation sensitive CE. Mixture of hydroxyethyl cellulose and hydroxypropyl cellulose were used in this CE system. Our method provided the potential to separate two 390-bp PCR products that differ in a single nucleotide. Differentiation and quantification of SMN1 and SMN2 are essential for clinical screening of SMA patients and carriers. The DNA samples included 22 SMA patients, 45 parents of SMA patients (obligatory carriers) and 217 controls. For evaluating accuracy, those 284 samples were blind-analyzed by this method and denaturing high pressure liquid chromatography (DHPLC). Eight of the total samples showed different results. Among them, two samples were diagnosed as having only SMN2 gene by DHPLC, however, they contained both SMN1 and SMN2 by our method. They were further confirmed by DNA sequencing. Our method showed good agreement with the DNA sequencing. The multiplex ligation-dependent probe amplification (MLPA) was used for confirming the other five samples, and showed the same results with our CE method. For only one sample, our CE showed different results with MLPA and DNA sequencing. One out of 284 samples (0.35%) belonged to mismatching. Our method provided a better accurate method and convenient method for clinical genotyping of SMA disease.

A large outbreak of hepatitis E among a displaced population in Darfur, Sudan, 2004: the role of water treatment methods.

PubMed

Guthmann, Jean-Paul; Klovstad, Hilde; Boccia, Delia; Hamid, Nuha; Pinoges, Loretxu; Nizou, Jacques-Yves; Tatay, Mercedes; Diaz, Francisco; Moren, Alain; Grais, Rebecca Freeman; Ciglenecki, Iza; Nicand, Elisabeth; Guerin, Philippe Jean

2006-06-15

The conflict in Darfur, Sudan, was responsible for the displacement of 1.8 million civilians. We investigated a large outbreak of hepatitis E virus (HEV) infection in Mornay camp (78,800 inhabitants) in western Darfur. To describe the outbreak, we used clinical and demographic information from cases recorded at the camp between 26 July and 31 December 2004. We conducted a case-cohort study and a retrospective cohort study to identify risk factors for clinical and asymptomatic hepatitis E, respectively. We collected stool and serum samples from animals and performed a bacteriological analysis of water samples. Human samples were tested for immunoglobulin G and immunoglobulin M antibody to HEV (for serum samples) and for amplification of the HEV genome (for serum and stool samples). In 6 months, 2621 hepatitis E cases were recorded (attack rate, 3.3%), with a case-fatality rate of 1.7% (45 deaths, 19 of which involved were pregnant women). Risk factors for clinical HEV infection included age of 15-45 years (odds ratio, 2.13; 95% confidence interval, 1.02-4.46) and drinking chlorinated surface water (odds ratio, 2.49; 95% confidence interval, 1.22-5.08). Both factors were also suggestive of increased risk for asymptomatic HEV infection, although this was not found to be statistically significant. HEV RNA was positively identified in serum samples obtained from 2 donkeys. No bacteria were identified from any sample of chlorinated water tested. Current recommendations to ensure a safe water supply may have been insufficient to inactivate HEV and control this epidemic. This research highlights the need to evaluate current water treatment methods and to identify alternative solutions adapted to complex emergencies.

Comparison of arterial and venous blood gases and the effects of analysis delay and air contamination on arterial samples in patients with chronic obstructive pulmonary disease and healthy controls.

PubMed

O'Connor, T M; Barry, P J; Jahangir, A; Finn, C; Buckley, B M; El-Gammal, A

2011-01-01

Arterial blood gases (ABGs) are often sampled incorrectly, leading to a 'mixed' or venous sample. Delays in analysis and air contamination are common. We measured the effects of these errors in patients with chronic obstructive pulmonary disease (COPD) exacerbations and controls. Arterial and venous samples were analyzed from 30 patients with COPD exacerbation and 30 controls. Venous samples were analysed immediately and arterial samples separated into non-air-contaminated and air-contaminated specimens and analysed at 0, 30, 60, 90 and 180 min. Mean venous pH was 7.371 and arterial pH was 7.407 (p < 0.0001). There was a correlation between venous and arterial pH (r = 0.5347, p < 0.0001). The regression equation to predict arterial pH was: arterial pH = 4.2289 + 0.43113 · venous pH. There were no clinically significant differences in arterial PO₂ associated with analysis delay. A statistically significant decline in pH was detected at 30 min in patients with COPD exacerbation (p = 0.0042) and 90 min in controls (p < 0.0001). A clinically significant decline in pH emerged at 73 min in patients with COPD exacerbation and 87 min in controls. Air contamination was associated with a clinically significant increase in PO₂ in all samples, including those that were immediately analyzed. Arterial and venous pH differ significantly. Venous pH cannot accurately replace arterial pH. Temporal delays in ABG analysis result in a significant decline in measured pH. ABGs should be analysed within 30 min. Air contamination leads to an immediate increase in measured PO₂, indicating that air-contaminated ABGs should be discarded. Copyright © 2010 S. Karger AG, Basel.

A Xhosa language translation of the CORE-OM using South African university student samples.

PubMed

Campbell, Megan M; Young, Charles

2016-10-01

The translation of well established psychometric tools from English into Xhosa may assist in improving access to psychological services for Xhosa speakers. The aim of this study was to translate the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM), a measure of general distress and dysfunction developed in the UK, into Xhosa for use at South African university student counselling centres. The CORE-OM and embedded CORE-10 were translated into Xhosa using a five-stage translation design. This design included (a) forward-translation, (b) back-translation, (c) committee approach, (d) qualitative piloting, and (e) quantitative piloting on South African university students. Clinical and general samples were drawn from English-medium South African universities. Clinical samples were generated from university student counselling centres. General student samples were generated through random stratified cluster sampling of full-time university students. Qualitative feedback from the translation process and results from quantitative piloting of the 34-item CORE-OM English and Xhosa versions supported the reduction of the scale to 10 items. This reduced scale is referred to as the South African CORE-10 (SA CORE-10). A measurement and structural model of the SA CORE-10 English version was developed and cross-validated using an English-speaking university student sample. Equivalence of this model with the SA CORE-10 Xhosa version was investigated using a first-language Xhosa-speaking university sample. Partial measurement equivalence was achieved at the metric level. The resultant SA CORE-10 Xhosa and English versions provide core measures of distress and dysfunction. Additional, culture- and language-specific domains could be added to increase sensitivity and specificity. © The Author(s) 2016.

Nurses' Needs for Education on Cancer and End-of-life Care.

ERIC Educational Resources Information Center

Meraviglia, Martha G.; McGuire, Catherine; Chesley, Dorothy A.

2003-01-01

From a random sample of Texas registered nurses, 352 respondents (8.3%) primarily obtained continuing education from workshops, inservice education, and independent studies, citing cost, location, content, and length of course as influencing factors. Their cancer educational needs included clinical trials, genetics, complementary therapies, and…

Power/Sample Size Calculations for Assessing Correlates of Risk in Clinical Efficacy Trials

PubMed Central

Gilbert, Peter B.; Janes, Holly E.; Huang, Yunda

2016-01-01

In a randomized controlled clinical trial that assesses treatment efficacy, a common objective is to assess the association of a measured biomarker response endpoint with the primary study endpoint in the active treatment group, using a case-cohort, case-control, or two-phase sampling design. Methods for power and sample size calculations for such biomarker association analyses typically do not account for the level of treatment efficacy, precluding interpretation of the biomarker association results in terms of biomarker effect modification of treatment efficacy, with detriment that the power calculations may tacitly and inadvertently assume that the treatment harms some study participants. We develop power and sample size methods accounting for this issue, and the methods also account for inter-individual variability of the biomarker that is not biologically relevant (e.g., due to technical measurement error). We focus on a binary study endpoint and on a biomarker subject to measurement error that is normally distributed or categorical with two or three levels. We illustrate the methods with preventive HIV vaccine efficacy trials, and include an R package implementing the methods. PMID:27037797

Effect of cryopreservation on sperm DNA integrity in patients with teratospermia.

PubMed

Kalthur, Guruprasad; Adiga, Satish Kumar; Upadhya, Dinesh; Rao, Satish; Kumar, Pratap

2008-06-01

To test whether sperm with abnormal head morphology are more likely to undergo DNA damage and/or chromatin modification during the process of freeze-thawing. In this prospective study, the semen samples from forty-four men attending the infertility clinic were included. Samples were divided into aliquots to allow direct comparison of fresh and frozen spermatozoa from the same ejaculate. The sperm morphology and the sperm DNA damage were evaluated before and after cryopreservation. The relationship between sperm head abnormalities and freeze-thaw-induced DNA modification was assessed. University hospital fertility center. Men attending infertility clinic for semen analysis. The normospermic and teratospermic semen samples were evaluated for DNA damage before and after cryopreservation by comet assay and acridine orange bindability test. Elucidation of association between sperm morphologic defect and cryodamage. A threefold increase in the amount of DNA damage was observed in teratospermic samples compared with their normospermic counterparts, indicating a higher susceptibility of morphologically abnormal sperm to cryodamage. The susceptibility of morphologically abnormal sperm to DNA damage/chromatin modification during the freeze-thaw process is significantly higher than that of sperm with normal morphology.

Microbial load monitor

NASA Technical Reports Server (NTRS)

Caplin, R. S.; Royer, E. R.

1978-01-01

Attempts are made to provide a total design of a Microbial Load Monitor (MLM) system flight engineering model. Activities include assembly and testing of Sample Receiving and Card Loading Devices (SRCLDs), operator related software, and testing of biological samples in the MLM. Progress was made in assembling SRCLDs with minimal leaks and which operate reliably in the Sample Loading System. Seven operator commands are used to control various aspects of the MLM such as calibrating and reading the incubating reading head, setting the clock and reading time, and status of Card. Testing of the instrument, both in hardware and biologically, was performed. Hardware testing concentrated on SRCLDs. Biological testing covered 66 clinical and seeded samples. Tentative thresholds were set and media performance listed.

Checklist content on a standardized patient assessment: an ex post facto review.

PubMed

Boulet, John R; van Zanten, Marta; de Champlain, André; Hawkins, Richard E; Peitzman, Steven J

2008-03-01

While checklists are often used to score standardized patient based clinical assessments, little research has focused on issues related to their development or the level of agreement with respect to the importance of specific items. Five physicians independently reviewed checklists from 11 simulation scenarios that were part of the former Educational Commission for Foreign Medical Graduate's Clinical Skills Assessment and classified the clinical appropriateness of each of the checklist items. Approximately 78% of the original checklist items were judged to be needed, or indicated, given the presenting complaint and the purpose of the assessment. Rater agreement was relatively poor with pairwise associations (Kappa coefficient) ranging from 0.09 to 0.29. However, when only consensus indicated items were included, there was little change in examinee scores, including their reliability over encounters. Although most checklist items in this sample were judged to be appropriate, some could potentially be eliminated, thereby minimizing the scoring burden placed on the standardized patients. Periodic review of checklist items, concentrating on their clinical importance, is warranted.

[POLYGYNAX IN THE TREATMENT OF VAGINAL INFECTIONS IN PREGNANT AND NON-PREGNANT WOMEN--CLINICAL EXPERIENCE].

PubMed

Popovski, N; Popovski, K; Nedelkovski, V

2016-01-01

Vaginal infections /VI/ represent some of the most common diseases by infection of FGS. The aim of this study is to analyze clinical and bacteriological efficacy of Polygynax in the treatment of vaginal infections and to take into account the correlation between the results of microbiological controls and reduction of clinical symptoms. The study included 100 patients, including 50 pregnant and non-pregnant 50 for a period of 3 months. All of them was diagnosed with vaginitis clinical examination, taken material from vagina for microbiological testing. The studied women was conducted targeted therapy Polygynax 12 capsules, in the form of vaginal capsules for 12 days, after which the sample control microbiology. Behind the subjective complaints of the patient and to reduce them as a result of treatment. The effective implementation of Polygynax 12 capsules is equally good as in non-pregnant and pregnant women. In a summary of the survey data to make relevant analyzes and conclusions from the results.

Logic Learning Machine and standard supervised methods for Hodgkin's lymphoma prognosis using gene expression data and clinical variables.

PubMed

Parodi, Stefano; Manneschi, Chiara; Verda, Damiano; Ferrari, Enrico; Muselli, Marco

2018-03-01

This study evaluates the performance of a set of machine learning techniques in predicting the prognosis of Hodgkin's lymphoma using clinical factors and gene expression data. Analysed samples from 130 Hodgkin's lymphoma patients included a small set of clinical variables and more than 54,000 gene features. Machine learning classifiers included three black-box algorithms ( k-nearest neighbour, Artificial Neural Network, and Support Vector Machine) and two methods based on intelligible rules (Decision Tree and the innovative Logic Learning Machine method). Support Vector Machine clearly outperformed any of the other methods. Among the two rule-based algorithms, Logic Learning Machine performed better and identified a set of simple intelligible rules based on a combination of clinical variables and gene expressions. Decision Tree identified a non-coding gene ( XIST) involved in the early phases of X chromosome inactivation that was overexpressed in females and in non-relapsed patients. XIST expression might be responsible for the better prognosis of female Hodgkin's lymphoma patients.

The impact of machine learning techniques in the study of bipolar disorder: A systematic review.

PubMed

Librenza-Garcia, Diego; Kotzian, Bruno Jaskulski; Yang, Jessica; Mwangi, Benson; Cao, Bo; Pereira Lima, Luiza Nunes; Bermudez, Mariane Bagatin; Boeira, Manuela Vianna; Kapczinski, Flávio; Passos, Ives Cavalcante

2017-09-01

Machine learning techniques provide new methods to predict diagnosis and clinical outcomes at an individual level. We aim to review the existing literature on the use of machine learning techniques in the assessment of subjects with bipolar disorder. We systematically searched PubMed, Embase and Web of Science for articles published in any language up to January 2017. We found 757 abstracts and included 51 studies in our review. Most of the included studies used multiple levels of biological data to distinguish the diagnosis of bipolar disorder from other psychiatric disorders or healthy controls. We also found studies that assessed the prediction of clinical outcomes and studies using unsupervised machine learning to build more consistent clinical phenotypes of bipolar disorder. We concluded that given the clinical heterogeneity of samples of patients with BD, machine learning techniques may provide clinicians and researchers with important insights in fields such as diagnosis, personalized treatment and prognosis orientation. Copyright © 2017 Elsevier Ltd. All rights reserved.

Literature searching for clinical and cost-effectiveness studies used in health technology assessment reports carried out for the National Institute for Clinical Excellence appraisal system.

PubMed

Royle, P; Waugh, N

2003-01-01

To contribute to making searching for Technology Assessment Reports (TARs) more cost-effective by suggesting an optimum literature retrieval strategy. A sample of 20 recent TARs. All sources used to search for clinical and cost-effectiveness studies were recorded. In addition, all studies that were included in the clinical and cost-effectiveness sections of the TARs were identified, and their characteristics recorded, including author, journal, year, study design, study size and quality score. Each was also classified by publication type, and then checked to see whether it was indexed in the following databases: MEDLINE, EMBASE, and then either the Cochrane Controlled Trials Register (CCTR) for clinical effectiveness studies or the NHS Economic Evaluation Database (NHS EED) for the cost-effectiveness studies. Any study not found in at least one of these databases was checked to see whether it was indexed in the Science Citation Index (SCI) and BIOSIS, and the American Society of Clinical Oncology (ASCO) Online if a cancer review. Any studies still not found were checked to see whether they were in a number of additional databases. The median number of sources searched per TAR was 20, and the range was from 13 to 33 sources. Six sources (CCTR, DARE, EMBASE, MEDLINE, NHS EED and sponsor/industry submissions to National Institute for Clinical Excellence) were used in all reviews. After searching the MEDLINE, EMBASE and NHS EED databases, 87.3% of the clinical effectiveness studies and 94.8% of the cost-effectiveness studies were found, rising to 98.2% when SCI, BIOSIS and ASCO Online and 97.9% when SCI and ASCO Online, respectively, were added. The median number of sources searched for the 14 TARs that included an economic model was 9.0 per TAR. A sensitive search filter for identifying non-randomised controlled trials (RCT), constructed for MEDLINE and using the search terms from the bibliographic records in the included studies, retrieved only 85% of the known sample. Therefore, it is recommended that when searching for non-RCT studies a search is done for the intervention alone, and records are then scanned manually for those that look relevant. Searching additional databases beyond the Cochrane Library (which includes CCTR, NHS EED and the HTA database), MEDLINE, EMBASE and SCI, plus BIOSIS limited to meeting abstracts only, was seldom found to be effective in retrieving additional studies for inclusion in the clinical and cost-effectiveness sections of TARs (apart from reviews of cancer therapies, where a search of the ASCO database is recommended). A more selective approach to database searching would suffice in most cases and would save resources, thereby making the TAR process more efficient. However, searching non-database sources (including submissions from manufacturers, recent meeting abstracts, contact with experts and checking reference lists) does appear to be a productive way of identifying further studies.

Vertebral endplate signal changes (Modic change): a systematic literature review of prevalence and association with non-specific low back pain

PubMed Central

Karppinen, Jaro; Sorensen, Joan S.; Niinimäki, Jaakko; Leboeuf-Yde, Charlotte

2008-01-01

The prevalence of “vertebral endplate signal changes” (VESC) and its association with low back pain (LBP) varies greatly between studies. This wide range in reported prevalence rates and associations with LBP could be explained by differences in the definitions of VESC, LBP, or study sample. The objectives of this systematic critical review were to investigate the current literature in relation to the prevalence of VESC (including Modic changes) and the association with non-specific low back pain (LBP). The MEDLINE, EMBASE, and SveMED databases were searched for the period 1984 to November 2007. Included were the articles that reported the prevalence of VESC in non-LBP, general, working, and clinical populations. Included were also articles that investigated the association between VESC and LBP. Articles on specific LBP conditions were excluded. A checklist including items related to the research questions and overall quality of the articles was used for data collection and quality assessment. The reported prevalence rates were studied in relation to mean age, gender, study sample, year of publication, country of study, and quality score. To estimate the association between VESC and LBP, 2 × 2 tables were created to calculate the exact odds ratio (OR) with 95% confidence intervals. Eighty-two study samples from 77 original articles were identified and included in the analysis. The median of the reported prevalence rates for any type of VESC was 43% in patients with non-specific LBP and/or sciatica and 6% in non-clinical populations. The prevalence was positively associated with age and was negatively associated with the overall quality of the studies. A positive association between VESC and non-specific LBP was found in seven of ten studies from the general, working, and clinical populations with ORs from 2.0 to 19.9. This systematic review shows that VESC is a common MRI-finding in patients with non-specific LBP and is associated with pain. However, it should be noted that VESC may be present in individuals without LBP. PMID:18787845

The job self-efficacy and job involvement of clinical nursing teachers.

PubMed

Yang, Hui-Ling; Kao, Yu-Hsiu; Huang, Yi-Ching

2006-09-01

This paper explored the present status of self-efficacy and job involvement of clinical nursing teachers and investigated the predictive power of teachers' personal background variables on such, as well as the relationship between self-efficacy and job involvement. A total of 419 participants in the survey sample were chosen among clinical nursing teachers at 19 public and private institutes of technology and junior colleges in Taiwan in 2004. The self-developed structural questionnaire was categorized into three sections, including personal background data, job self-efficacy related to the clinical teaching inventory and job involvement related to clinical teaching inventory. Of the total 419 questionnaires distributed for this cross-sectional survey, 266 valid copies were registered, at a recovery rate of 63%. Findings indicated that both the job self-efficacy and job involvement of clinical nursing teachers are at a medium to high level and that significant differences exist in job self-efficacy and job involvement based on differences in age, marital status, teaching seniority, teacher qualifications, and job satisfaction. Second, samples have significantly different performance in self-efficacy due to differences in education level attained and the medical institution to which nursing teachers had been assigned. Self-efficacy and job involvement are significantly positively correlated. These results can serve as a reference for the cultivation of nursing teachers and reform of clinical nursing education in the future.

The preanalytic phase in veterinary clinical pathology.

PubMed

Braun, Jean-Pierre; Bourgès-Abella, Nathalie; Geffré, Anne; Concordet, Didier; Trumel, Cathy

2015-03-01

This article presents the general causes of preanalytic variability with a few examples showing specialists and practitioners that special and improved care should be given to this too often neglected phase. The preanalytic phase of clinical pathology includes all the steps from specimen collection to analysis. It is the phase where most laboratory errors occur in human, and probably also in veterinary clinical pathology. Numerous causes may affect the validity of the results, including technical factors, such as the choice of anticoagulant, the blood vessel sampled, and the duration and conditions of specimen handling. While the latter factors can be defined, influence of biologic and physiologic factors such as feeding and fasting, stress, and biologic and endocrine rhythms can often not be controlled. Nevertheless, as many factors as possible should at least be documented. The importance of the preanalytic phase is often not given the necessary attention, although the validity of the results and consequent clinical decision making and medical management of animal patients would likely be improved if the quality of specimens submitted to the laboratory was optimized. © 2014 American Society for Veterinary Clinical Pathology.

Clinical trials in Brazilian journals of ophthalmology: where we are.

PubMed

Lira, Rodrigo Pessoa Cavalcanti; Leal, Franz Schubert; Gonçalves, Fauze Abdulmassih; Amorim, Fernando Henrique Ramos; Felix, João Paulo Fernandes; Arieta, Carlos Eduardo Leite

2013-01-01

To compare clinical trials published in Brazilian journals of ophthalmology and in foreign journals of ophthalmology with respect to the number of citations and the quality of reporting [by applying the Consolidated Standards for Reporting Trials (CONSORT) statement writing standards]. The sample of this systematic review comprised the two Brazilian journals of ophthalmology indexed at Science Citation Index Expanded and six of the foreign journals of ophthalmology with highest Impact Factor® according ISI. All clinical trials (CTs) published from January 2009 to December 2010 at the Brazilians journals and a 1:1 randomized sample of the foreign journals were included. The primary outcome was the number of citations through the end of 2011. Subgroup analysis included language. The secondary outcome included likelihood of citation (cited at least once versus no citation), and presence or absence of CONSORT statement indicators. The citation counts were statistically significantly higher (P<0.001) in the Foreign Group (10.50) compared with the Brazilian Group (0.45). The likelihood citation was statistically significantly higher (P<0.001) in the Foreign Group (20/20 - 100%) compared with the Brazilian Group (8/20 - 40%). The subgroup analysis of the language influence in Brazilian articles showed that the citation counts were statistically significantly higher in the papers published in English (P<0.04). Of 37 possible CONSORT items, the mean for the Foreign Group was 20.55 and for the Brazilian Group was 13.65 (P<0.003). The number of citations and the quality of reporting of clinical trials in Brazilian journals of ophthalmology still are low when compared with the foreign journals of ophthalmology with highest Impact Factor®.

Importance of Aspergillus spp. isolation in Acute exacerbations of severe COPD: prevalence, factors and follow-up: the FUNGI-COPD study

PubMed Central

2014-01-01

Background Acute exacerbations of COPD (AECOPD) are often associated with infectious agents, some of which may be non-usual, including Aspergillus spp. However, the importance of Aspergillus spp. in the clinical management of AECOPD still remains unclear. Objectives The aims of the study were to analyze the prevalence and risk factors associated with Aspergillus spp. isolation in AECOPD, and to investigate the associated clinical outcomes during a 1-year follow-up period. Methods Patients presenting with an AECOPD requiring hospitalization were prospectively included from four hospitals across Spain. Clinical, radiological and microbiological data were collected at admission and during the follow-up period (1, 6 and 12 months after discharge), and re-admissions and mortality data collected during the follow-up. Results A total of 240 patients with severe AECOPD were included. Valid sputum samples were obtained in 144 (58%) patients, and in this group, the prevalence of Aspergillus spp. isolation was 16.6% on admission and 14.1% at one-year follow-up. Multivariate logistic-regression showed that AECOPD in the previous year (OR 12.35; 95% CI, 1.9-29.1; p < 0.001), concurrent isolation of pathogenic bacteria (OR 3.64; 95% CI 1.65-9.45, p = 0.001) and concomitant isolation of Pseudomonas aeruginosa (OR 2.80; 95% IC, 1.81-11.42; p = 0.001) were the main risk factors for Aspergillus spp. isolation. Conclusions The main risk factors for Aspergillus spp. isolation were AECOPD in the previous year and concomitant isolation of Pseudomonas aeruginosa. However, although Aspergillus spp. is often isolated in sputum samples from patients with AECOPD, the pathogenic and clinical significance remains unclear. PMID:24517318

Estimated prevalence of erosive tooth wear in permanent teeth of children and adolescents: an epidemiological systematic review and meta-regression analysis.

PubMed

Salas, M M S; Nascimento, G G; Huysmans, M C; Demarco, F F

2015-01-01

The main purpose of this systematic review was to estimate the prevalence of dental erosion in permanent teeth of children and adolescents. An electronic search was performed up to and including March 2014. Eligibility criteria included population-based studies in permanent teeth of children and adolescents aged 8-19-year-old reporting the prevalence or data that allowed the calculation of prevalence rates of tooth erosion. Data collection assessed information regarding geographic location, type of index used for clinical examination, sample size, year of publication, age, examined teeth and tissue exposure. The estimated prevalence of erosive wear was determined, followed by a meta-regression analysis. Twenty-two papers were included in the systematic review. The overall estimated prevalence of tooth erosion was 30.4% (95%IC 23.8-37.0). In the multivariate meta-regression model use of the Tooth Wear Index for clinical examination, studies with sample smaller than 1000 subjects and those conducted in the Middle East and Africa remained associated with higher dental erosion prevalence rates. Our results demonstrated that the estimated prevalence of erosive wear in permanent teeth of children and adolescents is 30.4% with high heterogeneity between studies. Additionally, the correct choice of a clinical index for dental erosion detection and the geographic location play an important role for the large variability of erosive tooth wear in permanent teeth of children and adolescents. The prevalence of tooth erosion observed in permanent teeth of children and adolescents was considerable high. Our results demonstrated that prevalence rate of erosive wear was influenced by methodological and diagnosis factors. When tooth erosion is assessed, the clinical index should be considered. Copyright © 2014 Elsevier Ltd. All rights reserved.

Comparing adult cannabis treatment-seekers enrolled in a clinical trial with national samples of cannabis users in the United States

PubMed Central

McClure, Erin A.; King, Jacqueline S.; Wahle, Aimee; Matthews, Abigail G.; Sonne, Susan C.; Lofwall, Michelle R.; McRae-Clark, Aimee L.; Ghitza, Udi E.; Martinez, Melissa; Cloud, Kasie; Virk, Harvir S.; Gray, Kevin M.

2017-01-01

Background Cannabis use rates are increasing among adults in the United States (US) while the perception of harm is declining. This may result in an increased prevalence of cannabis use disorder and the need for more clinical trials to evaluate efficacious treatment strategies. Clinical trials are the gold standard for evaluating treatment, yet study samples are rarely representative of the target population. This finding has not yet been established for cannabis treatment trials. This study compared demographic and cannabis use characteristics of a cannabis cessation clinical trial sample (run through National Drug Abuse Treatment Clinical Trials Network) with three nationally representative datasets from the US; 1) National Survey on Drug Use and Health, 2) National Epidemiologic Survey on Alcohol and Related Conditions-III, and 3) Treatment Episodes Data Set – Admissions. Methods Comparisons were made between the clinical trial sample and appropriate cannabis using sub-samples from the national datasets, and propensity scores were calculated to determine the degree of similarity between samples. Results Results showed that the clinical trial sample was significantly different from all three national datasets, with the clinical trial sample having greater representation among older adults, African Americans, Hispanic/Latinos, adults with more education, non-tobacco users, and daily and almost daily cannabis users. Conclusions These results are consistent with previous studies of other substance use disorder populations and extend sample representation issues to a cannabis use disorder population. This illustrates the need to ensure representative samples within cannabis treatment clinical trials to improve the generalizability of promising findings. PMID:28511033

Comparing adult cannabis treatment-seekers enrolled in a clinical trial with national samples of cannabis users in the United States.

PubMed

McClure, Erin A; King, Jacqueline S; Wahle, Aimee; Matthews, Abigail G; Sonne, Susan C; Lofwall, Michelle R; McRae-Clark, Aimee L; Ghitza, Udi E; Martinez, Melissa; Cloud, Kasie; Virk, Harvir S; Gray, Kevin M

2017-07-01

Cannabis use rates are increasing among adults in the United States (US) while the perception of harm is declining. This may result in an increased prevalence of cannabis use disorder and the need for more clinical trials to evaluate efficacious treatment strategies. Clinical trials are the gold standard for evaluating treatment, yet study samples are rarely representative of the target population. This finding has not yet been established for cannabis treatment trials. This study compared demographic and cannabis use characteristics of a cannabis cessation clinical trial sample (run through National Drug Abuse Treatment Clinical Trials Network) with three nationally representative datasets from the US; 1) National Survey on Drug Use and Health, 2) National Epidemiologic Survey on Alcohol and Related Conditions-III, and 3) Treatment: Episodes Data Set - Admissions. Comparisons were made between the clinical trial sample and appropriate cannabis using sub-samples from the national datasets, and propensity scores were calculated to determine the degree of similarity between samples. showed that the clinical trial sample was significantly different from all three national datasets, with the clinical trial sample having greater representation among older adults, African Americans, Hispanic/Latinos, adults with more education, non-tobacco users, and daily and almost daily cannabis users. These results are consistent with previous studies of other substance use disorder populations and extend sample representation issues to a cannabis use disorder population. This illustrates the need to ensure representative samples within cannabis treatment clinical trials to improve the generalizability of promising findings. Copyright © 2017 Elsevier B.V. All rights reserved.

Accurate clinical detection of exon copy number variants in a targeted NGS panel using DECoN.

PubMed

Fowler, Anna; Mahamdallie, Shazia; Ruark, Elise; Seal, Sheila; Ramsay, Emma; Clarke, Matthew; Uddin, Imran; Wylie, Harriet; Strydom, Ann; Lunter, Gerton; Rahman, Nazneen

2016-11-25

Background: Targeted next generation sequencing (NGS) panels are increasingly being used in clinical genomics to increase capacity, throughput and affordability of gene testing. Identifying whole exon deletions or duplications (termed exon copy number variants, 'exon CNVs') in exon-targeted NGS panels has proved challenging, particularly for single exon CNVs.  Methods: We developed a tool for the Detection of Exon Copy Number variants (DECoN), which is optimised for analysis of exon-targeted NGS panels in the clinical setting. We evaluated DECoN performance using 96 samples with independently validated exon CNV data. We performed simulations to evaluate DECoN detection performance of single exon CNVs and to evaluate performance using different coverage levels and sample numbers. Finally, we implemented DECoN in a clinical laboratory that tests BRCA1 and BRCA2 with the TruSight Cancer Panel (TSCP). We used DECoN to analyse 1,919 samples, validating exon CNV detections by multiplex ligation-dependent probe amplification (MLPA).  Results: In the evaluation set, DECoN achieved 100% sensitivity and 99% specificity for BRCA exon CNVs, including identification of 8 single exon CNVs. DECoN also identified 14/15 exon CNVs in 8 other genes. Simulations of all possible BRCA single exon CNVs gave a mean sensitivity of 98% for deletions and 95% for duplications. DECoN performance remained excellent with different levels of coverage and sample numbers; sensitivity and specificity was >98% with the typical NGS run parameters. In the clinical pipeline, DECoN automatically analyses pools of 48 samples at a time, taking 24 minutes per pool, on average. DECoN detected 24 BRCA exon CNVs, of which 23 were confirmed by MLPA, giving a false discovery rate of 4%. Specificity was 99.7%.  Conclusions: DECoN is a fast, accurate, exon CNV detection tool readily implementable in research and clinical NGS pipelines. It has high sensitivity and specificity and acceptable false discovery rate. DECoN is freely available at www.icr.ac.uk/decon.

Weight gain, metabolic disturbances, and physical health care in a Brazilian sample of outpatients with schizophrenia

PubMed Central

Gordon, Pedro Caldana; Xavier, Josefa Cynara; Louzã, Mario Rodrigues

2013-01-01

Background In the last few decades, a large number of studies have produced compelling evidence that patients with schizophrenia are at increased risk for developing several medical conditions and diseases, including obesity, metabolic disturbances, and cardiovascular diseases. Several protocols have been designed with the aim of reducing such risk. Objective: To investigate current physical health status in a population of outpatients with schizophrenia. Methods: A cross-sectional study was conducted in our outpatient clinic, selecting subjects who met DSM-IV diagnosis criteria for schizophrenia. Data were collected regarding clinical characteristics, lifestyle, medication in use, and biometric and laboratory parameters. Results: A total of 261 patients were included. We found a high prevalence of elevated body mass index (BMI . 25) (70%), dyslipidemia (73.2%), and metabolic syndrome (28.7%). Patients’ ages were associated with worsened lipid profiles, but other variables, such as disorder duration or type of antipsychotic in use, were not associated with any metabolic disturbance. Despite the increased prevalence of these conditions, only a small portion of the sample was under regular medical treatment. Conclusion: Outpatients with schizophrenia show signs of poor physical health conditions. These findings reinforce the need for an intensive and appropriate approach to assure that these patients receive adequate clinical referral and treatment. PMID:23355783

Depressive symptoms among patients at a clinic in the Red Light District of Tijuana, Mexico

PubMed Central

Ferraiolo, Natalie; Pinedo, Miguel; McCurley, Jessica; Burgos, Jose Luis; Vargas-Ojeda, Adriana Carolina; Rodriguez, Michael A.; Ojeda, Victoria D.

2016-01-01

Little is known about depression among structurally vulnerable groups living in Tijuana (e.g., migrants, deportees, substance users, sex workers, homeless) who may be at high risk for poor mental health. This study investigates the prevalence and correlates of depressive symptoms among vulnerable patients receiving services at a free clinic in Tijuana, Mexico. A convenience sample of 584 adult Mexican patients completed an interviewer-administered questionnaire in English or Spanish that included the 8-item NIH PROMIS depression short form and measures of individual, social, and structural factors affecting health. The prevalence of clinically significant depressive symptoms in our sample was 55%. In the multivariate analysis, female gender, poor/fair self-rated health, recent illicit drug use (past six months), feeling rejected (past six months), history of forced sex, and history of violence were independently associated with increased odds of experiencing depressive symptoms. When stratified by gender, we found important differences in significant factors, including recent illicit drug use in men and deportation in women. Among study participants, prevalence of depressive symptoms exceeds prevalence rates reported elsewhere in the U.S.-Mexico border region. These findings suggest that public health efforts to support mental health services in the border region are needed. PMID:28042307

Depressive symptoms among patients at a clinic in the Red Light District of Tijuana, Mexico.

PubMed

Ferraiolo, Natalie; Pinedo, Miguel; McCurley, Jessica; Burgos, Jose Luis; Vargas-Ojeda, Adriana Carolina; Rodriguez, Michael A; Ojeda, Victoria D

2016-01-01

Little is known about depression among structurally vulnerable groups living in Tijuana (e.g., migrants, deportees, substance users, sex workers, homeless) who may be at high risk for poor mental health. This study investigates the prevalence and correlates of depressive symptoms among vulnerable patients receiving services at a free clinic in Tijuana, Mexico. A convenience sample of 584 adult Mexican patients completed an interviewer-administered questionnaire in English or Spanish that included the 8-item NIH PROMIS depression short form and measures of individual, social, and structural factors affecting health. The prevalence of clinically significant depressive symptoms in our sample was 55%. In the multivariate analysis, female gender, poor/fair self-rated health, recent illicit drug use (past six months), feeling rejected (past six months), history of forced sex, and history of violence were independently associated with increased odds of experiencing depressive symptoms. When stratified by gender, we found important differences in significant factors, including recent illicit drug use in men and deportation in women. Among study participants, prevalence of depressive symptoms exceeds prevalence rates reported elsewhere in the U.S.-Mexico border region. These findings suggest that public health efforts to support mental health services in the border region are needed.

Metabolomic Fingerprinting in Various Body Fluids of a Diet-Controlled Clinical Smoking Cessation Study Using a Validated GC-TOF-MS Metabolomics Platform.

PubMed

Goettel, Michael; Niessner, Reinhard; Mueller, Daniel; Scherer, Max; Scherer, Gerhard; Pluym, Nikola

2017-10-06

Untargeted GC-TOF-MS analysis proved to be a suitable analytical platform to determine alterations in the metabolic profile. Several metabolic pathways were found to be altered in a first clinical study comparing smokers against nonsmokers. Subsequently, we conducted a clinical diet-controlled study to investigate alterations in the metabolic profile during the course of 3 months of smoking cessation. Sixty male subjects were included in the study, and plasma, saliva, and urine samples were collected during four 24 h stationary visits: at baseline, while still smoking, after 1 week, after 1 month, and after 3 months of cessation. Additionally, subjects were monitored for their compliance by measurements of CO in exhaled breath and salivary cotinine throughout the study. GC-TOF-MS fingerprinting was applied to plasma, saliva, and urine samples derived from 39 compliant subjects. In total, 52 metabolites were found to be significantly altered including 26 in plasma, 20 in saliva, and 12 in urine, respectively. In agreement with a previous study comparing smokers and nonsmokers, the fatty acid and amino acid metabolism showed significant alterations upon 3 months of smoking cessation. Thus these results may indicate a partial recovery of metabolic pathway perturbations, even after a relatively short period of smoking cessation.

A Psychometric Review of the Personality Inventory for DSM-5 (PID-5): Current Status and Future Directions.

PubMed

Al-Dajani, Nadia; Gralnick, Tara M; Bagby, R Michael

2016-01-01

The paradigm of personality psychopathology is shifting from one that is purely categorical in nature to one grounded in dimensional individual differences. Section III (Emerging Measures and Models) of the Diagnostic and Statistical Manual of Mental Disorders (5th ed. [DSM-5]; American Psychiatric Association, 2013), for example, includes a hybrid categorical/dimensional model of personality disorder classification. To inform the hybrid model, the DSM-5 Personality and Personality Disorders Work Group developed a self-report instrument to assess pathological personality traits-the Personality Inventory for the DSM-5 (PID-5). Since its recent introduction, 30 papers (39 samples) have been published examining various aspects of its psychometric properties. In this article, we review the psychometric characteristics of the PID-5 using the Standards for Educational and Psychological Testing as our framework. The PID-5 demonstrates adequate psychometric properties, including a replicable factor structure, convergence with existing personality instruments, and expected associations with broadly conceptualized clinical constructs. More research is needed with specific consideration to clinical utility, additional forms of reliability and validity, relations with psychopathological personality traits using clinical samples, alternative methods of criterion validation, effective employment of cut scores, and the inclusion of validity scales to propel this movement forward.

qPCR detection of Mycobacterium leprae in biopsies and slit skin smear of different leprosy clinical forms.

PubMed

Azevedo, Michelle de Campos Soriani; Ramuno, Natália Mortari; Fachin, Luciana Raquel Vincenzi; Tassa, Mônica; Rosa, Patrícia Sammarco; Belone, Andrea de Faria Fernandes; Diório, Suzana Madeira; Soares, Cleverson Teixeira; Garlet, Gustavo Pompermaier; Trombone, Ana Paula Favaro

Leprosy, whose etiological agent is Mycobacterium leprae, is a chronic infectious disease that mainly affects the skin and peripheral nervous system. The diagnosis of leprosy is based on clinical evaluation, whereas histopathological analysis and bacilloscopy are complementary diagnostic tools. Quantitative PCR (qPCR), a current useful tool for diagnosis of infectious diseases, has been used to detect several pathogens including Mycobacterium leprae. The validation of this technique in a robust set of samples comprising the different clinical forms of leprosy is still necessary. Thus, in this study samples from 126 skin biopsies (collected from patients on all clinical forms and reactional states of leprosy) and 25 slit skin smear of leprosy patients were comparatively analyzed by qPCR (performed with primers for the RLEP region of M. leprae DNA) and routine bacilloscopy performed in histological sections or in slit skin smear. Considering clinical diagnostic as the gold standard, 84.9% of the leprosy patients were qPCR positive in skin biopsies, resulting in 84.92% sensitivity, with 84.92 and 61.22% positive (PPV) and negative (NPV) predictive values, respectively. Concerning bacilloscopy of histological sections (BI/H), the sensitivity was 80.15% and the PPV and NPV were 80.15 and 44.44%, respectively. The concordance between qPCR and BI/H was 87.30%. Regarding the slit skin smear, 84% of the samples tested positive in the qPCR. Additionally, qPCR showed 100% specificity, since all samples from different mycobacteria, from healthy individuals, and from other granulomatous diseases presented negative results. In conclusion, the qPCR technique for detection of M. leprae using RLEP primers proved to be specific and sensitive, and qPCR can be used as a complementary test to diagnose leprosy irrespective of the clinical form of disease. Copyright © 2016 Sociedade Brasileira de Infectologia. Published by Elsevier Editora Ltda. All rights reserved.

Parent and Teacher Concordance of Child Outcomes for Youth with Autism Spectrum Disorder

PubMed Central

Suhrheinrich, Jessica; Rieth, Sarah R.; Stahmer, Aubyn C.

2017-01-01

Cross-informant ratings of are considered gold standard for child behavioral assessment. To date, little work has examined informant ratings of adaptive functioning for youth with autism spectrum disorder (ASD). In a large, diverse sample of youth with ASD, this study evaluated parent–teacher concordance of ratings of adaptive functioning and ASD-specific symptomatology across time. The impact of child clinical characteristics on concordance was also examined. Participants included 246 children, their caregivers and teachers. Parent–teacher concordance was variable but generally consistent across time. Concordance was significantly impacted by autism severity and child cognitive abilities. Findings inform the broader concordance literature and support the need to consider child clinical factors when assessing child functioning in samples of children with ASD. PMID:29164440

Detection of 12 respiratory viruses by duplex real time PCR assays in respiratory samples.

PubMed

Arvia, Rosaria; Corcioli, Fabiana; Ciccone, Nunziata; Della Malva, Nunzia; Azzi, Alberta

2015-12-01

Different viruses can be responsible for similar clinical manifestations of respiratory infections. Thus, the etiological diagnosis of respiratory viral diseases requires the detection of a large number of viruses. In this study, 6 duplex real-time PCR assays, using EvaGreen intercalating dye, were developed to detect 12 major viruses responsible for respiratory diseases: influenza A and B viruses, enteroviruses (including enterovirus spp, and rhinovirus spp), respiratory syncytial virus, human metapneumovirus, coronaviruses group I (of which CoV 229E and CoV NL63 are part) and II (including CoV OC43 and CoV HKU1), parainfluenza viruses type 1, 2, 3 and 4, human adenoviruses and human bocaviruses. The 2 target viruses of each duplex reaction were distinguishable by the melting temperatures of their amplicons. The 6 duplex real time PCR assays were applied for diagnostic purpose on 202 respiratory samples from 157 patients. One hundred fifty-seven samples were throat swabs and 45 were bronchoalveolar lavages. The results of the duplex PCR assays were confirmed by comparison with a commercial, validated, assay; in addition, the positive results were confirmed by sequencing. The analytical sensitivity of the duplex PCR assays varied from 10(3) copies/ml to 10(4) copies/ml. For parainfluenza virus 2 only it was 10(5) copies/ml. Seventy clinical samples (35%) from 55 patients (30 children and 25 adults) were positive for 1 or more viruses. In adult patients, influenza A virus was the most frequently detected respiratory virus followed by rhinoviruses. In contrast, respiratory syncytial virus was the most common virus in children, followed by enteroviruses, influenza A virus and coronavirus NL63. The small number of samples/patients does not allow us to draw any epidemiological conclusion. Altogether, the results of this study indicate that the 6 duplex PCR assays described in this study are sensitive, specific and cost-effective. Thus, this assay could be particularly useful to identify the main respiratory viruses directly from clinical samples, after nucleic acid extraction, and, also, to screen a large number of patients for epidemiological studies. Copyright © 2015 Elsevier Ltd. All rights reserved.

Amoebic liver abscess in northern Sri Lanka: first report of immunological and molecular confirmation of aetiology.

PubMed

Kannathasan, Selvam; Murugananthan, Arumugam; Kumanan, Thirunavukarasu; Iddawala, Devika; de Silva, Nilanthi Renuka; Rajeshkannan, Nadarajah; Haque, Rashidul

2017-01-07

Since 1985, amoebic liver abscess (ALA) has been a public health problem in northern Sri Lanka. Clinicians arrive at a diagnosis based on clinical and ultrasonographic findings, which cannot differentiate pyogenic liver abscess (PLA) from ALA. As the treatment and outcome of the ALA and PLA differs, determining the etiological agent is crucial. All clinically diagnosed ALA patients admitted to the Teaching Hospital (TH) in Jaffna during the study period were included and the clinical features, haematological parameters, and ultrasound scanning findings were obtained. Aspirated pus, blood, and faecal samples from patients were also collected. Pus and faeces were examined microscopically for amoebae. Pus was cultured in Robinson's medium for amoebae, and MacConkey and blood agar for bacterial growth. ELISA kits were used for immunodiagnosis of Entamoeba histolytica infection. DNA was extracted from selected pus samples and amplified using nested PCR and the purified product was sequenced. From July 2012 to July 2015, 346 of 367 clinically diagnosed ALA patients admitted to Jaffna Teaching Hospital were enrolled in this study. Almost all patients (98.6%) were males with a history of heavy alcohol consumption (100%). The main clinical features were fever (100%), right hypochodric pain (100%), tender hepatomegaly (90%) and intercostal tenderness (60%). Most patients had leukocytosis (86.7%), elevated ESR (85.8%) and elevated alkaline phosphatase (72.3%). Most of the abscesses were in the right lobe (85.3%) and solitary (76.3%) in nature. Among the 221 (63.87%) drained abscesses, 93.2% were chocolate brown in colour with the mean volume of 41.22 ± 1.16 ml. Only four pus samples (2%) were positive for amoeba by culture and the rest of the pus and faecal samples were negative microscopically and by culture. Furthermore, all pus samples were negative for bacterial growth. Antibody against E. histolytica (99.7%) and the E. histolytica antigen were detected in the pus samples (100%). Moreover, PCR and sequencing confirmed these results. To our knowledge, this is the first report from Sri Lanka that provides immunological and molecular confirmation that Entamoeba histolytica is a common cause of liver abscesses in the region.

Clarifying Evidence-Based Medicine in Educational and Therapeutic Experiences of Clinical Faculty Members: A Qualitative Study in Iran.

PubMed

Safari, Yahya

2015-03-26

Although evidence-based medicine has been a significant part of recent research efforts to reform the health care system, it requires an assessment of real life community and patient. The present study strives to clarify the concept of evidence-based medicine in educational and therapeutic experiences of clinical faculty members of Kermanshah University of Medical Sciences (2014). It was a qualitative study of phenomenology. The population consists of 12 clinical faculty members of Kermanshah University Medical Sciences. Sampling was carried out using a purposeful method. Sample volume was determined using adequacy of samples' law. Data gathering occurred through semi-structured interviews. Collaizzi pattern was employed for data interpretation concurrent with data gathering. interpreting the data, three main themes were extracted. They include: 1. Unawareness and disuse (unaware of the concept, disuse, referral to colleagues, experiment prescription) 2. Conscious or unconscious use (using journals and scientific websites, aware of the process). 3. Beliefs (belief or disbelief in necessity). It sounds essential to change the behavior of clinical faculty members from passive to active with respect to employing evidence-based medicine as well as to alter negative attitudes into positive ones. In so doing, systematic training program aiming at behavior changing is necessary. Also, providing dissent facilities and infrastructures and removing barriers to the use of EBM can be effective.

Detection of borreliae in archived sera from patients with clinically suspect Lyme disease.

PubMed

Lee, Sin Hang; Vigliotti, Jessica S; Vigliotti, Veronica S; Jones, William; Shearer, David M

2014-03-11

The diagnoses of Lyme disease based on clinical manifestations, serological findings and detection of infectious agents often contradict each other. We tested 52 blind-coded serum samples, including 20 pre-treatment and 12 post-treatment sera from clinically suspect Lyme disease patients, for the presence of residual Lyme disease infectious agents, using nested PCR amplification of a signature segment of the borrelial 16S ribosomal RNA gene for detection and direct DNA sequencing of the PCR amplicon for molecular validation. These archived sera were split from the samples drawn for the 2-tier serology tests performed by a CDC-approved laboratory, and are used as reference materials for evaluating new diagnostic reagents. Of the 12 post-treatment serum samples, we found DNA evidence of a novel borrelia of uncertain significance in one, which was also positive for the 2-tier serology test. The rest of the post-treatment sera and all 20 control sera were PCR-negative. Of the 20 pre-treatment sera from clinically suspect early Lyme disease patients, we found Borrelia miyamotoi in one which was 2-tier serology-negative, and a Borrelia burgdorferi in two-one negative and one positive for 2-tier serology. We conclude that a sensitive and reliable DNA-based test is needed to support the diagnosis of Lyme disease and Lyme disease-like borreliosis.

C-SPECT - a Clinical Cardiac SPECT/Tct Platform: Design Concepts and Performance Potential

PubMed Central

Chang, Wei; Ordonez, Caesar E.; Liang, Haoning; Li, Yusheng; Liu, Jingai

2013-01-01

Because of scarcity of photons emitted from the heart, clinical cardiac SPECT imaging is mainly limited by photon statistics. The sub-optimal detection efficiency of current SPECT systems not only limits the quality of clinical cardiac SPECT imaging but also makes more advanced potential applications difficult to be realized. We propose a high-performance system platform - C-SPECT, which has its sampling geometry optimized for detection of emitted photons in quality and quantity. The C-SPECT has a stationary C-shaped gantry that surrounds the left-front side of a patient’s thorax. The stationary C-shaped collimator and detector systems in the gantry provide effective and efficient detection and sampling of photon emission. For cardiac imaging, the C-SPECT platform could achieve 2 to 4 times the system geometric efficiency of conventional SPECT systems at the same sampling resolution. This platform also includes an integrated transmission CT for attenuation correction. The ability of C-SPECT systems to perform sequential high-quality emission and transmission imaging could bring cost-effective high-performance to clinical imaging. In addition, a C-SPECT system could provide high detection efficiency to accommodate fast acquisition rate for gated and dynamic cardiac imaging. This paper describes the design concepts and performance potential of C-SPECT, and illustrates how these concepts can be implemented in a basic system. PMID:23885129

Rapidly-administered short forms of the Wechsler Adult Intelligence Scale-3rd edition.

PubMed

Donnell, Alison J; Pliskin, Neil; Holdnack, James; Axelrod, Bradley; Randolph, Christopher

2007-11-01

Although the Wechsler Full Scale IQ (FSIQ) is a common component of most neuropsychological evaluations, there are many clinical situations where the complete administration of this battery is precluded by various constraints, including limitations of time and patient compliance. These constraints are particularly true for dementia evaluations involving elderly patients. The present study reports data on two short forms particularly suited to dementia evaluations, each requiring less than 20min of administration time. One of the short forms was previously validated in dementia for the WAIS-R [Randolph, C., Mohr, E., & Chase, T. N. (1993). Assessment of intellectual function in dementing disorders: Validity of WAIS-R short forms for patients with Alzheimer's, Huntington's, and Parkinson's disease. Journal of Clinical and Experimental Neuropsychology, 15, 743-753]; the second was developed specifically for patients with motor disabilities. These short forms were validated using the WAIS-III normative standardization sample (N=2450), neurologic sample (N=63), and matched controls (N=49), and a separate mixed clinical sample (N=70). The results suggest that each short form provides an accurate and reliable estimate of WAIS-III FSIQ, validating their use in appropriate clinical contexts. The present data support the use of these short forms for dementia evaluations, and suggests that they may be applicable for the evaluation of other neurological and neuropsychiatric disorders that involve acquired neurocognitive impairment.

Intramammary expression and therapeutic effect of a human lysozyme-expressing vector for treating bovine mastitis*

PubMed Central

Sun, Huai-Chang; Xue, Fang-Ming; Qian, Ke; Fang, Hao-Xia; Qiu, Hua-Lei; Zhang, Xin-Yu; Yin, Zhao-Hua

2006-01-01

To develop a gene therapy strategy for treating bovine mastitis, a new mammary-specific vector containing human lysozyme (hLYZ) cDNA and kanamycin resistance gene was constructed for intramammary expression and clinical studies. After one time acupuncture or intracisternal infusion of healthy cows with 400 μg of the p215C3LYZ vector, over 2.0 μg/ml of rhLYZ could be detected by enzymatic assay for about 3 weeks in the milk samples. Western blotting showed that rhLYZ secreted into milk samples from the vector-injected cows had molecular weight similar to that of the natural hLYZ in human colostrums. Twenty days after the primary injection, the quarters were re-injected with the same vector by quarter acupuncture and even higher concentrations of rhLYZ could be detected. Indirect competitive ELISA of milk samples showed that the vector injection did not induce detectable humoral immune response against hLYZ. Clinical studies showed that twice acupuncture of quarters with the p215C3LYZ vector had overt therapeutic effect on clinical and subclinical mastitis previously treated with antibiotics, including disappearance of clinical symptoms and relatively high microbiological cure rates. These data provide a solid rationale for using the vector to develop gene therapy for treating bovine mastitis. PMID:16532537

Improving the quality of biomarker discovery research: the right samples and enough of them.

PubMed

Pepe, Margaret S; Li, Christopher I; Feng, Ziding

2015-06-01

Biomarker discovery research has yielded few biomarkers that validate for clinical use. A contributing factor may be poor study designs. The goal in discovery research is to identify a subset of potentially useful markers from a large set of candidates assayed on case and control samples. We recommend the PRoBE design for selecting samples. We propose sample size calculations that require specifying: (i) a definition for biomarker performance; (ii) the proportion of useful markers the study should identify (Discovery Power); and (iii) the tolerable number of useless markers amongst those identified (False Leads Expected, FLE). We apply the methodology to a study of 9,000 candidate biomarkers for risk of colon cancer recurrence where a useful biomarker has positive predictive value ≥ 30%. We find that 40 patients with recurrence and 160 without recurrence suffice to filter out 98% of useless markers (2% FLE) while identifying 95% of useful biomarkers (95% Discovery Power). Alternative methods for sample size calculation required more assumptions. Biomarker discovery research should utilize quality biospecimen repositories and include sample sizes that enable markers meeting prespecified performance characteristics for well-defined clinical applications to be identified. The scientific rigor of discovery research should be improved. ©2015 American Association for Cancer Research.

Symptom assessment in early psychosis: the use of well-established rating scales in clinical high-risk and recent-onset populations.

PubMed

Fulford, Daniel; Pearson, Rahel; Stuart, Barbara K; Fisher, Melissa; Mathalon, Daniel H; Vinogradov, Sophia; Loewy, Rachel L

2014-12-30

Symptom assessment in early psychosis research typically relies on scales validated in chronic schizophrenia samples. Our goal was to inform investigators who are selecting symptom scales for early psychosis research. We described measure characteristics, baseline scores, and scale inter-relationships in clinical-high-risk (CHR) and recent-onset psychotic disorder (RO) samples using the Positive and Negative Syndrome Scale, Brief Psychiatric Rating Scale, Scale for the Assessment of Positive Symptoms, and Scale for the Assessment of Negative Symptoms; for the CHR group only, we included the Scale of Prodromal Symptoms. For investigators selecting symptom measures in intervention or longitudinal studies, we also examined the relationship of symptom scales with psychosocial functioning. In both samples, symptom subscales in the same domain, across measures, were moderately to highly intercorrelated. Within all measures, positive symptoms were not correlated with negative symptoms, but disorganized symptoms overlapped with both positive and negative symptoms. Functioning was significantly related to negative and disorganized, but not positive, symptoms in both samples on most measures. Findings suggest strong overlap in symptom severity ratings among the most common scales. In recent-onset samples, each has strengths and weaknesses. In CHR samples, they appear to add little information above and beyond the SOPS. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Dimensional structure of DSM-5 posttraumatic stress symptoms in Spanish trauma victims.

PubMed

Soberón, Carmen; Crespo, María; Del Mar Gómez-Gutiérrez, María; Fernández-Lansac, Violeta; Armour, Cherie

2016-01-01

Confirmatory factor analytic studies have shown that posttraumatic stress disorder (PTSD) symptoms included in the fifth edition of the Diagnostic and Statistical Manual Disorders (DSM-5) may be better explained by two 6-factor models (the Externalizing Behaviours model and the Anhedonia model) and a 7-factor Hybrid model. The latter model comprises the symptom clusters of intrusion, avoidance, negative affect, anhedonia, externalizing behaviours, and anxious and dysphoric arousal. This model has received empirical support mainly in American samples. Of note, there have been a limited number of studies conducted on samples from other countries. This study aimed to examine the underlying dimensionality of DSM-5 PTSD symptoms in a Spanish clinical sample exposed to a range of traumatic events. Participants included 165 adults (78.8% females) seeking treatment in trauma services in the Madrid area (Spain). PTSD was assessed using the Global Assessment of Posttraumatic Stress Scale 5, a Spanish self-report instrument assessing posttraumatic symptoms according to the DSM-5 criteria. Confirmatory factor analyses were conducted in Mplus. Both the 7-factor Hybrid model and the 6-factor Anhedonia model demonstrated good and equivalent fit to the data. The findings of this study replicate and extend previous research by providing support for both the 7-factor Hybrid model and the 6-factor Anhedonia model in a clinical sample of Spanish trauma survivors. Given equivalent fit for these two models and the fewer number of latent factors in the Anhedonia model, it was selected as optimal in a traumatized Spanish sample. Implications and future research directions are discussed.

Breath Analysis in Disease Diagnosis: Methodological Considerations and Applications

PubMed Central

Lourenço, Célia; Turner, Claire

2014-01-01

Breath analysis is a promising field with great potential for non-invasive diagnosis of a number of disease states. Analysis of the concentrations of volatile organic compounds (VOCs) in breath with an acceptable accuracy are assessed by means of using analytical techniques with high sensitivity, accuracy, precision, low response time, and low detection limit, which are desirable characteristics for the detection of VOCs in human breath. “Breath fingerprinting”, indicative of a specific clinical status, relies on the use of multivariate statistics methods with powerful in-built algorithms. The need for standardisation of sample collection and analysis is the main issue concerning breath analysis, blocking the introduction of breath tests into clinical practice. This review describes recent scientific developments in basic research and clinical applications, namely issues concerning sampling and biochemistry, highlighting the diagnostic potential of breath analysis for disease diagnosis. Several considerations that need to be taken into account in breath analysis are documented here, including the growing need for metabolomics to deal with breath profiles. PMID:24957037

Breath analysis in disease diagnosis: methodological considerations and applications.

PubMed

Lourenço, Célia; Turner, Claire

2014-06-20

Breath analysis is a promising field with great potential for non-invasive diagnosis of a number of disease states. Analysis of the concentrations of volatile organic compounds (VOCs) in breath with an acceptable accuracy are assessed by means of using analytical techniques with high sensitivity, accuracy, precision, low response time, and low detection limit, which are desirable characteristics for the detection of VOCs in human breath. "Breath fingerprinting", indicative of a specific clinical status, relies on the use of multivariate statistics methods with powerful in-built algorithms. The need for standardisation of sample collection and analysis is the main issue concerning breath analysis, blocking the introduction of breath tests into clinical practice. This review describes recent scientific developments in basic research and clinical applications, namely issues concerning sampling and biochemistry, highlighting the diagnostic potential of breath analysis for disease diagnosis. Several considerations that need to be taken into account in breath analysis are documented here, including the growing need for metabolomics to deal with breath profiles.

Direct detection and characterization of foot-and-mouth disease virus in East Africa using a field-ready real-time PCR platform.

PubMed

Howson, E L A; Armson, B; Lyons, N A; Chepkwony, E; Kasanga, C J; Kandusi, S; Ndusilo, N; Yamazaki, W; Gizaw, D; Cleaveland, S; Lembo, T; Rauh, R; Nelson, W M; Wood, B A; Mioulet, V; King, D P; Fowler, V L

2018-02-01

Effective control and monitoring of foot-and-mouth disease (FMD) relies upon rapid and accurate disease confirmation. Currently, clinical samples are usually tested in reference laboratories using standardized assays recommended by The World Organisation for Animal Health (OIE). However, the requirements for prompt and serotype-specific diagnosis during FMD outbreaks, and the need to establish robust laboratory testing capacity in FMD-endemic countries have motivated the development of simple diagnostic platforms to support local decision-making. Using a portable thermocycler, the T-COR™ 8, this study describes the laboratory and field evaluation of a commercially available, lyophilized pan-serotype-specific real-time RT-PCR (rRT-PCR) assay and a newly available FMD virus (FMDV) typing assay (East Africa-specific for serotypes: O, A, Southern African Territories [SAT] 1 and 2). Analytical sensitivity, diagnostic sensitivity and specificity of the pan-serotype-specific lyophilized assay were comparable to that of an OIE-recommended laboratory-based rRT-PCR (determined using a panel of 57 FMDV-positive samples and six non-FMDV vesicular disease samples for differential diagnosis). The FMDV-typing assay was able to correctly identify the serotype of 33/36 FMDV-positive samples (no cross-reactivity between serotypes was evident). Furthermore, the assays were able to accurately detect and type FMDV RNA in multiple sample types, including epithelial tissue suspensions, serum, oesophageal-pharyngeal (OP) fluid and oral swabs, both with and without the use of nucleic acid extraction. When deployed in laboratory and field settings in Tanzania, Kenya and Ethiopia, both assays reliably detected and serotyped FMDV RNA in samples (n = 144) collected from pre-clinical, clinical and clinically recovered cattle. These data support the use of field-ready rRT-PCR platforms in endemic settings for simple, highly sensitive and rapid detection and/or characterization of FMDV. © 2017 The Authors. Transboundary and Emerging Diseases Published by Blackwell Verlag GmbH.